Remsima: detailed information

Package leaflet: Information for the user

Remsima 100 mg powder for concentrate for solution for infusion

infliximab
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will also give you a patient reminder card containing important safety information that you must be aware of before and during treatment with Remsima.
When starting a new card, keep this card as a reference for 4 months after the last dose of Remsima.
If you have any doubts, consult your doctor.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

What Remsima is and what it is used for
What you need to know before using Remsima
How to use Remsima
Possible side effects
How to store Remsima
Contents of the pack and other information

1. What Remsima is and what it is used for

Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody – a type of
protein that binds to a specific target in the body called tumour necrosis factor (TNF) alpha.
Remsima belongs to a group of medicines known as tumour necrosis factor (TNF) blockers. It is used in adults to treat the following inflammatory diseases:

Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis (Bechterew's disease)
Psoriasis

Remsima is also used in adults and children aged 6 years and older for:

Crohn's disease
Ulcerative colitis

Remsima works by selectively binding to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes in the body; therefore, by blocking it, inflammation in the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you suffer from rheumatoid arthritis, you will initially be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima in combination with another medicine called methotrexate to:

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you suffer from psoriatic arthritis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

Ankylosing spondylitis (Bechterew's disease)
Ankylosing spondylitis is an inflammatory disease of the spine. If you suffer from ankylosing spondylitis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

reduce the signs and symptoms of the disease,
improve physical function.

Psoriasis
Psoriasis is an inflammatory disease of the skin. If you suffer from moderate to severe plaque psoriasis, you will first be treated with other medicines or other treatments, such as phototherapy. If these medicines or treatments do not work adequately, you will be treated with Remsima to reduce the signs and symptoms of the disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you suffer from ulcerative colitis, you will first be treated with other medicines. If these medicines do not work adequately, you will be given Remsima to treat the disease.

Crohn's disease
Crohn's disease is an inflammatory disease of the intestine. If you suffer from Crohn's disease, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

treat active Crohn's disease,
reduce the number of abnormal openings (fistulas) between the intestine and the skin, when other medicines or surgery have been inadequate.

2. What you should know before using Remsima

Do not be given Remsima if

you are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6),
you are allergic (hypersensitive) to mouse proteins,
you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (a severe bacterial infection of the blood),
you have moderate or severe heart failure.

Do not use Remsima if any of the above conditions apply to you. If you are unsure, speak with your doctor before being given Remsima.

Warnings and precautions

Talk to your doctor before or during treatment with Remsima if you:

Have previously received a medicine containing infliximab

Inform your doctor if you have previously been treated with medicines containing infliximab and if you are restarting treatment with Remsima.
If you have stopped treatment with infliximab for more than 16 weeks, there is an increased risk of allergic reactions when restarting treatment with Remsima.

Infections

Inform your doctor before being given Remsima if you have an infection, even if it is very mild.
Inform your doctor before being given Remsima if you have ever lived in or travelled to areas where fungal infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of the body.
You may be more susceptible to infections while being treated with Remsima. If you are 65 years of age or older, your risk is higher.
These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms present in the environment, and sepsis, which can be life-threatening. Inform your doctor immediately if you develop symptoms of infection during treatment with Remsima. Symptoms include fever, cough, flu-like symptoms, feeling unwell, redness of the skin, very warm skin, wounds, or dental problems. Your doctor may recommend temporarily stopping Remsima.

Tuberculosis (TB)

It is very important that you inform your doctor if you have ever had tuberculosis or if you have been in close contact with people who have had or currently have tuberculosis.
Your doctor will perform tests to assess whether you have tuberculosis. Cases of tuberculosis have been reported in patients treated with infliximab, even in patients who had been treated with TB medications. Your doctor will record these tests on your Patient Alert Card.
If your doctor believes you are at risk of tuberculosis, you may be treated with TB medications before being given Remsima. Inform your doctor immediately if you notice signs of tuberculosis during treatment with Remsima. Signs include persistent cough, weight loss, feeling tired, fever, and night sweats.

Hepatitis B virus

Inform your doctor before being given Remsima if you are a carrier of hepatitis B or if you have previously had hepatitis B.
Inform your doctor if you think you may be at risk of contracting hepatitis B.
Your doctor must assess whether you have the hepatitis B virus.
Treatment with TNF blockers such as Remsima can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can lead to death.
If reactivation of hepatitis B occurs, your doctor may need to stop treatment and may give you medicines such as effective antiviral therapy with supportive treatment.

Heart problems

Inform your doctor if you have any heart problems, such as mild heart failure.
Your doctor will closely monitor your heart.

Inform your doctor immediately if you notice new signs of heart failure or worsening of existing symptoms during treatment with Remsima. Signs include shortness of breath or swelling of the feet.

Tumours and lymphoma

Inform your doctor before being given Remsima if you have or have had lymphoma (a type of blood cancer) or other types of cancer.
Patients with severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma.
Children and adults taking Remsima may have an increased risk of developing lymphoma or other types of cancer.
Some patients treated with TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescents or young males, and most had Crohn’s disease or ulcerative colitis. This type of cancer is usually fatal. Almost all patients had also been treated with medicines containing azathioprine or mercaptopurine in addition to TNF blockers.
Some patients treated with infliximab have developed certain types of skin cancer. If you notice changes in your skin or skin growths during or after treatment, inform your doctor.
Some women receiving treatment for rheumatoid arthritis with infliximab have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women taking Remsima, including women over 60 years of age.

Lung disease or heavy smokers

Inform your doctor before being given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Patients with COPD who are heavy smokers may have an increased risk of cancer when treated with Remsima.

Nervous system disorders

Inform your doctor if you have or have had a problem with your nervous system before being given Remsima. This includes multiple sclerosis, Guillain-Barré syndrome, seizures, or a diagnosis of "optic neuritis". Inform your doctor immediately if you notice symptoms of a nervous system disorder during treatment with Remsima. Signs include changes in vision, weakness in arms or legs, numbness or tingling anywhere in the body.

Abnormal skin openings

Inform your doctor if you have any abnormal openings in the skin (fistulas) before being given Remsima.

Vaccinations

Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.
You should receive recommended vaccinations before starting treatment with Remsima. You may receive some vaccines during treatment with Remsima, but you must not receive live vaccines (vaccines containing a live, but weakened, infectious agent) while being treated with Remsima, as they may cause infections.
If you received Remsima during pregnancy, your baby may have an increased risk of infection following administration of a live vaccine during the first year of life. It is important that you inform the paediatrician and other healthcare providers about your use of Remsima so they can determine when your baby should receive any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).
If you are breastfeeding, it is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is given to your baby. For further information, see the section on pregnancy and breastfeeding.

Infectious therapeutic agents

Talk to your doctor if you have recently received or plan to receive treatment with an infectious therapeutic agent (such as BCG instillation used for cancer treatment).

Surgery or dental procedures

Inform your doctor if you are scheduled for any surgical or dental procedures.
Inform your surgeon or dentist that you are being treated with Remsima, and show them your Patient Reminder Card.

Liver problems

Some patients treated with infliximab have developed serious liver problems. Inform your doctor immediately if you experience symptoms of liver problems during treatment with Remsima. Signs include yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, skin rashes, or fever.

Reduction in blood cell counts

In some patients treated with infliximab, the body may not be able to produce enough blood cells that help fight infections or stop bleeding. Inform your doctor immediately if you experience symptoms of reduced blood cell counts during treatment with Remsima. Signs include persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin, or a pale appearance.

Immune system disorders

Some patients treated with infliximab have developed symptoms of an immune system disorder called lupus. Inform your doctor immediately if you develop symptoms of lupus during treatment with Remsima. Signs include joint pain or a rash on the cheeks or arms that is sensitive to sunlight.

Children and adolescents

The information above also applies to children and adolescents. In addition:

Some child and adolescent patients who have taken TNF blockers such as infliximab have developed tumours, including unusual types, which have sometimes been fatal.
Compared to adults, more children taking infliximab have developed infections.
Children should receive recommended vaccinations before starting treatment with Remsima. Children may receive some vaccines during treatment with Remsima, but they must not receive live vaccines while being treated with Remsima.

Remsima should only be used in children for Crohn’s disease or ulcerative colitis. These children must be aged 6 years or older.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor before being given Remsima.

Other medicines and Remsima

Patients with inflammatory diseases are often already taking medicines to treat their condition. These medicines may cause side effects. Your doctor will advise you which other medicines you should continue taking while on Remsima treatment.

Inform your doctor if you are taking, have recently taken, or might take any other medicine, including any other medicine used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or medicines obtained without a prescription, such as vitamins and herbal remedies.

In particular, inform your doctor if you are taking any of the following medicines:

Medicines that affect the immune system.
Kineret (which contains anakinra). Remsima and Kineret must not be given together.
Orencia (which contains abatacept). Remsima and Orencia must not be given together.

Live vaccines must not be given during treatment with Remsima. If you used Remsima during pregnancy or are receiving Remsima while breastfeeding, inform the paediatrician and other healthcare providers caring for your baby about your use of Remsima before any vaccine is given to the baby.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before being given Remsima.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Remsima should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
You must avoid becoming pregnant while being treated with Remsima and for at least 6 months after stopping treatment. Talk to your doctor about using an appropriate contraceptive method during this time.
If you received Remsima during pregnancy, your baby may have an increased risk of infection.
It is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is given to your baby. If you received Remsima during pregnancy, administration of the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may lead to infection with serious complications, including death. Live vaccines such as the BCG vaccine must not be given to the baby within 12 months after birth unless otherwise recommended by the paediatrician (for more information, see the section on vaccinations).
If you are breastfeeding, it is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is given to your baby. Live vaccines must not be given to the baby during breastfeeding unless otherwise recommended by the paediatrician.
Severe decreases in white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy. If your baby has persistent fever or infections, contact your baby’s doctor immediately.

Driving and using machines

Remsima is unlikely to affect your ability to drive or use machines. However, if you feel tired, dizzy, or unwell after treatment with Remsima, you must not drive or operate tools or machinery.

Remsima contains sodium

Remsima contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free". However, before administration, Remsima is mixed with a solution containing sodium. Inform your doctor if you are on a low-salt diet.

3. How to use Remsima

Rheumatoid arthritis
The usual dose is 3 mg per kg of body weight.
Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis, and
Crohn's disease
The usual dose is 5 mg per kg of body weight.

How Remsima is administered

Remsima will be administered to you by a doctor or a nurse.
The doctor or nurse will prepare the medicine for infusion.
The medicine will be given by intravenous infusion (in a vein), usually in the arm, over a period of 2 hours. After the third treatment, your doctor may decide to administer your dose of Remsima over a period of 1 hour.
You will be monitored during the administration of Remsima and for 1-2 hours afterwards.

How much Remsima is administered

Your doctor will determine the dose and the interval between doses of Remsima. This will depend on your disease, body weight, and response to treatment with Remsima.
The table below shows the administration schedule for this medicine after the first dose.

2nd dose	2 weeks after the 1st dose
3rd dose	6 weeks after the 1st dose
Additional doses	Every 6-8 weeks, depending on the disease

Use in children and adolescents
In children (6 years of age and older) treated for Crohn's disease or ulcerative colitis, the
recommended dose is the same as in adults.

If you are given more Remsima than you should
Since this medicine is administered to you by a doctor or nurse, it is unlikely that you will receive too much.
The adverse effects of an overdose of Remsima are not known.

If you forget or miss an infusion of Remsima
If you forget or miss an appointment for Remsima administration, schedule another appointment as soon as possible.

If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most of these side effects are mild to moderate in severity. However, some patients may experience serious side effects and require medical treatment. Side effects may also occur after treatment with Remsima has ended.
Immediately inform your doctor if you notice any of the following:

Signs of an allergic reaction, such as swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing, rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be severe and potentially life-threatening. An allergic reaction may occur within 2 hours of the injection or later. Additional signs of allergic-type side effects that may occur up to 12 days after the injection include muscle pain, fever, joint or jaw pain, sore throat or headache.
Signs of a heart problem, such as discomfort or pain in the chest, arm pain, stomach pain, shortness of breath, anxiety, feeling faint, dizziness, fainting, sweating, nausea, vomiting, palpitations or thumping in the chest, fast or slow heartbeat, and swelling of the feet.
Signs of an infection (including tuberculosis), such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, pus collection in the intestine or around the anus (abscess), dental problems or burning sensation when urinating.
Possible signs of cancer, including but not limited to swollen lymph nodes, weight loss, fever, unusual skin lumps, changes in moles or skin colour, or unusual vaginal bleeding.
Signs of a lung problem, such as cough, difficulty breathing or chest tightness.
Signs of neurological problems (including eye problems), such as signs of a stroke (sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; difficulty seeing with one or both eyes, difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, tingling/numbness in any part of the body, or weakness in arms or legs, changes in vision such as double vision or other eye problems.
Signs of a liver problem, (including hepatitis B infection, if you have previously had hepatitis B) such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, skin rash or fever.
Signs of an immune system disorder, such as joint pain or a rash on the cheeks or arms that is sensitive to sunlight (lupus), or cough, shortness of breath, fever or rash (sarcoidosis).
Signs of reduced blood cell counts, such as persistent fever, increased tendency to bleed or bruise easily, small red or purple spots caused by bleeding under the skin, or pale appearance.
Signs of serious skin problems, such as reddish spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding skin (exfoliation), mouth, throat, nose, genital or eye ulcers, or small pus-filled bumps that may spread over the body. These skin reactions may be accompanied by fever.

Immediately inform your doctor if you notice the onset of any of the symptoms described above.

The following side effects have been observed with Remsima:
Very common: may affect more than 1 in 10 people

Stomach pain, nausea
Viral infections such as herpes or flu
Upper respiratory tract infections such as sinusitis
Headache
Side effect related to the infusion
Pain.

Common: may affect up to 1 in 10 people

Changes in liver function, increased liver enzymes (detected in blood tests)
Infections of the lungs or chest, such as bronchitis or pneumonia
Breathing difficulties or pain during breathing, chest pain
Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Hives-type rash, itchy rash or dry skin
Balance problems or dizziness
Fever, increased sweating
Circulatory problems, such as low or high blood pressure
Bruising, hot flushes or nosebleeds, feeling hot, red or flushed skin (redness)
Feeling tired or weak
Bacterial infections such as systemic infection, abscess or skin infection (cellulitis)
Fungal skin infection
Blood problems such as anaemia or low white blood cell count
Swollen lymph nodes
Depression, sleep disturbances
Eye problems, including red eyes and infections
Fast heartbeat (tachycardia) or palpitations
Joint, muscle or back pain
Urinary tract infection
Psoriasis, skin problems such as eczema and hair loss
Injection site reactions such as pain, swelling, redness or itching
Chills, fluid accumulation under the skin causing swelling
Clouding or tingling sensation.

Uncommon: may affect up to 1 in 100 people

Poor blood supply, swelling of a vein
Collection of blood outside blood vessels (haematoma) or bruising
Skin problems such as blistering, warts, abnormal skin colouring or pigmentation, swollen lips, skin thickening, or red, scaly and cracked skin
Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Wounds that heal slowly
Swelling of the liver (hepatitis) or gallbladder (cholecystitis), liver damage
Distractibility, irritability, confusion, nervousness
Eye problems including blurred or reduced vision, swollen eyes or styes
New or worsened heart failure, slowing of heart rate
Fainting
Seizures, nervous system disorders
Intestinal perforation or intestinal blockage, stomach pain or cramps
Swelling of the pancreas (pancreatitis)
Fungal infections such as yeast infection or fungal nail infection
Lung problems (such as oedema)
Excess fluid around the lungs (pleural effusion), inflammation of the layers covering the lungs (pleuritis)
Narrowing of the airways in the lungs, causing breathing difficulties
Inflammation of the membrane lining the lungs, causing sharp chest pain that worsens with breathing (pleuritis)
Tuberculosis
Kidney infections
Low platelet count, excessive white blood cell count, bruising or black and blue spots
Vaginal infections
Blood test results showing “antibodies” against your own body.
Changes in cholesterol and fat levels in the blood.
Weight gain (in most patients, weight gain was minimal).

Rare: may affect up to 1 in 1,000 people

A type of blood cancer (lymphoma)
Poor oxygen supply to organs through the blood, circulatory problems such as narrowing of a blood vessel
Inflammation of the membrane covering the brain (meningitis)
Infections due to a weakened immune system
Hepatitis B infection, if you have previously had hepatitis B
Liver inflammation caused by an immune system problem (autoimmune hepatitis)
Liver problem causing yellowing of the skin or eyes (jaundice)
Swelling or growth of abnormal tissue
Severe allergic reaction that may cause loss of consciousness and may be life-threatening (anaphylactic shock)
Swelling of small blood vessels (vasculitis)
Immunological disorders that may affect the lungs, skin and lymph nodes (such as sarcoidosis)
Accumulation of immune system cells as a result of an inflammatory response (granulomatous lesions)
Lack of interest or emotions
Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Other skin problems such as erythema multiforme, blisters and peeling skin or boils (furunculosis)
Severe nervous system disorders, such as transverse myelitis, multiple sclerosis-like illness, optic neuritis and Guillain-Barré syndrome
Inflammation of the eye that may cause vision changes, including blindness
Fluid in the membrane surrounding the heart (pericardial effusion)
Severe lung problems (such as interstitial pneumonia)
Melanoma (a type of skin cancer)
Cervical cancer
Low number of blood cells, including a severe decrease in white blood cells
Small red or purple spots caused by bleeding under the skin
Abnormal levels of a blood protein called “complement factor” which is part of the immune system
Lichenoid reactions (itchy reddish/violet rash and/or white-greyish thread-like lines on mucous membranes).

Not known: frequency cannot be estimated from the available data

Tumour in children and adults
A rare blood cancer affecting mainly adolescent or young males (hepatosplenic T-cell lymphoma)
Liver failure
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin.
Worsening of a condition called dermatomyositis (presents as a rash accompanied by muscle weakness)
Heart attack
Stroke
Temporary loss of vision during or within 2 hours after infusion
Infection caused by a live vaccine due to a weakened immune system.
Problems following a medical procedure (including infectious and non-infectious complications).

Additional side effects in children and adolescents
Children who have taken infliximab for Crohn's disease have shown some differences in side effects compared to adults who have taken infliximab for Crohn's disease. Side effects occurring more frequently in children were: low overall red blood cell count (anaemia), blood in stools, overall low white blood cell count (leucopenia), redness or flushing (hot flushes), viral infections, low number of infection-fighting white blood cells (neutropenia), bone fracture, bacterial infection and allergic reactions of the respiratory tract.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Remsima

Remsima will generally be stored by healthcare personnel. If you need to store it yourself, the storage instructions are as follows:

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after “SCAD”/”EXP” and on the carton after “Scad.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
This medicine may also be stored in its original packaging outside the refrigerator at a temperature not exceeding 25 °C for a single period of up to six months, but not beyond the original expiry date. In this case, it must not be returned to the refrigerator. Write the new expiry date on the carton, including day/month/year. Dispose of this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.
When Remsima is prepared for infusion, it is recommended to use it as soon as possible (within 3 hours). However, if the solution is prepared under complete aseptic conditions, it may be stored in a refrigerator at a temperature between 2 °C - 8 °C for up to 60 days and for a further 24 hours at 25 °C after removal from the refrigerator.
Do not use this medicine if it has changed colour or if particles are present.

6. Package contents and other information

What Remsima contains

The active substance is infliximab. Each vial contains 100 mg of infliximab. After reconstitution, each mL contains 10 mg of infliximab.
The other ingredients are sucrose, polysorbate 80, monosodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dihydrate.

Description of the appearance of Remsima and package contents
Remsima is supplied in a glass vial containing a powder for concentrate for solution for infusion. The powder is white.
Remsima is available in packs of 1, 2, 3, 4 or 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan GmbH
Wegenerstraße 13,
89231 Neu Ulm,
Germany
Nuvisan France SARL
2400, Route des Colles,
06410, Biot,
France
Kymos, SL
Ronda De Can Fatjó,
7B. 08290 Cerdanyola del Vallès,
Barcelona,
Spain
Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim am Rhein
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1528 7418 Tel: + 36 1 231 0493

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft Celltrion Healthcare Belgium BVBA
Teл.: + 36 1 231 0493 Tél/Tel: + 32 1528 7418

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: + 36 1 231 0493 Tel: +36 1 231 0493

Danmark Malta
Orion Pharma A/S Mint Health Ltd.
Tlf.: + 45 86 14 00 00 Tel: + 356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: + 49 (0)30 346494150 Tel: +31 20 888 7300
[email protected]

Eesti Norge
Orion Pharma Eesti OÜ Orion Pharma AS
Tel: + 372 6 644 550 Tlf: + 47 40 00 42 10

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. Astro-Pharma GmbH
Τηλ: +30 210 8009111 - 120 Tel.: +43 1 97 99 860
[email protected]

España Polska
Kern Pharma, S.L. Celltrion Healthcare Hungary Kft.
Tel: + 34 93 700 25 25 Tel.: + 36 1 231 0493

France Portugal
Celltrion Healthcare France SAS Celltrion Portugal, Unipessoal Lda.
Tel: +33 (0)1 71 25 27 00 Tel: + 351 21 936 8542

Hrvatska România
OKTAL PHARMA d.o.o. Celltrion Healthcare Hungary Kft
Tel: + 385 1 6595 777 Tel: + 36 1 231 0493
[email protected]

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel: + 386 1 519 29 22
[email protected]

Ísland Slovenská republika
Vistor hf. Celltrion Healthcare Hungary Kft.
Sími: +354 535 7000 Tel: + 36 1 231 0493

Italia Suomi/Finland
Celltrion Healthcare Italy S.r.l. Orion Pharma
Via Luigi Galvani, 24 - 20124 Milano (MI) Puh/Tel: + 358 10 4261
Tel: +39 0247 927040

Κύπρος Sverige
C.A. Papaellinas Ltd Orion Pharma AB
Τηλ: + 357 22741741 Tel: + 46 8 623 64 40

Latvija
Celltrion Healthcare Hungary Kft.
Tel: + 36 1 231 0493

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Patients treated with Remsima must be given the patient reminder card.

Instructions for use and handling – storage conditions

Store at 2 °C - 8 °C.
Remsima may be stored at temperatures not exceeding 25 °C for a single period of up to
6 months, provided this does not extend beyond the original expiry date. The new expiry date must be
written on the carton. After removal from the refrigerator, Remsima must not be returned to refrigerated storage.

Instructions for use and handling – reconstitution, dilution and administration
To improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded.

Calculate the dose and number of Remsima vials required. Each Remsima vial contains 100 mg of infliximab. Calculate the total volume required of the reconstituted Remsima solution.
Under aseptic conditions, reconstitute each vial of Remsima with 10 mL of Water for Injections using a syringe fitted with a 21 gauge (0.8 mm) or smaller needle. Remove the aluminium cap and disinfect the top of the vial with a cotton swab moistened with 70% alcohol. Insert the needle through the centre of the rubber stopper and direct the stream of Water for Injections onto the glass wall of the vial. Gently rotate the vial to completely dissolve the lyophilised powder. Do not shake vigorously or for prolonged periods. DO NOT SHAKE. Foam may form during reconstitution. Allow the reconstituted solution to stand for 5 minutes. Check that the solution is colourless to yellow and opalescent; the solution may contain small translucent particles, as infliximab is a protein. Do not use the solution if opaque particles, discolouration or other foreign matter are observed.
Dilute the total volume of reconstituted Remsima solution to 250 mL using Sodium Chloride 9 mg/mL (0.9%) solution for infusion. Do not dilute the reconstituted Remsima solution with any other diluent. The dilution may be performed by removing from the glass vial or infusion bag containing 250 mL of Sodium Chloride 9 mg/mL (0.9%) solution for infusion, a volume equal to that of the reconstituted Remsima. Slowly add the total volume of reconstituted Remsima solution to the 250 mL infusion bag or vial. Mix gently. For volumes exceeding 250 mL, use a larger infusion bag (e.g. 500 mL, 1,000 mL) or multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL. If stored refrigerated after reconstitution and dilution, the infusion solution should be brought to room temperature at 25 °C for 3 hours prior to proceeding as described in point 4 (infusion). Storage for longer than 24 hours at 2 °C - 8 °C applies only to Remsima preparations in infusion bags.
Administer the infusion solution over an infusion time no shorter than that recommended (see section 3). Use only an infusion set with an in-line sterile, non-pyrogenic filter with low protein-binding capacity (pore diameter 1.2 micrometres or less). Since no preservative is included, administration of the intravenous infusion solution should begin as soon as possible and within 3 hours of reconstitution and dilution. If not used immediately, the storage times during use and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 °C - 8 °C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions. Unused solution must not be stored for later use.
Before administration, visually inspect Remsima for particulate matter or discoloration. If opaque particles, discoloration or foreign particles are observed, do not use.
Any unused medicinal product or waste material derived from this medicinal product should be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Remsima 120 mg solution for injection in pre-filled syringe

infliximab
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will also provide you with a patient reminder card containing important safety information that you must be aware of before and during treatment with Remsima.
When starting a new card, keep this card as a reference for 4 months after the last dose of Remsima.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Remsima is and what it is used for
What you need to know before using Remsima
How to use Remsima
Possible side effects
How to store Remsima
Contents of the pack and other information
Instructions for use

1. What Remsima is and what it is used for

Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody – a type of
protein that binds to a specific target in the body called tumour necrosis factor (TNF) alpha.
Remsima belongs to a group of medicines known as “tumour necrosis factor (TNF) blockers”. It is used in adults to treat the following inflammatory diseases:

Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis (Bechterew’s disease)
Psoriasis
Crohn’s disease
Ulcerative colitis

Remsima works by selectively binding to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes in the body, so by blocking it, inflammation in the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have rheumatoid arthritis, you will initially be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima in combination with another medicine called methotrexate to:

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have psoriatic arthritis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

Ankylosing spondylitis (Bechterew’s disease)
Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

reduce the signs and symptoms of the disease,
improve physical function.

Psoriasis
Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be treated with other medicines or other treatments, such as phototherapy. If these medicines or treatments do not work adequately, you will be treated with Remsima to reduce the signs and symptoms of the disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be treated with other medicines. If these medicines do not work adequately, you will be given Remsima to treat the disease.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remsima to:

treat active Crohn’s disease,
reduce the number of abnormal openings (fistulas) between the intestine and the skin, when other medicines or surgery have been inadequate.

2. What you should know before using Remsima

Do not use Remsima if

you are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6),
you are allergic (hypersensitive) to mouse proteins,
you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (a severe bacterial blood infection),
you have moderate or severe heart failure.

Do not use Remsima if any of the conditions listed above apply to you. If you are unsure, speak with your doctor before being administered Remsima.

Warnings and precautions

Talk to your doctor before or during treatment with Remsima if you:

Have previously received a medicine containing infliximab

Inform your doctor if you have previously been treated with medicines containing infliximab and if you are restarting treatment with Remsima.
If you have stopped treatment with infliximab for more than 16 weeks, there is an increased risk of allergic reactions when restarting treatment with Remsima.

Localised reactions at the injection site

Some patients who have received infliximab by subcutaneous injection have experienced localised reactions at the injection site. Signs of a localised reaction at the injection site may include redness, pain, itching, swelling, hardening, bruising, bleeding, cold sensation, tingling, irritation, rash, ulcer, hives, blisters, and scabbing at the skin of the injection site.
Most of these reactions are mild to moderate and resolve on their own within one day.

Infections

Inform your doctor before being administered Remsima if you have an infection, even if it is very mild.
Inform your doctor before being administered Remsima if you have ever lived in or travelled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of the body.
You may be more susceptible to infections while being treated with Remsima. If you are 65 years of age or older, your risk is higher.
These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms present in the environment, and sepsis, which can be life-threatening. Inform your doctor immediately if you develop symptoms of infection during treatment with Remsima. Symptoms include fever, cough, flu-like symptoms, feeling unwell, redness of the skin or very warm skin, wounds, or dental problems. Your doctor may recommend temporarily stopping Remsima administration.

Tuberculosis (TB)

It is very important that you inform your doctor if you have ever had tuberculosis or if you have been in close contact with people who have had or currently have tuberculosis.
Your doctor will perform tests to assess whether you have tuberculosis. Cases of tuberculosis have been reported in patients treated with infliximab, including in patients who had previously received treatment for TB. Your doctor will record these tests on the Patient Alert Card.
If your doctor believes you are at risk of tuberculosis, you may be treated with anti-TB medications before being administered Remsima. Inform your doctor immediately if you notice signs of tuberculosis during treatment with Remsima. Signs include persistent cough, weight loss, feeling tired, fever, and night sweats.

Hepatitis B virus

Inform your doctor before using Remsima if you are a carrier of hepatitis B or if you have previously had hepatitis B.
Inform your doctor if you think you may be at risk of contracting hepatitis B.
Your doctor must assess whether you have the hepatitis B virus.
Treatment with TNF blockers such as Remsima can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can lead to death.
If hepatitis B reactivation occurs, your doctor may need to stop treatment and may administer medications such as effective antiviral therapy with supportive care.

Heart problems

Inform your doctor if you have any heart problems, such as mild heart failure.
Your doctor will closely monitor your heart. Inform your doctor immediately if you notice new signs of heart failure or worsening symptoms during treatment with Remsima. Signs include shortness of breath or swelling of the feet.

Tumours and lymphoma

Inform your doctor before being administered Remsima if you have or have had lymphoma (a type of blood cancer) or other types of cancer.
Patients with severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma.
Patients taking Remsima may have an increased risk of developing lymphoma or other types of cancer.
Some patients treated with TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescents or young males, and most had Crohn’s disease or ulcerative colitis. This type of cancer is usually fatal. Almost all patients had also been treated with medications containing azathioprine or mercaptopurine in addition to TNF blockers.
Some patients treated with infliximab have developed certain types of skin cancer. If you notice changes in your skin or skin growths during or after therapy, inform your doctor.
Some women receiving treatment for rheumatoid arthritis with infliximab have developed cervical cancer. Your doctor may recommend periodic cervical cancer screening for women taking Remsima, including women over 60 years of age.

Lung disease or heavy smokers

Inform your doctor before being administered Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Patients with COPD who are heavy smokers may have an increased risk of cancer if treated with Remsima.

Nervous system disorders

Inform your doctor if you have or have had a nervous system disorder before being administered Remsima. This includes multiple sclerosis, Guillain-Barré syndrome, seizures, or diagnoses of "optic neuritis". Inform your doctor immediately if you notice symptoms of a nervous system disorder during treatment with Remsima. Signs include changes in vision, weakness in arms and legs, numbness, or tingling in any part of the body.

Abnormal skin openings

Inform your doctor if you have any abnormal skin openings (fistulas) before being administered Remsima.

Vaccinations

Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.
You should receive recommended vaccinations before starting treatment with Remsima. You may receive some vaccines during treatment with Remsima, but you must not receive live vaccines (vaccines containing a live but weakened infectious agent) while being treated with Remsima, as they may cause infections.
If you received Remsima during pregnancy, your baby may have an increased risk of infection following administration of a live vaccine during the first year of life. It is important that you inform the paediatrician and other healthcare providers about your use of Remsima so they can decide when your baby should receive any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).
If you are breastfeeding, it is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is administered to your baby. For further information, see the section on Pregnancy and breastfeeding.

Infectious therapeutic agents

Talk to your doctor if you have recently received or plan to receive treatment with an infectious therapeutic agent (such as BCG instillation used for cancer treatment).

Surgery or dental procedures

Inform your doctor if you are scheduled for any surgical or dental procedures.
Inform your surgeon or dentist that you are being treated with Remsima, and show them your patient reminder card.

Liver problems

Some patients treated with infliximab have developed serious liver problems.
Inform your doctor immediately if you experience symptoms of liver problems during treatment with Remsima. Signs include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, rashes, or fever.

Reduction in blood cell count

In some patients treated with infliximab, the body may not produce enough blood cells that help fight infections or help stop bleeding.
Inform your doctor immediately if you experience symptoms of reduced blood cell count during treatment with Remsima. Signs include persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin, or paleness.

Immune system disorder

Some patients treated with infliximab have developed symptoms of an immune system disorder called lupus.
Inform your doctor immediately if you develop symptoms of lupus during treatment with Remsima. Signs include joint pain or a rash on the cheeks or arms that is sensitive to sunlight.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as there is no data demonstrating that this medicine is safe and effective in this age group.

Other medicines and Remsima
Patients with inflammatory diseases are often already taking medicines to treat their condition. These medicines may cause side effects. Your doctor will advise you which other medicines you should continue taking while on Remsima therapy.
Inform your doctor if you are taking, have recently taken, or might take any other medicine, including other medicines for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or over-the-counter medicines such as vitamins and herbal remedies.
In particular, inform your doctor if you are taking any of the following medicines:

Medicines that affect the immune system.
Kineret (which contains anakinra). Remsima and Kineret must not be administered together.
Orencia (which contains abatacept). Remsima and Orencia must not be administered together.

Live vaccines must not be administered during treatment with Remsima. If you used Remsima during pregnancy or are receiving Remsima while breastfeeding, inform the paediatrician and other healthcare providers caring for your baby about your use of Remsima before any vaccine is administered to the baby.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor, pharmacist, or nurse before using Remsima.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Remsima should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
You must avoid pregnancy while being treated with Remsima and for at least 6 months after stopping treatment. Talk to your doctor about using an appropriate contraceptive method during this period.
If you received Remsima during pregnancy, your baby may have an increased risk of infection.
It is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is administered to your baby. If you received Remsima during pregnancy, administration of the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months of birth may lead to infection with serious complications, including death. Live vaccines such as the BCG vaccine must not be administered to the baby within 12 months of birth unless otherwise recommended by the paediatrician. For further information, see the section on Vaccinations.
If you are breastfeeding, it is important that you inform the paediatrician and other healthcare providers about your use of Remsima before any vaccine is administered to your baby. Live vaccines must not be administered to the baby during breastfeeding unless otherwise recommended by the paediatrician.
Severe reductions in white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy. If your baby has fever or persistent infections, contact your baby’s doctor immediately.

Driving and using machines
It is unlikely that Remsima will affect your ability to drive or use machines. However, if you feel tired, dizzy, or unwell after treatment with Remsima, you must not drive or operate tools or machinery.

Remsima contains sodium and sorbitol
Remsima contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free", and 45 mg of sorbitol in each 120 mg dose.

3. How to use Remsima

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Rheumatoid arthritis
Your doctor will start your treatment with or without two doses of infliximab at 3 mg per kg of body
weight given by intravenous infusion (administered into a vein, usually in the arm, over a period of 2
hours). If treatment is initiated with intravenous infusions of infliximab, these will be given two weeks
apart. Four weeks after the last intravenous infusion, you will be given Remsima by subcutaneous
injection (injection under the skin). If treatment is initiated with subcutaneous injections of Remsima,
Remsima 120 mg must be administered by subcutaneous injection, followed by further subcutaneous
injections 1, 2, 3 and 4 weeks after the first injection, and then every 2 weeks thereafter.
The usual recommended dose of subcutaneous Remsima is 120 mg once every 2 weeks, regardless of
body weight.
Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease) and psoriasis
Your doctor will start your treatment with two doses of infliximab at 5 mg per kg of body weight given
by intravenous infusion (administered into a vein, usually in the arm, over a period of 2 hours). These
will be given two weeks apart. Four weeks after the last intravenous infusion, you will be given
Remsima by subcutaneous injection (injection under the skin).
The usual recommended dose of subcutaneous Remsima is 120 mg once every 2 weeks, regardless of
body weight.
Crohn’s disease and ulcerative colitis
Your doctor will start your treatment with two or three doses of infliximab at 5 mg per kg of body
weight given by intravenous infusion (administered into a vein, usually in the arm, over a period of 2
hours). These will be given two weeks apart, and an additional intravenous infusion may be given 4
weeks after the second infusion. Four weeks after the last intravenous infusion, you will be given
Remsima by subcutaneous injection (injection under the skin).
The usual recommended dose of subcutaneous Remsima is 120 mg once every 2 weeks, regardless of
body weight.
How Remsima is administered

Remsima 120 mg solution for injection is administered only by subcutaneous injection (injection under the skin). It is important to check the product labels to ensure that the correct formulation is administered as prescribed.
For patients with rheumatoid arthritis, the doctor may start treatment with Remsima with or without intravenous infusions of infliximab. For patients with ankylosing spondylitis, psoriatic arthritis or psoriasis, two doses of infliximab will be administered by intravenous infusion to initiate treatment with Remsima. For patients with Crohn’s disease or ulcerative colitis, two or three doses of infliximab will be administered by intravenous infusion to initiate treatment with Remsima. For patients with rheumatoid arthritis, if treatment with Remsima is started without the two intravenous infusions of infliximab, the following table shows the usual schedule for receiving Remsima 120 mg by subcutaneous injection after the first dose.

2nd dose	1 week after the 1st dose
3rd dose	2 weeks after the 1st dose
4th dose	3 weeks after the 1st dose
5th dose	4 weeks after the 1st dose
Further doses	6 weeks after the 1st dose and then every 2 weeks

Your doctor or nurse will administer doses of infliximab by intravenous infusion
two weeks apart, and, at the doctor’s discretion, an additional intravenous infusion
may be given 4 weeks after the second infusion in patients with Crohn’s disease and ulcerative colitis to initiate treatment with Remsima. The first subcutaneous injection
of Remsima will be administered 4 weeks after the last intravenous infusion, followed by subcutaneous injections of Remsima given every 2 weeks.
The first subcutaneous injection of Remsima will be administered under the supervision of your doctor.
After adequate training, if you feel ready and confident to self-inject, your doctor may allow you to administer subsequent doses of Remsima yourself at home.
Consult your doctor if you have any questions about self-injecting. You will find detailed “Instructions for use” at the end of this leaflet.

If you use more Remsima than you should
If you have used more Remsima than you should have (injecting too much at one time or using it too frequently), contact a doctor, pharmacist, or nurse immediately.
Keep the outer packaging with you, even if empty.

If you forget to use Remsima
Missed dose within up to 7 days
If you miss a dose of Remsima by up to 7 days after the originally scheduled date, you should take the missed dose immediately. Take the next dose on the originally scheduled date and then continue with the original dosing schedule.

Missed dose by 8 days or more
If you miss a dose of Remsima by 8 days or more after the originally scheduled date, do not take the missed dose. Take the next dose on the originally scheduled date and then continue with the original dosing schedule.

If you are unsure when to inject Remsima, consult your doctor.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most of these side effects are mild to moderate in severity. However, some patients may experience serious side effects and require medical treatment. Side effects may also occur after treatment with Remsima has ended.
Contact your doctor immediately if you notice any of the following:

Signs of an allergic reaction, such as swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be severe and potentially life-threatening. An allergic reaction may occur within 2 hours of the injection or later. Additional signs of allergic-type side effects that may appear up to 12 days after injection include muscle pain, fever, joint or jaw pain, sore throat or headache.
Signs of a local reaction at the injection site, such as redness, pain, itching, swelling, hardening, bruising, bleeding, cold sensation, tingling, irritation, rash, ulcer, hives, blisters or scab.
Signs of a heart problem, such as discomfort or pain in the chest, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, palpitations or thumping in the chest, fast or slow heartbeat, and swelling of the feet.
Signs of an infection (including tuberculosis), such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, sores, pus collection in the intestine or around the anus (abscess), dental problems or burning sensation when urinating.
Possible signs of cancer, including but not limited to swollen lymph nodes, weight loss, fever, unusual skin lumps, changes in moles or skin colour, or unusual vaginal bleeding.
Signs of a lung problem, such as cough, difficulty breathing or chest tightness.
Signs of neurological problems (including eye problems), such as signs of a stroke (sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden trouble seeing with one or both eyes; difficulty walking, dizziness, loss of balance or coordination, or a severe headache), seizures, tingling/numbness in any part of the body or feeling of weakness in arms or legs, vision changes such as double vision or other eye problems.
Signs of a liver problem, (including hepatitis B infection, if you have had hepatitis B in the past), such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, rash or fever.
Signs of an immune system disorder, such as joint pain or a rash on the cheeks or arms that is sensitive to sunlight (lupus), or cough, shortness of breath, fever or rash (sarcoidosis).
Signs of a reduced number of blood cells, such as persistent fever, easy bleeding or bruising, small red or purple spots under the skin due to bleeding, or paleness.
Signs of serious skin problems, such as reddish spots or circular patches, often with central blisters on the trunk, large areas of peeling or shedding skin, mouth, throat, nose, genital or eye ulcers, or small pus-filled bumps that may spread over the body. These skin reactions may be accompanied by fever.

Contact your doctor immediately if you notice any of the symptoms described above.

The following side effects have been observed with Remsima:
Very common: may affect more than 1 in 10 people

Stomach pain, nausea
Viral infections such as herpes or flu
Upper respiratory tract infections such as sinusitis
Headache
Side effect due to injection
Pain

Common: may affect up to 1 in 10 people

Changes in liver function, increased liver enzymes (detected by blood tests)
Infections of the lungs or chest, such as bronchitis or pneumonia
Difficulty breathing or pain when breathing, chest pain
Bleeding in the stomach or intestine, diarrhoea, indigestion, heartburn, constipation
Hives-like rash, itchy rash or dry skin
Balance problems or dizziness
Fever, increased sweating
Circulatory problems, such as low or high blood pressure
Bruising, hot flushes or nosebleeds, feeling hot, red skin (redness)
Feeling tired or weak
Bacterial infections such as systemic infection, abscess or skin infection (cellulitis)
Skin infection due to a fungus
Blood problems such as anaemia or low white blood cell count
Swollen lymph nodes
Depression, sleep disturbances
Eye problems, including red eyes and infections
Fast heartbeat (tachycardia) or palpitations
Joint, muscle or back pain
Urinary tract infection
Psoriasis, skin problems such as eczema and hair loss
Injection site reactions such as pain, swelling, redness or itching
Chills, fluid accumulation under the skin causing swelling
Numbness or tingling sensation

Uncommon: may affect up to 1 in 100 people

Poor blood supply, swelling of a vein
Collection of blood outside blood vessels (haematoma) or bruising
Skin problems such as blistering, warts, abnormal skin colour or pigmentation, swollen lips, skin thickening, or red, scaly and cracked skin
Severe allergic reactions (e.g., anaphylaxis), immune system disorder called lupus, allergic reactions to foreign proteins
Wounds that heal slowly
Swelling of the liver (hepatitis) or gallbladder (cholecystitis), liver damage
Distraction, irritability, confusion, nervousness
Eye problems including blurred or reduced vision, swollen eyes or stye
New or worsened heart failure, slowing of the heart rate
Fainting
Seizures, nervous disorders
Intestinal perforation or intestinal blockage, stomach pain or cramps
Swelling of the pancreas (pancreatitis)
Fungal infections such as yeast infection or fungal nail infection
Lung problems (such as oedema)
Excess fluid around the lungs (pleural effusion), inflammation of the layers covering the lungs (pleuritis)
Narrowing of the airways in the lungs, causing breathing difficulties
Inflammation of the membrane lining the lungs, causing sharp chest pain that worsens with breathing (pleuritis)
Tuberculosis
Kidney infections
Low platelet count, excessive white blood cells, bruising or black and blue spots
Vaginal infections
Blood test results showing “antibodies” against your own body
Changes in cholesterol and fat levels in the blood
Weight gain (for most patients, weight gain was minimal)

Rare: may affect up to 1 in 1,000 people

A type of blood cancer (lymphoma)
Poor oxygen supply to organs via the blood, circulatory problems such as narrowing of a blood vessel
Inflammation of the membrane covering the brain (meningitis)
Infections due to a weakened immune system
Hepatitis B infection, if you have had hepatitis B in the past
Liver inflammation caused by an immune system problem (autoimmune hepatitis)
Liver problem causing yellowing of the skin or eyes (jaundice)
Swelling or growth of abnormal tissue
Severe allergic reaction that may cause loss of consciousness and may be life-threatening (anaphylactic shock)
Swelling of small blood vessels (vasculitis)
Immunological disorders that may affect the lungs, skin and lymph nodes (such as sarcoidosis)
Accumulation of immune system cells as a result of an inflammatory response (granulomatous lesions)
Lack of interest or emotion
Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Other skin problems such as erythema multiforme, blisters and peeling skin or boils (furunculosis)
Severe nervous system disorders such as transverse myelitis, multiple sclerosis-like illness, optic neuritis and Guillain-Barré syndrome
Inflammation of the eye that may cause vision changes, including blindness
Fluid in the membrane surrounding the heart (pericardial effusion)
Severe lung problems (such as interstitial pneumonia)
Melanoma (a type of skin cancer)
Cervical cancer
Low number of blood cells, including a severe decrease in white blood cells
Small red or purple spots caused by bleeding under the skin
Abnormal levels of a blood protein called “complement factor” which is part of the immune system
Lichenoid reactions (itchy reddish/purplish rash and/or whitish-grey thread-like lines on mucous membranes)

Not known: frequency cannot be estimated from the available data

Cancer
A rare blood cancer affecting mainly young males (hepatosplenic T-cell lymphoma)
Liver failure
Merkel cell carcinoma (a type of skin cancer)
Worsening of a condition called dermatomyositis (characterised by a rash accompanied by muscle weakness)
Heart attack
Stroke
Temporary loss of vision during or within 2 hours after infusion
Infection caused by a live vaccine due to a weakened immune system
Problems following a medical procedure (including infectious and non-infectious complications)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Remsima

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after “SCAD”/”EXP” and on the carton after “Scad.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
This medicine can also be stored in its original carton outside the refrigerator at a temperature not exceeding 25 °C for a single period of up to 28 days, but not beyond the original expiry date. In this case, it must not be returned to the refrigerator. Write the new expiry date on the carton, including day/month/year. Dispose of this medicine if not used before the new expiry date or the printed expiry date on the carton, whichever comes first.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Remsima contains

The active substance is infliximab. Each single-dose pre-filled syringe of 1 mL contains 120 mg of infliximab.
The other components are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, water for injections.

Description of the appearance of Remsima and contents of the pack
Remsima is a solution ranging from transparent to opalescent, from colourless to light brown, supplied in a single-use pre-filled syringe.
Each pack contains 1 pre-filled syringe with 2 alcohol swabs, 2 pre-filled syringes with 2 alcohol swabs, 4 pre-filled syringes with 4 alcohol swabs, or 6 pre-filled syringes with 6 alcohol swabs.
Each pack contains 1 pre-filled syringe with needle safety guard and 2 alcohol swabs, 2 pre-filled syringes with needle safety guard and 2 alcohol swabs, 4 pre-filled syringes with needle safety guard and 4 alcohol swabs, or 6 pre-filled syringes with needle safety guard and 6 alcohol swabs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium
Celltrion Healthcare Belgium BVBA
Tel: +32 1528 7418
[email protected]

Bulgaria
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Czech Republic
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Czech Republic

Denmark
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Denmark

Germany
Celltrion Healthcare Deutschland GmbH
Tel: +49 (0)30 346494150
[email protected]

Estonia
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Estonia

Greece
BIANEX S.A.
Tel: +30 210 8009111 - 120

Spain
Kern Pharma, S.L.
Tel: +34 93 700 25 25

France
Celltrion Healthcare France SAS
Tel: +33 (0)1 71 25 27 00

Croatia
OKTAL PHARMA d.o.o.
Tel: +385 1 6595 777
[email protected]

Ireland
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026

Iceland
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Iceland

Italy
Celltrion Healthcare Italy S.r.l.
Via Luigi Galvani, 24 - 20124 Milano (MI)
Tel: +39 0247 927040

Cyprus
C.A. Papaellinas Ltd
Tel: +357 22741741

Latvia
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Latvia

Lithuania
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Lithuania

Luxembourg
Celltrion Healthcare Belgium BVBA
Tel: +32 1528 7418
[email protected]

Hungary
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Malta
Mint Health Ltd.
Tel: +356 2093 9800
[email protected]

Netherlands
Celltrion Healthcare Netherlands B.V.
Tel: +31 20 888 7300
[email protected]

Norway
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Norway

Austria
Astro-Pharma GmbH
Tel: +43 1 97 99 860
[email protected]

Poland
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Poland

Portugal
Celltrion Portugal, Unipessoal Lda.
Tel: +351 21 936 8542

Romania
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Romania

Slovenia
OKTAL PHARMA d.o.o.
Tel: +386 1 519 29 22
[email protected]

Slovakia
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Slovakia

Finland
Celltrion Healthcare Finland Oy
Puh/Tel: +358 29 170 7755

Sweden
Celltrion Sweden AB
Tel: +46 8 80 11 77
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

7. Instructions for use

Read these instructions carefully before using the Remsima pre-filled syringe. Consult your
healthcare provider if you have any questions about how to use the Remsima pre-filled syringe.
Important information

Use the syringe ONLY if your healthcare provider has given you instructions on the correct way to prepare and administer an injection.
Ask your healthcare provider how often you should administer an injection.
Rotate the injection site each time you give an injection. Each new injection site should be at least 3 cm away from the previous injection site.
Do not use the syringe if it has been dropped or is visibly damaged. A damaged syringe may not work properly.
Do not reuse the syringe.
Do not shake the syringe.

Information about the Remsima pre-filled syringe
Parts of the syringe (see Figure A ):

Technical diagram of a medical device with labeled parts: plunger, support flange, body with medication, needle, and cap before and after use

Figure A

Do not remove the cap until you are ready. Once removed, do not replace the cap on the syringe.

Preparing for injection

1. Gather the injection materials.

a. Prepare a flat, clean surface, such as a table or countertop, in a well-lit area.
b. Remove the syringe from the refrigerated packaging by holding the barrel of the syringe in the center.
c. Make sure you have the following materials:

Syringe
Alcohol swab
Cotton ball or gauze*
Adhesive bandage*
Sharps container*
*Items not included in the package.

2. Inspect the syringe.

Do not use the syringe if:

It is broken or damaged.
The expiry date has passed.

3. Inspect the medicine (see Figure B).

The liquid should be clear and colourless to light brown.

Technical drawing of a syringe with a circular magnification showing a detailed view of the graduated scale on the transparent cylinder

Do not use the syringe if the liquid is cloudy,
discoloured, or contains particles.
Note: Air bubbles in the liquid may be visible. This is
normal.
Figure B

4. Wait for 30 minutes.

a. Leave the syringe at room temperature for 30 minutes to allow it to warm up naturally.
Do not heat the syringe using heat sources such as hot water or microwave.

5. Choose an injection site (see Figure C).

a. Select an injection site. You may inject

Human body diagram showing gray areas on arms, abdomen, and thighs for self-injection or caregiver administration, and dark areas on arms only for caregiver use

in:

The front of the thigh.
The abdomen, except for the area within 5 cm of the navel.
The outer upper part of the arm (ONLY caregiver). Do not inject into skin that is tender, damaged, bruised, or scratched, or within 5 cm of the navel. Note: Rotate the injection site each time an injection is given. Each new injection site should be at least 3 cm away from the previous one.

Figure C

6. Wash hands.

a. Wash hands with soap and water and dry them thoroughly.

7. Clean the injection site.

a. Clean the injection site with an alcohol swab.
b. Let the skin dry before injecting.
Do not blow on or touch the injection site again before injecting.
Administer the injection

8. Remove the cap (see Figure D).

a. Pull the cap off perpendicularly and

Two hands separating or joining a protective needle cap from a syringe, with black arrows indicating lateral movement

set it aside.
Do not touch the needle. Doing so could cause a needlestick injury.
Note: It is normal to see a few drops of liquid coming out
from the needle after removing the cap.
Figure D

9. Insert the syringe into the injection site (see Figure E).

a. Hold the syringe body in one hand between the

A hand holding a syringe inserted into the body at a 45-degree angle relative to the skin surface

thumb and index finger.
b. Using the other hand, gently pinch a fold of cleaned skin.
c. With a quick, dart-like motion, insert the needle fully into the skin fold at a 45-degree angle.
Figure E

10. Administer the injection (see Figure F).

a. After inserting the needle, keep the skin
A hand holding a syringe inserted at an angled motion into the upper back of a person, indicated by a black arrow
pinched.
b. Slowly push the plunger all the way down until the syringe is empty.
Figure F

11. Remove the needle from the injection site (see Figure G).

a. Remove the needle from the skin at the same angle
A hand holding a syringe directed toward the upper thigh, with a black arrow indicating the insertion movement
at which it was inserted.
b. Gently press a cotton ball or gauze pad against
the injection site and hold for 10
seconds.
c. Apply a bandage if necessary.
Do not rub the injection site.
Figure G
After the injection

12. Dispose of the syringe (see Figure H).

a. Place the used syringe into an approved sharps container immediately after use.
b. If an approved sharps container is not available, a household container may be used that is:

made of heavy-duty plastic;
able to close with a tight-fitting, puncture-resistant lid that does not come off and prevents the contents from leaking or spilling;
upright and stable during use;
leak-proof;
properly labeled to warn of hazardous waste inside.
c. When the sharps container is nearly full, it must be disposed of according to local requirements. Do not recap the syringe.
Figure H
Note: Keep the syringe and sharps container out of sight and reach of children.

Read these instructions carefully before using the Remsima syringe. Consult your
healthcare provider if you have any questions about how to use the Remsima syringe.
Important information

Use the syringe ONLY if your healthcare provider has given you instructions on the correct way to prepare and administer an injection.
Ask your healthcare provider how often you should administer an injection.
Rotate the injection site each time you give an injection. Each new injection site should be at least 3 cm away from the previous one.
Do not use the syringe if it has been dropped or is visibly damaged. A damaged syringe may not work properly.
Do not reuse the syringe.
Do not shake the syringe.

Information about the Remsima syringe
Parts of the syringe (see Figure A):

Technical diagram of a pre-filled syringe with descriptive labels indicating plunger, flange, medication, viewing window, needle, and cap

Figure A

Do not remove the cap until you are ready. Once removed, do not recap the syringe.

Prepare for injection

1. Gather injection materials.

a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
b. Remove the syringe from the refrigerated package by holding the barrel of the syringe at the center.
c. Ensure you have the following supplies:

Syringe
Alcohol swab
Cotton ball or gauze*
Adhesive bandage*
Sharps container*
*Items not included in the package.

2. Inspect the syringe.

Do not use the syringe if:

It is broken or damaged.
The expiry date has passed.

3. Inspect the medicine (see Figure B).

The liquid should be clear and colorless to slightly brown.

Black and white technical drawing of a syringe with a circular magnification showing a detailed view of the tip

Do not use the syringe if the liquid is cloudy, discolored, or contains particles.
Note: Air bubbles in the liquid may be visible. This is normal.
Figure B

4. Wait for 30 minutes.

a. Leave the syringe at room temperature for 30 minutes to allow it to warm up naturally.
Do not heat the syringe using heat sources such as hot water or a microwave.

5. Choose an injection site (see Figure C).

a. Select an injection site. You may inject in:

The front of the thigh.
The abdomen, except for the area within 5 cm of the navel.
The outer upper area of the arms (ONLY by the caregiver).

Do not inject into the skin within 5 cm of the navel or if the area is tender, damaged, bruised, or scratched.
Note: Rotate the injection site each time an injection is given. Each new injection site must be at least 3 cm away from the previous one.

Human body diagram with gray areas on arms, abdomen, and thighs indicating injection sites

Figure C

6. Wash hands.

a. Wash hands with water and soap and dry them thoroughly.

7. Clean the injection site.

a. Clean the injection site with an alcohol swab.
b. Allow the skin to dry before injecting.
Do not blow on or touch the injection site again before injecting.
Administer the injection

8. Remove the cap (see Figure D).

a. Pull the cap straight off and

Two hands screwing or unscrewing a protective cap onto a syringe needle, with black arrows indicating lateral movement

set it aside.
Do not touch the needle. Doing so could cause a needlestick injury.
Note: It is normal to see a few drops of liquid coming out
from the needle after removing the cap.
Figure D

9. Insert the syringe into the injection site (see Figure E).

a. Hold the syringe barrel with one hand between the

A hand holding an injector angled at 45 degrees relative to the skin surface for injection

thumb and index finger.
b. Using the other hand, gently pinch a fold of skin that has been cleaned.
c. With a quick, dart-like motion, insert the needle fully into the skin fold at a 45-degree angle.
Figure E

10. Administer the injection (see Figure F).

a. After inserting the needle, keep the pinched skin lifted.
A hand holding an autoinjector preparing to administer an injection
b. Slowly push the plunger all the way down until the syringe is empty.
Figure F

11. Remove the syringe from the injection site (see Figure G).

a. When the syringe is empty, slowly lift your
thumb off the plunger until the needle is
completely covered by the automatic
safety shield.
b. Gently press a cotton ball or gauze pad against
the injection site and hold for 0 seconds.
c. Apply a bandage, if needed.
Do not rub the injection site.
Figure G
After the injection

12. Dispose of the syringe (see Figure H).

a. Place the used syringe into an approved sharps container immediately after use.

A hand holding a syringe with removed cap above a biohazard waste container with biohazard symbol

b. If you do not have an approved sharps container, you may use a household container that is:

made of heavy-duty plastic;
able to close with a tight-fitting, puncture-resistant lid that prevents the contents from spilling;
upright and stable during use;
leak-proof;
properly labeled to warn of hazardous waste inside.

c. When the sharps container is nearly full, it must be disposed of according to local requirements. Do not recap the syringe.

Figure H
Note: Keep the syringe and sharps container out of sight and reach of children.

Package leaflet: information for the user

Remsima 120 mg solution for injection in a prefilled pen

infliximab
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will also provide you with a patient reminder card containing important safety information that you must be aware of before and during treatment with Remsima.
When starting a new card, keep this card as a reference for 4 months after the last dose of Remsima.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Remsima is and what it is used for
What you need to know before using Remsima
How to use Remsima
Possible side effects
How to store Remsima
Contents of the pack and other information
Instructions for use

1. What Remsima is and what it is used for

Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody – a type of protein that binds to a specific target in the body called tumour necrosis factor (TNF) alpha.
Remsima belongs to a group of medicines called "tumour necrosis factor (TNF) blockers". It is used in adults to treat the following inflammatory diseases:

Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis (Bechterew’s disease)
Psoriasis
Crohn’s disease
Ulcerative colitis

Remsima works by selectively binding to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes in the body, so by blocking it, inflammation in the body can be reduced.

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

reduce the signs and symptoms of the disease,
slow down the progression of joint damage,
improve physical function.

reduce the signs and symptoms of the disease,
improve physical function.

treat active Crohn’s disease,
reduce the number of abnormal openings (fistulas) between the intestine and the skin, when other medicines or surgery have been inadequate.

2. What you need to know before using Remsima

Do not use Remsima if

you are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6),
you are allergic (hypersensitive) to mouse proteins,
you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (a serious bacterial infection of the blood),
you have moderate or severe heart failure.

Do not use Remsima if any of the above conditions apply to you. If you are unsure, speak with your doctor before being administered Remsima.

Warnings and precautions

Talk to your doctor before or during treatment with Remsima if you:

Have previously received a medicine containing infliximab

Inform your doctor if you have previously been treated with medicines containing infliximab and if you are restarting treatment with Remsima.
If you have stopped treatment with infliximab for more than 16 weeks, there is an increased risk of allergic reactions when restarting treatment with Remsima.

Injection site reactions

Some patients who have received infliximab by subcutaneous injection have experienced localized reactions at the injection site. Signs of a localized reaction at the injection site may include redness, pain, itching, swelling, hardening, bruising, bleeding, cold sensation, tingling, irritation, rash, ulcer, hives, blisters, and scabbing at the injection site skin.
Most of these reactions are mild to moderate and resolve on their own within one day.

Infections

Inform your doctor before receiving Remsima if you have an infection, even if it is very mild.
Inform your doctor before receiving Remsima if you have ever lived in or traveled to areas where fungal infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of the body.
You may be more susceptible to infections while being treated with Remsima. If you are 65 years of age or older, your risk is higher.
These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other environmental organisms, and sepsis, which can be life-threatening. Inform your doctor immediately if you develop symptoms of infection during treatment with Remsima. Symptoms include fever, cough, flu-like symptoms, feeling unwell, redness of the skin, or very warm skin, wounds, or dental problems. Your doctor may recommend temporarily stopping Remsima administration.

Tuberculosis (TB)

It is very important that you inform your doctor if you have ever had tuberculosis or if you have been in close contact with people who have had or currently have tuberculosis.
Your doctor will perform tests to assess whether you have tuberculosis. Cases of tuberculosis have been reported in patients treated with infliximab, including in patients who had been treated with TB medications. Your doctor will record these tests on the Patient Alert Card.
If your doctor believes you are at risk of tuberculosis, you may be treated with anti-tuberculosis medications before receiving Remsima. Inform your doctor immediately if you notice signs of tuberculosis during treatment with Remsima. Signs include persistent cough, weight loss, feeling tired, fever, and night sweats.

Hepatitis B virus

Inform your doctor before using Remsima if you are a carrier of hepatitis B or if you have previously had hepatitis B.
Inform your doctor if you think you may be at risk of contracting hepatitis B.
Your doctor must evaluate whether you have the hepatitis B virus.
Treatment with TNF blockers such as Remsima can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can lead to death.
If hepatitis B reactivation occurs, your doctor may need to stop treatment and may administer medications such as effective antiviral therapy with supportive care.

Heart problems

Inform your doctor if you have any heart problems, such as mild heart failure.
Your doctor will closely monitor your heart. Inform your doctor immediately if you notice new signs of heart failure or worsening symptoms during treatment with Remsima. Signs include shortness of breath or swelling of the feet.

Tumours and lymphoma

Inform your doctor before being administered Remsima if you have or have had lymphoma (a type of blood cancer) or other types of cancer.
Patients with severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma.
Patients taking Remsima may have an increased risk of developing lymphoma or other types of cancer.
Some patients treated with TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescents or young males, and most had Crohn’s disease or ulcerative colitis. This type of cancer is usually fatal. Almost all patients had also been treated with medications containing azathioprine or mercaptopurine in addition to TNF blockers.
Some patients treated with infliximab have developed certain types of skin cancer. If you notice changes in your skin or skin growths during or after therapy, inform your doctor.
Some women receiving infliximab for rheumatoid arthritis have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women taking Remsima, including women over 60 years of age.

Lung disease or heavy smokers

Inform your doctor before being administered Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Patients with COPD or who are heavy smokers may have an increased risk of cancer when treated with Remsima.

Nervous system disorders

Inform your doctor if you have or have had a nervous system disorder before being administered Remsima. This includes multiple sclerosis, Guillain-Barré syndrome, seizures, or diagnoses of “optic neuritis”. Inform your doctor immediately if you notice symptoms of a nervous system disorder during treatment with Remsima. Signs include changes in vision, weakness in arms and legs, numbness or tingling in any part of the body.

Abnormal skin openings

Inform your doctor if you have any abnormal skin openings (fistulas) before being administered Remsima.

Vaccinations

Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.
You should receive recommended vaccinations before starting treatment with Remsima. You may receive certain vaccines during treatment with Remsima, but you must not receive live vaccines (vaccines containing a live, but weakened infectious agent) while being treated with Remsima, as they may cause infections.
If you received Remsima during pregnancy, your baby may have an increased risk of developing an infection following administration of a live vaccine during the first year of life. It is important that you inform your paediatrician and other healthcare providers about your use of Remsima so they can determine when your baby should receive any vaccines, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).
If you are breastfeeding, it is important that you inform your paediatrician and other healthcare providers about your use of Remsima before any vaccines are administered to your baby. For further information, see the section on Pregnancy and breastfeeding.

Infectious therapeutic agents

Talk to your doctor if you have recently taken or plan to take treatment with an infectious therapeutic agent (such as BCG instillation used to treat cancer).

Surgery or dental procedures

Inform your doctor if you are scheduled for any surgical or dental procedures.
Inform the surgeon or dentist that you are being treated with Remsima, and show them your patient reminder card.

Liver problems

Some patients treated with infliximab have developed serious liver problems.
Inform your doctor immediately if you experience symptoms of liver problems during treatment with Remsima. Signs include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, rashes, or fever.

Reduction in blood cell count

In some patients treated with infliximab, the body may not be able to produce enough blood cells that help fight infections or help stop bleeding.
Inform your doctor immediately if you experience symptoms of reduced blood cell count during treatment with Remsima. Signs include persistent fever, easy bleeding or bruising, small red or purple spots under the skin due to bleeding, or paleness.

Immune system disorder

Some patients treated with infliximab have developed symptoms of an immune system disorder called lupus.
Inform your doctor immediately if you develop symptoms of lupus during treatment with Remsima. Signs include joint pain or a rash on the cheeks or arms that is sensitive to sunlight.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as there are no data demonstrating that this medicine is safe and effective in this age group.

Other medicines and Remsima
Patients with inflammatory diseases are often already taking medicines to treat their condition. These medicines can cause side effects. Your doctor will advise you on which other medicines you should continue taking while on Remsima treatment.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or medicines obtained without a prescription, such as vitamins and herbal remedies.
In particular, inform your doctor if you are taking any of the following medicines:

Medicines that act on the immune system.
Kineret (which contains anakinra). Remsima and Kineret must not be administered together.
Orencia (which contains abatacept). Remsima and Orencia must not be administered together.

During treatment with Remsima, you must not be given live vaccines. If you are using Remsima during pregnancy or if you are receiving Remsima while breastfeeding, inform your paediatrician and other healthcare providers involved in your baby’s care about your use of Remsima before any vaccines are administered to your baby.

If you are unsure whether any of the above conditions apply to you, consult your doctor, pharmacist, or nurse before using Remsima.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Remsima should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
You must avoid pregnancy while being treated with Remsima and for at least 6 months after stopping treatment. Discuss with your doctor the use of an appropriate contraceptive method during this period.
If you received Remsima during pregnancy, your baby may have an increased risk of developing an infection.
It is important that you inform your paediatrician and other healthcare providers about your use of Remsima before any vaccines are administered to your baby. If you received Remsima during pregnancy, administration of the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may lead to infection with serious complications, including death. Live vaccines such as the BCG vaccine must not be administered to the baby within 12 months after birth, unless otherwise recommended by the paediatrician. For further information, see the section on Vaccinations.
If you are breastfeeding, it is important that you inform your paediatrician and other healthcare providers about your use of Remsima before any vaccines are administered to your baby. Live vaccines must not be administered to the baby during breastfeeding, unless otherwise recommended by the paediatrician.
Severe decreases in white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy. If your baby has fever or recurrent infections, contact your baby’s doctor immediately.

Remsima contains sodium and sorbitol
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”, and contains 45 mg of sorbitol in each 120 mg dose.

3. How to use Remsima

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Rheumatoid arthritis
Your doctor will start your treatment with or without two doses of infliximab at 3 mg per kg of body
weight by intravenous infusion (administered into a vein, usually in the arm, over a period of 2 hours). If treatment is initiated with infliximab doses administered by intravenous infusion, these will be given two weeks apart. Four weeks after the last intravenous infusion, you will receive Remsima by injection under the skin (subcutaneous injection). If treatment is initiated with Remsima by subcutaneous injection, Remsima 120 mg must be administered by subcutaneous injection, followed by additional subcutaneous injections 1, 2, 3, and 4 weeks after the first injection, and then every 2 weeks thereafter.
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2
weeks, regardless of body weight.
Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease) and psoriasis
Your doctor will start your treatment with two doses of infliximab at 5 mg per kg of body weight by
intravenous infusion (administered into a vein, usually in the arm, over a period of 2 hours). These will be administered two weeks apart. Four weeks after the last intravenous infusion, you will receive Remsima by injection under the skin (subcutaneous injection).
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2
weeks, regardless of body weight.
Crohn's disease and ulcerative colitis
Your doctor will start your treatment with two or three doses of infliximab at 5 mg per kg of body
weight by intravenous infusion (administered into a vein, usually in the arm, over a period of 2 hours). These will be administered two weeks apart, and an additional intravenous infusion may be given 4 weeks after the second infusion. Four weeks after the last intravenous infusion, you will receive Remsima by injection under the skin (subcutaneous injection).
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2
weeks, regardless of body weight.
How Remsima is administered

Remsima 120 mg solution for injection is administered only by subcutaneous injection (injection under the skin). It is important to check the product labels to ensure that the correct formulation is administered as prescribed.
For patients with rheumatoid arthritis, your doctor may start treatment with Remsima with or without intravenous infliximab doses. For patients with ankylosing spondylitis, psoriatic arthritis, or psoriasis, two doses of infliximab by intravenous infusion will be administered to initiate treatment with Remsima. For patients with Crohn's disease or ulcerative colitis, two or three doses of infliximab by intravenous infusion will be administered to initiate treatment with Remsima.
For patients with rheumatoid arthritis, if treatment with Remsima is initiated without two intravenous infliximab doses, the following table shows the usual frequency with which you will receive Remsima 120 mg by subcutaneous injection after the first dose.

2nd dose	1 week after the 1st dose
3rd dose	2 weeks after the 1st dose
4th dose	3 weeks after the 1st dose
5th dose	4 weeks after the 1st dose
Further doses	6 weeks after the 1st dose and subsequently every 2 weeks

For Crohn’s disease and ulcerative colitis, your doctor or nurse will administer the infliximab doses
via intravenous infusion two weeks apart, and, at the doctor’s discretion, an additional intravenous
infusion may be given 4 weeks after the second infusion to initiate treatment with Remsima. The first
subcutaneous injection of Remsima will be administered 4 weeks after the last intravenous infusion,
followed by subcutaneous injections of Remsima given every 2 weeks.
The first subcutaneous injection of Remsima will be administered under the supervision of your doctor.
After adequate training, if you feel ready and confident to self-inject, your doctor may allow you to administer subsequent doses of Remsima yourself at home.
Consult your doctor if you have any questions about self-injection. Detailed “Instructions for use” can be found at the end of this leaflet.

If you use more Remsima than you should
If you have used more Remsima than you should have (by injecting too much at one time or using it too frequently), contact your doctor, pharmacist, or nurse immediately.
Keep the outer packaging with you, even if empty.

If you forget to use Remsima
Missed dose within up to 7 days
If you miss a dose of Remsima by up to 7 days after the originally scheduled dose, you should take the missed dose immediately. Take the next dose on the originally scheduled date and then continue with the original dosing schedule.

Missed dose by 8 days or more
If you miss a dose of Remsima by 8 days or more after the originally scheduled dose, you should not take the missed dose. Take the next dose on the originally scheduled date and then continue with the original dosing schedule.

If you are unsure about when to inject Remsima, consult your doctor.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most of these side effects are mild to moderate in severity. However, some patients may experience serious side effects and require medical treatment. Side effects may also occur after treatment with Remsima has ended.
Contact your doctor immediately if you notice any of the following:

Signs of an allergic reaction, such as swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of the hands, feet or ankles. Some of these reactions can be serious and potentially life-threatening. An allergic reaction may occur within 2 hours of the injection or later. Additional signs of allergic-type side effects that may occur up to 12 days after injection include muscle pain, fever, joint or jaw pain, sore throat or headache.
Signs of a localized reaction at the injection site, such as redness, pain, itching, swelling, hardening, bruising, bleeding, cold sensation, tingling, irritation, rash, ulcer, hives, blisters or scab.
Signs of a heart problem, such as discomfort or pain in the chest, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, palpitations or pounding in the chest, fast or slow heartbeat, and swelling of the feet.
Signs of an infection (including tuberculosis), such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, abscesses or pus collection in the intestine or around the anus, dental problems or burning sensation when urinating.
Possible signs of cancer, including but not limited to swollen lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colour, or unusual vaginal bleeding.
Signs of a lung problem, such as cough, difficulty breathing or chest tightness.
Signs of neurological problems (including eye problems), such as signs of stroke (sudden numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden vision problems in one or both eyes; difficulty walking, dizziness, loss of balance or coordination, or a severe headache), seizures, tingling/numbness in any part of the body, weakness in arms or legs, changes in vision such as double vision or other eye problems.
Signs of a liver problem, (including hepatitis B infection, if you have previously had hepatitis B) such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, rash or fever.
Signs of an immune system disorder, such as joint pain or a rash on the cheeks or arms that is sensitive to sunlight (lupus), or cough, shortness of breath, fever or rash (sarcoidosis).
Signs of a reduced number of blood cells, such as persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin, or pale appearance.
Signs of serious skin problems, such as reddish spots or circular patches, often with central blisters on the trunk, large areas of peeling or shedding skin (exfoliation), mouth, throat, nose, genital or eye ulcers, or small pus-filled bumps that may spread over the body. These skin reactions may be accompanied by fever.

Contact your doctor immediately if you notice any of the symptoms described above.
The following side effects have been observed with Remsima:
Very common: may affect more than 1 in 10 people

Stomach pain, nausea
Viral infections such as herpes or influenza
Upper respiratory tract infections such as sinusitis
Headache
Side effect due to injection
Pain.

Common: may affect up to 1 in 10 people

Changes in liver function, increased liver enzymes (detected by blood tests)
Infections of the lungs or chest, such as bronchitis or pneumonia
Difficulty breathing or pain when breathing, chest pain
Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Hives-like rash, itchy rash or dry skin
Balance problems or dizziness
Fever, increased sweating
Circulatory problems, such as low or high blood pressure
Bruising, hot flushes or nosebleeds, feeling hot, red skin (redness)
Feeling tired or weak
Bacterial infections such as systemic infection, abscess or skin infection (cellulitis)
Fungal skin infection
Blood problems such as anaemia or low white blood cell count
Swollen lymph nodes
Depression, sleep disorders
Eye problems, including red eyes and infections
Fast heartbeat (tachycardia) or palpitations
Joint, muscle or back pain
Urinary tract infection
Psoriasis, skin problems such as eczema and hair loss
Reactions at the injection site such as pain, swelling, redness or itching
Chills, fluid accumulation under the skin causing swelling
Numbness or tingling sensation.

Uncommon: may affect up to 1 in 100 people

Poor blood supply, swelling of a vein
Collection of blood outside blood vessels (haematoma) or bruising
Skin problems such as blistering, warts, abnormal skin colouring or pigmentation, swollen lips or thickened skin, or red, scaly and cracked skin
Severe allergic reactions (e.g., anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Wounds that heal slowly
Swelling of the liver (hepatitis) or gallbladder (cholecystitis), liver damage
Distraction, irritability, confusion, nervousness
Eye problems including blurred or reduced vision, swollen eyes or stye
New or worsening heart failure, slowing of heart rate
Fainting
Seizures, nervous system disorders
Intestinal perforation or intestinal blockage, stomach pain or cramps
Swelling of the pancreas (pancreatitis)
Fungal infections such as yeast infection or fungal nail infection
Lung problems (such as oedema)
Excess fluid around the lungs (pleural effusion), inflammation of the layers covering the lungs (pleuritis)
Narrowing of the airways in the lungs, causing difficulty breathing
Inflammation of the membrane lining the lungs, causing sharp chest pain that worsens with breathing (pleuritis)
Tuberculosis
Kidney infections
Low platelet count, excessive white blood cells, bruising or black and blue spots
Vaginal infections
Blood test results showing “antibodies” against your own body.
Changes in cholesterol and fat levels in the blood.
Weight gain (in most patients, weight gain was minimal).

Rare: may affect up to 1 in 1,000 people

A type of blood cancer (lymphoma)
Poor oxygen supply to organs through the blood, circulatory problems such as narrowing of a blood vessel
Inflammation of the membrane covering the brain (meningitis)
Infections due to a weakened immune system
Hepatitis B infection, if you have previously had hepatitis B
Liver inflammation caused by an immune system problem (autoimmune hepatitis)
Liver problem causing yellowing of the skin or eyes (jaundice)
Swelling or growth of abnormal tissue
Severe allergic reaction that may cause loss of consciousness and may be life-threatening (anaphylactic shock)
Swelling of small blood vessels (vasculitis)
Immune disorders that may affect the lungs, skin and lymph nodes (such as sarcoidosis)
Collection of immune system cells as a result of an inflammatory response (granulomatous lesions)
Lack of interest or emotion
Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Other skin problems such as erythema multiforme, blisters and peeling skin or boils (furunculosis)
Severe nervous system disorders such as transverse myelitis, multiple sclerosis-like illness, optic neuritis and Guillain-Barré syndrome
Inflammation of the eye that may cause vision changes, including blindness
Fluid in the membrane lining the heart (pericardial effusion)
Severe lung problems (such as interstitial pneumonia)
Melanoma (a type of skin cancer)
Cervical cancer
Low number of blood cells, including a severe decrease in white blood cells
Small red or purple spots caused by bleeding under the skin
Abnormal levels of a blood protein called “complement factor” which is part of the immune system
Lichenoid reactions (itchy reddish-purple rash and/or white-grey thread-like lines on mucous membranes).

Not known: frequency cannot be estimated from the available data

Cancer
A rare blood cancer affecting mainly adolescent or young males (hepatosplenic T-cell lymphoma)
Liver failure
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly appears as purple lesions on the skin.
Worsening of a condition called dermatomyositis (presents as a rash accompanied by muscle weakness)
Heart attack
Stroke
Temporary loss of vision during or within 2 hours after infusion
Infection caused by a live vaccine due to a weakened immune system.
Problems following a medical procedure (including infectious and non-infectious complications).

5. How to store Remsima

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after “SCAD”/”EXP” and on the carton after “Scad.”. The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C - 8 °C). Do not freeze. Keep the pre-filled pen in the outer packaging to protect the medicine from light.
This medicine may also be stored outside the refrigerator, in its original carton, at a temperature not exceeding 25 °C, for a single period of up to 28 days, but not beyond the original expiry date. In this case, it must not be returned to the refrigerator. Write the new expiry date on the carton, including day/month/year. Dispose of this medicine if not used within the new expiry date or the printed expiry date, whichever comes first.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Remsima contains

The active substance is infliximab. Each 1 mL single-use pre-filled pen contains 120 mg of infliximab.
The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, water for injections.

Description of the appearance of Remsima and contents of the pack
Remsima is a solution that ranges from clear to opalescent and from colourless to light brown, supplied in a single-use pre-filled pen.
Each pack contains 1 pre-filled pen with 2 alcohol swabs, 2 pre-filled pens with 2 alcohol swabs, 4 pre-filled pens with 4 alcohol swabs, or 6 pre-filled pens with 6 alcohol swabs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: +32 1528 7418 1062 Budapest
[email protected] Váci út 1-3. WestEnd Office Building B tower
Vengrija

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
1062 Budapest Tél/Tel: +32 1528 7418
Váci út 1-3. WestEnd Office Building B tower [email protected]
Ungarija

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
1062 Budapest 1062 Budapest
Váci út 1-3. WestEnd Office Building B tower Váci út 1-3. WestEnd Office Building B tower
Maďarsko Magyarország

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd.
Fuglevangsvej 11, 1962 Tel: +356 2093 9800
Frederiksberg C, Denmark [email protected]
Tlf: +45 3535 2989
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: +31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
1062 Budapest Fjordalléen 16, 0250 Oslo, Norway
Váci út 1-3. WestEnd Office Building B tower [email protected]
Ungari

Ελλάδα Österreich
BIANEX A.E. Astro-Pharma GmbH
Tel: +30 210 8009111 - 120 Tel: +43 1 97 99 860
[email protected]

España Polska
Kern Pharma, S.L. Celltrion Healthcare Hungary Kft.
Tel: +34 93 700 25 25 1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Węgry

France Portugal
Celltrion Healthcare France SAS Celltrion Portugal, Unipessoal Lda.
Tél: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542

Hrvatska România
OKTAL PHARMA d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 1062 Budapest
[email protected] Váci út 1-3. WestEnd Office Building B tower
Ungaria

Ireland Slovenija
Celltrion Healthcare Ireland Limited OKTAL PHARMA d.o.o.
Tel: +353 1 223 4026 Tel: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Vistor hf. Celltrion Healthcare Hungary Kft.
Sími: +354 535 7000 1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Maďarsko

Italia Suomi/Finland
Celltrion Healthcare Italy S.r.l. Celltrion Healthcare Finland Oy.
Via Luigi Galvani, 24 - 20124 Milano (MI) Puh/Tel: +358 29 170 7755
Tel: +39 0247 927040

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Tel: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Ungārija

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

7. Instructions for use

Read these instructions carefully before using the Remsima pen.
Consult your healthcare provider if you have any questions about how to use the Remsima pen.

Important information

Use the pen ONLY if your healthcare provider has given you instructions on how to properly prepare and administer an injection.
Ask your healthcare provider how often you should administer an injection.
Rotate the injection site each time you give an injection. Each new injection site should be at least 3 cm away from the previous injection site.
Do not use the pen if it has been dropped or is visibly damaged. A damaged pen may not work properly.
Do not reuse the pen.
Do not ever shake the pen.

Information about the Remsima pen
Parts of the pen (see Figure A ):

Diagram of a medical device with labels showing the body, medication, viewing window, needle, and cap

Figure A

Do not remove the cap until you are ready. Once the cap is removed, do not replace the cap on the pen.

Preparing for injection

1. Gather injection materials.

a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
b. Remove the pen from the packaging stored in the refrigerator.
c. Make sure you have the following materials:

Pen
Alcohol swab
Cotton ball or gauze*
Bandage*
Sharps container*
*Items not included in the package.

2. Inspect the pen.

Do not use the pen if:

It is broken or damaged.
The expiry date has passed.

3. Inspect the medicine (see Figure B).

The liquid should be clear and colourless to light brown.

Technical drawing of a white injection pen with an enlarged detail showing the drug level viewing window for liquid medication

Do not use the pen if the liquid is cloudy,
discoloured, or contains particles.
Note: Air bubbles may be visible in the liquid. This is
normal.
Figure B

4. Wait for 30 minutes.

a. Leave the pen at room temperature for 30 minutes to allow it to warm up naturally.
Do not heat the pen using heat sources such as hot water or microwave.

5. Choose an injection site (see Figure C).

a. Select an injection site. You can inject into:

The front of the thigh.
The abdomen, except for the area within 5 cm of the navel.
The outer upper part of the arm (ONLY for the caregiver).

Do not inject into skin within 5 cm of the navel or if it is tender, damaged, bruised, or scratched.
Note: Rotate the injection site each time an injection is given. Each new injection site must be at least 3 cm away from the previous one.

Figure C
Human body diagram with gray areas on arms and abdomen indicating recommended injection sites

6. Wash hands.

a. Wash hands with water and soap and dry them thoroughly.

7. Clean the injection site.

a. Clean the injection site with an alcohol swab.
b. Let the skin dry before injecting.
Do not blow on or touch the injection site again before injecting.
Administer the injection

8. Remove the cap (see Figure D).

a. Pull off the olive-green cap and set it aside.
Do not touch the needle. Doing so may result in a needlestick injury.
Note: It is normal to see a few drops of liquid coming out from the needle after removing the cap.
Figure D
Two hands separating a white medical device from a green cylindrical cap via horizontal movement indicated by black arrows

9. Position the pen at the injection site (see Figure E).

a. Hold the pen so that you can see the window.

A hand holding an injection pen positioned vertically at 90 degrees on the upper thigh or buttock

b. Without pinching or pulling the skin, place the
pen on the injection site at a 90-degree
angle.
Figure E

10. Start the injection (see Figure F).

a. Press the pen firmly against the skin.

A hand holding a medical device placed on the skin of the buttock with a downward arrow and a symbol indicating first click

Note: When the injection starts, you will hear a loud 1st "click" and the olive-green plunger rod will begin to fill the viewing window.
b. Continue to hold the pen firmly against the skin and listen for the 2nd loud "click".
Figure F

11. Completing the injection (see Figure G).

a. After hearing the 2nd loud "click", continue to

A hand holding a cylindrical medical device placed on the thigh with a downward arrow and a circle labeled 'second click'

hold the pen firmly against the skin and
count slowly to at least five to
ensure the full dose is injected.
Figure G

12. Remove the pen from the injection site.

a. Look at the pen and make sure that the olive-green
plunger rod completely fills the
window.
b. Lift the pen away from the injection site ( see
Figure H ).
c. Gently press a cotton ball or gauze pad against
the injection site and apply a bandage, if necessary.
Do not rub the injection site.
Note: After removing the pen from the injection site,
the needle will be automatically covered (see Figure
I).
Note: If the olive-green plunger rod does not completely fill
the window, you are not receiving the full dose.
In this case, do not reuse the pen.
Contact your healthcare provider immediately.
Figure H

Technical drawing of a white medical device with an oval window showing green liquid and a gray protective cover labeled 'Needle Shield'

Figure I
After the injection

13. Disposing of the pen (see Figure J).

a. Place the used pen immediately into an approved sharps container after use.
b. If an approved sharps container is not available, you may use a household container that is:

made of heavy-duty plastic;
able to be closed with a tight-fitting, puncture-resistant lid that prevents leakage of sharps;
upright and stable during use;
leak-proof;
properly labeled to warn of hazardous waste inside.
c. When the sharps container is nearly full, it must be disposed of according to local requirements. Do not re-cap the pen.
Figure J
Note: Keep the pen and sharps container out of sight and reach of children.

Remsima

Package leaflet: Information for the user

Remsima 100 mg powder for concentrate for solution for infusion

1. What Remsima is and what it is used for

2. What you should know before using Remsima

3. How to use Remsima

4. Possible side effects

5. How to store Remsima

6. Package contents and other information

Further sources of information More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Instructions for use and handling – storage conditions

Package leaflet: Information for the user

Remsima 120 mg solution for injection in pre-filled syringe

1. What Remsima is and what it is used for

2. What you should know before using Remsima

3. How to use Remsima

4. Possible side effects

5. How to store Remsima

6. Package contents and other information

7. Instructions for use

1. Gather the injection materials.

2. Inspect the syringe.

3. Inspect the medicine (see Figure B).

4. Wait for 30 minutes.

5. Choose an injection site (see Figure C).

6. Wash hands.

7. Clean the injection site.

8. Remove the cap (see Figure D).

9. Insert the syringe into the injection site (see Figure E).

10. Administer the injection (see Figure F).

11. Remove the needle from the injection site (see Figure G).

12. Dispose of the syringe (see Figure H).

1. Gather injection materials.

2. Inspect the syringe.

3. Inspect the medicine (see Figure B).

4. Wait for 30 minutes.

5. Choose an injection site (see Figure C).

6. Wash hands.

7. Clean the injection site.

8. Remove the cap (see Figure D).

9. Insert the syringe into the injection site (see Figure E).

10. Administer the injection (see Figure F).

11. Remove the syringe from the injection site (see Figure G).

12. Dispose of the syringe (see Figure H).

Package leaflet: information for the user

Remsima 120 mg solution for injection in a prefilled pen

1. What Remsima is and what it is used for

2. What you need to know before using Remsima

3. How to use Remsima

4. Possible side effects

5. How to store Remsima

6. Package contents and other information

7. Instructions for use

1. Gather injection materials.

2. Inspect the pen.

3. Inspect the medicine (see Figure B).

4. Wait for 30 minutes.

5. Choose an injection site (see Figure C).

6. Wash hands.

7. Clean the injection site.

8. Remove the cap (see Figure D).

9. Position the pen at the injection site (see Figure E).

10. Start the injection (see Figure F).

11. Completing the injection (see Figure G).

12. Remove the pen from the injection site.

13. Disposing of the pen (see Figure J).

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.