Package leaflet: Information for the user

Inflectra 100 mg powder for concentrate for solution for infusion

infliximab
Please read 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 Inflectra.
When you start a new card, keep this card as a reference for 4 months after your last dose of Inflectra.
If you have any questions, ask your doctor.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What Inflectra is and what it is used for

Inflectra contains the active substance called infliximab, which is of human and animal (mouse) origin.
Infliximab is a monoclonal antibody, a type of protein that binds to a specific target in the
body called tumour necrosis factor (TNF) alpha.
Inflectra 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

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

Crohn's disease
Ulcerative colitis

Inflectra works by selectively binding to TNF alpha (tumour necrosis factor alpha) and
blocking its action. TNF alpha is involved in inflammatory processes in the body, and 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 active rheumatoid arthritis, you will initially be treated with other medicines. If these medicines do not work adequately, you will be treated with Inflectra, which you will take 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 the response to these medicines is not adequate, you will be treated with Inflectra 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 the response to these medicines is not adequate, you will be treated with Inflectra 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 the response to these medicines or treatments is not adequate, you will be treated with Inflectra 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 the response to these medicines is not adequate, Inflectra will be administered 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 Inflectra 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 need to know before using Inflectra

Do not receive Inflectra 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 blood infection),
you have moderate or severe heart failure.

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

Warnings and precautions

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

Have previously received a medicine containing infliximab

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

Infections

Inform your doctor before receiving Inflectra if you have an infection, even if it is very mild.
Inform your doctor before receiving Inflectra 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 Inflectra. 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 Inflectra. Symptoms include fever, cough, flu-like symptoms, feeling unwell, red or very warm skin, wounds, or dental problems. Your doctor may recommend temporarily stopping Inflectra.

Tuberculosis (TB)

It is very important that you inform your doctor if you have ever had tuberculosis or have been in close contact with someone who has or has had 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 been treated with TB medications. Your doctor will record these test results on your patient reminder card.
If your doctor believes you are at risk of tuberculosis, you may be treated with TB medications before starting Inflectra.
Inform your doctor immediately if you notice signs of tuberculosis during treatment with Inflectra. Signs include persistent cough, weight loss, fatigue, fever, and night sweats.

Hepatitis B virus

Inform your doctor before receiving Inflectra if you are a carrier of hepatitis B or have ever had hepatitis B.
Inform your doctor if you believe 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 Inflectra, 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 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 symptoms during treatment with Inflectra. Signs include shortness of breath or swelling in the feet.

Tumours and lymphoma

Inform your doctor before receiving Inflectra 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 Inflectra may have an increased risk of developing lymphoma or other types of tumours.
Some patients treated with TNF blockers, including infliximab, have developed a rare type of tumour called hepatosplenic T-cell lymphoma. Most of these patients were adolescent or young adult males with Crohn’s disease or ulcerative colitis. This type of tumour 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 being treated for rheumatoid arthritis with infliximab have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women taking Inflectra, including women over 60 years of age.

Lung disease or regular smokers

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

Nervous system disorders

Inform your doctor before receiving Inflectra if you have or have had a nervous system disorder. 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 Inflectra. Signs include vision changes, weakness in arms or legs, numbness, or tingling anywhere in the body.

Abnormal skin openings

Inform your doctor if you have any abnormal skin openings (fistulas) before receiving Inflectra.

Vaccinations

Inform your doctor if you have recently been vaccinated or plan to be vaccinated.
You should receive recommended vaccinations before starting treatment with Inflectra. You may receive some vaccines during treatment with Inflectra, but you must not receive live vaccines (vaccines containing a live but weakened infectious agent) while being treated with Inflectra, as they could cause infections.
If you received Inflectra 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 to inform the paediatrician and other healthcare providers about your use of Inflectra 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 to inform the paediatrician and other healthcare providers about your use of Inflectra before your baby receives any vaccines. 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 intravesical BCG administration 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 Inflectra, 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 Inflectra. 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 rash, or fever.

Reduced blood cell counts

In some patients treated with infliximab, the body may not 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 Inflectra. Signs include persistent fever, easy bleeding or bruising, small red or purple spots under the skin due to bleeding, or paleness.

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

Inflectra should only be used in children for Crohn’s disease or ulcerative colitis. These children must be at least 6 years of age.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor before receiving Inflectra.

Other medicines and Inflectra
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 during treatment with Inflectra.

Inform your doctor if you are taking, have recently taken, or might take any other medicines, including any other medicines for 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 (containing anakinra). Inflectra and Kineret must not be administered together.
Orencia (containing abatacept). Inflectra and Orencia must not be administered together.

During treatment with Inflectra, you must not receive live vaccines. If you are using Inflectra during pregnancy or receiving Inflectra while breastfeeding, inform the paediatrician and other healthcare providers caring for your baby about your use of Inflectra before any vaccines are administered to the baby.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before receiving Inflectra.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. Inflectra should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
You should avoid becoming pregnant while being treated with Inflectra 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 Inflectra during pregnancy, your baby may have an increased risk of infection.
It is important to inform the paediatrician and other healthcare providers about your use of Inflectra before your baby receives any vaccines. If you received Inflectra during pregnancy, administering 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 more information, see the section on Vaccinations.
If you are breastfeeding, it is important to inform the paediatrician and other healthcare providers about your use of Inflectra before your baby receives any vaccines. 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 persistent infections, contact the paediatrician immediately.

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

Inflectra contains sodium
Inflectra contains less than 1 mmol (23 mg) of sodium per dose, meaning it is practically “sodium-free”. However, before administration, Inflectra is mixed with a solution containing sodium. Inform your doctor if you are on a low-salt diet.

3. How to use Inflectra

How much Inflectra is administered

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

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

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

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

Use in children and adolescents
In children (aged 6 years and older) being treated for Crohn's disease or ulcerative colitis, the
recommended dose is the same as in adults.
If you are given more Inflectra than you should
Since this medicine is administered by a doctor or nurse, it is unlikely that you will receive too much. Undesirable effects following an overdose of Inflectra are not known.
If you miss or skip an Inflectra infusion
If you miss or skip an appointment for Inflectra 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 everybody 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 Inflectra has ended.
Tell your doctor immediately if you notice any of the following side effects:

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 serious and potentially life-threatening. An allergic reaction may occur within 2 hours of the infusion or later. Additional signs of allergic reaction side effects that may occur up to 12 days after the infusion 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, lightheadedness, dizziness, fainting, sweating, nausea (feeling unwell), 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, persistent cough, 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 a burning sensation when urinating.
Possible signs of cancer include, but are 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 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 severe headache), seizures, tingling/numbness in any part of the body or feeling weak 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 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 reduced blood cell counts, such as persistent fever, easier 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 sloughing 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 Inflectra:
Very common: may affect more than 1 in 10 people

Stomach pain, feeling unwell
Viral infections such as herpes or flu
Upper respiratory tract infections such as sinusitis
Headache
Infusion-related side effect
Pain.

Common: may affect up to 1 in 10 people

Changes in liver function, increased liver enzymes (detected by blood tests)
Lung or chest infections, such as bronchitis or pneumonia
Breathing difficulties or pain during 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, 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 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 worsened heart failure, slowed 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)
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 (pleurisy)
Tuberculosis
Kidney infections
Low platelet count, excessive white blood cell count
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 tumour (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 weakened immune system
Hepatitis B infection, if you have previously had hepatitis B
Inflammation of the liver 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)
Collection of immune system cells as a result of an inflammatory response (granulomatous lesions)
Lack of interest or emotion
Severe skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and generalised acute exanthematous pustulosis
Other skin problems such as erythema multiforme, blisters and peeling skin or boils (folliculitis)
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
Lichenoid reactions (itchy reddish-purple rash and/or white-grey thread-like lines on mucous membranes)
Abnormal values of a blood protein called “complement factor” which is part of the immune system.

Not known: frequency cannot be estimated from the available data

Tumour in children and adults
A rare blood tumour 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 weakened immune system.

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 red blood cell count (anaemia), blood in stools, overall low white blood cell count (leucopenia), flushing or redness (hot flushes), viral infections, low white blood cell count fighting infection (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 Inflectra

Inflectra will generally be stored by healthcare professionals at the hospital or clinic. If you need to store it, 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 and carton after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (between 2 °C and 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 Inflectra is prepared for infusion, it is recommended to use it as soon as possible (within 3 hours). However, if the solution is prepared under completely aseptic conditions, it may be stored in a refrigerator at a temperature between 2 °C and 8 °C for up to 60 days, and for an additional 24 hours at 25 °C after removal from the refrigerator.
Do not use this medicine if it is discoloured or if particles are present.

6. Package contents and other information

What Inflectra contains

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

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

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Hospira Zagreb d.o.o.
Prudnička cesta 60
10291 Prigorje Brdovečko
Croatia

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

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: + 36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Drugsales Ltd
Tel: +420 283 004 111 Tel: +356 21419070/1/2

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: + 33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: +1800 633 363 (toll free) Tel: +421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ: +357 22817690 Tel: + 44 (0)1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

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

The following information is intended for healthcare professionals only:

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

Instructions for use and handling – storage conditions

Store at 2 °C – 8 °C.
Inflectra 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, Inflectra must not be
refrigerated again.

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

Calculate the dose and the number of Inflectra vials required. Each Inflectra vial contains 100 mg of infliximab. Calculate the total volume required of the reconstituted Inflectra solution.
Under aseptic conditions, reconstitute each vial of Inflectra 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 with a cotton swab soaked in 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 swirl the solution to completely dissolve the lyophilized 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 some small translucent particles, as infliximab is a protein. Do not use the solution if opaque particles, discolouration or foreign matter are observed.
Dilute the total volume of reconstituted Inflectra solution to 250 mL using sodium chloride 9 mg/mL (0.9%) solution for infusion. Do not dilute the reconstituted Inflectra 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 Inflectra. Slowly add the total volume of reconstituted Inflectra solution to the 250 mL infusion vial or bag. 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 must be brought to room temperature at 25°C for 3 hours before proceeding as indicated in point 4 (infusion). Storage for longer than 24 hours at 2 °C – 8 °C applies only to Inflectra preparations in the infusion bag.
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). As no preservative is present, 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 in-use storage times and conditions prior to use are the responsibility of the user and normally do not exceed 24 hours at 2 °C to 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 Inflectra to ensure there are no particles or changes in colour. If opaque particles, discolouration or foreign particles are observed, do not use.
Unused medicinal product and waste material arising from this medicinal product must be disposed of in accordance with current local regulations.

Inflectra