Zessly 100 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zessly 100 mg powder for concentrate for solution for infusion

infliximab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Your doctor will also provide you with a patient alert card containing important safety information you need to know before and during your treatment with Zessly.
• If you have any questions, consult your doctor.
• This medicine has been prescribed only for you; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zessly is and what it is used for
2. What you need to know before using Zessly
3. How Zessly is administered
4. Possible side effects
5. How to store Zessly
6. Contents of the pack and other information

1. What Zessly is and what it is used for

Zessly contains the active substance infliximab. Infliximab is a monoclonal antibody, a type of protein that binds specifically to a target in the body called TNF (tumour necrosis factor) alpha.

Zessly belongs to a group of medicines known as “TNF blockers”. It is used in adults for the following inflammatory diseases:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis (Bechterew’s disease)
• Psoriasis

Zessly is also used in adults and children from 6 years of age for:

• Crohn’s disease
• Ulcerative colitis

Zessly 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 your body can be reduced.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Zessly in combination with another medicine called methotrexate to:

• Reduce the signs and symptoms of your disease
• Delay damage to your joints
• Improve your physical function

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Zessly to:

• Reduce the signs and symptoms of your disease
• Reduce joint damage
• Improve your 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 given other medicines. If these medicines do not work well enough, you will be given Zessly to:

• Reduce the signs and symptoms of your disease
• Improve your physical function

Psoriasis

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

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Zessly to treat your disease.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work well enough, you will be given Zessly to:

• Treat active Crohn’s disease
• Reduce the number of abnormal passages (fistulas) between your intestine and skin, which have not been controlled by other medicines or surgery

2. What you need to know before using Zessly

Do not use Zessly if:

• You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
• You are allergic (hypersensitive) to proteins derived from mice.
• You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
• You have moderate or severe heart failure (impaired heart function).

If any of the above apply to you, do not use Zessly. If you are unsure, consult your doctor before receiving Zessly.

Warnings and precautions

Talk to your doctor before or during treatment with Zessly if:

You have previously received treatment with a medicine containing infliximab

• Inform your doctor if you have previously received treatment with a medicine containing infliximab and are now starting treatment with Zessly again.
• If you have interrupted treatment with infliximab for more than 16 weeks, there is an increased risk of allergic reactions when restarting treatment.

Infections

• Before receiving Zessly, inform your doctor if you have an infection, even if it is mild.
• Before receiving Zessly, inform your doctor if you have ever lived in or traveled 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 Zessly. The risk is higher if you are over 65 years of age.
• These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other environmental organisms, and sepsis, which can potentially be fatal.

Contact your doctor immediately if you notice signs of infection during treatment with Zessly, such as fever, cough, flu-like symptoms, general malaise, redness or warmth of the skin, wounds, or dental problems. Your doctor may recommend temporarily stopping treatment with Zessly.

Tuberculosis (TB)

• It is very important to inform your doctor if you have ever had TB or have been in close contact with someone who has or had TB.
• Your doctor will perform a test to check for TB. Cases of TB have been reported in patients treated with infliximab, including in patients who have previously been treated for TB. Your doctor will record these test results on your patient information card.
• If your doctor determines you are at risk for TB, you may be treated with TB medications before starting Zessly.

Contact your doctor immediately if you notice signs of TB during treatment with Zessly. Symptoms include persistent cough, weight loss, fatigue, fever, and night sweats.

Hepatitis B virus

• Before receiving Zessly, inform your doctor if you are a carrier of hepatitis B or have ever had hepatitis B.
• Inform your doctor if you think you may be at risk of contracting hepatitis B.
• Your doctor should perform tests for hepatitis B virus.
• Treatment with TNF blockers, such as Zessly, may cause reactivation of hepatitis B virus in carriers, which in some cases can be potentially fatal.

Heart problems

• Inform your doctor if you have any heart problems, such as mild heart dysfunction (mild heart failure).
• Your doctor will want to closely monitor your heart.

Contact your doctor immediately if you notice new symptoms or worsening of heart dysfunction during treatment with Zessly. Symptoms include difficulty breathing or swelling in the feet.

Cancer and lymphoma

• Before receiving Zessly, inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Patients with severe rheumatoid arthritis, especially those who have had the disease for a long time, may have an increased risk of developing lymphoma.
• Children and adults treated with Zessly may have an increased risk of developing lymphoma or other types of cancer.
• Some patients receiving TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescent boys or young men, and the majority had Crohn’s disease or ulcerative colitis. This type of cancer is usually fatal. Almost all of these patients had also received azathioprine or 6-mercaptopurine in addition to TNF blockers.
• Some patients treated with infliximab have developed certain types of skin cancer. Inform your doctor if you notice changes in your skin or skin growths during or after treatment.
• Some women treated with infliximab for rheumatoid arthritis have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women treated with Zessly, including those over 60 years of age.

Lung disease or heavy smokers

• Before receiving Zessly, inform your doctor if you have a lung condition called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
• Patients with COPD and heavy smokers may have an increased risk of developing cancer during treatment with Zessly.

Nervous system disorders

• Inform your doctor if you have or have ever had a condition affecting your nervous system before receiving Zessly. This includes multiple sclerosis, Guillain-Barré syndrome, seizures, or a diagnosis of “optic neuritis.”

Contact your doctor immediately if you notice symptoms of a nervous system disorder during treatment with Zessly. Symptoms may 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 an abnormal skin ulcer (fistula) before receiving Zessly.

Vaccines

• Consult your doctor if you have recently received or need to receive a vaccine.

• Before starting treatment with Zessly, you should receive all recommended vaccines. You may receive some vaccines during treatment with Zessly, but you must not receive live microbial vaccines (vaccines containing a live but weakened infectious agent) while using Zessly, as they may cause infections.

• If you received Zessly during pregnancy, your baby may have an increased risk of infection from receiving live microbial vaccines during the first year of life. It is important to inform your baby’s doctors and other healthcare professionals about your Zessly treatment so they can determine when your baby can be vaccinated, including live microbial vaccines such as the BCG vaccine (used to prevent tuberculosis).

• If you are breastfeeding, it is important to inform your baby’s doctors and other healthcare professionals about your Zessly treatment before your baby is vaccinated. For more information, see the section on Pregnancy and breastfeeding.

Therapeutic infectious agents

• Inform your doctor if you have recently received or are scheduled to receive treatment with an infectious agent (such as BCG instillation used to treat cancer).

Surgery or dental procedures

• Inform your doctor if you are scheduled for surgery or a dental procedure.
• Inform your surgeon or dentist that you are being treated with Zessly and show them your patient information card.

Liver problems

• Some patients treated with medicines containing infliximab have developed serious liver problems.

Contact your doctor immediately if you notice symptoms of liver problems during treatment with Zessly. Symptoms may 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.

Low blood cell counts

• In some patients receiving treatment with medicines containing infliximab, the body may not produce enough blood cells needed to fight infections or stop bleeding.

Contact your doctor immediately if you notice symptoms of low blood cell counts during treatment with Zessly. Symptoms may include persistent fever, bleeding, easy bruising, small red or purple spots under the skin caused by bleeding, or paleness.

Immune system disorders

• Some patients treated with medicines containing infliximab have developed symptoms of an immune system disorder called lupus.

Contact your doctor immediately if you develop symptoms of lupus during treatment with Zessly. Symptoms may include joint pain or a rash on the cheeks or arms after sun exposure.

Children and adolescents

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

• Some children and adolescents treated with TNF blockers, such as infliximab, have developed cancers, including rare types, some of which have been fatal.
• More children treated with infliximab developed infections compared to adults.
• Children should receive all recommended vaccines before starting treatment with Zessly.

Children may receive some vaccines during treatment with Zessly, but they must not receive live microbial vaccines while using Zessly.

If you are unsure whether any of the above apply to you, consult your doctor before receiving Zessly.

Other medicines and Zessly

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

Inform your doctor if you are currently using or have recently used any other medicines, including other treatments for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or over-the-counter medicines such as vitamins or herbal remedies.

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

• Medicines that affect your immune system.
• Kineret (anakinra). Zessly and Kineret must not be used together.
• Orencia (abatacept). Zessly and Orencia must not be used together.

You must not receive live microbial vaccines while using Zessly. If you used Zessly during pregnancy or are receiving Zessly while breastfeeding, inform your baby’s doctor and other healthcare professionals about your Zessly treatment before your baby receives any vaccine.

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Zessly should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
• You should avoid becoming pregnant while being treated with Zessly and for 6 months after stopping treatment. Discuss contraceptive methods with your doctor during this time.
• If you received Zessly during pregnancy, your baby may have an increased risk of infection.
• It is important to inform your baby’s doctors and other healthcare professionals about your Zessly treatment before your baby is vaccinated. If you received Zessly during pregnancy, giving your baby the BCG vaccine (used to prevent tuberculosis) within 12 months after birth may cause infection with serious complications, including death. Live microbial vaccines such as BCG should not be given to your baby within 12 months after birth unless otherwise recommended by your baby’s doctor. For more information, see the section on Vaccines.
• If you are breastfeeding, it is important to inform your baby’s doctors and other healthcare professionals about your Zessly treatment before your baby is vaccinated. Live microbial vaccines should not be given to your baby while you are breastfeeding unless otherwise recommended by your baby’s doctor.
• In infants born to women treated with infliximab during pregnancy, a serious decrease in white blood cell count has been reported. If your baby has fever or recurrent infections, contact your baby’s doctor immediately.

Driving and using machines

It is unlikely that Zessly will affect your ability to drive or operate tools or machines. However, if you feel tired, dizzy, or unwell after receiving Zessly, do not drive or use tools or machines.

Zessly contains sodium

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

3. How to use Zessly

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 Zessly will be administered to you

• Zessly will be administered by your doctor or nurse.
• Your doctor or nurse will prepare the medicine for infusion.
• The medicine will be given as an intravenous infusion (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to administer your dose of Zessly over 1 hour.
• You will be monitored during administration of Zessly and for 1 to 2 hours afterwards.

How much Zessly will be administered to you

• Your doctor will decide your dose and how often you will receive Zessly. This will depend on your condition, body weight, and response to Zessly.
• The table below shows how often this medicine is usually administered after your first dose.

2nd dose	2 weeks after your 1st treatment
3rd dose	6 weeks after your 1st treatment
Further doses	Every 6 to 8 weeks, depending on your condition

Use in children and adolescents

Zessly should only be used in children if they are being treated for Crohn's disease or ulcerative colitis. These children must be 6 years of age or older.

If you are given too much Zessly

As this medicine is administered by your doctor or nurse, it is unlikely that you will be given too much Zessly. The adverse effects of an overdose of Zessly are unknown.

If you miss or do not attend your Zessly infusion

If you miss or do not attend an appointment to receive Zessly, schedule a new appointment as soon as possible.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. Most of the adverse effects are mild to moderate. However, some patients may experience serious adverse effects and may require treatment. Adverse effects may also occur after your treatment with Zessly has ended.

Tell 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, skin rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be serious or potentially fatal. An allergic reaction may occur within 2 hours of your injection or later. Additional signs of allergic adverse effects may occur up to 12 days after your injection, such as muscle pain, fever, joint or jaw pain, sore throat, or headache.
• • Signs of a heart problem such as chest pain or discomfort, arm pain, stomach pain, shortness of breath, anxiety, dizziness, fainting, sweating, nausea (feeling sick), vomiting, palpitations or pounding in the chest, fast or slow heartbeat, and swelling of the feet.
  • Signs of infection (including TB) such as fever, fatigue, persistent cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, abscesses or pus accumulation in the abdomen or around the anus, dental problems, or a 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 color, or unusual vaginal bleeding.
  • Signs of a lung problem such as cough, difficulty breathing, or chest tightness.
  • Signs of a nervous system problem (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 a severe headache), seizures, numbness/tingling anywhere in the body, weakness in arms or legs, vision changes such as double vision or other eye problems.
  • Signs of a liver problem (including hepatitis B infection, when 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 sun-sensitive rash on the cheeks or arms (lupus), or cough, difficulty breathing, fever, or skin rash (sarcoidosis).
  • Signs of low blood cell counts such as persistent fever, bleeding or bruising easily, small red or purple spots under the skin caused by bleeding, or paleness.
  • Signs of serious skin problems such as red, circular, target-like spots, often with central blisters on the trunk, large areas of peeling or sloughing 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.

Tell your doctor immediately if you notice any of the above.

The following adverse effects have been observed with medicines containing infliximab:

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
• Adverse reaction due to infusion
• Pain

Common (may affect up to 1 in 10 people)

• Changes in liver function, increased liver enzymes (shown in blood tests)
• Lung or chest infections such as bronchitis or pneumonia
• Difficulty or painful breathing, chest pain
• Bleeding in the stomach or intestines, diarrhea, indigestion, heartburn, constipation
• Hives (wheals), itchy skin rash or dry skin
• Balance problems or dizziness
• Fever, increased sweating
• Circulatory problems such as low or high blood pressure
• Bruising, flushing or nosebleeds, warmth, redness of the skin (rubefaction)
• Feeling tired or weak
• Bacterial infections such as sepsis, abscess, or skin infection (cellulitis)
• Fungal skin infection
• Blood problems such as anemia or low white blood cell count
• Swollen lymph nodes
• Depression, sleep problems
• Eye problems, including red eyes and infections
• Rapid 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
• Blood accumulation outside blood vessels (hematoma) or bruising
• Skin problems such as blisters, warts, abnormal skin color or pigmentation, swollen lips, skin thickening, redness, scaly or peeling skin
• Severe allergic reactions (e.g., anaphylaxis), immune system disorder called lupus, allergic reactions to foreign proteins
• Wounds that heal slowly
• Inflammation of the liver (hepatitis) or gallbladder, liver damage
• Feeling forgetful, irritable, confused, nervous
• Eye problems, including blurred or reduced vision, swollen eyes or styes
• Heart malfunction or worsening of existing heart condition, decreased heart rate
• Fainting
• Seizures, nerve problems
• Intestinal ulcer or intestinal obstruction, stomach pain or cramps
• Inflammation of the pancreas (pancreatitis)
• Fungal infections such as Candida infection or fungal nail infection
• Lung problems (such as edema)
• Fluid around the lungs (pleural effusion)
• Narrowing of the airways in the lungs, causing difficulty breathing
• Inflammation of the membrane protecting the lungs, causing severe chest pain that worsens with breathing (pleurisy)
• Tuberculosis
• Kidney infections
• Low platelet count, too many white blood cells in blood
• 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 small)

Rare (may affect up to 1 in 1,000 people)

• A type of blood cancer (lymphoma)
• Your blood does not supply enough oxygen to your body, circulatory problems such as narrowing of a blood vessel
• Inflammation of the membranes protecting the brain (meningitis)
• Infections due to a weakened immune system
• Hepatitis B infection, when 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 and eyes (jaundice)
• Swelling or abnormal tissue growth
• Severe allergic reaction that may cause loss of consciousness and may be potentially fatal (anaphylactic shock)
• Inflammation of small blood vessels (vasculitis)
• Immune system disorders that may affect the lungs, skin and lymph nodes (such as sarcoidosis)
• Accumulations of immune 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 generalized exanthematous pustulosis
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy red-purple rash and/or thick white-gray lines on mucous membranes), blisters and peeling of the skin, or boils (furunculosis)
• Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
• Inflammation in the eye that may cause vision changes, including blindness
• Fluid in the membrane protecting the heart (pericardial effusion)
• Serious lung problems (such as interstitial lung disease)
• Melanoma (a type of skin cancer)
• Cervical cancer
• Low blood cell counts, including a severe decrease in the number of white blood cells in blood
• Small red or purple spots caused by bleeding under the skin
• Abnormal values of a blood protein called “complement factor” which is part of the immune system

Frequency not known (frequency cannot be estimated from the available data)

• Cancer in children and adults
• A rare blood cancer affecting mainly young adolescent boys or young men (hepatosplenic T-cell lymphoma)
• Liver failure
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma usually presents more frequently as purplish skin lesions
• Worsening of a disease called dermatomyositis (manifested as a skin rash accompanied by muscle weakness)
• Heart attack
• Stroke
• Temporary loss of vision during or within 2 hours of infusion
• Infection due to a live microorganism vaccine because of a weakened immune system

Other adverse effects in children and adolescents

Children treated with infliximab for Crohn’s disease showed some differences in adverse effects compared to adults treated with infliximab for Crohn’s disease. The adverse effects that occurred more frequently in children were: low red blood cells (anemia), blood in stool, low total white blood cell counts (leukopenia), facial redness or flushing (rubefaction), viral infections, low levels of white blood cells fighting infection (neutropenia), bone fracture, bacterial infection, and allergic reactions of the respiratory tract.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zessly

Zessly is generally stored by healthcare professionals. If storage information is needed, the details 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 CAD or EXP. The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (2 °C - 8 °C).
• This medicine can also be stored in its original carton outside the refrigerator at temperatures up to 30 °C for a single period of up to six months, but not beyond the original expiry date. In this case, the medicine must not be returned to refrigerated storage. Write the new expiry date on the carton, including day/month/year. Discard this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.
• It is recommended that Zessly for infusion be used as soon as possible (within 3 hours). However, if the solution is prepared under aseptic conditions, it may be stored in a refrigerator at 2 °C to 8 °C for up to 24 hours.
• Do not use this medicine if there is any change in colour or if particles are present.

6. Contents of the pack and other information

Composition of Zessly

• 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 disodium succinate hexahydrate, succinic acid, sucrose and polysorbate 80 (see section 2).

Nature of the product and contents of the container

Zessly is presented as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate). The powder is white.

Zessly is available in packs of 1, 2, 3, 4 or 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer

Sandoz GmbH
Biochemiestr. 10
6336 Langkampfen
Austria

Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97	Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037
	Luxembourg/Luxembourg Sandoz nv/sa Tel/Tel.: +32 2 722 97 97
Czech Republic Sandoz s.r.o. Tel: +420 225 775 111	Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890
Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf: +45 63 95 10 00	Malta Sandoz Pharmaceuticals d.d. Tel: +35699644126
Germany Hexal AG Tel: +49 8024 908 0	Netherlands Sandoz B.V. Tel: +31 36 52 41 600
Estonia Sandoz d.d. Estonian branch Tel: +372 665 2400	Austria Sandoz GmbH Tel: +43 5338 2000
Greece SANDOZ HELLAS MONOPROSOPIKI EPE Tel: +30 216 600 5000	Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00
Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856	Portugal Sandoz Farmacêutica Lda. Tel: +351 21 000 86 00
France Sandoz SAS Tel: +33 1 49 64 48 00	Romania Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 60
Croatia Sandoz d.o.o. Tel: +385 1 23 53 111	Slovenia Sandoz pharmaceutical company d.d. Tel: +386 1 580 29 02
Ireland Rowex Ltd. Tel: +353 27 50077	Slovakia Sandoz d.d. - organizational unit Tel: +421 2 48200 600
Italy Sandoz S.p.A. Tel: +39 02 96541	Finland/Finland Sandoz A/S Puh/Tel: +358 10 6133 400
Cyprus Sandoz Pharmaceuticals d.d. Tel: +357 22 69 0690	United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2000
Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

This information is intended for healthcare professionals only:

Patients treated with infliximab should be given the patient information card.

Instructions for use and handling – storage conditions

Store at 2 °C–8 °C.

Zessly may be stored at temperatures up to a maximum of 30 °C for a single period of up to 6 months, but without exceeding the original expiry date. The new expiry date must be written on the carton. Once removed from refrigerated storage, Zessly must not be returned to refrigerated storage.

Instructions for use and handling – reconstitution, dilution, and administration

To improve traceability of biological medicines, the trade name and batch number of the administered medicine should be clearly recorded.

1. Calculate the dose and the number of Zessly vials required. Each Zessly vial contains 100 mg of infliximab. Calculate the total volume of reconstituted Zessly solution required.

2. Under aseptic conditions, reconstitute each Zessly vial with 10 ml of water for injections, using a syringe fitted with a 21-gauge (0.8 mm) or smaller needle. Remove the cap from the vial and clean the top with an alcohol swab (70% alcohol). Insert the needle of the syringe into the vial in the center of the rubber stopper and direct the water for injections against the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. The formation of foam during reconstitution is not uncommon. Allow the reconstituted solution to stand for 5 minutes. Check that the solution is colourless to light brown and opalescent. A few fine translucent particles may be visible in the solution, as infliximab is a protein. Do not use if the solution contains opaque particles, discoloration, or other foreign particles.

3. Dilute the total dose volume of reconstituted Zessly solution to 250 ml with 9 mg/ml (0.9%) sodium chloride solution for injection. Do not dilute the reconstituted Zessly solution with any other diluent. Dilution may be performed by removing from the glass bottle or infusion bag containing 250 ml of 9 mg/ml (0.9%) sodium chloride solution for injection a volume equal to the volume of reconstituted Zessly. Slowly add the total volume of reconstituted Zessly solution to the 250 ml infusion bottle or bag. Mix gently.

4. Administer the infusion solution over a period no shorter than the recommended infusion time. Use only an infusion set with a low protein-binding, non-pyrogenic, sterile filter (pore size 1.2 micrometres or smaller). As the product contains no preservatives, it is recommended that administration of the infusion solution begins as soon as possible and within 3 hours of reconstitution and dilution. When reconstitution and dilution are performed under aseptic conditions, the Zessly infusion solution may be used within 24 hours if stored at 2 °C–8 °C. Do not store any unused portion of the infusion solution for later use.

5. No physical or biochemical compatibility studies have been conducted to evaluate co-administration of Zessly with other agents. Do not administer Zessly concomitantly with other agents through the same intravenous line.

6. Prior to administration, visually inspect Zessly for particles or discoloration. Do not use if visible opaque particles, discoloration, or foreign particles are observed.

7. Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.