ZESSLY

Package leaflet: Information for the user

Zessly 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 Zessly.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What Zessly is and what it is used for
2. What you need to know before using Zessly
3. How to use Zessly
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 to a specific target in the body called tumour necrosis factor (TNF) alpha.
Zessly belongs to a group of medicines known as "TNF blockers". It is used in adults to treat the
following inflammatory diseases:

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

Zessly is also used in adults and children aged 6 years and older 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 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 Zessly 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 Zessly 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 Zessly to:

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

Psoriasis
Psoriasis is an inflammatory skin disease. 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 Zessly to reduce the signs
and symptoms of the disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. 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
Zessly to treat the disease.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. 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
Zessly 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 Zessly

Do not use Zessly 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.
• You have moderate or severe heart failure.

Do not use Zessly if any of the above conditions apply to you. If you are unsure, speak with 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 any medicine containing infliximab

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

Infections

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

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 been treated with anti-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 anti-TB medications before starting Zessly. Inform your doctor immediately if you notice signs of tuberculosis during treatment with Zessly. Signs include persistent cough, weight loss, feeling tired, fever, and night sweats.

Hepatitis B virus

• Inform your doctor before receiving Zessly 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 Zessly may cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can be fatal.

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 Zessly. Signs include shortness of breath or swelling in the feet.

Tumors and lymphoma

• Inform your doctor before receiving Zessly 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 Zessly 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 adolescent or young male patients, 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 6-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 Zessly, including women over 60 years of age.

Lung disease or heavy smokers

• Inform your doctor before receiving Zessly 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 Zessly.

Nervous system disorders

• Inform your doctor if you have or have had a nervous system disorder before receiving Zessly. 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 Zessly. 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 receiving Zessly.

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 Zessly. You may receive certain vaccines during treatment with Zessly, but you must not receive live vaccines (vaccines containing a live, but weakened, infectious agent) while being treated with Zessly, as they may cause infections.
• If you received Zessly 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 your pediatrician and other healthcare providers about your use of Zessly 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 your pediatrician and other healthcare providers about your use of Zessly before any vaccines are given to your baby. Live vaccines should not be given to your baby during breastfeeding unless otherwise recommended by the pediatrician. 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 to treat cancer).

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 Zessly, 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 Zessly. Symptoms 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 count

• 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 low blood cell count during treatment with Zessly. Symptoms include persistent fever, easy bleeding or bruising, small red or purple spots under the skin caused by 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 Zessly. 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 adolescent patients who have taken TNF-blocking medicines, such as infliximab, have developed tumors, 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 Zessly. Children may receive certain vaccines during treatment with Zessly, but they must not receive live vaccines while being treated with Zessly.

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

Other medicines and Zessly

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 Zessly treatment.

Inform your doctor if you are taking or have recently taken any other medicines, including 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 (anakinra). Zessly and Kineret must not be given together.
• Orencia (abatacept). Zessly and Orencia must not be given together.

Live vaccines must not be administered during treatment with Zessly. If you used Zessly during pregnancy or are receiving Zessly while breastfeeding, inform your pediatrician and other healthcare providers about your use of Zessly before any vaccines are given to your baby.

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Zessly should be used during pregnancy or breastfeeding only if your doctor considers it necessary.
• You should avoid becoming pregnant while being treated with Zessly 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 Zessly during pregnancy, your baby may have an increased risk of infection.
• It is important to inform your pediatrician and other healthcare providers about your use of Zessly before any vaccines are given to your baby. If you received Zessly during pregnancy, administering the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may result in infection with serious complications, including death. Live vaccines such as the BCG vaccine should not be given to your baby within 12 months after birth unless otherwise recommended by the pediatrician. (For more information, see the section on Vaccinations.)
• If you are breastfeeding, it is important to inform your pediatrician and other healthcare providers about your use of Zessly before any vaccines are given to your baby. Live vaccines should not be given to your baby during breastfeeding unless otherwise recommended by the pediatrician.
• 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

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

Zessly contains sodium

Zessly contains less than 1 mmol (23 mg) of sodium per dose, i.e., 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 is administered

• Zessly will be administered to you by a doctor or 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 infusion, your doctor may decide to administer the dose of Zessly over a period of 1 hour.
• You will be monitored during administration of Zessly and for 1–2 hours afterwards.

How much Zessly is administered

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

Use in children and adolescents
Zessly should be used in children only for Crohn's disease or ulcerative colitis. These children must be at least 6 years of age.
If you are given more Zessly than you should have
Since this medicine is administered to you by a doctor or nurse, it is unlikely that you will receive too much. Undesirable effects following an overdose of Zessly are not known.
If you forget or miss an infusion of Zessly
If you forget or miss an appointment for Zessly 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 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 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, 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 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 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 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 a 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 in 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 or 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 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, 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.

Tell your doctor immediately if you notice any of the symptoms described above.
The following side effects have been observed with infliximab:
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
• Side effect due to 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
• 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 (flushing)
• Feeling tired or weak
• Bacterial infections such as systemic infection, abscess or skin infection (cellulitis)
• Fungal infection of the skin
• Blood disorders 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
• Blood collection outside blood vessels (haematoma) or bruising
• Skin problems such as blistering, warts, abnormal skin colouring or pigmentation, swollen lips, 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 (pleuritis)
• 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 (for most patients, weight gain has been 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 lining the brain (meningitis)
• Infections due to 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 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 generalised pustular exanthema
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish/violet rash and/or white-grey thread-like lines on mucous membranes), 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.

Not known: frequency cannot be estimated from the available data

• Tumours 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 appears as purple lesions on the skin
• Worsening of a condition called dermatomyositis (appears 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.

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 taking infliximab for Crohn’s disease.
Side effects occurring more frequently in children were: low red blood cell count (anaemia), blood in stools, low overall white blood cell count (leucopenia), paleness or flushing (hot flushes), viral infections, low count of infection-fighting white blood cells (neutropenia), bone fracture, bacterial infection and allergic respiratory reactions.
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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Zessly

Zessly will generally be stored by healthcare personnel. 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 (2 °C - 8 °C).
• This medicine may also be stored in the original carton outside the refrigerator at temperatures not exceeding 30 °C for a single period of up to six months, provided this does not extend 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 Zessly is prepared for infusion, it is recommended to use it as soon as possible (within 3 hours). However, if the solution is prepared under conditions of complete asepsis, it may be stored in the refrigerator for up to 24 hours at 2 °C - 8 °C.
• Do not use this medicine if it has discolored or if particles are present.

6. Package contents and other information

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

Description of the appearance of Zessly and contents of the pack
Zessly is supplied 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

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

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf: +45 63 95 10 00 Tel: +35699644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz farmacevtska družba d.d.
Sandoz d.o.o.
Tel: +386 1 580 29 02
Tel: +385 1 23 53 111

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
Sandoz Pharmaceuticals d.d. Sandoz GmbH
Τηλ: +357 22 69 0690 Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

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 exclusively for healthcare professionals:

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

Instructions for use and handling – Storage conditions

Store at 2 °C – 8 °C.
Zessly may be stored at temperatures not exceeding 30 °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 recorded on the carton. After removal from the refrigerator, Zessly must not be returned to refrigerated storage.

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

1. Calculate the required dose and number of Zessly vials needed. 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 aluminium cap and disinfect the rubber stopper with a cotton swab soaked in 70% alcohol. Insert the needle through the center of the rubber stopper and direct the stream of Water for Injections against 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 brown and opalescent; the solution may contain a few small translucent particles, as infliximab is a protein. Do not use the solution if opaque particles, discoloration or foreign matter are observed.
3. Dilute the total volume of the reconstituted Zessly solution to 250 ml using a 9 mg/ml (0.9%) sodium chloride solution for injection. Do not dilute the reconstituted Zessly solution with any other diluent. The dilution may be performed by withdrawing from the glass vial or the 250 ml infusion bag a volume of 9 mg/ml (0.9%) sodium chloride solution for injection equal to the volume of reconstituted Zessly. Slowly add the total volume of reconstituted Zessly solution to the vial or 250 ml infusion bag. Mix gently.
4. Administer the infusion solution over a period not shorter than the recommended infusion time. Use only an infusion set with an in-line sterile, non-pyrogenic filter with low protein binding capacity (pore size 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 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. Any unused solution must not be stored for later use.
5. No physical and biochemical compatibility studies have been conducted to evaluate the co-administration of Zessly with other agents. Do not administer Zessly concomitantly with other medicinal products in the same intravenous line.
6. Before administration, visually inspect Zessly for the presence of particles or discoloration. If opaque particles, discoloration or foreign particles are observed, do not use the solution.
7. Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.