Truxima

Package leaflet: Information for the patient

Truxima 100 mg concentrate for solution for infusion, 500 mg concentrate for solution for infusion

rituximab
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Truxima is and what it is used for

What Truxima is
Truxima contains the active substance "rituximab", a type of protein called a "monoclonal antibody" designed to bind to specific white blood cells, namely the "B-lymphocytes". When it binds to the surface of these cells, rituximab causes their death.

What Truxima is used for
Truxima can be used to treat a variety of conditions in adults and children. Your doctor may prescribe Truxima for the treatment of:

a) Non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma is a disease of the lymphatic tissue (part of the immune system) that involves B-lymphocytes, a specific type of white blood cell.
In adults, Truxima may be given as monotherapy (alone) or in combination with other medicines collectively referred to as "chemotherapy".
In adult patients who respond to treatment, Truxima may be used as maintenance therapy for up to 2 additional years after completion of initial treatment.
In children and adolescents, Truxima is administered in combination with "chemotherapy".

b) Chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL affects a specific type of lymphocyte, the B-cell, which originates in the bone marrow and matures in the lymph nodes. Patients with CLL have too many abnormal lymphocytes that accumulate mainly in the bone marrow and blood. The proliferation of these abnormal B-lymphocytes causes the symptoms you may experience. Truxima, in combination with chemotherapy, destroys these cells, which are then gradually eliminated from the body through biological processes.

c) Rheumatoid arthritis
Truxima is used to treat rheumatoid arthritis. Rheumatoid arthritis is a disease affecting the joints. B-lymphocytes are responsible for some of the symptoms you experience. Truxima is used to treat rheumatoid arthritis in patients who have already tried other medicines that either stopped working, were not effective enough, or caused undesirable side effects. Truxima is usually taken in combination with another medicine called methotrexate.
Truxima slows down joint damage caused by rheumatoid arthritis and improves the ability to perform normal daily activities.
The best response to Truxima is observed in patients who have positive blood tests for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and help confirm the diagnosis.

d) Granulomatosis with polyangiitis and microscopic polyangiitis
Truxima is used to treat adults and children aged 2 years and older with granulomatosis with polyangiitis (previously known as Wegener’s disease) or microscopic polyangiitis, in combination with corticosteroids.
Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of blood vessel inflammation that primarily affect the lungs and kidneys, but may also involve other organs. B-lymphocytes play a role in causing these conditions.

e) Pemphigus vulgaris
Truxima is used to treat patients with moderate to severe pemphigus vulgaris. Pemphigus vulgaris is an autoimmune disease that causes painful blisters to form on the skin and mucous membranes (lining tissues) of the mouth, nose, throat, and genitals.

2. What you need to know before using Truxima

Do not take Truxima:

• if you are allergic to rituximab, to other proteins similar to rituximab, or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have a severe active infection;
• if your immune system is weakened;
• if you have severe heart failure or uncontrolled severe heart disease and you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris.

Do not take Truxima if any of the above conditions apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before receiving Truxima.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Truxima:

• if you have previously had hepatitis infection or might currently have it, as in some cases Truxima could cause reactivation of hepatitis B, which in very rare cases can be fatal. Patients who have previously had hepatitis B infection will be closely monitored by the doctor for any signs of this infection;
• if you have previously had heart problems (such as angina, palpitations, or heart failure) or respiratory problems.

If any of the above conditions apply to you (or if you have any doubts), talk to your doctor, pharmacist, or nurse before receiving Truxima. Your doctor may need to take special care during treatment with Truxima.
If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or
pemphigus vulgaris, talk to your doctor

• if you think you have an infection, even a mild one such as a cold. The cells affected by Truxima are important for fighting infections, and you should wait until the infection has resolved before taking Truxima. Also, inform your doctor if you have had frequent infections in the past or suffer from severe infections;
• if you think you may need any vaccination soon, including travel vaccinations. Some vaccines should not be given at the same time as Truxima or in the months following Truxima treatment. Your doctor will assess whether you can receive any vaccine before starting Truxima.

Children and adolescents
Non-Hodgkin’s lymphoma
Truxima may be used to treat children and adolescents aged 6 months and older with non-Hodgkin’s lymphoma, specifically diffuse large B-cell lymphoma (DLBCL), CD20-positive Burkitt lymphoma (BL)/Burkitt leukemia (mature B-cell acute leukemia; BAL), or Burkitt-like lymphoma (BLL).
Talk to your doctor, pharmacist, or nurse before administering this medicine if you or your child are under 18 years of age.
Granulomatosis with polyangiitis or microscopic polyangiitis
Truxima may be used to treat children and adolescents aged 2 years and older with granulomatosis with polyangiitis (previously called Wegener’s disease) or microscopic polyangiitis. Currently, limited information is available on the use of Truxima in children and adolescents with other diseases.
Talk to your doctor, pharmacist, or nurse before administering this medicine if you or your child are under 18 years of age.
Other medicines and Truxima
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines, as Truxima may affect how some medicines work and vice versa.
In particular, inform your doctor:

• if you are taking medicines for high blood pressure. You may be advised not to take these medicines within the 12 hours before receiving Truxima, as some people experience a drop in blood pressure during Truxima infusion;
• if you have previously taken medicines that affect the immune system—such as chemotherapy or immunosuppressive drugs.

If any of the above conditions apply to you (or if you have any doubts), talk to your doctor, pharmacist, or nurse before receiving Truxima.
Pregnancy, breastfeeding, and fertility
You must inform your doctor or nurse if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as Truxima can cross the placenta and may affect the unborn child.
If you could become pregnant during treatment with Truxima and within 12 months after the last dose of Truxima, you and your partner must use an effective method of contraception.
Truxima passes into breast milk in very small amounts. As the long-term effects on infants breastfed during treatment are unknown, for precautionary reasons, breastfeeding is not recommended during treatment with Truxima and for 6 months after treatment with Truxima.
Driving and using machines
Rituximab does not affect or has a negligible effect on the ability to drive or operate machinery.
Truxima contains sodium
This medicine contains 52.6 mg of sodium (a key component of table salt) per 10 mL vial and 263.2 mg of sodium per 50 mL vial, equivalent to 2.6% (for the 10 mL vial) and 13.2% (for the 50 mL vial) of the maximum daily recommended dietary sodium intake for an adult.

3. How to take Truxima

How Truxima is administered
Truxima will be administered to you by a doctor or a nurse experienced in the use of this treatment.
They will closely monitor you during the administration of the medicine in order to detect any possible
adverse reactions.
Truxima is always administered as an intravenous infusion (slow infusion into a vein).

Medicines given before each Truxima infusion
Before each Truxima infusion, you will be given other medicines (premedication) to prevent or reduce
the occurrence of possible side effects.

Dose and frequency of treatment

a) If you are being treated for non-Hodgkin's lymphoma

• If you are receiving Truxima alone
  Truxima will be given once weekly for 4 weeks. Repeated cycles of Truxima treatment may be possible.
• If you are receiving Truxima in combination with chemotherapy
  You will receive Truxima on the same day as your chemotherapy; administration usually occurs every 3 weeks, for up to 8 cycles.
• If you respond well to treatment, Truxima may be given as maintenance therapy every 2 or 3 months for 2 years. Depending on your response to the medicine, your doctor may modify this treatment schedule.
• If you are under 18 years of age, Truxima will be given in combination with chemotherapy. You will receive Truxima up to 6 times over a period of 3.5 to 5.5 months.

b) If you are being treated for chronic lymphocytic leukemia
If you are being treated with Truxima in combination with chemotherapy, you will receive Truxima infusions on day 0 of cycle 1, then on day 1 of each subsequent cycle, for a total of 6 cycles. Each cycle lasts 28 days. Chemotherapy must be administered after the Truxima infusion. Your doctor will decide whether you need to receive concomitant supportive therapy.

c) If you are being treated for rheumatoid arthritis
Each treatment cycle consists of two separate infusions given 2 weeks apart. Repeated cycles of Truxima treatment may be possible. Based on your disease signs and symptoms, your doctor will determine when to administer further Truxima cycles. This may occur several months apart.

d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Treatment with Truxima consists of four separate infusions given weekly. A corticosteroid will be administered by injection before starting Truxima treatment. Oral corticosteroid therapy may be initiated at any time by your doctor to manage your condition.
If you are 18 years of age or older and respond well to treatment, Truxima may be given as maintenance therapy. This will consist of two separate infusions given 2 weeks apart, followed by an infusion every 6 months for at least 2 years. Depending on your response to the medicine, your doctor may decide to extend Truxima treatment (up to a maximum duration of 5 years).

e) If you are being treated for pemphigus vulgaris
Each treatment cycle consists of two separate infusions given 2 weeks apart. If you respond well to treatment, Truxima may be given as maintenance therapy at 1 year and 18 months after initial treatment, and subsequently, if necessary, every 6 months. Depending on your response to the medicine, your doctor may modify this dosing schedule.

If you have any further questions about the use of this medicine, please ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild or moderate, but in some cases they may be severe and require treatment. Rarely, some of these reactions have been fatal.

Infusion reactions
During or within the first 24 hours after the infusion, you may develop fever, chills and tremors. Less frequently, some patients may experience pain at the infusion site, blistering, itching, feeling unwell (nausea), fatigue, headache, breathing difficulties, increased blood pressure, wheezing, throat irritation, swelling of the tongue or throat, itchy or runny nose, vomiting, redness or palpitations, heart attack or reduced platelet count. If you have heart disease or angina, these reactions may worsen. If you or your child experiences any of these symptoms, inform immediately the person administering the infusion, as it may be necessary to slow down or stop the infusion. Additional treatment may be required, for example with an antihistamine or paracetamol. Once these symptoms have resolved or improved, the infusion may be resumed. These reactions are less likely to occur after the second infusion. If these reactions are severe, your doctor may decide to discontinue treatment with Truxima.

Infections
Inform your doctor immediately if you or your child shows signs of infection, including:

• fever, cough, sore throat, burning when urinating, feeling weak or generally unwell;
• memory loss, thinking disturbances, difficulty walking or loss of vision – these may be due to a very rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML);
• fever, headache and neck stiffness, lack of coordination (ataxia), personality changes, hallucinations, altered consciousness, seizures or coma – these may be due to a serious brain infection (enteroviral meningoencephalitis), which can be fatal.

You may be more prone to infections during treatment with Truxima.
These are often colds, but cases of pneumonia, urinary tract infections and serious viral infections have also occurred. These conditions are listed below under the section “Other side effects”.
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will find this information also in the Patient Alert Card that will be given to you by your doctor. It is important that you carry this alert card with you and show it to family members or anyone caring for you.

Skin reactions
Very rarely, serious skin reactions with blistering may occur, which can be life-threatening. Redness, often associated with blistering, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area or around the eyelids, and fever may occur. Inform your doctor immediately if any of these symptoms occur.

Other side effects

a) If you or your child is being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukemia

Very common side effects (may affect more than 1 in 10 people):

• bacterial or viral infections, bronchitis
• low white blood cell count, with or without fever, or low platelet count (blood cells)
• feeling unwell (nausea)
• areas of hair loss on the scalp, chills, headache
• weakened immune system – due to a reduction in the blood levels of certain antibodies called “immunoglobulins” (IgG), which help the body protect itself from infections.

Common side effects (may affect up to 1 in 10 people):

• blood infections (sepsis), lung infection, shingles (herpes zoster), common cold, bronchial infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
• low red blood cell count (anaemia), low count of all blood cells
• allergic reactions (hypersensitivity)
• high blood sugar levels, weight loss, facial and body swelling, elevated levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low blood calcium levels
• abnormal skin sensations – such as numbness, tingling, prickling, burning, feeling of stretched skin, reduced sense of touch
• restlessness, difficulty sleeping
• marked redness of the face and other areas of the skin, due to dilation of blood vessels
• dizziness or anxiety
• increased tearing, tear duct problems, inflamed eye (conjunctivitis)
• ringing or noises in the ears, ear pain
• heart problems – such as heart attack and irregular or rapid heartbeat
• high or low blood pressure (decreased blood pressure, especially when standing)
• muscle tension in the airways causing wheezing (bronchospasm), inflammation or irritation of the lungs, throat or sinuses, shortness of breath, runny nose
• feeling unwell, vomiting, diarrhoea, stomach pain, irritation or ulcers in the throat and mouth, swallowing difficulties, constipation, indigestion
• eating disorders: inadequate food intake leading to weight loss
• hives, increased sweating, night sweats
• muscle problems – such as muscle tension, joint or muscle pain, back and neck pain
• general discomfort, malaise or fatigue, tremors, flu-like symptoms
• multi-organ failure.

Uncommon side effects (may affect up to 1 in 100 people):

• blood clotting problems, reduced production of red blood cells and increased destruction of red blood cells (aplastic haemolytic anaemia), swelling or enlarged lymph nodes
• depressed mood and loss of interest or pleasure in activities, nervousness
• taste disturbances – such as altered sense of taste
• heart problems – such as slow heart rate or chest pain (angina)
• asthma, insufficient oxygen supply to body organs
• stomach swelling.

Very rare side effects (may affect up to 1 in 10,000 people):

• temporary increase in certain types of antibodies (called immunoglobulins - IgM) in the blood, chemical changes in the blood due to the breakdown of dying tumour cells
• nerve damage in arms and legs, facial paralysis
• heart failure
• inflammation of blood vessels, including those causing skin symptoms
• respiratory failure
• damage to the intestinal wall (perforation)
• serious skin problems with blistering, which may be life-threatening. Redness, often associated with blistering, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area or around the eyelids, and fever may occur
• kidney failure
• severe loss of vision

Not known (frequency cannot be estimated from the available data):

• delayed reduction in white blood cells
• reduced platelet count shortly after infusion – a condition that may be reversible, but in rare cases life-threatening
• hearing loss, loss of other senses
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis)

Children and adolescents with non-Hodgkin’s lymphoma
In general, the side effects observed in children and adolescents with non-Hodgkin’s lymphoma have been similar to those seen in adults with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia. The most commonly observed side effects were fever associated with low levels of a type of white blood cell (neutrophils), inflammation or mouth ulcers (aphthae) affecting the lining of the mouth, and allergic reactions (hypersensitivity).

b) If you are being treated for rheumatoid arthritis

Very common side effects (may affect more than 1 in 10 people):

• lung infections (bacterial)
• pain when urinating (urinary tract infection)
• allergic reactions, which are likely to occur during infusion but may occur up to 24 hours after infusion
• changes in blood pressure, nausea, skin rashes, fever, itching, stuffy or runny nose, sneezing, tremors, rapid heartbeat and fatigue
• headache
• changes in laboratory tests required by your doctor. These include a reduction in specific proteins in the blood (immunoglobulins) that help protect against infections.

Common side effects (may affect up to 1 in 10 people):

• infections such as bronchial inflammation (bronchitis)
• a feeling of fullness or pulsating pain behind the nose, cheeks and eyes (sinusitis), abdominal pain, vomiting and diarrhoea, breathing problems
• fungal foot infection (athlete’s foot)
• high cholesterol levels in the blood
• abnormal skin sensations, such as numbness, tingling, prickling or burning, sciatica, migraine, dizziness
• hair loss
• anxiety, depression
• indigestion, diarrhoea, acid reflux, irritation and/or ulceration of the throat and mouth
• stomach, back, muscle and/or joint pain.

Uncommon side effects (may affect up to 1 in 100 people):

• fluid retention in the face and body
• inflammation, irritation and/or tension in the lungs, throat, cough
• skin reactions, including hives, itching, rashes
• allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse.

Very rare side effects (may affect up to 1 in 10,000 people):

• a complex of symptoms occurring within a few weeks after Truxima infusion, including allergic-type reactions such as skin rashes, itching, joint pain, swollen lymph glands and fever
• serious skin reactions with blistering that may be life-threatening. Redness, often associated with blistering, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area or around the eyelids, and fever may occur.

Not known (frequency cannot be estimated from the available data):

• Serious viral infections
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis)

Other side effects rarely reported with Truxima treatment include a reduction in the number of white blood cells (neutrophils) in the blood, which are needed to fight infections. Some infections may be serious (please refer to the information on Infections within this section).

c) If you or your child is being treated for granulomatosis with polyangiitis or microscopic polyangiitis

Very common side effects (may affect more than 1 in 10 people):

• infections, such as chest infections, urinary tract infections (pain when urinating), colds and herpes infections
• allergic reactions which are likely to occur during infusion but may occur up to 24 hours after infusion
• diarrhoea
• cough or shortness of breath
• nosebleeds
• increased blood pressure
• joint or back pain
• muscle cramps or tremors
• dizziness
• tremors (often in the hands)
• difficulty sleeping (insomnia)
• swelling of the hands and ankles.

Common side effects (may affect up to 1 in 10 people):

• indigestion
• constipation
• skin rashes, including acne or spots
• redness or flushing of the skin
• fever
• stuffy or runny nose
• muscle tension or muscle pain
• pain in muscles or in hands or feet
• low red blood cell count (anaemia)
• low platelet count in the blood
• increased potassium levels in the blood
• changes in heart rhythm or rapid heartbeat.

Very rare side effects (may affect up to 1 in 10,000 people):

• serious skin reactions with blistering that may be life-threatening. Redness, often associated with blistering, may appear on the skin or mucous membranes, such as inside the mouth, in the genital area or around the eyelids, and fever may occur
• reactivation of a previous hepatitis B infection.

Not known (frequency cannot be estimated from the available data):

• Serious viral infections
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis)

Children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis
In general, the side effects in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis have been similar in type to those observed in adults with granulomatosis with polyangiitis or microscopic polyangiitis. The most frequently observed side effects were infections, allergic reactions and nausea.

d) If you are being treated for pemphigus vulgaris

Very common side effects (may affect more than 1 in 10 people):

• allergic reactions which are likely to occur during infusion but may occur up to 24 hours after infusion
• headache
• infections, such as chest infections
• persistent depression
• hair loss.

Common side effects (may affect up to 1 in 10 people):

• infections, such as common cold, herpes infections, eye infection, oral thrush and urinary tract infections (pain when urinating)
• mood disorders, such as irritability and depression
• skin conditions, such as itching, hives and benign nodules
• fatigue or dizziness
• fever
• joint or back pain
• abdominal pain
• muscle pain
• increased heart rate.

Not known (frequency cannot be estimated from the available data):

• Serious viral infections
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis)

Truxima may also cause changes in laboratory tests required by your doctor.
If you are taking Truxima in combination with other medicines, some of the side effects you experience may be due to the other medicines.

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 Truxima

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after
Exp. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C – 8 °C). Keep the vial in the outer packaging to protect the
medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Truxima contains

• The active substance in Truxima is rituximab. The 10 mL vial contains 100 mg of rituximab (10 mg/mL). The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
• The excipients are sodium chloride, disodium citrate dihydrate, polysorbate 80 and water for injections (see section 2 “Truxima contains sodium”).

Description of the appearance of Truxima and contents of the pack
Truxima is a clear, colourless solution supplied as a concentrate for infusion solution.
The 10 mL vials are available in packs of 2 vials.
The 50 mL vials are available in packs of 1 vial.

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

Manufacturer
Millmount Healthcare Ltd.
Block 7, City North Business Campus,
Stamullen, Co. Meath K32 YD60, Ireland
Nuvisan GmbH
Wegenerstrasse 13, Ludwigsfeld
89231 Neu-Ulm, Bavaria
Germany
Nuvisan France SARL
2400, Route des Colles, 06410, Biot,
France
KYMOS S.L.
Ronda de Can Fatjó, 7B Parc Tecnològic del Vallès
08290 – Cerdanyola del Vallès, Barcelona,
Spain
Midas Pharma GmbH
Rheinstrasse 49, West Ingelheim Am Rhein,
Rhineland-Palatinate 55218 Ingelheim,
Germany

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

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

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

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

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

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

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

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

España Polska
Kern Pharma, S.L. Celltrion Healthcare Hungary Kft.
Tel: +34 93 700 2525 Tel: +36 1 231 0493

France Portugal
CELLTIRION HEALTHCARE FRANCE SAS PharmaKERN Portugal – Produtos Farmacêuticos,
Tél: +33 (0)1 71 25 27 00 Sociedade Unipessoal, Lda.
Tel: +351 214 200 290

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

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

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

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L Orion Pharma
Tel: +39 0247 927040 Puh/Tel: + 358 10 4261
[email protected]

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

Latvija United Kingdom (Northern Ireland)
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Ireland Limited
Tel: +36 1 231 0493 Tel: +353 1 223 4026
[email protected]

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