Remicade 100 mg powder for concentrate for solution for infusion: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Remicade 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; you may need to read it again.
Your doctor will also provide you with a patient information card containing important safety information you need to know before and during your treatment with Remicade.
If you have any questions, consult your doctor.
This medicine has been prescribed for you only, and you should not give it 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

What Remicade is and what it is used for
What you need to know before using Remicade
How Remicade is administered
Possible adverse effects
How to store Remicade
Contents of the pack and other information

1. What Remicade is and what it is used for

Remicade 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.

Remicade 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

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

Crohn's disease
Ulcerative colitis

Remicade 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 Remicade 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 joint disease, 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 Remicade 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 Remicade to:

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

Psoriasis

Psoriasis is an inflammatory skin disease. 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 Remicade 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 Remicade 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 Remicade to:

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

2. What you need to know before using Remicade

Do not use Remicade if:

You are allergic to infliximab or to any of the other components of Remicade (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 septicemia.
You have moderate or severe heart failure (impaired heart function).

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

Warnings and precautions

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

You have previously received treatment with Remicade

Inform your doctor if you have previously been treated with Remicade and are now restarting treatment with Remicade.

If you have interrupted treatment with Remicade for more than 16 weeks, there is an increased risk of allergic reactions when restarting treatment.

Infections

Before receiving Remicade, inform your doctor if you have an infection, even if it is very mild.
Before receiving Remicade, inform your doctor if you have ever lived in or traveled to areas where 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 your body.
You may be more susceptible to infections while being treated with Remicade. If you are over 65 years of age, your risk is higher.
These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other environmental organisms, and septicemia, which can potentially be fatal.

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

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 Remicade, including in patients who have previously been treated with TB medications. 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 Remicade.

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

Hepatitis B virus

Before receiving Remicade, 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 the hepatitis B virus.
Treatment with TNF blockers, such as Remicade, may cause reactivation of the hepatitis B virus in carriers of this virus, 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.

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

Cancer and lymphoma

Before receiving Remicade, 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 who have had the disease for a long time may have an increased risk of developing lymphoma.
Children and adults treated with Remicade may have an increased risk of developing lymphoma or other types of cancer.
Some patients who have received TNF blockers, including Remicade, 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 Remicade for rheumatoid arthritis have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women treated with Remicade, including those over 60 years of age.

Lung disease or heavy smokers

Before receiving Remicade, inform your doctor if you have a lung disease 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 with Remicade treatment.

Nervous system disorders

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

Immediately inform your doctor if you notice symptoms of a nervous system disorder during treatment with Remicade. Symptoms may include changes in vision, weakness in arms or legs, numbness or tingling anywhere in your body.

Abnormal skin openings

Inform your doctor if you have an abnormal skin ulcer (fistula) before receiving Remicade.

Vaccinations

Consult your doctor if you have recently received or need to receive a vaccine.
Before starting treatment with Remicade, you should receive all recommended vaccines. You may receive some vaccines during treatment with Remicade, but you must not receive live microbial vaccines (vaccines containing a live but weakened infectious agent) while using Remicade, as they may cause infections.
If you received Remicade while pregnant, your baby may also have an increased risk of infection from receiving a live microbial vaccine during the first year of life. It is important to inform your baby’s doctors and other healthcare professionals about your Remicade treatment so they can decide 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 Remicade 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 in cancer treatment).

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 Remicade and show them your patient information card.

Liver problems

Some patients who received Remicade have developed serious liver problems.

Immediately inform your doctor if you notice symptoms of liver problems during treatment with Remicade. 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 rashes, or fever.

Low blood cell counts

In some patients receiving Remicade, the body may not produce enough blood cells that help fight infections or stop bleeding.

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

Immune system disorder

Some patients who received Remicade have developed symptoms of an immune system disorder called lupus.

Immediately inform your doctor if you develop symptoms of lupus during treatment with Remicade. 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 Remicade, have developed cancers, including rare types, some of which have been fatal.
More children treated with Remicade developed infections compared to adults.
Children should receive all recommended vaccines before starting treatment with Remicade. Children may receive some vaccines during treatment with Remicade, but they must not receive live microbial vaccines while using Remicade.

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

Other medicines and Remicade

Patients with inflammatory conditions may already be taking medications to treat their condition. These medications may cause adverse effects. Your doctor will advise you on which other medications you should continue using while on Remicade treatment.

Inform your doctor if you are taking or have recently taken 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:

Medications that affect your immune system.
Kineret (anakinra). Remicade and Kineret should not be used together.
Orencia (abatacept). Remicade and Orencia should not be used together.

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

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. Remicade should only be used during pregnancy or breastfeeding if your doctor considers it necessary for you.
You should avoid becoming pregnant while being treated with Remicade and for 6 months after stopping treatment. Discuss contraceptive use during this time with your doctor.
If you received Remicade 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 Remicade treatment before your baby is vaccinated. If you received Remicade during pregnancy, administering the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may lead to serious complications, including death. Live microbial vaccines such as the BCG vaccine 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 Vaccinations.
If you are breastfeeding, it is important to inform your baby’s doctors and other healthcare professionals about your Remicade 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 Remicade during pregnancy, a severe decrease in white blood cell count has been reported. If your baby has persistent fevers or infections, contact your baby’s doctor immediately.

Driving and use of machines

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

Remicade contains sodium

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

Remicade contains polysorbate 80

This medicine contains 0.50 mg of polysorbate 80 (E433) per dose, equivalent to 0.05 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How Remicade will be administered to you

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 Remicade will be administered to you

Remicade 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 Remicade dose over 1 hour.
You will be monitored during the administration of Remicade and for 1 to 2 hours afterwards.

How much Remicade will be administered to you

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

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

Use in children and adolescents

Remicade 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 Remicade

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

If you miss or do not attend your Remicade infusion

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most 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 Remicade has ended.

Tell your doctor immediately if you notice any of the following:

Signs of an allergic reaction such as swelling of your 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 infusion or later. Additional signs of allergic adverse reactions may occur up to 12 days after your infusion, 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, difficulty breathing, anxiety, dizziness, lightheadedness, fainting, sweating, nausea, 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, wounds, pus accumulation in the abdomen 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 nodules, changes in moles or skin coloration, 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 in the face, arm or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; vision problems in one or both eyes; difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, numbness/tingling anywhere in the body, weakness in arms or legs, vision disturbances such as double vision, or other eye problems.
Signs of a liver problem (including hepatitis B infection, when you have had hepatitis B previously) 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 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 caused by bleeding under the skin, or paleness.
Signs of serious skin problems such as ring-shaped red patches, often with central blisters on the trunk, large areas of peeling and shedding skin, mouth, throat, nose, genital or eye ulcers, or small pus-filled bumps that may spread over the body. These skin reactions may be accompanied by fever.

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

The following adverse effects have been observed with Remicade:

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-like rash (wheals), itchy 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 (rubor)
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 coloration 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 blockage, 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 lung, 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 had hepatitis B previously
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 reddish-purple rash and/or thick white-gray lines on mucous membranes), blisters and skin peeling, or boils (furunculosis)
Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like illness, 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 the 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 available data

Cancer in children and adults
A rare blood cancer affecting mainly 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 appears 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 live microorganism vaccines due to a weakened immune system
Problems following a medical procedure (including infectious and non-infectious complications).

Other adverse effects in children and adolescents

Children treated with Remicade for Crohn's disease showed some differences in adverse effects compared to adults treated with Remicade for Crohn's disease. 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 (rubor), viral infections, low levels of infection-fighting white blood cells (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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Remicade

Remicade is generally stored by healthcare professionals. If you require storage information, 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 the 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 may also be stored in its original carton at room temperature not exceeding 25 °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. Dispose of this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever comes first.
It is recommended that Remicade, once prepared for infusion, be used as soon as possible (within 3 hours). However, if the solution is prepared under aseptic conditions, it may be stored refrigerated between 2 °C and 8 °C for up to 28 days and for an additional 24 hours at 25 °C once removed from the refrigerator.
Do not use this medicine if there is any change in colour or presence of particles.

6. Contents of the container and additional information

Composition of Remicade

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 hydrogen phosphate, sodium dihydrogen phosphate, polysorbate 80 (E433), and sucrose (see ‘‘Remicade contains polysorbate 80’’ in section 2).

Presentation of the product and contents of the container

Remicade is supplied as a glass vial containing a lyophilized white granular powder for concentrate for solution for infusion.

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

Marketing Authorization Holder and Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

The Netherlands

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

Belgium/Belgium/Belgium

Janssen-Cilag NV

Tel/Tel: +32 14 64 94 11