REMICADE

Package leaflet: Information for the user

Remicade 100 mg powder for concentrate for solution for infusion

infliximab
Please read this leaflet carefully before 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 reminder card containing important safety information that you must be aware of before and during treatment with Remicade.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What Remicade is and what it is used for
2. What you need to know before using Remicade
3. How to use Remicade
4. Possible side effects
5. How to store Remicade
6. 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 to treat 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 the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have rheumatoid arthritis, you will initially be treated with other medicines. If these medicines do not work adequately, you will be treated with Remicade 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 have psoriatic arthritis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remicade 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 have ankylosing spondylitis, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remicade to:

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

Psoriasis
Psoriasis is an inflammatory disease of the skin. If you have 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 Remicade to reduce the signs and symptoms of the disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be treated with other medicines. If these medicines do not work adequately, Remicade will be administered to treat the disease.

Crohn's disease
Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be treated with other medicines. If these medicines do not work adequately, you will be treated with Remicade 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 Remicade

Do not use Remicade 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 Remicade if any of the above conditions apply to you. If you are unsure,
speak with your doctor before being administered Remicade.
Warnings and precautions
Talk to your doctor before or during treatment with Remicade if you have:
Previously received Remicade

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

Infections

• Inform your doctor before being administered Remicade if you have an infection, even if it is very mild.
• Inform your doctor before being administered Remicade 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 Remicade. 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 organisms in the environment, and sepsis, which can be life-threatening. Inform your doctor immediately if you develop symptoms of infection during treatment with Remicade. Symptoms include fever, cough, flu-like symptoms, feeling unwell, redness of the skin or very warm skin, wounds, or dental problems. Your doctor may recommend temporarily stopping Remicade.

Tuberculosis (TB)

• It is very important that you inform your doctor if you have ever had tuberculosis or 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 Remicade, including in patients who had previously been treated with medications for TB. Your doctor will record these tests on your patient reminder card.
• If your doctor believes you are at risk of tuberculosis, you may be treated with medications for TB before being administered Remicade. Inform your doctor immediately if you notice signs of tuberculosis during treatment with Remicade. Signs include persistent cough, weight loss, feeling tired, fever, or night sweats.

Hepatitis B virus

• Inform your doctor before being administered Remicade if you are a carrier of hepatitis B or have previously had hepatitis B.
• Inform your doctor if you believe you may be at risk of contracting hepatitis B.
• Your doctor must evaluate whether you have the hepatitis B virus.
• Treatment with TNF blockers such as Remicade can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can lead to death.

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

Tumors and lymphoma

• Inform your doctor before being administered Remicade 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 Remicade may have an increased risk of developing lymphoma or another type of cancer.
• Some patients treated with TNF blockers, including Remicade, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescents or young males, 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 being treated for rheumatoid arthritis with Remicade have developed cervical cancer. Your doctor may recommend regular cervical cancer screening for women taking Remicade, including women over 60 years of age.

Lung disease or regular smokers

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

Nervous system disorders

• Inform your doctor if you have or have had a nervous system disorder before being administered Remicade. This includes multiple sclerosis, Guillain-Barré syndrome, or episodes or diagnoses of "optic neuritis." Inform your doctor immediately if you notice symptoms of a nervous system disorder during treatment with Remicade. Signs include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.

Abnormal skin openings

• Inform your doctor if you have any abnormal openings in the skin (fistulas) before being administered Remicade.

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 Remicade. You may receive certain vaccines during treatment with Remicade, but you must not receive live vaccines (vaccines containing a live, but weakened, infectious agent) while being treated with Remicade, as they may cause infections.
• If you received Remicade 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 that you inform your pediatrician and other healthcare providers about your use of Remicade 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 that you inform your pediatrician and other healthcare providers about your use of Remicade before your baby receives any type of vaccine. For further information, see the section on Pregnancy and breastfeeding.

Infectious therapeutic agents

• Talk to your doctor if you have recently taken or plan to take treatment with an infectious therapeutic agent (such as BCG instillation used to treat cancer).

Surgery or dental procedures

• Inform your doctor if you are scheduled for any surgery or dental procedures.
• Inform your surgeon or dentist that you are being treated with Remicade, and show them your patient reminder card.

Liver problems

• Some patients treated with Remicade have developed serious liver problems. Inform your doctor immediately if you experience symptoms of liver problems during treatment with Remicade. Symptoms include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, rashes, or fever.
  Reduction in blood cell count

• In some patients treated with Remicade, the body may not produce enough blood cells that help fight infections or help stop bleeding. Inform your doctor immediately if you experience symptoms of reduced blood cell count during treatment with Remicade. Symptoms include persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin, or paleness.

Immune system disorder

• Some patients treated with Remicade have developed symptoms of an immune system disorder called lupus. Inform your doctor immediately if you develop symptoms of lupus during treatment with Remicade. 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 child and adolescent patients who have taken TNF blockers such as Remicade have developed tumors, including unusual types, which have sometimes been fatal.
• Compared to adults, more children taking Remicade have developed infections.
• Children should receive recommended vaccinations before starting treatment with Remicade. Children may receive certain vaccines during treatment with Remicade, but they must not receive live vaccines while being treated with Remicade.

If you are unsure whether any of the conditions listed above apply to you, contact your doctor
before being administered Remicade.
Other medicines and Remicade
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 Remicade treatment.
Inform your doctor if you are taking or have recently taken any other medicines, including
any other medicines used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis,
ankylosing spondylitis, psoriatic arthritis, or psoriasis, or medicines obtained without
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). Remicade and Kineret must not be administered together.
• Orencia (abatacept). Remicade and Orencia must not be administered together.

Live vaccines must not be administered during treatment with Remicade. If you used Remicade
during pregnancy or are receiving Remicade while breastfeeding, inform your pediatrician and
other healthcare providers involved in your baby’s care about your use of Remicade before your
baby receives any type of vaccine.
If you are unsure whether any of the conditions listed above apply to you, contact your doctor
before being administered Remicade.
Pregnancy, breastfeeding, and fertility

• If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Remicade should be used during pregnancy or breastfeeding only if your doctor considers it necessary.
• You must avoid pregnancy while being treated with Remicade and for at least 6 months after stopping treatment. Discuss with your doctor the use of an appropriate contraceptive method during this period.
• If you received Remicade during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform your pediatrician and other healthcare providers about your use of Remicade before your baby receives any type of vaccine. If you received Remicade during pregnancy, administration of the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may lead to infection with serious complications, including death. Live vaccines such as the BCG vaccine must not be given to your baby within 12 months after birth, unless otherwise recommended by your pediatrician. (For more information, see the section on Vaccinations).
• If you are breastfeeding, it is important that you inform your pediatrician and other healthcare providers about your use of Remicade before your baby receives any type of vaccine. Live vaccines must not be given to your baby during breastfeeding, unless otherwise recommended by your pediatrician.
• Severe decreases in white blood cell count have been reported in infants born to women treated with Remicade during pregnancy. If your baby has persistent fevers or infections, contact your baby’s doctor immediately.

Driving and using machines
It is unlikely that Remicade will affect your ability to drive or use machines. However, if you feel
tired, dizzy, or unwell after treatment with Remicade, you must not drive or operate tools or machinery.
Remicade contains sodium
Remicade contains less than 1 mmol (23 mg) of sodium per dose, i.e., 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 to use Remicade

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 is administered

• Remicade 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 (over a period of 2 hours) into a vein, usually in the arm. After the third treatment, your doctor may decide to administer your dose of Remicade over a period of 1 hour.
• You will be monitored during and for 1–2 hours after the administration of Remicade.

How much Remicade is administered

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

Use in children and adolescents
Remicade 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 Remicade than you should
Since this medicine is administered to you by a doctor or nurse, it is unlikely that you will receive too much.
Adverse effects following an overdose of Remicade are not known.
If you forget or miss an infusion of Remicade
If you forget or miss an appointment for Remicade 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 will experience 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 Remicade has ended.
Contact 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 severe and potentially life-threatening. An allergic reaction may occur within 2 hours of the infusion or later. Additional signs of allergic-type adverse reactions that may occur up to 12 days after the infusion include muscle pain, fever, joint or jaw pain, sore throat or headache.
• Signs of a heart problem, such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, palpitations or pounding in the chest, fast or slow heartbeat, and swelling of the feet.
• Signs of an infection (including tuberculosis), such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, pus collection in the intestine or around the anus (abscess), dental problems or a burning sensation when urinating.
• Possible signs of cancer, 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; difficulty seeing with 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, weakness in arms or legs, changes in vision such as double vision, or other eye problems.
• Signs of a liver problem (including hepatitis B infection, if you have had hepatitis B in the past), 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, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or paleness.
• Signs of serious skin problems, such as reddish spots or circular patches often with central blisters on the trunk, large areas of peeling or 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.

Contact your doctor immediately if you notice any of the symptoms described above.
The following side effects have been reported with Remicade:
Very common: may affect more than 1 in 10 people

• Stomach pain, nausea
• Viral infections such as herpes or influenza
• Upper respiratory tract infections such as sinusitis
• Headache
• Adverse reaction related to the 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 intestine, diarrhoea, indigestion, heartburn, constipation
• Hives-type rash, itchy rash or dry skin
• Balance problems or dizziness
• Fever, increased sweating
• Circulatory problems such as low or high blood pressure
• Bruising, hot flushes or nosebleeds, feeling hot, flushed skin (redness)
• Feeling tired or weak
• Bacterial infections such as systemic infection, abscess or skin infection (cellulitis)
• Fungal skin infection
• Blood problems such as anaemia or low white blood cell count
• Swollen lymph nodes
• Depression, sleep disturbances
• Eye problems, including red eyes and infections
• Fast heartbeat (tachycardia) or palpitations
• Joint, muscle or back pain
• Urinary tract infection
• Psoriasis, skin problems such as eczema and hair loss
• Injection site reactions such as pain, swelling, redness or itching
• Chills, fluid accumulation under the skin causing swelling
• Clouding or tingling sensation.

Uncommon: may affect up to 1 in 100 people

• Poor blood supply, swelling of a vein
• Collection of blood outside blood vessels (haematoma) or bruising
• Skin problems such as blistering, warts, abnormal skin or lip colouring or pigmentation, swollen or thickened skin, or red, scaly and cracked skin
• Severe allergic reactions (e.g., anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
• Wounds that heal slowly
• Swelling of the liver (hepatitis) or gallbladder (gallbladder), liver damage
• Distraction, irritability, confusion, nervousness
• Eye problems including blurred or reduced vision, swollen eyes or stye
• New or worsened heart failure, slow heart rate
• Fainting
• Seizures, nervous system 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 difficulty breathing
• 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 blood fat levels
• Weight gain (in most patients, weight gain was minimal).

Rare: may affect up to 1 in 1,000 people

• A type of blood cancer (lymphoma)
• Poor oxygen supply to organs via the blood, circulatory problems such as narrowing of a blood vessel
• Inflammation of the membrane lining the brain (meningitis)
• Infections due to a weakened immune system
• Hepatitis B infection, if you have had hepatitis B in the past
• Liver inflammation caused by an immune system disorder (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 emotion
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and generalised pustular eruption
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish/violet rash and/or whitish-grey linear streaks 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 adult 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 (presents as a rash accompanied by muscle weakness)
• Heart attack
• Stroke
• Temporary loss of vision during or within 2 hours after infusion
• Infection caused by a live vaccine due to a weakened immune system.
• Problems following a medical procedure (including infectious and non-infectious complications).

Additional side effects in children and adolescents
Children who have taken Remicade for Crohn’s disease have shown some differences in side effects compared to adults who have taken Remicade for Crohn’s disease.
Side effects that occurred more frequently in children were: low red blood cell count (anaemia), blood in stools, low overall white blood cell count (leucopenia), redness or flushing, viral infections, low number of infection-fighting white blood cells (neutropenia), bone fracture, bacterial infection and allergic reactions of the respiratory tract.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Remicade

Remicade will generally be stored by healthcare professionals. If you need to store it, the details regarding storage 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 after “Exp” and on the carton after “Scad”. 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 its original carton outside the refrigerator at a temperature not exceeding 25 °C for a single period of up to six months, but not beyond the original expiry date. In this case, it must not be returned to the refrigerator. Write the new expiry date (including day/month/year) on the carton. 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 Remicade is prepared for infusion, it is recommended to use it as soon as possible (within 3 hours). However, if the solution is prepared under completely aseptic conditions, it may be stored in a refrigerator at a temperature between 2 °C and 8 °C for up to 28 days, and for an additional 24 hours at 25 °C after removal from the refrigerator.
• Do not use this medicine if it has changed colour or if particles are present.

6. Package contents and other information

What Remicade contains

• The active substance is infliximab. Each vial contains 100 mg of infliximab. After reconstitution, each mL contains 10 mg of infliximab.
• The other components are disodium phosphate, monosodium phosphate, polysorbate 80 (E433), and sucrose (see “Remicade contains polysorbate 80” in section 2).

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

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

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

België/Belgique/Belgien   Lietuva
Janssen-Cilag NV       UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11   Tel: +370 5 278 68 88
[email protected]   [email protected]

България         Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00      Tél/Tel: +32 14 64 94 11
[email protected]      [email protected]

Česká republika     Magyarország
Janssen-Cilag s.r.o.     Janssen-Cilag Kft.
Tel: +420 227 012 227    Tel.: +36 1 884 2858
[email protected]

Danmark         Malta
Janssen-Cilag A/S      AM MANGION LTD
Tlf.: +45 4594 8282     Tel: +356 2397 6000
[email protected]

Deutschland       Nederland
Janssen-Cilag GmbH     Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected]      [email protected]

Eesti           Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410      Tlf: +47 24 12 65 00
[email protected]        [email protected]

Ελλάδα          Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε.           Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España          Polska
Janssen-Cilag, S.A.     Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00    Tel.: +48 22 237 60 00
[email protected]

France          Portugal
Janssen-Cilag        Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska         România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700    Tel: +40 21 207 1800
[email protected]

Ireland         Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122     Tel: +386 1 401 18 00
[email protected]    [email protected]

Ísland          Slovenská republika
Janssen-Cilag AB      Johnson & Johnson, s.r.o.
c/o Vistor ehf.       Tel: +421 232 408 400
Sími: +354 535 7000

Italia          Suomi/Finland
Janssen-Cilag SpA      Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected]   [email protected]

Κύπρος          Sverige
Βαρνάβας Χατζηπαναγής Λτδ  Janssen-Cilag AB
Τηλ: +357 22 207 700    Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
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Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:
Patients treated with Remicade must be given the patient reminder card.

Instructions for use and handling – storage conditions

Store at 2 °C–8 °C.
Remicade may be stored at temperatures not exceeding 25 °C for a single period of up to
6 months, provided this does not extend beyond the original expiry date. The new expiry date must be
written on the carton. After removal from the refrigerator, Remicade must not be returned to the refrigerator.
Instructions for use and handling – reconstitution, dilution and administration
In order to improve the traceability of biological medicinal products, the trade name and batch number
of the administered product must be clearly recorded.

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

2. Under aseptic conditions, reconstitute each vial of Remicade with 10 mL of Water for Injections using a syringe with a 21 gauge (0.8 mm) or smaller needle. Remove the aluminium cap and disinfect the top with a cotton swab moistened with 70% alcohol. Insert the needle through the centre of the rubber stopper and direct the stream of Water for Injections onto the glass wall of the vial. Gently swirl the solution to completely dissolve the lyophilised powder. Do not shake vigorously or for prolonged periods. DO NOT SHAKE. Foam may form during reconstitution. Allow the reconstituted solution to stand for 5 minutes. Check that the solution is colourless to yellow and opalescent; the solution may contain a few small translucent particles, as infliximab is a protein. Do not use the solution if opaque particles, discolouration or foreign matter are observed.

3. Dilute the total volume of reconstituted Remicade solution to 250 mL using Sodium Chloride 9 mg/mL (0.9%) Solution for Infusion. Do not dilute the reconstituted Remicade solution with any other diluent. The dilution may be performed by removing from the glass bottle or infusion bag a volume of Sodium Chloride 9 mg/mL (0.9%) Solution for Infusion equal to the volume of reconstituted Remicade. Slowly add the total volume of reconstituted Remicade solution to the 250 mL infusion bottle or bag. Mix gently. For volumes exceeding 250 mL, use a larger infusion bag (e.g., 500 mL, 1 000 mL) or multiple 250 mL infusion bags, to ensure that the concentration of the infusion solution does not exceed 4 mg/mL. If stored refrigerated after reconstitution and dilution, the infusion solution must be allowed to reach room temperature (25 °C) for 3 hours before proceeding as described in point 4 (infusion). Storage for periods exceeding 24 hours at 2 °C–8 °C applies only to Remicade preparations in the infusion bag.

4. Administer the infusion solution over an infusion time not shorter than that recommended. Use only an infusion set with a sterile, non-pyrogenic in-line filter with low protein binding (pore diameter 1.2 micrometres or less). Since no preservative is present, administration of the intravenous infusion solution should begin as soon as possible and within 3 hours of reconstitution and dilution. If not used immediately, the storage times during use and storage conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2 °C and 8 °C, unless
   the reconstitution/dilution was carried out under controlled and validated aseptic conditions.
   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 Remicade with other agents. Do not administer Remicade concomitantly with other medicinal products in the same intravenous line.

6. Before administration, visually inspect Remicade for the presence of particles or discolouration. If opaque particles, discolouration or foreign matter are observed, do not use.

7. Unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.