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Remicade 100 mg powder for concentrate for solution forinfus
2013-11-01 11:23:30 来源: 作者: 【 】 浏览:536次 评论:0

For doctors

 

What is it and how is it used?

Remicade contains the active substance called infliximab. Infliximab is a type of protein of human and mouse origin.

Remicade belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:

Remicade is also used in adults and children 6 years of age or older for:

Remicade works by blocking the action of a protein called ‘tumour necrosis factor alpha’ (TNF α). This protein is involved in inflammatory processes of the body and blocking it can reduce the inflammation in your body.

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 you do not respond well enough to these medicines, you will be given Remicade which you will take in combination with another medicine called methotrexate to:

Psoriatic arthritis

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

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 you do not respond well enough to these medicines, you will be given Remicade to:

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

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

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

What do you have to consider before using it?

You should not be given Remicade if:

Do not have Remicade if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remicade.

Take special care with Remicade

Check with your doctor before you are given Remicade if you have:

Had treatment with Remicade before

Infections

Tuberculosis (TB)

Hepatitis B virus (HBV)

Heart problems

Cancer and lymphoma

Lung disease or heavy smoking

Nervous system disease

Abnormal skin openings

Vaccinations

Operations or dental procedures

If you are not sure if any of the above apply to you, talk to your doctor before you are given Remicade.

Using other medicines
Patients who have inflammatory diseases already take medicines to treat their problem. These medicines may cause side effects. Your doctor will advise you what other medicines you must keep using while you are having Remicade.

Tell your doctor if you are using or have recently used any other medicines, including medicines obtained without a prescription, such as vitamins and herbal medicines.

In particular, tell your doctor if you are using any of the following medicines:

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Remicade.

Pregnancy and breast-feeding

Driving and using machines
Remicade is not likely to affect your ability to drive or use tools or machines. If you feel tired or unwell after having Remicade, do not drive or use any tools or machines.

How is it used?

How Remicade is given

How much Remicade is given

1st treatment 0 weeks 2nd treatment 2 weeks after your 1st treatment 3rd treatment 6 weeks after your 1st treatment Further treatments Every 6 to 8 weeks depending on your disease

Rheumatoid arthritis
The usual dose is 3 mg for every kg of body weight. After the third treatment, your doctor may decide to give you Remicade over a 1 hour period.

Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease), psoriasis, ulcerative colitis and Crohn's disease
The usual dose is 5 mg for every kg of body weight.

Use in children
Remicade should only be used in children if they are being treated for Crohn’s disease. These children must be 6 years of age or older.

If you are given too much Remicade
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. There are no known side effects of having too much of Remicade.

If you forget or miss your Remicade infusion
If you forget or miss an appointment to receive Remicade, make another appointment as soon as possible.

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

What are possible side effects?

Like all medicines, Remicade can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However some patients may experience serious side effects and may require treatment. Side effects may also occur after your treatment with Remicade has stopped.

Tell your doctor straight away if you notice any of the following:

Tell your doctor straight away if you notice any of the above.

Common side effects (affects 1 to 10 patients in 100)

Uncommon side effects (affects 1 to 10 patients in 1,000)

Rare side effects (affects 1 to 10 patients in 10,000)

Other side effects (the frequency is unknown)

If any of the side effects gets serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor.

How should it be stored?

Remicade will be stored by the health professionals at the hospital or clinic. The storage details should you need them are as follows:

The solution should not be used if discoloured or if there are particles present.

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For doctors

What is it?

Remicade is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance infliximab.

What is it used for?

Remicade is an anti-inflammatory medicine. It is usually used when other medicines or treatments have failed, in adults with the following diseases:

rheumatoid arthritis an immune system disease causing inflammation of the joints. Remicade is used with methotrexate a medicine that acts on the immune system

Crohns disease a disease causing inflammation of the digestive tract, when the disease is moderate to severe or fistulising with the formation of fistulae, abnormal passageways between the gut and other organs

ulcerative colitis a disease causing inflammation and ulcers in the lining of the gut

ankylosing spondylitis a disease causing inflammation and pain in the joints of the spine

psoriatic arthritis a disease causing red, scaly patches on the skin and inflammation of the joints

psoriasis a disease causing red, scaly patches on the skin.

Remicade is also used in patients aged between six and 17 years with severe, active Crohn’s disease, when they have not responded to or cannot take other medicines or treatments.

See the summary of product characteristics (also part of the EPAR) for full details.

The medicine can only be obtained with a prescription.

How is it used?

Remicade must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remicade can be used to treat.

Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary. The dose is 5 mg per kilogram for the other diseases. How often the treatment is repeated depends on which disease is being treated, and on the patient’s response to the medicine.

Remicade is given as an infusion lasting one or two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. They may be given other medicines before or during treatment with Remicade to reduce the risk of infusion-related reactions. For more information, see the package leaflet.

Patients who receive Remicade must be given the special alert card that summarises the safety information about the medicine.

How does it work?

The active substance in Remicade, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha). This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remicade is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.

How has it been studied?

For rheumatoid arthritis, Remicade has been studied in a total of 1,432 patients in two studies. Remicade was given with methotrexate and compared with methotrexate alone. The main measure of effectiveness was the change in the symptoms, joint damage and physical function after up to 54 weeks.

For Crohn’s disease, Remicade has been compared with placebo (a dummy treatment) in 1,090 adults in four studies. The main measures of effectiveness were the improvement in the severity of symptoms or the healing of fistulae. The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn’s disease who were aged between six and 17 years. A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn’s disease). The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.

For ulcerative colitis (728 patients), ankylosing spondylitis (70 patients), psoriatic arthritis (104 patients) and psoriasis (627 patients), Remicade has been compared with placebo. In all of these studies, the main measure of effectiveness was the change in symptoms after up to 16 weeks.

Remicade Page

What benefits has it shown during the studies?

Remicade was more effective than the comparator medicines in all of the studies:

in rheumatoid arthritis, more patients taking Remicade in combination with methotrexate showed a reduction in symptoms than those taking methotrexate alone, as well as less damage to the joints and greater improvements in physical function

in Crohns disease in adults, compared with placebo, Remicade produced a greater improvement in symptoms, led to fistulae healing in more patients and increased the time that patients continued to respond to treatment. Most of the children and adolescents with Crohns disease also showed a reduction in symptoms after adding Remicade to their existing treatment. In the sixth study, Remicade alone and in combination with azathioprine was more effective than azathioprine alone

in ulcerative colitis, ankylosing spondylitis and psoriatic arthritis, more patients receiving Remicade had a reduction in symptoms than those receiving placebo

in psoriasis, Remicade led to a greater improvement in symptoms than placebo.

What is the risk associated?

Most side effects seen in patients taking Remicade are related to the infusion and not to the medicine itself, including dyspnoea (breathlessness), urticaria (hives) and headache. Some patients can experience anaphylactic shock (a severe allergic reaction) during infusion, or delayed hypersensitivity (allergic reaction after the first exposure to the medicine). Patients experiencing these symptoms should have their infusion slowed down or treatment interrupted.

The most common side effects with Remicade (seen in between 1 and 10 patients in 100) are viral infections (such as flu or cold sores), serum sickness-like reactions (including skin rash, joint pain or fever), headache, vertigo (dizziness), flushing, upper respiratory tract infection (colds), lower respiratory tract infection (such as bronchitis or pneumonia), dyspnoea, sinusitis (inflammation of the sinuses), nausea (feeling sick), diarrhoea, abdominal (tummy) pain, dyspepsia (heartburn), rash, pruritus (itching), urticaria, increased sweating, dry skin, fatigue (tiredness), chest pain, fever and elevated liver enzymes in the blood. Some side effects, including infections, may be more common in children than in adults. For the full list of all side effects reported with Remicade, see the package leaflet.

Remicade should not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade. Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Why has it been approved?

The CHMP decided that Remicade’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Remicade will set up an educational programme for doctors who intend to prescribe the medicine to children with Crohn’s disease, to explain the risks of treatment.

Remicade Page 3/4

Further information

The European Commission granted a marketing authorisation valid throughout the European Union on 13 August 1999. The marketing authorisation holder is to Janssen Biologics B.V. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Remicade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011. Remicade Page

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 Name

 Remicade 100 mg powder for concentrate for solution for
infusion

 Composition

 Each vial contains 100 mg of infliximab. Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced by recombinant DNA technology. After reconstitution each ml contains 10 mg of infliximab.

For a full list of excipients, see section 6.1.

 Pharmaceutical Form

 Powder for concentrate for solution for infusion.

The powder is a freeze-dried white pellet.

 Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

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