Remicade Vial For Injection 100 mg (Refrigerator)

Product Description:

• Remicade contains the active ingredient infliximab. Infliximab is a type of monoclonal antibody – a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor)-alpha.


• Remicade belongs to a group of medicines called "TNF inhibitors".

 It is used by adults for the following inflammatory diseases:

• Rheumatoid arthritis


• Psoriatic arthritis


• Ankylosing spondylitis ( Ankylosing spondylitis )


• Psoriasis

Remicade is also used by adults and children aged 6 years and over for:

• Crohn's Disease


• Ulcerative Colitis

Remicade works by selectively attaching to TNF-alpha and blocking its action.

• TNF-alpha is involved in inflammatory processes in the body, so blocking it can reduce the inflammation in your body.

How To Use:

Rheumatoid Arthritis:

• The usual dose is 3 mg per kg of body weight.

Psoriatic arthritis, ankylosing spondylitis ( Ankylosing spondylitis ), psoriasis, ulcerative colitis and Crohn's disease

• The usual dose is 5 mg per kg of body weight.

How Remicade is given:

• Remicade will be given to you by a doctor or nurse.


• The doctor or nurse will prepare the medicine for infusion.


• The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. 


• After the third treatment, your doctor may decide that you should receive the Remicade dose over 1 hour.


• You will be observed while you receive Remicade and for 1 to 2 hours afterwards.

How much Remicade is given:

• Your doctor will determine your dose and how often you will receive Remicade.


• This depends on your illness, your weight and how well you respond to Remicade.


• The table below shows how often you will usually receive this medicine after your first dose.

Use of Remicade in children and adolescents:

• Remicade should only be used by children if they are being treated for Crohn's disease or ulcerative colitis . 


• These children must be 6 years or older.

If you get too much Remicade:

• As this medicine will be given to you by a doctor or nurse, it is unlikely that you will get too much.


• There are no known side effects from taking too much Remicade.

If you forget or arrive late for your Remicade infusion:

• If you forget or are late for an appointment to receive Remicade, you must make a new appointment as soon as possible.


• Ask your doctor if you have any questions about the use of this medicine.

Warnings And Precautions:

You should not receive Remicade if:

• You are allergic to infliximab or any of the other ingredients in Remicade (listed in section 6).


• You are allergic (hypersensitive) to proteins that come from mice.


• You have tuberculosis (TB) or another serious infection , such as pneumonia or blood poisoning .


• You have moderate or severe heart failure.


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

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

• Had treatment with Remicade previously.


• Inform the doctor if you have previously been treated with Remicade and are now starting treatment with Remicade again.


• If you have had a break in treatment with Remicade for more than 16 weeks, there is a higher risk of allergic reactions when you start treatment again.


• Infections


• Tell your doctor before receiving Remicade if you have an infection , even if it is less serious.


• Tell your doctor before receiving Remicade if you have stayed in or traveled to areas where infections called histoplasmosis , coccidioidomycosis or blastomycosis are common. 


• These infections are caused by a specific type of fungus that can affect your lungs or other parts of your body.


• You may get infections more easily when you are treated with Remicade. You may have a greater risk if you are 65 or older.


• These infections can be serious and include tuberculosis , infections caused by viruses, fungi, bacteria or other organisms in the environment and blood poisoning , which can be life-threatening.


• Tell your doctor immediately if you develop signs of infection during treatment with Remicade. Signs include fever , cough, flu-like symptoms, feeling unwell, red or warm skin, sores or dental problems.


• Your doctor may recommend temporarily stopping treatment with Remicade.


• Tuberculosis (TB).


• Heart problems


• Cancer and lymphomas




• Operations or dental treatments.


• Liver problems.


• Low blood values.


• Disorders of the immune system.

Children And Youth:

The above information also applies to children and young people. Plus:

• Some children and teenagers who have received TNF inhibitors, e.g. Remicade, has developed cancers , including rare types of cancer that have sometimes resulted in death.


• More children than adults who receive Remicade develop infections .


• Children should receive the recommended vaccines before treatment with Remicade is started. 


• Children can receive some vaccines during treatment with Remicade, but should not receive live vaccines during treatment with Remicade.


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

Pregnancy, Breastfeeding And Fertility:

• Talk to your doctor before receiving this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant. Remicade should only be used during pregnancy or when you are breastfeeding if your doctor thinks it is necessary for you.


• You should avoid becoming pregnant during treatment with Remicade, and for 6 months after the end of treatment. 


• Discuss the use of contraception during this period with your doctor.


• If you were given Remicade when you were pregnant, there may be a greater risk of your baby getting an infection .


• It is important that you tell your child's doctor and other healthcare professionals that you are using Remicade before your child is vaccinated.


• If you received Remicade when you were pregnant, BCG vaccine (used to prevent tuberculosis ) given to your baby within 12 months after birth can lead to an infection with serious complications, including death. 


• Live vaccines such as the BCG vaccine should not be given to your child until 12 months after birth, unless your child's doctor recommends otherwise. For more information, see the section on vaccinations.


• If you are breast-feeding, it is important that you tell the infant's doctor and other healthcare personnel that you are using Remicade before the infant receives the vaccine. Live vaccines should not be given to your child while you are breastfeeding unless your child's doctor recommends otherwise.


• Severely reduced white blood cell counts have been reported in infants of women treated with Remicade during pregnancy. If your child continues to have a fever or infections , contact your child's doctor immediately.

Driving And Using Machines:

• Remicade is unlikely to affect your ability to drive or use tools or machines.


• If you feel tired, dizzy or unwell after receiving Remicade, do not drive or use any tools or machines.

Ingredients:

• The active substance is INFLIXIMAB.


• Each vial contains 100 mg of infliximab. After reconstitution, each ml contains 10 mg of INFLIXIMAB.

What Remicade looks like and contents of the pack:

• Remicade comes in a vial containing a powder to concentrate for solution for infusion. 


• The powder is a freeze-dried, white pellet. 

Product Details: