REMICADE® 100mg vial (Non-English)

Rheumatoid arthritis:

• The recommended treatment to start with is an infusion of 3 mg/kg of body weight over a 2-hour period.
• You will be also taking methotrexate as part of your treatment.
• Your initial dose will be followed by additional infusions of 3 mg/kg doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Crohn's Disease:

• The recommended dose for severe, active Crohn's disease is an infusion of 5 mg/kg of body weight. The recommended dose for closure of enterocutaneous fistulae is also 5 mg/kg of body weight: you will be given two additional 5 mg/kg doses at 2 and 6 weeks following the first infusion.
• After dilution, Remicade is given in a vein. This usually will be in your arm.
• For severe, active disease, you will receive a single treatment of Remicade. If you have fistulising disease you will normally get additional doses at 2 and 6 weeks after the first dose. If signs and symptoms of your disease return, you may be retreated. There is a risk of hypersensitivity reactions if retreatment is given after an interval of more than 14 weeks.

Remicade can be used to treat two different diseases, namely Crohn's disease and rheumatoid arthritis.

REMICADE is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis - adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn’s Disease - children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
• Ankylosing Spondylitis in adults
• Psoriatic Arthritis in adults
• Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
• Ulcerative Colitis - children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

Remicade is a type of medicine that interrupts the inflammation process. The active ingredient, infliximab, is a human-mouse monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to other unique proteins.

Infliximab binds to a specific protein (tumour necrosis factor alpha) that is thought to cause your rheumatoid arthritis if it collects in your joints or Crohn’s disease if it attacks the bowel.

The amount of the naturally occurring protein, tumour necrosis factor alpha (TNFα), is increased in both rheumatoid arthritis and Crohn’s disease. Remicade (infliximab) is an antiTNF antibody that can prevent the harmful effects of TNFα.

• Each treatment will take at least 2 hours for Remicade to be given to you in your vein.
• Patient needs to stay at least 1-2 hours after Remicade is given to you before going home.
• Treatment will be supervised by a doctor who specializes in the treatment of rheumatoid arthritis or bowel diseases.

Instructions for use and handling – reconstitution, dilution and administration

1. Calculate the dose and the number of Remicade vials needed. Each Remicade vial contains 100 mg infliximab. Calculate the total volume of reconstituted Remicade solution required.
2. Reconstitute each Remicade vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. Remove flip-top from the vial and wipe the top with a 70% alcohol swab. Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial. Do not use the vial if the vacuum is not present. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual. Allow the reconstituted solution to stand for 5 minutes. Check that the solution is colorless to light yellow and opalescent. The solution may develop a few fine translucent particles, as infliximab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present.
3. Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with 0.9% w/v sodium chloride solution for infusion. This can be accomplished by withdrawing a volume of the 0.9% w/v sodium chloride solution from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Remicade. Slowly add the total volume of reconstituted Remicade solution to the 250-ml infusion bottle or bag. Gently mix.
4. Administer the infusion solution over a period of not less than 2 hours (at not more than 2 ml/min). Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometer or less). Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution. Do not store any unused portion of the infusion solution for reuse.
5. No physical biochemical compatibility studies have been conducted to evaluate the coadministration of Remicade with other agents. Do not infuse Remicade concomitantly in the same intravenous line with other agents.
6. Visually inspect parenteral medicinal products for particulate matter or discoloration prior to administration. Do not use if visibly opaque particles, discoloration or foreign particulates are observed.
7. Discard any unused portion of the solution.

Contraindications

• Do not use Remicade: if you have a history of a serious hypersensitivity or allergy to any ingredient of the product or to mouse (murine) proteins or if you have an infection or abscess.
• Take special care with Remicade: Treatment with Remicade in children 0-17 years with rheumatoid arthritis or Crohn’s disease has not been studied. Until safety and efficacy data in children are available, such treatment is to be avoided.
• Specific studies with Remicade have not been conducted in elderly patients, or in patients with hepatic or renal disease.
• Taking Remicade again after a drug-free period of more than 14 weeks is not recommended.

After-care

If your last Remicade dose was given to you 2 years ago or more and you are given Remicade again, it is possible that you might have an allergic reaction 3 to 12 days after your infusion.