Remicade - Indications & Dosage

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The REMICADE infusion should begin within 3 hours of preparation.

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

2. Reconstitute each REMICADE vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smallerneedle. Remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through thecenter of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Do not use the vial ifthe vacuum is not present. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorousagitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual. Allow the reconstituted solution to stand for5 minutes. The solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles asinfliximab 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% Sodium Chloride Injection, USP, bywithdrawing a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of reconstituted REMICADE from the 0.9%Sodium Chloride Injection, USP, 250 mL bottle or bag. Slowly add the total volume of reconstituted REMICADE solution to the250 mL infusion bottle or bag. Gently mix.

4. The infusion solution must be administered over a period of not less than 2 hours and must use an infusion set with an in-line, sterile,non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less). Any unused portion of the infusion solution should not be storedfor reuse.

5. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of REMICADE with other agents.REMICADE should not be infused concomitantly in the same intravenous line with other agents.6. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration, or other foreign particulates are observed, the solution should not be used.

Storage

Store the lyophilized product under refrigeration at 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. Do not use beyond the expiration date. This product contains no preservative.