infliximab: package leaflet

100 mg infliximab. Calculate the total volume of reconstituted Remicade solution required.

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. Gently swirl the solution by rotating the vial to dissolve the lyophilised 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 colourless 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, discolouration, or other foreign particles are present.

chloride 9 mg/ml (0.9%) solution for infusion. Do not dilute the reconstituted Remicade solution with any other diluent. The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion 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. For volumes greater than 250 ml, either use a larger infusion bag (e.g. 500 ml, 1000 ml) or use 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 equilibrate at room temperature to 25°C for 3 hours prior to Step 4 (infusion).
Storage beyond 24 hours at 2°C-8°C applies to preparation of Remicade in the infusion bag only.

Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre 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. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions. Do not store any unused portion of the infusion solution for reuse.

co-administration of Remicade with other agents. Do not infuse Remicade concomitantly in the same intravenous line with other agents.

not use if visibly opaque particles, discolouration or foreign particles are observed.
7.
Any unused product or waste material should be disposed of in accordance with local requirements.