Remicade

Remicade Caution For Usage

infliximab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma

Marketer:

Johnson & Johnson
Full Prescribing Info
Caution For Usage
Special precautions for disposal and other handling: 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.
Under aseptic conditions, 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. 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.
Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium 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.
Administer the infusion solution over a period of not less than the infusion time recommended (see Dosage & Administration). 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. When reconstitution and dilution are performed under aseptic conditions, Remicade infusion solution can be used within 24 hours if stored at 2 °C to 8 °C. Do not store any unused portion of the infusion solution for reuse.
No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents.
Do not infuse Remicade concomitantly in the same intravenous line with other agents.
Visually inspect Remicade for particulate matter or discolouration prior to administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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