Remsima Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: 1. The dose and the number of Remsima vials have to be calculated. Each Remsima vial contains 100 mg infliximab. The required total volume of reconstituted Remsima solution has to be calculated.
2. Under aseptic conditions, each Remsima vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. The flip-top from the vial has to be removed and the top has to be wiped with a 70% alcohol swab. The syringe needle should be inserted into the vial through the centre of the rubber stopper and the stream of water for injections directed to the glass wall of the vial. The solution has to be gently swirled by rotating the vial to dissolve the powder. Prolonged or vigorous agitation must be avoided. THE VIAL MUST NOT BE SHAKEN. Foaming of the solution on reconstitution may occur. The reconstituted solution should stand for 5 minutes. The solution should be colourless to light yellow and opalescent. The solution may develop a few fine translucent particles, as infliximab is a protein. The solution must not be used if opaque particles, discolouration, or other foreign particles are present.
3. The required volume of the reconstituted Remsima solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion. This 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 Remsima. The required volume of reconstituted Remsima solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
4. The infusion solution has to be administered over a period of not less than the infusion time recommended (see Dosage & Administration). Only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometer or less) should be used. 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, Remsima infusion solution can be used within 24 hours if stored at 2°C to 8°C. Any unused portion of the infusion solution should not be stored for reuse.
5. Remsima should be visually inspected for particulate matter or discolouration prior to administration. If visibly opaque particles, discolouration or foreign particles are observed it should not be used.
6. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.