Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Disodium succinate hexahydrate
Succinic acid
Polysorbate 80

6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage
Store unopened vial in a refrigerator (2°C – 8°C).
Ixifi® unopened vials may also be stored at temperatures up to a maximum of 30°C for a single period of up to 6 months, but not exceeding the original expiry date. The new expiry date must be written on the carton.
Upon removal from refrigerated storage, Ixifi® must not be returned to refrigerated storage.

After reconstitution:
Infusion of IXIFI should be initiated within 3 hours of reconstitution and dilution, and the infusion must be administered over a period of not less than 2 hours.

After dilution:
Infusion of IXIFI should be initiated within 3 hours of reconstitution and dilution, and the infusion must be administered over a period of not less than 2 hours.

6.5 Nature and contents of container
Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap.
Ixifi® is available in packs containing 1, 2, 3, 4 or 5 vials.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
1. Calculate the dose and the number of Ixifi® vials needed. Each Ixifi® vial contains 100 mg infliximab.
Calculate the total volume of reconstituted Ixifi® solution required.
2. Under aseptic conditions, reconstitute each Ixifi® 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 brown 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.

3. Dilute the total volume of the reconstituted Ixifi® solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for injection. Do not dilute the reconstituted Ixifi® 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 injection from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Ixifi®. Slowly add the total volume of reconstituted Ixifi® solution to the 250-ml infusion bottle or bag. Gently mix.


4. Administer the infusion solution over a period of not less than the infusion time recommended (see section
4.2). 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, Ixifi® infusion solution can be used within 24 hours if stored at 2°C – 8°C. Do not store any unused portion of the infusion solution for reuse.

5. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Ixifi® with other agents. Do not infuse Ixifi® concomitantly in the same intravenous line with other agents.

6. Visually inspect Ixifi® for particulate matter or discolouration prior to administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.

7. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.