No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Long-term studies have not been performed to eva luate the carcinogenic potential of infliximab. Studies in mice deficient in TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Polysorbate 80
Monobasic sodium phosphate
Dibasic sodium phosphate
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
3 years.
Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used as soon as possible but 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 should not be longer than 24 hours at 2 to 8°C.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature and contents of container
Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap, containing 100 mg of infliximab.
Remicade is available in packs of 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 Remicade vials needed. Each Remicade vial contains 100 mg infliximab. Calculate the total volume of reconstituted Remicade solution required.
2. 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. Do not use the vial if the vacuum is not present. 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.
3. Dilute the total volume of the reconstituted Remicade solution dose 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 Remicade. Slowly add the total volume of reconstituted Remicade 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 micrometer 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 ho |
