Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol (E421)
Hydrochloric acid
Sodium hydroxide
6.2 Incompatibilities
Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer’s injection and Ringer’s injection.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Unopened vial
The expiry date of the product is indicated on the packaging materials.
Reconstituted and infusion solution
Chemical and physical in-use stability of reconstituted solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 4 days below 25°C.
Chemical and physical in-use stability of infusion solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 2 days below 25°C.
From a microbiological point of view, the product should be used immediately. 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 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store Below 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Clear, colorless 10 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 100 mg of pemetrexed.
Pack of 1 vial with protective plastic overwrap.
Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Clear, colorless 50 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 500 mg of pemetrexed.
Pack of 1 vial with protective plastic overwrap.
Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Clear, colorless 100 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 1000 mg of pemetrexed.
Pack of 1 vial with protective plastic overwrap.
6.6 Special precautions for disposal and other handling
1. Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
2. Calculate the dose and the number of Pemetrexed Sandoz vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
3. Pemetrexed Sandoz 100 mg
Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Pemetrexed Sandoz 500 mg
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Pemetrexed Sandoz 1000 mg
Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to pale yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required.
4. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative) or with glucose 50 mg/ml (5%) solution for injection (without preservative) and administered as an intravenous infusion over 10 minutes.
5. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
6. Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
7. Pemetrexed solutions are for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Preparation and administration precautions: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Pemetrexed is not a vesicant. There is not a specific antidote for extravasation of pemetrexed. There have been few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator. Extravasation should be managed by local standard practice as with other non-vesicants.