Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Trometamol
Monothioglycerol
Citric acid
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

6.2 Incompatibilities
Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection. In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.

Pemetrexed EVER Pharma contains trometamol as an excipient. Trometamol is incompatible with cisplatin resulting in degradation of cisplatin. This medicinal product must not be mixed with other medicinal products. Intravenous lines should be flushed after administration of Pemetrexed EVER Pharma.
6.3 Shelf life

Unopened vial
2 years

For intravenous infusion, Pemetrexed EVER Pharma 25 mg/ml concentrate for solution for infusion should be diluted in one of the following solutions:

- 0.9% NaCl
- 5% glucose
 to a final concentration of about 2 mg/mL, 4.5 mg/mL, and 9 mg/mL in 100 mL each and stored at different conditions (ambient temperature 20 °C – 30 °C under normal daylight conditions and refrigerated 2 °C – 8 °C) in infusion bag materials (polypropylene and polyolefin). Chemical and physical in-use stability of the diluted drug product (infusion solution) was demonstrated for 28 days at refrigerated temperature (2ºC –8ºC) and for 7 days at ambient temperature (20ºC–30ºC).

6.4 Special precautions for storage

Store below 30°C. Do not freeze.
6.5    Nature and contents of container

Colourless glass vial (type 1) with a bromobutyl rubber stopper with fluoropolymer coating and an aluminium cap with plastic flip-off. Vials may or may not be sheathed in a protective sleeve

6.6    Special precautions for disposal and other handling

Pregnant personnel should not handle this medicine.
1. Use aseptic technique during dilution of pemetrexed for intravenous infusion administration.
2. Calculate the dose and the number of Pemetrexed EVER Pharma vials needed.
3. The appropriate volume of Pemetrexed EVER Pharma must be diluted to 100 ml with 9 mg/ml (0.9%) sodium chloride solution for injection or 5 % glucose solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
4. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
5. Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
6. Pemetrexed solutions are for single use only. Any unused medicinal product or waste material must 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.