Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1     List of Excipients
Water for injection, Hydrochloric acid (E507).

6.2     Incompatibilities
This medicinal product must not be mixed with any other medicinal product except those mentioned in section 4.2 Posology and method of administration.
Foscarnet is not compatible with dextrose 30% solution, amphotericin B, aciclovir sodium, ganciclovir, pentamidine isethionate, trimethoprim-sulfamtoxazole and vancomycin hydrochloride. Neither is foscarnet compatible with solutions containing calcium. It is recommended that other drugs should not be infused concomitantly in the same line.


6.3 Shelf-Life
Unopened:
The expiry date of the product is indicated on the packaging materials Once opened:
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 2-8°C.
Each bottle of Foscavir 24mg/ml should only be used to treat one patient with a single infusion.
Any unused medical product or waste material should be disposed os in accordance with local requirements.


6.4     Special Precautions for Storage
Do not store above 25°C. Do not refrigerate. Do not freeze. If refrigerated or exposed to temperatures below freezing point precipitation may occur. By keeping the bottle at room temperature with repeated shaking, the precipitate can be brought into solution again.
For storage conditions after first opening and/or dilution of the medicinal product, see section 6.3 Shelf-Life.


6.5     Nature and Content of Container
Infusion glass bottles of 250ml

6.6     Special precautions for Disposal and other handling
Individually dispensed doses of foscarnet can be aseptically transferred to plastic infusion bags by the hospital pharmacy. The physico-chemical stability of foscarnet and dilutions thereof in equal parts with 0.9% sodium chloride (9mg/ml) or 5% dextrose (50mg/ml) in PVC bags is 7 days. However, diluted solutions should be refrigerated and storage restricted to 24 hours.


Each bottle of Foscavir 24mg/ml should only be used to treat one patient with a single infusion.


Accidental skin and eye contact with the foscarnet sodium solution may cause local irritation and burning sensation. If accidental contact occurs, the exposed area should be rinsed with water.