Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol
Tartaric acid
Hydrochloric acid
Sodium hydroxide
Nitrogen

6.2   Incompatibilities
None known.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted and diluted solutions
The product should be used immediately after reconstitution as it contains no antibacterial preservative. If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored at 2-80 C after breakage.

6.4   Special precautions for storage

Keep the vial in the outer carton in order to protect from light.
Store below 30°C.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.


6.5   Nature and contents of container
HYCAMTIN 4 mg is supplied in 17 ml type I glass vials, together with 20 mm grey butyl rubber stoppers and 20 mm aluminium seals with plastic flip-off caps.
HYCAMTIN 4 mg is available in a pack containing 1 vial.

6.6   Special precautions for disposal and other handling

The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections. The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml. Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to a final concentration of between 25 and 50 microgram/ml.

The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
− Personnel should be trained to reconstitute the medicinal product.
− Pregnant staff should be excluded from working with this medicinal product.
− Personnel handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
− Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.

7.    REGISTRATION HOLDER AND IMPORTER AND IT’S ADDRESS

Novartis Israel Ltd., P.O.B: 7126, Tel-Aviv