Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Tartaric acid (E334)
Hydrochloric acid (E507) (for pH adjustment)
Sodium hydroxide (E524) (for pH adjustment)
Water for injections
6.2      Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.



6.3    Shelf life after dilution

Diluted solution
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, 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 12 hours if stored below 25°C or 24 hours at 2-8°C.


6.4    Special precautions for storage
Store in a refrigerator (2°-8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.

For storage conditions of the diluted medicinal product, see section 6.3.

6.5    Nature and contents of container
Colourless, type I glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snap-cap. Each vial contains 1 ml or 4 ml of concentrate.

Topotecan Teva is available in cartons containing 1 vial and 5 vials.

Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling

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

Instructions for dilution
The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan. Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.



Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.

7.     REGISTRATION NUMBER
144 28 33245 00