Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Mannitol
Sulfuric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections.

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

Vial before opening
The expiry date of the product is indicated on the packaging materials.
After dilution
Chemical and physical in-use stability of the solution prepared for injection or infusion has been demonstrated for 24 hours at 2-8°C and also at 15 to 25°C when diluted to a concentration range of 0.01 mg/ml to 0.1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution for infusion or in 50 mg/ml (5%) glucose solution for infusion.
From a microbiological point of view, the diluted solution 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 to 8°C, unless dilution has taken place under controlled and validated aseptic conditions

6.4   Special precautions for storage

Store and transport refrigerated (2-8°C).
Keep vial in the outer carton in order to protect from light.
6.5   Nature and contents of container

Colourless Type I glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snap-cap containing 1 ml, 2 ml or 5 ml of solution.

Pack sizes:
One vial containing 1 ml of solution
One vial containing 2 ml of solution
One vial containing 5 ml of solution

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling
Inspection prior to use
Only clear solutions without particles should be used. The product should not be used in case of a defective container.
Handling and disposal
Injectable solutions of cytotoxic drugs should be prepared by specialized trained personnel who are familiar with the drugs used, under conditions that guarantee environmental protection and especially protection of personnel handling the drugs. Vincristine should not be used by pregnant staff.
Any contact with the liquid should be avoided. The solutions should be prepared in a special area in which smoking, eating and drinking are prohibited. During the preparation a strictly aseptical work technique must be applied; as protective measures the use of gloves, mouth mask, safety goggles and protective clothing are needed. The use of a LAF-cabinet with vertical flow direction is recommended. During administration gloves should be worn. With waste processing, the nature of this product should be taken into account.
If the solution does get in contact with the skin, mucous membranes or eyes, immediate excessive flushing with water should occur.
Extravasation should be avoided. Should extravasation occur, the injection should be stopped immediately and the possibly remaining dose should be injected in a different vein. Local injection of hyaluronidase 250 IU/mL (1 mL subcutaneous around the lesion and moderate heat application at the site where the extravasation occurred), can help disperse the product and limit the discomfort and possible cellulitis to a minimum. In the unit where vincristine sulfate is administered, the hospital’s cytostatics extravasation set of the hospital should be available.
Excreta and vomitus should be handled with caution.
Broken containers should be handled with the same precautions and treated as contaminated waste. Contaminated waste should be disposed of by incineration in rigid, appropriately labelled containers.