Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Lactose
Trometamol
Zinc acetate dihydrate

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products (see section 6.6).

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability following reconstitution has been demonstrated for 24 hours at 2-8ºC. From a microbiological point of view, Voraxaze should be used immediately after reconstitution. 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 reconstitution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2°C–8°C).
Do not freeze.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

3 mL type 1 glass vials (Ph Eur) with a bromobutyl stopper and standard blue flip off seal.

Pack size of 1 vial.
6.6   Special precautions for disposal

Each vial should be reconstituted with 1 mL of sterile 0.9% sodium chloride solution. Reconstitution should take place immediately prior to use (do not further dilute). It should be administered intravenously by bolus intravenous injection over 5 minutes.

After reconstitution with 1 mL of sterile 0.9% sodium chloride solution each 1 mL will contain 1,000 units of glucarpidase. A syringe suitable for withdrawing small volumes should be used to remove the solution from the vials. It may not always be possible to withdraw a full 1 mL from the vial but removal of at least 0.90 mL from the vial will provide an adequate amount of glucarpidase for dosing purposes.

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