Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Powder:
Mannitol
Solvent:
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
Unopened vial: 2 years

Reconstituted product: use immediately

6.4   Special precautions for storage
Store in a refrigerator (2°C – 8°C); in the original package in order to protect from light.
After dispensing to the patient, the unopened product may be stored in the original package at room temperature (not above 30°C) for up to three months.

This product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.

Do not freeze or place next to the freezer compartment or a freezer pack.

6.5   Nature and contents of container
Powder: 2 ml vials (Type I glass) with a stopper (bromobutyl rubber) and flip-off aluminium cap.

1 vial contains 0.25 mg cetrorelix.

Solvent: Pre-filled syringe (Type I glass) with plunger stopper (siliconised bromobutyl rubber) and tip cap (polypropylene and styrene butadiene rubber).

1 pre-filled syringe contains 1 ml of water for injections.

Additionally for each vial the pack contains:
1 injection needle (20 gauge)
1 hypodermic injection needle (27 gauge)
2 alcohol swabs

Pack sizes of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes.

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

This product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.

Cetrotide should only be reconstituted with the solvent provided, using a gentle, swirling motion. Vigorous shaking with bubble formation should be avoided.

The reconstituted solution is without particles and clear. Do not use if the solution contains particles or if the solution is not clear.

Withdraw the entire contents of the vial. This ensures a delivery to the patient of a dose of at least 0.23 mg cetrorelix.

The solution should be used immediately after reconstitution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7.    REGISTRATION NO.
117 19 29780