Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Succinic acid
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products.
6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.

Once removed from the refrigerator:
•     Parsabiv is stable for up to 7 days in the original carton.
•     If removed from the original carton Parsabiv is stable for up to 4 hours if protected from direct sunlight.

6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Store in the original carton in order to protect from light.
6.5   Nature and contents of container

Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminum seal with flip-off dust cover.
Each vial contains 0.5 / 1 / 2 mL solution for injection.

Pack sizes of 6 vials.

6.6   Special precautions for disposal and other handling
For single use only.

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