Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

D-Sorbitol (E-420)
Glacial Acetic Acid
Sodium Hydroxide
Polysorbate 20
Water for injection

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Pegfilgrastim Kamada may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Pegfilgrastim Kamada left at room temperature for more than 72 hours should be discarded.

Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pegfilgrastim Kamada.

Keep the container in the outer carton, in order to protect from light.

6.5   Nature and contents of container

Pre-filled syringe (Type I glass), with a (bromobutyl) rubber stopper and a stainless steel needle with an automatic needle guard. The needle has flexible, rigid needle shield.

Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution for injection.

Pack size of one pre-filled syringe with automatic needle guard (0.6ml) and supplied in a blistered packaging.
6.6     Special precautions for disposal and other handling

Before administration, Pegfilgrastim Kamada solution should be inspected visually for particulate matter.
Only a solution that is clear and colorless should be injected.

Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Allow the pre-filled syringe for manual administration to reach room temperature for 30 minutes before injecting.

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