Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

D-sorbitol
Acetate
Polysorbate 20
Sodium
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) in the outer carton package, in order to protect from light.

Do not shake.
Pegil can be stored at room temperature for up to 72 hours.
Discard syringes stored at room temperature for more than 72 hours.
Do not freeze. If frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.


6.5   Nature and contents of container
Pre-filled syringe (Type I glass), with a rubber stopper, stainless steel needle and needle cap, with an automatic needle guard.


Each pre-filled syringe contains 0.6 mL of solution for injection. Pack size of one pre-filled syringe, in a blistered packaging.


6.6   Special precautions for disposal and other handling
Before administration, Pegil 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 to reach room temperature before injecting.
Any unused product or waste material should be disposed of in accordance with local requirements.