Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Acetate (10 mM)
Sorbitol
Polysorbate 20
Water for injection
Sodium hydroxide

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).

Neulastim may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Neulastim 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 Neulastim.

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 rubber stopper, stainless steel needle and needle cap, with or without an automatic needle guard.

The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).

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

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Before administration, Neulastim 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.


7.    MANUFACTURER:
Amgen Europe B.V., Breda, The Netherlands.