Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Glacial acetic acid
Polysorbate 20
Arginine hydrochloride
Sodium acetate trihydrate
Water for injections

6.2   Incompatibilities

Not applicable.
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).

DO NOT FREEZE.

AVONEX can be stored at room temperature (between 15°C and 30°C) for up to one week.
Store in the original package (sealed plastic tray) in order to protect from light (see section 6.5).

6.5    Nature and contents of container

Avonex in prefilled syringe: 1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.

Pack size: box of four or twelve pre-filled syringes of 0.5 ml. Each syringe is packed in a sealed plastic tray, which also contains one injection needle for intramuscular use.

Avonex in prefilled Pen: A pre-filled syringe of AVONEX is contained within a single-use, disposable, spring-powered pen injector called AVONEX PEN. The syringe inside the pen is a 1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.

Pack size: Each single-use AVONEX PEN is packed in an individual carton, with one injection needle and a pen cover. AVONEX PEN is available in pack sizes of four or twelve.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
Avonex in prefilled syringe
AVONEX is provided as ready to use solution for injection in a pre-filled syringe.

Once removed from the refrigerator, AVONEX in a pre-filled syringe should be allowed to warm to room temperature (15°C -30°C) for about 30 minutes.

Do not use external heat sources such as hot water to warm AVONEX 30 micrograms solution for injection.

If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled syringe must not be used. The injection needle for intramuscular injection is provided. The formulation does not contain a preservative. Each pre-filled syringe of AVONEX contains a single dose only. Discard the unused portion of any pre-filled syringe.

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

Avonex in prefilled Pen
For single-use only: The solution for injection in a pre-filled syringe is contained within the AVONEX PEN.

Once removed from the refrigerator, the AVONEX PEN should be allowed to warm to room temperature (15°C to 30°C) for about 30 minutes.

Do not use external heat sources such as hot water to warm AVONEX 30 micrograms solution for injection.

Each single-use, disposable, pre-filled pen contains a single dose of AVONEX. The solution for injection can be observed through an oval medication display window on the AVONEX PEN. If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled pen must not be used. The injection needle is provided. The formulation does not contain a preservative.

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


Registration holder and importer
Medison Pharma Ltd.
Hashiloach 10, Petach Tikva
Israel