Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Mannitol
Water for Injections

6.2 Incompatibilities
In the absence of compatibility studies, 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 
6.4 Special precautions for storage
Keep the pre-filled syringes/ pre-filled pens in the outer carton, in order to protect from light.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
If the pre-filled syringes/ pre-filled pens cannot be stored in a refrigerator, they can be stored between 15°C and 25°C, once for up to one month.
After this one month period, if the Copaxone pre-filled syringes/ pre-filled pens have not been used and are still in their original packaging, they must be returned to storage in a refrigerator (2°C to 8°C).


6.5 Nature and contents of container

Pre-filled syringe
A pre-filled syringe containing Copaxone 40 mg/ml solution for injection consists of a 1 ml colourless type I glass syringe barrel with stainless-steel needle, a blue plunger rod, a grey rubber plunger stopper and a needle shield.
Copaxone 40 mg/ml is available in packs containing 12 pre-filled syringes of 1 ml solution for injection.
Pre-filled pen

A pre-filled pen consists of a single-use spring-loaded disposable injector with a needle protection shield, containing one pre-filled syringe with 1 mL of solution for injection. The syringe inside the pen consists of a colourless type I glass syringe barrel, a stainless steel needle and a bromobutyl rubber plunger stopper.

The pre-filled pen presentation is available in packs containing 3 or 12 pre-filled pens of 1 ml solution for injection or in a or in a multipack containing 36 (3 packs of 12) pre-filled pens of 1 ml solution for injection.
Not all pack sizes may be marketed.


6.6 Special precautions for disposal
For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.