Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
D-Mannitol
Benzyl alcohol
Poloxamer 188
L-methionine
Sodium acetate

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date of the product is indicated on the label and on the package.

6.4   Special precautions for storage
Store in a refrigerator (2°C – 8°C) away from the cooling element. Do not freeze. Store in the original package in order to protect from light.
The device (RebiSmart) containing a pre-filled cartridge of Rebif must be stored in the device storage box in a refrigerator (2°C – 8°C).
After first injection with the Rebif cartridge use within 28 days.

For the purpose of ambulatory use, the patient may remove Rebif from the refrigerator and store it not above 25°C for one single period of up to 14 days. Rebif must then be returned to the refrigerator and used before the expiry date.

6.5   Nature and contents of container

Rebif 22/44 micrograms (Interferon beta-1a) pre-filled syringe is available as 1 mL (Type 1 glass) syringe with a stainless steel needle, containing 0.5 mL solution.
Or


Rebif 22/44 micrograms (Interferon beta-1a) cartridge is available as cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 mL solution for injection.


Package size of 1,3 or 12 syringes are available.
Pack size of 4 cartridges is available.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The solution for injection in a pre-filled syringe is ready for use. It may also be administered with a suitable auto-injector.

The solution for injection in a pre-filled syringe is for single use only.

The solution for injection in a pre-filled cartridge is ready for use with the RebiSmart electronic injection device. For storage of the device with the cartridge, see section 6.4.

The cartridge is for multidose use.

Only clear to opalescent solution without particles and without visible signs of deterioration should be used.

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