Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Benzyl alcohol
Sodium Chloride
Ammonium acetate
Polysorbate 80
Glacial Acetic acid
Sodium Hydroxide
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
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

6.5   Nature and contents of container

0.5 ml of solution in pre-filled syringe (type I glass) with a plunger stopper (butyl rubber), a tip cap (butyl rubber), plunger rod (plastic), needle (stainless steel); pack size of 1.

6.6   Special precautions for disposal and other handling

For single use only.
Any unused product or waste material, including needles and syringes, should be disposed of in accordance with local requirements.


7.    MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon 4524079. www.roche.co.il 

8.    MARKETING AUTHORISATION NUMBER(S)
Roferon-A 3 MIU/0.5 ml: 108-53-29258-00
Roferon-A 4.5 MIU/0.5 ml:108-54-29259-00