Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride
Polysorbate 80
Benzyl alcohol
Sodium acetate trihydrate
Acetic acid, glacial
Water for injections
Sodium acetate trihydrate solution 10%

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PEGASYS                                                         MoH Approved Prescribing Information Pre-Filled Syringe, Pre-Filled Pen 135 & 180 mcg                                    December 2015 Acetic acid 10%

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe and pre-filled pen in the outer carton in order to protect from light.

6.4   Nature and contents of container

Pre-filled syringe:
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle. Available in packs of 1 or 4. Not all pack sizes may be marketed.

Pre-filled pen:
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a fixed needle (stainless steel), plunger stopper (butyl rubber laminated with fluororesin) and a needle shield (polyisoprene) in a pre-filled pen.
Available in packs containing 1, 4 pre-filled pens. Not all pack-sizes may be marketed.

6.5   Special precautions for disposal and other handling

The solution for injection is for single use only. It should be inspected visually for particulate matter and discoloration before administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Comprehensive instructions for the preparation and administration are given in the package leaflet.