Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium chloride
Water for injection
Sodium hydroxide
Hydrochloric acid
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.
If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.

6.4   Special precautions for storage

Store below 25°C. Do not freeze.
6.5   Nature and contents of container

Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.

Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a blue plunger and an automatic safety system.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The subcutaneous injection is administered in the same way as with a classical syringe. Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.

Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.

Instruction on self-administration by subcutaneous injection is included in the Package Leaflet.

The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.

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


7. Manufacturer:

Aspen Notre Dame De Bondeville, Notre Dame De Bondeville, France

8. Registration Holder:
Padagis Israel Agencies Ltd., 1 Rakefet St., Shoham.