Pharmaceutical particulars : מידע רוקחי

6.      Pharmaceutical particulars
6.1     List of excipients
Mannitol, Hydrochloric acid solution and Sodium Hydroxide solution (for pH adjustment), and 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.
Once the vial has been opened, the product must be used immediately.

6.4     Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
For storage conditions after first opening of the medicinal product (see Section 6.3).
6.5     Nature and contents of container

One colourless glass vial (2 ml), closed with a suitable rubber stopper and a 13 mm aluminium crimp cap with a plastic flip-off.
Lithographed cardboard box containing 1 vial of 0.9 ml and internal package leaflet.

6.6      Special precautions for disposal and other handling
The vials should be inspected visually for particulate matter and discoloration prior to administration.

Preparation of the initial intravenous injection:
Withdraw 0.9 ml of a 0.9 ml labelled vial of Atosiban EVER Pharma 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit. The Atosiban EVER Pharma 6.75 mg/0.9 ml, solution for injection should be used immediately.

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