Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Benzyl alcohol, sodium chloride, sodium hydroxide, water for injection.

6.2   Incompatibilities
Heparin must not be drawn up into a syringe or administered in an infusion along with other medicinal products because of the danger of physical and chemical incompatibilities.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Once the vial has been opened, administer the product immediately.
6.4   Special precautions for storage

Do not store over 30º C.

6.5   Nature and contents of container
Type I glass vials, with bromobutyl rubber stopper and aluminium protective capsule.

5 ml vials in packs of 50 vials.

6.6   Special precautions for disposal and other handling
Administration of the subcutaneous injection
The injection should be administered with a fine injection needle held perpendicular to the body axis, into a raised fold of abdominal skin or on the anterior aspect of the thigh; the injection must be strictly subcutaneous.
Any drops adhering to the injection needle should be removed before the injection, as introducing heparin sodium into the injection channel can result in superficial bruising and in rare cases local allergic irritation.

Only use if the solution is clear and colourless, and free of visible particles. Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.

7.   LICENCE HOLDER AND MANUFACTURER

Licence holder:
Kamada Ltd., Beit Kama, MP NEGEV 8532500, Israel
Manufacturer:
LABORATORIOS FARMACÉUTICOS ROVI, S.A.
Julián Camarillo, 35 - 28037 Madrid - Spain