Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Benzyl alcohol, sodium chloride, sodium hydroxide, sulphuric acid 96%, 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
3 years


The product should be used immediately after opening.

6.4   Special precautions for storage

Store below 250C.

The solution may take on a darker colour after long-term storage; the therapeutic effect is not affected by this.

6.5   Nature and contents of container

Pack of 5 vials, each containing 5 ml solution for injection or infusion 
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.

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7.    LICENCE HOLDER AND MANUFACTURER
Licence holder:
Teva Medical Marketing
Haorgim St. 8,
Ashdod

Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Str. 3,
Blaubeuren, Germany