Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Benzyl alcohol, sodium chloride, 2 N sodium hydroxide or 2 N hydrochloric acid, 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.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

The product should be used immediately after opening.
After first opening the container
A vial can be stored for up to 14 days following first withdrawal, provided the solution is withdrawn under strictly aseptic conditions. The date of first opening must be noted on the label.

After dilution according to directions
Dilutions with the solutions stated in section 6.6 are chemically and physically stable at room temperature for 48 hours.
From a microbiological point of view, dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4   Special precautions for storage
Store below 250C.


6.5   Nature and contents of container
Pack of 10 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.

For intravenous infusion, Heparin Sodium B.Braun 5000 IU/ML may be diluted with the following solutions for infusion:

• Sodium chloride 9 mg/mL solution for infusion
• Glucose 50 mg/mL solution for infusion
• Glucose 100 mg/mL solution for infusion
• Ringer’s solution for infusion
Dilutions with these solutions are stable at room temperature for 48 hours.