Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Glycine
Water for injections.
6.2    Incompatibilities

This medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.

No other preparations may be added to the Hepatect CP solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.


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

6.4    Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
6.5    Nature and contents of container

Hepatect CP is a ready-for-use solution for infusion provided in vials (Type II glass) with a stopper (bromobutyl) and a cap (aluminium):

Pack size of 1 vial with 2 ml, 10 ml, 40 ml, or 100 ml solution.

Not all pack sizes may be marketed.
6.6    Special precautions for disposal and other handling

The product must be brought to room or body temperature before use.
The solution should be administered immediately after opening the receptacle.
The solution should be clear or slightly opalescent and colourless to pale yellow.
Do not use solutions that are cloudy or have deposits.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.