Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Glycine
Water for injections

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

No other preparations may be added to the Zutectra 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.
Once the protective cap has been removed from the pre-filled syringe, the solution should be administered immediately.

6.4   Special precautions for storage

Store and transport refrigerated (2°C-8°C).
Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.



6.5   Nature and contents of container
One mL solution for injection in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).

Pack size of five pre-filled syringes in a blistered pack.

6.6   Special precautions for disposal and other handling
This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.

The solution can vary from clear to opalescent and colourless to pale yellow.

Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MANUFACTURER:
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany.