Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Aminoacetic acid (glycine), sodium chloride, hydrochloric acid or sodium hydroxide (in small amounts for pH adjustment), water for injections

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

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Beriglobin P must not be used after the expiry date given on the pack and container.
Once the container has been opened its contents are to be used immediately.

6.4   Special precautions for storage

Store in a refrigerator (+2 °C to +8 °) in the outer carton in order to protect from light. Do not freeze!
Keep out of the sight and reach of children!


6.5   Nature and contents of container
Immediate containers prefilled SCF syringes of colourless glass (Type I)

Presentations
Pack with 1 prefilled syringe of 2 ml
Pack with 1 prefilled syringe of 5 ml
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Beriglobin P is a ready-for use solution.
The medicinal product should be brought to room or body temperature before use.
The product should be inspected visually for particulate matter and discoloration prior to administration.
Solutions that are cloudy or have deposits should not be used.
Any unused product or waste material should be disposed of in accordance with local requirements.