Pharmaceutical particulars : מידע רוקחי

   6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Glycine
Human albumin
Sodium chloride
Water for injection

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.

6.4 Special precautions for storage
Store in a refrigerator (+2°C to +8°C). Do not freeze.
The product must not be used after the expiry date (EXP) printed on the outer carton.
Keep the syringe originally blistered in the outer carton in order to protect from light.
6.5 Nature and contents of container
2 ml solution in a pre-filled syringe (type I glass) with 1 injection needle in a pack size.

6.6 Special precautions for disposal and other handling
Rhophylac should be brought to room temperature (250C) before use.
Rhophylac should be inspected visually for particulate matter and discolouration prior to administration.
Do not use solutions which are cloudy or have deposits.
Rhophylac is for single use only (one syringe – one patient).
Any unused product or waste material should be disposed of in accordance with local requirements.

7. MANUFACTURED BY
CSL Behring AG
Wankdorfstrasse 10
3014 Bern 22
Switzerland

8. REGISTRATION HOLDER
CSL BEHRING LTD.,
Dolev st., Ra’anana   66 0