Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients
The following excipients are included:
Trometamol,
Sodium calcium edetate,
Hydrochloric acid (pH adjustment),
Sodium hydroxide (pH adjustment)
Water for injections.
The pH of the product is 6.8 - 7.7.

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. A separate syringe should be used.


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

6.4.   Special Precautions for Storage
Store below 25ºC.
Keep the container in the outer carton and do not freeze.
Vials are intended for single use any unused portions must be discarded.


6.5    Nature and content of container
Transparent glass vial (type I) containing 100 or 200 ml of solution in each pack, consisting of 1 vial.

Not all packaging types may be marketed.



6.6    Special precautions for disposal and other handling
Like all parenteral products, Kopaq should be inspected visually for particulate matter, discolouration and the integrity of the container prior to use.

Kopaq may be warmed to body temperature (37° C) before administration. Any unused product or waste material should be disposed of in accordance with local requirements.
The product should be drawn into the syringe immediately before use. Vials are intended for single use only; any unused portions must be discarded.


7.     MARKETING AUTHORISATION HOLDER
A.L.Medi-Market Ltd., 3 Hakatif street, Emek Hefer Industrial Park, 3877701