Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of excipients
Lactic acid
Water for injection.

6.2.   Incompatibilities

Not applicable.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4.   Special precuations for storage

Store below 30°C.
Store in the original package to protect from light.
Keep out of the sight and reach of children.

6.5.   Nature and contents of container
1 ml of solution in an amber coloured glass ampoules Type I.
Pack of 5 ampoules x 1 ml.

6.6.   Instructions for use and handling
Solution for injection – ampoules

•   Before using the ampoule, roll it briefly between both hand palms to warm up the product.
•   Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free.
•   With the other hand, hold the tip of ampoule putting the index finger against the neck of ampoule, and the thumb on the coloured point in parallel to the identification coloured rings.
•   Keeping the thumb on the point, sharply break the tip of ampoule while holding firmly the other part of the ampoule in the hand.

 coloured ring(s) coloured point breaking level



Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. Manufacturer and Registration holder:
Manufacturer: Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-2340
Beerse, Belguim

Registration Holder: J-C Health Care Ltd., Kibbutz Shefayim, 6099000, Israel