Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

L-Arginine
L-Histidine
Poloxamer 188
L-Aspartic Acid

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 – 8°C).
Do not freeze. Do not use the syringe if it has been frozen.
Always keep the syringe dry.

Keep the PFS in the outer carton in order to protect from light and moisture.
If unopened and kept in the outer carton, the syringe may be left out of the refrigerator below 30°C for a single period up to 8 days. After storage at room temperature the product should not be returned to the refrigerator and should be either used or discarded.

6.5   Nature and contents of container

1 mL solution in a PFS (polymer) with a staked-in, stainless steel needle, fitted with a chlorinated butyl rubber-polypropylene rigid needle shield and sealed with a chlorinated butyl rubber plunger stopper. The PFS is labelled and assembled with an automatic needle guard, plunger rod, and extended finger flanges (EFF).

Pack size of 1 PFS.

6.6   Special precautions for disposal and other handling
After removing the carton from the refrigerator, the sealed carton should be open and the PFS carefully lifted out of the carton by holding the barrel. It is important to let the PFS reach room temperature by waiting for 30 minutes before initiating the administration process.

The medicinal product should not be used if the liquid is cloudy, discoloured, has visible particles in it or if any part of the PFS appears to be damaged.

The injection must be performed right after removing the cap and no later than 5 minutes, to prevent the medicinal product from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.

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


7.    MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon, 4524079 

8.    MARKETING AUTHORISATION NUMBER

169-11-36563-00