Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment), Water for Injections.
6.2 Incompatibilities
Do not add the papaverine solution to a lactated Ringer's solution as it may form a precipitate.

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

6.4 Special precautions for storage
Store below 25°C.
Do not freeze.
6.5 Nature and contents of container
Carton box containing 10 amber glass ampoules.
Each ampoule contains 2 ml solution.


6.6 Special precautions for disposal and handling
Before administration, Papaverine Teva Injection should be drawn out according to the rules of good clinical practice, in the most aseptic manner possible, using a sterile syringe, immediately after opening the ampule. The drawn out drug solution should then be administered immediately.

The solution should be visually inspected prior to administration for any particulate matter.
Do not use the solution if the liquid is not clear. Discard ampules containing visible particles.

This solution does not contain any antimicrobial preservative and is therefore for single use, which is not likely to prevent microorganism growth.
Any unused medicinal product must not be stored for later use.
Any unused product or waste material should be disposed of in accordance with the current regulations.

In general, there is a risk of irritation or necrosis at the injection site in case of too rapid administration or if too much volume is injected.


7. LICENCE HOLDER AND MANUFACTURER
TEVA ISRAEL LTD
124 Dvora HaNevi'a St., Tel Aviv 6944020 Israel