Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Edetate tetrasodium, mannitol, tromethamine.

6.2 Incompatibilities

PantoAvenir I.V. must not be prepared with any other solutions apart from the ones specified above (see 4-2).

6.3 Shelf life

PantoAvenir I.V. is stable over a period of 2 years.
The reconstituted solution must be used within 12 hours after preparation.

6.4 Special precautions for storage

Vial: Store at temperatures up to 25ºC
Keep the vial in the original carton.
6.5 Nature and contents of container

PantoAvenir I.V., as the dry substance in glass vial
1 vial in a carton box and 20 vials in a carton box.

6.6 Instructions for use/handling
A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution into the vial containing the dry substance. This solution may be administered directly or may be administered after mixing with 100 ml physiological sodium chloride solution, or 5% Glucose.

Reconstituted vial: the reconstituted solution is stable for 12 hours at 25ºC or 24 hours in a refrigerator (2 - 8ºC).

After reconstitution, the solution may be used within the following 12 or 24 hours, although from a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25°C or 24 hours in a refrigerator (2 - 8ºC).

PantoAvenir I.V must not be prepared or mixed with solvents other than those stated.
The drug should be administered intravenously over 2 -15 minutes.

Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) has to be discarded.
The contents of the vial is intended for single use only.


Manufacturer:
Laboratory Reig Jofre S.A., Barcelona, Spain