Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS
6.1.     List of excipients


None.

6.2.     Incompatibilities

Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective.
Aminoglycosides are incompatible with cephalosporins in parenteral mixtures.


6.3.     Shelf life

Unopened: The expiry date of the product is indicated on the packaging materials.

Reconstituted solution: twenty four (24) hours.
Satisfactory potency is maintained for twenty four (24) hours when stored refrigerated with the following intravenous infusion fluids:
•        Water for injection

•       0.9% Sodium chloride
•       Dextrose 5 %
•       5% Dextrose and 0.9% Sodium chloride
•       Ringer’s lactated solution From a microbiological point of view, reconstituted solution for intramuscular or intravenous administration should be used immediately upon reconstitution .If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 80C unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.
Any unused solution remaining must be discarded at twenty four hours.


6.4.    Special precautions for storage

Unopened: Store below 25°C. Keep the vial in the outer carton, in order to protect from light..
Reconstituted solutions should preferably be used immediately upon reconstitution.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

Cefotaxime is also compatible with Lignocaine 1% injection, but freshly prepared solutions only must be used.
Cefotaxime is also compatible with metronidazole infusion (500 mg/100 ml) and both will maintain potency when refrigerated for up to 24 hours.


6.5.    Nature and contents of container

Clear type I glass vials, sealed with a grey bromobutyl rubber stopper and aluminium cap. Vials are cartonned in packs of 10 with an instruction leaflet.


6.6.    Special precautions for disposal

Reconstitution of the vials should be done with suitable aseptic precautions. From a microbiological point of view, reconstituted solution for intramuscular or intravenous administration 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 24 hours at 2 to 8°C.
Infusion solutions, as specified in section 6.3, should not be stored for more than twenty-four hours.
Any unused solution should be discarded. Before use, examine solutions for evidence of particles, any 

such solutions should not be used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.      MARKETING AUTHORISATION HOLDER

A.L. Medi-Market Ltd., 3 Hakatif St., Emek Hefer Industrial Park, 3877701