Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients

None
6.2      Incompatibilities

Cefazolin is incompatible with amikacin disulfate, amobarbital sodium, ascorbic acid, bleomycin sulfate, calcium glucoheptonate, calcium gluconate, cimetidine hydrochloride, colistin methane sulfonate sodium, erythromycin glucoheptonate, kanamycin sulfate, oxytetracyclin hydrochloride, pentobarbital sodium, polymyxin B sulfate, tetracycline hydrochloride.



6.3      Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution:
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. The time after reconstitution should not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
6.4      Special precautions for storage

Powder for solution for injection: Store below 25 °C. Keep in the outer carton in order to protect from light.

Reconstituted solution:
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. The time after reconstitution should not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.


6.5      Nature and contents of container
Nature
15 ml uncolored glass vials, type III and halogenated butyl rubber stoppers with flip-off crimp seal.

Contents
Vials in packs of: 10 or 25 vials per carton box.
Not all pack sizes may be marketed.

6.6      Special precautions for disposal and other handling


Solutions for I.V. injections are prepared by dissolving the powder in water for injection or 0.9% sodium chloride solution. Use at least 4 ml of the solvent for each gram of powder.
Intramuscular doses should be injected into a large muscle mass. For I.M. administration the drug should be dissolved in 0.5% lidocaine solution. Dissolve 1g of the powder in 4 ml of the solvent.
Only use freshly prepared, clear and colourless solutions. For single use only.
Any unused solution should be discarded.
Inspect the reconstituted solution visually for particulate matter and for discoloration prior to administration. The reconstituted solution is clear.