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, oxytetracycline hydrochloride, pentobarbital sodium, polymyxin B sulfate, tetracycline hydrochloride.
6.3 Shelf life

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

6.4 Special precautions for storage
Powder for solution for injection/infusion: Store below 25°C. Keep in the outer carton in order to protect from light.

After reconstitution:
The chemical-physical stability of the reconstituted product in WFI for I.M. and I.V.
administration is maintained for 24 hours at 25 ± 2°C and 10 days at 5 ± 3°C.

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 24 hours at 5 ± 3°C, unless reconstitution has taken place in controlled and validated aseptic conditions.


After dilution:
Chemical and physical in-use stability has been demonstrated for 36 hours if stored at 30 ± 2°C and for 96 hours if stored at 5 ± 3°C for the following diluents normally used for intravenous infusion:
- 0.9% Sodium Chloride
- Lactated Ringer's Injection
- 5% Glucose and 0.9% Sodium Chloride
- 10% Glucose Injection
- 5% Glucose Injection

6.5 Nature and contents of container

Nature
10 ml uncolored glass vials, type III and bromobutyl rubber stoppers with type 1 flip-off cap.
Contents
Vials in packs of 10 per carton box.


6.6 Special precautions for disposal and other handling
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.