Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.
6.2 Incompatibilities

Cefazolin is incompatible of with amikacin disulfate, amobarbital sodium, ascorbic acid, bleomycin sulphate, 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.
6.4 Special precautions for storage

Store below 25°C.

From a microbiological point of view, unless the method of opening and reconstitution/dilution precludes the risk of microbial contamination, 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.

Chemical and physical in-use stability has been demonstrated as follows: 
- In-use stability after reconstitution for I.M administration / Direct (bolus) I.V injection: Diluent and volume              Purpose of use                   Stability after reconstitution

4 ml lidocaine 0.5%             I.M administration               24 h below 25°C or 72 h in the refrigerator (2°C - 8°C).

10 ml water for injections      Direct I.V injection             24 h below 25°C or 72 h in the refrigerator (2°C-8°C).

4 ml sodium chloride 0.9%       Direct I.V injection             12 h below 25° C or 72 h in the refrigerator (2°C- 8°C).



-    In-use stability after reconstitution for intermittent I.V infusion in 100 ml of Sodium chloride 0,9% / Dextrose 5% has been demonstrated for 12 hours below 25°C.

-    Obtained solutions should be protected from light.

6.5 Nature and contents of container
Sterile powder is packaged in glass vials with 1000 mg of sodium cefazolin.

Pack sizes: 1,5,10,50 vials.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and handling

Do not use after the expiry date which is stated on the carton.

Reconstituted solutions should be inspected visually. Only clear solutions free of visible particles should be used.

Keep out of the reach and sight of children.

7. MARKETING AUTHORISATION HOLDER
NEOPHARM (ISRAEL) 1996 LTD

Hashiloach 6, POB 7063 Petach Tiqva 4917001.