Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
None

6.2      Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicines.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Cefazolin is incompatible with aminoglycosides, amobarbital-Na, ascorbic acid, bleomycin sulfate, calcium glucoheptonate, calcium gluconate, cimetidine, colistin methanesulfonate-Na, erythromycin glucoheptonat, lidocaine HCl, pentobarbital Na, polymyxin B sulfate, tetracyclines (see section 4.5).


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

Reconstituted solution:
The reconstituted solution is preferably to be used immediately.

Chemical and physical in-use stability after reconstitution for all types of administration has been demonstrated for 24 hours at 2-8°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 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4        Special precautions for storage

Store below 25 °C in the original package.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5        Nature and contents of container

Clear, colourless, borosilicate type I glass vials, sealed with a 20 mm bromobutyl rubber stopper and an aluminium cap.
10 vials per carton.

6.6        Special precautions for disposal and other handling

Intramuscular administration: The vial is reconstituted with 2.5 ml water for injection. Shake well to completely dissolve. The administration is deeply i.m.

Intravenous injection: The vial is first reconstituted with 2.5 ml water for injection and then is diluted with water for injection to a volume of 10 ml water for injection, until it is completely dissolved and slowly, (never less than 3 minutes) injected for 5 min directly into a vein or into the intravenous infusion line.

Intravenous infusion: The vial is reconstituted with 2.5 ml water for injection until it is completely dissolved and then diluted in 100 ml in one of the following diluents: 
•   0.9% sodium chloride;
•   0.9% sodium chloride and 5% dextrose;
•   Lactated Ringer's solution.

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.

7.         MANUFACTURER:
MEDOCHEMIE LTD (FACTORY C), 2, Michael Erakleous, Agios Athanassios
Industrial Area, 4101 Agios Athanassios, Limassol.Cyprus