Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1. List of excipients

None.

6.2. Incompatibilities

The contents of the vial should only be used in a solution with water for injections, 5% glucose solution or 0.9% sodium chloride, in order to avoid incompatibilities.
In order to avoid undesirable chemical reactions or undesirable effects, the already dissolved vials should not be mixed with other mixed injections or infusions (e.g. Ringer's lactate solution, etc.).
Oxidising and reducing substances, alcohol, glycerol, macrogols and other hydroxy- compounds can inactivate benzylpenicillin.
Benzylpenicillin solutions are most stable in the pH range of 6–7 (optimum at pH 6.8).
Benzylpenicillin is incompatible in solution with the following:
− cimetidine
− cytarabine
− chlorpromazine hydrochloride
− dopamine hydrochloride
− heparin
− hydroxyzine hydrochloride
− lactate
− lincomycin hydrochloride
− metaraminol
− sodium hydrogen carbonate
−    oxytetracycline
−    pentobarbital
−    tetracycline hydrochloride
−    thiopental sodium
−    vancomycin

Benzylpenicillin is not compatible with vitamin B complex and ascorbic acid in mixed solutions.


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

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°C to 8°C

For reconstituted product used for IM injection in-use storage times and conditions are 48 hours at 2°C to 8°C and 8 hours below 25 °C.

For the diluted product used for IV Injection/Infusion in-use storage times and conditions are 24 hours at 2°C to 8°C and 4 hours below 25 °C.


6.4. Special precautions for storage

Store below 25 °C.

For in-use storage times and conditions, refer to section 6.3

6.5. Nature and contents of container

Type III glass vials with halogenated butyl rubber stopper.
Pack sizes:
Penicillin G Sodium 5 MU dry powder vial:
1, 10 and 25 vials (with a volume of 15 mL).
Penicillin G Sodium 10 MU dry powder vial:
1, 10 and 25 vials (with a volume of 30 mL).

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other instructions for handling Reconstitution
Constitute as follows:
Penicillin G Sodium 5 MU: add 3.5 ml Water for Injection to provide a concentration of 1 MU/ml.
Penicillin G Sodium 10 MU: add 7 ml Water for Injection to provide a concentration of 1 MU/ml.

Preparation for IV infusion solution:
Penicillin G sodium 5 MU: dissolve in 50 ml Water for Injection.
Penicillin G sodium 10 MU: dissolve in 100 ml Water for Injection.

If this ratio is observed, an approximately isotonic solution is obtained.
The product should be used immediately after dissolution.
This medicinal product is for single use only

Reconstitution and dissolution should take place in controlled and validated aseptic conditions.

7.         LICENCE HOLDER AND MANUFACTURER

License Holder
Teva Israel Ltd ,124 Dvora HaNevi'a St, Tel Aviv, Israel