Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

For Gentamicin B.Braun 1 mg/ml:
Sodium chloride
Water for injections

For Gentamicin B.Braun 3 mg/ml:
Disodium edetate
Sodium chloride
Water for injections


6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products. On no account may aminoglycosides be mixed in an infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), erythromycin, or lipiphysan (A special oil-in-water-emulsion for parenteral nutrition) as this may cause physico-chemical inactivation. This also applies to a combination of gentamicin with diazepam, furosemide, flecainide acetate or heparin sodium.

The following active substances or solution for reconstitution/dilution should not be administered simultaneously:
Gentamicin is incompatible with amphotericin B, cephalothin sodium, nitrofurantoin sodium, sulfadiazine sodium and tetracyclines.
Addition of gentamicin to solutions containing bicarbonate may lead to the release of carbon dioxide.



6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
After first opening
From the 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.
6.4 Special precautions for storage Do not store above 25˚с.

6.5 Nature and contents of container

For Gentamicin B.Braun 1 mg/ml:
Bottles of low-density polyethylene containing 80 ml (1 mg/ml).
10 x 80 ml
20 x 80 ml
For Gentamicin B.Braun 3 mg/ml:
Bottles of low-density polyethylene containing 80 ml (3 mg/ml) and 120 ml (3 mg/ml).
10 x 80 ml
20 x 80 ml
10 x 120 ml
20 x 120 ml

Not all package sizes may be marketed.


6.6 Special precautions for disposal
Gentamicin B. Braun 1 mg/ml and Gentamicin B. Braun 3 mg/ml is a ready-to-use formulation and should not be diluted prior to administration.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.
For single use only. Do not re-connect partially used containers.
Unused solution should be discarded.
The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.
Any unused product or waste material should be disposed of in accordance with local requirements.