Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Disodium Edetate, Sodium Chloride, Sulfuric Acid, and Water for Injection.
6.2 Incompatibilities
In general, gentamicin should not be mixed with other medicinal products. In particular, the following are incompatible in mixed solution with gentamicin injection: 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. Dilution in the body will obviate the danger of physical and chemical incompatibility and enable gentamicin to be given concurrently with the drugs listed above either as a bolus injection into the drip tubing, with adequate flushing, or at separate sites. In the case of carbenicillin, administration should only be at a separate site.
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.
The solution for injection should be used immediately after the ampoule has been opened!
Only clear solutions should be used for injection and infusion.


6.4 Special precautions for storage
Do not store above 25 °C. Keep the vials in the original packaging in order to protect from light.

Prepared solutions of Gentamicin Panpharma in various diluents (sodium chloride 0.9% and dextrose 5%) are stable for 24 hours if stored at 25oC and 3 hours at 25oC after 24 hours at 2-8 o
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 15-25 Cº, unless dilution has taken place in controlled and validated aseptic conditions.


6.5    Nature and contents of container
Cartons containing 10 ampoules of 2 ml.

6.6    Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
For single use only.