Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients
Sodium citrate
Sodium metabisulphite
Sulfuric acid (for pH adjustment)
Water for Injections

6.2 Incompatibilities
Amikacin is incompatible with some penicillins and cephalosporins, amphotericin chlorothiazide sodium, erythromycin gluceptate, heparin, nitrofurantoin sodium, phenytoin sodium, thiopentone sodium and warfarin sodium, and depending on the composition and strength of the vehicle, tetracyclines, vitamins of the B group with vitamin C, and potassium chloride.
At times, amikacin may be indicated as concurrent therapy with other antibacterial agents in mixed or superinfections. In such instances, amikacin should not be physically mixed with other antibacterial agents in syringes, infusion bottles or any other equipment. Each agent should be administered separately.
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, 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.
Following dilution in 0.9% sodium chloride or dextrose 5% solutions, chemical and physical in- use stability has been demonstrated for 24 hours at 25°C and at 50 C.


6.5 Nature and contents of container
500 mg/2 ml – clear Type I glass vial with rubber closure in packs of 1 vial.
6.6 Special precautions for disposal and other handling
Single use only.
The solution may darken from Colourless to light yellow, but this does not indicate a loss of potency.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.