Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients
Sodium citrate dih d ate
Sodium metabisulphite
Sulphuric acid concentrated
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 e pi date of the p odu t is i di ated o the pa kagi g ate ials.
6.4 Special precautions for storage

Prior to first use
Store below 30°C. Do ot ef ige ate o f eeze.
Following dilution

In 0.9% sodium chloride and 5% glucose solutions chemical and physical in-use stability has been demonstrated for 24 hours at temperature not above 25°C.

From a microbiological point of view, the product should be used immidiately. If not used immidiately, 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 dilution has taken place in controlled and validated aseptic conditions.


6.5 Nature and contents of container
Type I clear glass ampoules of 2 ml filling capacity in packs of 10 and 100 ampoules.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Single use only. Discard any unused contents.
The solutio    a da ke f o      olou ess to a pale ello     ut this does ot i di ate a loss of pote    .

A   u used     edi i al p odu t o   aste   ate ial should e disposed of i a o da e ith lo al  e ui e e ts.