Leaflet AMIKOZIT 500mg / 2ml solution for injection

Product code:
W53277001
Quantity:
1
Indicated for:
bacterial infections
Route of administration:
injectable
Substance:
amikacin (aminoglycoside antibiotic)
ATC
J01GB06 — Antiinfectives for systemic use | Aminoglycoside antibacterials | Other aminoglycosides

Precautions:

Dose adjustment in renal impairment

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea

Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Nephrotoxicity

Nephrotoxicity

This medicine may affect the kidneys.

Ototoxicity

Ototoxicity

This medicine may affect hearing or balance.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

Amikacin is an antibiotic from the aminoglycoside class, used to treat severe bacterial infections caused by gram-negative bacteria, such as urinary tract infections, respiratory infections, or sepsis. It works by inhibiting bacterial protein synthesis, leading to bacterial destruction.

Amikacin is usually administered intravenously or intramuscularly, with the dosage adjusted based on the patient's weight, the severity of the infection, and renal function. Treatment is typically short-term to reduce the risk of toxicity.

Side effects may include kidney function impairment (nephrotoxicity), auditory nerve damage (ototoxicity), and allergic reactions. For this reason, patients receiving amikacin should be closely monitored, particularly for renal and auditory function.

Amikacin is an effective option for treating severe infections, but its use must be carefully supervised to minimize associated risks. It is important that the medication is used as directed by a specialist physician.

General data about AMIKOZIT 500mg / 2ml

Substance:
amikacin
Date of latest medicines list:
01-06-2026
Product code:
W53277001
Concentration:
500mg / 2ml
Pharmaceutical form:
solution for injection
Packing volume:
2 ml
Product type:
Generic medicine
Price:
71.26 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ZENTIVA S.A. - ROMANIA
Holder:
ZENTIVA S.A. - ROMANIA
Number:
11496/2019/01
Shelf life:
3 years

Pharmaceutical forms available for amikacin

Concentrations available for amikacin

  • 100mg/2ml
  • 125mg/ml
  • 1g/4ml
  • 250mg/ml
  • 500mg/2ml
  • 50mg/ml

Compensation lists for AMIKOZIT 500mg / 2ml Zentiva

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment

Price
71.26 RON
Copayment
71.26 RON
Patient
0.00 RON

NHP 1.B (C2) - Tuberculosis

Price
71.26 RON
Copayment
71.26 RON
Patient
0.00 RON