Leaflet AMIKACINA NORIDEM 250mg / ml solution for injection / infusion

Indicated for: bacterial infections

Route of administration: injectable / infusion

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 AMIKACINA NORIDEM 250mg / ml

  • Substance: amikacin
  • Date of latest medicines list: 01-10-2024
  • Product code: W70527001
  • Concentration: 250mg / ml
  • Pharmaceutical form: solution for injection / infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: DEMO S.A. PHARMACEUTICAL INDUSTRY - GRECIA
  • Holder: NORIDEM ENTERPRISES LIMITED - CIPRU
  • Number: 15586/2024/01
  • Shelf life: 2 years

Pharmaceutical forms available for amikacin

Concentrations available for amikacin

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