Leaflet GENTAMICIN KRKA 40mg / ml solution for injection

Indicated for: bacterial infections

Route of administration: injectable

Substance: gentamicin (aminoglycoside antibiotic)

ATC: J01GB03 (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.

Gentamicin is an antibiotic from the aminoglycoside class, used to treat severe bacterial infections caused by gram-negative bacteria and, in some cases, gram-positive bacteria. It is commonly used for urinary tract infections, respiratory infections, sepsis, skin and soft tissue infections, and intra-abdominal infections.

Gentamicin works by inhibiting bacterial protein synthesis by binding to bacterial ribosomes. This leads to the destruction of susceptible bacteria, providing a bactericidal effect. It is effective against bacteria such as Escherichia coli, Klebsiella, Pseudomonas aeruginosa, and Proteus.

The medication is usually administered via intramuscular or intravenous injection but can also be used topically (as ointments or drops) for eye or skin infections. The dosage and duration of treatment are determined by the doctor, depending on the severity of the infection and the patient’s condition.

Side effects may include kidney toxicity (nephrotoxicity) and hearing toxicity (ototoxicity), especially with prolonged treatment or high doses. Other side effects may include skin rashes, nausea, dizziness, or allergic reactions. For this reason, kidney and hearing function should be monitored during treatment.

Gentamicin should be used with caution in patients with renal impairment, the elderly, or those taking other medications with nephrotoxic or ototoxic potential. It is essential for patients to strictly follow the doctor’s instructions and not discontinue treatment without consulting them.

General data about GENTAMICIN KRKA 40mg / ml

  • Substance: gentamicin
  • Date of latest medicines list: 01-07-2013
  • Product code: W03308002
  • Concentration: 40mg / ml
  • Pharmaceutical form: solution for injection
  • Packing volume: 1 ml
  • 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: KRKA D.D., NOVO MESTO - SLOVENIA
  • Holder: KRKA D.D. NOVO MESTO - SLOVENIA
  • Number: 13060/2020/02
  • Shelf life: 5 years

Concentrations available for gentamicin

  • 0.3%
  • 20mg/ml
  • 3mg/ml
  • 40mg/ml
  • 80mg/2ml
  • 80mg/ml