Leaflet TOBI 300mg / 5ml solution for inhalation by nebulization


Indicated for: bacterial infections

Substance: tobramycin (aminoglycoside antibiotic)

ATC: J01GB01 (Antiinfectives for systemic use | Aminoglycoside antibacterials | Other aminoglycosides)

Tobramycin is an aminoglycoside antibiotic used to treat severe bacterial infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa. It is commonly used for respiratory infections, skin infections, urinary tract infections, and eye infections. Tobramycin works by inhibiting bacterial protein synthesis, leading to bacterial destruction.

The medication is available in various forms, including injectable solutions, eye drops, and inhalation solutions (for pulmonary infections, such as those associated with cystic fibrosis). The dosage and route of administration depend on the type and severity of the infection.

Common side effects include local irritation (for topical use), nausea, vomiting, and skin rashes. When administered systemically, tobramycin can cause serious adverse effects, such as ototoxicity (hearing damage), nephrotoxicity (kidney damage), and neurotoxicity. For this reason, careful monitoring of kidney function and hearing is required during treatment. Tobramycin is contraindicated in patients with hypersensitivity to aminoglycosides.

General data about TOBI 300mg / 5ml

  • Substance: tobramycin
  • Date of last drug list: 01-05-2022
  • Commercial code: W68686002
  • Concentration: 300mg / 5ml
  • Pharmaceutical form: solution for inhalation by nebulization
  • Packing volume: 5ml
  • Product type: original
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: NOVARTIS PHARMA GMBH - GERMANIA
  • Holder: VIATRIS HEALTHCARE LIMITED - IRLANDA
  • Number: 8377/2015/02
  • Shelf life: 3 years; Dupa scoaterea din frigider: 28 days

Concentrations available for tobramycin

  • 0.3%
  • 300mg
  • 300mg/5ml
  • 3mg/g
  • 3mg/ml
  • 40mg/ml

Combinations with other substances