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

Product code:
W68686002
Quantity:
56
Indicated for:
bacterial infections
Route of administration:
inhalation
Substance:
tobramycin (aminoglycoside antibiotic)
ATC
J01GB01 — 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.

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 latest medicines list:
01-05-2022
Product code:
W68686002
Concentration:
300mg / 5ml
Pharmaceutical form:
solution for inhalation by nebuliser
Packing volume:
5ml
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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