Leaflet TOBRAMICINA SUN 300mg solution for nebulization

Product code:
W63762002
Quantity:
112
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 may be needed in kidney disease.

Anaphylaxis

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

Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Nephrotoxicity

This medicine may affect the kidneys.

Ototoxicity

This medicine may affect hearing or balance.

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 TOBRAMICINA SUN 300mg

Substance:
tobramycin
Date of latest medicines list:
01-12-2017
Product code:
W63762002
Concentration:
300mg
Pharmaceutical form:
solution for nebulization
Quantity:
112
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:
SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - OLANDA
Holder:
SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - OLANDA
Number:
9993/2017/02
Shelf life:
2 years-after packing for marketing;after the first opening a fiolei-it is used immediately

Concentrations available for tobramycin

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

Combinations with other substances