Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gentamicin sulfate
Advanz Pharma
S03AA06
Gentamicin sulfate
3mg/1ml
Ear/eye drops solution
Auricular; Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11030100; GTIN: 5060064171677
OBJECT 1 GENTICIN EYE/EAR DROPS/GENTAMICIN 0.3% W/V EYE/EAR DROPS Summary of Product Characteristics Updated 26-Feb-2015 | Concordia International - formerly AMCo 1. Name of the medicinal product Genticin eye/ear drops. Gentamicin 0.3% w/v eye/ear drops 2. Qualitative and quantitative composition Gentamicin Sulphate Ph. Eur. ≡ 0.3% w/v gentamicin base. 3. Pharmaceutical form Sterile, isotonic solution in dropper bottles. 4. Clinical particulars 4.1 Therapeutic indications Gentamicin eye/ear drops are indicated: 1. For the treatment of superficial eye and ear infections caused by organisms sensitive to gentamicin. 2. For prophylaxis against infection in trauma of the eye or ear. 4.2 Posology and method of administration _ADULTS, INCLUDING THE ELDERLY AND CHILDREN_ _Eyes: _1 or 2 drops should be instilled in the affected eye up to six times a day, or more frequently if required. (Severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled). _Ears:_ The area should be cleaned and 2 - 3 drops instilled in the affected ear three to four times a day and at night, or more frequently if required. 4.3 Contraindications Hypersensitivity to gentamicin or to any of the ingredients. Known or suspected perforation of the ear drum is a contra-indication to use in otitis externa only. 4.4 Special warnings and precautions for use Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur. In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment. Gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly. The condition of the Lesen Sie das vollständige Dokument