Genticin 0.3% eye/ear drops

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Gentamicin sulfate

Dostupné z:

Advanz Pharma

ATC kód:

S03AA06

INN (Medzinárodný Name):

Gentamicin sulfate

Dávkovanie:

3mg/1ml

Forma lieku:

Ear/eye drops solution

Spôsob podávania:

Auricular; Ocular

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 11030100; GTIN: 5060064171677

Súhrn charakteristických

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