SOFRAMYCIN EYE 0.5 %w/w Eye Ointment

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

FRAMYCETIN SULFATE

Предлага се от:

Roussel Laboratories Limited

INN (Международно Name):

FRAMYCETIN SULFATE

дозиране:

0.5 %w/w

Лекарствена форма:

Eye Ointment

Статус Оторизация:

Withdrawn

Дата Оторизация:

2007-04-01

Данни за продукта

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soframycin Eye Ointment 5mg/g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Framycetin Sulphate 0.5% w/w (5mg/g)
For excipents, see 6.1.
3 PHARMACEUTICAL FORM
Eye Ointment
A clear to white, translucent, smooth, homogenous, sterile, greasy
eye ointment.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of superficial bacterial infections of the eye due to
micro-organisms sensitive to the anti-
infective.
Soframycin is used
for the treatment of bacterial infections of the eye, notably
conjunctivitis and blepharitis, for styes, 
corneal abrasions and burns, and prophylactically following
the removal of foreign bodies. It is also indicated for 
corneal ulcers (alone or as a complement to
the use of Soframycin by sub-conjunctival injection).
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Topical, into conjunctival sac.
For continued effect, three applications of the ointment daily
or at bedtime if drops have been used during the day.
4.3 CONTRAINDICATIONS
Known  hypersensitivity  to  framycetin  or  chemically  related  antibiotics  or  any  of  the  other  components  in  the 
preparation
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of an anti-infective may result in
the development of superinfection due to micro-organisms,
including 
fungi, resistant to that anti-infective.
Aminoglycosides have been reported to
cause irreversible partial or total deafness when given
systemically, topically to 
open wounds or broken skin and
intraperitoneally. These effects have not been reported with
topical ocular 
administration of framycetin. However, the possibility should
be considered when using high dose topical treatment in 
the elderly, small children or those patients with
renal or hepatic impairment.
In cases of severe infect