SOFRAMYCIN Eye Drops Solution 0.5 %w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FRAMYCETIN SULFATE

Available from:

Roussel Laboratories Limited

Dosage:

0.5 %w/w

Pharmaceutical form:

Eye Drops Solution

Authorization date:

1977-04-01

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soframycin Eye Drops 5mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Framycetin Sulphate  0.5 % w/v (5mg/ml)
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, solution
A clear, bright, sterile, aqueous solution.
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.
Application one to three times daily.
For rapid effect, preferably  during the daytime, one or two drops every one or two hours should be instilled in acute 
conditions (generally for two or three days), reducing to 1 or 2
drops three or four times daily
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