INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SOFRAMYCIN EYE DROPS
SOFRAMYCIN EYE OINTMENT

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

SOFRAMYCIN EYE DROPS
SOFRAMYCIN EYE OINTMENT

COMPOSITION
Soframycin Eye Drops:
Each mL contains:
        Framycetin Sulphate BP        5 mg
        Phenyl Mercuric Nitrate        0,002 %

Soframycin Eye Ointment:
        Framycetin Sulphate        5 mg in 1 gram of base.

PHARMACOLOGICAL CLASSIFICATION
A. 15.1 Ophthalmic preparations with antibiotics.

PHARMACOLOGICAL ACTION
Soframcyin is a powerful bactericidal antibiotic. It is active against a wide variety of both gram-positive and gram-negative bacteria commonly found in superficial eye infections; staphylococci (including strains resistant to other antibiotics); Pseudomonas aeruginosa; coliforms and pneumococci.

INDICATIONS
Conjunctivitis Blepharitis bacterial
Styes
Corneal abrasions and burns
Prophylactically following removal of foreign bodies

Also indicated for corneal ulcers (alone or as a complement to the use of Soframycin by subconjunctival injection).

CONTRA-INDICATIONS
Soframycin Eye Drops:
Known sensitivity to any of the ingredients.

Soframycin Eye Ointment:
Known sensitivity to Framycetin.

DOSAGE AND DIRECTIONS FOR USE
Soframycin Eye Drops:
Preferably for daytime use. From 1 - 2 drops every one or two hours in acute conditions (generally for two or three days), to 1 or 2 drops three or four times daily.

Do not use more than 30 days after opening.

Soframycin Eye Ointment:
Two or three applications of the ointment in the eye daily, or at bedtime if eye drops have been used during the day.

Do not use more than 30 days after opening.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Sensitisation reactions occur rarely.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Not applicable.

CONDITIONS OF REGISTRATION
Advertising to the medical profession only.

IDENTIFICATION
Soframycin Eye Drops:
Clear, bright, colourless, odourless, aqueous solution.

Soframycin Eye Ointment:
Smooth, uniform, clear to white, greasy, translucent ointment.

PRESENTATION
Soframycin Eye Drops:
Amber glass bottle of 8 mL fitted with a special chlorbutyl dropper assembly.

Soframycin Eye Ointment:
Eye ointment contained in a polyvinyl chloride tube (5g size).

STORAGE INSTRUCTIONS
Store in a cool, dry place.
Keep out of reach of children.

REFERENCE NUMBER
Soframycin Eye Drops:        H 1344 (Act 101/1965)
Soframycin Eye Ointment:        H 1343 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Roussel Laboratories (Pty) Ltd.
Reg. No. 66/01057/07
5th Street
Marlboro Ext. 1
Sandton
2199

DATE OF PUBLICATION OF THIS PACKAGE INSERT
7 May 1986
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