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Logo SOFRA-TULLE

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SOFRA-TULLE

COMPOSITION:
       
Framycetin Sulphate BP 10 mg per gram of base

PHARMACOLOGICAL CLASSIFICATION:
A. 14.2 Wound Dressings

PHARMACOLOGICAL ACTION:
Soframycin (framycetin sulphate), a broad spectrum antibiotic, will control and eradicate most secondary infections which may be present in the lesion and at the same time will provide an excellent mechanical protection which does not adhere to granulating skin. It is easy to apply and may be removed painlessly. Application of the dressing does not result in maceration of the lesion.

INDICATIONS:
Traumatic:        Lacerations, abrasions, grazes (gravel rash), bites (animal and insect), cuts, puncture wounds, crush injuries, surgical wounds and incisions, traumatic ulcers.
Ulcerative:        Varicose ulcers, diabetic ulcers, bed-sores, tropical ulcers.
Thermal:        Burns, scalds.
Elective:        Skin grafts (donor and recipient sites), avulsion of finger or toe-nails, circumcision.
Miscellaneous:        Secondary infected skin conditions, e.g. eczema, dermatitis, herpes zoster, colostomy, acute paronychia, incised abscesses (packing), ingrowing toe-nails.

CONTRA-INDICATIONS:
Allergy to lanolin or to Soframycin.

DOSAGE AND DIRECTION FOR USE:
If necessary, the wound may first be cleaned. Following this a single Sofra-tulle dressing should be applied directly to the wound and covered with an appropriate dressing. In the case of ulcers it is advisable to cut the dressing exactly to the size of the ulcer and not to overlap onto the surrounding epidermis. When the lesion is very exudative it is advisable to change the dressing at least once day, otherwise it may be left in situfor 2 - 3 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In most cases absorption of the antibiotic from the site of application is so slight that it can be discounted. However, where very large body areas are involved (e.g. burns or scalds involving 30 % or more of the body surface area) the possibility of ototoxicity following absorption should be considered.

CONDITIONS OF REGISTRATION:
To be advertised to the professions only.

IDENTIFICATION:
Sofra-tulle Pieces:
A laminated foil sachet containing a piece of leno-weave cotton gauze 10cm x 10cm uniformly impregnated with Framycetin ointment base. Both sides of the gauze are covered with a piece of white parchment.

Sofra-tulle Strips:
Laminated foil sachet containing a leno-weave cotton gauze strip 10cm x 30cm uniformly impregnated with Framycetin ointment base. Both sides of the gauze are covered with a piece of white parchment.

PRESENTATION:
Sofra-tulle Pieces:        As individual sterile dressings 10cm x 10cm sealed in a laminated foil sachet.
Sofra-tulle Strips:        As a 10cm x 30cm sterile strip dressing sealed in a laminated foil sachet.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C.
Keep out of reach of children.

REFERENCE NUMBER:
Sofra-tulle Pieces:        H 1019 (Act 101/1965)
Sofra-tulle Strips:        H 1020 (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:
July, 1968

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