SUFRE-Tulle* FRAMYCETIN SULPHATE BP 1% Sterile Tulle bandages (10cm x 10cm and Roll Size as per customer demand)

This is a prescription product: by or on the order of a physician. This product is NOT being offered for sale to end users/patients in any country. It is being offered to companies interested in carrying the product in their respective portfolios and markets. It is not offered in markets where enforceable patents exist.

SUFRE-Tulle* is manufactured in a fully GMP production facility and is backed by full quality documentation. It consists of a cotton leno-weave fabric, impregnated with a base composed of white soft paraffin, anhydrous lanolin, and 1.0% w/w framycetin sulphate.

Framycetin is an antibiotic of the aminoglycoside group with a wide spectrum of antibacterial activity. Organisms sensitive to framycetin include Staphylococcus aureus, Escherischia coli, Klebsiella species, and some strains of Pseudomonas aeruginosa; it is not active against yeasts, fungi or viruses.

The dressing is used as a primary wound contact layer in the management of infected wounds, combining low adherence with antimicrobial activity.

INDICATIONS

SUFRE-Tulle* may be used in the management of wounds, including minor traumatic injuries, ulcers, burns, and other lesions that are clinically infected by organisms shown to be sensitive to framycetin.

CONTRA-INDICATIONS

SUFRE-Tulle* is contra-indicated in patients who are allergic to lanolin, or who have previously demonstrated a sensitivity to framycetin, neomycin, or any other chemically related product. The dressing should not be used in the treatment of wounds that are free of clinical infection, or infected by organisms that are resistant to the antibiotic.

METHODS OF USE

The wound should be cleansed with a suitable sterile solution, such as normal saline; a single layer of SUFRE-Tulle should then be applied and covered with an absorbent pad, held in place

with tape or a bandage, as appropriate. When used to dress ulcers, SUFRE-Tulle* should be shaped to fit the crater and not allowed to extend over the surrounding skin.

FRAMYCETIN SULPHATE Details used in SUFRE-TULLE as Antibiotic.

Pharmacological action:

Framycetin Sulphate is an antibiotic, belonging to the Aminoglycoside group, with bactericidal effect with a wide antibacterial spectrum. The mechanism of action of framycetin appears to be related to inhibition of bacterial protein synthesis via binding to ribosomal subunits.

Framycetin is active against Staphylococcus spp., including coagulase-negative Staphylococci, Escherichia coli, Klebsiella spp., Salmonella, Shigella, Enterobacter spp., Proteus spp., Serratia marcescens, Pasteurella spp., Vibrio spp., Borellia and Leptospira spp. and Mycobacterium tuberculosis including also Streptomycin-resistant strains. Framycetin shows comparatively high activity against some strains of Pseudomonas aeruginosa, which is a main problematic pathogen.

The resistance to framycetin is hardly achieved after often and very prolonged use. For avoidance the occurrence of resistance or with reference to the extension of the therapeutic spectrum, usually in drug forms with framycetin are included other antibacterial agents, as well as steroid antiphlogistics. In dermatological practice framycetin is administered for treatment of wounds, ulcers, burns and other skin defects, infected with susceptible microorgan¬isms. The antibiotic is preferred agent for treatment of bacterial dermatoses and pyodermes as impetigo, furunculosis etc.

In ophthalmology the antibiotic is successfully applied for treatment of con¬junctivas, blepharitis and infections of the front ocular segments. The topical forms with framycetin manifest high effect at the treatment of corneal ulcers. In spite of the possible manifestation of ototoxicity Framycetin Sulphate alone or in combination with other antibacterial or anti-inflammatory agents is used also for preparation of ear drops. With reference to the wide usage of framycetin in otorhinolaryngology and the single incidents, it is accepted that the ototoxicity risks are insignificant after topical application. Topical forms containing framycetin are successfully used at the treatment of rhinitis caused by Staphylococci.