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PART 1 B: SUMMARY OF PRODUCT CHARACTERISTICS - (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sulphur Colecton (Cattle) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION A.1 Quantitative Composition Of The Proprietary Product A1.1 Active Constituents Constituent Quantity Sulphur for external use. 10.0% (w/w) Salicylic Acid. 1.5% (w/w in an aqueous gel base. 3. PHARMACEUTICAL FORM Gel: Yellow aqueous gel for topical application in cattle. 4. PHARMACOLOGICAL PROPERTIES Summary Presentation of the Active Ingredients Salicylic acid is an aromatic carboxylic acid possessing anti-inflammatory, analgesic, antimicrobial and keratolytic properties. Anti-inflammatory and analgesic action appears to be mediated by the inhibition of prostaglandin synthesis via the inhibition of the cylo-oxygenase enzyme. Sulphur is a non-metallic element, used for topical dermatologic therapy, possessing antiseptic, antifungal, antiparasitic, anti-acne, anti-pruritic, antiseborrhoeic and keratolytic properties. Pharmacological action is mediated through the formation of disulphides and polythionic acids formed by the interaction of sulphur with organic substances or micro-organisms present on the skin. 4.1 Pharmacodynamic properties Salicylic acid: Exhibits antimycotic and antimicrobial actions and is considered a safe broad spectrum antiseptic. In addition salicylic acid has anti-inflammatory and analgesic properties. Salicylic acid also has keratolytic properties with keratin dispersing and keratostatic activities. Salicylic acid displays superficial astringent and antipruritic properties. Salicylic acid appears to exert its anti-inflammatory action and analgesic properties by the inhibition of prostaglandin synthesis via the inhibition of the cylo-oxygenase enzyme. Salicylic acid belongs to the group of aromatic carboxylic acids and is also considered a member of the group of non-steroidal anti-inflammatory substances (NSAIDS). 1 Sulphur for External Use Sulphur exhibits antiseptic, antifungal and antiparasitic properties. Additionally antiacne, anti-pruritic and antiseborrhoeic properties are reported for sulphur. Sulphur is a keratolytic agent. Sulphur belongs to the group of non-metallic elements. The pharmacological activity of topically applied sulphur is mediated through the formation of disulphides and polythionic acids formed by the interaction of sulphur with organic substances or microorganisms present on the skin. 4.2 Pharmacokinetic properties Various figures are cited in the literature for absorption of salicylic acid through the skin. Plasma binding of salicylic acid is 50% with a half life in cattle of 30 minutes. 1% of topically applied sulphur has been shown to be absorbed. 5. CLINICAL PARTICULARS 5.0 Target Species Bovine 5.1 Indications for use a) An aid in the control of mastitis b) A soothing antiseptic gel for cattle for the treatment of minor skin conditions 5.2 Contra-Indications None known 5.3 Undesirable Effects None known 5.4 Special Precautions for Use Wash and dry udders and teats before milking If symptoms of mastitis persist after 6 days consult your veterinary surgeon For external use only. 5.5 Use during Pregnancy and Lactation The product may be used in pregnant and lactating cows. 5.6 Interactions a) With other medicaments: b) Other interactions: None known None known 5.7 Posology and Method of Administration Recommended Dosage Schedules 1. Clinical Mastitis: At each milking rub in sufficient product to cover the infected quarter (approximately 20 - 30 g - up to 1 level tablespoon). Continue treatment for a minimum of three days. If symptoms persist after 6 days consult your veterinary surgeon. 2 2. At calving down: Use as for clinical mastitis: 3. Treatment of minor skin conditions: Apply twice daily to the affected area until the condition clears. 5.8 Overdose The possibility of overdose due to topical application or of accidental poisoning by Sulphur Colecton is very remote. The signs or symptoms of overdose or accidental poisoning are: a) Due to salicylic acid. (As for aspirin overdose) In Animals: Depression, vomiting, loss of appetite, increased respiratory rate and elevated temperature. In Humans: Signs of salicylism - Confusion, dizziness, headaches, rapid breathing, ringing or buzzing in ears. Treatment: Stop applications of Sulphur Colecton. Intravenous forced alkaline diuresis or sodium bicarbonate by stomach tube, intraperitoneal lactate Ringers solution and frusemide (furosemide) intramuscularly. b) Due to sulphur. (Oral ingestion of extreme doses only) Humans and animals - Symptoms of hydrogen sulphide poisoning. Purgation, depression, anorexia, weak and rapid pulse, paralysis. Treatment:- Cease application of Sulphur Colecton. 5.9 Special warnings for each target species Topical application only If signs of disease persist or appear consult a veterinary surgeon 5.10 Withdrawal periods Meat: Zero days Milk: Zero days 5.11 Special safety precautions to be taken by the person administering the product to animals. Avoid contact with eyes. In the case of contact with eyes flush them thoroughly with water. Wash hands after use. The use of a barrier cream is recommended should dryness of the hands occur. 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities None known 6.2 Shelf Life 3 years 6.3 Special Precautions for Storage. Do not store above 25oC. Do not freeze. No other specific storage or transport directions are required for this product. 3 6.4 Nature and Contents of Container Market Packs Polyethylene squeeze-dispensing bottles with suspending hook and fitted with 28 mm disc top closures. 620 ml capacity. Nett Contents: 600 grammes Alternative Market Packs Polypropylene screw cap or tamper evident jar with polypropylene screw cap or tamper evident lid. Capacity 250 ml.. Nett Contents: 180 grammes 6.5 Marketing Authorisation Holder J.J. and M. A. Zakarias, 43 Bibury Avenue, Stoke Lodge, Bristol, BS12 6DF Telephone/Fax 01454 613831 6.6 Special Precautions for the Disposal of Unused Medicinal Product 0r Waste Materials, if any None 7. FINAL INFORMATION Marketing Authorisation Numbers: VM 00292/4002 Conditions of supply of the Veterinary Medicinal product to animal owners: GSL Date Renewal Issued: 06 April 2002 Date of last revision of SPC: December 2002 4