Download PART 1 B - Veterinary Medicines Directorate

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).
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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.
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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.
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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
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