4.5

Special precautions for use

i.

Special precautions for use in animals

Wash and dry udders and teats before milking

If symptoms of mastitis persist after 6 days consult your veterinary surgeon

For external use only

ii.

Special precautions for the person administering the veterinary medicinal product to animals

Avoid contact with eyes. In the event of accidental eye contact, rinse with plenty of clean water and seek medical advice. In the event of accidental ingestion wash out mouth thoroughly with water, then drink plenty of water and seek medical advice. Wash hands after use. The use of a barrier cream is recommended should dryness of the hands occur.

4.6

Adverse reactions (frequency and seriousness)

None known

4.7

Use during pregnancy, lactation or lay

The product may be used in pregnant and lactating cows.

4.8

Interaction with other medicinal products and other forms of interaction

a) With other medicinal products: None known

b) Other interactions: None known

4.9

Amount(s) to be administered and administration route

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. 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.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

The possibility of overdose due to topical application or of accidental poisoning by Golden Udder 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.

Treatment: Stop applications of Golden Udder. Intravenous forced alkaline diuresis or sodium bicarbonate by stomach tube, intraperitoneal lactate Ringers solution and frusemide (frusemide) intramuscularly.

b) Due to sulphur. (Oral ingestion of extreme doses only)

Animals - Symptoms of hydrogen sulphide poisoning.

Purgation, depression, anorexia, weak and rapid pulse, paralysis.

Treatment:- Cease application of Golden Udder.

4.11

Withdrawal period(s)

Meat: Zero days

Milk: Zero hours

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

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.

ATC Vet Code: QD11 AC08

5.1

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 anti-pruritic 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).

Sulphur for External Use

Sulphur exhibits antiseptic, antifungal, and antiparasitic properties. Additionally anti-acne, anti-pruritic and antiseborrhoeic properties are reported for sulphur. Sulphur is a keratolytic agent. 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 micro-organisms present on the skin.

Sulphur belongs to the group of non-metallic elements.

5.2

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.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tragacanth, gum

Zinc oxide

Water Potable

6.2

Incompatibilities

None known

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale 3 years

6.4

Special precautions for storage

Do not store above 25⁰C.

Do not freeze.

6.5

Nature and composition of immediate packaging

600g high density polyethylene bottle with integral hook and polypropylene cap with integral valve/spout.

180g polypropylene screw jar with polypropylene cap (screw fit or push fit) tamper evident.

Not all pack types may be marketed.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

7

MARKETING AUTHORISATION HOLDER

J. J. And M. A. Zakarias,

43 Bibury Avenue

Stoke Lodge

Bristol

BS12 6DF

8.

MARKETING AUTHORISATION NUMBER(S)

VM 00292/4007

9.

DATE OF FIRST AUTHORISATION

Date: 06 April 2002

10.

DATE OF REVISION OF THE TEXT

Date: January 2009