Medine.co.uk

Golden Hoof Plus 99.6% W/W Powder For Cutaneous Solution

Revised: June 2016

AN: 00338/2016

SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT


Golden Hoof Plus 99.6%w/w Powder for cutaneous solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION


Active substances


Zinc Sulphate Hexahydrate ZnSO4.6H2O


For a full list of excipients, see section 6.1

Quantity


min 99.6% w/w


3.

PHARMACEUTICAL FORM


Powder for cutaneous solution.

Small monoclinic or rhombic crystals for dissolution in water and subsequent topical application.

4.

CLINICAL PARTICULARS

4.1

Target species


Sheep

4.2

Indications for use, specifying the target species


For the control and healing of footrot and footscald in sheep

4.3

Contraindications


None.

4.4

Special warnings:


Can be dangerous if taken internally in quantity. Although poorly absorbed from the gut, zinc can cause corrosive toxicity in the G-I tract.

4.5

Special precautions for use

i.

Special precautions for use in animals


For external use only.


Drinking water should be made available in order to prevent animals from drinking the solution in cases of extreme thirst.



ii.

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


Wash hands and exposed skin before meals and after work.

Wash splashes form the eyes immediately with clean water.

Wear Wellington boots and rubber gloves when handling the solid or solution.

Prevent access to the bath by children and animals when not being used.

4.6

Adverse reactions (frequency and seriousness)


None known.

4.7

Use during pregnancy, lactation or lay


No adverse effects from use during pregnancy and lactation.

4.8

Interaction with other medicinal products and other forms of interaction


None known.

4.9

Amounts to be administered and administration route


The product should be mixed with water to provide a 10% (w/v) solution for topical application as a footbath (1kg powder / 10 litres in water). The volume of water required to provide sufficient depth to allow complete immersion of the feet should be determined and the corresponding quantity of the product used.


All animals in a group should be treated.


Badly infected feet should be sparingly and carefully pared to expose infected tissue before footbathing. Paring equipment should be disinfected between each animal being treated.


For maintenance treatment at times of high risk and for the treatment of footscald sheep should stand in the footbath solution for a minimum of 2 minutes.


For the treatment of footrot separate out infected animals and stand in the solution for up to 30 minutes.


Animals should be allowed sufficient time (minimum of 15 minutes) for drying, on concrete or grating, before returning to grass (preferably rested from sheep for at least two weeks)

4.10

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


Zinc sulphate is poorly absorbed through the skin. Therefore providing drinking water is provided prior to foot bathing to prevent oral intake of the prepared dip, overdose is not applicable.

4.11

Withdrawal periods


Meat: 0 days

Milk: 0 hours


5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties


Zinc sulphate has antiseptic properties without the irritancy of some other metallic compounds. It is also believed to harden the hoof.


ATC Vet Code: QD51

5.2

Pharmacokinetic properties


Not Applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients


Sodium dodecylbenzene sulphonate

Silica colloidal anhydrous

6.2

Incompatibilities


None known.

6.3

Shelf life


Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4

Special precautions for storage


Store in a dry place. Keep in tightly closed original container.

6.5

Nature and composition of immediate packaging


Low density polyethylene white heat sealed sacks or low density polyethylene white sacks within a white plastic bucket with lid containing 10kg or 20kg of white crystalline powder for dissolution in water.

Not all pack sizes 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


Do not contaminate water including ponds, ditches, ground and surface waters. Should it be necessary to dispose of unused product or reusable solution, contact your nearest Environment Agency for advice.

7.

MARKETING AUTHORISATION HOLDER


Shep-Fair Products Ltd

Unit 4

Wonastow Industrial Estate West

Monmouth

NP25 5JA

8.

MARKETING AUTHORISATION NUMBER


Vm 06077/4001

9.

DATE OF FIRST AUTHORISATION



24 June 1987


10.

DATE OF REVISION OF THE TEXT



June 2016



14 June 2016





Page 6 of 6