Summary of Product Characteristics

1. Name of the veterinary medicinal product

Veterinary Wound Powder – 2% w/w Cutaneous Powder

2. Qualitative and quantitative composition.

Active Substance(s) %w/w

Tosylchloramide Sodium 2.00

For a full list of excipients, see section 6.1

3. Pharmaceutical form.

Cutaneous powder

A creamy white fine powder

4. Clinical particulars.

4.1 Target species;

Horses

4.2 Indications for use, specifying the target species;

An antiseptic for use on minor wounds, saddle sores, cuts, bites and scratches on horses

4.3 Contra indication;

None

4.4 Special warnings for each target species;

Toxic if ingested

For external use only.

4.5 Special precautions for use.

i. Special precautions for use in animals

None

ii. Special precautions to be taken by the person administering the medicinal product to the animals.

Avoid contact with eyes. If contact with eyes occurs, wash with copious amounts of water.

Avoid inhaling powder. If ingested seek medical advice immediately.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness);

None reported

4.7 Use during pregnancy, lactation or lay;

No problems expected.

4.8 Interaction with other medicinal products and other forms of interaction;

Interaction with medicinal products – None reported.

Other– Unstable in contact with water vapour

Acidic materials liberates a toxic gas

4.9 Amounts to be administered and administration route;

Thoroughly wash the affected area with clean water and liberally puff the powder onto the wound. Repeat if necessary.

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

Not likely

4.11 Withdrawal period(s);

Not to be used in animals intended for human consumption.

Treated horses may never be slaughtered for human consumption

The horse must have been declared as not intended for human consumption under national horse passport legislation.

5. Pharmacological Properties.

5.1 Pharmacodynamic properties;

ATCvet Code: QD080X04

Pharmacotherapeutic Group: Antiseptics and disinfectants, Other antiseptics and disinfectants

Antiseptic – Chloramine T has a broad spectrum action and is capable of killing most bacteria and some fungi, yeasts, algae and protozoa.

Chloramine T is unstable in the presence of water, as at a wound, and slowly releases chlorine. This available chlorine has the antiseptic action. Chloramine T has the advantage that it is non irritating and that its activity is less affected by the presence of organic matter than some other antiseptics.

5.2 Pharmacokinetic properties;

Chloramine T is poorly absorbed and rapidly and extensively metabolised and excreted.

6. Pharmaceutical particulars

Maize starch

6.2 Incompatibilities

None known

6.3 Shelf life;

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage.

No special precautions for storage

6.5 Nature and composition of immediate packaging.

20g and 125g white, low density polyethylene puffer bottle with white polyethylene cap (screw – fit) with spout.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of unused veterinary medicinal products or waste materials derived from the use of such products -

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.

Battle, Hayward and Bower Ltd

Crofton Drive,

Lincoln.

LN3 4NP

8. Marketing Authorisation Number

Vm00676/4099

9. Date of the first authorisation

27^thApril 1992

10. Date of revision of the text

June 2010