Summary of Product Characteristics

1. Name of the veterinary medicinal product

Foot Rot Aerosol – 10% w/w Cutaneous spray solution

2. Qualitative and Quantitative composition

Active substance: Cetrimide 10%w/w

Excipients:Brilliant Blue (E133) 0.5%w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical form.

Cutaneous spray solution.

Clear blue liquid

4. Clinical particulars.

4.1 Target species;

Sheep

4.2 Indications for use, specifying the target species;

As an aid in the treatment of foot rot in sheep.

4.3 Contra indication;

Avoid spraying in or near the eyes.

4.4 Special warnings for each target species;

For external use only.

4.5 Special precautions for use including special precautions to be taken by the person administering the medicinal product to the animals;

Highly flammable. Do not smoke when using this product.

Use in a well-ventilated area. Avoid inhaling spray mist.

Wash hands after use.

Avoid contact with the eyes. In the event of eye contact, wash immediately with copious amounts of clean water. Seek medical advice in irritation persists

Do not spray on a naked flame, or on incandescent material.

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- Inactivated by soaps and anionic substances.

4.9 Amounts to be administered and administration route;

Pare the feet thoroughly of each infected sheep, see that only healthy horn remains. The removal of diseased horn may result in some bleeding, but this is unavoidable. Spray each pared foot for one or two seconds and return the sheep to a dry pen for about 1 hour before returning to pasture. As foot rot is highly contagious, treated sheep should not be returned to infected ground for at least a week if this can possibly be avoided.

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

Not likely

4.11 Withdrawal period for the various foodstuffs, including those for which the withdrawal period is zero;

Sheep – Meat – Zero days

Milk – Zero hours

5. Pharmacological Properties.

5.1 Pharmacodynamic properties;

ATCvet code: QD051

Pharmacotherapeutic Group: Products for the treatment of claws and hoofs

Antiseptic – Cetrimide is chiefly tetradecyltrimethylammonium bromide with smaller amounts of dodecyl and hexadecyl-trimentylammonium bromides. It is a cationic surface active agent and is effective against gram positive and at higher concentrations against some gram negative bacteria and some fungi.

5.2 Pharmacokinetic properties;

Cetrimide bonds strongly to collagen and keratin to form cetrimide:protein complexes, consequently there is no significant absorption after dermal application.

6. Pharmaceutical particulars

Brilliant Blue FCF (E133)

Diethyl phthalate

Denatured Ethanol B 100

Mowilith CT5A50% solution (co polymer of vinyl acetate/crotonic acid)

Carbon dioxide (propellant)

6.2 Incompatibilities

Inactivated by soaps and anionic substances.

6.3 Shelf life

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

6.4 Special precautions for storage.

Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C

6.5 Nature and composition of immediate packaging.

Tinplate aerosol can with suitable PV00691 valve and actuator capable of producing a discharge rate of 0.7 to 1.1g of product per second.

Contains 150g of concentrate.

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

Vm00676/4100

9. Date of the first authorisation

24^thApril 1992

10. Date of revision of the text

June 2010