SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

Kaolin Poultice B.P.

2. Qualitative and Quantitative Composition

	Quantity in 100g
Active ingredients
Heavy Kaolin	52.70g
Thymol	0.05g
Boric Acid	4.50g
Peppermint Oil	0.05ml
Methyl Salicylate	0.20ml
Glycerol	42.50g

3. Pharmaceutical Form

Poultice

4. Pharmacological Properties

Active Ingredients

Heavy Kaolin

Thymol

Boric Acid

Peppermint Oil

Methyl Salicylate

Pharmacodynamic Properties

Kaolin Poultice BP possesses emollient properties. It provides heat and moisture locally to relieve pain and draw pus, if present, from a wound. It also exerts an osmotic effect, collecting fluid and toxic products at the site of application. A rubifacient or counter-irritant action may be obtained.

Pharmacokinetic Properties

The product is for external use only.

5. Clinical Particulars

5.0 Target Species

Horses

5.1 Indications for Use

As an aid in the reduction of inflammation and to alleviate pain in horses.

5.2 Contra-indications

Not for use in horses intended for human consumption.

5.3 Undesirable Effects

Rarely hypersensitivity reactions can occur.

5.4 Special Precautions for Use

Use as directed, or as instructed by veterinary surgeon.

5.5 Use During Pregnancy and Lactation

Avoid in pregnancy and lactation, unless advised by a veterinary surgeon.

5.6 Interaction with other Medicaments and other forms of Interaction

No significant clinical interactions known.

5.7 Posology and Method of Administration

Hot

Take the required amount of Kaolin Poultice BP from the tub and put into a container suitable for heating. Place the container in hot water making sure that no water can get in. Stir thoroughly, making sure that the material is heated evenly, then spread thickly onto lint or any other suitable material. Test temperature of poultice before applying to affected area. Apply to the affected area and bandage tightly. The poultice may be left on for 12-24 hours (according to veterinary advice) and then washed off.

Natural

Kaolin Poultice BP may be used straight from the tub. No heating or cooling is required. Take the required amount of material from the tub and spread thickly onto lint or any other suitable material. Apply to the affected area and bandage tightly. Wash off to remove.

Cold

Prepare as above then place in a fridge to chill to the required temperature. Apply to the affected area and bandage tightly. Wash off to remove.

5.8 Overdose (symptoms, emergency procedures, antidotes)

Should accidental ingestion occur, treat symptomatically.

5.9 Special Warnings for each Target Species

If signs of disease persist or appear, consult a veterinary surgeon.

5.10 Withdrawal Period

Not for use in horses intended for human consumption.

5.11 Special Safety Precautions to be taken by the Person Administering the Product to Animals

In the event of contact with the skin or eye, wash from the affected area with copious amounts of water. Seek medical attention if irritation persists.

Wash hands after use.

6. Pharmaceutical Particulars

6.1 Major Incompatibilities

None known.

6.2 Shelf Life

3 years.

6.3 Special Precautions for Storage

Do not store above 30°C.

Close container after use.

6.4 Nature and Contents of Container

Polypropylene tub and lid containing 1kg.

High density polyethylene tub and lid containing 4kg.

6.5 Special Precautions for the Disposal of Unused Medicinal Product or Waste Materials, if any

None.

7. Final Information

Name and Permanent Address of the Holder of the Authorisation to Market the Product

KL Pharmaceutical Limited

21 Macadam Place

South Newmoor

Irvine, Ayrshire

KA11 4HP

a) Marketing Authorisation: Vm 03436/4001

b) Date of Revision of the SPC: November 2007

c) Date Renewal Issued: 30 June 2007