Summary of Product Characteristics s5

Revised: 28 January 2009

AN: 01360/2008

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT:

Sergeant’s Pet Patrol Cutaneous Spray Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active Substances % w/w

Tetramethrin 0.10

Phenothrin 0.20

Piperonyl butoxide 0.50

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM:

Cutaneous Spray, Solution.

Clear, colourless solution of characteristic odour.

4. CLINICAL PARTICULARS:

4.1 Target Species

Dogs and Cats

4.2 Indications for use, specifying the target species

Indicated for the control of flea infestations on dogs and cats.

4.3 Contra-indications

i) Do not use on puppies or kittens less than 12 weeks of age or on nursing females.

ii)Treatment of the animal should not exceed once per 15 days.

4.4 Special warnings for each target species

i) For external use only.

ii) Avoid spraying the animal’s eyes and mouth

iii) Remove fleas from young puppies and kittens, and from nursing females by careful use of a flea comb.

iv) Fleas from pets often infest animal’s basket, bedding and regular resting areas such as carpets and soft furnishings, which should be treated with a suitable insecticide and vacuumed regularly.

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 products to animals

Extremely flammable.
Do not spray on a naked flame or on any incandescent material.
Do not smoke when using the product.
Do not breathe spray mist and use in a well ventilated area.
Avoid contact with eyes. If case of accidental eye contact occurs, rinse with clean, fresh water. If eye irritation persists, seek medical advice.
Persons who are hypersensitive (allergic) to pyrethrum extract should handle the product with care.
Treated animals should not be allowed to sleep or play with people, particularly children, until the animal is dry.
Keep away from food and drink, including animal feeding stuffs.

Wash hands and exposed skin after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Do not use on nursing females.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Topical.

Dosage Schedule:

Apply the spray evenly to the animal against the natural lie of the coat.

Avoid spraying the animal’s eyes and mouth.

Protection against re-infestation is usually retained for up to 15 days.

Treatment may be repeated after 15 days if any re-infestation is apparent.

Dogs: Spray for 3 – 5 seconds on a small dog (e.g. terrier)

Spray for 10 seconds on a medium-sized dog (e.g. collie)

Spray for 15 seconds on a large dog (e.g. Alsatian)

Cats: Spray for up to 3 seconds depending on the size of the cat.

Some cats are sensitive to aerosols, in which case, consideration should be given to using either a cat flea powder or a cat flea collar.

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

Do not exceed the recommended dosage. There is no antidote and treatment should be symptomatic.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES:

5.1 Pharmacodynamic properties

Tetramethrin is a synthetic pyrethroid showing very low toxicity to mammals. It has a strong knock-down action against arthropod pests affecting human and animal health.

Phenothrin is a synthetic pyrethroid showing a killing action against a broad spectrum of arthropod pests. It also is of low toxicity to mammals.

Both chemicals are synergized by Piperonyl Butoxide.

5.2 Pharmacokinetic properties

Not applicable as this product is for topical use.

6. PHARMACEUTICAL PARTICULARS:

6.1 List of excipients

Kerosene odourless
Propane/Isobutane/Butane 40 Propellant

6.1 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

i) Do not store above 25°C

ii) Pressurised container: protect from sunlight and do not expose to temperatures above 50°C. Do not pierce or burn even after use.

iii) Extremely flammable.

6.5 Nature and composition of immediate packaging

95 g (150 ml) plain tinplate three-piece soldered seamed can.

Dosing device: CA38F valve with M 843 3846 actuator delivering approximately 1g of product per second.

Dosing device: KPM 060 1634 valve with V17 19/222 actuator capable of delivering approximately 1g of product per second.

Dosing device: KPM 060 1634 valve with V17 19/222 spray cap containing V06 222 insert. Capable of delivering approximately 1g of product per second.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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. Dangerous to fish and crustaceans. Do not contaminate aquaria or fish bowls with the product.

7. MARKETING AUTHORISATION HOLDER:
Bob Martin (UK) Ltd.

Wemberham Lane

Yatton

Somerset

BS49 4BS

U.K.

8. MARKETING AUTHORISATION NUMBER:

Vm 00715/4102

9. DATE OF THE FIRST AUTHORISATION:

18 June 1992

10. DATE OF REVISION OF THE TEXT:

January 2009