4.5

Special precautions for use

i.

Special precautions for use in animals

For external use only.

ii.

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

Use in a well ventilated area.

Avoid inhaling the powder.

Wash hands and exposed skin after use.

Avoid contact with eyes. In case of accidental eye contact, rinse with clean, fresh water. If eye irritation persists, seek medical advice.

If you feel unwell as a result of handling this product, you should consult your Doctor.

Treated animals should not be allowed to sleep or play with people, particularly children, until the powder has been brushed out.

4.6

Adverse reactions (frequency and seriousness)

None.

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.

4.9

Amount(s) to be administered and administration route

5-10g to be used for a small dog.

10-15g to be used for a medium sized dog.

15-20g to be used for a large dog.

5-9g to be used on cats according to size.

Shake gently before use. Dust evenly over the whole body whilst stroking or brushing against the lie of the hair to ensure powder penetrates to the skin. Avoid getting powder into animal’s eyes, nose or mouth. Brush off excess powder.

The pack contains sufficient powder to treat a medium sized dog 6 – 8 times. If necessary repeat every 7 days until infestation is cleared.

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

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

4.10

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

Cats and dogs treated with 3 x the recommended dose showed no signs of clinical toxicity or irritation. Signs of overdose include hyperaesthesia, twitching and collapse. Treatment is symptomatic.

4.11

Withdrawal period(s)

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Ectoparaciticides, insecticides and repellents, Ecoparasiticides for topical use, incl. insecticides, Pyrethrins and pyrethroids

ATC Vet Code: QP53AC05.

5.1

Pharmacodynamic properties

Permethrin, like other synthetic pyrethroids, is a neuropoison acting on the axons in the peripheral and central nervous system by interacting with sodium channels.

5.2

Pharmacokinetic properties

When permethrin is orally administered to mammals it is rapidly metabolized and almost completely excreted via urine or faeces within a short period of time. The trans isomer is eliminated faster then the cis isomer, it being the more susceptible of the two to esterase attack. The major metabolic reactions are ester hydrolysis, ester cleavage, oxidation and conjugation. Permethrin does not have a tendency to accumulate in tissues. None of the metabolites of permethrin show a higher acute toxicity then the base permethrin. Given that this product is administered externally, absorption rates are considerably lower then when orally administered.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Purified Silicaceous earth.

Talc Purified

6.2

Incompatibilities

None known.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4

Special precautions for storage

Store away from food, drink and animal feeding stuffs.

Store in a dry place.

6.5

Nature and composition of immediate packaging

Size: 85g

Container: White high density polyethylene bottle with sifter top.

Closures: White polypropylene screw cap-closure (push fit).

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Harmful to fish and crustaceans – do not contaminate aquaria or fish bowls with the product.

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

Bio-Tech Solutions Ltd.

Windmill Works

Kelleythorpe Industrial Estate

Driffield

East Yorkshire

YO25 9DJ

8.

MARKETING AUTHORISATION NUMBER

Vm 20889/4002

9.

DATE OF FIRST AUTHORISATION

Date: 6.8.2003

10.

DATE OF REVISION OF THE TEXT

Date: February 2010