Medine.co.uk

Butox Swish, Pour-On Suspension 0.75% W/V

Revised: March 2012

AN: 01983/2011


SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OFthe VETERINARY MEDICINAL PRODUCT


Butox Swish, pour-on suspension 0.75% w/v


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Active substance

Deltamethrin 0.750 g/100ml


Excipients

Formaldehyde solution 35% 0.019 g/100ml


For full list of excipients, see section 6.1


3. PHARMACEUTICAL FORM


Pour on suspension.

Off-white homogenous suspension.


4. CLINICAL PARTICULARS


4.1 Target species


Cattle


4.2 Indications for use, specifying the target species


Control of biting and nuisance flies of cattle, including Haematobia irritans, Hippobosca equina, Stomoxys calcitrans, Musca autumnalis and Musca domestica.

Control of biting and sucking lice of cattle, including Damalinia bovis, Haematpoinus eurysternus, and Linognathus vituli.


4.3 Contra-indications


None


4.4 Special warning for each target species


None


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


Information for doctors: Advice on clinical management is available from National Poisons Information Service.


4.6 Adverse reactions (frequency and seriousness)


None observed.


4.7 Use during pregnancy or lactation


No restrictions apply for use during pregnancy and lactation.


4.8 Interaction with other medicinal products and other forms of interaction


Some organo-phosphorous insecticides can reduce metabolism rate and thus enhance deltamethrin toxicity. Therefore, avoid the use of such organo-phosphorous insecticides (consult the supplier).


4.9 Amounts to be administered and administration route


For external use only.

Pour on the product along the backline of the animals, from the head to the tail, at the following recommended dose rates:


Indications

Dose rate

Flies:

Control of biting and nuisance flies


up to 100kg : 10 ml

100 – 300 kg : 20 ml

over 300 kg : 30 ml

Lice:

Control of biting and sucking lice


10 ml per animal irrespective of weight.


Flies:a single application provides protection against flies for 8 to 10 weeks depending on the infestation degree, fly species and weather conditions. Treatment should be repeated within 8 - 10 weeks depending on the weather and the fly species.


Lice:a single application provides protection against lice for 8 to 10 weeks. All in contact animals must be treated at the same time. A single application is sufficient against lice.


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


Overdose of twice the level of recommended treatments does not induce any adverse effects.


4.11 Withdrawal period(s)


Recommended withdrawal periods are as follows:

Edible tissues: 20 days

Milk: zero hours


5. PHARMACOLOGICAL PROPERTIES


Pharmacotherapeutic group:pyrethroid ectoparasiticide for topical use

ATCvet code:QP53AC11


5.1 Pharmacodynamic properties


The product is an ectoparasiticide whose active ingredient deltamethrin belongs to the synthetic pyrethroids class. Its mode of action affects the neurotransmission in the target parasite.

5.2 Pharmacokinetic particulars


After dermal application, deltamethrin is slightly absorbed through skin of cattle and sheep and remains available to the target ectoparasite. The main route of excretion of the absorbed amount in the target animal is the faeces. In terms of residues, fat is the target issue.


6. PHARMACEUTICAL PARTICULARS


List of excipients


Formaldehyde solution 35%

Dispersing agent SI

Sodium lauryl sulphate

Silicon dioxide Precipitated

Rhodorsil 416

Rhodorsil 426R

Xanthan Gum

Citric Acid monohydrate

Propylene glycol

Purified Water

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


Protect from direct sunlight. Keep away from food, drink and animal feeding stuffs.


6.5 Nature and composition of immediate packaging


250 ml and 1L high-density polyethylene translucent dosing flask, closed by two low density polyethylene screw caps fitted internally with a compressible wad. (“squeeze and pour" bottle).


2.5L portable polyethylene bottle closed with a polypropylene stopper fitted with a heat-sealable aluminium-polyethylene seal (for use with an applicator gun).


Not all pack sizes may be marketed.


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


Dangerous to fish and other aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container.

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


Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes, Bucks.

MK7 7AJ


8. MARKETING AUTHORISATION Number


Vm01708/4495


9. Date of first AUTHORISation


Date:Date of first authorisation: 27 February 2004


10. Date of Revision of text


Date:March 2012

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