Butox Swish, Pour-On Suspension 0.75% W/V
Revised: March 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OFthe VETERINARY MEDICINAL PRODUCT
Butox Swish, pour-on suspension 0.75% w/v
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Deltamethrin 0.750 g/100ml
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
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.
4.4 Special warning for each target species
4.5 Special precautions for use
i. Special precautions for use in animals
ii. Special precautions to be taken by the person administering the medicinal product to the animals
Do not eat, drink or smoke while using the product.
Wash hands and exposed skin before meals and after work.
In case of contact with eyes and skin, wash immediately with water.
In the event of accidental ingestion, seek medical advice immediately.
Wear protective gloves when applying the product or handling recently treated animals.
If clothing becomes heavily contaminated remove and wash before re-use.
This product contains deltamethrin which may produce tingling, itchiness, and blotchy redness on exposed skin. If you feel unwell after working with this product, consult your doctor and show this label. Tell your doctor you have been using Butox Swish which contains deltamethrin.
Information for doctors: Advice on clinical management is available from National Poisons Information Service.
4.6 Adverse reactions (frequency and seriousness)
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:
Control of biting and nuisance flies
up to 100kg : 10 ml
100 – 300 kg : 20 ml
over 300 kg : 30 ml
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
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
Citric Acid monohydrate
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.
Milton Keynes, Bucks.
8. MARKETING AUTHORISATION Number
9. Date of first AUTHORISation
Date:Date of first authorisation: 27 February 2004
10. Date of Revision of text
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