NOAH Compendium

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Date: Monday, November 30, 2020 20:24

Description: MSD-AH
Release 2.60
Butox® Swish Pour-on Suspension 0.75% w/v
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cattle
Active ingredient: Deltamethrin
Product:Butox® Swish Pour-on Suspension 0.75% w/v
Product index: Butox® Swish
Cattle - milk: Zero hours
Cattle - meat: 20 days
Qualitative and quantitative composition
Active substance
Deltamethrin 0.750 g/100 ml
Excipients
Formaldehyde solution 35% 0.019 g/100 ml
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Pour on suspension.
Off-white homogenous suspension.
Clinical particulars
Target Species
Cattle
Indications for use
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.
Contraindications
None
Special warnings for each target species
None
Special precautions for use
None
Operator warnings
∙ 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 the National Poisons Information Service.
Adverse Reactions
None observed.
Use during pregnancy or lactation
No restrictions apply for use during pregnancy and lactation.
Interactions
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).
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 100 kg:10 ml
100-300 kg:20 ml
over 300 kg:30 ml
Lice
Contol 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.
Overdose
Overdose of twice the level of recommended treatments does not induce any adverse effects.
Withdrawal periods
Edible tissues: 20 days
Milk: zero hours
Pharmacological particulars
ATC Vet Code: QP53AC11
Pharmacotherapeutic group: pyrethroid ectoparasiticide for topical use

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.
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.
Pharmaceutical particulars
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
Major incompatibilities
None known
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Protect from direct sunlight. Keep away from food, drink and animal feeding stuffs.
Immediate packaging
250 ml and 1 L high-density polyethylene translucent dosing flask, closed by two low density polyethylene screw caps fitted internally with a compressible wad. (“squeeze and pour" bottle).
2.5 L 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.
Disposal
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.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
Vm 01708/4495
Significant changes
Date of the first authorisation or date of renewal
27 February 2004
Date of revision of the text
03 July 2020
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Butox Swish 1x250ml:
GTIN:8713184029355
GTIN description:Butox Swish 1x1l:
GTIN:8713184029362
GTIN description:Butox Swish PO 1x2.5l:
GTIN:8713184029379