Butox®7.5 Pour On

This summary of product characteristics (SPC) is specific to the European Union. Please note that Butox®7.5 pour on may not be licensed for use in your country or the product's data sheet may be different depending on local regulations. For more information please contact your local MSD Animal Health representative.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

NAME OF THE VETERINARY MEDICINAL PRODUCT

Butox® 7.5 pour on

COMPOSITION

Active substance:
Deltamethrin                                                     0.750 g/100 mL

Excipients:
Formaldehyde solution (35%)            0.019 g
Propylene glycol

PHARMACEUTICAL FORM

Aqueous suspension for external use (ready to use pour-on).

CLINICAL PARTICULARS

Target species
Cattle and sheep

Indications for use
For the control of ectoparasitic infestations in cattle and sheep caused by ticks, lice, flies and keds.

Contraindications
None

Special warnings for each target species
None

Special precautions for use, including special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke while using the product.
Wash hands and exposed skin before meals and after work.

Adverse reactions
None observed.

Use during pregnancy and lactation
Can be used during pregnancy and lactation.

Interaction with other veterinary medicinal products and other forms of interaction
Some organo-phosphorous insecticides can reduce metabolism rate and thus enhance deltamethrin toxicity.  Therefore, it is not advisable to proceed with such combinations.

Posology and method of administration
For external use only.
Shake well before use.
Pour on the product along the backline of the animals from the head to the tail, at the following recommended dose rates:

Dose rate of Butox®7.5 pour on
IndicationsDose rate
Flies
Prevention and treatment ofbiting and nuisance flies on calves and other cattle

Cattle

  • up to 100kg:10ml
  • 100kg to 300kg:20ml
  • more than 300kg:30ml
Lice
Prevention and treatment of biting and sucking lice on calves, adult cattle and sheep

Cattle, sheep

  • up to 500kg:10ml
  • more than 500kg:20ml
Keds
Prevention and treatment of sheep keds
Sheep
10ml per animal
Ticks
Prevention and treatment ticks
Cattle
15ml per 100kg Not more than 75 ml per animal

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 he repeated within 8 to 10 weeks depending on the weather and the fly species.

Lice: a single application is usually sufficient. All in contact animals must he treated at the same time. Sheep should be treated after shearing.

Ticks: a single application provides protection against ticks for 4-5 weeks.

Overdose
Overdoses of three times the recommended dose as well as a treatment for an extended period (3 days) did not induce any adverse effects in cattle and sheep.

Withdrawal periods
Cattle meat and offal:    0 days
Cattle milk:                   0 days
Sheep meat and offal:    1 day
Sheep milk:                   0 days

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: pyrethroid ectoparasiticide for topical use
ATCvet code: QP53AC11

Pharmacodynamic properties
Butox 7.5 Pour On 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 properties
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

Incompatibilities
None known

Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
Shelf-life after first opening the immediate packaging: no information

Special precautions for storage
Do not store above 25 °C.
Keep out of the reach of children, away from food, drink and animal feeding stuffs.

Immediate packaging
250 mL and 1L dosing flask
2500 ml portable bottle.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials
Any unused product or waste material should be disposed of in accordance with the national requirements. Dangerous to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used containers.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V.
Wim de Körverstr. 35
5831 AN Boxmeer
The Netherlands

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