Butox 7.5 mg/ml Pour On Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Deltamethrin

Available from:

Intervet Ireland Limited

ATC code:

QP53AC11

INN (International Name):

Deltamethrin

Dosage:

7.5 milligram(s)/millilitre

Pharmaceutical form:

Pour-on suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

deltamethrin

Therapeutic indications:

Ectoparasiticide

Authorization status:

Authorised

Authorization date:

1999-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Butox 7.5 mg/ml Pour On Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention and treatment of cattle flies.
Prevention and treatment of cattle and sheep lice.
Prevention and treatment of sheep keds.
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cases of resistance to deltamethrin have been reported in parasites of
cattle and sheep. Use of this product should be based
on local (regional, farm) epidemiological information about parasite
susceptibility to deltamethrin.
Each ml contains:
Active Substance
Deltamethrin
7.50 mg
Excipients
Formaldehyde 35 % solution
0.19 mg
Propylene glycol
160.0 mg
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
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.
Avoid contact