Bayticol 10 mg/ml Pour-On Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flumethrin

Available from:

Elanco GmbH

ATC code:

QP53AC05

INN (International Name):

Flumethrin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

flumethrin

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

Health Products Regulatory Authority
16 October 2020
CRN009PTW
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bayticol 10 mg/ml Pour-On Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Flumethrin 10 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of ticks (_Ixodes ricinus_), biting lice (_Damalinia
bovis_) and sucking lice (_Linognathus vituli, Haemotopinus _
_eurysternus_) and psoroptic mange in cattle.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS:
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS:
Avoid contact with eyes, skin and mouth. Avoid breathing in the
vapour. Avoid ingestion.
Do not eat, drink or smoke when using the product.
Wear protective gloves (disposable nitrile safety gloves) when
applying the product or when handling recently treated animals.
In case of accidental spillage onto the skin wash with water and soap,
in case of accidental spillage into the eyes or mouth,
wash with plenty of water.
In case of spillage take off wet clothes, wash hands and skin
thoroughly with soap and water.
Wash hands, exposed skin and face with water and soap after leaving
the working area and before meals.
Additional protective clothes (long-sleeved shirt, long pants, boots
and water resistant apron) are necessary if an amount of
more than 10 litres of product is applied to animals per day.
Health Products Regulatory Authority
16 October 2020
CRN009PTW
Page 2 of 3
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Slightly irritant to the skin and mucous membranes.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Bayticol is safe to use in pregnant and lactating animals.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND