Bovipour 5 mg/ml Pour-on Solution for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2007-05-25

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2018
CRN008QMW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovipour 5 mg/ml Pour-on Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE
Ivermectin 5.0 mg
EXCIPIENTS
For a full list of excipients, see section 6.1 .
3 PHARMACEUTICAL FORM
Pour-on solution.
A clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following species of gastrointestinal
roundworms,
lungworms, warbles, mites and lice:
GASTRO-INTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi_ (including inhibited _O ostertagi_)
_Haemonchus placei _
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Cooperia _spp
_Oesophagostomum radiatum_
_Strongyloides papillosus_ (adult only)
_Trichuris _spp (adult only)
LUNGWORMS(ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus _
Health Products Regulatory Authority
12 November 2018
CRN008QMW
Page 2 of 7
EYE WORMS (ADULT):
_Thelazia _spp
WARBLES(PARASITIC STAGES):
_Hypoderma bovis_
_Hypoderma lineatum _
MITES:
_Chorioptes bovis _(reduction of infestation)
_Sarcoptes scabiei_ var _bovis_.
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
BITING LICE:
_Damalinia bovis_ The product given at the recommended dosage of 500
micrograms/kg bodyweight, has persistent activity against
_Trichostrongylus axei_ and
_Cooperia _spp acquired during the 14 days after treatment, only if
the whole herd is
treated simultaneously. It also has a persistent activity against
_Ostertagia ostertagi_
and _Oesophagostomum radiatum_ acquired during the first 21 days after
treatment
and _Dictyocaulus viviparus_ (lungworm) acquired during the first 28
days after
treatment. It also has a persistent activity on horn flies
(_Haematobia irritans_) for 28
days after treatment, partial efficacy may last for up to 35 days post
application.
Occasionally variable activity may be