Bovimec 5 mg/ml Pour-On solution for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Bimeda Animal Health Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

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:

2021-12-10

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovimec 5 mg/ml Pour-on solution for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Ivermectin 5 mg
Excipient:
Brillant Blue FCF (E133) 0.00724 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pour-on solution
A clear, blue coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
_(beef and non-lactating dairy cattle)_
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections with the following species of
gastrointestinal roundworms, lungworms,
warbles, mites and lice for beef and non-lactating dairy cattle:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi _
(including inhibited
_O. ostertagi_
)
_Haemonchus placei_
_Trichostrongylus axei_
_Trichostrongylus colubriformis _
_Cooperia _
spp.
_Oesophagostomum radiatum_
_Strongyloides papillosus _
(adults only)
_Trichuris _
spp. (adults only)
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
EYEWORMS:
_Thelazia _
spp. (adults)
WARBLES
(parasitic stages):
_Hypoderma bovis_
_H. lineatum_
MITES:
_Sarcoptes scabiei _
var. bovis
_Chorioptes bovis_
LICE:
_Linognathus vituli_
_Haematopinus eurysternus _
_Solenopotes capillatus _
_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 observed against
_Haemonchus placei (L4), Coope