Bovimec 10 mg/ml solution for injection 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

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2006-08-18

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovimec 10 mg/ml solution for injection for cattle [IE]
Bovimec B 10 mg/ml solution for injection for cattle [BE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Ivermectin 10mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
Glycerol
Glycerol formal
A clear, colourless solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (Beef and non-lactating cattle)
The veterinary medicinal product can be given to all ages of animals
including young calves.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
The veterinary medicinal product is indicated for the effective
treatment and control of the following
harmful parasites of cattle:
Gastrointestinal roundworms:
_Ostertagia _
spp. (including inhibited
_O. ostertagi_
) (adult and fourth-stage larvae)
_ _
_Haemonchus placei _
(adult and fourth-stage larvae)
_Trichostrongylus _
spp. (adult and fourth-stage larvae)
_ _
_Cooperia _
spp.
_ _
(adult and fourth-stage larvae)
_Nematodirus _
spp.
_ _
(adult)
Lungworms:
_Dictyocaulus viviparus. _
(adult and fourth-stage larvae)
Warbles (parasitic stages):
_Hypoderma _
spp.
_ _
Mange mites:
_Psoroptes bovis _
_Sarcoptes scabiei _
var
_. bovis. _
_ _
Sucking lice:
_Linognathus vituli _
_Haematopinus eurysternus _
3
_Persistent activity _
Treatment at the recommended dose rate controls re-infection with
_Haemonchus placei _
and
_Cooperia _
spp.
_ _
acquired up to 14 days after treatment,
_Ostertagia ostertagi _
acquired up to 21 days after treatment
and
_Dictyocaulus viviparus_
acquired up to 28 days after treatment.
To obtain optimal benefit from the persistent activity of the
veterinary medicinal product for grazing
animals, it is recommended that calves which are set-stocked in the
first grazing season should be
treated 3, 8 and 13 weeks after the day of turn-out. This can protect
the animals from parasitic
gastroenteritis and lungworm disease throughout the grazing season,
provided they are set-stocked, all
the calves are includ