Bimectin 1% w/v Solution for Injection

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:

1.0 percent weight/volume

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:

2000-04-14

Summary of Product characteristics

Health Products Regulatory Authority
28 June 2019
CRN008SC8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimectin 1% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
Ivermectin 1.0 % w/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless, slightly viscous, non-aqueous sterile solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the effective treatment and control of the following harmful
parasites of cattle, sheep and pigs:
_CATTLE_
GASTROINTESTINAL ROUNDWORMS (adult and fourth-stage larvae):
_Ostertagia_ spp. (including inhibited _O. ostertagi_)
_Haemonchus placei_
_Trichostrongylus axei_
_T. colubriformis_
_Cooperia_ spp.
_Bunostomum phlebotomum_
_Oesophagostomum radiatum_
_Strongyloides papillosus_ (adult)
_Nematodirus helvetianus_ (adult)
_N. spathiger_ (adult)
_Trichuris_ spp (adult).
LUNGWORMS (adult and fourth-stage larvae):
_Dictyocaulus viviparus_
EYE WORMS (adult):
_Thelazia_ spp.
WARBLES:
_Hypoderma bovis_
_H. lineatum_
MANGE MITES:
_Psoroptes bovis_
_Sarcoptes scabiei_ var. _bovis_
Health Products Regulatory Authority
28 June 2019
CRN008SC8
Page 2 of 7
SUCKING LICE:
_Linognathus vituli_
_Haematopinus eurysternus_
_Solenopotes capillatus_
May also be used as an aid in the control of the mange mite
_Chorioptes bovis_ and biting lice _Damalinia bovis_, but complete
elimination may not occur.
_Persistent Activity_
Treatment at the recommended dose rate can control re-infection with
_Haemonchus placei_ and _Cooperia_ spp. acquired up to
14 days after treatment, _Ostertagia ostertagi_ and _Oesophagostomum
radiatum_ acquired up to 21 days after treatment and
_Dictyocaulus viviparus_ up to 28 days after treatment.
To obtain optimal benefit from the persistent activity of the product
for grazing animals, it is recommended that calves which
are set-stocked in the first grazing season sh