Animec 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:

2004-12-03

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Animec 5 mg/ml Pour-on Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Ivermectin 5 mg/ml
Excipients
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
A clear, slightly yellow coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the effective treatment and control 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_
_Trichostongylus axei _
_Trichostrongyulus colubiformis _
_Cooperia _spp
_Oesophagostomum radiatum _
_Strongyloides papillosus_ (adult)
_Trichuris spp_ (adult)
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
EYE WORMS (ADULT)
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 6
_Thelazia_ spp
WARBLES (PARASITIC STAGES):
_Hypoderma bovis_
_Hypoderma lineatum_
MITES:
_Chorioptes bovis_
_Sarcoptes scabiei_ var. _bovis._
SUCKING LICE:
_Linognathus vituli_
_Haematopinus eurysternus_
_Solenopotes capillatus_
BITING LICE
_Damalinia bovis_
Animec Pour-On given at the recommended dosage of 500 micrograms/kg
bodyweight, controls infections with _Trichostrongylus axei _and
_Cooperia _acquired up
to 14 days after treatment, _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 controls horn flies (_Haematobia irritans_) for up 35 days
after treatment.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient. This product is
for application to skin surface only, do not give orally or
parenterally.
4.4 SPECIAL WARNINGS F