Chanimec 0.5% w/v Pour-on Solution

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:

0.5 percent weight/volume

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 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Chanimec 0.5% w/v Pour-on Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin 0.5 % w/v (5 mg/ml)
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)
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus _
EYE WORMS (ADULT):
_Thelazia_ spp
Health Products Regulatory Authority
22 November 2018
CRN008PVZ
Page 2 of 7
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
observed against _Haemonchus plac