Medimec 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
Medimec 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)
_Trichuris _spp. (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 _H