Macromectin 0.5% w/v Pour-On Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Norbrook Laboratories (Ireland) 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:

2005-11-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Macromectin 0.5% w/v Pour-On Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
_ACTIVE INGREDIENT _
Ivermectin 0.5 mg
_EXCIPIENT(S) _
Isopropyl alcohol to 1.0ml
Patent Blue V (E131) 0.005mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pour-on solution
A clear blue liquid
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of the following pathogenic
species of parasites of cattle:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi _L4, adult
(including inhibited stage)
_Haemonchus placei _L4, adult
_Trichostrongylus axei _L4, adult
_T. colubriformis _L4, adult
_Cooperia _spp L4, adult
_Oesophagostomum radiatum _L4, adult
_Strongyloides papillosus _adults
_Trichuris _spp adults
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus _
EYEWORMS (ADULT):
_Thelazia _spp_ _
WARBLES (PARASITIC STAGES):
_Hypoderma bovis _
_H. lineatum _
MITES:
_Sarcoptes scabiei _var bovis
_Chorioptes bovis _(reduction of infestation)
LICE:
_Linognathus vituli, _
_Haematopinus eurysternus, _
_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.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance.
The product has been formulated for