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 Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Pour-on solution

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

ivermectin

Therapeutic indications:

Endectoparasiticides

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
5mg
_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.
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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 (ADULTS AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
EYEWORMS (ADULTS):
_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 b