Mastermectin 0.5% Pour-On Solution for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

ECO Animal Health Europe 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:

2001-01-26

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN008YC5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Mastermectin 0.5% Pour-On Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each 1 ml contains:
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ACTIVE SUBSTANCE:
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Ivermectin Ph. Eur.
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0.5% w/v
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EXCIPIENTS:
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Benzyl alcohol Ph. Eur.
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1% w/v
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For a full list of excipients, please see Section 6.1.
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3 PHARMACEUTICAL FORM
Pour-on solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle: For the treatment of infections with the following
parasites
Gastro-intestinal worms -
_Haemonchus placei _(adult and fourth stage larvae)
_Ostertagia ostertagi_ (adult and fourth stage larvae, including
inhibited larvae)
_Trichostrongylus axei _(adult and fourth stage larvae)
_Trichostrongylus colubriformis _(adult and fourth stage larvae)
_Cooperia punctata_ (adult only)
_Cooperia oncophora_ (adult only)
_Strongyloides papillosus_ (adult only)
_Oesophagostomum radiatum,_ (adult and fourth stage larvae)
Lungworm (adult and fourth stage larvae) – _Dictyocaulus viviparus_.
Warbles (parasitic stages) – _Hypoderma bovis_, _Hypoderma
lineatum_.
Mange mites – _Sarcoptes scabiei var. bovis_. The product may also
be used to reduce infection of the mange mite_ Chorioptes _
_bovis, _but complete elimination may not occur.
Sucking and biting lice – _Linognathus vituli_, _Haematopinus
eurysternus_, _Bovicola (Damalinia) bovis._
_Mastermectin 0.5% Cattle Pour-On has persistent activity against
infections acquired with Trichostrongylus axei and Cooperia spp. _
_up to 14 days after treatment, but only in the case of group
treatment; Ostertagia ostertagi and Oesophagostomum radiatum up _
_to 21 days after treatment; Dictyocaulus viviparus up to 28 days
after treatment. It also has persistent activity against horn flies _
_(Haematobia irritans) for up to 28 days after treatm