Robonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprinomectin

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP54AA04

INN (International Name):

Eprinomectin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

eprinomectin

Authorization status:

Authorised

Authorization date:

2013-03-01

Summary of Product characteristics

Health Products Regulatory Authority
01 April 2019
CRN008ZJQ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Robonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1ml of solution contains:
​
​
ACTIVE SUBSTANCE:
​
​
Eprinomectin
​5 mg
​
EXCIPIENTS:
​
​
Butylated Hydroxytoluene (E321)
​0.1 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pour-on solution.
A Clear to Very Light Yellow Solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and dairy cattle)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment and prevention of the following parasites
Gastrointestinal Roundworms (adults and fourth stage larvae):
_Ostertagia _spp., _Ostertagia lyrata _(adult)_, Ostertagia ostertagi
_(including inhibited _O. ostertagi_)_, Cooperia _spp. (including
inhibited _Cooperia _spp),_ Cooperia oncophora, Cooperia pectinata,
Cooperia punctata, Cooperia surnabada, Haemonchus placei, _
_Trichostrongylus _spp.,_ Trichostrongylus axei, Trichostrongylus
colubriformis, Bunostomum phlebotomum, Nematodirus _
_helvetianus, Oesophagostomum _spp. (adult),_ Oesophagostomum
radiatum, Trichuris_ spp (adult).
Lungworms (adults and fourth stage larvae):
_Dictyocaulus viviparus_
Warbles (parasitic stages):
_Hypoderma bovis, H. lineatum _
Health Products Regulatory Authority
01 April 2019
CRN008ZJQ
Page 2 of 6
Mange Mites:
_Chorioptes bovis, Sarcoptes scabiei_ var_ bovis_
Lice:
_Damalinia (Bovicola) bovis _(biting lice),_ Linognathus vituli
_(sucking lice),_ Haematopinus eurysternus _(sucking lice),_
Solenopotes _
_capillatus _(sucking lice).
Horn Flies:
_Haematobia irritans_.
PROLONGED ACTIVITY
Applied as recommended, the product prevents reinfections with:
​
PARASITE*
​
PROLONGED ACTIVITY
​
_Dictyocaulus viviparus_
​
up to 28 days
_​_
_Ostertagia_ spp
​
up to 28 days
​
_Oesophagostomum radiatum_ ​
up to 28 days
_​_
_Cooperia_ spp
​
up to 21 days
_​_
_