Robonex Pour-On for Beef and Dairy Cattle 5mg/ml Solution for topical administration
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
07-09-2013
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Active ingredient:
eprinomectin 5 mg/ml
Available from:
Norbrook Laboratories Limited
ATC code:
QP54AA04
Pharmaceutical form:
Topical Solution
Therapeutic group:
eprinomectin
Therapeutic area:
Cattle Food, Cattle Lactating
Authorization date:
2013-01-23
Summary of Product characteristics
Issued: March 2013
AN: 01864/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noreprinec 5 mg/ml Pour-On Solution for Beef and Dairy Cattle (UK)
Robonex 5mg/ml Pour-On Solution for Beef and Dairy Cattle (BE, FR, IE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of solution contains:
ACTIVE SUBSTANCE:
Eprinomectin
5mg
EXCIPIENTS:
Butylated Hydroxytoluene (E321)
0.1mg
For a 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
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):
Issued: March 2013
AN: 01864/2011
Page 2 of 7
_Dictyocaulus viviparus _
_ _
Warbles (parasitic stages):
_Hypoderma bovis, H. lineatum _
_ _
Mange Mites:
_Chorioptes bovis, Sarcoptes scabiei_ var_ bovis _
Lice:_ _
_Damalinia bovis _(biting lice),_ Linognathus vituli _(sucking lice),_ _
_Haematopinus eurys
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