Robonex Pour-on Beef and Dairy Cattle
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-08-2013
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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
Authorization date:
2013-01-23
Summary of Product characteristics
AN:00049/2013
Revised: May 2013
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Robonex 5mg/ml Pour-On Solution for Beef and Dairy Cattle (UK, IT)
Noreprinec 5mg/ml Pour-On Solution for Beef and Dairy Cattle (BE, LU, PT, ES)
Norprinomectin 5mg/ml Pour-On Solution for Beef and Dairy Cattle (FR)
Eprivet 5mg/ml Pour-On Solution for Beef and Dairy Cattle (IE)
Anamex 5mg/ml Pour-On Solution for Beef and Dairy Cattle (AT, BG, CY, CZ,
DK, EE, EL, HU, LV, LT, MT, RO, SK, SI)
Anamex vet 5mg/ml Pour-On Solution for Beef and Dairy Cattle (SE)
Anamex vet 5mg/ml Pour-On Solution for Cattle (FI)
Anamex vet (NO)
Anamex 5mg/ml Pour-On Solution for Cattle (PL)
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, _
AN:00049/2013
Revised: May 2013
Page 2 of 8
_Tr
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