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

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Eprinomectin

Saatavilla:

Norbrook Laboratories (Ireland) Limited

ATC-koodi:

QP54AA04

INN (Kansainvälinen yleisnimi):

Eprinomectin

Annos:

5 milligram(s)/millilitre

Lääkemuoto:

Pour-on solution

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

eprinomectin

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-03-01

Valmisteyhteenveto

Health Products Regulatory Authority
21 December 2018
CRN008SZ5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eprizero 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
21 December 2018
CRN008SZ5
Page 2 of 8
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
​
_Tr