Eprivalan 5 mg/ml pour-on solution for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprinomectin

Available from:

Boehringer Ingelheim Vetmedica GmbH

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 group:

Cattle

Therapeutic area:

eprinomectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2016-09-30

Summary of Product characteristics

Health Products Regulatory Authority
06 August 2021
CRN00CHV9
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eprivalan 5mg/ml pour-on solution for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Eprinomectin
5.0 mg
EXCIPIENTS:
Butylhydroxytoluene (E321)
0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution
Clear slightly yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and dairy cattle)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infestation by the following parasites sensitive to
eprinomectin:
​
WARBLES (parasitic stages)
_Hypoderma bovis_
_Hypoderma lineatum_
Health Products Regulatory Authority
06 August 2021
CRN00CHV9
Page 2 of 7
MANGE MITES
_Chorioptes bovis_
_Sarcoptes scabiei _var. _bovis_
LICE
_Linognathus vituli_
_Damalinia bovis_
_Haematopinus eurysternus_
_Solenopotes capillatus_
PROLONGED ACTIVITY
Applied as recommended, the product controls reinfections with:
PARASITE
PROLONGED ACTIVITY
_Dictyocaulus viviparus_
Up to 28 days
_Ostertagia ostertagi_
Up to 28 days
_Ostertagia lyrata_
Up to 28 days
_Oesophagostomum radiatum_
Up to 28 days
_Cooperia oncophora_
Up to 21 days
_Cooperia surnabada_
Up to 21 days
_Cooperia punctata_
Up to 21 days
_Trichostrongylus axei_
Up to 21 days
_Trichostrongylus colubriformis_
Up to 21 days
_Haemonchus placei_
Up to 14 days
_Nematodirus helvetianus_
Up to 14 days
For best results the veterinary medicinal product should be part of a
programme to control both internal and external parasites
of cattle based on the epidemiology of these parasites.
4.3 CONTRAINDICATIONS
This product is formulated only for topical application to beef and
dairy cattle, including lactating dairy cattle. Do not use in
other animal species. Do not administer orally or by injection.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For effectiv