Epromec 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:

Chanelle Pharmaceuticals Manufacturing 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 group:

Cattle

Therapeutic area:

eprinomectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2015-05-22

Summary of Product characteristics

Health Products Regulatory Authority
30 July 2020
CRN009G7N
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Epromec 5 mg/ml Pour-on Solution for beef and dairy cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Eprinomectin 5 mg
EXCIPIENTS:
Butylated hydroxytoluene (E321) 10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
Clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and dairy cattle)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infestations by the following internal and external
parasites sensitive to eprinomectin:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH-STAGE LARVAE)
_Ostertagia _spp.
_Ostertagia lyrata (_adults only)
_Ostertagia ostertagi _(including inhibited L4)
_Cooperia _spp. (including inhibited L4)
_Cooperia oncophora_
_Cooperia pectinata_
_Cooperia punctata_
_Cooperia surnabada_
_Haemonchus placei_
_Trichostrongylus _spp.
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Bunostomun phlebotomum_
_Nematodirus helvetianus_
_Oesophagostomum _spp. (adults only)
_Oesophagostomum radiatum_
_Trichuris _spp(adults only)
LUNGWORMS
_Dictyocaulus viviparus _(adults and L4)
WARBLES (PARASITIC STAGES)
_Hypoderma bovis_
_Hypoderma lineatum_
Health Products Regulatory Authority
30 July 2020
CRN009G7N
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_
PREVENTION OF REINFESTATIONS:
The product protects the animals against reinfestations with:
_Nematodirus helvetianus _for 14 days.
- _Trichostrongylus axei _and _Haemonchus placei _for 21 days.
_- Dictyocaulus viviparus, Cooperia oncophora, Cooperia punctata,
Cooperia surnabada, Oesophagostomum radiatum _and
_Ostertagia ostertagi _for 28 days_._
4.3 CONTRAINDICATIONS
The pr