NEOPRINIL POUR-ON 5 mg/ml pour-on solution for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eprinomectin

Available from:

Virbac S.A.

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:

2014-09-12

Summary of Product characteristics

Health Products Regulatory Authority
11 February 2019
CRN000YGQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NEOPRINIL POUR-ON 5 mg/ml pour-on solution for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
​
ACTIVE SUBSTANCE:
​
​
Eprinomectin
​
5.00 mg
EXCIPIENT:
​
​
Butylhydroxytoluene (E321)
​
0.10 mg
​
All-rac-alpha-tocopherol (E307)
​
0.06 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
Slightly yellowish, clear oily solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In beef and dairy cattle:
Treatment of infestations by the following parasites sensitive to
eprinomectin:
Gastrointestinal roundworms (adults and L4 larvae):_ Ostertagia
ostertagi _(including
inhibited L4 larvae), _Ostertagia lyrata _(only adults), _Haemonchus
placei_,
_Trichostrongylus axei_, _Trichostrongylus colubriformis, Cooperia sp.
_(including inhibited
L4), _Cooperia oncophora_, _Cooperia punctata_, _Cooperia pectinata_,
_Cooperia surnabada_,
_Bunostomum phlebotomum_, _Nematodirus helvetianus_, _Oesophagostomum
radiatum_,
_Oesophagostomum _sp. (only adults), _Trichuris discolor _(only
adults);
Lungworms:_ Dictyocaulus viviparus _(adults and L4);
Warbles (parasitic stages):_ Hypoderma bovis_, _Hypoderma lineatum;_
Mange mites:_ Chorioptes bovis_, _Sarcoptes scabiei _var. _Bovis;_
Sucking lice:_ Linognathus vituli_, _Haematopinus eurysternus_,
_Solenopotes capillatus_;
Health Products Regulatory Authority
11 February 2019
CRN000YGQ
Page 2 of 10
Biting lice:_ Damalinia bovis_;
Flies:_ Haematobia irritans._
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
D