Enovex 1% w/v Solution for Injection for cattle, sheep and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

1.0 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

1999-10-29

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2019
CRN008TW9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enovex 1% w/v Solution for Injection for cattle, sheep and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
Active Substance
Ivermectin 10 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
In cattle: treatment of infections by the following parasites:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi (_including inhibited _O. ostertagi), Ostertagia
lyrata, Haemonchus _
_placei, Trichostrongylus axei, Trichostrongyluscolubriformis,
Cooperia oncophora, _
_Cooperia punctata, Cooperia pectinata, Bunostomum phlebotomum, _
_Oesophagostomum radiatum, Nematodirus _
_helvetianus (adult)._
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
WARBLES (PARASITIC STAGES):
_Hypoderma bovis, Hypoderma lineatum_
SUCKING LICE:
Health Products Regulatory Authority
24 January 2019
CRN008TW9
Page 2 of 8
_Linognathus vituli, Haematopinus eurysternus_
MANGE MITES:
_Psoroptes communis_ var _bovis, Sarcoptes scabiei _var _bovis_
The product may also be used to reduce infection of the mange mite
_Chorioptes _
_bovis_, but complete elimination may not occur.
_SHEEP_
Enovex Injection is indicated for the effective treatment and control
of the following:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia circumcincta_ (including inhibited larvae_), O.
trifurcata, Haemonchus _
_contortus_ (including inhibited larvae), _Trichostrongylus axei_
(adults_),Trichostrongylus _
_colubriformis _(adults)_, Trichostrongylus vitrinus_ (adults_),
Cooperia curticei, _
_Oesophagostomum venulosum _(adults)_, Oesophagostomum columbianum, _
_Nematodirus filicollis, Chabertia ovina, Trichuris ovis _(adults).
Inhibited larv