Noromectin 1% w/v Solution for Injection for Cattle 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:

2000-03-13

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2019
CRN008TQS
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1% w/v Solution for Injection for Cattle and Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active Ingredient(s)_
Each ml:
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 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_, _Trichostrongylus colubriformis_,
_Cooperia oncophora, _
_Cooperia punctata, Cooperia pectinata, Oesophagostomum radiatum,
Nematodirus _
_helvetianus _(adult).
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
WARBLES (PARASITIC STAGES):
_Hypoderma bovis, Hypoderma lineatum_
SUCKING LICE:
_Linognathus vituli, Haematopinus eurysternus_
Health Products Regulatory Authority
13 February 2019
CRN008TQS
Page 2 of 7
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.
_PIGS_
In pigs: treatment of infections by the following parasites:
GASTROINTESTINAL ROUNDWORMS:
_Ascaris suum_ (adults and fourth-stage larvae)
_Hyostrongylus rubidus_ (adults and fourth-stage larvae)
_Oesophagostomum_ spp (adults and fourth-stage larvae)
_Strongyloides ransomi_ (adults)
LUNGWORMS:
_Metastrongylus_ spp (adults)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei_ var _suis_
4.3 CONTRAINDICATIONS
Do not use in dogs or cats as severe adverse reactions may occur.
The product is not for intravenous or intramuscular use.
Do not use in cases of known hypersensitivity to the act