Noromectin 0.5% w/v Pour-On Solution for Cattle

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Ivermectin

MAH:

Norbrook Laboratories Limited

ATC_code:

QP54AA01

INN:

Ivermectin

dosage:

0.5 percent weight/volume

pharmaceutical_form:

Pour-on solution

prescription_type:

LM: Licensed Merchant as defined in relevant national legislation

therapeutic_group:

Cattle

therapeutic_area:

ivermectin

therapeutic_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

2000-03-13

SPC

Health Products Regulatory Authority
15 January 2018
CRN000WPZ
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 0.5% w/v Pour-On Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance_
Ivermectin 0.5% w/v
_Excipients: _
Patent Blue V (E131) dye 0.0005% w/v
Isopropyl alcohol to 100.0% v/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pour-on solution
A clear, blue solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and non-lactating cattle).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Noromectin Pour-On is indicated for the effective treatment and
control of the
following harmful species of gastrointestinal roundworms, lungworms,
eyeworms,
warbles, mites and lice.
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi _(including inhibited _O ostertagi_),
_Haemonchus placei, _
_Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia _spp,
_Oesophagostomum radiatum, Strongyloides papillosus _(adult)_,
Trichuris _spp (adult).
Occasionally variable activity may be observed against _H. placei_
(L4), _Cooperia_ spp, _T. _
_axei_ and _T. colubriformis_.
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_
EYEWORMS (ADULT):
_Thelazia rhodesii_
Health Products Regulatory Authority
15 January 2018
CRN000WPZ
Page 2 of 6
WARBLES (PARASITIC STAGES):
_Hypoderma bovis, Hypoderma lineatum_
SUCKING LICE:
_Linognathus vituli, Haematopinus eurysternus,_
BITING LICE:
_Damalinia (bovicola) bovis_
MANGE MITES:
_Chorioptes bovis, Sarcoptes scabiei _var _bovis_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk
of development of resistance and could ultimately result in
ineffective therapy.
- Too frequent and repeated use of anthelmintics from the same class,
over an
extended period of time.
- Underdosing which may be due to unde