NOROMECTIN POUR-ON VETERINARY

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

IVERMECTIN

Disponible desde:

COMEX LTD

formulario farmacéutico:

SOLUTION

Composición:

IVERMECTIN 0.5 %W/V

Vía de administración:

TOPICAL

tipo de receta:

Required

Fabricado por:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

indicaciones terapéuticas:

For the treatment of gastrointestinal roundworms, lungworms, eyeworm, warbles, chrorioptic and sarcoptic mange and sucking and biting lice in beef.

Fecha de autorización:

2022-01-31

Información para el usuario

_ _
VETERINARY MEDICINE USER LEAFLET
Veterinarian Prescription only medicine
For animal use only_ _
1.
NAME FORM AND STRENGTH OF THE VETERINARY MEDICINE:
_NOROMECTIN POUR-ON VETERINARY, TOPICAL SOLUTION, 0.5% W/V _
2.
ACTIVE INGREDIENTS:
Each 1 ml of the medicine contains:
_Ivermectin 5mg _
The medicine also contains the excipient:
Patent Blue V (E131) 0.0005% w/v
For a full list of excipients, see section 13 “Further
information”
.
3.
INDICATIONS FOR USE:
For the treatment of gastrointestinal roundworms, lungworms, eyeworm,
warbles,
chorioptic and sarcoptic mange and sucking and biting lice in beef
cattle.
THERAPEUTIC GROUP: Avermectins.
4.
CONTRAINDICATIONS:
Do not apply to areas of skin which have mange, scabs or other lesions
or to areas
contaminated with mud or manure.
Formulated for specific use in cattle. It should not be applied or
administered to other
species, as severe reactions, including fatalities in dogs, may occur.
5.
ADVERSE REACTIONS:
Undesirable effects are not expected when the product is used at the
recommended
dose rate.
Side effects can be reported to the Ministry of Health by clicking on
the link "Reporting
adverse events due to drug treatment" found on the home page of the
Ministry of
Health website (www.health.gov.il) which refers to the online form for
reporting
adverse events, or by entering the link:
https://sideeffects.health.gov.il
6.
TARGET SPECIES:
Beef cattle only.
7.
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE:
The medicine should be administered topically at 500
μg
per kg bodyweight (1 ml per
10 kg bodyweight).
8.
HOW TO USE THE PRODUCT:
The formulation should be applied along the midline of the back in a
narrow strip
between the withers and the tailhead.
2.5 litre pack (Collapsible Back Pack)
•
Remove the shipping cap from the backpack container and replace with
the vent cap
provided.
•
Attach the hose from the automatic dosing equipment to the outlet from
the vent cap.
•
Follow the applicator gun manufacturer’s directions for priming the
gun, adjusting th

Ficha técnica

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin Pour-On Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
% W/V
Ivermectin
0.5
EXCIPIENT(S):
Patent Blue V (E131)
0.0005
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Pour-on Solution
A clear blue liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Beef cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the effective treatment and control of the following
gastrointestinal
roundworms, lungworms, eyeworms, warbles, chorioptic and sarcoptic
mange and
sucking and biting lice in beef cattle.
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).
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus_.
EYEWORMS (ADULT):
_Thelazia _spp
WARBLES (PARASITIC STAGES):
_Hypoderma bovis, Hypoderma lineatum_.
Page 2 of 6
LICE:
_Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus,
Damalinia _
_bovis_.
MANGE MITES:
_Chorioptes bovis, Sarcoptes scabiei _var _bovis_.
Rainfall before or after treatment will not affect the efficacy of
Noromectin 0.5% w/v
Pour-On Solution.
4.3
CONTRAINDICATIONS
Do not apply to areas of skin which have mange, scabs or other lesions
or to areas
contaminated with mud or manure.
Formulated for specific use in cattle. It should not be applied or
administered to other
species, as severe reactions, including fatalities in dogs, may occur.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Assess bodyweight as accurately as possible before calculating the
dosage.
4.5
SPECIAL PRECAUTIONS FOR USE
For external use only.
Cases of intolerance with fatal outcome are reported in dogs,
especially Collies, old
English Sheepdogs and related breeds or crosses, a