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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ivermectin

Διαθέσιμο από:

Norbrook Laboratories (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

QP54AA01

INN (Διεθνής Όνομα):

Ivermectin

Δοσολογία:

0.5 percent weight/volume

Φαρμακοτεχνική μορφή:

Pour-on solution

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

ivermectin

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2000-03-13

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
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 _
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 underestimation of bodyweight,
misadministration of the product, or lack of calibration of the d