Topimec 5 mg/ml Pour-on Solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ivermectin

Διαθέσιμο από:

Chanelle Animal Health Ltd.

Φαρμακολογική κατηγορία (ATC):

QP54AA01

INN (Διεθνής Όνομα):

Ivermectin

Δοσολογία:

5 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Pour-on solution

Τρόπος διάθεσης:

LM: Licensed Merchant as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

ivermectin

Θεραπευτικές ενδείξεις:

Endectoparasiticides

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-05-13

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
19 April 2018
CRN000YCJ
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Topimec 5 mg/ml Pour-on Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ivermectin 5.00 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
A clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and non-lactating dairy cattle)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections with the following species of
gastrointestinal
roundworms, lungworms, warbles, mites and lice for beef and
non-lactating dairy
cattle:
GASTRO-INTESTINAL 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 only)
LUNGWORMS (ADULT AND FOURTH STAGE LARVAE):
_Dictyocaulus viviparus _
EYE WORMS (ADULT):
_Thelazia_ spp.
Health Products Regulatory Authority
19 April 2018
CRN000YCJ
Page 2 of 7
WARBLES(PARASITIC STAGES):
_Hypoderma bovis_
_Hypoderma lineatum _
MITES:
_Chorioptes bovis _(reduction of infestation)
_Sarcoptes scabiei_ var _bovis_.
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
BITING LICE:
_Damalinia bovis_
The product given at the recommended dosage of 500 micrograms/kg
bodyweight,
has persistent activity against _Trichostrongylus axei_ and _Cooperia
_spp acquired during
the 14 days after treatment, only if the whole herd is treated
simultaneously. It also
has a persistent activity against _Ostertagia ostertagi_ and
_Oesophagostomum radiatum_
acquired during the first 21 days after treatment and _Dictyocaulus
viviparus_
(lungworm) acquired during the first 28 days after treatment. It also
has a persistent
activity on horn flies (_Haematobia irritans_) for 28 days after
treatment, partial efficacy
may last for up to 35 days post application. Occasionally