Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Ivermectin; Closantel sodium

MAH:

Norbrook Laboratories (Ireland) Limited

ATC_code:

QP54AA51

INN:

Ivermectin; Closantel sodium

dosage:

5, 200 milligram(s)/millilitre

pharmaceutical_form:

Pour-on solution

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_area:

ivermectin, combinations

authorization_status:

Authorised

authorization_date:

2009-08-07

SPC

Health Products Regulatory Authority
07 October 2021
CRN00CHZN
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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ACTIVE INGREDIENT(S)
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Ivermectin
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5
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mg/ml
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Closantel (as closantel sodium)
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200
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mg/ml
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EXCIPIENTS
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Brilliant Blue FCF (E133)
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0.1
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mg/ml
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For the full list of excipients see section 6.1.
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3 PHARMACEUTICAL FORM
Pour-On solution.
A clear blue/green solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed trematode (fluke) and nematode or arthropod
infestations due to roundworms, lungworms,
eyeworms, warbles, mites and lice of cattle.
Gastrointestinal roundworms (adults and fourth stage larvae)
_Ostertagia ostertagi _(including inhibited _O. ostertagi_),
_Haemonchus placei_, _Trichostrongylus axei_, _Trichostrongylus
colubriformis_,
_Cooperia_spp_, Oesophagostomum radiatum, Nematodirus
helvetianus_(adult), _Strongyloides papillosus _(adult).
Lungworms (adult and fourth stage larvae)
_Dictyocaulus viviparus_
Trematodes (adult and late immatures)
_Fasciola gigantica_
_Fasciola hepatica_
Treatment of fluke at 12 weeks (mature) >95% efficacy.
Treatment of fluke at 7 weeks (late immature) >95% efficacy.
Eyeworms (adult)
_Thelazia_ spp
Cattle grubs (parasitic stages)
_Hypoderma bovis, Hypoderma lineatum_
Lice
_Linognathus vituli, Haematopinus eurysternus, Damalinia bovis_
Health Products Regulatory Authority
07 October 2021
CRN00CHZN
Page 2 of 6
Mange Mites
_Chorioptes bovis, Sarcoptes scabiei _var _bovis_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substances
or to any of the excipients.
Do not apply to areas of skin which have mange, scabs or other lesions
or to areas contaminated with mud or manure.
Avermectins may not be well tolerated in non-target