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

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

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Ficha técnica Ficha técnica (SPC)
23-01-2024

Ingredientes activos:

Closantel, Ivermectin

Disponible desde:

Norbrook Laboratories Limited

Código ATC:

QP54AA51

Designación común internacional (DCI):

Closantel, Ivermectin

formulario farmacéutico:

Pour-on solution

tipo de receta:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Grupo terapéutico:

Cattle

Área terapéutica:

Endectocide

Estado de Autorización:

Authorized

Fecha de autorización:

2009-08-04

Ficha técnica

                                Revised: April 2022
AN: 02842/2021 & 00070/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5mg/ml + 200 mg/ml Pour-On Solution for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT(S)
Ivermectin
5 mg/ml
Closantel (as closantel sodium)
200 mg/ml
EXCIPIENTS
Brilliant Blue FCF (E133)
0.1 mg/ml
For the full list of excipients see section 6.1.
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.
Revised: April 2022
AN: 02842/2021 & 00070/2022
Page 2 of 8
Eyeworms (adult)
_Thelazia_ spp
Cattle grubs (parasitic stages)
_Hypoderma bovis, Hypoderma lineatum_
Lice
_Linognathus vituli, Haematopinus eurysternus, Damalinia bovis_
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
species
(cases
of
intolerance with fatal outcome are reported in dogs – especially
Collies, Old
English Sheep
                                
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