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

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Closantel ; Ivermectin

Tersedia dari:

Norbrook Laboratories Limited

Kode ATC:

QP54AA51

INN (Nama Internasional):

Closantel ; Ivermectin

Dosis:

200, 5 milligram(s)/millilitre

Bentuk farmasi:

Pour-on solution

Jenis Resep:

LM: Licensed Merchant as defined in relevant national legislation

Kelompok Terapi:

Cattle

Area terapi:

ivermectin, combinations

Indikasi Terapi:

Endectoparasiticides

Status otorisasi:

Authorised

Tanggal Otorisasi:

2009-08-07

Karakteristik produk

Health Products Regulatory Authority
09 April 2018
CRN000XN9
Page 1 of 9
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin 5 mg/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_
Health Products Regulatory Authority
09 April 2018
CRN000XN9
Page 2 of 9
_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_
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 Sheepdogs
and related breeds or crosses,