CLOSAMECTIN 5 MG/ML + 200 MG/ML POUR-ON SOLUTION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.), IVERMECTIN

Available from:

Norbrook Laboratories Limited

ATC code:

QP54AA51

INN (International Name):

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.), IVERMECTIN

Dosage:

5/20

Pharmaceutical form:

Pour-on Solution

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine

Therapeutic area:

Ivermectin, combinations

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2009-08-07

Summary of Product characteristics

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
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 18/01/2017_
_CRN 7025743_
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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_
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 w