DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

OXYCLOZANIDE

Available from:

Merial Animal Health Limited

ATC code:

QP52AG06

INN (International Name):

OXYCLOZANIDE

Dosage:

34 Mg/Ml

Pharmaceutical form:

Oral Suspension

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine

Therapeutic area:

Oxyclozanide

Therapeutic indications:

Anthelmintic

Authorization status:

Authorised

Authorization date:

2017-01-13

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Distocur 34 mg/ml Oral suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxyclozanide ………………………………………… 34.0 mg
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)………………….
1.35 mg
Propyl parahydroxybenzoate ………………………….
0.15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
A whitish to beige suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the adult stage of_ Fasciola
hepatica,_ sensitive to oxyclozanide.
Elimination of gravid tapeworm segments (_Moniezia spp_.).
4.3 CONTRAINDICATIONS
Do not use in grazing animals. The product is restricted to use on
stabled animals (see section 4.5iii).
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
To date no resistance to oxyclozanide has been reported.
Use of the product should be based on local (regional, farm)
epidemiological information about susceptibility of nematodes and
recommendations on how to limit further selection
for resistance t
                                
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