Distocur 34 mg/ml Oral suspension for cattle and sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxyclozanide

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QP52AG06

INN (International Name):

Oxyclozanide

Dosage:

34 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

oxyclozanide

Authorization status:

Authorised

Authorization date:

2017-01-13

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2019
CRN000Z3D
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Distocur 34 mg/ml Oral suspension for cattle and sheep
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.
Whitish to beige suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle and sheep:
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 cases of known hypersensitivity to the active substance
or to any of the excipients.
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 trematodes and
recommendations on how to limit further selection for
resistance to anthelmintics.
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and could
ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class,
over an extended period of time.
- Underdosing, which may be due to underestimation of body weight,
misadministration of the product or lack of calibration of
the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be
further investigated using appropriate tests (e.g. Faecal Egg
Count Reduction Test). Where the results of the test(s) strongly
suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmaceutical class and having a different mode
of action