Distocur 34 mg/ml Oral Suspension for Cattle and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxyclozanide

Available from:

Dopharma Research B.V.

ATC code:

QP52AG06

INN (International Name):

Oxyclozanide

Pharmaceutical form:

Oral suspension

Prescription type:

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

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

2016-11-16

Summary of Product characteristics

Revised: August 2021
AN: 01731/2020 & 01732/2020
Page 1 of 6
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
For treatment of infections caused by the adult stage of_ Fasciola
hepatica,_ sensitive to
oxyclozanide.
For elimination of gravid tapeworm segments (_Monoezia _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
_Fasciola hepatica_ 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.
Revised: August 2021
AN: 01731/2020 & 01732/2020
Page 2 of 6
-
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 an