Distocur 34 mg/ml Oral Suspension for Cattle and Sheep

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Oxyclozanide

Saatavilla:

Dopharma Research B.V.

ATC-koodi:

QP52AG06

INN (Kansainvälinen yleisnimi):

Oxyclozanide

Lääkemuoto:

Oral suspension

Prescription tyyppi:

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

Terapeuttinen ryhmä:

Cattle, Sheep

Terapeuttinen alue:

Anthelmintic flukicide

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2016-11-16

Valmisteyhteenveto

Revised: November 2022
AN: 02755/2022
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Methyl parahydroxybenzoate (E218)
1.35 mg
Propyl parahydroxybenzoate
0.15 mg
Aluminium magnesium silicate
Carmellose sodium (E466)
Sodium laurilsulfate
Monohydrate citric acid (E330)
Sodium citrate (E331)
Purified water
Whitish to beige oral suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and sheep.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For treatment of infections caused by the adult stage of_ Fasciola
hepatica,_ sensitive to
oxyclozanide.
For elimination of gravid tapeworm segments (_Moniezia _spp.).
Revised: November 2022
AN: 02755/2022
Page 2 of 6
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
3.4
SPECIAL WARNINGS
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.
-
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). Wh