Distocur 34 mg/ml Oral Suspension for Cattle and Sheep

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Oxyclozanide

Fáanlegur frá:

Boehringer Ingelheim Animal Health UK Ltd

ATC númer:

QP52AG06

INN (Alþjóðlegt nafn):

Oxyclozanide

Lyfjaform:

Oral suspension

Gerð lyfseðils:

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

Meðferðarhópur:

Cattle

Lækningarsvæði:

Anthelmintic flukicide

Leyfisstaða:

Authorized

Leyfisdagur:

2016-11-16

Vara einkenni

Revised: July 2019
AN: 00598/2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Distocur 34 mg/ml Oral Suspension for Cattle and Sheep
Distocur.vet 34 mg/ml Oral Suspension for Cattle (DK, NO, SE)
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
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.
Page 1 of 6
Revised: July 2019
AN: 00598/2018
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