Distocur 34 mg/ml Oral suspension for cattle and sheep

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Oxyclozanide

Dostupné z:

Dopharma Research B.V.

ATC kód:

QP52AG06

INN (Medzinárodný Name):

Oxyclozanide

Dávkovanie:

34 milligram(s)/millilitre

Forma lieku:

Oral suspension

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

oxyclozanide

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-01-13

Súhrn charakteristických

1
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.).
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.
2
-
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