DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

OXYCLOZANIDE

Διαθέσιμο από:

Merial Animal Health Limited

Φαρμακολογική κατηγορία (ATC):

QP52AG06

INN (Διεθνής Όνομα):

OXYCLOZANIDE

Δοσολογία:

34 Mg/Ml

Φαρμακοτεχνική μορφή:

Oral Suspension

Τρόπος διάθεσης:

LM-Licensed Merchant

Θεραπευτική ομάδα:

Bovine

Θεραπευτική περιοχή:

Oxyclozanide

Θεραπευτικές ενδείξεις:

Anthelmintic

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-01-13

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Distocur 34 mg/ml Oral suspension for cattle
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
A whitish to beige suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
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 grazing animals. The product is restricted to use on
stabled animals (see section 4.5iii).
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
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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 nematodes and
recommendations on how to limit further selection
for resistance t