DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

OXYCLOZANIDE

Tilgjengelig fra:

Merial Animal Health Limited

ATC-kode:

QP52AG06

INN (International Name):

OXYCLOZANIDE

Dosering :

34 Mg/Ml

Legemiddelform:

Oral Suspension

Resept typen:

LM-Licensed Merchant

Terapeutisk gruppe:

Bovine

Terapeutisk område:

Oxyclozanide

Indikasjoner:

Anthelmintic

Autorisasjon status:

Authorised

Autorisasjon dato:

2017-01-13

Preparatomtale

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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_4_
_/_
_0_
_3_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_9_
_6_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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