Zanil Fluke Drench

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Lastnosti izdelka Lastnosti izdelka (SPC)
25-11-2017
Javno poročilo o oceni Javno poročilo o oceni (PAR)
25-11-2017

Aktivna sestavina:

Oxyclozanide

Dostopno od:

Intervet Ireland Limited

Koda artikla:

QP52A

INN (mednarodno ime):

Oxyclozanide

Odmerek:

3.4 percent weight/volume

Farmacevtska oblika:

Oral suspension

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle, Sheep

Terapevtsko območje:

ANTHELMINTICS

Terapevtske indikacije:

Endoparasiticide

Status dovoljenje:

Authorised

Datum dovoljenje:

1999-10-01

Lastnosti izdelka

                                Health Products Regulatory Authority
24 November 2017
CRN000TVF
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zanil Fluke Drench
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Oxyclozanide
3.4
% w/v
EXCIPIENTS
Methyl Parahydroxybenzoate E218
0.15
% w/v
Propyl Parahydroxybenzoate E216
0.015
% w/v
Sodium Metabisulphite E223
Sodium Citrate E331
3 PHARMACEUTICAL FORM
Oral suspension.
A smooth off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Indications_: For the treatment and control of fascioliasis in cattle
and sheep.
It removes practically all adult flukes (_Fasciola _spp.) present in
the bile ducts of the
liver. Tapeworm segments (_Moniezia_) are also removed.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
Health Products Regulatory Authority
24 November 2017
CRN000TVF
Page 2 of 6

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 to another pharmacological class and having a different mode
of action
should be used.
Milking cattle, particularly high yielders, may show a reduction in
yield, occasionally
of 5 % or more, for about 48 hours after handling.The effect of this
small loss may be
minimised byspreading herd dosing over a period of about one week.
4.5 SPECIAL PRECAUTIONS 
                                
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