Flukiver 5% w/v Oral Suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Closantel sodium

Saatavilla:

Elanco GmbH

ATC-koodi:

QP52AG09

INN (Kansainvälinen yleisnimi):

Closantel sodium

Annos:

5 percent weight/volume

Lääkemuoto:

Oral suspension

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Sheep

Terapeuttinen alue:

closantel

Käyttöaiheet:

Endoparasiticide

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-01-18

Valmisteyhteenveto

Health Products Regulatory Authority
06 June 2018
CRN000YJZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Closantel (as Clostanel sodium) 50 mg/ml
Excipients:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A white suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and lambs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult and immature liver fluke,
haematophagous
nematodes and larval stages of some arthropods in sheep.
Liver fluke:
_Fasciola hepatica _(average efficacy against 6 week immature stages
is 86%)
_Fasciola gigantica_
Haematophagous nematodes
_Haemonchus contortus_ (including benzimidazole resistant strains)
_Chabertia ovina_
_Gaigeria pachyscelis_
Arthropods
Health Products Regulatory Authority
06 June 2018
CRN000YJZ
Page 2 of 6
_Oestrus ovis_ (Sheep Nasal Bot Fly)
Ticks (_lxodes ricinus_) feeding on sheep at the time of treatment are
likely to produce
fewer viable eggs.
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.
· Underdosing which may be due to underestimation of bodyweight,
misadministration of the product, or lack of calibration of the dosing
device.
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 tests strongly suggest resistance to a particular anthelmintic, an
anthelmintic
belonging to another pharmacological class and having a different mode
of action
should be used.
4.5 SPECIAL PR