Flukiver 5% w/v Oral Suspension

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Closantel

Saatavilla:

Elanco Europe Ltd

ATC-koodi:

QP52AG09

INN (Kansainvälinen yleisnimi):

Closantel

Lääkemuoto:

Oral suspension

Prescription tyyppi:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeuttinen ryhmä:

Sheep

Terapeuttinen alue:

Anthelmintic flukicide

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

1986-12-01

Valmisteyhteenveto

Revised: October 2020
AN: 00844/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
MG/ML
Closantel
50.00
(as Closantel Sodium Dihydrate
54.375)
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Off-white to slightly yellow, homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and lambs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of chronic and subacute fascioliasis (due to _Fasciola
hepatica_) in sheep and
lambs.
For the control of _Oestrus ovis_ (Sheep Nasal Bot Fly)_._
For the control of inhibited, immature and adult stages of _Haemonchus
contortus_ (Barber
Pole Worm) including benzimidazole resistant strains.
Flukiver is active against mature and immature flukes.
_Fluke activity:_
_Stage_
_Percentage kill_
Adults
97-100 %
6-8 weeks immature
91-95%
5 weeks immature
91%
3-4 weeks immature
23-73 %
Ticks (_Ixodes ricinus_) feeding on sheep at the time of treatment are
likely to produce fewer
viable eggs.
Revised: October 2020
AN: 00844/2020
Page 2 of 5
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR 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
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.
Resistance