Flukiver 5% w/v Oral Suspension

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Closantel

متاح من:

Eli Lilly and Company Limited

ATC رمز:

QP52AG09

INN (الاسم الدولي):

Closantel

الشكل الصيدلاني:

Oral suspension

نوع الوصفة الطبية :

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

المجموعة العلاجية:

Sheep

المجال العلاجي:

Anthelmintic flukicide

الوضع إذن:

Authorized

تاريخ الترخيص:

1986-12-01

خصائص المنتج

Revised: February 2013
AN: 01421/2012
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.
4.3
CONTRAINDICATIONS
None
Page 1 of 5
Revised: February 2013
AN: 01421/2012
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 to closan