Flukiver Bovis 50 mg/ml Solution for Injection for Cattle

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

Ingredientes activos:

Closantel

Disponible desde:

Eli Lilly and Company Limited

Código ATC:

QP52AG09

Designación común internacional (DCI):

Closantel

formulario farmacéutico:

Solution for injection

tipo de receta:

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

Grupo terapéutico:

Cattle

Área terapéutica:

Anthelmintic

Estado de Autorización:

Expired

Fecha de autorización:

2010-08-02

Ficha técnica

Revised: October 2015
AN: 01454/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Closantel
50
mg
(equivalent to closantel sodium dihydrate
54.375
mg)
EXCIPIENTS:
Propylene glycol
414.4
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow to amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of liver fluke, gastro-intestinal
nematodes and
arthropods.
TREMATODES

_Fasciola hepatica_

_Fasciola gigantica_
NEMATODES

_Haemonchus placei_

_Bunostomum phlebotomum_

_Oesophagostomum radiatum_
ARTHROPODS

_Hypoderma bovis_

_Hypoderma lineatum_
4.3
CONTRAINDICATIONS
Revised: October 2015
AN: 01454/2014
Page 2 of 6
See section 4.11.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Not for IV or IM use.
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.
The
use
of
this
product
should
be
based
on
local
(regional,
farm)
epidemiological
information
about
susceptibili