Fasinex 5% w/v Oral Suspension

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Triclabendazole

Disponível em:

Elanco Europe Ltd

Código ATC:

QP52AC

DCI (Denominação Comum Internacional):

Triclabendazole

Dosagem:

5 percent weight/volume

Forma farmacêutica:

Oral suspension

Tipo de prescrição:

LM: Licensed Merchant as defined in relevant national legislation

Grupo terapêutico:

Sheep

Área terapêutica:

Benzimidazoles and related substances

Indicações terapêuticas:

Endoparasiticide

Status de autorização:

Authorised

Data de autorização:

2016-10-21

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
White to cream-coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Ovines.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult, immature and early immature
stages of liver fluke susceptible to triclabendazole.
Target Species:_ Fasciola hepatica_.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance.
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.
Each ml contains:
ACTIVE SUBSTANCE
Triclabendazole
50
mg
EXCIPIENTS
Methyl Parahydroxybenzoate (E218) 1.1
mg
Propyl Parahydroxybenzoate (E216)
0.24 mg
Benzoic Acid (E210)
1.0
mg
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__