Fasinex 5% w/v Oral Suspension

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Triclabendazole

Предлага се от:

Elanco GmbH

АТС код:

QP52AC

INN (Международно Name):

Triclabendazole

дозиране:

5 percent weight/volume

Лекарствена форма:

Oral suspension

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Sheep

Терапевтична област:

Benzimidazoles and related substances

Терапевтични показания:

Endoparasiticide

Статус Оторизация:

Authorised

Дата Оторизация:

2016-10-21

Данни за продукта

Health Products Regulatory Authority
01 June 2018
CRN000YK1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasinex 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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:
Health Products Regulatory Authority
01 June 2018
CRN000YK1
Page 2 of 6
- 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 PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only use for liver fluke strains susceptible to Triclabendazole. Clean
drenching
equipment before and after use. Where a dosing gun is used to
administer the
product, care must be taken to avoid the occurrence