Triclaben 5% Oral Suspension for Sheep

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Triclabendazole

Disponibil de la:

Chanelle Pharmaceuticals Manufacturing Limited

Codul ATC:

QP52AC

INN (nume internaţional):

Triclabendazole

Dozare:

5 percent weight/volume

Forma farmaceutică:

Oral suspension

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Sheep

Zonă Terapeutică:

Benzimidazoles and related substances

Indicații terapeutice:

Endoparasiticide

Statutul autorizaţiei:

Authorised

Data de autorizare:

2002-12-06

Caracteristicilor produsului

Health Products Regulatory Authority
09 May 2019
CRN0091RX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Triclaben 5% Oral Suspension for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Each ml contains 50mg Triclabendazole
ADJUVANT(S): N/A
EXCIPIENT(S): Each ml contains: 2.0mg Methyl Parahydroxybenzoate
(E218)
0.2mg Propyl Parahydroxybenzoate (E216)
17.5 microgram Brilliant Blue (E133).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
Description: An aqueous blue-coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Triclaben 5% is indicated for the treatment of fasciolosis in sheep
caused by early immature, immature and adult stages of
liverfluke (_Fasciola hepatica)_ susceptible to triclabendazole.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient.
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.

Under dosing, which may be due to under estimation 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 triclabendazole has been reported in _Fasciola hepatica_
in sheep. Therefore, the use of this product should be
based on local (regional / farm) epidemiological information about
susceptibility of the _Fasciola hepatica_ and
reco