TRODAX 340 MG/ML SOLUTION FOR INJECTION

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

NITROXINIL

Commercializzato da:

Merial Animal Health Limited

Codice ATC:

QP52AG08

INN (Nome Internazionale):

NITROXINIL

Dosaggio:

340 Mg/Ml

Forma farmaceutica:

Solution for Injection

Tipo di ricetta:

LM-Licensed Merchant

Gruppo terapeutico:

Bovine, Ovine

Area terapeutica:

Nitroxinil

Indicazioni terapeutiche:

Endoparasiticide

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

1999-10-01

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Trodax 340 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Nitroxynil
340 mg/ml
as N-ethylglucamine salt.
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Bright orange-red solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Trodax 34% is indicated for the treatment of fascioliasis (infestation of mature and immature Fasciola hepatica) in cattle
and sheep. It is also effective, at the recommended dose rate, against adult and larval infestations of Haemonchus contortus
in cattle and sheep and Haemonchus placei, Oesophagostomum radiatum and Bunostomum phlebotomum in cattle.
However, Trodax should not be regarded or used as a broad spectrum anthelmintic.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient.
Do not exceed the stated dose.
Do not use in dogs as fatalities have been reported.
IRISH MEDICINES BOARD
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_Date Printed 10/07/2013_
_CRN 7014909_
_page number: 1_
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�