Trodax 340 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitroxynil

Available from:

Merial Animal Health Limited

ATC code:

QP52AG08

INN (International Name):

Nitroxynil

Dosage:

340 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle, Sheep

Therapeutic area:

nitroxinil

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

1999-10-01

Summary of Product characteristics

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.
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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 anthelmi