Trodax 340 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitroxynil

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QP52AG08

INN (International Name):

Nitroxynil

Dosage:

340 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

nitroxinil

Authorization status:

Authorised

Authorization date:

1999-10-01

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN008YK4
Page 1 of 5
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
The product 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.
Health Products Regulatory Authority
21 March 2019
CRN008YK4
Page 2 of 5
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