Trodax 34% w/v Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Nitroxynil

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QP52AG08

INN (International Name):

Nitroxynil

Pharmaceutical form:

Solution for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

2005-09-12

Summary of Product characteristics

Revised: November 2018
AN: 01111/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TRODAX Trodax 34% w/v Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitroxynil 34.0% w/v
As N-ethylglucamine salt.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, 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, Oesphagostomum radiatum_ and _Bunostomum _
_phlebotomum_ in cattle. However, Trodax should not be regarded or
used
as a broad spectrum anthelmintic.
4.3
CONTRA-INDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in dogs as fatalities have been reported.
Do not exceed stated dose.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not retreat at intervals less than 60 days (cattle) or 49 days
(sheep).
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 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.
To date, no resistan