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Trodax 34% Injection is a powerful flukicide for cattle and sheep. Trodax 34% Injection solution is indicated for the treatment of fascioliasis, the infestation of mature and immature fluke in cattle and sheep.
Target Species: Cattle, sheep
Treats and Controls: Mature fluke, Immature fluke
Administration Method: Subcutaneous injection (under the skin)
Withdrawal Time: 60 days for cattle intended for meat and offal, not permitted for use on cattle producing milk for human consumption, including during the dry period. 60 days for sheep intended for meat and offal, not permitted for use on sheep producing milk for human consumption.
Dosage for cattle: 1.5 ml per 50 kg of bodyweight
|Body Weight||Dose Volume||Number of full doses per pack:|
Dosage for sheep:0.75 ml per 25 kg of bodyweight
|Body Weight||Dose Volume||Number of full doses per pack:|
|over 75kg||2.5 ml||100||200||400|
Always read the label and all enclosed information for Trodax 34% Injection before administering to animals!
How Livestock Contract Liver Fluke
Animals are infected by ingesting encapsulated larvae (metacercariae) on contaminated grass. Typically,individual farms will have wet “flukey areas” that should not be used or grazed at times of the year whenmetacercariae are likely to be present, i.e. late summer to winter (depending on climatic conditions). However,cattle and sheep often graze on such areas. Therefore, it cannot be assumed that liver fluke infection is absentfrom any area of Ireland.
This product is only licensed for sale within the Republic of Ireland
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Trodax 340 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitroxynil 340 mg/ml
as N-ethylglucamine salt.
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.
Do not use in animals with known hypersensitivity to the active ingredient.
Do not exceed the stated dose.
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 be used.
4.5 Special precautions for use
Special precautions for use in animals
Ensure the injection does not enter subcutaneous muscle.
Ewes in advanced pregnancy and not intended to produce milk for human consumption should be driven, handled and
Estimate the weight of the sheep carefully and use injection equipment calibrated to accurately deliver the calculated
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Trodax solution stains and care should be taken not to spill it, especially on the fleece of sheep.
Wash splashes from skin and eyes immediately.
Wear suitable gloves to avoid staining the skin.
4.6 Adverse reactions (frequency and seriousness)
Small swellings are occasionally observed at the injection site in cattle. These can be avoided by injecting the dose in
two separate sites and massaging well to disperse the solution.
No systemic ill effects are to be expected when animals (including pregnant cows and ewes) are treated at normal
4.7 Use during pregnancy, lactation or lay
The product is safe for use during pregnancy. However, the product is not permitted for use in animals producing milk
for human consumption, including pregnant animals intended to produce milk for human consumption.
4.8 Interaction with other medicinal products and other forms of interaction
No signs of incompatibility are to be expected if Trodax is administered to cattle or sheep concurrently with therapeutic
doses of the following anthelmintics: levamisole and thiabendazole, or with clostridial vaccine.
4.9 Amounts to be administered and administration route
Administer by subcutaneous injection.
The standard dosage is 10mg nitroxynl per kilogram bodyweight.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight
and dosed accordingly, in order to avoid under- or overdosing.
Sheep: Administer according to the following doses scale:
14-20 kg 0.5ml
31-40kg 1.0 ml
41-55kg 1.5 ml
56-75kg 2.0 ml
over 75kg 2.5 ml
In outbreaks of fascioliasis each sheep in the flock should be injected immediately the presence of the disease is
recognised, repeating treatment as necessary throughout the period when infestation is occurring, at intervals of not less
than one month. On farms with fluke-infested pastures, routine preventative dosing should be carried out at intervals of
not less than one month, having regard for such factors as the past disease history of the farm, the frequency and
severity of neighbouring outbreaks and regional forecasts of incidence.
Cattle: 1.5ml of Trodax 34% per 50 kg (1cwt) liveweight
Both infected and in-contact animals should be treated, treatment being repeated as considered necessary, though not
more frequently than once per month. The treatment of cattle helps to reduce contamination of pastures on farms
where fascioliasis is endemic or certain roundworm occurrence is evident.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the event of accidental overdosage, the symptoms are pyrexia, rapid respiration and increased excitability. Patients
should be kept cool, and dextrose saline should be administered intravenously.
Sheep and cattle may be slaughtered for human consumption only after 60 days from the last treatment.
Not permitted for use in animals producing milk for human consumption, including pregnant animals intended to
produce milk for human consumption.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Phamacotherapeutic group: Anthelmintics, nitroxinil.
ATCvet code: QP52AG08
5.1 Pharmacodynamic properties
The main pharmacological action of nitroxynil is fasciolicidal. The lethal action against Fasciola hepatica has been
demonstrated in vitro and in vivo in laboratory animals, and in sheep and cattle. The mechanism of action is thought to
be due to uncoupling of oxidative phosphorylation.
Few other pharmacodynamic effects have been observed at therapeutic doses. Hyperpnoea and increased rectal
temperature are seen at high doses, and near toxic doses cause an increase in blood pressure.
5.2 Pharmacokinetic properties
The pharmacokinetics of nitroxynil in sheep and cattle are very similar. After subcutaneous injection of a single dose
of 10mg/kg peak plasma levels of 83.6ug/ml are achieved at 9.3 hours in sheep, and peak plasma levels of 91.6ug/ml
are achieved at 13 hours in cattle. The plasma half lives are 5 days and 8 days in sheep and cattle respectively. This
slow rate of elimination is in accordance with the observed long duration of action of Trodax against fluke in sheep and
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
Do not mix with any other veterinary medicinal product
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Do not store above 250C. Protect from light.
6.5 Nature and composition of immediate packaging
100 ml DIN bottles with chlorobutyl rubber stopper.
250 ml, 500ml and 1 litre containers of natural polypropylene with chlorobutyl rubber stopper.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused product or waste material should be disposed of in accordance with national requirements.
7 MARKETING AUTHORISATION HOLDER
Merial Animal Health Limited
Harlow Business Park
Essex, CM19 5TG
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009
10 DATE OF REVISION OF THE TEXT
29th April 2010
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