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:

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 resistance to nitroxynil has been reported. The use of the product should be based on local (regional, farm) epidemiological information about susceptibility of trematodes and nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

4.5

Special precautions for use

(i) 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 handled and dosed carefully.

Estimate the weight of the sheep carefully and use injection equipment calibrated to accurately deliver the calculated dosage.

Trodax solution stains and care should be taken not to spill it, especially on the fleece of sheep.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to the animals

Wear impermeable gloves to avoid staining the skin. Wash splashes from skin and eyes immediately. Obtain medical help if irritation persists.

In case of accidental or deliberate ingestion, wash out the mouth with water and obtain medical help.

Care must be taken to avoid accidental self-injection. Seek medical assistance in case of accidental injection.

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 dosage.

4.7

Use during pregnancy, lactation or lay

This product is safe for use in pregnant animals.

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 levamisole or with clostridial vaccine.

4.9

Amounts to be administered and administration route

Administer by subcutaneous injection.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

The standard dosage is 10mg nitroxynil per kilogram bodyweight.

Sheep: Administer according to the following doses scale:

Liveweight (kg)	Dose (ml)
14-20kg	0.5
21-30kg	0.75
31-40kg	1.0
41-55kg	1.5
56-75kg	2.0
Over 75kg	2.5

On farms with fluke-infested pastures, routine dosing should be carried out at intervals of not less than 49 days (7 weeks), 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.

In outbreaks of acute fascioliasis advice on the best treatment should be sought from a veterinary surgeon.

Cattle: 1.5ml of Trodax 34% per 50kg (1cwt) liveweight.

Both infected and in-contact animals should be treated, treatment being repeated as considered necessary, though not more frequently than once per 60 days. 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.