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Trodax 34% Injection
Trodax 34% Injection
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Trodax 34% Injection


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Delivery Time: 2-4 Days

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.

Active Ingredient:Ntroxynil

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 WeightDose VolumeNumber of full doses per pack:
250ml500ml1 Litre
50kg1.5 ml166333666
100kg3 ml83166333
150kg4.5 ml55111222
200kg6 ml4183166
250kg7.5 ml3366133
300kg9 ml2755111
350kg10.5 ml234795
400kg12 ml204183
450kg13.5 ml183774
500kg15 ml163366
550kg16.5 ml15360
600kg18 ml132755

 

Dosage for sheep:0.75 ml per 25 kg of bodyweight 

Body WeightDose VolumeNumber of full doses per pack:
250ml500ml1 Litre
14-20kg0.5 ml50010002000
21-30kg0.75 ml3336661333
31-40kg1 ml2505001000
41-55kg1.5 ml166333666
56-75kg2 ml125250500
over 75kg2.5 ml100200400

 

Always read the label and all enclosed information for Turodax 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.

 

 

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.

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

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:
Liveweight Dose
14-20 kg 0.5ml
21-30kg 0.75ml
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.

4.11Withdrawal Period(s)
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
cattle.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Eglumine
Water for Injections

6.2 Incompatibilities
Do not mix with any other veterinary medicinal product

6.3 Shelf-life
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
Sandringham House
Harlow Business Park
Harlow
Essex, CM19 5TG
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10857/039/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009
10 DATE OF REVISION OF THE TEXT
29th April 2010

At Agridirect we have joined forces with Fastway & DPD, to ensure your products are delivered to your door within 2-4 working days from time of order.

Our delivery charges are as follows:

Ireland

€4.99 for all orders UNDER €70

There is FREE delivery on all orders OVER €70 ( some exceptions apply on bulky products)

U.K. and France

€14.99 for all orders UNDER €70

€9.99 for all orders OVER €70

Delivery is from Monday to Friday ONLY

There may be an additional charge on certain bulky items. This charge will be detailed on any applicable product and will be explained before the checkout stage.

Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.
 

All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.
 

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.
 

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods, while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover loss of value of goods.
 

We accept no responsibility for goods damaged or lost while in transit to us. 
 

The cost of the return, including all packaging and freight, lies solely with the consumer.
 

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

 

Packaging

All returns must be the complete product which includes boxes, manuals and accessories that may have been include with the order.

All returns must be packaged appropriately for shipping, we will not accept responsibility for damages or loss which occur during shipping of a return product.
 

Address: Please ship the product to the following address: Agridirect, Drumrahan Retail, Church Street, Ballyconnell, Co Cavan
 

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.

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