NOAH Compendium

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Date: Sunday, October 21, 2018 16:52

Release 2.15
Trodax 34% w/v Solution for Injection
 
Species: Sheep, Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Flukicides
Active ingredient: Nitroxynil
Product:Trodax 34% Solution for Injection
Product index: Trodax
Cattle - milk: See note
Cattle - meat: 60 days
Sheep - meat: 49 days
Withdrawal notes: Not authorised for use in cattle and sheep producing milk for human consumption including the dry period. Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption
Qualitative and quantitative composition
Active substance: Nitroxynil 34.0% w/v (as N-ethylglucamine salt).
For the full list of excipients, see below.
Pharmaceutical form
Solution for injection. Clear, orange-red solution.
Clinical particulars
Target species
Sheep and cattle.
Indications for use
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.
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.
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 bodyweight, 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 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.
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.
Special precautions to be taken by the person administering the product to 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.
Adverse reactions
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.
Use during pregnancy, lactation or lay
This product is safe for use in pregnant animals.
Interactions
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.
Amounts to be administered and administration route
Administer by subcutaneous injection. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. The standard dosage is 10 mg nitroxynil/kg bodyweight.
Sheep: Administer according to the following doses scale:
Liveweight (kg)
Dose (ml)
14 - 20
0.5
21 - 30
0.75
31 - 40
1.0
41 - 55
1.5
56 - 75
2.0
Over 75
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 50 kg (1 cwt) 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.
Overdose
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.
Withdrawal periods
Cattle may be slaughtered for human consumption only after 60 days from the last treatment. Sheep may be slaughtered for human consumption only after 49 days from the last treatment.
Not authorised for use in cattle and sheep producing milk for human consumption including the dry period. Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Pharmaceutical particulars
Excipients
Water for injections
Major incompatibilities
Do not dilute or mix with other compounds.
Shelf life
Shelf life of the product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25 °C, protect from light. Once the container has been broached, the contents should be used within 28 days. This product does not contain a preservative. Avoid the introduction of contamination. Should any apparent growth or discoloration occur, the product should be discarded.
Immediate packaging
Multi-dose containers of 250 ml and 2 x 500 ml.
Disposal
Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4187
Significant changes
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Trodax 34% w/v Solution for Injection 250 ml
GTIN:03661103020622
GTIN description:Trodax 34% w/v Solution for Injection 2x 500 ml
GTIN:03661103020639