Cydectin Triclamox Pour-on is a broad spectrum flukicide and wormer for cattle. It is used for the treatment and control of gastro-intestinal worms, lungworms,  liver fluke and roundworms in beef cattle.

Active Ingredient: Moxidectin, Triclabendazole

Target Species: Cattle

Treats and Controls: Gastro-intestinal worms, lungworms,  liver fluke and roundworms

Administration Method: Pour On

Withdrawal Time: 143 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.

Dosage: 1 ml per 10 kg of bodyweight

Always read the label and all enclosed information for Cydectin Triclamoc Pour-On before administering to animals!

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for cattle.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:
Active substances
Moxidectin 5.0 mg
Triclabendazole 200.0 mg
Excipients
Butylhydroxytoluene (E321) 5.0 mg
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Pour-on solution.
A clear, amber liquid.

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle.

4.2 Indications for use, specifying the target species
In cattle:
Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by
moxidectin and triclabendazole sensitive strains:
The product has a persistent effect in preventing re-infection by Ostertagia ostertagi and by Dictyocaulus viviparus for
5 weeks after a single dose.

4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substance(s) or to any of the excipient(s).

Parasite                                               Adult stage            L4              Inhibited stages
NEMATODES 
Gastro-intestinal nematodes:                                                                                        
Haemonchus placei                                      
                   

Ostertagia ostertagi                                     
                   
                 

Trichostrongylus axei                                   
                    

Nematodirus helvetianus                             
                   

Cooperia oncophora                                     
                   

Cooperia punctata                                       

Oesophagostomum radiatum                       

Bunostomum phlebotomum                         


Respiratory tract nematode:                                                                                       
Dictyocaulus viviparus                                 


TREMATODES                                                                                                              
Liver fluke:                                                              6 - 8 weeks
                                                                                  immatures
Fasciola hepatica                                       
                   


ECTOPARASITES                                                                                                       
Linognathus vituli                                       

Bovicola bovis                                             

Solenopotes capillatus                               

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 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.
In 2010, no confirmed resistance to moxidectin in cattle parasites has been reported in Europe, however, resistance to other macrocyclic lactones (MLs) has been reported mainly in Cooperia oncophora in some European countries, and resistance to moxidectin has been reported in the Southern Hemisphere.
Resistance to other MLs in some strains of Cooperia spp. can imply concurrent resistance to Moxidectin.
Resistance to triclabendazole has been reported in Fasciola hepatica in cattle in some European countries. Triclabendazole resistant F. hepatica hosted in sheep can be transferred to cattle grazing the same pasture.

Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to limit further selection for resistance to anthelmintics.
This product should not be used for the treatment of single infections.
It has been shown that rainfall immediately before or within 2 hours after treatment will not affect the efficacy of the
product.

4.5 Special precautions for use

i. Special precautions for use in animals
This product has been formulated specifically for pour-on administration for cattle and must not be given by any other
route of administration or to any other species.
All animals in a group should be treated.

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wear gloves, protective work clothing and safety glasses when using the product
Do not smoke, drink or eat while handling the product.
Avoid direct contact with skin and eyes
Wash hands after use
If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.
People with known hypersensitivity to the active substance should not handle the product. If irritation persists, seek
medical advice and show the label to the doctor.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
The product is safe for use in pregnant and lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction
None known.

4.9 Amounts to be administered and administration route
For external use only.
0.5 mg moxidectin/kg body weight and 20 mg triclabendazole/kg body weight (equivalent to 1 ml of solution for 10 kg)
and as a single topical application.
To be administered directly to the hair and skin along the midline of the back of the animal from the withers to the tail
head.
Apply to clean healthy skin.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
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.
Shake before use.

Directions for using the Squeeze-Pour System (500 ml and 1 litre bottles only) :
Step 1: Remove screw cap from dispensing chamber only. Remove foil seal.
Step 2: Gently squeeze the bottle to fill the measuring chamber with the required amount of liquid.
Step 3: Pour the measured volume of fluid from the chamber onto the animal as directed.
Repeat steps 2 and 3 for subsequent animals
Step 4: Reapply the screw cap to the dispensing chamber after use.

Directions for using a pour-on applicator (2.5 and 5 litre backpack):
Connect the pour-on applicator to the backpack as follows:
Attach the open end of the draw-off tubing to the cap with the stem.
Replace shipping cap with the cap that has the draw-off tubing. Tighten the draw-off cap.
Gently prime the pour-on applicator, checking for leaks.
Follow manufacturer’s directions for correct use and care of equipment.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Signs of overdoses have not been seen at 5 times the recommended dose.
However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia.
Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours.
There is no specific antidote.

4.11 Withdrawal Period(s)
Meat and offal: 143 days
Milk: Do not use in cattle of any age intended to produce milk for human consumption.
Due to the significant likelihood of cross-contamination of non-treated animals with this product due to grooming
(licking), treated animals should be housed separately from non-treated animals throughout the withdrawal period.
Non-compliance with this recommendation may lead to residues violations in non-treated animals.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
antiparasitic product, endectocides

ATC vet code:
QP54AB52, moxidectin combination

5.1 Pharmacodynamic properties
Moxidectin is an endectocide active against a wide range of internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family.
Its principal mode of action is interfering with neuromuscular transmission of the GABA (gamma amino butyric acid)-gated or glutamate-gated chloride channels.
Moxidectin stimulates the release of GABA and increases its binding to the postsynaptic receptors, and binds to the glutamategated chloride channels.
The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This results in flaccid paralysis and eventual death of parasites exposed to the drug.
Triclabendazole is a flukicide belonging to the benzimidazole group of anthelmintics.
It is well established that benzimidazole anthelmintics selectively bind to -tubulin, thus causing the depolymerisation of microtubules and the subsequent disruption of microtubule-based processes in helminths.

5.2 Pharmacokinetic properties
Moxidectin is distributed throughout the body tissues but due to its lipophilicity the highest drug concentrations are
obtained in fat tissue.
Moxidectin undergoes biotransformation by hydroxylation.
The only significant route of excretion is the faeces.
The main pharmacokinetic parameters of moxidectin when administered as pour-on in the final combined formulation of this product were the following: AUClast 50.9 ng.d.mL-1, Cmax 4.69 ng.mL-1, Tmax 8.7 d, MRT 10.74 d .

The majority of the oral dose of triclabendazole in rats, sheep, goats and rabbits is eliminated in faeces after 6-10 days, as unchanged drug or products of biliary excretion.
Urinary excretion is minimal. Sulphone, sulphoxide, ketone and 4- hydroxy triclabendazole derivatives are the main metabolites identified in plasma.
Plasma kinetic studies of sulfoxide and sulfone derivatives in various species after oral administration showed the sulfoxide to predominate in rabbits, sheep and humans, and the sulfone in the horse, dog and cattle.
The main pharmacokinetic parameters of triclabendazole sulfoxide when administered in the final combined formulation of this product were: AUClast 26.9 μg.h.mL-1, Cmax 2.92 μg.mL-1, Tmax 3.3 d, MRT 9.72 d.
The main pharmacokinetic parameters of triclabendazole sulfone when administered in the final combined formulation were: AUClast 110.2 μg.h.mL-1, Cmax 7.78 μg. mL-1, Tmax 12.9 d, MRT 12.98 d.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Butylhydroxytoluene (E321)
-Hexalactone
Cineole
Caprylocaproyl Macrogolglycerides

6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary
medicinal products.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage
Do not store above 25°C.
Protect from light.
Do not freeze.
If accidentally frozen, shake vigorously before use.

6.5 Nature and composition of immediate packaging
0.5, 1, 2.5 and 5 litre HDPE containers with polypropylene screw cap and polyethylene inner seal.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER
Zoetis Ireland Limited
25/28 North Wall Quay
Dublin 1
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10438/019/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
5th April 2012

10 DATE OF REVISION OF THE TEXT
January 2014

Cattle Pour-ons

These should be applied along the length of the flattest part of the animal’s back, from the withers to the tail head.
In general, animals should not be treated when the hair is wet or if rain is anticipated within two hours of treatment. However, some products are waterproof and can be used on wet animals.
Areas of damaged skin should be avoided, as should areas contaminated with mud or manure

Pharmacodynamics

Triclabendazole and its metabolites are active against both the immature and mature worms of Fasciola hepatica and Fasciola gigantica helminths.

Mechanism of action

Triclabendazole is an anthelmintic agent against Fasciola species.
The mechanism of action against Fasciola species is not fully understood at this time.
In vitro studies and animal studies suggest that triclabendazole and its active metabolites (sulfoxide and sulfone) are absorbed by the outer body covering of the immature and mature worms, causing a reduction in the resting membrane potential, the inhibition of tubulin function as well as protein and enzyme synthesis necessary for survival. These metabolic disturbances lead to an inhibition of motility, disruption of the worm outer surface, in addition to the inhibition of spermatogenesis and egg/embryonic cells.

A note on resistance
In vitro studies, in vivo studies, as well as case reports suggest a possibility for the development of resistance to triclabendazole.
The mechanism of resistance may be multifactorial and include changes in drug uptake/efflux mechanisms, target molecules, and changes in drug metabolism.

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect 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.

All returns should be complete which includes boxes, manuals and accessories that may have been included 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.

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

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.

2) To print off your return label click here or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point here.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

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.

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.