SUMMARY OF PRODUCT CHARACTERISTICS

Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

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

Pour-on solution.

A clear, amber liquid.

Cattle

In cattle:

Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:

Parasite	Adult stage		Inhibited stages
NEMATODES		L4
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	●

The product has a persistent effect in preventing re-infection by Ostertagia ostertagiand by Dictyocaulus viviparusfor 5 weeks after a single dose.

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

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 implyconcurrent resistance to Moxidectin. Resistance to triclabendazole has been reported in Fasciola hepaticain cattle in some European countries. Triclabendazole resistant F. hepaticahosted 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.

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.

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.

None known.

The product is safe for use in pregnant and lactating animals.

None known.

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.

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.

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.

Pharmacotherapeutic group:antiparasitic product, endectocides

ATC vet code:QP54AB52, moxidectin combination

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 glutamate-gated 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 β-tubulin, thus causing the depolymerisation of microtubules and the subsequent disruption of microtubule-based processes in helminths.

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.

Butylhydroxytoluene (E321)

γ-Hexalactone

Cineole

Caprylocaproyl Macrogolglycerides

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

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 6 months.

Do not store above 25°C.

Protect from light.

Do not freeze.

If accidentally frozen, shake vigorously before use.

0.5, 1, 2.5 and 5 litre HDPE containers with polypropylene screw cap and polyethylene inner seal

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.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm42058/4031

Date: 05 March 2012

Date: December 2013

05 December 2013