SUMMARY OF PRODUCT CHARACTERISTICS

Cydectin TriclaMox 1mg/ml + 50 mg/ml Oral Solution for sheep

Austria, Germany : Cydectin TriclaMox 1mg/ml + 50 mg/ml orale Lösung für Schafe

Belgium : Cydectin TriclaMox 1mg/ml + 50 mg/ml Orale Oplossing voor schapen, : Cydectin TriclaMox 1mg/ml + 50 mg/ml solution orale pour ovins, Cydectin TriclaMox 1mg/ml + 50 mg/ml orale Lösung für Schafe

Denmark: Cydectin TriclaMox 1 mg/ml + 50 mg/ml Oral opløsning til får

France, Luxembourg : Cydectine TriclaMox 1mg/ml + 50 mg/ml solution orale pour ovins

Greece : Cydectin TriclaMox 1mg/ml + 50 mg/ml Πόσιμοδιάλυμαγιαπρόβατα

Iceland: Cydectin TriclaMox 1mg/ml + 50 mg/ml Mixtúra, lausn handa sauðfé

Italy : Cydectin TriclaMox 1mg/ml + 50 mg/ml Soluzione Orale per Pecore

Ireland, UK: Cydectin TriclaMox 1mg/ml + 50 mg/ml Oral Solution for sheep

The Netherlands: Cydectin TriclaMox 1mg/ml + 50 mg/ml Orale Oplossing voor schapen

Portugal: Cydectin TriclaMox 1mg/ml + 50 mg/ml Solução Oral para Ovinos

Spain: Cydectin TriclaMox 1 mg/ml + 50 mg/ml Solución Oral para Ovino

Sweden: Cydectin TriclaMox 1 mg/ml + 50 mg/ml, Oral lösning till får

Each ml contains:

Active substances
Moxidectin Triclabendazole	1.0 mg 50.0 mg
Excipients Benzyl alcohol (E1519) Butylhydroxytoluene (E321) For the full list of excipients, see section 6.1	40.0 mg 1.0 mg

Oral solution

A clear yellow to brown liquid

Sheep

For the treatment of mixed nematode and fluke infections caused by moxidectin and triclabendazole sensitive strains of:

Parasite Adult stage L4 Inhibited stages NEMATODES Gastro-intestinal nematodes: Haemonchus contortus ● ● ● Teladorsagia circumcincta ● ● ● Ostertagia trifurcata ● ● Trichostrongylus axei ● ● ● Trichostrongylus colubriformis ● ● Trichostrongylus vitrinus ● ● Nematodirus battus ● ● Nematodirus spathiger ● ● Nematodirus filicolis ● Strongyloides papillosus ● Cooperia curticei ● Cooperia oncophora ● ● Oesophagostomum columbianum ● ● Oesophagostomum venulosum ● Chabertia ovina ● ● Trichuris ovis ● Respiratory tract nematode: Dictyocaulus filaria ● TREMATODES Liver fluke: Adult stage Early Immature stages Late Immature stages Fasciola hepatica ● ● ●

The product has a persistent efficacy and protects sheep against infection or re-infection with the following parasites for the period indicated:

Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of:
.Haemonchus contortus
.Teladorsagiacircumcincta
.Trichostrongylus colubriformis
.Cooperia curticei

Do not use in cases of 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.

Resistance to macrocyclic lactones has been reported inTeladorsagiain sheep in a number of countries. In 2008, throughout Europe, moxidectin resistance is very rare; it has been reported in a single case involving a levamisole-, benzimidazole and ivermectin-resistant strain ofTeladorsagia circumcincta. Resistance to triclabendazole has been reported in Fasciola hepaticain sheep in some European countries. 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 use the product under sustainable conditions to limit further selection for resistance to antiparasitic compounds. These precautions are especially important when moxidectin is being used to control resistant strains.

i. Special precautions for use in animals

This product should not be used for the treatment of single infections.

All animals in a group should be treated.

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

Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat when using this product.
Wear impermeable rubber gloves during use.

None known.

This product is safe for use in breeding animals. See also Section 4.11.

None known.

Should be given as a single oral drench of 1 ml/5 kg bodyweight, equivalent to 0.2 mg moxidectin/kg bodyweight and 10 mg triclabendazole/kg bodyweight, using any standard drenching equipment.

To ensure a correct dosage, body weight 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 body weight and dosed accordingly, in order to avoid under- or overdosing.

Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they should be consistent with the mode of action of moxidectin and/or triclabendazole and would be manifested as transient salivation, depression, drowsiness, ataxia and reduced food intake 8 to 12 hours post-treatment. Treatment is not generally necessary and recovery is generally complete within 1 to 5 days. There is no specific antidote.

Meat and offal: 31 days

Milk:not authorized for use in ewes producing milk intended for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.

Pharmacotherapeutic group:antiparasitic product, endectocide

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 in the final formulation were the following: AUC_tot58 ng.day.mL^-1, C_max12 ng.mL^-1, T max : 6 hours and plasma half-life 3.5 days.

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. The main pharmacokinetic parameters of the active metabolite triclabendazole sulfoxide when triclabendazone was administered in the final combined formulation were: AUC_tot608 µg.h.mL^-1, C_max10 µg.mL^-1, T_max21 h and plasma half-life 20 h.

Benzyl alcohol (E1519)
Butylhydroxytoluene (E321)

Polysorbate 80
Sorbitan oleate

Propylene glycol, dicaprylocaprate

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.

1 litre, 2.5 litre and 5 litre polyethylene containers with polypropylene screw-cap.

Not all pack sizes may be marketed

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 3A

Vm42058/4030

Date:18 December 2009

Date:December 2014

Approved: 10/12/2014