Cydectin TriclaMox Drench for Sheep 1mg

Click here to Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cydectin TriclaMox 1mg/ml 50 mg/ml Oral Solution for sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substances Moxidectin 1.0 mg Triclabendazole 50.0 mg Excipients Benzyl Alcohol 40.0 mg Butylhyroxytoluene 1.0 mg For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Oral solution A clear yellow to brown liquid 4 CLINICAL PARTICULARS 4.1 Target Species Sheep Each ml contains: Active substances Moxidectin 1.0 mg Triclabendazole 50.0 mg Excipients Benzyl Alcohol 40.0 mg Butylhyroxytoluene 1.0 mg For a full list of excipients see section 6.1 4.2 Indications for use, specifying the target species For the treatment of mixed nematode and fluke infections in sheep, 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: Species                                     Protection period (days) Teladorsagia circumcincta                       35 Haemonchus contortus                           35 Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of: .Haemonchus contortus .Teladorsagia circumcincta .Trichostrongylus colubriformis .Cooperia curticei 4.3 Contraindications Do not use in cases of hypersensitivity to the active substance(s) or to any of the excipient(s). 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 effective therapy:
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
Underdosing, which may be due to an 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 in Teladorsagia in 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 of Teladorsagia circumcinta. Resistance to trilabendazole has been reported in Fasciola hepatica in 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. 4.5 Special precautions for use Special precautions for use in animals This product should not be used for the treatment of single infections. 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. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay This product is safe for use in breeding animals. See also Section 4.11. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route 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. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they shouldmbe 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. 4.11 Withdrawal Period(s) Meat and offal: 31 days Milk: not authorised 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. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: antiparasitic product, endectocide ATC vet code : QP 54 AB 52, 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 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 -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 in the final formulation were the following: AUCtot 58 ng.day.mL-1, Cmax 12 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: UCtot 608 μg.h.mL-1, Cmax 10 μg.mL-1, Tmax 21 h and plasma half-life 20 h. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Benzyl alcohol Polysorbate 80 Sorbitan oleate Propylene glycol, dicaprylocaprate Butylhydroxytoluene 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:24 months. 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. 6.5 Nature and composition of immediate packaging 1 litre, 2.5 litre and 5 litre polyethylene containers with polypropylene screw-cap. Not all pack sizes may be marketed. 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: 10438/018/001 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 18th December 2009 10 DATE OF REVISION OF THE TEXT January 2014