Click here to Download Data Sheet Health Products Regulatory Authority Summary of Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cydectin 0.1% w/v oral drench for sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance Moxidectin Solid 1.00 mg Excipients Benzyl Alcohol 40.00 mg Butylated Hydroxy Toluene 2.50 mg Disodium Edetate 0.27 mg 3 PHARMACEUTICAL FORM Oral solution 4 CLINICAL PARTICULARS 4.1 Target Species Sheep Each ml contains Active substance Moxidectin Solid 1.00 mg Excipients Benzyl Alcohol 40.00 mg Butylated Hydroxy Toluene 2.50 mg Disodium Edetate 0.27 mg 4.2 Indications for use, specifying the target species Infections of sheep with parasites sensitive to moxidectin. For the treatment and prevention of infections caused by: Adult and immature gastro-intestinal nematodes: - Haemonchus contortus (including inhibited larvae) - Ostertagia circumcincta (including inhibited larvae) - Ostertagia trifurcata - Trichostrongylus axei (including inhibited larvae) - Trichostrongylus colubriformis - Trichostrongylus vitrinus - Nematodirus battus - Nematodirus spathiger - Nematodirus filicolis (adults only) - Strongyloides papillosus (larval stages only) - Cooperia curticei (adults only) - Cooperia oncoaphora - Oesophagostomum columbianum - Oesophagostomum venulosym (adults only) - Chabertia ovina - Trichuris ovis (adults only) Adult respiratory tract nematode: - Dictyocaulus filaria The product has a persistent effect in preventing reinfection: • for 5 weeks by Ostertagia circumcincta and Haemonchus contortus • for 4 weeks by Oesophagostomum columbianum Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of: • Haemonchus contortus • Ostertagia circumcincta • Trichostrongylus colubriformi Cooperia curticei 4.3 Contraindications None 4.4 Special warnings for each target species None 4.5 Special precautions for use None known 4.6 Adverse reactions (frequency and seriousness) None known 4.7 Use during pregnancy, lactation or lay Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals. 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 live bodyweight, equivalent to 200 μg moxidectin/kg live bodyweight, using any standard drenching equipment. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Symptoms generally do not occur at less than 5 times the recommended dose. They are manifested as transient salivation, depression, drowsiness and ataxia 8 to 12 hours post-treatment. Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours. There is no specific antidote. 4.11Withdrawal Period(s) Meat and offal: 14 days. Milk: 5 days 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Endectocides (milbemycins) ATC Vet code: QP 54 AB 02 5.1 Pharmacodynamic properties Moxidectin is a parasiticide active against a wide range of economically important 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. 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. 5.2 Pharmacokinetic properties 22% of an oral dose of moxidectin is absorbed with maximum blood concentrations being achieved 9 hours post treatment. The drug is distributed throughout the body tissues but due to its lipophilicity the target tissue is fat where concentrations are 10 to 20 times higher than those found in other tissues. The depletion half life in fat is 23-28 days. Moxidectin undergoes limited biotransformation by hydroxylation. The only significant route of excretion is the faeces. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Benzyl Alcohol Butylated Hydroxytoluene Disodium Edetate Polysorbate 80 Propylene Glycol Dibasic Sodium Phosphate Dodecahydrate Monobasic Sodium Phosphate Dihydrate Purified Water 6.2 Incompatibilities Not to be mixed with other Veterinary Medicinal Products before administration. 6.3 Shelf-life 24 months Once opened use the product within 6 months. 6.4 Special precautions for storage Protect from light. Do not store above 25°C 6.5 Nature and composition of immediate packaging Polyethylene containers of 1 litre, 2.5 litre and 5 litre content. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials DANGEROUS to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or used containers. Any unused product or waste material should be disposed of in accordance with national requirements. 7 MARKETING AUTHORISATION HOLDER Fort Dodge Animal Health Limited, Flanders Road, Hedge End, Southampton, SO30 4QH, United Kingdom. 8 MARKETING AUTHORISATION NUMBER(S) VPA 10861/044/001 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 11th October 2005 10 DATE OF REVISION OF THE TEXT 12th February 2009
