Click here to Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Arrest Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension. 4 CLINICAL PARTICULARS 4.1 Target Species Sheep. 4.2 Indications for use, specifying the target species For the treatment of roundworm, lungworm and tapeworm infections of sheep caused by: Gastrointestinal Roundworms: Bunostomum, Chabertia, Cooperia, Haemonchus, Nematodirus, Oesophagostomum, Ostertagia, Trichostrongylus Lungworms: Dictyocaulus Tapeworm: Moniezia spp The product is active against mature and immature parasite stages sensitive to fenbendazole or levamisole. Fenbendazole is ovicidal and will kill worm eggs. 4.3 Contraindications Do not use in animals that are severely stressed or in ill-health. 4.4 Special warnings for each target species Do not administer to sheep under stress or in poor condition. Active Substance Levamisole Hydrochloride 3.75 % w/v Fenbendazole 2.50 % w/v Excipients Formaldehyde Solution 0.20 % w/v Potassium Sorbate 0.18 % w/v 4.5 Special precautions for use Assess bodyweight as accurately as possible before calculating dosage recommended. Do not exceed dose rates. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce the risk, dosing programmes should be discussed with your veterinary surgeon. Care must be taken to avoid injury to the throat when drenching animals. Special Precautions to be taken by the Person Administering the Product to Animals Direct contact with skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves. Wash hands after use. Levamisole can cause idiosyncratic reactions and serious blood disorders in a very small number of people. If symptoms such as dizziness, nausea, vomiting or abdominal discomfort are experienced when using the product, or sore mouth and fever occur shortly afterwards, seek medical advice immediately and show the package insert or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay Do not use in sheep producing milk for human consumption. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route Shake well before use. Using suitably calibrated drenching equipment, administer orally. Sheep: 1 ml per 5 kg bodyweight given orally delivers a dose of 7.5 mg/kg levamisole hydrochloride and 5 mg/kg fenbendazole. For example: Bodyweight Dose Up to 10 kg 2 ml 10-15 kg 3 ml 16-20 kg 4 ml 21-25 kg 5 ml 26-30 kg 6 ml Above 30 kg give 1 ml per each 5 kg bodyweight 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Symptoms of levamisole overdosing are similar to those of poisoning by organophosphorus compounds: salivation, constriction of the pupils and respiratory distress. Anaphylactic reactions have been reported. Treatment in these cases is with antihistamines. Extremely high dose of fenbendazole (up to 100 x therapeutic dose) would be required to cause any signs of depression and anorexia in sheep. 4.11 Withdrawal Period(s) Meat and Offal: 21 days Not permitted for use in sheep producing milk for human consumption. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Fenbendazole – Benzimidazole Levamisole hydrochloride – Imidazothiazole ATCvet Code: QP52A 5.1 Pharmacodynamic properties The primary mode of action is the prevention of microtubule polymerisation with consequent loss of the parasites’ essential enzyme activities. Differential binding affinities between nematode and mammalian tubulin may explain the selective toxicity of Fenbendazole and other Benzimidazoles. Levamisole stimulates both parasympathetic and sympathetic ganglia in parasitic worms, causing a rapid, reversible paralysis which allows them to be expelled from the gut by normal peristaltic action. High concentrations inhibit the fumerate reductase system, and this effect may contribute to anthelmintic action or be linked to the paralysing effects. 5.2 Pharmacokinetic properties Fenbendazole is slowly absorbed from the gastrointestinal tract and mostly excreted unchanged in faeces. In sheep, peak Fenbendazole blood levels occur and decrease slowly (tmax ~ 8 to 36 hours); Cmax ~ 53 to 111 micrograms/L; t1/2 ~ 2 to 3 days. The main metabolites in blood plasma are fenbendazole, oxfendazole and fenbendazole sulphone. Target tissue for residues is liver. Levamisole is rapidly absorbed from the gastrointestinal tract. The percentage of the dose absorbed by the oral route ~ 50%. In sheep, peak levamisole blood levels occur and decrease rapidly (tmax ~ 1 to 2 hours); Cmax ~ 350 to 1000 micrograms/L; t1/2 ~ 3 hours. Residues of the drug are higher and more persistent in liver than in kidney or muscle tissue. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Anhydrous Citric Acid Colloidal Anhydrous Silica Formaldehyde Solution Propylene Glycol Polyoxyl Stearate Potassium Sorbate Polyethylene Glycol 6000 Xanthan Gum Purified Water 6.2 Incompatibilities None known. 6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 6.4 Special precautions for storage Do not store above 25ºC. Store in tightly closed original container in upright position. Protect from light and frost. 6.5 Nature and composition of immediate packaging White HDPE packs with polypropylene screw caps. Packs contain 1 litre (flat bottom backpack), 2.5 litre (back pack), 5 litre (back pack) and 10 litre (jerrican). Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations. Do not contaminate surface waters or ditches with the product or used containers as this may be dangerous for fish and other aquatic organisms. 7 MARKETING AUTHORISATION HOLDER Ancare Ireland Limited 30 Coolmine Business Park Clonsilla Road Dublin 15 8 MARKETING AUTHORISATION NUMBER(S) VPA 10915/3/1 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26th January 2001 Date of last renewal: 26th January 2006 10 DATE OF REVISION OF THE TEXT December 2013
