Click here to Download Data Sheet Health Products Regulatory Authority 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur 10 % w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active Substance Fenbendazole 100 mg Excipients Sodium Methyl Parahydroxybenzoate 2.000 mg Sodium Propyl Parahydroxybenzoate 0.216 mg Benzyl alcohol 4.835 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension 4 CLINICAL PARTICULARS 4.1 Target Species Horses and cattle 4.2 Indications for use, specifying the target species For the treatment of immature and mature stages of nematodes of the gastro-intestinal and respiratory tracts of cattle and horses including encysted mucosal small redworm larvae in horses. Panacur has an ovicidal effect on roundworm eggs. Also effective against cestodes in cattle. For the treatment of horses infected with adult large strongyles and adult and larval small strongyles. Also controls ascarids and oxyurids species. For the treatment of cattle infected with adult and immature stages of: Haemonchus spp., Ostertagia spp., Trichostrongylus spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Trichuris spp., Strongyloides spp., Oesophagostomum spp., Capillaria spp., Dictyocaulus spp. Used at the recommended dose and time, Panacur is effective against inhibited larvae of Ostertagia spp. and against Moniezia spp. of tapeworm. 4.3 Contraindications Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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 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. 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 benzimidazoles has been reported in gastro-intestinal nematodes in horses. Therefore, the use of this product should be based on local epidemiological information about susceptibility of the nematodes and recommendations on how to limit further selection for resistance to anthelmintics. 4.5 Special precautions for use Special precaution(s) for use in animals As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing. Special precautions to be taken by the person administering the veterinary medicinal product to animals Direct contact with the skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves. Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay Can be administered at any stage of pregnancy or lactation. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route For oral administration only. The suspension should be shaken well before use and is ready for use without further dilution. The product can be administered by any standard dosing gun or drenching equipment. To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. Routine dosage for cattle and horses: 7.5 mg fenbendazole/kg bodyweight as a single dose corresponding to 7.5 ml per 100 kg bodyweight. Examples: BODY WEIGHT VOLUME UP TO 100kg 7.5 ml 100-200kg 15ml 200-300kg 22.5ml 300-400kg 30ml For bodyweight in excess of 400 kg use 30 ml plus an additional 3.75 ml per 50 kg. Treatment should be repeated every 6-8 weeks during the grazing season. Treatment of specific indications in horses: For the treatment of mucosal stages of Trichonema spp. - 30 mg/kg. For the treatment of migrating stages of Strongylus vulgaris and Strongylus edentatus - 60 mg/kg. Alternatively for the control of migrating larval stages of large strongyles and encysted mucosal stages of small strongyles (cyathostomes) administer 7.5 mg/kg fenbendazole daily for five days. Diarrhoea caused by Strongyloides westeri in sucking foals should be treated with a dose of 25 ml Panacur 10% per 50 kg bodyweight (50 mg fenbendazole/kg bodyweight). 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary None known. 4.11 Withdrawal period(s) Cattle: Meat and offal: 14 days Milk: 4 days Horses: Meat and offal: 14 days Not authorised for mares producing milk for human consumption. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Anthelmintics; Benzimidazoles and related substances ATCvet code: QP52AC13 5.1 Pharmacodynamic properties Fenbendazole is an anthelmintic belonging to the benzimidazole-carbamate group. It acts by interfering with the energy metabolism of the nematode. The anthelmintic affects both adult and immature stages of gastro-intestinal and respiratory nematodes. This anthelmintic efficacy is based on inhibition of the polymerisation of tubulin to microtubuli. 5.2 Pharmacokinetic properties Fenbendazole is only partly absorbed after oral administration and is then metabolised in the liver. The half-life of fenbendazole in serum after oral application of the recommended dose is 10-18 hours in cattle, 21-33 hours in sheep and 10 hours in pigs. Fenbendazole and its metabolites are distributed throughout the body but highest concentrations are found in the liver. The elimination of fenbendazole and its metabolites occurs primarily via the faeces (>90%) and to a smaller extent as well in the urine and milk. Fenbendazole is metabolised to its sulfoxide, then to sulfone and amines. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Colloidal Silicon Dioxide Sodium Carboxymethyl Cellulose Povidone 25000 Sodium Citrate Dihydrate Citric Acid Monohydrate Sodium Methyl Parahydroxybenzoate Sodium Propyl Parahydroxybenzoate Benzyl Alcohol Purified Water 6.2 Incompatibilities None known. 6.3 Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years 6.4 Special precautions for storage Do not store above 25°C. Protect from freezing. 6.5 Nature and composition of immediate packaging Multidose aluminium foil sealed polyethylene containers with polypropylene screw caps containing 250 ml, 1 litre and 2.5 litres of suspension. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. 7 MARKETING AUTHORISATION HOLDER Intervet Ireland Limited Magna Drive Magna Business Park, Citywest Road Dublin 24 Ireland 8 MARKETING AUTHORISATION NUMBER(S) VPA10996/111/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/10/1999 Date of last renewal: 30/09/2009 10 DATE OF REVISION OF THE TEXT September 2017
