SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF VETERINARY MEDICAL PRODUCT Vetzyme One Dose Wormer for Large Dogs 2. QUALITATIVE & QUANTITATIVE COMPOSITION Each tablet contains 500mg nitroscanate 3. PHARMACEUTICAL FORM Film-coated tablet 4. PHARMACOLOGICAL PROPERTIES Broad spectrum anthelmintic ATC Vet Code: QP52AX01 5. 5.1 CLINICAL PARTICULARS Target Species Dogs 5.2 Indications for use Vetzyme One Dose Wormer is a broad spectrum anthelmintic for use in dogs. It is highly effective in a single dose against common canine nematodes and cestodes in the UK. Toxocara canis, Toxacaris leonina, Ancylostoma caninum, Uncinaria stenocephala, Taenia ovis, Taenia hydatigena, Taenia pisiformis and Dipylidium caninum. At the recommended dosage, Lopatol gives only limited control of Echinococcus granulosus. 5.3 Contra-indications Tablets are film coated and should not be broken or divided. 5.4 Undesirable effects The tablets, when administered as recommended are unlikely to cause vomiting. Do not repeat treatment if vomiting occurs shortly after dosing. 5.5 Special precautions for use None 5.6 Use during pregnancy and lactation Not contraindicated in pregnant animals. Nursing bitches should be treated at same time and as frequently as puppies up to 12 weeks of age, i.e. 2, 4, 6, 8, 12 weeks 5.7 Interaction with other medicaments and other forms of interaction None known 5.8 Posology and method of administration For oral administration only. For the routine treatment of adult dogs and puppies weighing more than 6Kg, the dose of nitroscanate is 50mg/kg (1 x 500mg tablet per 10kg/22lb bodyweight). Practical dosage regime: 500mg tablets Bodyweight Number of tablets 6.1 - 10kg 10.1 - 20kg 20.1 - 30kg 30.1 – 40Kg 1 x 500mg 2 x 200mg 3 x 500mg 4 x 500mg For best results give the tablets together with about one-fifth of the daily food ration in the morning when the dogs stomach is empty. Give the remaining food ration in the evening. The tablets should be given whole. 5.9 Overdose Overdose may cause nausea and vomiting. High doses may have CNS effects. Treat symptomatically. 5.10 Special warnings for each target species None. 5.11 Withdrawal periods Not applicable 5.12 Special precautions to be taken by the person administering the product None. 6. 6.1 PHARMACEUTICAL PARTICULARS Incompatibilities (major) None known 6.2 Shelf-life 5 years 6.3 Special precautions for storage Do not store above 25°C Store in a dry place 6.4 Nature and contents of container Polyethylene-coated aluminium foil strip-pack containing film coated tablets. Pack sizes 4 tablets. 6.5 Name or style and permanent address or registered place of business of the holder of the authorisation to place the product on the market Novartis Animal Health UK Ltd New Cambridge House Litlington Nr. Royston Herts SG8 0SS 6.6 Special precautions for the disposal of unused product or waste materials, if any None. 7. FINAL INFORMATION Marketing authorisation number: Vm 12501/4065 Date of Revision of SPC: 12th January 2006 Date of first authorisation/last renewal: 23rd June 2005