SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One g contains: Active substances: Sulfacholorpyridazine sodium 500 mg Trimethoprim 100 mg Excipients: Macrogol 4000, glucose monohydrate 3. PHARMACEUTICAL FORM Powder for oral solution. 4. PACKAGING Polypropylene containers with LDPE inner bags of 100 g and 1 kg. Not all pack sizes may be marketed. 5. INDICATIONS FOR USE Treatment and prevention of respiratory, intestinal and systemic infections caused by sulfachloropyridazine-trimethoprim-sensitive organisms in chickens, turkeys and geese. 6. DOSAGE AND ADMINISTRATION To be administered orally, in the drinking water. Dosage: 40 mg Vetrisulf per kg b.w. per day (equivalent to 24 mg total active ingredient/kg b.w. per day) Administration dissolved: in the drinking water. * up to 7 days old: 100 g per 1000 litres drinking water * one to 4 weeks of age: 200 g per 1000 litres drinking water * over 4 weeks of age: 300 g per 1000 litres drinking water Treatment should be continued for a period of three to five days. 7. CONTRAINDICATIONS Not for use in laying poultry when eggs are intended for human consumption. 8. WITHDRAWAL PERIODS Meat and offal of chickens: 2 days Meat and offal of turkeys: 2 days Meat and offal of geese: 2 days 1
9. PRECAUTIONS Special precautions for use in animals Do not use in case of hypersensitivity to the active substances or the excipients. Special precautions to be taken by the person administering the veterinary medicinal product to animals Direct contact of the product with skin, eyes and mucous membranes should be avoided. Wash hands after use. 10. UNDESIRABLE EFEFCTS VETRISULF is of low toxicity and side-effects are very rarely encountered. If suspected adverse reactions do occur, treatment should be discontinued. In the tolerance studies no undesirable effects were detected. 11. OVERDOSE AND TREATMENT Overdosage of VETRISULF very rarely occurs because of good tolerance by each species to be used in. In the tolerance studies, the product failed to induce any toxic effect even when administered at a dosage of three times the recommended. If suspected toxic reactions do occur due to extreme overdosage, the medication should be discontinued and appropriate symptomatic treatment should be performed if necessary. 12. SUMMARY PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Potentiated sulphonamides; ATCvet code: QJ01EW12 12.1 Pharmacodynamic properties VETRISULF is a broad-spectrum antimicrobial containing sulfachloropyridazine sodium and trimethoprim as active ingredients. The 5:1 combination of the two components inhibits sequential steps in the synthesis of folic acid and thus the purines required for DNA synthesis. This mode of action ensures a synergistic antibacterial effect against most pathogens with resulting benefits as regards spectrum, bactericidal action and dosage. In addition, the risk of development of bactericidal resistance is markedly reduced. The combination of SCP and TMP is actice against a variety of gram-positive and gram-negative organisms, including Streptococcus, Staphylococcus, and Clostridium spp., Erysipelothrix rhusiopathiae, E. coli, Salmonella, Klebsiella, Pasteurella, Bordetella and Haemophilus spp. Median MICs of the 5:1 SCP and TMP combination against gram-negative and grampositive strains were found to be 0.2+0.02 and 0.2+0.04 g/ml, respectively. 12.2 Pharmacokinetic particulars Extensive pharmacological studies have shown that both SCP and TMP are rapidly absorbed from the gastrointestinal tract (with t max of 1-2 h for both compounds) and widely distributed in the organism attaining effective concentrations in most body 2
tissues and fluids. Both SCP and TMP are rapidly eliminated from the organism with elimination half-lives of 1.3-1.9 h for SCP and 1.0-2.4 h for TMP in poultry species. 13. DRUG INTERACTIONS None known. 14. STORAGE CONDITIONS Do not store above 25 C. Store in the original container tightly closed in order to protect from moisture. 15. SHELF LIFE Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after first opening the immediate packaging: 3 months Shelf-life after reconstitution in drinking water: 24 hours 3
LABELLING 1) NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf 500 mg/100 mg powder for oral solution for chickens, turkeys and geese 2) STATEMENT OF ACTIVE SUBSTANCE(S) Sulfachlorpyridazine sodium Trimethoprim 500 mg 100 mg 3) PHARMACEUTICAL FORM Powder for oral solution 100 g, 1 kg 4) PACKAGE SIZE 100 g 1 kg 5) TARGET SPECIES Chicken, turkey, goose 6) INDICATIONS Treatment and prevention of respiratory, intestinal and systemic infections caused by sulfachloropyridazine-trimethoprim-sensitive organisms in chickens, turkeys and geese. 7) METHOD AND ROUTE(S) OF ADMINISTRATION Oral administration in the drinking water. Read the package leaflet before use. 8) WITHDRAWAL PERIOD Meat and offal of chickens: 2 days Meat and offal of turkeys: 2 days Meat and offal of geese: 2 days 4
9) SPECIAL WARNING(S), IF NECESSARY Direct contact of the product with the skin, eyes and mucous membranes should be avoided. Read package leaflet before use. 10) EXPIRY DATE EXP {month/year} Shelf life after first opening of container: 3 months Shelf life after reconstitution in drinking water: 24 hours 11) SPECIAL STORAGE CONDITIONS Do not store above 25 C. Store in the original container tightly closed in order to protect from moisture. 12) SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 13) THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15) NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Lavet Pharmaceuticals Ltd. 1161 Budapest Ottó u. 14. Hungary 5
16) MARKETING AUTHORISATION NUMBER(S). 17) MANUFACTURER S BATCH NUMBER Batch: {number} 6
PACKAGE LEAFLET Vetrisulf 500 mg/100 mg powder for oral solution for chickens, turkeys and geese 1. NAME and ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing authorisation holder: Lavet Pharmaceuticals Ltd., 1161 Budapest, Ottó u. 14, Hungary Manufacturer for the batch release: Lavet Pharmaceuticals Ltd., 2143 Kistarcsa, Batthyány u. 6, Hungary 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf 500 mg/100 mg powder for oral solution for chickens, turkeys and geese 3. STATEMENT of ACTIVE SUBSTANCE(S) Active substances: Sulphachloropyridazine sodium 500 mg/g Trimethoprim 100 mg/g 4. INDICATIONS Treatment and prevention of respiratory, intestinal and systemic infections caused by sulfachloropyridazine-trimethoprim-sensitive organisms in poultry. 5. CONTRAINDICATIONS Do not use in laying hens when eggs are intended for human consumption. 6. ADVERSE REACTIONS Vetrisulf is of low toxicity and side-effects are very rarely encountered. If suspected adverse reactions do occur, treatment should be discontinued. In the tolerance studies no undesirable effects were detected. 7. TARGET SPECIES Chicken, turkey and goose 8. DOSAGE for EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Dosage: 40 mg Vetrisulf per kg of body weight/day for 3-5 days (equivalent to 24 mg of combined active ingredients/kg b.w./day). Administration: to be administered in the drinking water according to the following general guide: * up to 7 days old: 100 g per 1000 litres drinking water * one to 4 weeks of age: 200 g per 1000 litres drinking water * over 4 weeks of age: 300 g per 1000 litres drinking water. 9. ADVICE on CORRECT ADMINISTRATION 7
The solution should be prepared freshly each day. No other source of drinking water should be available during the medication period. 10. WITHDRAWAL PERIOD Meat and offal of chickens: 2 days Meat and offal of turkeys: 2 days Meat and offal of geese: 2 days 11. SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children. Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after first opening the immediate packaging: 3 months Shelf-life after dilution or reconstitution according to directions: 24 hours 12. SPECIAL WARNING(S), if NECESSARY Persons with known hypersensitivity to sulphonamides should avoid any contact with the product. In order to avoid irritation of skin and/or eyes, use gloves when handling this product. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 14. DATE on WHICH the PACKAGE LEAFLET WAS LAST REVISED 15. OTHER INFORMATION Pack sizes: 100 g in polypropylene containers with LDPE inner bag 1 kg in polypropylene containers with LDPE inner bag Not all pack sizes may be marketed. For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 8