SUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese
|
|
- Maurice Sherman
- 5 years ago
- Views:
Transcription
1 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
2 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: QJ01EW 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 and g/ml, respectively 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
3 tissues and fluids. Both SCP and TMP are rapidly eliminated from the organism with elimination half-lives of h for SCP and 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
4 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
5 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 Budapest Ottó u. 14. Hungary 5
6 16) MARKETING AUTHORISATION NUMBER(S). 17) MANUFACTURER S BATCH NUMBER Batch: {number} 6
7 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
8 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
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DOXYPRIM 40% soluble powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Doxycycline hyclate 400.0 mg Excipients:
More information4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals
1.B1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXYCOL Soluble Powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Amoxicillin trihydrate 640.0
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.B. SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lamox 800 mg/g powder for use in drinking water for chickens and pigs 2. QUALITATIVE
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Linco-Sol 400 mg/g powder for use in drinking water for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active
More informationSUMMARY of PRODUCT CHARACTERISTICS
SUMMARY of PRODUCT CHARACTERISTICS 1. Name of the veterinary medicinal product HELM-EX Flavour Tablets 2. Qualitative and quantitative composition Each tablet contains: Active ubstances Praziquantel 50.0
More information[Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS
[Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Curofen 50 mg/g Premix for Medicated Feeding Stuff for Pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationPART IB1 SUMMARY OF PRODUCT CHARACTERISTICS OCTACILLIN
PART IB1 SUMMARY OF PRODUCT CHARACTERISTICS OCTACILLIN 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Octacillin 800 mg/g powder for use in drinking water for chickens NL: Octacillin 800 mg/g poeder voor gebruik
More informationIrish Medicines Board
IRISH MEDICINES BOARD ACT 1995, as amended European Communities (Animal Remedies) (No. 2) Regulations 2007 VPA: 10999/033/001A Case No: 7006569 The in exercise of the powers conferred on it by Animal Remedies
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Amphen 200 mg/g Granules for use in drinking water for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active
More informationSUMMARY OF THE PRODUCT CHARACTERISTICS
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Exflow 10 mg/g powder for use in drinking water for cattle (calves), pigs, chickens, turkeys and ducks Exflow Vet 10
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT WONDERCEF powder and solvent for solution for injection for horses not intended for the production of foods for human consumption.
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor 70 mg/g powder for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs. 2. QUALITATIVE
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ophtocycline 10 mg/g eye ointment for dogs, cats and horses (AT, BE, BG, CY, CZ, EL, ES, HR, HU, IE, IT, LU, NL,
More informationSUMMARY of PRODUCT CHARACTERISTICS (SPC)
1. Name of the veterinary medicinal product Cestal Plus flavour tablets ad us. vet. active substances: praziquantel pyrantel pamoate fenbendazole SUMMARY of PRODUCT CHARACTERISTICS (SPC) 2. Qualitative
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tilmovet 250 mg/ml Concentrate for Oral Solution (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK) for pigs, chickens, turkeys and
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml Oral suspension for cattle. Distocur.vet 34 mg/ml Oral suspension for cattle. (DK, NO, SE) 2.
More informationHealth Products Regulatory Authority
1 NAME OF THE VETERINARY MEDICINAL PRODUCT Genta 50 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substances Gentamicin sulphate equivalent to Gentamicin
More informationSUMMARY OF PRODUCT CHARACTERISTICS. NUFLOR 300 mg/ml solution for injection for cattle and sheep
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NUFLOR 300 mg/ml solution for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephacare flavour 50 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 2. Qualitative and quantitative composition Active substance Halofuginone
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 20 mg/ml solution for injection for cattle and pigs (UK, IE, FR) Odimar 20 mg/ml solution for injection for cattle
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMPROLINE 400 mg/ml solution for use in drinking water for chickens and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationFLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER
FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
More information[Version 8.1,01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
[Version 8.1,01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pneumospectin 50 mg/ml +100 mg/ml solution for injection for cattle (calves), sheep, goat, pig,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COLICEN 4.000.000 UI/ml solution for use in drinking water/milk 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur AquaSol 200 mg/ml oral suspension for use in drinking water for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationLABELLING AND PACKAGE LEAFLET
LABELLING AND PACKAGE LEAFLET 1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILTEFORAN 20 mg/ml oral solution for dogs miltefosine 2.
More informationB. PACKAGE LEAFLET 1
B. PACKAGE LEAFLET 1 PACKAGE LEAFLET NICILAN 400 mg/100 mg tablets for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
More informationFor the treatment of infections caused by a wide range of Gram-positive and Gramnegative pathogenic bacteria including:
SUMMARY OF PRODUCT CHARCTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amoxycare Suspension for Injection 15% w/v 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active Substance(s)
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RONAXAN 20mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance : Doxycycline (as doxycycline
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats (UK, IE, FR) Floxadil 50 mg/ml Solution for Injection
More informationMARBOCYL 10% SUMMARY OF PRODUCT CHARACTERISTICS
MARBOCYL 10% SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL 10%, solution for injection for cattle and swine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Marbofloxacin...100.0
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Intra Hoof-Fit Gel 40 mg/g + 40 mg/g gel for dairy cattle Intra Pasta 40 mg/g + 40 mg/g gel for dairy cattle Pecopro vet
More informationSUMMARY OF PRODUCT CHARACTERISTICS
[Version 8, 10/2012] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS (Based on the current SPC of the reference product Baytril RSI 100 mg/ml Injektionslösung für Rinder und Schweine) 1 1. NAME OF THE VETERINARY
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Doxyveto-C 500 mg/g powder for use in drinking water/milk replacer for cattle, pig, chicken (BG, FR, HR, HU, LU, NL, PT, RO,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amfipen LA 100 mg/ml suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains:
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 250 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PT, RO,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of Veterinary Medicinal Product Endofluke 100 mg/ml Oral Suspension 2. Qualitative and Quantitative Composition Active Substance per ml Triclabendazole 100mg
More informationANNEX III LABELLING AND PACKAGE LEAFLET
ANNEX III LABELLING AND PACKAGE LEAFLET 1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Card box and package leaflet for brown glass bottle (Type 1) 1. NAME OF THE
More information1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Summary of Prodcuct Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Max 100 mg/ml Solution for Injection for Cattle and Pigs Enroxal Max 100 mg/ml Solution for Injection for Cattle and
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PL, PT, RO, SI,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oxycare 20 %w/v LA Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: Oxytetracycline (Equivalent
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS Revised: March 2015 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Malaseb shampoo for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substances: Chlorhexidine
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs > 4-10 kg NexGard 68 mg chewable
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT TAF SPRAY 28.5 mg/g Cutaneous Spray, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains: Active substance: Thiamphenicol
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Colfive 5,000,000 IU/ml concentrate for oral solutionfor calves, pigs, lambs, chickens and turkeys[at, CZ, DE, DK, EL, ES,
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COXEVAC suspension for injection for cattle and goats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 56 mg chewable tablets for dogs (1.3 2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5 5.5 kg) Credelio
More informationSUMMARY OF PRODUCT CHARACTERISTICS. KARIDOX 100 mg/ml oral solution for use in drinking water for chickens and pigs [UK, ES, IT, NL, DK, RO]
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KARIDOX 100 mg/ml oral solution for use in drinking water for chickens and pigs [UK, ES, IT, NL, DK, RO] DOXYSOL 10% [FR]
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican Herpes 205 powder and solvent for emulsion for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active
More informationSUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
More informationSummary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Enrotab 50 mg tablets for dogs
Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotab 50 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Enrofloxacin
More informationLABELLING AND PACKAGE LEAFLET A. LABELLING
LABELLING AND PACKAGE LEAFLET A. LABELLING DATA TO BE MARKED ON THE EXTERIOR OF THE PACKAGING DATA TO BE MARKED ON THE DIRECT PACKAGING DESCRIPTION AND TYPE OF THE PACKAGING 1. NAME OF THE VETERINARY MEDICAL
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NOSEDORM 5 mg/ml Solution for injection for dogs and cats [DE, ES, FR, PT] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Lincomycin (as Lincomycin hydrochloride) Neomycin (as Neomycin sulphate) Excipients Disodium edetate
SUMMARY OF PRODUCT CHARACTERISTICS AN: 00221/2013 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin Forte S Intramammary Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances Lincomycin
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Pharmasin 250 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets
1. NAME OF THE VETERINARY MEDICINAL PRODUCT for medicated feeding stuff for pigs, broilers and pullets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tylosine (as tylosin phosphate) : 250 mg per g. (equivalent
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Clostanel sodium)
More informationEar drops suspension. A smooth, uniform, white to off-white viscous suspension.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT OTOMAX EAR DROPS SUSPENSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the veterinary medicinal product contains:
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Selectan 300 mg/ml solution for injection for cattle and swine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationPart II SUMMARY OF PRODUCT CHARACTERISTICS. Each tablet contains 25 mg Clindamycin (as Clindamycin Hydrochloride)
Clindacyl 25mg Tablets Vm 08007/4104 Part II SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CLINDACYL 25 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rycarfa 100 mg tablets for dogs (BE, DE, ES, FR, IE, IT, NL, PT, UK) Rycarfa vet 100 mg tablets for dogs (DK, FI) Carprox
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Active substance: cefalexin (as cefalexin monohydrate) mg
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cefaseptin 750 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active substance: cefalexin
More informationVetoquinol/DOLPAC Small dogs/european Renewal June 2011 SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland France Luxembourg
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Apravet 552 IU/mg powder for use in drinking water/milk for pigs, calves, chickens and rabbits DK: Apravet WS EE:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Acecare 2mg/ml Solution for Injection for Dogs and Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Valbazen 100 mg/ml Total Spectrum Wormer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Albendazole
More informationLUTEOSYL(d)-Cloprostenol mg/ml Solution for injection for cattle and pigs
SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT In France, Germany, Hungary, Italy, Poland, Spain and The Netherlands; LUTEOSYL 0.075 mg/ml
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex CAT 52.5 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pipette (0.7 ml) contains:
More informationB. PACKAGE LEAFLET 1
B. PACKAGE LEAFLET 1 PACKAGE LEAFLET FOR: Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Melosolute 20 mg/ml solution for injection for cattle, pigs and horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Kelacyl 100 mg/ml, solution for injection for cattle and pigs (BG, CY, CZ, DE, EL, FR, HU, IE, IT, LT, PL, PT, RO, SK, UK)
More information[09/2018] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
[09/2018] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cronyxin 50 mg/g Oral paste for horses (DE, AT, BE, EE, LV, LT, ES, FR, IE, IT, NL, PL, UK) Cronyxin vet
More informationFor the treatment and prevention of infections caused by:
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYDECTIN 0.1 % W/V ORAL SOLUTION for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance Moxidectin
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
[Version 7.3.1, 11/2010] FINAL SPC, LABELLING AND PACKAGE LEAFLET ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAC Clostridium Ovino suspension for injection
More informationBOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Hymatil 300 mg/ml solution for injection for cattle and sheep Tilmicosin
BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hymatil 300 mg/ml solution for injection for cattle and sheep Tilmicosin 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains: Tilmicosin 300 mg;
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection
SUMMARY OF PRODUCT CHARACTERISTICS Revised: June 2018 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationIrish Medicines Board
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007 (S.I. No. 786 of 2007) VPA: 10999/056/001 Case No: 7004318 The Irish Medicines Board in exercise of the powers
More informationUbroseal Dry Cow 2.6 g intramammary suspension for cattle
Health Products Regulatory Authority 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ubroseal Dry Cow 2.6 g intramammary suspension for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4g intramammary
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS page 1 of 7 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur PetPaste 187.5 mg/g oral paste for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g oral
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT, BE, CZ, EE, ES, FR, IE, IS, IT, LT, LU, LV, NO, PL, PT, RO, SE, SI, SK, UK: Genestran 75 micrograms/ml solution for injection
More information[Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
[Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RABORAL V-RG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 1 dose: Active substance: -
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Maprelin 75 µg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Procaine penicillin Dihydrostreptomycin Sulfate
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Streptacare Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: Each ml contains: Procaine
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.05 ml dose
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: Active
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis ColiClos suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Advantage 40 Spot-on solution for Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Imidacloprid 40 mg/pipette
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orafluke 5% w/v Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of suspension contains: Active Substances
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS VIRBAGEN OMEGA - EN 1
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS VIRBAGEN OMEGA - EN 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Virbagen Omega 5 MU for dogs Virbagen Omega 10 MU for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIPRANT 20 mg tablets for dogs GALLIPRANT 60 mg tablets for dogs GALLIPRANT 100 mg tablets for dogs 2. QUALITATIVE
More informationMARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS
MARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL FD 1 %, powder and solvent for solution for injection, for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carofertin 10 mg/ml Emulsion for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for and. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder vial
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationSUMMARY OF PRODUCTS CHARACTERISTICS
SUMMARY OF PRODUCTS CHARACTERISTICS Revised: 15 January 2009 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tramazole 2.5% w/v SC Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/18
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/18 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oncept IL-2 lyophilisate and solvent for suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More information