Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
cefovecin (as sodium salt)
Zoetis Belgium SA
QJ01DD91
cefovecin
Dogs; Cats
Antibacterials for systemic use
DogsFor the treatment of skin and soft-tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β-haemolytic streptococci, Escherichia coli and / or Pasteurella multocida.For the treatment of urinary-tract infections associated with Escherichia coli and / or Proteus spp.As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues associated with Porphyromonas spp. and Prevotella spp.CatsFor the treatment of skin and soft-tissue abscesses and wounds associated with Pasteurella multocida, Usobacterium spp., Bacteroides spp., Prevotella oralis, β-haemolytic streptococci and / or Staphylococcus pseudintermedius.For the treatment of urinary-tract infections associated with Escherichia coli.
Revision: 13
Authorised
2006-06-19
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: CONVENIA 80 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR DOGS AND CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Haupt Pharma Latina S.r.l. S.S. 156 Km 47,600 04100 Borgo San Michele Latina ITALY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 23 ml vial of lyophilised powder contains: ACTIVE SUBSTANCE: 852 mg cefovecin (as sodium salt) EXCIPIENTS: 19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216) Each 19 ml vial of diluent contains: EXCIPIENTS: 13 mg/ml benzyl alcohol 10.8 ml water for injections Each 5 ml vial of lyophilised powder contains: ACTIVE SUBSTANCE: 340 mg cefovecin (as sodium salt) EXCIPIENTS: 7.67 mg methyl parahydroxybenzoate (E218) 0.85 mg propyl parahydroxybenzoate (E216) Each 10 ml vial of diluent contains: EXCIPIENTS: 13 mg/ml benzyl alcohol 4.45 ml water for injections When reconstituted according to label instructions, the solution for injection contains: 80.0 mg/ml cefovecin (as sodium salt) 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol 4. INDICATION(S) For use only for the following infections requiring prolonged treatment. The antimicrobial activity of Convenia following a single injection lasts for up to 14 days. 22 Dogs: For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with _Staphylococcus pseudintermedius, _ haemolytic _ _ Streptococci _, Escherichia coli _ and/or _Pasteurella _ _multocida_ . For the treatment of urinary tract infections associated with _Escherichia coli _ and Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH 23 ML VIAL OF LYOPHILISED POWDER CONTAINS: ACTIVE SUBSTANCE: 852 mg cefovecin (as sodium salt) EXCIPIENTS: 19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216) EACH 19 ML VIAL OF DILUENT CONTAINS: EXCIPIENTS: 13 mg/ml benzyl alcohol 10.8 ml water for injections EACH 5 ML VIAL OF LYOPHILISED POWDER CONTAINS: ACTIVE SUBSTANCE: 340 mg cefovecin (as sodium salt) EXCIPIENTS: 7.67 mg methyl parahydroxybenzoate (E218) 0.85 mg propyl parahydroxybenzoate (E216) EACH 10 ML VIAL OF DILUENT CONTAINS: EXCIPIENTS: 13 mg/ml benzyl alcohol 4.45 ml water for injections When reconstituted according to label instructions, the solution for injection contains: 80.0 mg/ml cefovecin (as sodium salt) 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use only for the following infections which require prolonged treatment. The antimicrobial activity of Convenia following a single injection lasts for up to 14 days. Dogs: For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with _Staphylococcus pseudintermedius, _ -haemolytic _ _ Streptococci _, Escherichia coli _ and/or _Pasteurella _ _multocida_ . For the treatment of urinary tract infections associated with _Escherichia coli_ and/or _Proteus _ spp. 3 As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues asso Прочетете целия документ