Pays: Allemagne
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
ketoprofen 100 mg/ml
KELA ALBORATORIES N.V.
QM01AE03
Solution for injection
ketoprofen
Cattle Food, Horses Food, Pigs Food
2011-09-28
DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS CORREO ELECTRÓNICO mresvet@aemps.es C/ CAMPEZO, 1 – EDIFICIO 8 28022 MADRID TEL: 91 822 54 01 FAX: 91 822 5443 Dokument1Drafr PuAR kel aprofen ESV0160001DC-comments applicant FORMATIERT: Schriftart: (Standard) A rial, 9 Pt., Schriftartfarbe: Grau-50 %, Englisch (USA ), Rechtschreibung und Grammatik nicht prüfen AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS C/Campezo 1, Edificio 8 28022 – Madrid España (SPAIN) PROCEDURE ES/V/0160/001/DC PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT KELAPROFEN 100 mg/ml sol ution for inj ection for cattle, horses and pigs. ES/V/0160/001/DC KELA NV Appl i cation for Decentralised Procedure October 2011 Publ i cly available assessment report MINISTERIO DE SANIDAD, SERVICIOS SOCIALES E IGUALDAD AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PR ODUCTOS SANITAR IOS Page 2 of 11 MODULE 1 PRODUCT SUMMARY EU Procedure number ES/V/0160/001/DC Name, strength and pharmaceutical form KELAPROFEN 100 mg/ml solution for injection for cattle, horses and pigs. Applicant KELA N.V., St. Lenaartseweg 48, 2320 Hoogstraten, Belgium. Active substance(s) Ketoprofen ATC Vet code QM01AE03 Target species Cattle, horses and pigs Indication for use Horse - the alleviation of inflammation and pain associated with musculoskeletal disorders; - the alleviation of visceral pain associated with colic. C attle - the supportive treatment of parturient paresis associated with calving; - reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS KELAPROFEN 100 MG/ML KELA N.V. Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Kelaprofen 100 mg/ml, solution for injection for cattle, horses and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml ACTIVE SUBSTANCE: Ketoprofen 100mg EXCIPIENTS: Benzyl alcohol (E1519) 10mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless or yellowish solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horse - the alleviation of inflammation and pain associated with musculoskeletal disorders; - the alleviation of visceral pain associated with colic. Cattle - the supportive treatment of parturient paresis associated with calving; - reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy; - reducing oedema of the udder associated with calving. Pigs - reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - the supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate. SUMMARY OF PRODUCT CHARACTERISTICS KELAPROFEN 100 MG/ML KELA N.V. Page 2 of 6 4.3 CONTRA-INDICATIONS Do not u Lire le document complet