Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Ketoprofen
Richter Pharma AG
QM01AE03
Ketoprofen
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Horses, Pigs
ketoprofen
N.S.A.I.D.
Authorised
2010-04-23
Health Products Regulatory Authority 16 February 2022 CRN00CCS8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rifen 100 mg/ml solution for injection for horses, cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Ketoprofen 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 10 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to brownish-yellowish solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse, cattle, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horse Diseases affecting the osteoarticular and muscular-skeletal system associated with acute pain and inflammation -Lameness of traumatic origin -Arthritis -Osteitis, spavin -Tendinitis, bursitis -Naviculitis -Laminitis -Myositis Ketoprofen is also indicated for post-surgical inflammation, symptomatic therapy of colic and fever. Cattle Diseases associated with inflammation, pain or fever -Respiratory diseases -Mastitis -Osteoarticular and muscular-skeletal disorders such as lameness, arthritis and to ease uprise post parturition -Injuries For the relief of post-operative pain associated with dehorning in calves. Pigs Diseases associated with inflammation, pain or fever -Treatment associated with the Postpartum Dysgalactia Syndrome/Mastitis Metritis Agalactia (MMA) Health Products Regulatory Authority 16 February 2022 CRN00CCS8 Page 2 of 5 Syndrome -Respiratory tract infections -Symptomatic treatment of fever For the short-term relief of post operative pain associated with minor soft tissue surgery such as castration in piglets. Where necessary ketoprofen should be combined with appropriate antimicrobial therapy. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, or to any of the excipients. Do not use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis, impaired hepatic, renal or cardiac function. Do not use with other NSAID drugs concurrently or Perskaitykite visą dokumentą