देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Ketoprofen
Interchemie Werken De Adelaar Eesti AS.
QM01AE03
Ketoprofen
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
ketoprofen
Authorised
2022-04-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ketosol-100, 100 mg/ml solution for injection for cattle, pigs and horses (EE, BG, HR, LV, RO, SI and SK) Ketoject, 100 mg/ml solution for injection for cattle, pigs and horses (IT, PL and HU) Ketoject 100 mg/ml solution for injection for cattle, pigs and horses (CZ) Ketosol, 100 mg/ml solution for injection for cattle, pigs and horses (CY, DE, EL, ES, FR, IE, LU, NL, PT) Ketosol vet, 100 mg/ml solution for injection for cattle, pigs and horses (SE) Ketochemie, 100 mg/ml solution for injection for cattle, pigs and horses (AT, BE, DK, FI) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each ml contains: ACTIVE SUBSTANCE: Ketoprofen.........................100.0 mg EXCIPIENTS: Benzyl alcohol (E1519)......10.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, slightly yellow solution, free from visible particles. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle, pigs, horses. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Diseases associated with inflammation, pain or fever: - respiratory tract infections. - mastitis. - osteoarticular and muscular-skeletal disorders such as lameness, arthritis. - to ease uprise post parturition. - injuries. Where necessary ketoprofen should be combined with appropriate antimicrobial therapy. Pigs: Diseases associated with inflammation, pain or fever: - Postpartum Dysgalactia Syndrome (PPDS) (Mastitis Metritis Agalactia (MMA) syndrome). - respiratory tract infections. Where necessary ketoprofen should be combined with appropriate antimicrobial therapy. Horses: Diseases affecting the osteoarticular and muscular-skeletal system associated with acute pain and inflammation: - lameness of traumatic origin. - arthritis. - osteitis. - tendinitis, bursitis. - navicular syndrome. - laminitis. - myositis. Ketoprofen is also indicated for post-surgical inflammation and symptomatic therapy of colic. 4.3. CONTRAINDICATIONS Do not use in cases o पूरा दस्तावेज़ पढ़ें