País: Israel
Idioma: inglés
Fuente: Ministry of Health
LORNOXICAM
CTS LTD
M01AC05
FILM COATED TABLETS
LORNOXICAM 8 MG
PER OS
Required
TAKEDA PHARMA A/S, DENMARK
LORNOXICAM
LORNOXICAM
Short term treatment of moderate pain such as pain after dental surgery.Treatment of pain associated with acute lumbo-sciatica. Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.
2023-03-31
ISR F.2/0417/6092608 Code: 2114 Takeda Pharma A/S Denmark, Dybendal Alle 10, DK-2630 Taastrup, Denmark. Takeda Pharma A/S Denmark, Dybendal Alle 10, DK-2630 Taastrup, Denmark. 6092608_F2_V01_0417.indd 2 07.04.17 15:03 Leer el documento completo
1 XEFO 8MG TABLETS _Summary of product characteristics _ 1. NAME OF THE MEDICINAL PRODUCT XEFO 8 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 8 mg lornoxicam Excipients: Lactose monohydrate 90 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets White to yellowish oblong film coated tablets, with imprint "LO8" 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - Short term treatment of moderate pain such as pain after dental surgery - Treatment of pain associated with acute lumbo-sciatica - Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For all patients the appropriate dosing regimen should be based upon individual response to treatment. Pain 8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg. Osteoarthritis and Rheumatoid arthritis Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. Maintenance dose should not exceed 16 mg lornoxicam daily. Xefo film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid. Additional information on special populations DOSAGE FOR CHILDREN AND ELDERLY PATIENTS: CHILDREN AND ADOLESCENTS Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy. ELDERLY No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4). Renal impairment For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4). 2 Hepatic impairment For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4). Undesirable eff Leer el documento completo