Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lornoxicam
Takeda GmbH
M01AC05
lornoxicam
8mg
tablets film-coated
(10/1x10/) blister
Prescription
Registered
2015-06-09
March 2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xefocam 8mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 8 mg lornoxicam. Excipients with known effect: 90 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to yellowish oblong film-coated tablet with imprint “L08”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term relief of acute mild to moderate pain - Symptomatic relief of pain and inflammation in osteoarthritis. - Symptomatic relief of pain and inflammation in rheumatoid arthritis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 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. Additional information on special populations Children and adolescents Lornoxicam is not recommended for use in children and adolescents below age 18 because of a lack of data on safety and efficacy. March 2015 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). 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 effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4.). METHOD OF ADMINIST Olvassa el a teljes dokumentumot