Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibuprofen
A LAB PHARMACEUTICALS LLC
M01AE01
ibuprofen
600mg
tablets film-coated
(10/1x10/) in blister
Prescription
Registered
2023-07-21
A - L A B P H A R M A C E U P T I C A L S , L L C Address: Kochinyan 13/16 street Yerevan - Armenia Tell: ( +374)11 981000 Web: www.alab.am E-Mail: info@alab.am C O N F I D E N T I A L P a g e 1 o f 1 4 1.3 PRODUCT INFORMATION 1.3.1 SPC, LABELING & PACKAGE LEAFLET SPC – SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PARABRUFEN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ibuprofen 600mg. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet for oral use Pink colored caplet shaped film-coated tablet having break line on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Parabrufen tablet is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions, Parabrufen tablet is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Parabrufen tablet can also be used in soft tissue injuries such as sprains and strains. Parabrufen tablet is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine headache. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. In long-term treatment a low maintenance dose should be the aim. A - L A B P H A R M A C E U P T I C A L S , L L C Address: Kochinyan 13/16 street Yerevan - Armenia Tell: ( +374)11 981000 Web: www.alab.am E-Mail: info@alab.am C O N F I D E N T I A L P a g e 2 o f 1 4 Undesirable effects may be minimized by using the lowest effective dose for the shortest duration Прочитать полный документ