Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etoricoxib
Merck Sharp & Dohme B.V. Waarderweg 39
M01AH05
etoricoxib
60mg
tablets film-coated
(7/1x7/) in blister, (28/4x7/) in blister
Prescription
Registered
2021-04-20
SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDICAL USE OF DRUG 1. NAME OF THE MEDICINAL PRODUCT ARCOXIA 60 mg film-coated tablets ARCOXIA 90 mg film-coated tablets ARCOXIA 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. Qualitative composition Etoricoxib. 2.2 Quantitative composition Each film-coated tablet contains _active substance_: 60, 90 or 120 mg of etoricoxib . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. _60 mg tablets_: Dark green, apple-shaped, biconvex tablets debossed ‘ARCOXIA 60’ on one side and ‘200’ on the other side. _90 mg tablets_: White, apple-shaped, biconvex tablets debossed ‘ARCOXIA 90’ on one side and ‘202’ on the other side. _120 mg tablets_: Pale-green, apple-shaped, biconvex tablets debossed ‘ARCOXIA 120’ on one side and ‘204’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARCOXIA is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. ARCOXIA is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ARCOXIA is administered orally and may be taken with or without food. The onset of the effect of the medicinal product may be faster when ARCOXIA is administered before meals. This should be considered when rapid symptomatic relief is needed. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patien Izlasiet visu dokumentu