国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
ETORICOXIB
ORGANON SINGAPORE PTE. LTD.
M01AH05
120 mg
TABLET, FILM COATED
ETORICOXIB 120 mg
ORAL
Prescription Only
Rovi Pharma Industrial Services S.A.
ACTIVE
2002-10-18
SG-SPC-MK0663-T-082011 Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ,, USA Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA All rights reserved Page 1 1. NAME OF THE MEDICINAL PRODUCT ARCOXIA ® 30 mg Film-coated Tablets ARCOXIA ® 60 mg Film-coated Tablets ARCOXIA ® 90 mg Film-coated Tablets ARCOXIA ® 120 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 30mg Tablets: Blue-green, apple-shaped, biconvex tablets debossed '101' on one side and 'ACX 30' on the other side. 60 mg Tablets: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and ‘ARCOXIA 60’ on the other side. 90 mg Tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side. 120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and ‘ARCOXIA 120’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARCOXIA tablets are indicated for: - Symptomatic relief of osteoarthritis (OA), - Rheumatoid arthritis (RA), - Symptomatic relief of ankylosing spondylitis (AS), - Pain and signs of inflammation associated with acute gouty arthritis, - Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks, taking 完全なドキュメントを読む
SG-SPC-OG0663-T-012023 1. NAME OF THE MEDICINAL PRODUCT ARCOXIAⓇ 30 mg Film-coated Tablets ARCOXIAⓇ 60 mg Film-coated Tablets ARCOXIAⓇ 90 mg Film-coated Tablets ARCOXIAⓇ 120 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 30 mg Tablets: Blue-green, apple-shaped, biconvex tablets debossed ‘101’ on one side and ‘ACX 30’ on the other side. 60 mg Tablets: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and ‘ARCOXIA 60’ on the other side. 90 mg Tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side. 120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and ‘ARCOXIA 120’ on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications ARCOXIA tablets are indicated for: − Symptomatic relief of osteoarthritis (OA), − Rheumatoid arthritis (RA), − Symptomatic relief of ankylosing spondylitis (AS), − Pain and signs of inflammation associated with acute gouty arthritis, − Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks, taking into consideration other available therapeutic options (see 4.3 ‘Contra-indications’ and 4.4 ‘Special warnings and precautions for use’). 4.2 Posology and method of administration ARCOXIA is administered orally and may be taken with or without food. The onset of drug effect may be faster when ARCOXIA is administered without food. This should be considered when rapid symptomatic relief is needed. ARCOXIA should be administered for the shortest duration possible and the lowest effective daily dose should be used. Osteoarthritis The recommended dose is 30 mg once daily. In some patients with insufficien 完全なドキュメントを読む