Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Celecoxib
VIATRIS PRIVATE LIMITED
M01AH01
400mg
CAPSULE
Celecoxib 400mg
ORAL
Prescription Only
Viatris Pharmaceuticals, LLC
ACTIVE
2009-05-21
Page 1 of 26 _CELEBREX_ _TM_ _ _ 1. NAME OF THE MEDICINAL PRODUCT CELEBREX™. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg celecoxib. Each 200 mg capsule contains 200 mg celecoxib. Each 400 mg capsule contains 400 mg celecoxib. 3. PHARMACEUTICAL FORM Hard capsules for oral use. 100 mg Capsules: Opaque, white capsules with blue bands marked 7767 and 100. 200 mg Capsules: Opaque, white capsules with gold bands marked 7767 and 200. 400 mg Capsules: Opaque, white capsules with green bands marked 7767 and 400. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Symptomatic treatment of osteoarthritis and rheumatoid arthritis. • Management of acute pain in adults. • Treatment of primary dysmenorrhoea. • Relief of signs and symptoms of ankylosing spondylitis. • Management of chronic low back pain. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see Sections 4.3 Contraindications, 4.4 Special warnings and precautions for use), taking into consideration other available therapeutic options. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Celecoxib capsules, at doses up to 200 mg twice per day can be taken with or without food. Page 2 of 26 As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. _Symptomatic Treatment of Osteoarthritis_: The recommended dose is 200 mg administered as a single dose or as 100 mg twice per day. _Symptomatic Relief in the Treatment of Rheumatoid Arthritis_: The recommended daily dose is 100 mg or 200 mg twice per day. _Ankylosing Spondylitis (AS): _The r Olvassa el a teljes dokumentumot
CELEBREX ® 1. NAME OF THE MEDICINAL PRODUCT CELEBREX ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg celecoxib. Each 200 mg capsule contains 200 mg celecoxib. Each 400 mg capsule contains 400 mg celecoxib. 3. PHARMACEUTICAL FORM Hard capsules for oral use. 100 mg capsules: Opaque, white capsules with blue bands marked 7767 and 100. 200 mg capsules: Opaque, white capsules with gold bands marked 7767 and 200. 400 mg capsules: Opaque, white capsules with green bands marked 7767 and 400. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). • Management of acute pain in adults. • Treatment of primary dysmenorrhea. • Relief of signs and symptoms of ankylosing spondylitis (AS). • Management of chronic low back pain. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see Sections 4.3 CONTRAINDICATIONS and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ), taking into consideration other available therapeutic options. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food. As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. _SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA)_: The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. _SYMPTOMATIC RELIEF IN THE TREATMENT OF RHEUMATOID ARTHRITIS (RA)_: The recommended daily dose of celecoxib is 100 mg or 200 mg twice per day. _ANKYLOSING SPONDYLITIS (AS): _ The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. The maximum recommended daily dose is 400 mg for above indications. _MANAGEMENT OF ACUTE PAIN IN ADULTS_: The recommended dose of celecoxib is 400 mg, initially, followed by an addition Olvassa el a teljes dokumentumot