TEVA-FLURBIPROFEN TABLET
Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
Karakteristik produk
(SPC)
14-07-2015
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Bahan aktif:
FLURBIPROFEN
Tersedia dari:
TEVA CANADA LIMITED
Kode ATC:
M01AE09
INN (Nama Internasional):
FLURBIPROFEN
Dosis:
50MG
Bentuk farmasi:
TABLET
Komposisi:
FLURBIPROFEN 50MG
Rute administrasi :
ORAL
Unit dalam paket:
100/500
Jenis Resep:
Prescription
Area terapi:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Ringkasan produk:
Active ingredient group (AIG) number: 0115998002; AHFS:
Status otorisasi:
CANCELLED POST MARKET
Tanggal Otorisasi:
2019-08-08
Karakteristik produk
PRODUCT MONOGRAPH
PR
TEVA-FLURBIPROFEN
(Flurbiprofen tablets BP)
50 mg and 100 mg Tablets
Nonsteroidal anti-inflammatory drug (NSAID)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No.: 184835
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
...............................................................................................
16
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
..........................................................................
22
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 23
STORAGE AND
STABILITY.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.....................................................................
27
CLINICAL TRIALS
.......................................................................................................
28
DETAILED PHARMACOLOGY
.................................................................................
30
TOXICOLOGY
..............................................................................................................
30
REFERENCES
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