TEVA-NABUMETONE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
14-07-2015
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Aktívna zložka:
NABUMETONE
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
M01AX01
INN (Medzinárodný Name):
NABUMETONE
Dávkovanie:
500MG
Forma lieku:
TABLET
Zloženie:
NABUMETONE 500MG
Spôsob podávania:
ORAL
Počet v balení:
60/100/500/1000
Typ predpisu:
Prescription
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0122821001; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-04-30
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
TEVA-NABUMETONE
nabumetone
500 mg and 750 mg Film Coated Tablets
BP Standard
Nonsteroidal Anti-Inflammatory Agent
Teva Canada Limited
DATE OF PREPARATION:
30 Novopharm Court
July 8, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
SUBMISSION CONTROL NO: 185040
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
9
DRUG INTERACTIONS
.............................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
...........................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 13
STORAGE AND STABILITY
.....................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 15
PART II: SCIENTIFIC INFORMATION
................................................................... 17
PHARMACEUTICAL INFORMATION
.....................................................................
17
CLINICAL TRIALS
.....................................................................................................
18
DETAILED PHARMACOLOGY
................................................................................
18
TOXICOLOGY
.....................................................
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