TEVA-MEDROXYPROGESTERONE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
26-02-2015
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Aktiva substanser:
MEDROXYPROGESTERONE ACETATE
Tillgänglig från:
TEVA CANADA LIMITED
ATC-kod:
G03DA02
INN (International namn):
MEDROXYPROGESTERONE
Dos:
5MG
Läkemedelsform:
TABLET
Sammansättning:
MEDROXYPROGESTERONE ACETATE 5MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500/1000
Receptbelagda typ:
Prescription
Terapiområde:
PROGESTINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0106339005; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2011-01-18
Produktens egenskaper
PRODUCT MONOGRAPH
PR
TEVA-MEDROXYPROGESTERONE
medroxyprogesterone acetate tablets USP
2.5 mg, 5 mg and 10 mg
PROGESTIN
Teva Canada Limited
Date of Revision:
30 Novopharm Court
May 12, 2014
Toronto, Ontario
M1B 2K9
Control No: 173232
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
..........................................................................................................
16
DOSAGE AND ADMINISTRATION
......................................................................................
18
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL
TRIALS..................................................................................................................
26
DETAILED PHARMACOLOGY
.............................................................................................
28
TOXICOLOGY
..............
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