MEDROXY-5 TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
01-02-2018
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Aktiva substanser:
MEDROXYPROGESTERONE ACETATE
Tillgänglig från:
PRO DOC LIMITEE
ATC-kod:
G03DA02
INN (International namn):
MEDROXYPROGESTERONE
Dos:
5MG
Läkemedelsform:
TABLET
Sammansättning:
MEDROXYPROGESTERONE ACETATE 5MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
PROGESTINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0106339005; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2020-08-20
Produktens egenskaper
Page 1 of 39
PRODUCT MONOGRAPH
Pr
MEDROXY-2,5
Pr
MEDROXY-5
(MEDROXYPROGESTERONE ACETATE TABLETS USP)
2.5 MG, 5 MG
PROGESTIN
PRO DOC LTÉE
Date of Revision:
2925, boul. Industriel
1 February 2018
Laval, Quebec
H7L 3W9
Control No.: 212978
Page 2 of 39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
13
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 23
PART II: SCIENTIFIC INFORMATION
.............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
...............................................................................................................
24
DETAILED PHARMACOLOGY
..............................
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