APO-MEDROXY TABLETS
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
12-08-2017
Nekateri dokumenti za ta izdelek trenutno niso na voljo, pošljete lahko zahtevo v našo stranko in obvestili vas bomo takoj, ko jih bomo lahko pridobili.
Pošlji zahtevo.
Pošlji zahtevo.
Aktivna sestavina:
MEDROXYPROGESTERONE ACETATE
Dostopno od:
APOTEX INC
Koda artikla:
G03DA02
INN (mednarodno ime):
MEDROXYPROGESTERONE
Odmerek:
5MG
Farmacevtska oblika:
TABLET
Sestava:
MEDROXYPROGESTERONE ACETATE 5MG
Pot uporabe:
ORAL
Enote v paketu:
100/500
Tip zastaranja:
Prescription
Terapevtsko območje:
PROGESTINS
Povzetek izdelek:
Active ingredient group (AIG) number: 0106339005; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2001-11-02
Lastnosti izdelka
Page 1 of 39
PRODUCT MONOGRAPH
Pr
APO-MEDROXY
(MEDROXYPROGESTERONE ACETATE TABLETS USP)
2.5 MG, 5 MG, 10 MG AND 100 MG
PROGESTIN
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Date of Revision:
M9L 1T9
July 21, 2017
CONTROL NO. 207292
Page 2 of 39
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
.......................................................................................................
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
.................................
Preberite celoten dokument
