TEVA-MEDROXYPROGESTERONE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MEDROXYPROGESTERONE ACETATE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

G03DA02

INN (International ime):

MEDROXYPROGESTERONE

Doziranje:

2.5MG

Farmaceutski oblik:

TABLET

Sastav:

MEDROXYPROGESTERONE ACETATE 2.5MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500/1000

Tip recepta:

Prescription

Područje terapije:

PROGESTINS

Proizvod sažetak:

Active ingredient group (AIG) number: 0106339004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2011-01-18

Svojstava lijeka

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
..............