PROMETRIUM CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PROGESTERONE

Tersedia dari:

ORGANON CANADA INC.

Kode ATC:

G03DA04

INN (Nama Internasional):

PROGESTERONE

Dosis:

100MG

Bentuk farmasi:

CAPSULE

Komposisi:

PROGESTERONE 100MG

Rute administrasi :

ORAL

Unit dalam paket:

28/100

Jenis Resep:

Prescription

Area terapi:

PROGESTINS

Ringkasan produk:

Active ingredient group (AIG) number: 0106327002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2011-02-17

Karakteristik produk

Page 1 of 34
PRODUCT MONOGRAPH
PROMETRIUM
®
Progesterone capsules
100 mg
Progestin
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Revision:
March 29, 2021
Submission Control No: 249484
_ _
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Page 2 of 34
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
..........................................................................................................21
TOXICOLOGY
..............................................................................................................