ORTHO 1/35 TABLETS (21 DAY)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NORETHINDRONE; ETHINYL ESTRADIOL

Tersedia dari:

JANSSEN INC

Kode ATC:

G03AA05

INN (Nama Internasional):

NORETHISTERONE AND ESTROGEN

Dosis:

1MG; .035MG

Bentuk farmasi:

TABLET

Komposisi:

NORETHINDRONE 1MG; ETHINYL ESTRADIOL .035MG

Rute administrasi :

ORAL

Unit dalam paket:

21

Jenis Resep:

Prescription

Area terapi:

CONTRACEPTIVES

Ringkasan produk:

Active ingredient group (AIG) number: 0210010002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-09-29

Karakteristik produk

_201117 ORTHO 1-35_APM.doc _
_EDMS-ERI-134831449 v5.0 _
_Page 1 of 56 _
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PRODUCT MONOGRAPH
PR
ORTHO
® 1/35
norethindrone and ethinyl estradiol Tablets, USP
1.0 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
Oral Contraceptive
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 14, 2017
SUBMISSION CONTROL NO.: 201117
© 2017 Janssen Inc.
All trademarks used under license.
_201117 ORTHO 1-35_APM.doc _
_EDMS-ERI-134831449 v5.0 _
_Page 2 of 56 _
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
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
....................................................................................
30