ORTHO 7/7/7 TABLETS (28 DAY)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

NORETHINDRONE; ETHINYL ESTRADIOL; NORETHINDRONE; ETHINYL ESTRADIOL; NORETHINDRONE; ETHINYL ESTRADIOL

Boleh didapati daripada:

JANSSEN INC

Kod ATC:

G03AB04

INN (Nama Antarabangsa):

NORETHISTERONE AND ESTROGEN

Dos:

0.5MG; 0.035MG; 0.75MG; 0.035MG; 1MG; 0.035MG

Borang farmaseutikal:

TABLET

Komposisi:

NORETHINDRONE 0.5MG; ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.75MG; ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG; ETHINYL ESTRADIOL 0.035MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

12X1/28

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CONTRACEPTIVES

Ringkasan produk:

Active ingredient group (AIG) number: 0616240002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-09-01

Ciri produk

_201105 ORTHO 7-7-7 _APM.doc _
_EDMS-ERI-134831445 v5.0 _
_Page 1 of 61 _
PRODUCT MONOGRAPH
PR
ORTHO
® 7/7/7
norethindrone and ethinyl estradiol Tablets, USP
0.5 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
0.75 mg norethindrone and 0.035 mg ethinyl estradiol Tablets
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.: 201105
© 2017 Janssen Inc.
All trademarks used under license.
_201105 ORTHO 7-7-7 _APM.doc _
_EDMS-ERI-134831445 v5.0 _
_Page 2 of 61 _
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 27
STORAGE AND STABILITY
.................................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................