ORTHO 7/7/7 TABLETS (21 DAY)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

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

זמין מ:

JANSSEN INC

קוד ATC:

G03AB04

INN (שם בינלאומי):

NORETHISTERONE AND ESTROGEN

כמות:

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

טופס פרצבטיות:

TABLET

הרכב:

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

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

12 X 1/21

סוג מרשם:

Prescription

איזור תרפויטי:

CONTRACEPTIVES

leaflet_short:

Active ingredient group (AIG) number: 0616240001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2017-09-29

מאפייני מוצר

_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
...................................................