ORTHO 7/7/7 TABLETS (28 DAY)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

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

Disponibbli minn:

JANSSEN INC

Kodiċi ATC:

G03AB04

INN (Isem Internazzjonali):

NORETHISTERONE AND ESTROGEN

Dożaġġ:

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

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

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

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

12X1/28

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

CONTRACEPTIVES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2017-09-01

Karatteristiċi tal-prodott

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