ORTHO 1/35 TABLETS (21 DAY)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

NORETHINDRONE; ETHINYL ESTRADIOL

Pieejams no:

JANSSEN INC

ATĶ kods:

G03AA05

SNN (starptautisko nepatentēto nosaukumu):

NORETHISTERONE AND ESTROGEN

Deva:

1MG; .035MG

Zāļu forma:

TABLET

Kompozīcija:

NORETHINDRONE 1MG; ETHINYL ESTRADIOL .035MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

21

Receptes veids:

Prescription

Ārstniecības joma:

CONTRACEPTIVES

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2017-09-29

Produkta apraksts

_201117 ORTHO 1-35_APM.doc _
_EDMS-ERI-134831449 v5.0 _
_Page 1 of 56 _
.
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