ORTHO 0.5/35 TABLETS (21 DAY)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NORETHINDRONE; ETHINYL ESTRADIOL

Διαθέσιμο από:

JANSSEN INC

Φαρμακολογική κατηγορία (ATC):

G03AA05

INN (Διεθνής Όνομα):

NORETHISTERONE AND ESTROGEN

Δοσολογία:

.5MG; .035MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

NORETHINDRONE .5MG; ETHINYL ESTRADIOL .035MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

21

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CONTRACEPTIVES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0210010001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-09-28

Αρχείο Π.Χ.Π.

_201106 ORTHO 0.5-35_APM.doc _
_EDMS-ERI-134788094 v5.0 _
_Page 1 of 55 _
PRODUCT MONOGRAPH
PR
ORTHO
® 0.5/35
norethindrone and ethinyl estradiol Tablets, USP
0.5 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: 201106
© 2017 Janssen Inc.
All trademarks used under license.
_201106 ORTHO 0.5-35_APM.doc _
_EDMS-ERI-134788094 v5.0 _
_Page 2 of 55 _
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
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 28
STORAGE AND STABILITY
.................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 28
PART II: SCIENTIFIC INFORMATION
...................................................................................