ORTHO 0.5/35 TABLETS (21 DAY)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
20-03-2017
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
NORETHINDRONE; ETHINYL ESTRADIOL
Inapatikana kutoka:
JANSSEN INC
ATC kanuni:
G03AA05
INN (Jina la Kimataifa):
NORETHISTERONE AND ESTROGEN
Kipimo:
.5MG; .035MG
Dawa fomu:
TABLET
Tungo:
NORETHINDRONE .5MG; ETHINYL ESTRADIOL .035MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
21
Dawa ya aina:
Prescription
Eneo la matibabu:
CONTRACEPTIVES
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0210010001; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2017-09-28
Tabia za bidhaa
_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
...................................................................................
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