Држава: Канада
Језик: Енглески
Извор: Health Canada
NORETHINDRONE; ETHINYL ESTRADIOL
JANSSEN INC
G03AA05
NORETHISTERONE AND ESTROGEN
.5MG; .035MG
TABLET
NORETHINDRONE .5MG; ETHINYL ESTRADIOL .035MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0210010001; AHFS:
CANCELLED POST MARKET
2017-09-28
_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 ................................................................................... Прочитајте комплетан документ