Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
JANSSEN INC
G03AB11
NORGESTIMATE AND ESTROGEN
0.180MG; 0.025MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG
TABLET
NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG
ORAL
28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0636783003; AHFS:
CANCELLED POST MARKET
2020-09-29
_ _ _Page 1 of 58 _ PRODUCT MONOGRAPH PR TRI-CYCLEN ® LO norgestimate and ethinyl estradiol Tablets, House Std. 0.180 mg norgestimate and 0.025 mg ethinyl estradiol Tablets 0.215 mg norgestimate and 0.025 mg ethinyl estradiol Tablets 0.250 mg norgestimate and 0.025 mg ethinyl estradiol Tablets Oral Contraceptive Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada Date of Revision: March 3, 2020 Submission Control No.: 235080 All trademarks used under license. © 2020 Janssen Inc. _ _ _Page 2 of 58 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE....................................................................................... 3 CONTRAINDICATIONS ............................................................................................................. 5 WARNINGS AND PRECAUTIONS ........................................................................................... 6 ADVERSE REACTIONS ........................................................................................................... 13 DRUG INTERACTIONS ........................................................................................................... 19 DOSAGE AND ADMINISTRATION ....................................................................................... 26 OVERDOSAGE ........................................................................................................................... 32 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 33 STORAGE AND STABILITY ................................................................................................... 36 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 36 PART II: SCIENTIFIC INFORMATION ........................................... Soma hati kamili