TRI-CYCLEN TABLETS - 28-DAY

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; NORGESTIMATE

可用日期:

JANSSEN INC

ATC代码:

G03AB11

INN（国际名称）:

NORGESTIMATE AND ESTROGEN

剂量:

0.215MG; 0.035MG; 0.25MG; 0.035MG; 0.035MG; 0.18MG

药物剂型:

TABLET

组成:

NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.18MG

给药途径:

ORAL

每包单位数:

28

处方类型:

Prescription

治疗领域:

CONTRACEPTIVES

產品總結:

Active ingredient group (AIG) number: 0636783001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2020-03-05

产品特点

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_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
...........................................