TRI-CIRA LO 28 TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

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

可用日期:

APOTEX INC

ATC代码:

G03AB09

INN（国际名称）:

NORGESTIMATE AND ETHINYLESTRADIOL

剂量:

0.18MG; 0.025MG; 0.215MG; 0.025MG; 0.25MG; 0.025MG

药物剂型:

TABLET

组成:

NORGESTIMATE 0.18MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.025MG

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: 0636783003; AHFS:

授权状态:

APPROVED

授权日期:

2021-03-23

产品特点

Page 1 of 67
PRODUCT MONOGRAPH
PR
TRI-CIRA LO
TM 21
PR
TRI-CIRA LO
TM 28
Norgestimate and Ethinyl Estradiol Tablets
0.18 mg norgestimate and 0.025 mg ethinyl estradiol
0.215 mg norgestimate and 0.025 mg ethinyl estradiol
0.25 mg norgestimate and 0.025 mg ethinyl estradiol
Apotex Standard
Oral Contraceptive
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
March 19, 2021
Submission Control No.:245005
Page 2 of 67
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................3
SUMMARY PRODUCT INFORMATION
.............................................................................3
INDICATIONS AND CLINICAL USE
..................................................................................4
CONTRAINDICATIONS
.......................................................................................................5
WARNINGS AND PRECAUTIONS
......................................................................................6
ADVERSE REACTIONS
.....................................................................................................
14
DRUG INTERACTIONS
......................................................................................................
20
DOSAGE AND ADMINISTRATION
..................................................................................
29
OVERDOSAGE....................................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 35
STORAGE AND STABILITY
..............................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
40
PHARMACEUTICAL INFORMATION
..............................................................................
40
CLINICAL TR