ZAMINE 21 TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DROSPIRENONE; ETHINYL ESTRADIOL

זמין מ:

APOTEX INC

קוד ATC:

G03AA12

INN (שם בינלאומי):

DROSPIRENONE AND ESTROGEN

כמות:

3MG; 0.03MG

טופס פרצבטיות:

TABLET

הרכב:

DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

21

סוג מרשם:

Prescription

איזור תרפויטי:

CONTRACEPTIVES

leaflet_short:

Active ingredient group (AIG) number: 0250430001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-08-15

מאפייני מוצר

Page 1 of 57
PRODUCT MONOGRAPH
PR ZAMINE
®
21
PR ZAMINE
®
28
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, USP
3 MG DROSPIRENONE AND 0.03 MG ETHINYL ESTRADIOL TABLETS
ORAL CONTRACEPTIVE
ACNE THERAPY
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
MAY 11, 2020
TORONTO, ONTARIO
M9L 1T9
Submission Control No - 237824
Page 2 of 57
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
.......................................................................................................14
DRUG INTERACTIONS
.......................................................................................................18
DOSAGE AND ADMINISTRATION
......................................................................................24
OVERDOSAGE
....................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
......................................................................27
STORAGE AND STABILITY
................................................................................................31
SPECIAL HANDLING INSTRUCTIONS
................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................31
PART II: SCIENTIFIC INFORMATION .................................................................................33
PHARMACEUTICAL INFORMATION
......................................................