ZAMINE 21 TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DROSPIRENONE; ETHINYL ESTRADIOL

Prieinama:

APOTEX INC

ATC kodas:

G03AA12

INN (Tarptautinis Pavadinimas):

DROSPIRENONE AND ESTROGEN

Dozė:

3MG; 0.03MG

Vaisto forma:

TABLET

Sudėtis:

DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

21

Recepto tipas:

Prescription

Gydymo sritis:

CONTRACEPTIVES

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2013-08-15

Prekės savybės

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
......................................................