ZAMINE 28 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:

28

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
3.0 MG DROSPIRENONE AND 0.03 MG ETHINYL ESTRADIOL TABLETS
ORAL CONTRACEPTIVE
ACNE THERAPY APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JUNE 9, 2015
TORONTO, ONTARIO
M9L 1T9
CONTROL NO.: 184863
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
...............................................................................
33
CLIN