ZARAH 21 TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DROSPIRENONE; ETHINYL ESTRADIOL

Dostupné s:

COBALT PHARMACEUTICALS COMPANY

ATC kód:

G03AA12

INN (Mezinárodní Name):

DROSPIRENONE AND ESTROGEN

Dávkování:

3MG; 0.03MG

Léková forma:

TABLET

Složení:

DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG

Podání:

ORAL

Jednotky v balení:

21

Druh předpisu:

Prescription

Terapeutické oblasti:

CONTRACEPTIVES

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-11-12

Charakteristika produktu

_ZARAH_
_TM_
_ Product Monograph _
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_Page 1 of 58_
PRODUCT MONOGRAPH
PR
ZARAH
™ 21
PR
ZARAH
™ 28
(3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets)
Oral Contraceptive
Acne Therapy
Cobalt Pharmaceuticals Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
July 03, 2015
Submission Control No.: 181396
_ZARAH_
_TM_
_ Product Monograph _
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_Page 2 of 58_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
......................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
......................