DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DROSPIRENONE; ETHINYL ESTRADIOL

Disponible des:

GLENMARK PHARMACEUTICALS CANADA INC.

Codi ATC:

G03AA12

Designació comuna internacional (DCI):

DROSPIRENONE AND ESTROGEN

Dosis:

3MG; 0.02MG

formulario farmacéutico:

TABLET

Composición:

DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.02MG

Vía de administración:

ORAL

Unidades en paquete:

28

tipo de receta:

Prescription

Área terapéutica:

CONTRACEPTIVES

Resumen del producto:

Active ingredient group (AIG) number: 0250430002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2020-09-01

Fitxa tècnica

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_Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_
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PRODUCT MONOGRAPH
PR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP
3 mg drospirenone and 0.02 mg ethinyl estradiol tablets
Oral Contraceptive
Acne Therapy
Submission Control Number: 245894
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, Ontario
L4K 4M2
Date of Revision:
April 09, 2021
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_Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_
_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND STABILITY
.........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
..............