DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
09-04-2021
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
DROSPIRENONE; ETHINYL ESTRADIOL
Tilgængelig fra:
GLENMARK PHARMACEUTICALS CANADA INC.
ATC-kode:
G03AA12
INN (International Name):
DROSPIRENONE AND ESTROGEN
Dosering:
3MG; 0.02MG
Lægemiddelform:
TABLET
Sammensætning:
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.02MG
Indgivelsesvej:
ORAL
Enheder i pakken:
28
Recept type:
Prescription
Terapeutisk område:
CONTRACEPTIVES
Produkt oversigt:
Active ingredient group (AIG) number: 0250430002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2020-09-01
Produktets egenskaber
_____________________________________________________________________________________________
_Pr_
_Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_
_Page 1 of 67_
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
_____________________________________________________________________________________________
_Pr_
_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
..............
Læs hele dokumentet
