DIANE-35 TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Pieejams no:

BAYER INC

ATĶ kods:

G03HB01

SNN (starptautisko nepatentēto nosaukumu):

CYPROTERONE AND ESTROGEN

Deva:

2MG; 35MCG

Zāļu forma:

TABLET

Kompozīcija:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 35MCG

Ievadīšanas:

ORAL

Vienības iepakojumā:

21

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0232337001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

1997-09-17

Produkta apraksts

_DIANE-35 Product Monograph_
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIANE
®
-35
cyproterone acetate and ethinyl estradiol tablets
2 mg cyproterone acetate and 0.035 mg ethinyl estradiol tablets
Acne Therapy
Bayer Inc.
Date of Revision:
2920 Matheson Boulevard East
March 16, 2017
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Submission Control No.: 201157
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_DIANE-35 Product Monograph_
Page 2 of 44
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
.................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART
II:
SCIENTIFIC
INFORMATION
.....