CYESTRA-35 TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Pieejams no:

PALADIN LABS INC.

ATĶ kods:

G03HB01

SNN (starptautisko nepatentēto nosaukumu):

CYPROTERONE AND ESTROGEN

Deva:

2MG; 0.035MG

Zāļu forma:

TABLET

Kompozīcija:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

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:

2007-03-01

Produkta apraksts

______________________________________________________________________________________________
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_CYESTRA-35 Product Monograph Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CYESTRA
®
-35
cyproterone acetate and ethinyl estradiol tablets
2 mg/0.035 mg
THERAPEUTIC CLASSIFICATION
Acne Therapy
Paladin Labs Inc.
Date of Preparation:
100 Alexis Nihon Blvd, Suite 600
January 17, 2019
St-Laurent, Quebec
Version: 6.0
H4M 2P2
Control # 223341
______________________________________________________________________________________________
_
_CYESTRA-35 Product Monograph Page 2 of 48 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................3
SUMMARY PRODUCT INFORMATION
......................................................................................3
INDICATION AND CLINICAL USE
..............................................................................................3
CONTRAINDICATIONS
...............................................................................................................3
WARNINGS AND PRECAUTIONS
...............................................................................................4
ADVERSE
REACTIONS..............................................................................................................
13
DRUG INTERACTIONS
..............................................................................................................
16
DOSAGE AND
ADMINISTRATION
.........................................................................................
20
OVERDOSAGE
...........................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
22
STORAGE AND STABILITY
......................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
............................