CYESTRA-35 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Διαθέσιμο από:

PALADIN LABS INC.

Φαρμακολογική κατηγορία (ATC):

G03HB01

INN (Διεθνής Όνομα):

CYPROTERONE AND ESTROGEN

Δοσολογία:

2MG; 0.035MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

21

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2007-03-01

Αρχείο Π.Χ.Π.

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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
______________________________________________________________________________________________
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_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
............................