YAZ PLUS TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM

Διαθέσιμο από:

BAYER INC

Φαρμακολογική κατηγορία (ATC):

G03AA12

INN (Διεθνής Όνομα):

DROSPIRENONE AND ESTROGEN

Δοσολογία:

3.00MG; 0.02MG; 0.451MG; 0.451MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DROSPIRENONE 3.00MG; ETHINYL ESTRADIOL 0.02MG; LEVOMEFOLATE CALCIUM 0.451MG; LEVOMEFOLATE CALCIUM 0.451MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CONTRACEPTIVES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0453183001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2012-06-06

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
YAZ
®
PLUS
3.0 mg drospirenone, 0.020 mg ethinyl estradiol, 0.451 mg levomefolate
calcium tablets and
0.451 mg levomefolate calcium tablets
Oral Contraceptive
Acne Therapy
Improvement in Folate Status
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
Canada
http://www.bayer.ca
Date of Revision:
March 2, 2017
Submission Control No: 201007
©2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_YAZ PLUS Product Monograph _
_ _
_Page 2 of 73 _
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
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
................................................................................37
PHARMACEUTICAL INFORMAT