YASMIN PLUS TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

DROSPIRENONE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM; ETHINYL ESTRADIOL

Tillgänglig från:

BAYER INC

ATC-kod:

G03AA12

INN (International namn):

DROSPIRENONE AND ESTROGEN

Dos:

3.0MG; 0.451MG; 0.451MG; 0.03MG

Läkemedelsform:

TABLET

Sammansättning:

DROSPIRENONE 3.0MG; LEVOMEFOLATE CALCIUM 0.451MG; LEVOMEFOLATE CALCIUM 0.451MG; ETHINYL ESTRADIOL 0.03MG

Administreringssätt:

ORAL

Enheter i paketet:

28

Receptbelagda typ:

Prescription

Terapiområde:

CONTRACEPTIVES

Produktsammanfattning:

Active ingredient group (AIG) number: 0453183002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2015-06-18

Produktens egenskaper

_ _
_YASMIN PLUS Product Monograph _
_ _
_Page 1 of 70 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
YASMIN
® PLUS
3.0 mg drospirenone, 0.030 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
http://www.bayer.ca
Date of Revision:
March 2, 2017
Submission Control No: 200982
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_YASMIN PLUS Product Monograph _
_ _
_Page 2 of 70 _
_ _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................29
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMAT