YASMIN PLUS TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DROSPIRENONE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM; ETHINYL ESTRADIOL

から入手可能:

BAYER INC

ATCコード:

G03AA12

INN（国際名）:

DROSPIRENONE AND ESTROGEN

投薬量:

3.0MG; 0.451MG; 0.451MG; 0.03MG

医薬品形態:

TABLET

構図:

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

投与経路:

ORAL

パッケージ内のユニット:

28

処方タイプ:

Prescription

治療領域:

CONTRACEPTIVES

製品概要:

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

認証ステータス:

APPROVED

承認日:

2015-06-18

製品の特徴

_ _
_YASMIN PLUS Product Monograph _
_ _
_Page 1 of 70 _
_ _
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