YASMIN PLUS TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DROSPIRENONE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM; ETHINYL ESTRADIOL

Tersedia dari:

BAYER INC

Kode ATC:

G03AA12

INN (Nama Internasional):

DROSPIRENONE AND ESTROGEN

Dosis:

3.0MG; 0.451MG; 0.451MG; 0.03MG

Bentuk farmasi:

TABLET

Komposisi:

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

Rute administrasi :

ORAL

Unit dalam paket:

28

Jenis Resep:

Prescription

Area terapi:

CONTRACEPTIVES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-06-18

Karakteristik produk

_ _
_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