TRI-LENA LO 28 TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Boleh didapati daripada:

ACTAVIS PHARMA COMPANY

Kod ATC:

G03AB11

INN (Nama Antarabangsa):

NORGESTIMATE AND ESTROGEN

Dos:

0.180MG; 0.025MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG

Borang farmaseutikal:

TABLET

Komposisi:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

28

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CONTRACEPTIVES

Ringkasan produk:

Active ingredient group (AIG) number: 0636783003; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2017-09-01

Ciri produk

_ _
_Tri-Lena™ Lo Product Monograph _
_Page 1 of 66 _
PRODUCT MONOGRAPH
PR
TRI-LENA
™ LO 21
PR
TRI-LENA
™ LO 28
Norgestimate and Ethinyl Estradiol Tablets, USP
0.180 mg norgestimate and 0.025 mg ethinyl estradiol tablets
0.215 mg norgestimate and 0.025 mg ethinyl estradiol tablets
0.250 mg norgestimate and 0.025 mg ethinyl estradiol tablets
Oral Contraceptive
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
L5N 6J5
Date of Revision:
April 6, 2016
Submission Control No: 193856
_ _
_Tri-Lena™ Lo Product Monograph _
_Page 2 of 66 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................35
ACTION AND CLINICAL PHARMACOLOGY
............................................................36
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
................................................................................41
PHARMACEUTICAL INFORMATION
.............