TRI-CIRA LO 21 TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

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

Boleh didapati daripada:

APOTEX INC

Kod ATC:

G03AB09

INN (Nama Antarabangsa):

NORGESTIMATE AND ETHINYLESTRADIOL

Dos:

0.18MG; 0.025MG; 0.215MG; 0.025MG; 0.25MG; 0.025MG

Borang farmaseutikal:

TABLET

Komposisi:

NORGESTIMATE 0.18MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.025MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

21

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CONTRACEPTIVES

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-03-23

Ciri produk

Page 1 of 67
PRODUCT MONOGRAPH
PR
TRI-CIRA LO
TM 21
PR
TRI-CIRA LO
TM 28
Norgestimate and Ethinyl Estradiol Tablets
0.18 mg norgestimate and 0.025 mg ethinyl estradiol
0.215 mg norgestimate and 0.025 mg ethinyl estradiol
0.25 mg norgestimate and 0.025 mg ethinyl estradiol
Apotex Standard
Oral Contraceptive
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
March 19, 2021
Submission Control No.:245005
Page 2 of 67
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................3
SUMMARY PRODUCT INFORMATION
.............................................................................3
INDICATIONS AND CLINICAL USE
..................................................................................4
CONTRAINDICATIONS
.......................................................................................................5
WARNINGS AND PRECAUTIONS
......................................................................................6
ADVERSE REACTIONS
.....................................................................................................
14
DRUG INTERACTIONS
......................................................................................................
20
DOSAGE AND ADMINISTRATION
..................................................................................
29
OVERDOSAGE....................................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 35
STORAGE AND STABILITY
..............................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
40
PHARMACEUTICAL INFORMATION
..............................................................................
40
CLINICAL TR