TRI-CYCLEN LO (21 DAY) TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

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

Boleh didapati daripada:

JANSSEN INC

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:

21

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CONTRACEPTIVES

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2020-08-28

Ciri produk

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PRODUCT MONOGRAPH
PR
TRI-CYCLEN
® LO
norgestimate and ethinyl estradiol Tablets, House Std.
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
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 3, 2020
Submission Control No.: 235080
All trademarks used under license.
© 2020 Janssen Inc.
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_Page 2 of 58 _
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
...........................................................................................................
13
DRUG INTERACTIONS
...........................................................................................................
19
DOSAGE AND ADMINISTRATION
.......................................................................................
26
OVERDOSAGE
...........................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
33
STORAGE AND STABILITY
...................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 36
PART II: SCIENTIFIC INFORMATION
...........................................