TRI-JORDYNA 28 TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

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

Tersedia dari:

GLENMARK PHARMACEUTICALS CANADA INC.

Kode ATC:

G03AB09

INN (Nama Internasional):

NORGESTIMATE AND ETHINYLESTRADIOL

Dosis:

0.035MG; 0.18MG; 0.215MG; 0.035MG; 0.25MG; 0.035MG

Bentuk farmasi:

TABLET

Komposisi:

ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.18MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Rute administrasi :

ORAL

Unit dalam paket:

84 TABS (3 X 28)

Jenis Resep:

Prescription

Area terapi:

CONTRACEPTIVES

Ringkasan produk:

Active ingredient group (AIG) number: 0636783002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-03-01

Karakteristik produk

_Pr_
_TRI-JORDYNA_
_™ _
_(Norgestimate and Ethinyl Estradiol Tablets USP) _
_Page 1 of 57_
_ _
PRODUCT MONOGRAPH
PR
TRI-JORDYNA™ 21
PR
TRI-JORDYNA ™ 28
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP
0.18 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.25 mg norgestimate and 0.035 mg ethinyl estradiol
Oral Contraceptive
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West,
Suite 407, Concord, ON
L4K 4M2
Date of Revision:
June 18, 2020
SUBMISSION CONTROL NO.: 238797
_Pr_
_TRI-JORDYNA_
_™ _
_(Norgestimate and Ethinyl Estradiol Tablets USP) _
_Page 2 of 57_
_ _
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
......................................................................................................
12
DRUG INTERACTIONS
......................................................................................................
17
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE
.....................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 28
STORAGE AND STABILITY
..............................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 30
PART II: SCIENTIFIC INFOR