TRI-JORDYNA 28 TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

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

Disponible des:

GLENMARK PHARMACEUTICALS CANADA INC.

Codi ATC:

G03AB09

Designació comuna internacional (DCI):

NORGESTIMATE AND ETHINYLESTRADIOL

Dosis:

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

formulario farmacéutico:

TABLET

Composición:

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

Vía de administración:

ORAL

Unidades en paquete:

84 TABS (3 X 28)

tipo de receta:

Prescription

Área terapéutica:

CONTRACEPTIVES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2019-03-01

Fitxa tècnica

_Pr_
_TRI-JORDYNA_
_™ _
_(Norgestimate and Ethinyl Estradiol Tablets USP) _
_Page 1 of 57_
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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