TRI-JORDYNA 28 TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

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

Dostupno od:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC koda:

G03AB09

INN (International ime):

NORGESTIMATE AND ETHINYLESTRADIOL

Doziranje:

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

Farmaceutski oblik:

TABLET

Sastav:

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

Administracija rute:

ORAL

Jedinice u paketu:

84 TABS (3 X 28)

Tip recepta:

Prescription

Područje terapije:

CONTRACEPTIVES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2019-03-01

Svojstava lijeka

_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