TRI-JORDYNA 28 TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

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

متاح من:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC رمز:

G03AB09

INN (الاسم الدولي):

NORGESTIMATE AND ETHINYLESTRADIOL

جرعة:

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

الشكل الصيدلاني:

TABLET

تركيب:

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

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

84 TABS (3 X 28)

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

CONTRACEPTIVES

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2019-03-01

خصائص المنتج

_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