TRI-JORDYNA 28 TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

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

제공처:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC 코드:

G03AB09

INN (International Name):

NORGESTIMATE AND ETHINYLESTRADIOL

복용량:

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

약제 형태:

TABLET

구성:

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

관리 경로:

ORAL

패키지 단위:

84 TABS (3 X 28)

처방전 유형:

Prescription

치료 영역:

CONTRACEPTIVES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2019-03-01

제품 특성 요약

_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