TRI-CIRA 28 TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

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

זמין מ:

APOTEX INC

קוד ATC:

G03AB09

INN (שם בינלאומי):

NORGESTIMATE AND ETHINYLESTRADIOL

כמות:

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

טופס פרצבטיות:

TABLET

הרכב:

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

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

CONTRACEPTIVES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2020-11-18

מאפייני מוצר

PRODUCT MONOGRAPH
PR
TRI-CIRA 21
PR
TRI-CIRA 28
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
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
Apotex Standard
Oral Contraceptive
Apotex. Inc.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Preparation:
November 17, 2020
SUBMISSION CONTROL NO.: 230304
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
............................................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................................
4
CONTRAINDICATIONS
.......................................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................
12
DRUG INTERACTIONS
......................................................................................................................
18
DOSAGE AND ADMINISTRATION
..................................................................................................
27
OVERDOSAGE
....................................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................................
33
STORAGE AND STABILITY
..............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................. 35
PART II: SCIENTIFIC INFORMATION
...........................