TRI-PREVIFEM (28 DAY) TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

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

זמין מ:

NOVOPHARM LIMITED

קוד ATC:

G03AB

INN (שם בינלאומי):

PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS

כמות:

0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG

טופס פרצבטיות:

TABLET

הרכב:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

28

סוג מרשם:

Prescription

איזור תרפויטי:

CONTRACEPTIVES

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2018-07-24

מאפייני מוצר

_Page 1_
PRODUCT MONOGRAPH
PR
TRI-PREVIFEM
0.180 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.250 mg norgestimate and 0.035 mg ethinyl estradiol
Tablets
Novopharm Standard
Oral Contraceptive
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 116255
Date of Preparation:
January 31, 2005
Date of revision:
December 2, 2008
_Page 2_
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...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.............................................................