TRI-PREVIFEM (28 DAY) TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

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

から入手可能:

NOVOPHARM LIMITED

ATCコード:

G03AB

INN（国際名）:

PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS

投薬量:

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

医薬品形態:

TABLET

構図:

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

投与経路:

ORAL

パッケージ内のユニット:

28

処方タイプ:

Prescription

治療領域:

CONTRACEPTIVES

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2018-07-24

製品の特徴

_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.............................................................