BACKUP PLAN TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
22-11-2017
この製品の一部のドキュメントは現在利用できません。カスタマーサービスにリクエストを送信できます。入手可能になり次第、お知らせします。
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有効成分:
LEVONORGESTREL
から入手可能:
APOTEX INC
ATCコード:
G03AD01
INN（国際名）:
LEVONORGESTREL
投薬量:
0.75MG
医薬品形態:
TABLET
構図:
LEVONORGESTREL 0.75MG
投与経路:
ORAL
パッケージ内のユニット:
2
処方タイプ:
OTC
治療領域:
CONTRACEPTIVES
製品概要:
Active ingredient group (AIG) number: 0125218002; AHFS:
認証ステータス:
CANCELLED PRE MARKET
承認日:
2019-05-04
製品の特徴
_Page 1 of 33 _
PRODUCT MONOGRAPH
BACKUP PLAN™
LEVONORGESTREL TABLETS 0.75 MG
APOTEX STANDARD
EMERGENCY CONTRACEPTION
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
NOVEMBER 22, 2017
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 209714
_Page 2 of 33 _
TABLE OF CONTENTS
PART I: HEALTH CARE PROFESSIONAL INFORMATION
.......................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
7
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
12
OVERDOSAGE
......................................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
13
STORAGE AND STABILITY
...............................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 16
PART II: SCIENTIFIC INFORMATION
.............................................................................
17
PHARMACEUTICAL INFORMATION
...............................................................................
17
CLINICAL TRIALS
...............................................................................................................
18
DETAILED PHARMACOLOGY
...............................
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