CASPOFUNGIN ACETATE FOR INJECTION POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

J02AX04

INN (국제 이름):

CASPOFUNGIN

복용량:

50MG

약제 형태:

POWDER FOR SOLUTION

구성:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

관리 경로:

INTRAVENOUS

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ECHINOCANDINS

제품 요약:

Active ingredient group (AIG) number: 0144763001; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2018-08-01

제품 특성 요약

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_Caspofungin Acetate for Injection _
_Page 1 of 53_
PRODUCT MONOGRAPH
PR
CASPOFUNGIN ACETATE FOR INJECTION
50 mg/vial and 70 mg/vial caspofungin (as caspofungin acetate)
Antifungal
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (QC)
J4B 7K8
Date of Revision:
July 17, 2017
Submission Control No: 207225
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_Caspofungin Acetate for Injection _
_Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
..........................................................................................................36
DETAILED PHAR