CASPOFUNGIN ACETATE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosage:

50MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ECHINOCANDINS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-08-01

Summary of Product characteristics

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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