CASPOFUNGIN ACETATE FOR INJECTION POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

J02AX04

INN (Medzinárodný Name):

CASPOFUNGIN

Dávkovanie:

50MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

ECHINOCANDINS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2018-08-01

Súhrn charakteristických

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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
_ _
_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