CASPOFUNGIN ACETATE FOR INJECTION POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

J02AX04

ІПН (Міжнародна Ім'я):

CASPOFUNGIN

Дозування:

50MG

Фармацевтична форма:

POWDER FOR SOLUTION

Склад:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

ECHINOCANDINS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2018-08-01

Характеристики продукта

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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