ACETYLCYSTEINE INJECTION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ACETYLCYSTEINE

Доступно од:

EUGIA PHARMA INC.

АТЦ код:

R05CB01

INN (Међународно име):

ACETYLCYSTEINE

Дозирање:

200MG

Фармацеутски облик:

SOLUTION

Састав:

ACETYLCYSTEINE 200MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

100

Тип рецептора:

Ethical

Резиме производа:

Active ingredient group (AIG) number: 0100024001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2023-02-03

Карактеристике производа

Page 1 of 18
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACETYLCYSTEINE INJECTION
200 mg / mL
Sterile Solution for Injection
House Standard
Antidote for Acetaminophen Poisoning
Eugia Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario
L4L 8K8, Canada
Submission Control No.: 270744
Date
of
Preparation:
FEB 1, 2023
Page 2 of 18
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................
3
ADVERSE REACTIONS
....................................................................................................
5
DRUG INTERACTIONS
.....................................................................................................
5
DOSAGE AND ADMINISTRATION
....................................................................................
5
OVERDOSAGE
................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 10
STORAGE AND
STABILITY.............................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 11
PART II: SCIENTIFIC INFORMATION
..........................................................................................
12
PHARMACEUTICAL INFORMATION
.....................................