ACETYLCYSTEINE INJECTION SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
01-02-2023
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Aktiv bestanddel:
ACETYLCYSTEINE
Tilgængelig fra:
EUGIA PHARMA INC.
ATC-kode:
R05CB01
INN (International Name):
ACETYLCYSTEINE
Dosering:
200MG
Lægemiddelform:
SOLUTION
Sammensætning:
ACETYLCYSTEINE 200MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
100
Recept type:
Ethical
Produkt oversigt:
Active ingredient group (AIG) number: 0100024001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2023-02-03
Produktets egenskaber
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
.....................................
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