ACETYLCYSTEINE INJECTION SOLUTION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
20-06-2022
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Aktiva substanser:
ACETYLCYSTEINE
Tillgänglig från:
AURO PHARMA INC
ATC-kod:
R05CB01
INN (International namn):
ACETYLCYSTEINE
Dos:
200MG
Läkemedelsform:
SOLUTION
Sammansättning:
ACETYLCYSTEINE 200MG
Administreringssätt:
INTRAVENOUS
Enheter i paketet:
100
Receptbelagda typ:
Ethical
Produktsammanfattning:
Active ingredient group (AIG) number: 0100024001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2022-06-20
Produktens egenskaper
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
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Submission Control No: 245418
Date of Preparation:
June 20, 2022.
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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