ACETYLCYSTEINE SOLUTION USP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETYLCYSTEINE

Available from:

HIKMA CANADA LIMITED

ATC code:

R05CB01

INN (International Name):

ACETYLCYSTEINE

Dosage:

200MG

Pharmaceutical form:

SOLUTION

Composition:

ACETYLCYSTEINE 200MG

Administration route:

INHALATION

Units in package:

15G/50G

Prescription type:

Ethical

Therapeutic area:

ANTIDOTES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-09-01

Summary of Product characteristics

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_Acetylcysteine Solution USP _
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Confidential
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACETYLCYSTEINE SOLUTION USP
200 mg / mL
Solution for Injection, Inhalation or Oral Administration
Mucolytic
Antidote for Acetaminophen Poisoning
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Submission Control No.: 264525
Date of
Preparation:
June 20, 2022
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_Acetylcysteine Solution USP _
_Page 2 of 31_
Confidential
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
DETAILED PHARMACOLOGY
..........................