ACETYLCYSTEINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACETYLCYSTEINE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

R05CB01

INN (International Name):

ACETYLCYSTEINE

Dosage:

200MG

Pharmaceutical form:

SOLUTION

Composition:

ACETYLCYSTEINE 200MG

Administration route:

INHALATION

Units in package:

10/30 ML

Prescription type:

Ethical

Therapeutic area:

ANTIDOTES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2000-12-11

Summary of Product characteristics

_Acetylcysteine Solution_
Page 1 of 30
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACETYLCYSTEINE SOLUTION
Sandoz Standard
200 mg/mL
Solution for Injection, Inhalation or Oral Administration
Mucolytic
Antidote for Acetaminophen Poisoning
Sandoz Canada Inc.
110 Rue de Lauzon
Date of Revision: March 24, 2021
Boucherville, QC, Canada
J4B 1E6
Control No.: 243471
_Acetylcysteine Solution_
Page 2 of 30
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
........................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................
7
OVERDOSAGE
....................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 17
STORAGE AND STABILITY
..............................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 19
PART II: SCIENTIFIC INFORMATION
.............................................................................
20
PHARMACEUTICAL