ACETYLCYSTEINE SOLUTION USP

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ACETYLCYSTEINE

Disponible depuis:

STERIMAX INC

Code ATC:

R05CB01

DCI (Dénomination commune internationale):

ACETYLCYSTEINE

Dosage:

200MG

forme pharmaceutique:

SOLUTION

Composition:

ACETYLCYSTEINE 200MG

Mode d'administration:

INHALATION

Unités en paquet:

100

Type d'ordonnance:

Ethical

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-05-30

Résumé des caractéristiques du produit

_Acetylcysteine Solution USP _
Page 1 of 30
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACETYLCYSTEINE SOLUTION USP
200 mg/mL
Solution for Injection, Inhalation or Oral Administration
Mucolytic
Antidote for Acetaminophen Poisoning
SteriMax Inc.
2770 Portland Drive
Oakville, ON, Canada
L6H 6R4
Date of Preparation: May 29, 2023
Control No.: 269824
_Acetylcysteine Solution USP _
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
..................................................