ACETYLCYSTEINE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ACETYLCYSTEINE

Διαθέσιμο από:

EUGIA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

R05CB01

INN (Διεθνής Όνομα):

ACETYLCYSTEINE

Δοσολογία:

200MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ACETYLCYSTEINE 200MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Ethical

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-02-03

Αρχείο Π.Χ.Π.

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
.....................................