ACETAMINOPHEN INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ACETAMINOPHEN

Διαθέσιμο από:

B. BRAUN MELSUNGEN AG

Φαρμακολογική κατηγορία (ATC):

N02BE01

INN (Διεθνής Όνομα):

ACETAMINOPHEN (PARACETAMOL)

Δοσολογία:

1000MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ACETAMINOPHEN 1000MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0102009015; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-02-24

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACETAMINOPHEN INJECTION
Acetaminophen Injection
Sterile solution for infusion, 10 mg/mL, intravenous
(Available as 100 mg/10 mL, 500 mg/50 mL and 1000 mg/100 mL)
Analgesic and Antipyretic
B. BRAUN MELSUNGEN AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Date of Initial Authorization:
February 24, 2023
Imported and Distributed by:
B. BRAUN OF CANADA, LTD.
2000 Ellesmere Road, Unit 16
Scarborough, Ontario M1H 2W4
Submission Control No: 244695
Acetaminophen Injection
Page 2 of 26
RECENT MAJOR LABEL CHANGES
None at time of authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
......................................................................................................................
4
1.1
Pediatrics.......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
...................................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment................................................