ACETAMINOPHEN INJECTION SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ACETAMINOPHEN

Disponibbli minn:

B. BRAUN MELSUNGEN AG

Kodiċi ATC:

N02BE01

INN (Isem Internazzjonali):

ACETAMINOPHEN (PARACETAMOL)

Dożaġġ:

100MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

ACETAMINOPHEN 100MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2023-02-24

Karatteristiċi tal-prodott

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