País: Canadà
Idioma: anglès
Font: Health Canada
ACETAMINOPHEN
B. BRAUN MELSUNGEN AG
N02BE01
ACETAMINOPHEN (PARACETAMOL)
1000MG
SOLUTION
ACETAMINOPHEN 1000MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0102009015; AHFS:
APPROVED
2023-02-24
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................................................ Llegiu el document complet