Страна: Канада
мова: англійська
Джерело: Health Canada
PROPOFOL
FRESENIUS KABI CANADA LTD
N01AX10
PROPOFOL
10MG
EMULSION
PROPOFOL 10MG
INTRAVENOUS
20/50/100ML
Prescription
MISCELLANEOUS GENERAL ANESTHETICS
Active ingredient group (AIG) number: 0121833001; AHFS:
APPROVED
2015-02-19
_PROPOFOL INJECTION (Propofol Injectable Emulsion) _ _Page 1 of 36_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PROPOFOL INJECTION Propofol Injectable Emulsion Emulsion, 10 mg / mL, Intravenous Mfr. Std. General Anesthetic FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Initial Authorization: FEB 23, 2015 Date of Revision: MAR 25, 2022 Submission Control Number: 260435 _PROPOFOL INJECTION (Propofol Injectable Emulsion) _ _Page 2 of 36_ _ _ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.1 Dosing Considerations 03/2022 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 ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 5 4.1 Dosing Considerations ...................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ...................................................... 6 4.3 Reconstitution ............................................................................................... 11 4.4 Administration Прочитайте повний документ