Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
PROPOFOL
MARCAN PHARMACEUTICALS INC
N01AX10
PROPOFOL
10MG
EMULSION
PROPOFOL 10MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0121833001; AHFS:
APPROVED
2022-03-21
_ _ _Page 1 of 38 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PROPOFOL INJECTION Propofol Injectable Emulsion, USP Emulsion, 10 mg / mL (1% w / v), Intravenous USP General Anaesthetic ATC CODE: N01AX10 Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite#112, Ottawa, ON, K2E1A2 Date of Initial Authorization: MAR 08, 2022 Submission Control No: 255332 _Page 2 of 38_ RECENT MAJOR LABEL CHANGES Not Applicable TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 1 INDICATIONS ......................................................................................................................... 4 1.1 P EDIA TRICS ........................................................................................................................ 4 1.2 G ERIATRICS ........................................................................................................................ 4 2 CONTRAINDICATIONS .......................................................................................................... 4 4 DOSAGE AND ADMINISTRATION.......................................................................................... 5 4.1 D OSING CONSIDERA TIONS .................................................................................................. 5 4.2 R ECOMMENDED D OSE AND D OSAGE A DJUSTMENT ............................................................... 6 INDUCTION OF GENERAL ANAESTHESIA .............................................................................. 6 4.3 R ECONSTITUTION ............................................................................................................ 12 4.4 A DMINISTRA TION ............................................................................................................ 12 5 OVERDOSAGE .................................................................................................................. 13 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 14 7 Soma hati kamili