Country: Canada
Language: English
Source: Health Canada
EPINEPHRINE (EPINEPHRINE BITARTRATE); BUPIVACAINE HYDROCHLORIDE
ASPEN PHARMACARE CANADA INC.
N01BB51
BUPIVACAINE, COMBINATIONS
5MCG; 2.5MG
SOLUTION
EPINEPHRINE (EPINEPHRINE BITARTRATE) 5MCG; BUPIVACAINE HYDROCHLORIDE 2.5MG
BLOCK/INFILTRATION
20ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0204884001; AHFS:
APPROVED
2000-02-14
_Read the complete document _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION SENSORCAINE ® Bupivacaine Hydrochloride Solution, 0.25% (2.5 mg/mL) and 0.5% (5 mg/mL), Epidural, Block/Infiltration USP SENSORCAINE ® WITH EPINEPHRINE Bupivacaine Hydrochloride and Epinephrine Solution, 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate [(1:200,000) 5 mcg/mL] and 0.5% bupivacaine hydrochloride (5 mg/mL) and epinephrine bitartrate [(1:200,000) 5 mcg/mL], Epidural, Block/Infiltration USP Local Anesthetics Aspen Pharmacare Canada Inc 8-1155 North Service Road West Oakville, Ontario, L6M 3E3 Date of Initial Authorization: MAR 02, 2000 Date of Revision: April 12, 2022 Submission Control Number: 254303 Trademarks are owned by or licensed to the Aspen Group of companies. © 2022 ASPEN GROUP OF COMPANIES OR ITS LICENSOR. ALL RIGHTS RESERVED. _<_ _SENSORCAINE_ _®_ _>< Bupivacaine Hydrochloride > Page 2 of 36 _ _<_ _SENSORCAINE_ _®_ _ with Epinephrine> _ _ _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions 04/2021 7.Warnings and Precautions, hepatic 04/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................4 1 INDICATIONS ..................................................................................................................4 1.1 Pediatrics ....................................................................................................................4 1.2 Geriatrics ....................................................................................................................4 2 CONTRAINDICATIONS ........................................