Страна: Канада
Язык: английский
Источник: Health Canada
BUPIVACAINE HYDROCHLORIDE
PFIZER CANADA ULC
N01BB01
BUPIVACAINE
15MG
SOLUTION
BUPIVACAINE HYDROCHLORIDE 15MG
INTRASPINAL
2ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0108896002; AHFS:
APPROVED
2004-05-04
_MARCAINE (Bupivacaine Hydrochloride Injection) _ _Page 1 of 39 _ _MARCAINE SPINAL (Bupivacaine Hydrochloride in Dextrose Injection) _ _MARCAINE E (Bupivacaine Hydrochloride in Dextrose Injection)_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MARCAINE® Bupivacaine Hydrochloride Injection Sterile Solution, 2.5 mg/mL, 5 mg/mL and 7.5 mg/mL, Parenteral – Retrobulbar, Epidural, Block/Infiltration MARCAINE® SPINAL Bupivacaine Hydrochloride in Dextrose Injection Sterile Solution, 7.5 mg/mL, Parenteral – Intraspinal MARCAINE® E Bupivacaine Hydrochloride and Epinephrine Injection Sterile Solution, Bupivacaine Hydrochloride (2.5 mg/mL and 5 mg/mL) and Epinephrine Bitartrate (9.1 mcg/mL), Parenteral – Epidural, Block/Infiltration USP Local Anesthetic Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Authorization: SEP 06, 2017 Date of Revision: MAY 11, 2023 Submission Control Number: 269793 _ _ _MARCAINE (Bupivacaine Hydrochloride Injection) _ _Page 2 of 39 _ _MARCAINE SPINAL (Bupivacaine Hydrochloride in Dextrose Injection) _ _MARCAINE E (Bupivacaine Hydrochloride and Epinephrine Injection)_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 05/2023 7 WARNINGS AND PRECAUTIONS, GENERAL, HEPATIC/BILIARY/PANCREATIC 05/2023 TABLE OF CONTENTS 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 ........................ Прочитать полный документ