MARCAINE SPINAL SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

BUPIVACAINE HYDROCHLORIDE

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

N01BB01

INN (International Nazwa):

BUPIVACAINE

Dawkowanie:

15MG

Forma farmaceutyczna:

SOLUTION

Skład:

BUPIVACAINE HYDROCHLORIDE 15MG

Droga podania:

INTRASPINAL

Sztuk w opakowaniu:

2ML

Typ recepty:

Ethical

Dziedzina terapeutyczna:

LOCAL ANESTHETICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108896002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2004-05-04

Charakterystyka produktu

_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
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