MARCAINE E SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

N01BB51

INN (Nama Internasional):

BUPIVACAINE, COMBINATIONS

Dosis:

100MG; 0.182MG

Bentuk farmasi:

SOLUTION

Komposisi:

BUPIVACAINE HYDROCHLORIDE 100MG; EPINEPHRINE BITARTRATE 0.182MG

Rute administrasi :

BLOCK/INFILTRATION

Unit dalam paket:

20ML

Jenis Resep:

Ethical

Area terapi:

LOCAL ANESTHETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0231290002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2004-05-04

Karakteristik produk

_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 07, 2017
Date of Revision:
MAY 11, 2023
Submission Control Number: 269757
_ _
_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
........................