MARCAINE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BUPIVACAINE HYDROCHLORIDE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

N01BB01

INN (Nama Internasional):

BUPIVACAINE

Dosis:

5MG

Bentuk farmasi:

SOLUTION

Komposisi:

BUPIVACAINE HYDROCHLORIDE 5MG

Rute administrasi :

BLOCK/INFILTRATION

Unit dalam paket:

10ML/20ML

Jenis Resep:

Ethical

Area terapi:

LOCAL ANESTHETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0108896004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2004-05-04

Karakteristik produk

PRODUCT MONOGRAPH
MARCAINE
®
(Bupivacaine Hydrochloride Injection USP)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
MARCAINE
® SPINAL
(Bupivacaine Hydrochloride in Dextrose Injection USP)
7.5 mg/mL
MARCAINE
® E
(Bupivacaine Hydrochloride and Epinephrine Injection USP)
Bupivacaine Hydrochloride 2.5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Bupivacaine Hydrochloride 5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Sterile Solution
Local Anesthetic
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 208287
Date of Revision:
September 6, 2017
_Product Monograph – Marcaine_
_®_
_, Marcaine_
_®_
_ Spinal, Marcaine_
_®_
_ E _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION