MARCAINE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BUPIVACAINE HYDROCHLORIDE

Disponible depuis:

PFIZER CANADA ULC

Code ATC:

N01BB01

DCI (Dénomination commune internationale):

BUPIVACAINE

Dosage:

125MG

forme pharmaceutique:

SOLUTION

Composition:

BUPIVACAINE HYDROCHLORIDE 125MG

Mode d'administration:

BLOCK/INFILTRATION

Unités en paquet:

50ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

LOCAL ANESTHETICS

Descriptif du produit:

Active ingredient group (AIG) number: 0108896001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2004-05-04

Résumé des caractéristiques du produit

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