BUPIVACAINE INJECTION BP SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BUPIVACAINE HYDROCHLORIDE

Disponible desde:

AURO PHARMA INC

Código ATC:

N01BB01

Designación común internacional (DCI):

BUPIVACAINE

Dosis:

5MG

formulario farmacéutico:

SOLUTION

Composición:

BUPIVACAINE HYDROCHLORIDE 5MG

Vía de administración:

BLOCK/INFILTRATION

Unidades en paquete:

10X10ML

tipo de receta:

Ethical

Área terapéutica:

LOCAL ANESTHETICS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-09-15

Ficha técnica

Page 1 of 27
PRODUCT MONOGRAPH
BUPIVACAINE INJECTION BP
Bupivacaine hydrochloride
0.25% (2.5 mg/ml) and 0.5% (5 mg/ml)
_Local Anesthetic_
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision: September 9, 2016
Submission Control No: 185259
Page 2 of 27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
...................................................................................................9
DRUG INTERACTIONS
.................................................................................................10
DOSAGE AND ADMINISTRATION
.............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................19
SPECIAL HANDLING INSTRUCTIONS
.......................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
..............................................................................20
PHARMACEUTICAL INFORMATION
.........................................................................20
DETAILED PHARMACOLOGY
........................................................................