BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Dostupné s:

NOVOCOL PHARMACEUTICAL OF CANADA INC

ATC kód:

N01BB51

INN (Mezinárodní Name):

BUPIVACAINE, COMBINATIONS

Dávkování:

5MG; 0.0091MG

Léková forma:

SOLUTION

Složení:

BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG

Podání:

BLOCK/INFILTRATION

Jednotky v balení:

1.8ML

Druh předpisu:

Ethical

Terapeutické oblasti:

LOCAL ANESTHETICS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2012-04-16

Charakteristika produktu

_Novocol Pharmaceutical of Canada, Inc._
Page 1 of 24
PRODUCT MONOGRAPH
BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION
(BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION USP)
_ _
_ _
_ _
_Local Anaesthetic for Dental Use _
Sponsor/Manufacturer:
Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Court,
Cambridge, Ontario,
N1R 6X3
Date of Preparation:
March 15, 2012
Submission Control No: 153985
_Novocol Pharmaceutical of Canada, Inc._
Page 2 of 24
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................................3
SUMMARY PRODUCT INFORMATION
....................................................................................................3
INDICATIONS AND CLINICAL
USE..........................................................................................................3
CONTRAINDICATIONS
...............................................................................................................................4
WARNINGS AND
PRECAUTIONS..............................................................................................................4
ADVERSE REACTIONS
...............................................................................................................................7
DRUG
INTERACTIONS................................................................................................................................8
DOSAGE AND
ADMINISTRATION..........................................................................................................10
OVERDOSAGE
............................................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
........................................................................................13
STORAGE AND STABILITY
.....................................................................................................................15
SPECIAL HANDLING INSTRUCTIONS
...........