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

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Saatavilla:

NOVOCOL PHARMACEUTICAL OF CANADA INC

ATC-koodi:

N01BB51

INN (Kansainvälinen yleisnimi):

BUPIVACAINE, COMBINATIONS

Annos:

5MG; 0.0091MG

Lääkemuoto:

SOLUTION

Koostumus:

BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG

Antoreitti:

BLOCK/INFILTRATION

Kpl paketissa:

1.8ML

Prescription tyyppi:

Ethical

Terapeuttinen alue:

LOCAL ANESTHETICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2012-04-16

Valmisteyhteenveto

_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
...........