MARCAINE SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Dostupno od:

SEPTODONT INC

ATC koda:

N01BB51

INN (International ime):

BUPIVACAINE, COMBINATIONS

Doziranje:

5MG; 0.0091MG

Farmaceutski oblik:

SOLUTION

Sastav:

BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG

Administracija rute:

BLOCK/INFILTRATION

Jedinice u paketu:

1.8ML

Tip recepta:

Ethical

Područje terapije:

LOCAL ANESTHETICS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2018-03-26

Svojstava lijeka

_Novocol Pharmaceutical of Canada, Inc. _
Page 1 of 23
PRODUCT MONOGRAPH
MARCAINE®
(BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION USP)
BUPIVACAINE HYDROCHLORIDE 0.5% AND EPINEPHRINE 1:200,000
_Local Anaesthetic for Dental Use _
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Sponsor:
Manufacturer:
Septodont Inc
Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Court
25 Wolseley Court,
Cambridge, Ontario,
Cambridge, Ontario,
N1R 6X3
N1R 6X3
Date of Revision:
March 26, 2018
Submission Control No.: 213506
_Novocol Pharmaceutical of Canada, Inc. _
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
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3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS.
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4
ADVERSE REACTIONS
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7
DRUG INTERACTIONS
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8
DOSAGE AND ADMINISTRATION
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9
OVERDOSAGE
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11
ACTION AND CLINICAL PHARMACOLOGY
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13
STORAGE AND STABILITY
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