MARCAINE SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Доступна з:

SEPTODONT INC

Код атс:

N01BB51

ІПН (Міжнародна Ім'я):

BUPIVACAINE, COMBINATIONS

Дозування:

5MG; 0.0091MG

Фармацевтична форма:

SOLUTION

Склад:

BUPIVACAINE HYDROCHLORIDE 5MG; EPINEPHRINE BITARTRATE 0.0091MG

Адміністрація маршрут:

BLOCK/INFILTRATION

Одиниць в упаковці:

1.8ML

Тип рецепту:

Ethical

Терапевтична области:

LOCAL ANESTHETICS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-03-26

Характеристики продукта

_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 _
_ _
_ _
_ _
_ _
_ _
_ _
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
.......................................................................................
3
SUMMARY PRODUCT INFORMATION
....................................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................................
3
CONTRAINDICATIONS
...............................................................................................................................
3
WARNINGS AND PRECAUTIONS.
............................................................................................................
4
ADVERSE REACTIONS
...............................................................................................................................
7
DRUG INTERACTIONS
................................................................................................................................
8
DOSAGE AND ADMINISTRATION
............................................................................................................
9
OVERDOSAGE
............................................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................................................
13
STORAGE AND STABILITY
...............................................................