BUPIVACAINE HYDROCHLORIDE INJECTION, USP SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BUPIVACAINE HYDROCHLORIDE

Доступно од:

STERIMAX INC

АТЦ код:

N01BB01

INN (Међународно име):

BUPIVACAINE

Дозирање:

7.5MG

Фармацеутски облик:

SOLUTION

Састав:

BUPIVACAINE HYDROCHLORIDE 7.5MG

Пут администрације:

RETROBULBAR

Јединице у пакету:

15G/50G

Тип рецептора:

Ethical

Терапеутска област:

LOCAL ANESTHETICS

Резиме производа:

Active ingredient group (AIG) number: 0108896002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2020-09-11

Карактеристике производа

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PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
2.5 mg/mL,
5 mg
/mL and 7.5 mg/mL Bupivacaine Hydrochloride, USP
Sterile Solution
Local Anesthetic
STERIMAX INC.
Oakville, Ontario
2770 Portland Drive
L6H 6R4
Date of Preparation:
September 8, 2020
Submission Control No: 238228
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_Bupivacaine Hydrochloride Injection, USP Product Monograph Page 2 of
35_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
.................................