BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BUPIVACAINE HYDROCHLORIDE

Доступно од:

OMEGA LABORATORIES LIMITED

АТЦ код:

N01BB01

INN (Међународно име):

BUPIVACAINE

Дозирање:

7.5MG

Фармацеутски облик:

SOLUTION

Састав:

BUPIVACAINE HYDROCHLORIDE 7.5MG

Пут администрације:

INTRASPINAL

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:

2021-02-11

Карактеристике производа

_Page 1 of 28 _
PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP
7.5 mg/mL
Sterile Hyperbaric Solution
Local Anesthetic for Spinal Use Only
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Omega Laboratories Limited
Date of Preparation: February 10, 2021
11 177 Hamon
Montreal, Quebec
H3M 3E4
Submission Control No.: 229408
_Page 2 of 28 _
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
.....................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................. 12
OVERDOSAGE
....................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................... 17
STORAGE AND STABILITY
.............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 19
PART II: SCIENTIFIC INFORMATION
................................................................... 20
PHARMACEUTICAL INFORMATION
............................................................. 20
DETAILED PHARMACOLOGY
........................................................................
20
TOXICOLOGY
....................................................................................................
21
REFERENCES
......................................................................................................
22
PART I