BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BUPIVACAINE HYDROCHLORIDE

Доступна з:

MYLAN PHARMACEUTICALS ULC

Код атс:

N01BB01

ІПН (Міжнародна Ім'я):

BUPIVACAINE

Дозування:

2.5MG

Фармацевтична форма:

SOLUTION

Склад:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Адміністрація маршрут:

BLOCK/INFILTRATION

Одиниць в упаковці:

100

Тип рецепту:

Ethical

Терапевтична области:

LOCAL ANESTHETICS

Огляд продуктів:

Active ingredient group (AIG) number: 0108896001; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2022-01-27

Характеристики продукта

_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 1 of 34 _
PRODUCT MONOGRAPH
Bupivacaine Hydrochloride Injection USP
2.5 mg/mL, 5 mg/mL and 7.5mg/mL Bupivacaine Hydrochloride
(as bupivacaine hydrochloride monohydrate)
Sterile Solution
Local Anesthetic
MYLAN PHARMACEUTICALS ULC
Date of Preparation: September 08, 2014
85 Advance Rd.
Etobicoke, ON
M8Z 2S6
Canada
Control No: 165243
_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 2 of 34 _
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
................................................................................................................
19
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 INF