ROPIVACAINE HYDROCHLORIDE INJECTION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ROPIVACAINE HYDROCHLORIDE

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

N01BB09

INN (Међународно име):

ROPIVACAINE

Дозирање:

2MG

Фармацеутски облик:

SOLUTION

Састав:

ROPIVACAINE HYDROCHLORIDE 2MG

Пут администрације:

BLOCK/INFILTRATION

Јединице у пакету:

100ML/200ML

Тип рецептора:

Ethical

Терапеутска област:

LOCAL ANESTHETICS

Резиме производа:

Active ingredient group (AIG) number: 0133273001; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2021-07-29

Карактеристике производа

_ _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
ROPIVACAINE HYDROCHLORIDE INJECTION
Ropivacaine Hydrochloride Injection
2 mg/mL
Local Anaesthetic
Teva Standard
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
June 21, 2013
Submission Control No: 157874
_ _
_ _
_Page 2 of 41_
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
............................................................................