ROPIVACAINE HYDROCHLORIDE INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ROPIVACAINE HYDROCHLORIDE

متاح من:

TEVA CANADA LIMITED

ATC رمز:

N01BB09

INN (الاسم الدولي):

ROPIVACAINE

جرعة:

2MG

الشكل الصيدلاني:

SOLUTION

تركيب:

ROPIVACAINE HYDROCHLORIDE 2MG

طريقة التعاطي:

BLOCK/INFILTRATION

الوحدات في الحزمة:

100ML/200ML

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

LOCAL ANESTHETICS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2021-07-29

خصائص المنتج

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_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
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_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
............................................................................