BUPIVACAINE HEAVY INJECTION BP SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUPIVACAINE HYDROCHLORIDE

متاح من:

AURO PHARMA INC

ATC رمز:

N01BB01

INN (الاسم الدولي):

BUPIVACAINE

جرعة:

15MG

الشكل الصيدلاني:

SOLUTION

تركيب:

BUPIVACAINE HYDROCHLORIDE 15MG

طريقة التعاطي:

INTRASPINAL

الوحدات في الحزمة:

10X2ML AMPOULE

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

LOCAL ANESTHETICS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2017-12-11

خصائص المنتج

_PAGE 1 OF 29 _
PRODUCT MONOGRAPH
BUPIVACAINE HEAVY INJECTION BP
Bupivacaine 0.75% in Glucose 7.5 mg/mL
_Local Anesthetic_
AURO PHARMA INC.
Date of Preparation:
3700 Steeles Avenue West, Suite # 402 December 11, 2017
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No: 203187
_PAGE 2 OF 29 _
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
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
DETAILED PHARMACOLOGY
...............................................................