BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUPIVACAINE HYDROCHLORIDE

متاح من:

MYLAN PHARMACEUTICALS ULC

ATC رمز:

N01BB01

INN (الاسم الدولي):

BUPIVACAINE

جرعة:

7.5MG

الشكل الصيدلاني:

SOLUTION

تركيب:

BUPIVACAINE HYDROCHLORIDE 7.5MG

طريقة التعاطي:

RETROBULBAR

الوحدات في الحزمة:

10ML/30ML

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

LOCAL ANESTHETICS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2022-01-27

خصائص المنتج

_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