LIDOCAINE HYDROCHLORIDE INJECTION USP SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LIDOCAINE HYDROCHLORIDE

متاح من:

HIKMA CANADA LIMITED

ATC رمز:

N01BB02

INN (الاسم الدولي):

LIDOCAINE

جرعة:

10MG

الشكل الصيدلاني:

SOLUTION

تركيب:

LIDOCAINE HYDROCHLORIDE 10MG

طريقة التعاطي:

BLOCK/INFILTRATION

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

LOCAL ANESTHETICS

ملخص المنتج:

Active ingredient group (AIG) number: 0101280004; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2014-03-04

خصائص المنتج

Page 1 of 29
PRESCRIBING INFORMATION
LIDOCAINE HYDROCHLORIDE INJECTION USP
1% lidocaine hydrochloride (10 mg/mL)
2% lidocaine hydrochloride (20 mg/mL)
For Infiltration and Nerve Block
Local Anesthetic
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation: April 22, 2022
Submission control no. 262671
Page 2 of 29
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
.........................................................................................................
11
DRUG
INTERACTIONS..........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
20
STORAGE AND STABILITY
.................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
22
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
................