XYLOCAINE 2% SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LIDOCAINE HYDROCHLORIDE

Available from:

ASPEN PHARMACARE CANADA INC.

ATC code:

N01BB02

INN (International Name):

LIDOCAINE

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

LIDOCAINE HYDROCHLORIDE 20MG

Administration route:

BLOCK/INFILTRATION

Units in package:

20ML/50ML

Prescription type:

Ethical

Therapeutic area:

LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0101280001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-08-17

Summary of Product characteristics

_XYLOCAINE Parenteral Solutions, lidocaine hydrochloride / lidocaine
hydrochloride and epinephrine bitartrate _
_ _
_Page 1 of 34 _
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
XYLOCAINE
® PARENTERAL SOLUTIONS
Lidocaine Hydrochloride Injection USP
0.5% lidocaine hydrochloride (5 mg/mL)
1% lidocaine hydrochloride (10 mg/mL)
2% lidocaine hydrochloride (20 mg/mL)
Lidocaine Hydrochloride and Epinephrine Injection USP
1% lidocaine hydrochloride (10 mg/mL) with 1:200,000 epinephrine (as
bitartrate) (0.005 mg/mL)
1% lidocaine hydrochloride (10 mg/mL) with 1:100,000 epinephrine (as
bitartrate) (0.010 mg/mL)
2% lidocaine hydrochloride (20 mg/mL) with 1:200,000 epinephrine (as
bitartrate) (0.005 mg/mL)
Local Anesthetic
N01BB52
Aspen Pharmacare Canada Inc.
8 – 1155 North Service Road West
Oakville, Ontario
L6M 3E3
Date of Initial Authorization:
DEC 31, 1954
Date of Revision:
MAR 07, 2023
Submission Control Number: 267392
_ _
_XYLOCAINE Parental Solutions, lidocaine hydrochloride / lidocaine
hydrochloride and epinephrine bitartrate _
_ _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
...........................................