XYLOCAINE JELLY 2% GEL

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LIDOCAINE HYDROCHLORIDE

Disponibil de la:

ASPEN PHARMACARE CANADA INC.

Codul ATC:

N01BB02

INN (nume internaţional):

LIDOCAINE

Dozare:

20MG

Forma farmaceutică:

GEL

Compoziție:

LIDOCAINE HYDROCHLORIDE 20MG

Calea de administrare:

TOPICAL

Unități în pachet:

10ML SYR

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

ANTIPRURITICS AND LOCAL ANESTHETICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2000-05-11

Caracteristicilor produsului

_©2019 Aspen Group of companies or its licensors. All rights
reserved. _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XYLOCAINE® JELLY 2%
Lidocaine hydrochloride
20 mg/mL
USP
Topical Anesthetic
Aspen Pharmacare Canada Inc.
8-1155 North Service Road West
Oakville, Ontario, L6M 3E3
Date of Initial Approval:
December 31, 1951
Date of Revision:
September 10, 2020
Submission Control No: 237711
Trademarks are owned by or licensed to the Aspen Group of companies.
_©2019 Aspen Group of companies or its licensor. All rights reserved.
_
_Page 2 of 26 _
TABLE OF CONTENTS
TABLE OF CONTENTS
..................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
1
INDICATIONS
......................................................................................................
3
1.1
Pediatrics
.....................................................................................................
3
1.2
Geriatrics
.....................................................................................................
3
2
CONTRAINDICATIONS
.......................................................................................
3
3
DOSAGE AND ADMINISTRATION
.....................................................................
4
3.1
Dosing
Considerations.................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
............................................ 4
4
OVERDOSAGE
....................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 8
6
WARNINGS AND PRECAUTIONS
......................................................................
8
6.1
Special Populations
................................................................................
11
6.1.1
Pregnant Women
....................................................