EMLA CREAM

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PRILOCAINE; LIDOCAINE

Commercializzato da:

ASPEN PHARMACARE CANADA INC.

Codice ATC:

N01BB54

INN (Nome Internazionale):

PRILOCAINE, COMBINATIONS

Dosaggio:

2.5%; 2.5%

Forma farmaceutica:

CREAM

Composizione:

PRILOCAINE 2.5%; LIDOCAINE 2.5%

Via di somministrazione:

TOPICAL

Confezione:

5G/30G

Tipo di ricetta:

Ethical

Area terapeutica:

ANTIPRURITICS AND LOCAL ANESTHETICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0222447001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2000-05-02

Scheda tecnica

_Product Monograph Master Template _
_Template Date: September 2020 _
_EMLA_
_®_
_ (Lidocaine & Prilocaine) _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
EMLA
®
Cream
Lidocaine and Prilocaine Cream
Cream, 2.5% Lidocaine and 2.5% Prilocaine, Topical
Manufacturer’s Standard
EMLA
®
Patch
Lidocaine and Prilocaine Transdermal Patch
Transdermal Patch, 2.5% Lidocaine and 2.5% Prilocaine, Topical
Topical Anesthetic for Dermal Analgesia
Aspen Pharmacare Canada Inc
8 – 1155 North Service Road West
Oakville, ON
L6M 3E3
Date of Initial Authorization:
December 31, 1991
Date of Revision:
April 20, 2022
Submission Control Number: 258891
Trademarks are owned by or licensed to the Aspen Group of companies.
_EMLA_
_®_
_ (Lidocaine & Prilocaine) _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
04/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1
Pregnant Women
04/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES................................................ Error!
Bookmark not defined.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (<18 years of age):
.............................................................................
5
1.2
Geriatrics:..........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
......