EMLA CREAM

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRILOCAINE; LIDOCAINE

Διαθέσιμο από:

ASPEN PHARMACARE CANADA INC.

Φαρμακολογική κατηγορία (ATC):

N01BB54

INN (Διεθνής Όνομα):

PRILOCAINE, COMBINATIONS

Δοσολογία:

2.5%; 2.5%

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

PRILOCAINE 2.5%; LIDOCAINE 2.5%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

5G/30G

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

ANTIPRURITICS AND LOCAL ANESTHETICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2000-05-02

Αρχείο Π.Χ.Π.

_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
......