国家: 加拿大
语言: 英文
来源: Health Canada
PRILOCAINE; LIDOCAINE
ASPEN PHARMACARE CANADA INC.
N01BB54
PRILOCAINE, COMBINATIONS
2.5%; 2.5%
CREAM
PRILOCAINE 2.5%; LIDOCAINE 2.5%
TOPICAL
5G/30G
Ethical
ANTIPRURITICS AND LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0222447001; AHFS:
APPROVED
2000-05-02
_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 ...... 阅读完整的文件