LIDOCAINE HYDROCHLORIDE INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
23-08-2022

Aktiv ingrediens:

LIDOCAINE HYDROCHLORIDE

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

C01BB01

INN (International Name):

LIDOCAINE

Dosering :

20MG

Legemiddelform:

SOLUTION

Sammensetning:

LIDOCAINE HYDROCHLORIDE 20MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

10X5ML

Resept typen:

Ethical

Terapeutisk område:

CLASS IB ANTIARRYTHMICS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-11-09

Preparatomtale

                                _LIDOCAINE HYDROCHLORIDE INJECTION USP (Lidocaine hydrochloride)
Product Monograph _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LIDOCAINE HYDROCHLORIDE INJECTION USP
Lidocaine hydrochloride
Sterile solution, 20 mg / mL, Intravenous
USP
Antiarrhythmic agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
May 18, 2004
Date of Revision:
AUG 23, 2022
Submission Control Number: 254627
_ _
_LIDOCAINE HYDROCHLORIDE INJECTION USP (Lidocaine hydrochloride)
Product Monograph _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
No major label changes related to safety and efficacy have been made
within the past 24 months.
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
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment............
                                
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Preparatomtale Preparatomtale fransk 23-08-2022

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