LEUCOVORIN CALCIUM INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LEUCOVORIN (LEUCOVORIN CALCIUM)

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

V03AF03

INN (International Name):

CALCIUM FOLINATE

Dosering :

10MG

Legemiddelform:

SOLUTION

Sammensetning:

LEUCOVORIN (LEUCOVORIN CALCIUM) 10MG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

5ML

Resept typen:

Prescription

Terapeutisk område:

ANTIDOTES

Produkt oppsummering:

Active ingredient group (AIG) number: 0108436002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2017-08-01

Preparatomtale

_Pr_
_Leucovorin Calcium Injection USP - Product Monograph _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEUCOVORIN CALCIUM INJECTION USP
Leucovorin calcium
Solution, 10 mg/mL, intravenous and intramuscular
USP
Folic Acid Derivative
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
MAY 09, 1997
Date of Revision:
DEC 13, 2022
Submission Control Number: 267164
_ _
_Pr_
_Leucovorin Calcium Injection USP - Product Monograph _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential; 7.1.1 Pregnant Women
12/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
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
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
...................................................................................................
7
4.4
Administration...................................................................................................
7
5
OVERDOSAGE
...............................................................................