LEUCOVORIN CALCIUM INJECTION SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LEUCOVORIN (LEUCOVORIN CALCIUM)

Dostępny od:

GENERIC MEDICAL PARTNERS INC

Kod ATC:

V03AF03

INN (International Nazwa):

CALCIUM FOLINATE

Dawkowanie:

10MG

Forma farmaceutyczna:

SOLUTION

Skład:

LEUCOVORIN (LEUCOVORIN CALCIUM) 10MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

5ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTIDOTES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-08-16

Charakterystyka produktu

LEUCOVORIN CALCIUM INJECTION
Page 1 of 26
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEUCOVORIN CALCIUM INJECTION
Leucovorin calcium
Solution, 10 mg/mL leucovorin (as leucovorin calcium), intravenous and
intramuscular
House Standard
Folic Acid Derivative
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711,
Toronto, Ontario, Canada
M3B 3K4
Date of Initial Authorization:
August 16, 2018
Date of Revision:
July 14, 2023
Submission Control Number: 272322
LEUCOVORIN CALCIUM INJECTION
Page 2 of 26
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2023
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
.......................................................... 5
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
..................................................... 5
4.3
Reconstitution........................................................