MINT-LEUCOVORIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

LEUCOVORIN (LEUCOVORIN CALCIUM)

Доступно од:

MINT PHARMACEUTICALS INC

АТЦ код:

V03AF03

INN (Међународно име):

CALCIUM FOLINATE

Дозирање:

5MG

Фармацеутски облик:

TABLET

Састав:

LEUCOVORIN (LEUCOVORIN CALCIUM) 5MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

ANTIDOTES

Резиме производа:

Active ingredient group (AIG) number: 0108436001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2020-03-05

Карактеристике производа

_MINT-LEUCOVORIN (leucovorin calcium) _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-LEUCOVORIN
Leucovorin calcium tablets
Tablets, 5 mg leucovorin (as leucovorin calcium), Oral
USP
Folic Acid Derivative
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
March 5, 2020
Date of Revision:
August 1, 2023
Submission Control Number: 273105
_MINT-LEUCOVORIN (leucovorin calcium) _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
08/2023
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
08/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
08/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
08/2023
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
........................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Admin