NAT-LANTHANUM TABLET (CHEWABLE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE)

Tilgængelig fra:

NATCO PHARMA (CANADA) INC

ATC-kode:

V03AE03

INN (International Name):

LANTHANUM CARBONATE

Dosering:

750MG

Lægemiddelform:

TABLET (CHEWABLE)

Sammensætning:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE) 750MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

PHOSPHATE-REMOVING AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0151709003; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2020-05-14

Produktets egenskaber

_NAT-LANTHANUM Product Monograph _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-LANTHANUM
Lanthanum carbonate dihydrate chewable tablets
Chewable tablets, 250 mg, 500 mg, 750 mg, and 1000 mg, oral
Phosphate binder
Natco Pharma (Canada) Inc.
Date of Initial Authorization:
2000 Argentia Road, Plaza 1, Suite 200
April 30, 2020
Mississauga, Ontario
L5N 1P7
Date of Revision:
August 24, 2023
Submission Control No: 275728
_ _
_NAT-LANTHANUM Product Monograph _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
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
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4