NAT-LANTHANUM TABLET (CHEWABLE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE)

Disponibil de la:

NATCO PHARMA (CANADA) INC

Codul ATC:

V03AE03

INN (nume internaţional):

LANTHANUM CARBONATE

Dozare:

750MG

Forma farmaceutică:

TABLET (CHEWABLE)

Compoziție:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE) 750MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PHOSPHATE-REMOVING AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-05-14

Caracteristicilor produsului

_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
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4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
........................................................................................................
5
4