NAT-LANTHANUM TABLET (CHEWABLE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE)

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

V03AE03

INN (International Name):

LANTHANUM CARBONATE

Dosage:

250MG

Pharmaceutical form:

TABLET (CHEWABLE)

Composition:

LANTHANUM (LANTHANUM CARBONATE DIHYDRATE) 250MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

PHOSPHATE-REMOVING AGENTS

Product summary:

Active ingredient group (AIG) number: 0151709001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-05-14

Summary of Product characteristics

_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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
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5
4