ACCEL-SEVELAMER TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SEVELAMER CARBONATE

Disponibil de la:

ACCEL PHARMA INC

Codul ATC:

V03AE02

INN (nume internaţional):

SEVELAMER

Dozare:

800MG

Forma farmaceutică:

TABLET

Compoziție:

SEVELAMER CARBONATE 800MG

Calea de administrare:

ORAL

Unități în pachet:

180

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PHOSPHATE-REMOVING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0152763001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-10-11

Caracteristicilor produsului

_ACCEL-SEVELAMER (sevelamer carbonate) Tablets _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACCEL-SEVELAMER
sevelamer carbonate tablets
Tablets, 800 mg, oral
Phosphate Binder
Accel Pharma Inc.
119 Labrosse Ave
Pointe-Claire, QC
H9R 1A3
Canada
Date of Initial Authorization:
FEB. 07, 2017
Date of Revision:
SEP. 21, 2021
Submission Control Number: 249772
_ACCEL-SEVELAMER (sevelamer carbonate) Tablets _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, [1.2 Geriatrics]
12/2020
4. DOSAGE AND ADMINISTRATION, [4.1 Dosing
Considerations]
12/2020
7. WARNINGS AND PRECAUTIONS, [7.1.4 Geriatrics]
12/2020
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
..................................................................................
4
4.1
Dosing
Considerations.........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................