JAMP CALCIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CALCIUM POLYSTYRENE SULFONATE

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

V03AE01

DCI (Denominação Comum Internacional):

POLYSTYRENE SULPHONATE

Dosagem:

999MG

Forma farmacêutica:

POWDER FOR SUSPENSION

Composição:

CALCIUM POLYSTYRENE SULFONATE 999MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Ethical

Área terapêutica:

POTASSIUM-REMOVING AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0113563002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2020-07-23

Características técnicas

_JAMP Calcium Polystyrene Sulfonate (calcium polystyrene sulfonate) _
_Page 1 of 20 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
JAMP CALCIUM POLYSTYRENE SULFONATE
Calcium Polystyrene Sulfonate Powder
Powder for suspension, 999 mg /g, For Oral or Rectal Use
Cation-Exchange Resin
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
July 23, 2020
Date of Revision:
January 25, 2023
Submission Control Number: 267739
_JAMP Calcium Polystyrene Sulfonate (calcium polystyrene sulfonate) _
_Page 2 of 20 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
...............................................................................................................
2
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics............................................................................................................
4
1.2
Geriatrics
............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing
Considerations.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 5
4.3
Reconstitution
....................................................................................................
6
4.4
Administration
....................................................................................................
7
5
OVERDOSAGE
...................................................................................