JAMP-CHOLESTYRAMINE POWDER FOR SUSPENSION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CHOLESTYRAMINE RESIN

Dostupno od:

JAMP PHARMA CORPORATION

ATC koda:

C10AC01

INN (International ime):

COLESTYRAMINE

Doziranje:

4G

Farmaceutski oblik:

POWDER FOR SUSPENSION

Sastav:

CHOLESTYRAMINE RESIN 4G

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

BILE ACID SEQUESTRANTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0101047008; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2019-11-29

Svojstava lijeka

JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 1
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-CHOLESTYRAMINE
Cholestyramine for Oral Suspension, USP
Light Powder, 4 g Cholestyramine Resin / Dose
Regular Powder, 4 g Cholestyramine Resin / Dose
Antihypercholesterolemic and Antidiarrheal
JAMP Pharma Corporation.
1310 rue Nobel,
Boucherville, Quebec,
J4B 5H3, Canada
Date of Authorization:
July 13, 2018
Date of Revision:
December 23, 2022
Submission Control Number: 265948
JAMP-Cholestyramine (Cholestyramine for Oral Suspension, USP) Page 2
of 27
RECENT MAJOR LABEL CHANGES
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
................................................................. 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
.......................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........