APO-COLESEVELAM TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
12-11-2019
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Werkstoffen:
COLESEVELAM HYDROCHLORIDE
Beschikbaar vanaf:
APOTEX INC
ATC-code:
C10AC04
INN (Algemene Internationale Benaming):
COLESEVELAM
Dosering:
625MG
farmaceutische vorm:
TABLET
Samenstelling:
COLESEVELAM HYDROCHLORIDE 625MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
BILE ACID SEQUESTRANTS
Product samenvatting:
Active ingredient group (AIG) number: 0153000001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2019-11-12
Productkenmerken
PRODUCT MONOGRAPH
Pr
APO-COLESEVELAM
Colesevelam Hydrochloride
Film-coated Tablets 625 mg
Bile Acid Sequestrant
ATC code: C10A C 04
Apotex Inc.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Approval:
November 12, 2019
SUBMISSION CONTROL NO: 224808
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
...........................................................................................................
3
CONTRAINDICATIONS
................................................................................................................................
3
WARNINGS AND PRECAUTIONS
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4
ADVERSE REACTIONS
................................................................................................................................
5
DRUG INTERACTIONS
................................................................................................................................
9
DOSAGE AND ADMINISTRATION
...........................................................................................................
12
OVERDOSAGE
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12
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................................
13
STORAGE AND STABILITY
......................................................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.....................................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................
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