LODALIS POWDER FOR SUSPENSION
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
04-12-2020
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Aktivna sestavina:
COLESEVELAM HYDROCHLORIDE
Dostopno od:
BAUSCH HEALTH, CANADA INC.
Koda artikla:
C10AC04
INN (mednarodno ime):
COLESEVELAM
Odmerek:
3.75G
Farmacevtska oblika:
POWDER FOR SUSPENSION
Sestava:
COLESEVELAM HYDROCHLORIDE 3.75G
Pot uporabe:
ORAL
Enote v paketu:
15G/50G
Tip zastaranja:
Prescription
Terapevtsko območje:
BILE ACID SEQUESTRANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0153000002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2020-12-09
Lastnosti izdelka
PRODUCT MONOGRAPH
PR
LODALIS
TM
Colesevelam Hydrochloride
Film-coated Tablets 625 mg
Powder for Oral Suspension, 3.75 g
BILE ACID SEQUESTRANT
ATC CODE: C10A C 04
BAUSCH HEALTH, CANADA INC.
2150 Blvd. St-Elzear West
Laval, Quebec
H7L 4A8
DATE OF PREPARATION:
December 22, 2011
DATE OF REVISION:
December 4, 2020
Submission Control No: 241993
_ _
_Pr_
_LODALIS_
_TM_
_ Product Monograph Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
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