TEVA-TOLTERODINE LA CAPSULE (EXTENDED RELEASE)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-12-2015
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Aktiv ingrediens:
TOLTERODINE TARTRATE
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
G04BD07
INN (International Name):
TOLTERODINE
Dosering :
4MG
Legemiddelform:
CAPSULE (EXTENDED RELEASE)
Sammensetning:
TOLTERODINE TARTRATE 4MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
Antimuscarinics
Produkt oppsummering:
Active ingredient group (AIG) number: 0135202003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2015-12-16
Preparatomtale
PRODUCT MONOGRAPH
PR
TEVA-TOLTERODINE LA
(TOLTERODINE L-TARTRATE EXTENDED RELEASE CAPSULES)
2 MG AND 4 MG CAPSULES
ANTICHOLINERGIC - ANTISPASMODIC AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 185410
Date of Revision:
June 29, 2015
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
......................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
....................................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
.........................................................................................
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