TEVA-OXYBUTYNIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
21-09-2021
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Aktivna sestavina:
OXYBUTYNIN CHLORIDE
Dostopno od:
TEVA CANADA LIMITED
Koda artikla:
G04BD04
INN (mednarodno ime):
OXYBUTYNIN
Odmerek:
5MG
Farmacevtska oblika:
TABLET
Sestava:
OXYBUTYNIN CHLORIDE 5MG
Pot uporabe:
ORAL
Enote v paketu:
100/500/1000
Tip zastaranja:
Prescription
Terapevtsko območje:
Antimuscarinics
Povzetek izdelek:
Active ingredient group (AIG) number: 0114692001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2014-06-12
Lastnosti izdelka
PRODUCT MONOGRAPH
PR
TEVA-OXYBUTYNIN
oxybutynin
chloride tablets, USP, 5 mg
Anticholinergic/Antispasmodic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
September 21, 2021
Submission Control No: 251700
2
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
..............................................................................................8
DOSAGE AND ADMINISTRATION
...........................................................................9
OVERDOSAGE
............................................................................................................9
STORAGE AND STABILITY
....................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 12
PART II: SCIENTIFIC INFORMATION
...........................................................................
13
PHARMACEUTICAL INFORMATION
....................................................................
13
CLINICAL TRIALS
...................................................................................................
14
DETAILED PHARMACOLOGY
...............................................................................
14
TOXICOLOGY...........................................................................................................
15
REFERENCES
........................................................
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