APO-OXYBUTYNIN SYRUP
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
24-01-2022
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Aktivna sestavina:
OXYBUTYNIN CHLORIDE
Dostopno od:
APOTEX INC
Koda artikla:
G04BD04
INN (mednarodno ime):
OXYBUTYNIN
Odmerek:
1MG
Farmacevtska oblika:
SYRUP
Sestava:
OXYBUTYNIN CHLORIDE 1MG
Pot uporabe:
ORAL
Enote v paketu:
473ML
Tip zastaranja:
Prescription
Terapevtsko območje:
Antimuscarinics
Povzetek izdelek:
Active ingredient group (AIG) number: 0114692002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
1997-04-22
Lastnosti izdelka
Page 1 of 23
PRODUCT MONOGRAPH
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Tablets 5 mg, USP
PR
APO-OXYBUTYNIN
Oxybutynin Chloride Syrup 1 mg / mL, USP
ANTICHOLINERGIC / ANTISPASMODIC AGENT
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9 DATE OF PREPARATION:
April 18,1995 DATE OF REVISION:
January 24, 2022
Submission Control number #259986
Page 2 of 23
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
.................................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
10
STORAGE AND STABILITY
...............................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................................
12
PART II: SCIENTIFIC INFORMATION
.........................................................................
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