APO-OXYBUTYNIN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
24-01-2022
Některé dokumenty pro tento produkt momentálně nejsou k dispozici, můžete poslat požadavek našemu zákaznickému servisu a my vás upozorníme, jakmile je dokážeme získat.
Poslat žádost.
Poslat žádost.
Aktivní složka:
OXYBUTYNIN CHLORIDE
Dostupné s:
APOTEX INC
ATC kód:
G04BD04
INN (Mezinárodní Name):
OXYBUTYNIN
Dávkování:
5MG
Léková forma:
TABLET
Složení:
OXYBUTYNIN CHLORIDE 5MG
Podání:
ORAL
Jednotky v balení:
100 & 500 TABLETS
Druh předpisu:
Prescription
Terapeutické oblasti:
Antimuscarinics
Přehled produktů:
Active ingredient group (AIG) number: 0114692001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2022-01-25
Charakteristika produktu
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
.........................................................................
Přečtěte si celý dokument
