APO-OXYBUTYNIN SYRUP
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
24-01-2022
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
OXYBUTYNIN CHLORIDE
Disponibbli minn:
APOTEX INC
Kodiċi ATC:
G04BD04
INN (Isem Internazzjonali):
OXYBUTYNIN
Dożaġġ:
1MG
Għamla farmaċewtika:
SYRUP
Kompożizzjoni:
OXYBUTYNIN CHLORIDE 1MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
473ML
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
Antimuscarinics
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0114692002; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
1997-04-22
Karatteristiċi tal-prodott
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
.........................................................................
Aqra d-dokument sħiħ
