APO-OXYBUTYNIN SYRUP

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
24-01-2022

有効成分:

OXYBUTYNIN CHLORIDE

から入手可能:

APOTEX INC

ATCコード:

G04BD04

INN(国際名):

OXYBUTYNIN

投薬量:

1MG

医薬品形態:

SYRUP

構図:

OXYBUTYNIN CHLORIDE 1MG

投与経路:

ORAL

パッケージ内のユニット:

473ML

処方タイプ:

Prescription

治療領域:

Antimuscarinics

製品概要:

Active ingredient group (AIG) number: 0114692002; AHFS:

認証ステータス:

APPROVED

承認日:

1997-04-22

製品の特徴

                                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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