BUSCOPAN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

HYOSCINE BUTYLBROMIDE

から入手可能:

SANOFI CONSUMER HEALTH INC

ATCコード:

A03BB01

INN（国際名）:

BUTYLSCOPOLAMINE

投薬量:

10MG

医薬品形態:

TABLET

構図:

HYOSCINE BUTYLBROMIDE 10MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Ethical

治療領域:

ANTIMUSCARINICS ANTISPASMODICS

製品概要:

Active ingredient group (AIG) number: 0104703001; AHFS:

認証ステータス:

APPROVED

承認日:

2017-04-26

製品の特徴

_Buscopan_
_®_
_ Prescribing Information _
_ _
_Page 1 of 28_
PRESCRIBING INFORMATION AND
PATIENT MEDICATION INFORMATION
BUSCOPAN
®
Hyoscine Butylbromide Tablets
Manufacturer’s Standard, 10 mg
PR
BUSCOPAN
®
Hyoscine Butylbromide Injection
Solution, intramuscular, subcutaneous, intravenous
Manufacturer’s Standard, 20 mg/mL
Antispasmodic
Sanofi Consumer Health Inc.
2905 Louis-R.-Renaud Place
Laval, Quebec H7V 0A3
Date of Revision:
March 31, 2021
Submission
Control No: 245198
_Buscopan_
_®_
_ Prescribing Information _
_ _
_Page 2 of 28_
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..............................................................................................7
DRUG INTERACTIONS
..............................................................................................9
DOSAGE AND ADMINISTRATION
.........................................................................
10
OVERDOSAGE
........................................................................................................
11
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
12
STORAGE AND STABILITY
....................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 13
PART II: SCIENTIFIC INFORMATION
.........................................................................
15
PHARMACEUTICAL INFORMATION
.....................................................................
15
PART III: PATIENT MED