HEMANGIOL SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)

から入手可能:

PIERRE FABRE DERMO-COSMETIQUE CANADA INC

ATCコード:

C07AA05

INN（国際名）:

PROPRANOLOL

投薬量:

3.75MG

医薬品形態:

SOLUTION

構図:

PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) 3.75MG

投与経路:

ORAL

パッケージ内のユニット:

120ML

処方タイプ:

Prescription

治療領域:

BETA-ADRENERGIC BLOCKING AGENTS

製品概要:

Active ingredient group (AIG) number: 0159470001; AHFS:

認証ステータス:

APPROVED

承認日:

2016-09-23

製品の特徴

_ _
_Product Monograph _
_ _
_HEMANGIOL (propranolol hydrochloride) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr HEMANGIOL
Propranolol solution
Oral solution, 3.75 mg/mL propranolol (as propranolol hydrochloride),
Oral use
Beta blocking agents, non-selective (C07AA05)
Pierre Fabre Dermo-Cosmetique Canada Inc
9955, Avenue de Châteauneuf, Bureau 115
Brossard (Québec), Canada J4Z 3V5
http://www.pierre-fabre.com
Date of Initial Authorization:
SEP 23, 2016
Date of Revision:
JUN 16, 2021
Submission Control Number: 247151
_ _
_Product Monograph _
_ _
_HEMANGIOL (propranolol hydrochloride) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
06/2021
7 WARNINGS AND PRECAUTIONS, General
10/2019
7 WARNINGS AND PRECAUTIONS, Cardiovascular - Cardiac failure
10/2019
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism -
Hypoglycemia
06/2021
7 WARNINGS AND PRECAUTIONS, Reproductive health
06/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
06/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
06/2021
8 ADVERSE REACTIONS, 8.4 Post-Market Adverse Reactions
10/2019
9 DRUG INTERACTIONS, 9.2 Drug Interactions Overview
10/2019
4 DOSAGE AND ADMINISTRATION. 4.3 Administration
10/2019
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics.............................................