INDERAL-LA CAPSULE (EXTENDED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PROPRANOLOL HYDROCHLORIDE

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

C07AA05

INN (nume internaţional):

PROPRANOLOL

Dozare:

120MG

Forma farmaceutică:

CAPSULE (EXTENDED RELEASE)

Compoziție:

PROPRANOLOL HYDROCHLORIDE 120MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BETA-ADRENERGIC BLOCKING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0101831001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2022-05-31

Caracteristicilor produsului

_INDERAL-LA (propranolol hydrochloride) Product Monograph_
_ _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
INDERAL
®
-LA
Propranolol Hydrochloride Extended-Release Capsules
Extended-Release Capsules, 60 mg, 80 mg, 120 mg and 160 mg, Oral
USP
Beta-Adrenergic Receptor Blocking Agent
Pfizer Canada ULC
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
SEP 21, 2010
Date of Revision:
June 16, 2021
Submission Control Number: 248972
®
Trademark AstraZeneca UK Limited
_ _
_INDERAL-LA (propranolol hydrochloride) Product Monograph _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
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...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.4
Administration...................................................................................................
6
4.5
Missed Dose
.....