LUPIN-PROPRANOLOL LA CAPSULE (EXTENDED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PROPRANOLOL HYDROCHLORIDE

Disponibil de la:

LUPIN PHARMA CANADA LIMITED

Codul ATC:

C07AA05

INN (nume internaţional):

PROPRANOLOL

Dozare:

80MG

Forma farmaceutică:

CAPSULE (EXTENDED RELEASE)

Compoziție:

PROPRANOLOL HYDROCHLORIDE 80MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BETA-ADRENERGIC BLOCKING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0101831002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-08-30

Caracteristicilor produsului

_Page 1 of 30 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPIN-PROPRANOLOL 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
Lupin Pharma Canada Ltd.
1001 De Maisonneuve Est, Suite 304
Montréal, Quebec
H2L 4P9
Date of Initial Authorization:
AUG 28, 2019
Date of Revision:
JAN 14, 2022
Submission Control Number: 255723
_Page 2 of 30 _
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
.........................................................................................................
6
5
OVERDOSAGE
.....