PMS-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

N06DA04

INN (mednarodno ime):

GALANTAMINE

Odmerek:

24MG

Farmacevtska oblika:

CAPSULE (EXTENDED RELEASE)

Sestava:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Prescription

Terapevtsko območje:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0144660005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-12-14

Lastnosti izdelka

_pms-GALANTAMINE ER _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-GALANTAMINE ER
galantamine hydrobromide extended release capsules
Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral
House Standard
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
DEC 14, 2012
Date of Revision:
JAN 28, 2022
Submission Control Number: 256025
_pms-GALANTAMINE ER _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2022
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
.......................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment.......................................................... 5
4.4
Administration......................................................................................................