GALANTAMINE ER CAPSULE (EXTENDED RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
25-02-2022

Viambatanisho vya kazi:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Inapatikana kutoka:

PRO DOC LIMITEE

ATC kanuni:

N06DA04

INN (Jina la Kimataifa):

GALANTAMINE

Kipimo:

24MG

Dawa fomu:

CAPSULE (EXTENDED RELEASE)

Tungo:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2023-07-10

Tabia za bidhaa

                                _GALANTAMINE ER _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GALANTAMINE ER
galantamine hydrobromide extended release capsules
Extended release capsules, 8 mg, 16 mg, 24 mg galantamine base, oral
House Standard
Cholinesterase Inhibitor
PRO DOC LTÉE
2925 Boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
DEC 03, 2013
Date of Revision:
FEB 25, 2022
Submission Control Number: 261429
_GALANTAMINE ER _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
02/2022
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
..............................................................................................................
6
4.5
Missed Dose
.........
                                
                                Soma hati kamili
                                
                            

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Tabia za bidhaa Tabia za bidhaa Kifaransa 25-02-2022

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