TEVA-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
12-10-2016
Niektoré dokumenty týkajúce sa tohto produktu nie sú momentálne k dispozícii, môžete poslať požiadavku na náš zákaznícky servis a my vás upozorníme hneď, ako ich dokážeme získať.
Poslať žiadosť.
Poslať žiadosť.
Aktívna zložka:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
N06DA04
INN (Medzinárodný Name):
GALANTAMINE
Dávkovanie:
16MG
Forma lieku:
CAPSULE (EXTENDED RELEASE)
Zloženie:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 16MG
Spôsob podávania:
ORAL
Počet v balení:
30/100
Typ predpisu:
Prescription
Terapeutické oblasti:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0144660004; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-06-22
Súhrn charakteristických
_TEVA-GALANTAMINE _
_ _
_Page 1 of 55 _
PRODUCT MONOGRAPH
PR
TEVA-GALANTAMINE ER
galantamine hydrobromide extended release capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Teva Canada Limited
Date of Revision:
30 Novopharm Court
September 3, 2014
Toronto, Ontario
M1B 2K9
Submission Control No: 177342
_TEVA-GALANTAMINE _
_ _
_Page 2 of 55 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
....................................................................................
35
TOXICOLOGY
...........
Prečítajte si celý dokument
