GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
Ürün özellikleri
(SPC)
23-06-2017
Bu ürün için bazı belgeler şu anda mevcut değil, müşteri hizmetlerimize bir istek gönderebilirsiniz ve bunları alır almaz size bildireceğiz.
İstek gönder.
İstek gönder.
Aktif bileşen:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Mevcut itibaren:
SANIS HEALTH INC
ATC kodu:
N06DA04
INN (International Adı):
GALANTAMINE
Doz:
24MG
Farmasötik formu:
CAPSULE (EXTENDED RELEASE)
Kompozisyon:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 24MG
Uygulama yolu:
ORAL
Paketteki üniteler:
100
Reçete türü:
Prescription
Terapötik alanı:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Ürün özeti:
Active ingredient group (AIG) number: 0144660005; AHFS:
Yetkilendirme durumu:
APPROVED
Yetkilendirme tarihi:
2016-01-07
Ürün özellikleri
Page 1 of 55
PRODUCT MONOGRAPH
PR
GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: June 22, 2017
Submission Control No: 206599
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
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
..............................................
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