TEVA-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
12-10-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
N06DA04
INN (Alþjóðlegt nafn):
GALANTAMINE
Skammtar:
8MG
Lyfjaform:
CAPSULE (EXTENDED RELEASE)
Samsetning:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0144660002; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-06-22
Vara einkenni
_TEVA-GALANTAMINE _
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_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 _
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_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
...........
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