MYLAN-GALANTAMINE ER CAPSULE (EXTENDED RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
21-04-2017
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
Inapatikana kutoka:
MYLAN PHARMACEUTICALS ULC
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:
APPROVED
Idhini ya tarehe:
2011-11-12
Tabia za bidhaa
Page 1 of 55
PRODUCT MONOGRAPH
Pr
MYLAN-GALANTAMINE ER
Galantamine Hydrobromide Extended-Release Capsules
8 mg, 16 mg, 24 mg galantamine base
Cholinesterase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 13, 2017
Submission Control No: 204535
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
...............................................................................................................
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
...............................................
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