APO-GALANTAMINE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
24-02-2023
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:
APOTEX INC
ATC kanuni:
N06DA04
INN (Jina la Kimataifa):
GALANTAMINE
Kipimo:
4MG
Dawa fomu:
TABLET
Tungo:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 4MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0144660001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2009-12-21
Tabia za bidhaa
APO-GALANTAMINE (galantamine hydrobromide tablets)
Page 1 of 57
PRODUCT MONOGRAPH
Pr
APO-GALANTAMINE
galantamine hydrobromide tablets
tablets, 4 mg, 8 mg, 12 mg galantamine base
Cholinesterase Inhibitor
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Preparation:
December 17, 2009
Date of Revision:
February 24, 2023
Submission Control No.: 267800
APO-GALANTAMINE (galantamine hydrobromide tablets)
Page 2 of 57
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
.........................................................................................................
7
DRUG INTERACTIONS
.......................................................................................................
13
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLIN
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