RATIO-GALANTAMINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GALANTAMINE (GALANTAMINE HYDROBROMIDE)

Διαθέσιμο από:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

N06DA04

INN (Διεθνής Όνομα):

GALANTAMINE

Δοσολογία:

8MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

GALANTAMINE (GALANTAMINE HYDROBROMIDE) 8MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0144660002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2015-10-16

Αρχείο Π.Χ.Π.

ratio-GALANTAMINE
Page 1 of 53
PRODUCT MONOGRAPH
Pr
RATIO-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
ratiopharm inc.
17 800 Rue Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Control #096316
Date of Preparation:
December 1, 2009
ratio-GALANTAMINE
Page 2 of 53
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................3
SUMMARY PRODUCT INFORMATION
...............................................................3
INDICATIONS AND CLINICAL USE
.....................................................................3
CONTRAINDICATIONS
..........................................................................................4
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
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
.....................................................................................