MINT-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RIZATRIPTAN (RIZATRIPTAN BENZOATE)

Διαθέσιμο από:

MINT PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

N02CC04

INN (Διεθνής Όνομα):

RIZATRIPTAN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET (ORALLY DISINTEGRATING)

Σύνθεση:

RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

6

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE SEROTONIN AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0137841002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-06-19

Αρχείο Π.Χ.Π.

_MINT-RIZATRIPTAN ODT_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MINT-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
MINT PHARMACEUTICALS INC.
Date of Preparation:
1093 MEYERSIDE DRIVE, UNIT 1
April 13, 2015
MISSISSAUGA, ONTARIO
L5T 1J6
CONTROL# 183267
_MINT-RIZATRIPTAN ODT_
_Page 2 of 38_
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
..............................................................................................................
11
DRUG INTERACTIONS
...............................................................................................................
17
DOSAGE AND ADMINISTRATION
...........................................................................................
19
OVERDOSAGE
.............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
21
STORAGE AND STABILITY
......................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 25
PART II: SCIENTIFIC INFORMATION
...............