MINT-PREGABALIN CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PREGABALIN

Διαθέσιμο από:

MINT PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

N02BF02

INN (Διεθνής Όνομα):

PREGABALIN

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

PREGABALIN 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0151121002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-05-02

Αρχείο Π.Χ.Π.

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_Mint-Pregabalin Product Monograph _
1 of 64
_ _
PRODUCT MONOGRAPH
PR
MINT-PREGABALIN
Pregabalin Capsules
Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300
mg
ANALGESIC AGENT
Mint Pharmaceuticals Inc.
6575 Davand Dr
Mississauga, Ontario, Canada
L5T 2M3
SUBMISSION CONTROL NUMBER: 255444
DATE OF PREPARATION:
September 22, 2021
______________________________________________________________________________
_Mint-Pregabalin Product Monograph _
2 of 64
_ _
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..................................................................................................15
DRUG
INTERACTIONS..................................................................................................34
DOSAGE AND ADMINISTRATION
.............................................................................36
OVERDOSAGE................................................................................................................39
ACTION AND CLINICAL
PHARMACOLOGY............................................................40
STORAGE AND
STABILITY..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................43
PART II: SCIENTIFIC
INFORMATION................................................................................45
PHARMACEUTICAL
INFORMATION.......................................