MINT-PREGABALIN CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PREGABALIN

Предлага се от:

MINT PHARMACEUTICALS INC

АТС код:

N02BF02

INN (Международно Name):

PREGABALIN

дозиране:

50MG

Лекарствена форма:

CAPSULE

Композиция:

PREGABALIN 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANTICONVULSANTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2014-05-02

Данни за продукта

______________________________________________________________________________
_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.......................................