SIGNIFOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PASIREOTIDE (PASIREOTIDE DIASPARTATE)

Предлага се от:

RECORDATI RARE DISEASES CANADA INC

АТС код:

H01CB05

INN (Международно Name):

PASIREOTIDE

дозиране:

0.3MG

Лекарствена форма:

SOLUTION

Композиция:

PASIREOTIDE (PASIREOTIDE DIASPARTATE) 0.3MG

Начин на приложение:

SUBCUTANEOUS

Броя в опаковка:

30/60

Вид предписание :

Prescription

Терапевтична област:

Somatostatin Agonists

Каталог на резюме:

Active ingredient group (AIG) number: 0154790001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-05-21

Данни за продукта

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PRODUCT MONOGRAPH
PR
SIGNIFOR
®
(Pasireotide Injection)
0.3 mg/mL, 0.6 mg/mL and 0.9 mg/mL
pasireotide (as pasireotide diaspartate)
SYNTHETIC
PASIREOTIDE
ANALOGUE
OF
SOMATOSTATIN
Recordati Rare Diseases Canada Inc.
Toronto, Ontario, Canada M4N 3N1
Control No: 234503
Date of Preparation:
September 23, 2013
Date of Revision:
July 8, 2020
Pr
SIGNIFOR is a registered trademark
_ _
_Page 2 of 40_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................28
PHARMACEUTICAL INFORMATION
..............................................................