SIGNIFOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PASIREOTIDE (PASIREOTIDE DIASPARTATE)

Доступно од:

RECORDATI RARE DISEASES CANADA INC

АТЦ код:

H01CB05

INN (Међународно име):

PASIREOTIDE

Дозирање:

0.6MG

Фармацеутски облик:

SOLUTION

Састав:

PASIREOTIDE (PASIREOTIDE DIASPARTATE) 0.6MG

Пут администрације:

SUBCUTANEOUS

Јединице у пакету:

60

Тип рецептора:

Prescription

Терапеутска област:

Somatostatin Agonists

Резиме производа:

Active ingredient group (AIG) number: 0154790002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2020-05-21

Карактеристике производа

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_Page 1 of 40_
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
..............................................................