ULTRATAG RBC SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TECHNETIUM TC 99M RED BLOOD CELLS

Доступно од:

CURIUM CANADA INC

АТЦ код:

V09GA06

INN (Међународно име):

TECHNETIUM (99m Tc) STANNOUS AGENT LABELLED CELLS

Дозирање:

20MCI

Фармацеутски облик:

SOLUTION

Састав:

TECHNETIUM TC 99M RED BLOOD CELLS 20MCI

Пут администрације:

INTRAVENOUS

Јединице у пакету:

15G/50G

Тип рецептора:

Schedule C

Терапеутска област:

ROENTGENOGRAPHY

Резиме производа:

Active ingredient group (AIG) number: 0152627001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2018-12-07

Карактеристике производа

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_Page 1 of 18_
PRODUCT MONOGRAPH
ULTRATAG™ RBC
Kit for the Preparation of Technetium Tc 99m-Labeled Red Blood Cells
Solution, 10 to 20 mCi per vial
Radiodiagnostic Agent
Distributed by:
Curium Canada Inc.
2752 boul. Daniel-Johnson, Suite 245-249
Laval, QC, H7T-2R3
CANADA
Date of Revision: May 10, 2019
Control No.: 226012
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_Page 2 of 18_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................5
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
RADIATION DOSIMETRY
.............................................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
SPECIAL HANDLING INSTRUCTIONS
.......................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIEN