ULTRATAG RBC SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TECHNETIUM TC 99M RED BLOOD CELLS

Disponibil de la:

CURIUM CANADA INC

Codul ATC:

V09GA06

INN (nume internaţional):

TECHNETIUM (99m Tc) STANNOUS AGENT LABELLED CELLS

Dozare:

20MCI

Forma farmaceutică:

SOLUTION

Compoziție:

TECHNETIUM TC 99M RED BLOOD CELLS 20MCI

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Schedule C

Zonă Terapeutică:

ROENTGENOGRAPHY

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-12-07

Caracteristicilor produsului

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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