THALLOUS CHLORIDE TI-201 INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

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Prenos Lastnosti izdelka (SPC)
26-04-2019

Aktivna sestavina:

THALLIUM CHLORIDE(TI 201)

Dostopno od:

CURIUM CANADA INC

Koda artikla:

V09GX01

INN (mednarodno ime):

THALLIUM 201 TL CHLORIDE

Odmerek:

37MBq

Farmacevtska oblika:

SOLUTION

Sestava:

THALLIUM CHLORIDE(TI 201) 37MBq

Pot uporabe:

INTRAVENOUS

Enote v paketu:

10ML

Tip zastaranja:

Schedule C

Terapevtsko območje:

ROENTGENOGRAPHY

Povzetek izdelek:

Active ingredient group (AIG) number: 0152598004; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-12-07

Lastnosti izdelka

                                _Page 1 of 21 _
PRODUCT MONOGRAPH
THALLOUS CHLORIDE TL 201 INJECTION
Thallium Tl 201
Solution for intravenous use containing per mL, 37 megabecquerels (1
millicurie)
Thallous Chloride Tl 201 at calibration time.
Radiodiagnostic Agent
Curium Canada Inc.
2572 boul. Daniel-Johnson, Suite 245-249
Laval, QC, H7T-2R3
CANADA
Date of Revision: April 26
th
, 2019
CONTROL NUMBER: 225111
_Page 2 of 21 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
5
CONTRAINDICATIONS
..................................................................................................
6
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
RADIATION DOSIMETRY
............................................................................................
12
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................
                                
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