NAF PLUS SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SODIUM FLUORIDE F 18

Verfügbar ab:

ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.

ATC-Code:

V09IX04

INN (Internationale Bezeichnung):

FLUDEOXYGLUCOSE (18F)

Dosierung:

7400MBq

Darreichungsform:

SOLUTION

Zusammensetzung:

SODIUM FLUORIDE F 18 7400MBq

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

30ML

Verschreibungstyp:

Schedule C

Therapiebereich:

ROENTGENOGRAPHY

Produktbesonderheiten:

Active ingredient group (AIG) number: 0153703002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-05-10

Fachinformation

PRODUCT MONOGRAPH
NaF Plus
Sodium Fluoride [
18
F] Injection, U.S.P.
Parenteral Solution
Diagnostic Radiopharmaceutical
Isologic Innovative Radiopharmaceuticals Ltd.
Date of Approval:
1855 32e Avenue, Lachine, Quebec H8T 3J1
Control # 171576
April 23, 2014
NaF Plus
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
DESCRIPTION
...........................................................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
4
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
5
DRUG
INTERACTIONS............................................................................................................
5
DOSAGE AND ADMINISTRATION
.......................................................................................
6
RADIATION DOSIMETRY
......................................................................................................
7
OVERDOSAGE
..........................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
8
STORAGE AND STABILITY
...................................................................................................
8
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................