NAF PLUS SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SODIUM FLUORIDE F 18

Commercializzato da:

ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.

Codice ATC:

V09IX04

INN (Nome Internazionale):

FLUDEOXYGLUCOSE (18F)

Dosaggio:

7400MBq

Forma farmaceutica:

SOLUTION

Composizione:

SODIUM FLUORIDE F 18 7400MBq

Via di somministrazione:

INTRAVENOUS

Confezione:

30ML

Tipo di ricetta:

Schedule C

Area terapeutica:

ROENTGENOGRAPHY

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2017-05-10

Scheda tecnica

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
..................................