ATLANTISCAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUDEOXYGLUCOSE 18F

Available from:

NOVA SCOTIA HEALTH AUTHORITY

ATC code:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE (18F)

Dosage:

200MCI

Pharmaceutical form:

SOLUTION

Composition:

FLUDEOXYGLUCOSE 18F 200MCI

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Schedule C

Therapeutic area:

DIAGNOSTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152591018; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-05-05

Summary of Product characteristics

1
AtlantiScan
MIRC
PRODUCT MONOGRAPH
ATLANTISCAN
(
18
F-Fluorodeoxyglucose (
18
F-FDG))
Parenteral Solution, up to 7.4 GBq/mL
Diagnostic Radiopharmaceutical
NOVA SCOTIA HEALTH AUTHORITY, DIAGNOSTIC IMAGING
VICTORIA GENERAL SITE
1276 SOUTH PARK STREET
HALIFAX, NS B3H 2Y9
Date of Approval: June 29, 2015
Submission Control No: 184655
2
AtlantiScan
MIRC
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
DESCRIPTION
3
Physical Characteristics
3
External Radiation
4
INDICATIONS AND CLINICAL USE
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5
ADVERSE REACTIONS
7
DRUG INTERACTIONS
8
DOSAGE AND ADMINISTRATION
8
Dosing considerations
8
Dosage
8
Administration
8
Image Acquisition and Interpretation
8
Instructions for Preparation and Use
9
Directions for Quality Control
9
RADIATION DOSIMETRY
9
OVERDOSAGE
10
ACTION AND CLINICAL PHARMACOLOGY
10
Mechanism of Action
10
Pharmacodynamics
10
Pharmacokinetics
10
Special Populations and Conditions
11
STORAGE AND STABILITY
11
SPECIAL HANDLING INSTRUCTIONS
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
11
PART II: SCIENTIFIC INFORMATION
12
PHARMACEUTICAL INFORMATION
12
Drug Substance
12
Product Characteristics
12
CLINICAL TRIALS
12
DETAILED PHARMACOLOGY
13
TOXICOLOGY
13
REFERENCES
14
PART III: CONSUMER INFORMATION
16
3
AtlantiScan
MIRC
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
Fludeoxyglucose F 18 Injection is a positron-emitting
radiopharmaceutical used as an
accessory to Positron Emission Tomography (PET) for the assessment of
abnormal
glucose metabolism.
The active ingredient 2-deoxy-2-[
18
F]fluoro-D-glucose, abbreviated
18
F-FDG, differs
from glucose only in having a radioactive fluorine (
18
F) in the 2 position. The 18F atom
decays into 18O, converting the molecule into D-[2-
18
O] glucose, an isotopologue of
glucose.
DESCRIPTION
PHYSICAL CHARACTERISTICS
Fluorine F 18 decays by positron (β+) emission and has a half-life of
109.7 minutes. The
fractions remaining at selected intervals after calibration are shown
in Tab