IASOcholine 1 GBq/mL, solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOROCHOLINE

Available from:

IASON GmbH Feldkirchner Str. 4, A-8054 Graz, Austria

ATC code:

V09IX

INN (International Name):

FLUOROCHOLINE (18-F) 100 MBq/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUOROCHOLINE (18-F) 100 MBq/ml

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Authorization status:

Withdrawn

Authorization date:

2013-04-26

Patient Information leaflet

FCH-VAR-MRP-09-2016
1
PACKAGE LEAFLET
FCH-VAR-MRP-09-2016
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
IASOCHOLINE 1 GBQ/ML, SOLUTION FOR INJECTION
fluorocholine (
18
F) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.
-
If you get any side effects talk to your nuclear medicine doctor. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What IASOcholine is and what it is used for ?
2.
What you need to know before IASOcholine is used ?
3.
How IASOcholine is used ?
4.
Possible side effects
5.
How IASOcholine is stored ?
6.
Contents of the pack and other information
1.
WHAT IASOCHOLINE IS AND WHAT IT IS USED FOR ?
This medicine is a radiopharmaceutical product for diagnostic use
only.
IASOcholine is used for diagnostic use in Positron Emission Tomography
(PET) examinations and is
administered prior to such an examination.
The active ingredient in IASOcholine allows to picture an enhanced
influx of the natural substance
choline in specific organs or tissues and is detected by PET and shown
as a picture.
Positron Emission Tomography is an imaging technology used in nuclear
medicine that produces
pictures
of
cross-sections
of
living
organisms.
It
works
with
a
minute
amount
of
radioactive
pharmaceutical to produce quantitative and precise images of specific
metabolic processes in the
body. This examination is carried out to help decide on how to treat
the illness you are suffering from
or you are suspected of suffering from.
2.
WHAT YOU NEED TO KNOW BEFORE IASOCHOLINE IS USED ?
_ _
IASOCHOLINE MUST NOT BE USED
-
if you are allergic (hypersensitive) to the active substance
fluorocholine (
18
F) chloride or any of
the other ingredients of this medicine (listed in section 6)
-
if you are pregnant.
WARNINGS AND PRECAUTIONS
TAKE SPE

Summary of Product characteristics

FCH-VAR-MRP-08-2015
1
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
FCH-VAR-MRP-08-2015
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
IASOcholine 1 GBq/mL, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL solution for injection contains 1 GBq of fluoromethyl-(
18
F)-dimethyl-2-hydroxyethyl-ammonium
chloride (fluorocholine (
18
F) chloride) at date and time of calibration.
The total activity of the vial at that time is between 0.5 GBq and
15.0 GBq.
The radionuclide fluoride (
18
F) has a half-life of 109.8 minutes and emits positron radiation with
a
maximum energy of 0.633 MeV followed by photon annihilation radiation
of 0.511 MeV.
Excipient with known effects : each mL of IASOcholine 1 GBq/mL,
solution for injection, contains 3.5 mg
of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Fluorocholine (
18
F) chloride is indicated for use with positron emission tomography
(PET).
IASOcholine is used
for imaging in patients undergoing oncologic diagnostic procedures
describing
function or diseases where enhanced choline influx of specific organs
or tissues is the diagnostic target.
The following indications for PET with fluorocholine (
18
F) chloride have been sufficiently documented:
Prostate cancer
Detection of bone metastases of prostate cancer in high risk patients.
Hepatocellular carcinoma

Localisation of lesions of proven well-differentiated hepatocellular
carcinoma

In addition to FDG PET, characterisation of liver nodes and/or staging
of proven or very likely
hepatocellular carcinoma,
when
FDG
PET
is
non
conclusive
or
when
surgery
or
grafting
is
scheduled.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND ELDERLY
FCH-VAR-MRP-08-2015
3
The recommended activity for an adult weighting 70 kg is 200 to 500
MBq administered by direct
intravenous injection. This activity has to be adapted according