Fluorocholine (18F) CIS bio international 225 MBq/mL solution for injection

Krajina: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktívna zložka:

FLUOROCHOLINE

Dostupné z:

CIS Bio International Route Nationale 306-Saclay, BP 32, 91192, Gif-sur-Yvette Cedex, France

ATC kód:

V09IX07

INN (Medzinárodný Name):

FLUOROCHOLINE (18-F) 225 MBq/ml

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

FLUOROCHOLINE (18-F) 225 MBq/ml

Typ predpisu:

POM

Terapeutické oblasti:

DIAGNOSTIC RADIOPHARMACEUTICALS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-01-05

Príbalový leták

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUOROCHOLINE (
18
F) CIS BIO INTERNATIONAL 225 MBQ/ML SOLUTION FOR INJECTION
Fluorocholine (
18
F) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 referring doctor or the
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluorocholine (
18
F) CIS bio international is and what it is used for
2.
What you need to know before Fluorocholine (
18
F) CIS bio international is used
3.
How Fluorocholine (
18
F) CIS bio international is used
4.
Possible side effects
5.
How Fluorocholine (
18
F) CIS bio international is stored
6.
Contents of the pack and other information
1.
WHAT FLUOROCHOLINE (
18
F) CIS BIO INTERNATIONAL IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only. Fluorocholine (
18
F)
CIS bio international contains the active ingredient fluorocholine (
18
F).
Fluorocholine (
18
F) CIS bio international is used in Positron Emission Tomography (PET)
examinations in adult males suffering from prostate diseases.
The active ingredient in Fluorocholine (
18
F) CIS bio international allows imaging specific parts
of your body and taking pictures.
This PET examination is carried out to help decide on how to treat the
illness you are
suffering from or you are suspected of suffering from.
The use of fluorocholine (
18
F) does involve exposure to a minute amount of radioactivity.
Your doctor and the nuclear medicine doctor have considered that the
clinical benefit that
you will obtain from the procedure with the radiopharmaceutical
outweighs the risk due to
radiation.
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2.
WHAT YOU NEED TO KNOW BEFORE FLUOROCHOLINE (
18
F) CIS

Súhrn charakteristických

Page
1
of
9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluorocholine (
18
F) CIS bio international 225 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL contains 225 MBq of fluorocholine (
18
F) chloride, also known as fluoromethylcholine (
18
F)
chloride, at the date and time of calibration.
The activity per vial ranges from 112 MBq to 3375 MBq at the date and
time of calibration.
Fluorine-18 decays to stable oxygen-18 with a half-life of 110 minutes
by emitting a positronic
radiation of maximum energy of of 633 keV, followed by photonic
annihilation radiations of
511 keV.
Excipient with known effect:
Each mL contains 3.54 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with a pH between 4.5 and 7.5.
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) in adult
males.
Fluorocholine (
18
F) CIS bio international 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
particularly
documented:
•
Initial staging of prostate cancer in high-risk patients, a category
defined according to
professional guidelines.
•
Localisation of local, regional or metastatic recurrence in case of
rising serum concentration
of prostate specific antigen (PSA)
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9
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is for use in designated nuclear medicine
facilities only, and should only be
handled by authorised personnel.
Posology
_Adults and elderly _
The recommended activity for an adult weighing 70 kg is 100 to 400 MBq
according to the body
weight of the patient, the type of camera used and acquisition mode.
T