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FLUDEOXYGLUCOSE (18F)-IBA SOLUTION FOR INJECTION

Active substance(s): FLUDEOXYGLUCOSE (18-F)

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IBA MOLECULAR UK LTD
FLUDEOXYGLUCOSE - FDG IBA IBA
PILMOLECULAR
(VERSION 5)UK LTD
FLUDEOXYGLUCOSE
QCS-066.05
SO40589
OneQCS.066.02
SO30297
10/09/2013
Two
31/05/2011

Previous Version

SO35361

Pharmacode No
N/A
Previous Version n/a
Material
50gsm Opaque
Pharmacode No
Flat Size
444 n/a
x 210
Material
Fold Size
210 50gsm
x 148 Opaque
Flat Size
444TO
x 210
View Panel
LOGO
VIEW
Fold Size
210
x 148
Fold Detail
PARALLEL
View Panel
LOGO TO VIEW
Packing Details
Shrinkwrapped
in trays
Fold Detail
PARALLEL
Colours Front
BLACK
Packing Details
Shrinkwrapped in trays
Colours Back
BLACK
Colours Front
BLACK

BLACK

Colours Back

BETA PLUS PHARMA S.A.
AVENUE HIPPOCRATE 10/1527
1200 BRUXELLES - BELGIUM

IBA MOLECULAR UK LTD
NOBEL WAY,
DINNINGTON,
SHEFFIELD
B.V. CYCLOTRON VU
SOUTH
YORKSHIRE S25
3QB – UNITED KINGDOM
DE BOELELAAN
1081

Pack size :

CIS1BIO
INTERNATIONAL
multidose
vial
PARC SCIENTIFIQUE ET TECHNIQUE G.BESSE
180,Marketing
ALLEE VON
NEUMANN Holder and Manufacturer
Authorisation
30035 NÎMES CEDEX 1 – FRANCE

PACKAGE
LEAFLET:
INFORMATION
FOR THE
PATIENT
PACKAGE
LEAFLET:
INFORMATION
FOR
THE PATIENT
FLUDEOXYGLUCOSE
(18F)-IBA
185 MBq/mL
solution
for injection
185 MBq/ml
solution
for injection
FLUDEOXYGLUCOSE
(18F)-IBA

1081 HV AMSTERDAM - NETHERLANDS

B.V. CYCLOTRON VU
DE BOELELAAN 1081
This medicinal product is authorised in the Member States of the
1081 HV AMSTERDAM – NETHERLANDS

Marketing Authorisation Holder:
CISIBA
BIO INTERNATIONAL
3, CHEMIN
DU CYCLOTRON
ASSISTANCE
PUBLIQUE
DES HÔPITAUX DE PARIS, SAINT-LOUIS
1348DE
LOUVAIN-LA-NEUVE
-BELGIUM
14 RUE
LA GRANGE AUX BELLES

Fludeoxyglucose (18F) 18
Fludeoxyglucose ( F)

EEA under the following names:
Austria
Detailed information on18this medicine is available on the website of MHRA.
Fludeoxyglucose ( F) IBA 185 MBq/mL, Injektionslösung

Read all of this leaflet carefully before you will be administered this medicine because it contains
Keepthis
You may need to read it again.
important information for you.

75010 PARIS – FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:

-

CIS IBA
BIO INTERNATIONAL
RADIO ISOTOPE FRANCE S.A.S.
HÔPITAL
XAVIER ARNOZAN
59, BOULEVARD
PINEL
AVENUE
HAUT
LEVÊQUE
69003DU
LYON
– FRANCE
33600 PESSAC – FRANCE

Austria:
Fludésoxyglucose (18F) IBA 185 MBq/mL, solution injectable
(18F) Fludeoxyglucose IBA

-

-

Belgium

Manufacturer:

France
Belgium, France, Luxemburg:
Fludésoxyglucose
(18F) IBA 185 MBq/mL, solution injectable
Fludésoxyglucose
(18F) IBA

BETA PLUS PHARMA S.A.

CIS BIO INTERNATIONAL
AVENUE
HIPPOCRATE
CENTRE
EUGENE
MARQUIS 10/1527
1200 BRUXELLES
- BELGIUM
AVENUE
DE LA BATAILLE
FLANDRES DUNKERQUE
35042 RENNES CEDEX – FRANCE

Italy:
Italy
Fluodeossiglucosio
(18F) IBA
Fluodeossiglucosio
(18F) IBA 185 MBq/mL, soluzione iniettabile

CIS BIO INTERNATIONAL

1.

The Netherlands:
Luxemburg
Fluorodesoxyglucose
(18F)
IBA
18

Fludésoxyglucose ( F) IBA 185 MBq/mL, solution injectable

CIS BIO INTERNATIONAL
IBA MOLECULAR ITALY S.R.L.
CHU DE BRABOIS
VIA
PERGOLESI
4 RUE
DU
MORVAN 33,
20052
MONZA – ITALY
54500 VANDOEUVRE-LES-NANCY
– FRANCE

Spain:
Fludesoxiglucosa
(18F) IBA
The Netherlands

18

more information about:

Spain
185 MBq/mL, solución inyectable
Fludesoxiglucosa
(18F) IBA
This
leaflet was last revised
in 09/2013.
The
following information is intended for medical or healthcare professionals only:
Slovenia

Fludeoksiglukoza (18F)-IBA 185 MBq/mL, raztopina za injiciranje

The complete Summary of Product Characteristics (SmPC) of Fludeoxyglucose (18F)-IBA is provided
as a separate document in the product package, with the objective to provide healthcare professionals

ALLIANCE
MEDICAL MOLECULAR
IMAGING LIMITED
OLD PORTSMOUTH
ROAD,
UNIT
19,
PEASMARSH,
QUADRUM
PARK,
GUILDFORD,
OLDSURREY
PORTSMOUTH
ROAD,
GU31LU
- UNITED KINGDOM
PEASMARSH,
GUILDFORD,
IBA MOLECULAR
UKKINGDOM
LTD
SURREY
GU3 1LU- UNITED

Please refer to the SmPC.

Sweden
Fludeoxyglucose (18F) IBA 185MBq/mL, injektionsvätska lösning
radiopharmaceutical.

SO30297_QCS.066.02_P2.indd
SO40589_QCS-066.05_P1
1

-

Detailed information on this medicine is available on the website of
MHRA.

exposure to small amounts of radioactivity; however, your doctor
should always consider the possible risks and
before using this
product.

QCS.066.02

QCS.066.02

5

1

5

QCS-066.05
FDG-IBA
IBA19/05/2011
Pharma S.A.

Do
notare
usediabetic
Fludeoxyglucose
(18F)-IBA:
If you
and your diabetes
is currently not equilibrated,
ifyou are allergic (hypersensitive) to
or any
If you areofaffected
by kidney
problems.
the other
ingredients
of Fludeoxyglucose (18F)-IBA.

Inform
your
nuclearcare
medicine
in the following
F)-IBA:
Take
special
with doctor
Fludeoxyglucose
(18cases:
If you are pregnant or believe you may be pregnant

you are administered this product because it involves
If you areifbreastfeeding

May 2011

QCS.066.02

2.
BEFORE
YOU ARE GIVEN FLUDEOXYGLUCOSE
Warnings
and
precautions
Talk to your nuclear
medicine doctor before being administered Fludeoxyglucose (18F)-IBA:
(18F)-IBA
-

UK
Fludeoxyglucose (18F)-IBA 185 MBq/mL solution for injection

QCS-066.05
FDG-IBA
IBA19/05/2011
Pharma S.A.


 What may be wrong with you, or 18
What you need
to know before Fludeoxyglucose ( F)-IBA is used

 How well your treatment has worked, or

 If
your disease
hasbecome
Fludeoxyglucose
(18F)-IBA
must not
used:back, or
18 or

 The vitality of your heart,
F) or any of the other ingredients of this medicine
 (listed insection
 Where
6). epilepsy localized in your brain.
2.

IBA MOLECULAR ITALY S.R.L.
IBA MOLECULAR
LTDMISERICORDIA 15,
PIAZZALE
SANTA MARIAUK
DELLA
UNIT
19, - ITALY
33100
UDINE

NOBEL WAY
DINNINGTON
SHEFFIELD
SOUTH YORKSHIRE S25 3QB - UNITED KINGDOM

WHAT FLUDEOXYGLUCOSE (18F)-IBA IS AND WHAT

It can be used for a technique called “positron emission tomographic”

18

QUADRUM PARK,

1.

18
Once
a small
amount
of Fludeoxyglucose
F)-IBA
been
injected,
medical images
(PET)
scan
on your
heart, your brain( or
your has
body.
With
this technique
it is that are
obtained
withtoa visualise
special camera
will enable
the in
doctor
capture
images
and to
see where your illness
possible
the activity
of cells
yourtobody.
This
will give
doctors
is or how it is progressing.

Fludeoxiglucose ( F) IBA 185 MBq/mL, solução injectável
Sweden:
Fludeoxiglukos (18F)-IBA

33100 UDINE - ITALY

Further information.

What Fludeoxyglucose ( 18F)-IBA is and what it is used for

18
TheThis
activemedicine
substanceiscontained
in Fludeoxyglucose
for diagnostic
use only. ( F)-IBA is designed for the capture of diagnostic
images of some parts of your body.

Fluorodesoxyglucose ( F) IBA 185 MBq/mL, oplossing voor injectie

IBAIBA
MOLECULAR
ITALY
S.R.L. S.R.L.
MOLECULAR
ITALY
VIALE
OXFORDSANTA
81,
PIAZZALE
MARIA DELLA MISERICORDIA 15,
00133 ROMA – ITALY

6.

This medicineIT
is aIS
radiopharmaceutical
product for diagnostic use only.
USED FOR

Slovenia:
[ 18 F]
fludeoksiglukoza IBA
Portugal

MOLECULAR
ITALY
IBAIBA
MOLECULAR
ITALY
S.R.L. S.R.L.
OXFORD
VIAVIALE
PERGOLESI
33, 81,
20052
MONZA
- ITALY
00133
ROMA
- ITALY

pharmacist.

What is in this leaflet:
1. What Fludeoxyglucose (18F)-IBA is and what it is used for.
what itisisused.
used for.
What
(18F)-IBA is and
2. 1.What you
needFludeoxyglucose
to know before Fludeoxyglucose
( 18F)-IBA
Before you are
given Fludeoxyglucose
(18F)-IBA.
3. 2.How Fludeoxyglucose
(18F)-IBA
will be used.
4. 3.Possible How
side effects.
you will be given Fludeoxyglucose (18F)-IBA.
18
5 4.How Fludeoxyglucose
F)-IBA is stored.
Possible side(effects.
6. 5.ContentsHow
of thetopack
other information(18F)-IBA.
storeand
Fludeoxyglucose

Denmark
Denmark,
Portugal, United Kingdom:
18
Fludeoxyglucose
(18F) (IBA
F) IBA 185MBq/mL, solution for injection
Fludeoxyglucose

CISPARC
BIO INTERNATIONAL
SCIENTIFIQUE ET TECHNIQUE G.BESSE
10 AVENUE
CHARLES
180, ALLEE
VON PEGUY
NEUMANN
95200
SARCELLES
– FRANCE
30035
NÎMES CEDEX
1 – FRANCE

If you have any further questions, ask your doctor or

pharmacist.
If you have
any further questions, ask your nuclear medicine doctor who will supervise the
- procedure.
If any of the side effects gets serious, or if you notice any side
noteffects,
listedtalk
in this
please
tell your
doctor
or
If you get effects
any side
to your nuclear
medicine
doctor.
This includes

6

6

QCS-066.05
FDG-IBA
IBA19/05/2011
Pharma S.A.

1

1

10/09/201313:29
14:23
31/05/2011

Before administration of Fludeoxyglucose (18F)-IBA you should:
drink plenty of water before the start of the examination in order to urinate as often as
-

avoid all important physical activity,
be fasting for at least 4 hours.

Children and adolescents
Please, talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Fludeoxyglucose (18F)-IBA
Tell your nuclear medicine doctor if you are taking or have recently taken or might take any other
medicines since they may interfere with your doctor’s interpretation of the images:

-

(valproate, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system
(adrenalin, noradrenalin, dopamine…),
glucose,
insulin,
medicines used to increase the production of blood cells.

Fludeoxyglucose (18F)-IBA with food and drink
You should be fasting for at least 4 hours before the administration of the product. You should drink
plenty of water and avoid drinking liquids containing sugar.
Your nuclear medicine doctor will measure your blood sugar before administering the product;indeed
a high blood glucose concentration (hyperglycemia) can make the nuclear medicine doctor’s
Pregnancy and breastfeeding
You must inform the nuclear medicine doctor before the administration of Fludeoxyglucose (18F)-IBA
if there is a possibility you might be pregnant, if you have missed your period or if you are
breastfeeding.
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the
procedure.
If you are pregnant
expected which would outweigh the risks.
If you are breastfeeding
You must stop breastfeeding for 12 hours after the injection and the maternal milk pumped must be
discarded.
Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise
the procedure.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your nuclear medicine doctor for advice before you will be administered this product.
Driving and using machines:
It is considered unlikely that Fludeoxyglucose (18F)-IBA will affect your ability to drive or to use
machines.

QCS-066.05
IBA Pharma S.A.

SO40589_QCS-066.05_P1 2

2

Fludeoxyglucose (18F)-IBA contains sodium.
This product may contain more than 1 mmol of sodium (23 mg). You should take this into account if you
are on a low sodium diet.

4.

3.

This radiopharmaceutical will deliver low amount of ionising radiation associated with the least risk of
cancer and hereditary abnormalities.

How Fludeoxyglucose ( F)-IBA will be used?
18

There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Fludeoxyglucose (18F)-IBA will only be used in special controlled areas. This product will only be
. These persons will
take special care for the safe use of this product and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the quantity of Fludeoxyglucose
(18F)-IBA to be used in your case. It will be the smallest quantity necessary to get the desired
information.
The quantity to be administered usually recommended for an adult ranges from 100 to 400 MBq
(depending on the patient’s body mass, the type of camera used for imaging and the acquisition mode).
Megabecquerel (MBq) is the unit used to express radioactivity.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

radiopharmaceutical overcomes the risk due to radiation.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects
You can also report side effects directly via:
Yellow Card Scheme,
website: www.mhra.gov.uk/yellowcard.

Use in children and adolescents
In case of use in children and adolescents, the quantity to be administered will be adapted to the
child’s weight.

By reporting side effects you can help provide more information on the safety of this medicine.

Administration of Fludeoxyglucose (18F)-IBA and conduct of the procedure
Fludeoxyglucose (18F)-IBA is administered intravenously.

You will not have to store this product. This product is stored under the responsibility of the specialist
in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national
regulation on radioactive materials.

After injection, you will need to be completely at rest, without reading or talking. Also, you will be
offered a drink and asked to urinate immediately preceding the procedure.

The following information is intended for the specialist only.

While the pictures are being taken, you will need to be completely at rest. You should not move or
talk.
Duration of the procedure:
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Fludeoxyglucose (18F)-IBA is administered as a single injection in a vein, 45-60 minutes before the imaging
acquisition takes place. The imaging acquisition with the camera, lasts 30 to 60 minutes.
After administration of Fludeoxyglucose (18F)-IBA, you should:
avoid any close contact with young children and pregnant women for the 12 hours following
the injection.
urinate frequently in order to eliminate the product from your body

How Fludeoxyglucose ( 18F)-IBA is stored

This product must not be used after the expiry date, which is stated on the label.
6.

Contents of the pack and other information

What Fludeoxyglucose (18F)-IBA contains
18
F). 1 mL of solution for injection contains 185 MBq
at the date and time of calibration.
The other ingredients are: sodium chloride, water for injections.
What Fludeoxyglucose (18F)-IBA looks like and contents of the pack
The activity per vial ranges from 90 MBq to 1850 MBq at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer

If you have been given more Fludeoxyglucose (18F)-IBA than you should
An overdose is unlikely because you will only receive a single dose of Fludeoxyglucose (18F)-IBA
precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of
an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in
charge of the procedure may recommend that you drink abundantly in order to facilitate the
elimination of Fludeoxyglucose (18F)-IBA from your body (indeed the principle way of elimination of
this medicine is renal, in the urine).
If you have any further question on the use of Fludeoxyglucose (18F)-IBA, please ask, your nuclear
medicine doctor who supervises the procedure.

QCS-066.05
IBA Pharma S.A.

5.

3

Marketing Authorisation Holder:
IBA PHARMA S.A.
3, CHEMIN DU CYCLOTRON
1348 OTTIGNIES - LOUVAIN-LA-NEUVE - BELGIUM
Manufacturer:
IBA RADIO ISOTOPE FRANCE S.A.S.
59, BOULEVARD PINEL
69003 LYON – FRANCE

QCS-066.05
IBA Pharma S.A.

4

10/09/2013 14:23

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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