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			Customer	IBA MOLECULAR UK LTD	Previous Version	SO35361
			Product Name	FLUDEOXYGLUCOSE - FDG -	Pharmacode No	N/A
				IBA PIL (VERSION 5)	Material	50gsm Opaque
			Item Code	QCS-066.05	Flat Size	444 x210
			Our Ref	SO40589	Fold Size	210x148
			Proof No	One	View Panel	LOGO TO VIEW
			Date	10/09/2013	Fold DetaM	PARALLEL
			ARTWORK APPROVED AMENDMENTS REQUIRED		PackViinegwDPeatnaeills	Shrinkwrapped in trays
					Colours Front	BLACK
					Colours BacD	BLACK
	Contego HEALTHCARE ^ M Tel: 01630 660063 Fax: 01638 667128 ISDN: 01638 560030	Specification and Artwork approved for printing by SIGNATURE PRINT............................................................................................ DATE..........................

IBA MOLECULAR UK LTD

NOBEL WAY,

DINNINGTON,

SHEFFIELD

SOUTH YORKSHIRE S25 3QB - UNITED KINGDOM

B.V. CYCLOTRON VU

DE BOELELAAN 1 081

1081 HV AMSTERDAM - NETHERLANDS

Detailed information on this medicine isavailable on the website of MHRA.

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

(ⁱ⁸F) Fludeoxyglucose IBA

Belgium, France, Luxemburg:

Fludesoxyglucose (¹⁸F) IBA

Denmark,Portugal, United Kingdom:

Fludeoxygfucose (¹⁸F) IBA

Italy:

Fluodeossiglucosio g⁸F) IBA

The Netherlands:

Fluorodesoxyglucose (¹⁸F) IBA

Spain:

Fludesoxiglucosa (¹⁸F) IBA Slovenia:

[ ^{1 8} F] fludeoksiglukoza IBA Sweden:

Fludeoxiglukos (¹⁸F)-IBA

Thts leaflet was last revised in 09/2013.

The following information is intended for medical or healthcare professionals only:

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 h-fterE    /e

radiopharmacoutical.

Please refer to the SmPC.

PACKAGE LEAFLET:INFORMATION FOR THL PATIENT FLUDEOXYGLUCOSE (¹⁸F)-IBA 185 MBq/inl solution for injection

Fludeoxyglucose (¹⁸F)

Read all of this leaflet carefully bgfore you widd 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 nucl ear medicine doctor. This includes any possiblesidruftects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What youneed to know beforg Fludeoxynucose (¹⁸F)-IBA is used.

3.    How Fludeoxyglucose (¹⁸F)-IBA will bexsed.

4.    Possible siieeSfects.

5    How Fludgoxyglucooe (¹⁸F'-IB A is stored.

6.    Contents oi the pack and other inOormgtion

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

This medicine is a radiopliarmaceutical product for diagnostic use only.

The aitive suOstance contained if Fludeoxyglucose (¹⁸F)-IBA is designed for the capture of diagnostic images of some parts of your body.

Once a small rmouns gS Fludeoxyglucose (¹⁸F)-IBAhas been injected, medicsl images that are obtained with a special camera will enable the doctor to cayture images an! do see where your illness is orhow it is progressing.

2.    What you need to know before Fludeoxyglucose (¹⁸F)-IBA is used Fludeoxyglucose (¹⁸F)-IBA must not be used:

-    If you are ^leieictrifludeoxygiucoie(¹⁸F) or any of the other ingredients of this medicine (listed in section 6).

Warnings anRprecautioLs

Talk to your nuclear medicine doctor before being administered Fludeoxyglucose (¹⁸F)-IBA:

-    If you are diabetic qnd gour diabetes is currently not equilibrated,

-    K you havx mi infection oo ,anigbnmnftory diseoye,

-    If you aro affected by kidney problems.

Inform your nuclear medicine doctor in the following cases:

-    If you are pregnant or believe you may be pregnant

-    If you are breastfeeding

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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 possible during the first hours after the study.

-    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:

-    any medicine that may induce a modification of the blood sugar rate (glycemia), such as medicines having an effect on inflammation (corticosteroids), medicines against convulsions (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 interpretation more difficult.

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

The nuclear medicine doctor will only administer this product during pregnancy if a benefit is 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.

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.

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

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 handled and given to you by people who are trained and qualified to use it safely. 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.

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.

Administration of Fludeoxyglucose (¹⁸F)-IBA and conduct of the procedure

Fludeoxyglucose (¹⁸F)-IBA is administered intravenously.

One injection is sufficient to conduct the test that your doctor needs.

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.

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

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.

4.    Possible side effects

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

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

Your doctor has considered that the clinical benefit that you will obtain from the procedure with the 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 not listed in this leaflet.

You can also report side effects directly via:

Yellow Card Scheme,

website: www.mhra.gov.uk/ye11owcard.

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

5.    How Fludeoxyglucose (¹⁸F)-IBA is stored

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.

The following information is intended for the specialist only.

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

-    The active substance is fludeoxyglucose (¹⁸F). 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

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

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IBA Pharma S.A.    3

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