Package leaflet: Information for the patient

Nanotop 0.5 mg

Kit for radiopharmaceutical preparation

Active substance: Human albumin, colloidal particles

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 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 Nanotop is and what it is used for

2.    What you need to know before Nanotop is used

3.    How Nanotop is used

4.    Possible side effects

5.    How Nanotop is stored

6.    Contents of the pack and other information

1. What Nanotop is and what it is used for

This medicine is a radiopharmaceutical product for diagnostic use only.

It is used for scintigraphic imaging and assessment of

•    sentinel lymph nodes in tumor diseases (Sentinel Node Mapping)

•    the integrity of the lymphatic system and differentiation of venous from lymphatic obstruction

The use of Nanotop does involve exposure to small amounts 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.

2. What you need to know before Nanotop is used Nanotop must not be used:

•    if you are allergic to Nanotop or to any of the excipients of this medicine (listed in section 6).

•    during pregnancy.

In patients with complete lymph obstruction, lymph node scintigraphy is not advisable because of the danger of radiation necroses at the site of injection.

Warnings and precautions

Take special care with Nanotop

-    if you are breast-feeding

Before administration of Nanotop 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.

Children and adolescents

Talk to your nuclear medicine doctor if you are under 18 years old

Medicines made from human blood or plasma

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

•    careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,

•    the testing of each donation and pools of plasma for signs of virus/infections,

• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infection.

There are no reports of viral infections with albumin manufactured to European Pharmacopoeia requirements by established processes.

It is strongly recommended that every time you receive a dose of Nanotop 0.5 mg kit for radiopharmaceutical preparation the name and batch number of the medicine are recorded in order to maintain a record of the batches used.

Other medicines and Nanotop

Iodinated contrast media used in lymphoangiography may interfere with lymphatic scanning using ^99mTc nano-sized albumin colloid.

Tell your nuclear medicine doctor if you are taking/using, have recently taken/used or might take/use any other medicines since they may interfere with the interpretation of the images.

If you must have made a scan of your lymph system, talk to your doctor before your scan, if you previously have been investigated by x-ray or scan with contrast agents. This can influence the outcome.

Pregnancy and breast-feeding

You must inform the nuclear medicine doctor before the administration of Nanotop if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant:

Do not use Nanotop during pregnancy.

If you are breast-feeding

If you are breast-feeding, please tell your doctor, as he/she may advise you to stop doing so until the radioactivity has left your body. The expressed milk should be discarded. Please ask your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

It is considered unlikely that Nanotop will affect your ability to drive or to use machines.

Nanotop contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium-free'.

3. How Nanotop is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Nanotop 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 Nanotop 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 5 to 200 MBq (megabecquerel, the unit used to express radioactivity).

Dosage reductions in renal or hepatic impairment are not necessary. Use in children and adolescents

In children and adolescents, the quantity to be administered will be adjusted to the child's weight.

Administration of Nanotop and conduct of the procedure

After radiolabelling the drug is administered subcutaneously (one or more injection sites). This product is not intended for regular or continuous administration.

After injection, you will be offered a drink and asked to urinate immediately preceding the test.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Nanotop, you should

Urinate frequently in order to eliminate the product from your body.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your Nuclear medicine doctor if you have any questions.

If you have been given more Nanotop than you should

An overdose is almost impossible because you will only receive a single dose of Nanotop precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.

Shelf life after first opening and radiolabelling

After radiolabelling: 6 hours. Do not store above 25°C after radiolabelling.

The ready for use injection suspension has to be stored according to the national regulations for radioactive material.

6. Contents of the pack and other information

What Nanotop contains

The active substance is

1 vial contains 0.5 mg human albumin, colloidal particles The country of origin of the blood plasma is Belgium

The excipients are Stannous chloride, dihydrate Glucose Poloxamer 238

Disodium phosphate dihydrate Sodium phytate

If you have further questions regarding the application of the medicinal product, ask your nuclear medicine doctor who will supervise the procedure.

4. Possible side effects

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

During the evaluation of side effects the following frequency data are taken as a basis:

more than 1 patient out of 10 1 to 10 patient out of 100 1 to 10 patient out of 1000 1 to 10 patient out of 10000 Less than 1 patient out of 10000 frequency cannot be estimated from available data

slight and temporary hypersensitivity reactions, which can express symptoms

at the administration area/skin local reactions, rush, itching as immune system disease vertigo, blood pressure decrease

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

When a protein-containing radiopharmaceutical such as ^99mTc-Nanotop is administered to a patient, hypersensitivity reactions may develop.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Nanotop is stored

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

What Nanotop looks like and contents of the pack

The pack consists of 5 glass vials of 10 ml in a cardboard box.

Each vial contains white or almost white lyophylisate for preparation of an injection suspension.

Marketing Authorisation Holder and Manufacturer

ROTOP Pharmaka AG Bautzner LandstraUe 400 01328 Dresden Germany

Tel: +49 (0) 351 - 26 310 100 Fax: +49 (0) 351 - 26 310 303 E-Mail: service@rotop-pharmaka.de

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

United Kingdom	Nanotop
Austria	NANOTOP 0,5 mg Kit fur ein radioaktives Arzneimittel
Finland	ROTOP-NanoHSA
France	ROTOP-NanoHSA 0,5 mg Trousse pour preparation radiopharmaceutique
Germany	NANOTOP
Italy	NANOTOP
Norway	Nanotop
Portugal	NANOTOP
Sweden	NanoHSA
Spain	ROTOP-NanoHSA 500 microgramos equipo de reactivos para preparacion radiofarmaceutica

This leaflet was last revised in February 2014.

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

The complete SmPC of {(Invented) name} is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please refer to the SmPC.

The following information is intended for the specialist only.

Nanotop must not be used after the expiry date which is stated on the label.

Storage conditions:

Do not store above 25 °C.