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1. Nanoscan 500micrograms Kit For Radiopharmaceutical Preparation
2. Nanoscan 500micrograms Kit For Radiopharmaceutical Preparation

PACKAGE LEAFLET: INFORMATION FOR THE USER

NanoScan 500 micrograms, Kit for radiopharmaceutical preparation

Human Serum Albumin nano sized colloid

Read all of this leaflet carefully before you will be administered this medicine.

-    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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your Nuclear medicine doctor who has

1. WHAT NANOSCAN IS AND WHAT IT IS USED FOR

This medicine is a radiopharmaceutical product for diagnostic use only.

Before treatment with NanoScan your doctor will explain to you the procedure you are about to undergo, and radioactive medicine you will be given.

NanoScan kit is a sterile preparation for studies of bone marrow scintigraphy, lymphoscintigraphy and sentinel node lymphoscintigraphy in melanoma malignum and in breast cancer. NanoScan belongs to a group of medicines called radiopharmaceutical agents. After labelling with ^99mTc-pertechnetate the Nuclear medicine doctor injects you into the vein (intravenous) or into the skin (subcutaneous) for visualisation and detection under a scintillation camera.

The use of radiolabelled NanoScan 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 overcomes the risk due to radiation.

This medicine has been prescribed for you only personally by your doctor.

2. BEFORE NANOSCAN IS ADMINISTERED NanoScan must never be used

•    if you are allergic (hypersensitive) to the active substance or any of other ingredients of NanoScan

•    if you are pregnant and you should undergo a lymphscintigraphy with Tc-labelled NanoScan

•    if you have a history of hypersensitivity to human albumine

Take special care with NanoScan

•    if you are pregnant or believe you may be pregnant

•    if you are under 18 years of age

•    if you are breast-feeding

Children and adolescents

Please speak to your Nuclear medicine doctor, if you are under 18 years old.

Please tell your Nuclear medicine doctor, if you have undergone a lymphoangiography with iodinated contrast media before you are receiving ^99mTc-NanoScan

Please tell your Nuclear medicine doctor, if you know that you are suffering on a kidney and/or liver disease and/or a malfunction of your gallbladder. Your doctor will explain to the details of the applied doses and procedures.

Taking other medicines

Please tell your Nuclear medicine doctor who will supervise the procedure, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Please tell your Nuclear medicine doctor, if you have undergone a lymphoangiography and iodinated contrast media have been used.

Using NanoScan with food and drink

Please do not drink alcohol, before you undergo this investigation. Pregnancy and breast-feeding

You must inform the Nuclear Medicine doctor before the administration of NanoScan, 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. Please ask your Nuclear medicine doctor before taking any medicine.

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 breast-feeding

Please ask your Nuclear medicine doctor when you can resume breast-feeding.

Tell your doctor if you are breastfeeding as he may delay the investigation until breastfeeding is completed or ask you to stop breastfeeding for a short while until the radioactivity is no longer in your body. He may ask you to use formula feedings to substitute breastfeeding for 13 hours following the administration of NanoScan. Breast milk produced within that time should be discarded.

Before NanoScan administration you should:

- drink plenty of water and to be well hydrated before the start of the examination in order to urinate as often as possible during the first hours after the study.

Driving and using machines

It is considered unlikely that NanoScan will affect your ability to drive or operate machinery.

Important information about some of the ingredients of NanoScan

This product contains 0.046 mmol Sodium per vial, i. e. essentially “Sodium free”.

3. HOW WILL NANOSCAN BE USED?

There are strict laws on the use, handling and disposal of radiopharmaceutical products. NanoScan will only be used in a hospital or specialist physician in Nuclear medicine. 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 NanoScan 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 40 to 500 MBq (Mega Becquerel, the united used to express radioactivity).

Use in children

In children and adolescents, the quantity to be administered will be adapted to the child’s body mass.

Administration of NanScan and conduct of the procedure

NanoScan is given as an injection into a vein or as subcutaneous injection. NanoScan should only be given by a qualified personal. 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.

If you have been administered more NanoScan than you should

An overdose is almost impossible, because you will only receive single or multiple doses of NanoScan precisely controlled by the Nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment. Should you have any further question on the use of NanoScan, please ask your Nuclear medicine doctor who supervises the procedure.

After administration of NanoScan, you should:

-    not take any other medicines until advised by your Nuclear medicine doctor

-    urinate frequently in order to eliminate the label (radionuclide) from your body

4. POSSIBLE SIDE EFFECTS

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

The following table presents how the frequencies are reflected in this section:

Very common (>1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

not known (cannot be estimated from the available data)

Tell your doctor if you notice any of the following side-effects:

■    hypersensitive-type reactions with pain in chest, rigor and collapse.

■    local allergic reaction mostly at the site of injection

This administered radiopharmaceutical will deliver low amounts of ionising radiation with very low risk of cancer and hereditary abnormalities.

If you notice any side effects, or if you notice any side effects not listed in this leaflet, please tell your Nuclear medicine doctor who supervises the procedure.

5. HOW X IS STORED

You will not have to store this medicine. This medicine 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 information is intended for the specialist only.

NanoScan will not be used after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.

NanoScan will not be used if it is noticed any particulate matter.

6. FURTHER INFORMATION What NANOSCAN CONTAINS

The active substance is Human Serum Albumin nano sized colloid Each vial contains 500 micrograms Human Serum Albumin nano sized colloid

The other ingredients are:

Stannous Chloride Dihydrate,

Sodium Phosphate Monobasic & Sodium Phosphate Dibasic, Glucose, Hydrochloric acid, Sodium hydroxide

What NanoScan looks like and contents of the pack Kit for radiopharmaceutical preparation NanoScan is a white powder

Pack sizes:

1 pack contains 6 vials Sample package: 2 vials Hospital packs:

Bundle pack of 2 packs of 6 vials Bundle pack of 4 packs of 6 vials Not all packs sizes may be marketed

Marketing authorisation holder:

RADIOPHARMACY Laboratory Ltd

2040, Budaors, Gyar st. 2. Hungary

Tel:    +36-23-886-950, +36-23-886-951

Fax:    +36-23-886-955

e-mail:    info@radiopharmacy-laboratory.eu

Manufacturer:

Medi-Radiopharma Ltd 2030 Erd, Szamos u. 10-12.

Hungary

This leaflet was last approved in

(DDMMYYYY)

Revision date

02/2015

The following Information is only for Physicians and Health Care Professionals

The complete SmPC of NanoScan 500micrograms is provided as a separate document.