Nanoalbumon

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nanoalbumon, kit for radiopharmaceutical preparation

Human albumin nanocolloid particles
Please read this leaflet carefully before receiving this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask the Nuclear Medicine Physician who will supervise the procedure.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform the Nuclear Medicine Physician who supervised the procedure.

Contents of this leaflet:

1. 1. What Nanoalbumon is and what it is used for
2. 2. Before using Nanoalbumon
3. 3. How to use Nanoalbumon
4. 4. Possible side effects
5. How to store Nanoalbumon
6. Further information

1. WHAT NANOALBUMON IS AND WHAT IT IS USED FOR

This medicinal product is a radiopharmaceutical intended for diagnostic use only.
Before treatment with Nanoalbumon, your doctor will explain to you the procedure you are about to undergo and the radioactive medicinal product that will be administered to you.
The Nanoalbumon kit is a sterile preparation used in bone marrow scintigraphy, lymphoscintigraphy, and sentinel lymph node scintigraphy in malignant melanoma and breast carcinoma. Nanoalbumon belongs to a group of medicines called radiopharmaceuticals. After labelling with Tc-pertechnetate, the Nuclear Medicine physician administers an injection either intravenously or subcutaneously to allow imaging and detection using a device called a gamma camera.
The use of radiolabelled Nanoalbumon involves exposure to small amounts of radioactivity. Your doctor and the Nuclear Medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.
This medicine has been prescribed for you personally by your .

2. BEFORE ADMINISTERING NANOALBUMON

Nanoalbumon must never be used

• if you are allergic (hypersensitive) to the active substance or to any of the excipients of Nanoalbumon
• if you are pregnant and need to undergo lymphoscintigraphy with technetium (Tc)-labelled Nanoalbumon
• if you have a history of hypersensitivity to human albumin

Exercise particular caution with Nanoalbumon

• if you are pregnant or think you might be
• if you are under 18 years of age
• if you are breastfeeding

Children and adolescents
If you are under 18 years of age, consult the Nuclear Medicine physician.
Inform the Nuclear Medicine physician if you have previously undergone lymphangiography with iodinated contrast media before receiving Tc-Nanoalbumon.
Inform the Nuclear Medicine physician if you know you have kidney and/or liver disease and/or gallbladder dysfunction. The physician will explain the specific details regarding doses and procedures.

Use of Nanoalbumon with other medicines
Inform the Nuclear Medicine physician supervising the procedure if you are currently taking or have recently taken any other medicines, including those obtained without a prescription.
Inform the Nuclear Medicine physician if you have undergone lymphangiography using iodinated contrast agents.

Use of Nanoalbumon with food and drink
Do not drink alcohol before undergoing this examination.

Pregnancy and breastfeeding
You must inform the Nuclear Medicine physician before administration of Nanoalbumon if there is any possibility that you may be pregnant, if you have missed your menstrual period, or if you are breastfeeding. If in doubt, it is important to consult the Nuclear Medicine physician who will supervise the procedure. Consult your Nuclear Medicine physician before taking any medication.

If you are pregnant
The Nuclear Medicine physician will administer this product during pregnancy only if the expected benefit outweighs the potential risks.

If you are breastfeeding
Ask your Nuclear Medicine physician when you may resume breastfeeding.
Inform the physician if you are breastfeeding, as they may choose to postpone the examination until you have finished breastfeeding, or may advise you to temporarily interrupt breastfeeding until the radioactivity is no longer present in your body. The physician may instruct you to use artificial baby milk to replace breastfeeding for 13 hours after administration of Nanoalbumon. Breast milk produced during this time must be discarded.

Before administration of Nanoalbumon you must:

• drink large amounts of water and ensure you are well hydrated before starting the examination, so that you can urinate as frequently as possible during the first few hours after the examination.

Driving and using machines
Nanoalbumon is considered unlikely to affect your ability to drive or operate machinery.

Important information about some excipients in Nanoalbumon
This product contains 0.046 mmol of sodium per vial and is therefore essentially "sodium-free".

3. HOW TO USE NANOALBUMON?

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Nanoalbumon will be used exclusively in a hospital setting or by a physician specialized in nuclear medicine.
This product will only be handled and administered to you by personnel who are trained and qualified to use it safely. These individuals will take special precautions to ensure the safe use of this product and will keep you informed about their actions.
The nuclear medicine physician overseeing the procedure will determine the amount of Nanoalbumon to be used in your case. The smallest necessary amount required to obtain the desired information will be administered.
The generally recommended administered activity for an adult ranges between 40 and 500 MBq (Mega Becquerel, the unit of measurement used to express radioactivity).

Use in children
In children and adolescents, the administered amount will be adjusted according to the child's body weight.

Administration of Nanoalbumon and conduct of the procedure
Nanoalbumon is administered as an intravenous or subcutaneous injection.
Nanoalbumon must only be administered by a qualified operator.
After the injection, you will be offered a drink and asked to urinate immediately before the test.

Duration of the procedure
The nuclear medicine physician will inform you about the expected duration of the procedure.

If you are administered more Nanoalbumon than required
An overdose is almost impossible, as you will receive only single or multiple doses of Nanoalbumon that are precisely controlled by the nuclear medicine physician supervising the procedure.
In the event of an overdose, you will receive appropriate treatment.
If you have any further questions regarding the use of Nanoalbumon, please consult the nuclear medicine physician who will supervise the procedure.

After administration of Nanoalbumon:

• you must not take any other medicines until advised by the Nuclear Medicine Physician
• you should urinate frequently to help eliminate the radiopharmaceutical (radionuclide) from your body.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Nanoalbumon can cause adverse reactions, although not everyone experiences them.
The following table shows the frequencies as 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: (frequency cannot be estimated from the available data)

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

• hypersensitivity-type reactions with chest pain, rigidity, and collapse.
• localized allergic reaction, mainly at the injection site.

This radiopharmaceutical, when administered, releases low amounts of ionizing radiation, with a very low risk of cancer and hereditary abnormalities.
If you notice any side effect, or if you notice any side effect not listed in this leaflet, inform the Nuclear Medicine doctor supervising the procedure.

5. HOW TO STORE NANOALBUMON

You must not store this medicinal product. This medicinal product will be stored under the responsibility of a specialist in appropriate premises. Storage of radiopharmaceuticals will be carried out in accordance with national regulations in force on radioactive materials.
The information is intended exclusively for the specialist.
Nanoalbumon must not be used after the expiry date stated on the carton and label. The expiry date refers to the last day of the month.
Nanoalbumon must not be used if any foreign particles are observed.

6. OTHER INFORMATION

What Nanoalbumon contains
The active substance is:
Human albumin nanocolloid particles
Each vial contains 500 micrograms of human albumin nanocolloid particles

The excipients are:
Tin (II) chloride dihydrate
Monobasic sodium phosphate and dibasic sodium phosphate, glucose, hydrochloric acid, sodium hydroxide

Description of the appearance of Nanoalbumon and contents of the pack
Kit for radiopharmaceutical preparation
Nanoalbumon is a white powder

Pack sizes:
1 pack contains 6 vials
Hospital packs:
Box of 2 packs containing 6 vials each
Box of 4 packs containing 6 vials each
It is possible that not all pack sizes are marketed

Marketing Authorization Holder:
RADIOPHARMACY Laboratory Ltd
2040, Budaörs, Gyár st. 2. Hungary
Tel: +36-23-886-950, +36-23-886-951
Fax: +36-23-886-955
e-mail: [email protected]

Manufacturer responsible for batch release:
Medi-Radiopharma Ltd
2030 Érd, Szamos u. 10-12.
Hungary

This leaflet was last approved on
(DDMMYYYY)

The following information is intended exclusively for physicians and healthcare professionals
The full Product Characteristics Summary (SmPC) of Nanoalbumon 500 micrograms is provided as a separate document.