Nanocolloids of albumin Radiopharmacy 500 micrograms radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nanocolloidal Albumin Radiopharmacy 500 micrograms kit for preparation of radiopharmaceutical

Technetium (99mTc) labelled nanocolloidal albumin

Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who supervises the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet (see section 4.).

Leaflet contents:

1. What Nanocolloidal Albumin Radiopharmacy 500 micrograms is and what it is used for
2. What you need to know before using Nanocolloidal Albumin Radiopharmacy 500 micrograms
3. How to use Nanocolloidal Albumin Radiopharmacy 500 micrograms
4. Possible side effects
5. How to store Nanocolloidal Albumin Radiopharmacy 500 micrograms
6. Contents of the pack and other information

1. What Nanocoloides de albúmina Radiopharmacy 500 micrograms is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic use.

Nanocoloides de albúmina Radiopharmacy 500 micrograms must be radiolabelled with technetium (99mTc), and the resulting product is used for gamma imaging and assessment of:

• bone marrow,

• inflammation in the body,

• lymphatic system integrity and differentiation between venous obstruction and lymphatic obstruction,

• sentinel lymph nodes in tumour diseases (sentinel lymph node mapping in melanoma, breast carcinoma, penile carcinoma, squamous cell carcinoma of the oral cavity, and vulvar carcinoma).

The use of technetium (99mTc)-labelled Nanocoloides de albúmina Radiopharmacy 500 micrograms involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician consider that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Nanocolloidal Albumin Radiopharmacy 500 micrograms

Nanocolloidal Albumin Radiopharmacy 500 micrograms must not be used

• if you are allergic to nanocolloidal human albumin or to any of the other components of this medicine (see section 6.).
• during pregnancy if you are due to undergo pelvic lymphoscintigraphy. In patients with complete lymphatic obstruction, lymphoscintigraphy is not recommended due to the risk of radiation-induced necrosis at the injection site.

Warnings and precautions

Take special care with Nanocolloidal Albumin Radiopharmacy 500 micrograms

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you have kidney or liver problems.

You must inform your nuclear medicine specialist if any of these apply to you. Your nuclear medicine specialist will tell you whether you need to take special precautions after using this medicine. Speak with your nuclear medicine specialist if you have any questions.

Before administration of Nanocolloidal Albumin Radiopharmacy 500 micrograms you should:

• drink plenty of water and remain well hydrated before starting the procedure, to ensure frequent urination during the first hours after completion of the procedure.

Children and adolescents

Inform your nuclear medicine specialist if you or your child are under 18 years of age.

Medicines manufactured from human blood or plasma

When medicines are manufactured from human blood or plasma, certain measures are implemented to prevent the transmission of infections to patients. These include:

• careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded,
• testing of each donation and plasma pools for signs of viruses/infections,
• inclusion of steps to inactivate or eliminate viruses during the blood or plasma processing.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This also applies to unknown or emerging viruses or to other types of infections.

There are no reports of viral infections associated with albumin manufactured according to European Pharmacopoeia specifications and in accordance with established processes.

It is strongly recommended that each time you receive a dose of Nanocolloidal Albumin Radiopharmacy 500 micrograms, the name and batch number of the medicine be recorded to maintain a record of the batches used.

Use of Nanocolloidal Albumin Radiopharmacy 500 micrograms with other medicines

Inform your nuclear medicine specialist if you are taking, have recently taken, or might need to take any other medicines, as they may interfere with the interpretation of images. Speak with your doctor before undergoing a lymphatic system scan, and if you have previously undergone X-rays or imaging scans with contrast agents. This may influence the results. Ask your nuclear medicine specialist before taking any medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before receiving this medicine.

You must inform the nuclear medicine specialist before administration of Nanocolloidal Albumin Radiopharmacy 500 micrograms if there is any possibility you are pregnant, if you have missed a menstrual period, or if you are breastfeeding. In case of doubt, it is important to consult the nuclear medicine specialist who will supervise the procedure.

Do not use Nanocolloidal Albumin Radiopharmacy 500 micrograms during pregnancy.

If you are breastfeeding, inform the nuclear medicine specialist, as he or she will advise you to stop breastfeeding until the radioactivity has left your body. This may take up to 24 hours. Breast milk expressed during this time should be discarded. Consult your nuclear medicine specialist on when you may resume breastfeeding.

Driving and using machines

Nanocolloidal Albumin Radiopharmacy 500 micrograms is considered unlikely to affect your ability to drive or operate machinery.

Nanocolloidal Albumin Radiopharmacy 500 micrograms contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial; therefore, it is essentially “sodium-free”.

3. How to use Nanocolloidal Albumin Radiopharmacy 500 micrograms

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Nanocolloidal Albumin Radiopharmacy 500 micrograms will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Nanocolloidal Albumin Radiopharmacy 500 micrograms to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The amount generally recommended for administration in adults is 5 to 500 MBq (Megabecquerels, the unit used to express radioactivity).

Dose reduction is not necessary in cases of renal or hepatic impairment.

Use in children and adolescents

In children and adolescents, the administered amount will be adjusted according to body weight.

Administration of Nanocolloidal Albumin Radiopharmacy 500 micrograms and performance of the procedure

Nanocolloidal Albumin Radiopharmacy 500 micrograms is administered after radiolabelling via intravenous or subcutaneous route (one or more injection sites).

This medicine is not intended for regular or continuous administration.

After injection, you will be offered fluids to drink and will be asked to urinate immediately before starting the procedure.

Duration of the procedure

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

After administration of Nanocolloidal Albumin Radiopharmacy 500 micrograms, you should:

• avoid direct contact with young children and pregnant women during the first 24 hours after administration
• urinate frequently to help eliminate the product from your body

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more Nanocolloidal Albumin Radiopharmacy 500 micrograms than you should have received

An overdose is unlikely, as you will receive a dose of Nanocolloidal Albumin Radiopharmacy 500 micrograms under the strict control of the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.

In particular, the physician in charge of the procedure may recommend drinking large amounts of fluids to facilitate the elimination of Nanocolloidal Albumin Radiopharmacy 500 micrograms from your body.

If you have any further questions about the use of Nanocolloidal Albumin Radiopharmacy 500 micrograms, please ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, Nanocolloidal Albumin Radiopharmacy 500 micrograms may cause adverse effects, although not everyone experiences them.

During evaluation, the following frequency data are used as the basis:

Very rare:

Mild and transient hypersensitivity reactions, which may present symptoms such as reactions at the site of administration/local cutaneous reactions, rash, pruritus, immune system disease, dizziness, decreased blood pressure.

When a radiopharmaceutical containing proteins, such as Nanocolloids of Albumin Radiopharmacy 500 micrograms, is administered to a patient, hypersensitivity reactions may occur, including rarely life-threatening anaphylaxis, with an unknown frequency.

Administration of this radiopharmaceutical involves exposure to small amounts of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

If you experience any adverse effects, inform the nuclear medicine specialist physician. This includes possible adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your physician or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Nanocolloidal Albumin Radiopharmacy 500 micrograms

You do not need to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended exclusively for the specialist.

Nanocolloidal Albumin Radiopharmacy 500 micrograms must not be used after the expiry date stated on the carton and label.

Nanocolloidal Albumin Radiopharmacy 500 micrograms must not be used if the integrity of this vial is compromised.

6. Contents of the pack and other information

Composition of Nanocolloidal Albumin Radiopharmacy 500 micrograms

The active substance is human nanocolloidal albumin. Each vial contains 500 micrograms of human albumin nanocolloid.

The other components are:

Tin(II) chloride dihydrate (E512), sodium dihydrogen phosphate dihydrate (E339), disodium hydrogen phosphate dihydrate (E339), glucose monohydrate, hydrochloric acid (E507), sodium hydroxide (E524), nitrogen (E941).

Appearance of the product and contents of the pack

This product is a reagent kit for radiopharmaceutical preparation.

Each vial contains a white or almost white powder for the preparation of an injectable solution.

Nanocolloidal Albumin Radiopharmacy 500 micrograms consists of six vials. The vial contents must be dissolved in a solution and combined with radioactive technetium prior to use as an injectable solution. Once the radioactive substance sodium pertechnetate (99mTc) is added to the vial, technetium (99mTc) labelled albumin nanocolloids are formed. This solution is ready for injection.

Pack sizes:

1 pack containing 6 vials

Pack of 2 vials

Only certain pack sizes may be 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:

Medi-Radiopharma Ltd
2030 Érd, Szamos u. 10-12.
Hungary

More information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Date of the last review of this leaflet: September 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products: http://aemps.gob.es

This information is intended for healthcare professionals only

The complete Summary of Product Characteristics for Nanocolloids of Albumin Radiopharmacy 500 micrograms is included in a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics [the summary of product characteristics should be included in the package]