HDP TECHNESCAN 3 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

HDP Technescan 3 mg kit for radiopharmaceutical preparation

Sodium Oxidronate

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 is supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is HDP Technescan and what is it used for
2. What you need to know before you are given HDP Technescan
3. How to use HDP Technescan
4. Possible side effects
5. Storage of HDP Technescan
6. Contents of the pack and other information

1. What is HDP Technescan and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

HDP Technescan contains the active substance sodium oxidronate. It is used for the preparation of a radioactive injectable solution of technetium-99m oxidronate.

HDP Technescan is used in adults and children to determine if there is any bone abnormality.

When this solution is injected into a vein, it temporarily accumulates in the bones. Due to its radioactivity, it can be detected from outside the body using special cameras, and images can be taken, known as scans. These scans show the distribution of radioactivity in your body and provide valuable information about your bone metabolism

The administration of HDP Technescan involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you are given HDP Technescan

Do not use HDP Technescan

• If you are allergic to sodium oxidronate or any of the other components of this medicine (listed in section 6), or to any of the components of the product labeled with technetium-99m oxidronate.

Warnings and precautions

Be particularly careful with HDP Technescan:

• If you are pregnantor think you may be pregnant.
• If you are breast-feeding.
• If you have kidney disease.
• If you have a condition called hypercalcemia(high calcium levels in your blood).

Please talk to your nuclear medicine doctor if any of the above conditions apply to you. This medicine may not be suitable for you. Your nuclear medicine doctor will advise you.

Before administration of HDP Technescan you must:

• drink plenty of water before starting the procedure to urinate very frequently during the first hours after its completion

Children and adolescents

If you are under 18 years of age, talk to your specialist doctor in nuclear medicine, particularly because a greater exposure to radiation in growing bones may be observed.

Other medicines and HDP Technescan

Tell your nuclear medicine doctor if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription, as they may interfere with the interpretation of the images.

Your nuclear medicine doctor/doctor may recommend that you stop taking the following medicines before the procedure with HDP Technescan:

• Medicines containing iron(used to treat anemia)
• Medicines containing aluminum salts(used to treat gastric problems)
• Medicines to treat reduced bone densitywith active substance names ending in "dronate"
• Some cancer medicines(vincristine, cyclophosphamide, doxorubicin, methotrexate)
• Some immunosuppressive medicines(cortisone)
• Some medicines to treat infections(gentamicin, amphotericin, tetracycline).

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine.

If you are pregnant, if you have a delayed menstrual period, or are breast-feeding, you must inform your nuclear medicine doctor before administration of HDP Technescan. In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

The nuclear medicine doctor will onlygive you this HDP Technescan if the expected benefit outweighs the risks.

If you are breast-feeding

Tell your doctor, as it may be necessary to delaythe procedure until breast-feeding is finished. Your doctor may also ask you to interrupt breast-feedingfor a short period of timeand discard that milk during that period, until the radioactivity is no longer in your body. Please consult your nuclear medicine doctor when you can resume breast-feeding.

Additionally, you may need to avoid close contact with your baby for a short period (1 hour after injection).

Driving and using machines

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

HDP Technescan contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is "sodium-free".

3. How to use HDP Technescan

There are strict rules on the use, handling, and disposal of radiopharmaceuticals.

HDP Technescan will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who supervises the procedure will decide the amount of technetium-99m oxidronate to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount to administer to an adult is 300 to740 MBq. (Megabecquerels, the unit used to express radioactivity).

Use in children and adolescents

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

Administration of HDP Technescan and performance of the procedure

HDP Technescan is administered by injection, usually into a vein in the arm.

A single injection is sufficient to perform the test that your doctor needs.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure. This will improve the quality of the scan.

Duration of the procedure

Depending on the information required, scans can be performed immediately and/or later after injection (up to 24 hours).

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

After administration of HDP Technescan, you must:

• avoid strenuous physical exercise until satisfactory scans have been performed, to avoid accumulation of the radioactive substance in your muscles.
• avoid close contact with small children and pregnant women for 1 hour after injection
• urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after you are given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more HDP Technescan than you should:

Overdose is unlikely because you will receive a precisely controlled single dose of HDP Technescan by the nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor may recommend that you drink plenty of water and urinate frequently to eliminate the remains of radioactivity from your body.

In case of doubt about the use of HDP Technescan, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

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

Side effects with frequency not known (cannot be estimated from the available data):

• Allergic reactionswith symptoms such as:
• • potentially life-threatening allergic shock, loss of consciousness
  • cardiorespiratory arrest, breathing difficulties
  • severe and usually painful swelling of the deeper layers of the skin, mainly on the face, tongue, and throat, swelling of different types caused by excess fluid
  • increased heart rate, high blood pressure
  • inflammation of the inside of the nose or the outer layer of the eye
  • skin inflammation, redness, rash, itching, increased sweating
  • Taste disturbance
  • sensory disorders, such as pins and needles or burning

Contact a doctor immediately in case of allergic reactions. Hospital staff will treat these allergic reactions immediately if they occur.

• Circulatory reactionswith symptoms such as:
• • Fainting, circulatory failure,
  • dizziness, headache
  • increased or decreased heart rate, low blood pressure
  • tremors, blurred vision, hot flashes

• Gastrointestinal reactionswith symptoms such as:
• • Vomiting, nausea.
  • Diarrhea.
  • Abdominal pain.

• Musculoskeletal reactionswith symptoms such as joint pain

• Reactions at the injection site, with symptoms such as infection, inflammation, pain, redness of the skin, swelling.
• General reactionswith symptoms such as chest pain and chills.

The onset of these reactions may be delayed from 4 to 24 hours after injection.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website http://www.aemps.gob.es.

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

5. Storage of HDP Technescan

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities.

The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

Do not use HDP Technescan after the expiry date stated on the label after "EXP".

Do not use HDP Technescan if you notice visible signs of deterioration.

6. Contents of the pack and other information

Composition of HDP Technescan

• The active substance is sodium oxidronate (or hydroxymethylene diphosphonate, HDP).
• The other components are gentisic acid, hydrochloric acid, sodium chloride, sodium hydroxide, tin(II) chloride dihydrate.

Appearance of the product and pack contents

HDP Technescan is a white to slightly yellow lyophilized powder. It is a kit for radiopharmaceutical preparation intended for use only by healthcare professionals.

It is supplied in a 10 ml colorless glass vial, closed with a rubber stopper and aluminum seal.

It is supplied in a box containing 5 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, nº 29, 3º-2

28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V

Westerduinweg 3

1755 LE Petten

(Netherlands)

Date of last revision of this leaflet:May 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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This information is intended only for healthcare professionals:

The full technical data sheet of HDP Technescan is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet of HDP Technescan.