HDP TechneScan 3 mg radiopharmaceutical preparation kit

Package leaflet: Information for the user

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, 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 HDP Technescan is and what it is 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. How to store HDP Technescan
6. Contents of the pack and other information

1. What HDP Technescan is and what it is 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 (99mTc) hydroxymethylene diphosphonate.

HDP Technescan is used in adults and children to determine whether there are any bone abnormalities.

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, known as scans, can be taken. 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 radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before HDP Technescan is administered to you

Do not use HDP Technescan

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

Warnings and precautions

Exercise special caution with HDP Technescan:

• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
• If you have kidney disease.
• If you have a condition called hypercalcemia (high level of calcium in your blood).

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

Before administration of HDP Technescan you must:

• Drink plenty of water before starting the procedure to urinate frequently during the first hours after completion.

Children and adolescents

If you are under 18 years of age, speak with your nuclear medicine specialist, particularly because increased radiation exposure may be observed in growing bones.

Other medicines and HDP Technescan

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as they could interfere with the interpretation of the images.

Your nuclear medicine physician/physician might recommend that you stop taking the following medicines before the HDP Technescan procedure:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before this medicine is administered to you.

If there is any possibility you are pregnant, if you have missed a menstrual period, or if you are breastfeeding, you must inform your nuclear medicine physician before HDP Technescan is administered. If in doubt, it is important that you consult the nuclear medicine physician supervising the procedure.

If you are pregnant

The nuclear medicine physician will only administer this HDP Technescan if the expected benefit outweighs the risks.

If you are breastfeeding

Inform your physician, as it may be necessary to postpone the procedure until breastfeeding ends. It is also possible that your physician will ask you to interrupt breastfeeding for a short period and discard the milk during that time, until radioactivity is no longer present in your body. Please consult your nuclear medicine physician regarding when you can resume breastfeeding.

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

Driving and use of machines

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

HDP Technescan contains sodium.

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

3. How to use HDP Technescan

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.

HDP Technescan will be used only in special controlled areas. This product will be handled and administered solely by trained and qualified personnel experienced in its safe use. These individuals will take special care in the safe handling of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of technetium (99mTc) medronate to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The generally recommended administered amount for an adult is 300 to 740 MBq (MegaBecquerels, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered amount will be adjusted according to 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 required by your physician.

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

Duration of the procedure

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

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

After administration of HDP Technescan, you should:

• avoid strenuous physical exercise until satisfactory scans have been obtained, to prevent accumulation of the radioactive substance in your muscles;
• avoid close contact with young children and pregnant women for 1 hour after the injection;
• 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 given more HDP Technescan than you should have received:

An overdose is unlikely, as you will receive a single dose of HDP Technescan carefully controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. In particular, the nuclear medicine physician may advise you to drink plenty of fluids and to urinate frequently to help eliminate residual radioactivity from your body.

If you have any doubts about the use of HDP Technescan, ask your supervising nuclear medicine physician.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Allergic reactions with 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 in the face, tongue, and throat; various types of swellings caused by fluid accumulation
  • increased heart rate, elevated blood pressure
  • inflammation of the inside of the nose or of the outer layer of the eye
  • skin inflammation, redness, rash, itching, increased sweating
  • Taste disturbance
  • sensory disturbances, such as tingling or burning sensations

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

• Circulatory reactions with symptoms such as:

  • Fainting, circulatory failure
  • Dizziness, headache
  • Increased or decreased heart rate, low blood pressure
  • Tremors, blurred vision, hot flushes

• Gastrointestinal reactions with symptoms such as:

  • Vomiting, nausea
  • Diarrhea
  • Abdominal pain

• Musculoskeletal reactions with symptoms such as joint pain

• Reactions at the injection site, with symptoms such as infection, inflammation, pain, skin redness, swelling

• General reactions with symptoms such as chest pain and chills

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es).

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

5. Storage of HDP Technescan

You will not be required 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 for specialists only.

Do not use HDP Technescan after the expiry date stated on the label following “EXP”.

Do not use HDP Technescan if there are any 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 contents of the pack

HDP Technescan is a white to slightly yellow lyophilized powder. It is a reagent 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 sealed with an aluminum cap.

It is packaged 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

(The Netherlands)

Date of the most recent revision of this summary: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

The complete technical data sheet of HDP Technescan is included as a separate document within 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