Patient Information Leaflet

HDP Technescan3 mg kit for radiopharmaceutical preparation

Sodium Oxidronate

Read this leaflet carefully before you receive this medicine as 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 doctor who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you receive HDP Technescan

3.How to use HDP Technescan

4.Possible side effects

5.Storage of HDP Technescan

6.Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

HDP Technescan is used in the study of bone-related diseases.

This medication contains sodium oxodronate, which is used in combination with the radioactive element technetium (99mTc) to obtain an injectable solution of technetium-99m oxodronate.

When this solution is injected into a vein, it temporarily accumulates in certain organs, such as bones.Due to the small amount of radioactivity in the radiopharmaceutical, it can be detected from the outside of the body using a special medical device called a gamma camera, and an image, known as a gamma scan, can be obtained.This gamma scan will show exactly the distribution of the radiopharmaceutical in the skeleton, indicating if there is any alteration in bone function.This can provide valuable information to the doctor about the structure and function of the bones.

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

No use HDP Technescan

If you are allergic to sodium oxalate or any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with HDP Technescan:

• If you are pregnant or think you may be.
• If you are breastfeeding.

Before HDP Technescan administration, you must:

• Drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion
• Avoid all intense physical activity

Children and adolescents

If you are under 18 years of age, speak with your nuclear medicine specialist.

Use of HDP Technescan with other medications

Inform your nuclear medicine specialist if you are using, have used recently, or may need to use any other medication,including those purchased without a prescription, as they may interfere with image interpretation.

The followingmedicationsmayalter or be altered by HDP Technescan:

• Medications for treating reduced bone densitywith active principles with names ending in "dronate".
• Vincristine, cyclophosphamide, doxorubicin, methotrexate: anticancer agents.
• Immunosuppressive medications(e.g. cortisone): agents that inhibit or prevent the activity of the immune system.
• Gentamicin, amphotericin: antibiotics.
• Medications based oniron.
• Medications based onaluminumto fix stomach acids.

Pregnancy, lactation, and fertility

If you are pregnant orin the lactation period, think you may be pregnant or intend to become pregnant, consult your nuclear medicine specialist before this medication is administered.

If there is a possibility you are pregnant, if you experience a delay in menstruation or are in the lactation period, inform your nuclear medicine specialist before HDP Technescan administration. In case of doubt, it is essential to consult your nuclear medicine specialist overseeing the procedure.

If you are pregnant

Your nuclear medicine specialistwill onlyadminister this medicationif the expected benefit outweighs the risks.

If you are in the lactation period

Inform your doctor as it may be possible todelay the administration of this medicationuntil you finish lactating. It may also be possible for you tointerrupt lactationand discard that milk until you no longer have radioactivity in your body. Your nuclear medicine specialist will indicate when you can resume lactation.

The possible effect of administering this medication on fertility is unknown.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

HDP Technescan contains sodium.

This medication contains less than 23 mg of sodium (1mmol) per dose; this is, essentially “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals.

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

The nuclear physician overseeing the procedure will decide the amount of HDP Technescan to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is between 300 to 740 MBq. (MegaBecquerel, the unit used to express radioactivity).

Use in Children and Adolescents

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

Administration of HDP Technescan and Procedure Performance

HDP Technescan is administered intravenously.

One injection is usually sufficient to perform the test your doctor needs. Depending on the information required, images will be taken immediately or two hours after the injection.

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

Procedure Duration

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

After HDP Technescan Administration, You Must:

• Urinate frequently to eliminate the product from your body.

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

If You Have Been Administered More HDP Technescan Than Necessary:

It is unlikely to have an overdose because you will receive a single, precisely controlled dose of HDP Technescan from the nuclear physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment.

In case of doubt about the use of HDP Technescan, ask your nuclear physician overseeing the procedure.

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

The administration of this radioactive drug involves receiving a small amount of ionizing radiationwith a very low risk of developing cancer and genetic defects.

The following adverse effects have been reported:

Unknown frequency (cannot be estimated from available data):

• Severe allergic reactions with symptoms such as:
• • Potentially fatal anaphylactic shock, loss of consciousness
  • Cardio-respiratory arrest, respiratory difficulties
  • Severe and usually painful swelling of the deepest layers of the skin, mainly on the face
  • Increased heart rate, elevated blood pressure
  • Respiratory difficulty, conjunctivitis, nasal inflammation and congestion, dermatitis, skin irritation, generalized itching
  • Swelling of various types (face, larynx, tongue, or other types of swelling) caused by fluid accumulation
  • Disturbances of taste, sensation of tingling, pinching, burning, increased sweating

The hospital staff will treat these allergic reactions immediately if they occur.

• Loss of consciousness, circulatory insufficiency, dizziness, headache
• Increased or decreased heart rate, low blood pressure
• Tremors, blurred vision, hot flashes
• Vomiting
• Nausea
• Diarrhea
• Abdominal pain
• Reactions at the injection site, such as infection, inflammation, pain, redness of the skin, swelling
• Chest pain
• Chills

Reporting Adverse Effects

If you experience any type of adverse effect, consult your specialist doctor or nuclear medicine doctor, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date appearing on the label.

Do not use this medication if visible signs of deterioration are observed.

Composition of HDP Technescan

• The active principle is sodium oxodronate.
• The other components are: tin (II) chloride dihydrate, gentisic acid, sodium chloride, hydrochloric acid and sodium hydroxide, all in a nitrogen atmosphere.

Appearance of the product and contents of the packaging

This medicine is presented in the form of white powder. It is supplied in multi-dose glass vials of type I of the Ph. Eur. of 10 ml, sealed with a bromobutyl rubber stopper and with an aluminum over seal.

Package size

5 vials, each vial contains 34 mg of sterile powder.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain S. A.

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

28100, Alcobendas, Madrid, Spain

Responsible for manufacturing:

Curium Netherlands B.V

Westerduinweg 3

1755 LE Petten

(Netherlands)

Last review date of this leaflet: October 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended solely for healthcare professionals:

The complete technical data sheet of HDP Technescan 3 mg equipment for radiopharmaceutical preparation is included as a separate document in the packaging of the product, 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 (the technical data sheet must be included in the box).