PROSPECTO: INFORMATION FOR THE USER

Sodium Pirofosfate Technescan 20 mg kit for radiopharmaceutical preparation

sodium dihydrate pirofosfate

1. What is Sodium Pirofosfate Technescan and what it is used for.

2. What you need to know before starting to use Sodium Pirofosfate Technescan.

3. How to use Sodium Pirofosfate Technescan.

4. Possible adverse effects.

5. Storage of Sodium Pirofosfate Technescan.

6. Contents of the package and additional information.

This medication is for diagnostic use only.

Sodium Pirofosfate Technescan is used to examine:

• the spleen,
• heart function,
• blood flow through organs,
• occult bleeding in the abdomen or intestines,
• blood volume.

This medication is a non-radioactive powder. When prepared by qualified individuals, it is used to induce a "stannous load" of red blood cells before the use of a radioactive sodium pertechnetate (99mTc) solution, necessary for labeling red blood cells. When injected into the body, it accumulates in certain organs, such as the spleen or red blood cells.

The use of Sodium Pirofosfate Technescan followed by sodium pertechnetate (99mTc) 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 Pirofosfato de sodio Technescan:

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

Warnings and precautions:

Be especially careful with Pirofosfato de sodio Technescan:

• If you are pregnant or think you may be.
• If you are breastfeeding.
• If you have kidney problems.

Before administration of Pirofosfato de sodio Technescan, you must:

• Drink plenty of water before starting the examination so that you urinate as frequently as possible during the first hour after the study.

Children and adolescents

If you are under 18 years of age, inform your nuclear medicine doctor.

Other medications and Pirofosfato de sodio Technescan:

Inform your nuclear medicine doctor if you are taking or have recently taken any other medication, as it may interfere with the interpretation of the images.

The followingmedications/substances may interfere with the test to be performed with Pirofosfato de sodio Technescan:

• Some medications used to prevent blood clotting, such as heparin
• Medications based on tin
• Medications that bind to stomach acid based on aluminum
• Medications used to lower blood pressure such as prazosin, metildopa, hydralazine, verapamil, nifedipine.
• Medications used to treat heart problems such as:
• • Quinidina
  • Medications with active ingredient names that end in “olol” such as propanolol
  • Digitoxina and similar medications
  • Nitrates such as nitroglycerin
• Some medications used to treat cancer, generally with active ingredient names that end in "rubicina"
• Iodinated contrast media
• Teflon catheters

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be, consult your nuclear medicine doctor before this medication is administered.

You must inform your nuclear medicine doctor before administration of Pirofosfato de sodio Technescan if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding. In case of doubt, it is essential that you consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risks.

If you are breastfeeding

Inform your nuclear medicine doctor, as they will advise you to stop breastfeeding until the radioactivity has left your body. This takes between 4 and 12 hours depending on the radioactive labeling method.

Expressed breast milk during this period should be discarded. Ask your nuclear medicine doctor when you can resume breastfeeding.

You should also avoid close contact with your baby during the 2 hours following the procedure.

Driving and operating machines

It is unlikely that Pirofosfato de sodio Technescan will affect your ability to drive and operate machines.

Pirofosfato de sodio Technescan contains sodium

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Sodium Pirofosfate Technescan will only be handled and administered by trained and qualified personnel to ensure safe use. These individuals will take special care in the safe use of this product and inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of Sodium Pirofosfate Technescan and pertechnetate (99mTc) sodium to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose of pertechnetate (99mTc) sodium for administration to an adult, injected into a vein, ranges from 1 to 925 MBq (MBq: the megabequerel is the unit used to express radioactivity). This can be done directly (in vivo labeling method) or after mixing it with a blood sample (in vitro labeling method).

Use in children and adolescents

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

Administration of Sodium Pirofosfate Technescan and procedure performance

Sodium Pirofosfate Technescan is administered via an intravenous injection followed by an injection of pertechnetate (99mTc) sodium 30 minutes later (in vivo labeling method).

Sodium Pirofosfate Technescan can also be administered by taking a blood sample that is mixed with pertechnetate (99mTc) sodium. Your radiactively labeled red blood cells are then injected into a vein.

One injection of Sodium Pirofosfate Technescan is sufficient to perform the procedure your nuclear medicine physician needs.

Procedure duration

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

After administration of Sodium Pirofosfate Technescan, you should:

• Avoid direct contact with small children and pregnant women during the 2 hours following the radioactive labeling procedure.
• Urinate frequently to eliminate the product from your body.

It is not recommended to repeat the procedure before 3 months, as the tin component of this medication remains in red blood cells for longer periods.

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

If you have been administered more Sodium Pirofosfate Technescan than you should

It is unlikely to experience an overdose, as you will receive a controlled and precise dose of Sodium Pirofosfate Technescan administered by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment. Specifically, the nuclear medicine physician may recommend that you drink plenty of water and urinate frequently to eliminate radioactivity from your body.

If you have any other questions about the use of Sodium Pirofosfate Technescan, ask your nuclear medicine physician overseeing the procedure.

Sincethis productis administered by a physician under strict control conditions, it is very difficult.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

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

Allergic Reactions:

• Redness
• General itching, urticaria, redness
• vasodilation that causes a drop in blood pressure
• Sweating
• Swelling of the arm or face
• Nausea, vomiting
• Accelerated heartbeats
• Loss of consciousness
• Difficulty breathing
• Difficulty swallowing
• Muscle spasms and pain
• Excessive tearing
• Alterations in taste

Vasovagal Reactions:

• Fainting
• Headache, dizziness
• State of confusion
• Low heart rate
• Ringing in the ears
• Trembling, chills
• Pallor
• Blurred vision
• Abnormal sensations in the skin like tingling

Local and General Reactions:

• Chest pain
• Local skin reactions at the injection site: skin rash, itching, pain, swelling, inflammation, and cellulitis (skin infection)

If you experience any of these, consult your nuclear medicine doctor immediately.

This radiopharmaceutical administers low doses of ionizing radiation, which is associated with a lower risk of cancer and genetic defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear medicine doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive material storage will be carried out in accordance with national regulations.

The following information is intended solely for the specialist:

Sodium Pirofosfate Technescan should not be used after the expiration date indicated on the label after "CAD".

Sodium Pirofosfate Technescan should not be used if there are visible signs of deterioration.

Composition of Sodium Pirophosphate Technescan

• The active principle is sodium pirophosphate decahydrate. Each vial contains 20 mg of sodium pirophosphate decahydrate.
• The other components are: stannous chloride dihydrate, sodium hydroxide, and hydrochloric acid.

Appearance of the product and contents of the packaging

Sodium Pirophosphate Technescan contains a powder supplied in 10 ml type I glass vials with a bromobutyl stopper and closed with an aluminum capsule.

Packaging size: 5 vials.

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: 03/2021.

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 Sodium Pirophosphate Technescan is included as a separate document in the product packaging, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

Consult the technical data sheet of Sodium Pirophosphate Technescan.