SODIUM PYROPHOSPHATE Technescan 20 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Pyrophosphate Technescan 20 mg reagent kit for radiopharmaceutical preparation

sodium pyrophosphate decahydrate

Contents of the pack:

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

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

This medicine is for diagnostic use only.

Sodium Pyrophosphate Technescan is used to examine:

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

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

The use of Sodium Pyrophosphate Technescan followed by sodium pertechnetate (99mTc) involves receiving a small amount of radioactivity. Your doctor and 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 use Sodium Pyrophosphate Technescan

Do not use Sodium Pyrophosphate Technescan:

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

Warnings and precautions:

Be particularly careful with Sodium Pyrophosphate Technescan:

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

Before administration of Sodium Pyrophosphate Technescan you should:

• 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 medicines and Sodium Pyrophosphate Technescan:

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

The following medicines/materials may interfere with the test to be performed with Sodium Pyrophosphate Technescan:

• Certain medicines used to prevent blood clotting, such as heparin
• Tin-based medicines
• Medicines that bind to stomach acids based on aluminum
• Medicines used to lower blood pressure, such as prazosin, methyldopa, hydralazine, verapamil, nifedipine.
• Medicines used to treat heart problems, such as:
• • Quinidine
  • Medicines with active ingredient names that end in "olol" such as propranolol
  • Digoxin and similar medicines
  • Nitrates such as nitroglycerin
• Certain medicines for treating cancer, usually with active ingredient names that end in "rubicin"
• Iodinated contrast media
• Teflon catheters

Pregnancy and breastfeeding

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

You should inform your nuclear medicine doctor before administration of Sodium Pyrophosphate Technescan if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is important that you consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

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

If you are breastfeeding

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

Breast milk extracted during this period must be discarded. Ask your nuclear medicine doctor when you can resume breastfeeding.

In addition, you should avoid close contact with your baby during the 2 hours following the procedure.

Driving and using machines

It is considered unlikely that Sodium Pyrophosphate Technescan will affect your ability to drive and use machines.

Sodium Pyrophosphate Technescan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose; i.e., it is essentially "sodium-free".

3. How to use Sodium Pyrophosphate Technescan

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. Sodium Pyrophosphate Technescan 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 Sodium Pyrophosphate Technescan and sodium pertechnetate (99mTc) to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount of sodium pertechnetate (99mTc) for administration to an adult, which is injected into a vein, ranges from 1 to 925 MBq (MBq: megabecquerel 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 Pyrophosphate Technescan and performance of the procedure

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

Sodium Pyrophosphate Technescan can also be administered by taking a blood sample that is mixed with sodium pertechnetate (99mTc). Your radiolabeled red blood cells will be injected into a vein afterwards.

A single injection of Sodium Pyrophosphate Technescan is sufficient to perform the procedure that your doctor needs.

Duration of the procedure

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

After administration of Sodium Pyrophosphate 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 part of this medicine remains in the red blood cells for longer periods.

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 Sodium Pyrophosphate Technescan than you should

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

If you have any further questions about the use of Sodium Pyrophosphate Technescan, ask your nuclear medicine doctor who supervises the procedure.

Since this product is administered by a doctor under strictly controlled conditions, it is very difficult.

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 reactions:

• redness
• generalized itching, hives, redness
• vasodilation that causes a drop in blood pressure
• sweating
• swelling of the arm or face
• nausea, vomiting
• rapid heartbeat
• loss of consciousness
• difficulty breathing
• difficulty swallowing
• muscle spasms and pain
• excessive tearing
• alterations in taste

Vasovagal reactions:

• fainting
• headache, dizziness
• confusion
• slow heartbeat
• ringing in the ears
• tremors, chills
• pallor
• blurred vision
• abnormal sensations in the skin such as tingling

Local and general reactions:

• Chest pain
• Local skin reactions at the injection site: 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 amounts of ionizing radiation, which is associated with a lower risk of cancer and genetic defects.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Pyrophosphate 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:

Sodium Pyrophosphate Technescan should not be used after the expiry date stated on the label after "EXP".

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

6. Contents of the pack and other information

Composition of Sodium Pyrophosphate Technescan

• The active substance is sodium pyrophosphate decahydrate. Each vial contains 20 mg of sodium pyrophosphate decahydrate.
• The other components are: tin(II) chloride dihydrate, sodium hydroxide, and hydrochloric acid.

Appearance and pack contents

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

Pack size: 5 vials.

Marketing authorisation holder and manufacturer:

Marketing authorisation 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: 03/2021.

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/)

This information is intended only for healthcare professionals:

The full technical specifications of Sodium Pyrophosphate Technescan are included as a separate document in the product packaging, in order to provide doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

Consult the technical specifications of Sodium Pyrophosphate Technescan.