Sodium pyrophosphate TechneScan 20 mg radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Technescan PYP 20 mg kit for radiopharmaceutical preparation

sodium pyrophosphate decahydrate

Contents of the package leaflet:

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

1. What Pirofosfato de sodio Technescan is and what it is used for

This medicine is for diagnostic use only.

Pirofosfato de sodio Technescan is used to examine:

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

This medicine is a non-radioactive powder. When prepared by qualified personnel, it is used to induce a "stannous charge" of red blood cells prior to the use of a radioactive solution of sodium pertechnetate (99mTc), which is required 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 Pirofosfato de sodio Technescan followed by sodium pertechnetate (99mTc) involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Pirofosfato de sodio Technescan

Do not use Pirofosfato de sodio Technescan:

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

Warnings and precautions:

Take special care with Pirofosfato de sodio Technescan:

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

Before administration of Pirofosfato de sodio 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 physician.

Other medicines and Pirofosfato de sodio Technescan:

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

The following medicines/materials may interfere with the test using Pirofosfato de sodio Technescan:

• Some medicines used to prevent blood clotting, such as heparin
• Tin-based medicines
• Stomach acid binders 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 substance names ending in "olol", such as propranolol
  • Digitoxin and similar medicines
  • Nitrates such as nitroglycerin
• Some cancer treatments, usually with active substance names ending in "rubicin"
• Iodinated contrast media
• Teflon catheters

Pregnancy and breastfeeding

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

You must inform the nuclear medicine physician before administration of Pirofosfato de sodio Technescan if there is any possibility you could be pregnant, if you have missed a period, or if you are breastfeeding. In case of doubt, it is important to consult your nuclear medicine physician supervising the procedure.

If you are pregnant

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

If you are breastfeeding

Inform your nuclear medicine physician, as they will advise you to interrupt breastfeeding until radioactivity has left your body. This takes between 4 and 12 hours, depending on the radiolabeling method used.

Breast milk expressed during this period must be discarded. Ask your nuclear medicine physician when you may resume breastfeeding.

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

Driving and use of machines

It is considered unlikely that Pirofosfato de sodio Technescan affects the ability to drive or operate machinery.

Pirofosfato de sodio Technescan contains sodium

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

3. How to use Pirofosfato de sodio Technescan

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Pirofosfato de sodio Technescan will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in ensuring the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Pirofosfato de sodio Technescan and sodium pertecnetate (99mTc) to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The generally recommended amount of sodium pertecnetate (99mTc) for administration in adults, which is injected intravenously, ranges between 1 and 925 MBq (MBq: the megabecquerel is the unit used to express radioactivity). This can be done directly (in vivo labelling method) or after mixing with a blood sample (in vitro labelling method).

Use in children and adolescents

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

Administration of Pirofosfato de sodio Technescan and performance of the procedure

Pirofosfato de sodio Technescan is administered by intravenous injection, followed 30 minutes later by an injection of sodium pertecnetate (99mTc) (in vivo labelling method).

Pirofosfato de sodio Technescan may also be administered by taking a sample of your blood, which is then mixed with sodium pertecnetate (99mTc). Your radioactively labelled red blood cells are then injected back into a vein.

One injection of Pirofosfato de sodio Technescan is sufficient to perform the procedure required by your physician.

Duration of the procedure

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

After administration of Pirofosfato de sodio Technescan you should:

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

Repeating the procedure is not recommended within 3 months, as the tin component of this medication remains in red blood cells for extended periods.

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

If you have been administered more Pirofosfato de sodio Technescan than you should have received

An overdose is unlikely because you will receive a single, precisely controlled dose of Pirofosfato de sodio Technescan, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician may advise you to drink plenty of fluids and to urinate frequently to help eliminate radioactivity from your body.

If you have any further questions about the use of Pirofosfato de sodio Technescan, ask your nuclear medicine physician supervising the procedure.

Since this product is administered by a physician under conditions of strict control, it is highly unlikely.

4. Possible adverse effects

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

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

Allergic reactions:

• flushing
• generalized itching, urticaria, redness
• dilation of blood vessels causing 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
• taste disturbances

Vasovagal reactions:

• fainting
• headache, dizziness
• confusion
• slow heart rate
• ringing in the ears
• tremor, chills
• pallor
• blurred vision
• abnormal skin sensations such as 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 physician immediately.

This radiopharmaceutical delivers low amounts of ionizing radiation, which is associated with a small risk of cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Technescan Sodium Pyrophosphate

You will not have 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 regarding radioactive materials.

The following information is intended for specialists only:

Technescan Sodium Pyrophosphate must not be used after the expiry date indicated on the label following "EXP".

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

6. Contents of the pack and other information

Composition of Pirofosfato de sodio Technescan

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

Appearance of the product and contents of the pack

Pirofosfato de sodio Technescan contains a powder supplied in 10 ml type I glass vials with a bromobutyl stopper and sealed with an aluminum cap.

Pack size: 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 review of this summary of product characteristics: 03/2021.

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

This information is intended for healthcare professionals only:

The complete package leaflet of Pirofosfato de sodio Technescan is included as a separate document within the product packaging, to provide physicians and healthcare professionals with scientific information as well as practical guidance on the administration and use of this radiopharmaceutical.

Refer to the package leaflet of Pirofosfato de sodio Technescan.