DMSA TechneScan 1 mg radiopharmaceutical preparation kit
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: Information for the patient
DMSA Technescan 1 mg kit for radiopharmaceutical preparation
Succimer
Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.
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Package leaflet:
- What DMSA Technescan is and what it is used for
- What you need to know before using DMSA Technescan
- How to use DMSA Technescan
- Possible side effects
- How to store DMSA Technescan
- Contents of the pack and other information
1. What DMSA Technescan is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
DMSA Technescan contains the active substance succimer. It is used to prepare a radioactive injectable solution of technetium (99mTc) succimer.
DMSA Technescan is used in adults and children to examine the kidneys. When injected, this medicine temporarily accumulates in the kidneys. Due to its radioactivity, it can be detected outside the body using a special camera, and images, known as scans, can be taken. These scans provide valuable information about the structure and/or function of your kidneys. The administration of DMSA Technescan involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.
2. What you need to know before using DMSA Technescan
Do not use DMSA Technescan:
- If you are allergic to succimer or to any of the other components of this medicine (listed in section 6), or to any of the components of the radiolabelled product (technetium [99mTc] succimer).
Warnings and precautions
Take special care with DMSA Technescan:
- If you are pregnant or think you might be pregnant.
- If you are breastfeeding.
- If you have kidney disease.
Consult your nuclear medicine physician if any of the above apply to you. This medicine may not be suitable for you. Your nuclear medicine physician will advise you.
Before administration of DMSA Technescan, you should:
- Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Other medicines and DMSA Technescan
Tell your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription, as they may interfere with the interpretation of the images.
Your nuclear medicine physician/physician may recommend that you stop taking the following medicines before the DMSA Technescan procedure:
- Ammonium chloride (ammonium salt, a substance present in some cough medicines and licorice extract)
- Sodium bicarbonate (a medicine used to reduce the acidity of blood and/or urine)
- Mannitol (a diuretic medicine that helps you produce more urine and eliminate excess salt and water from the body)
- Some antihypertensive medicines used to treat high blood pressure (so-called ACE inhibitors, such as captopril)
Some anticancer medicines (methotrexate, cyclophosphamide, vincristine) may also influence or be influenced by DMSA Technescan.
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 using this medicine.
You must inform the nuclear medicine physician before the administration of DMSA Technescan if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.
If in doubt, it is important to consult your nuclear medicine physician supervising the procedure.
If you are pregnant
The nuclear medicine physician will only administer DMSA Technescan during pregnancy if the expected benefit outweighs the risk.
If you are breastfeeding
Consult your nuclear medicine physician if you are breastfeeding, as they may postpone the treatment until breastfeeding has ended. They may also 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 may resume breastfeeding.
It is not necessary to avoid close contact with your baby after the procedure.
Driving and using machines
DMSA Technescan is considered unlikely to affect your ability to drive or use machines.
DMSA 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 DMSA Technescan
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. DMSA Technescan will only be used in specially controlled areas. This product 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 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 technetium (99mTc) succimer to be used in your case. This will be the minimum amount necessary to obtain the required information.
The amount generally recommended for administration to an adult is 30 to 120 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 DMSA Technescan and performance of the procedure
DMSA Technescan is administered by injection, usually into a vein in the arm.
A single injection is sufficient to perform the procedure required by your physician.
After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.
Duration of the procedure
Scans are generally performed 2 to 3 hours after injection. Occasionally, they may be delayed up to 24 hours after injection. Your nuclear medicine physician will inform you about the expected duration of the procedure.
After administration of DMSA Technescan, you should:
- Urinate frequently to 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 administered more DMSA Technescan than you should have received
An overdose is unlikely, as you will receive a single, precisely controlled dose of DMSA Technescan determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician may recommend that you drink plenty of fluids and urinate frequently to help eliminate residual radioactivity from your body.
If you have any further questions about the use of DMSA Technescan, please ask the nuclear medicine physician supervising the procedure.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions of unknown frequency (cannot be estimated from available data):
- Allergic reactions with symptoms such as skin rash, redness or itching, increased sweating, swelling of the eyes, tongue or throat, eye inflammation, cough, difficulty breathing, nausea, vomiting, increased salivation, abdominal pain, redness, or low blood pressure.
- Circulatory reactions with symptoms such as fainting, low blood pressure, headache, dizziness, paleness, or feeling weak or tired.
- Reactions at the injection site, with symptoms such as skin rash, swelling or inflammation.
Hospital staff will treat these reactions if they occur.
This radiopharmaceutical delivers low doses of ionizing radiation associated with a very low risk of cancer and hereditary abnormalities.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of DMSA Technescan
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 concerning radioactive materials.
The following information is intended for the specialist only.
Do not use DMSA Technescan after the expiry date stated on the label after EXP.
6. Contents of the pack and other information
Composition of DMSA Technescan
- The active substance is succimer (or dimercaptosuccinic acid).
One vial contains 1.2 milligrams of succimer.
- The other components are: inositol, stannous chloride dihydrate (E512), sodium hydroxide (E524), and hydrochloric acid (E507).
Appearance of the product and contents of the pack
DMSA Technescan is a reagent kit for radiopharmaceutical preparation intended for use only by healthcare professionals. Prior to use, the powder in the vial is mixed with a radioactive solution called technetium (99mTc) to form technetium (99mTc) succimer solution.
DMSA Technescan is supplied in a 10 ml colourless type I glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
One pack contains 5 vials.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Curium Pharma Spain S.A.
Avenida Doctor Severo Ochoa, No. 29
28100 Alcobendas, Madrid, Spain
Manufacturer:
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
Date of the most recent revision of this package leaflet: November 2023
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 full summary of product characteristics for DMSA Technescan is included as a separate document within the product pack, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. Please consult the summary of product characteristics for DMSA Technescan.