DTPA TechneScan 20.8 mg radiopharmaceutical preparation kit
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DTPA Technescan 20.8 mg kit for radiopharmaceutical preparation
Pentetic acid
Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.
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Package leaflet contents:
- What DTPA Technescan is and what it is used for
- What you need to know before using DTPA Technescan
- How to use DTPA Technescan
- Possible side effects
- How to store DTPA Technescan
- Contents of the pack and other information
1. What DTPA Technescan is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
DTPA Technescan is used in scans to examine:
- Kidneys.
- Brain.
- Lungs.
- Gastroesophageal reflux and gastric emptying.
This medicine is a non-radioactive powder. When mixed by qualified personnel with the radioactive substance sodium pertechnetate (99mTc), it forms technetium (99mTc) pentetate. When administered into the body, it accumulates in certain organs, such as the kidneys or brain.
The radioactive substance can be imaged from outside the body using special cameras that perform a scan. This scan shows where the radioactivity is located within the organ and body. It also provides the doctor with valuable information about the structure and function of the organ in question.
The use of DTPA Technescan involves exposure to small amounts of radiation. 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 DTPA Technescan
Do not use DTPA Technescan
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
- This medicine must not be administered into the spinal canal or into the cerebral space, known as the subarachnoid space.
Take special care with DTPA Technescan:
- If you are pregnant or think you might be pregnant.
- If you are breastfeeding.
Before administration of DTPA Technescan you should:
- Drink plenty of water before starting the procedure to urinate as frequently as possible during the first hours after completion. This will prevent the active substance from accumulating in the bladder.
- Inform your nuclear medicine physician if you have symptoms of reduced kidney function.
Children and adolescents
Consult your nuclear medicine physician if you are under 18 years of age.
Other medicines and DTPA Technescan
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may specifically interfere with the results of the Technescan DTPA procedure:
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Medicines that interfere with renal imaging:
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Medicines to treat hypertension, for example, medicines containing active substances with names ending in "pril", such as captopril,
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Medicines to treat inflammatory conditions, such as diclofenac,
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Medicines that stimulate fluid elimination from the body, such as furosemide or hydrochlorothiazide,
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Medicines that may affect your kidney function, such as:
- Medicines to treat infections (antibiotics), such as aminoglycosides
- Medicines to treat tumors, such as cisplatin
- Radiographic contrast agents
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Medicines that interfere with gastric emptying:
- Acute analgesics, such as morphine
- Medicines to treat Parkinson's disease, such as levodopa
- Medicines to prevent or relieve nausea and vomiting, such as metoclopramide
- Medicines that neutralize stomach acidity, such as aluminum-based antacids
- Medicines to treat ulcers, such as propantheline
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Medicines that interfere with brain imaging:
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Medicines that influence mood, emotional state, and behavior.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before using this medicine.
You must inform the nuclear medicine specialist before DTPA Technescan is administered if there is any possibility you could be pregnant, if you have missed a menstrual period, or if you are breastfeeding. In case of doubt, it is important that you consult your nuclear medicine specialist who will supervise the procedure.
- If you are pregnant
The nuclear medicine specialist will only administer this product during pregnancy if the expected benefit outweighs the potential risks.
- If you are breastfeeding
Inform your physician that you are breastfeeding, as it may be possible to postpone the study until after the breastfeeding period ends. Alternatively, your physician may ask you to interrupt breastfeeding for 12 hours and discard the milk produced during that time, until radioactivity is no longer present in your body. Consult your nuclear medicine specialist about when you can resume breastfeeding.
Driving and using machines
It is unlikely that DTPA Technescan will affect your ability to drive or operate machinery.
3. How to use DTPA Technescan
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. DTPA 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 about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of DTPA Technescan to be used in your case. The administered dose will depend on the type of procedure to be performed and other factors such as the route of administration. The dose will be the minimum necessary to obtain the required information. The generally recommended amount for administration in adults ranges between 7 and 1000 MBq (MegaBecquerel, 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 DTPA Technescan and performance of the procedure
DTPA Technescan is administered intravenously to obtain images of the kidneys or brain, orally to examine the stomach or esophagus, and by inhalation to assess the lungs. Usually, a single administration is sufficient.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of DTPA Technescan you should:
- Urinate frequently to eliminate the product from your body.
The nuclear medicine physician will inform you if you need to take special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.
If you are administered more DTPA Technescan than you should
An overdose is unlikely because you will receive a single dose of DTPA Technescan precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered.
If you have any further questions about the use of DTPA Technescan, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicinal product may produce adverse effects, although not everyone will experience them.
The following adverse effects may occur (frequency cannot be estimated from the available data):
- dilation of blood vessels causing sudden redness of the skin,
- dizziness,
- difficulty breathing (dyspnea),
- itching (pruritus),
- hives (urticaria),
- low blood pressure (hypotension).
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing 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 DTPA Technescan
You will not be required to store this medicine. This medicine is stored by the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
Keep this medicine out of sight and reach of children.
Do not use DTPA Technescan after the expiry date stated on the vial after "EXP.". The expiry date refers to the last day of the month indicated.
DTPA Technescan must not be used if there are any visible signs of deterioration.
6. Contents of the pack and other information
Composition of DTPA Technescan
- The active substance is pentetic acid.
Each vial contains 20.8 mg of pentetic acid.
- The other components are: gentisic acid, stannous chloride dihydrate, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid.
Appearance of the product and contents of the pack
DTPA Technescan is a white to slightly yellowish lyophilized powder for injectable solution. It is supplied in 10 ml glass vials sealed with a bromobutyl rubber stopper and an aluminum seal.
DTPA Technescan is supplied in a pack containing 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 revision of this summary: December 2022.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
This information is intended for healthcare professionals only:
The complete technical data sheet of DTPA Technescan is included as a separate document within the product pack to provide physicians and healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the technical data sheet included in the pack.