Indio (111 In) DTPA Curium Pharma Spain 37 MBq/ml solution for injection
SpainTable of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Indio (111In) DTPA Curium Pharma Spain is and what it is used for
- 2. BEFORE USING Indio (111In) DTPA Curium Pharma Spain
- 3. How to use Indio (111In) DTPA Curium Pharma Spain
- 4. Possible adverse effects
- 5. Storage of Indio (111In) DTPA Curium Pharma Spain
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Indio (111In) DTPA Curium Pharma Spain 37 MBq/ml solution for injection
Indium (111In) pentetate
Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.
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Package leaflet:
- What Indio (111In) DTPA Curium Pharma Spain is and what it is used for
- What you need to know before using Indio (111In) DTPA Curium Pharma Spain
- How to use Indio (111In) DTPA Curium Pharma Spain
- Possible side effects
- How to store Indio (111In) DTPA Curium Pharma Spain
- Contents of the pack and other information
1. What Indio (111In) DTPA Curium Pharma Spain is and what it is used for
This medicinal product is for diagnostic use only.
Indium (111In) DTPA is used to examine:
- the brain and spinal cord
- obstructions in the flow of cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord
- to differentiate between normal pressure hydrocephalus and other forms of hydrocephalus
- cerebrospinal fluid leakage through the nose or ears.
This medicine contains a radioactive substance which, when injected, accumulates in certain organs such as the brain.
The radioactive substance can be detected from outside the body using a special medical device called a gamma camera. This scan will show the distribution of the radiopharmaceutical in a specific organ and in the body. This may provide your doctor with valuable information regarding the structure and function of that organ.
The use of Indium (111In) DTPA 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 radiation risk.
2. BEFORE USING Indio (111In) DTPA Curium Pharma Spain
Do not use Indio (111In) DTPA Curium Pharma Spain:
If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
If you have:
- A tendency to bleed.
- Head hypertension not associated with hydrocephalus.
Warnings and precautions
Take special care with Indio (111In) DTPA Curium Pharma Spain:
If you have any kidney problems.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age, as the effects resulting from radiation exposure are proportionally greater than in adults.
Use of other medicines and Indio (111In) DTPA:
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines.
No medicines are known to interact with or be affected by Indio (111In) DTPA.
Pregnancy, breastfeeding, and fertility
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 Indio (111In) DTPA if there is any possibility you could 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 who will supervise the procedure.
- If you are pregnant
The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the risk, as it could harm the fetus.
- If you are breastfeeding
Inform your nuclear medicine physician if you are breastfeeding, as this may delay your treatment until breastfeeding has ended. Consideration should be given to expressing milk prior to administration of Indio (111In) DTPA and storing it for later use. Breastfeeding may be resumed when the level of radioactivity in breast milk no longer results in a radiation dose to the infant exceeding 1 mSv.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Indio (111In) DTPA Curium Pharma Spain contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose; hence, it is essentially “sodium-free”.
3. How to use Indio (111In) DTPA Curium Pharma Spain
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Indio (111In) DTPA 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 particular 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 Indio (111In) DTPA to be used in your case, which will be the minimum quantity necessary to obtain the required information.
The amount generally recommended for administration to an adult is:
- 9 – 20 MBq injected into the cranial or spinal cavity
(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 Indio (111In) DTPA and performance of the procedure
Indio (111In) DTPA is administered intrathecally (into the cranial or spinal cavity).
A single injection is usually sufficient to perform the procedure.
Duration of the procedure
Your nuclear medicine physician will inform you about the typical duration of the procedure.
After administration of Indio (111In) DTPA, you should:
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicinal product. Please consult your nuclear medicine physician if you have any doubts.
If you have been administered more Indio (111In) DTPA than you should have received
An overdose is unlikely, as you will receive a single, precisely controlled dose of Indio (111In) DTPA determined by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered.
Drinking as much as possible will help eliminate the radioactive substance more quickly.
If you have any further questions about the use of Indio (111In) DTPA, please ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, Indio (111In) DTPA Curium Pharma Spain may have adverse effects, although not everyone will experience them.
Cases of headache and signs of meningeal irritation have been reported, which improve within 48 hours. Cases of meningitis and fever have also been described.
In certain administration circumstances, reports have been received of ptosis or drooping eyelids, tinnitus or ringing in the ears, or deviation of the mouth corner.
Administration of this radiopharmaceutical involves receiving 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 doctor, pharmacist, or nurse, 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 Indio (111In) DTPA Curium Pharma Spain
You will not have to store this medicine. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for specialists only:
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the container label.
- Store below 25 °C. If more than one dose is to be used, the vial must be stored between 2 and 8 °C after the first aliquot has been withdrawn.
6. Contents of the pack and other information
Composition of Indium (111In) DTPA Curium Pharma Spain
- The active substance is indium pentetate (111In). Each ml of solution contains 37 MBq of indium (111In) at the date and time of calibration.
- The other components are: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), calcium chloride dihydrate and water for injections.
Appearance of the product and contents of the pack
Indium (111In) DTPA Curium Pharma Spain is supplied in multidose vials made of Ph. Eur. type I glass with a 10 ml capacity, sealed with a bromobutyl rubber stopper and an aluminum seal. Each package contains one vial with either 0.5 ml or 1 ml.
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 review of this summary: August 2020
This information is intended for healthcare professionals only:
The complete summary of product characteristics for Indium (111In) DTPA Curium Pharma Spain is included as a section at the end of this leaflet, to provide physicians and healthcare professionals with scientific information, as well as practical guidance on the administration and use of this radiopharmaceutical.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/