Indium (111In) DTPA Curium Netherlands

Package leaflet: Information for the patient

INDIO (In) DTPA Curium Netherlands 37 MBq/mL injection solution

indium (111In) DTPA
Please read this leaflet carefully before you are given this
medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the nuclear medicine specialist who will supervise the examination.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What Indium (111In) DTPA is and what it is used for
2. What you need to know before you are given Indium (111In) DTPA
3. How Indium (111In) DTPA is used
4. Possible side effects
5. How to store Indium (111In) DTPA
6. Contents of the pack and other information

1. What Indio (111In) DTPA is and what it is used for

Medicinal product for diagnostic use only.
It is indicated for cisternoscintigraphy in adults:

• Detection of possible obstructions in cerebrospinal fluid flow.
• Differentiation between normal pressure hydrocephalus and other forms of hydrocephalus.
• Detection of cerebrospinal fluid leaks (rhinorrhea or otorrhea).

For each patient, exposure to ionizing radiation must be justified based on the potential benefit. The administered activity must be such as to ensure the lowest radiation dose reasonably achievable while obtaining the desired diagnostic information.

2. What you need to know before being administered Indio (111In) DTPA

Indio (111In) DTPA must not be used

• if you are allergic to indium (111In) DTPA or to any of the other components of this medicinal product (listed in section 6).
• if you suffer from allergies
• if you have a tendency to bleed
• if you have increased intracranial pressure
• if you are pregnant or breastfeeding

WARNINGS AND PRECAUTIONS
Before receiving Indio (111In) DTPA you should be
well hydrated prior to the start of the procedure and encouraged to urinate as frequently as possible during the first hours after the procedure, in order to reduce radiation exposure.

Children and adolescents
This medicinal product is not intended for use in children and adolescents.

Other medicines and Indio (111In) DTPA
No interaction studies have been performed and no interactions have been reported to date.

Pregnancy, breastfeeding and fertility

Pregnancy
Nuclear medicine procedures involving radiopharmaceuticals performed in pregnant women result in radiation exposure to the fetus.
Such procedures should only be performed during pregnancy if absolutely necessary, when the expected benefit outweighs the potential risks to both mother and fetus. In particular, procedures resulting in radiation doses to the uterus exceeding 0.5 mGy are considered potentially hazardous.

Breastfeeding
Before administering radiopharmaceuticals to a woman who is breastfeeding, consider the possibility of postponing administration until after weaning. Additionally, ensure that the most appropriate radiopharmaceutical has been selected, taking into account the secretion of radioactivity into breast milk. If administration is deemed necessary, breastfeeding must be discontinued for 14 days, during which time expressed milk should be discarded.
Breastfeeding may normally resume when the level of radioactivity in milk results in a radiation dose to the infant not exceeding 1 mSv.

Fertility
The effect of Indio (111In) DTPA Curium Netherlands on fertility is unknown.

Driving and using machines
Indio (111In) DTPA has a negligible influence on the ability to drive vehicles or operate machinery.

Indio (111In) DTPA contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How Indio (111In) DTPA is used

Indio (111In) DTPA is administered by intrathecal injection (lumbar or suboccipital) to
evaluate hydrocephalus or obstruction of cerebrospinal fluid flow.
To assess the patency of neurosurgical shunts, Indio (111In) DTPA must be injected
directly into the shunt's valve chamber.
Use in adults
The recommended administered amount normally ranges between 9 and 20 MBq depending on body weight (MBq: megabecquerel, the unit used to express radioactivity).
Administration method of Indio (111In) DTPA and procedure performance
To evaluate hydrocephalus or cerebrospinal fluid flow obstruction, the first cranial imaging should preferably be performed 1–1.5 hours after injection. Additional imaging investigations are carried out at 3, 6 and 24 hours, or, when necessary, also at 48 or 72 hours after administration, depending on the required diagnostic information.
After suboccipital injection, scintigraphy should begin, if possible, as early as 15 minutes after injection. For subsequent imaging, the previously indicated time points should be advanced by 1 or more hours.
In cases of otorrhea or rhinorrhea, the leakage may be so minimal that it is not detectable on scintigraphic images. Leaks through the nose or ear can be detected by inserting hydrophilic cotton swabs into the external ear or nasal cavity and measuring the radioactivity of these swabs.
If you have been given more Indio (111In) DTPA than you should have received
In the event of accidental administration of an excessive dose of radioactivity, the absorbed dose in the patient can be reduced by enhancing the elimination of the radionuclide from the body through forced diuresis and frequent bladder emptying.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions described are as follows:
Frequency not known (frequency cannot be estimated from the available data)

• nervous system disorders (bacterial meningitis, aseptic meningitis, meningism, headache, meningeal disorder, ptosis, tinnitus, facial paralysis)
• systemic disorders (pyrexia)

Performing a lumbar or occipital puncture may cause adverse reactions, which are usually mild. Symptoms include headache and signs of meningeal irritation, which normally improve within 48 hours.
Cases of aseptic meningitis and fever have been reported.
In the case of suboccipital administration, if the radiopharmaceutical is deposited close to the exit sites of cranial nerves from the brainstem, activation of the oculomotor, facial, and vestibulocochlear nerves may occur, leading to transient effects such as eyelid ptosis, tinnitus, or drooping of one corner of the mouth.
Bacterial meningitis due to the administration procedure itself has been reported.
Exposure to ionizing radiation is associated with the induction of tumors and a potential risk of hereditary defects.
For diagnostic investigations in nuclear medicine, current evidence suggests that the frequency of such adverse reactions is negligible, as the radiation doses involved are low.
For most diagnostic procedures using nuclear medicine techniques, the administered radiation dose (ED, Effective Dose Equivalent) is less than 20 mSv.
Higher doses may be justified only under certain clinical circumstances.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult the specialist physician in nuclear medicine. You may also report adverse reactions directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Indio (111In) DTPA

It is not your responsibility to store this medicine. This medicine is stored under the
supervision of a specialist in appropriate premises. Radiopharmaceuticals must be
stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
8 days from the date of end of production (EoP) and one day from the reference date of activity
(ART).
The product must be stored until use in a radiation-shielded container, inside the original closed packaging.
Do not store above +25°C.
Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive products.

6. Contents of the pack and other information

What Indio (111In) DTPA contains
1 ml contains at the reference date and time of activity (ART):

• Indium (111In) chloride 37 MBq
• Pentetic acid 0.1 mg

Physical characteristics of the radioactive isotope in the active substance indium-111:
Physical half-life: 2.8 days
Main emitted radiation:

The other components are: sodium chloride, dibasic sodium phosphate dodecahydrate, calcium chloride dihydrate, hydrochloric acid, water for injections.
Description of the appearance of Indium (111In) DTPA and contents of the container
Indium (111In) DTPA is an injectable solution.
10 mL glass vial (Type I Ph. Eur.) closed with a bromobutyl rubber stopper and sealed with an aluminium cap. Pack containing 1 vial with an activity of 37 MBq/mL and a volume of 0.5 to 1.0 mL at the reference date and time (ART).
Marketing Authorization Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency: www.aifa.gov.it.
The following information is intended exclusively for physicians or healthcare professionals.
Instructions for use
Withdrawals must be performed under aseptic conditions. The vial must not be opened before disinfecting the stopper. The solution should be withdrawn through the stopper using a single-dose syringe equipped with appropriate lead shielding and a sterile disposable needle.
Incompatibilities
No interaction studies have been conducted, and no interactions have been reported to date.
SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING
General warnings
Radiopharmaceuticals must be received, used, and administered only by authorized personnel in specially designated healthcare facilities. Receipt, storage, use, transfer, and disposal must be carried out in accordance with regulations and/or appropriate authorizations issued by the local competent authorities.
Radiopharmaceuticals must be prepared so as to meet both radiation protection standards and pharmaceutical quality requirements. Adequate aseptic precautions must be taken.
If at any point during product preparation the integrity of the vial is compromised, the product must not be used.
Administration of radiopharmaceuticals poses risks to other individuals due to external irradiation or contamination from excreted urine, vomit, etc. Therefore, radiation protection measures must be implemented in accordance with national regulations.
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with applicable local regulations.
DOSIMETRY
Indium-111 is produced by cyclotron and decays with a half-life of 2.83 days to cadmium-111 (stable). The following table lists the energy values of gamma radiation emissions.
Gamma rays 171 keV (abundance 90.9%)
Gamma rays 245 keV (abundance 94%)
X-rays 23–26 keV
Data derived from ICRP Publication No. 53 (1988) "Radiation Dose to Patients from Radiopharmaceuticals". Ann. ICRP 18 (1–4).
Doses vary according to the route of administration and are calculated based on the following assumptions.
After lumbar injection, half of the activity is transferred from the caudal terminal cistern of the spinal column into the blood with half-lives (and fractions) of 8 hours (97%) and 30 days (3%). The remaining half is transferred into the space surrounding the spinal cord with half-lives (and fractions) of 20 minutes (25%) and 8 hours (75%). Fifty percent of the total activity present in the space surrounding the spinal cord is transferred into the blood with a half-life (and fraction) of 18 hours (97%) and 30 days (3%), while the other half is transferred into the cisternal space surrounding the brain with a half-life (and fraction) of 18 hours (100%).
All activity in the cisternal space surrounding the brain is transferred into the blood with half-lives (and fractions) of 18 hours (97%) and 30 days (3%).
In case of cisternal injection into the cisternal space surrounding the brain, half of the total activity is transferred into the blood with half-lives (and fractions) of 18 hours (97%) and 30 days (3%), while the other half is transferred to a heterogeneous region (caudal terminal cistern in the spinal column + space surrounding the spinal cord) with a half-life (and fractions) of 18 hours (100%). Activity in the heterogeneous region is transferred into the blood with half-lives (and fractions) of 18 hours (97%) and 30 days (3%).
It is assumed that activity reaching the blood is metabolized according to the model of Indium (111In) DTPA administered intravenously.
Absorbed dose per unit of administered activity via cisternal injection

The effective equivalent dose resulting from the administration of an activity of 20 MBq (maximum recommended activity) in a 70 kg adult is approximately 2.4 mSv.
This value includes the effective equivalent dose related to the presence of In impurities (with a half-life of 49.51 days), which amounts to 2.1 mSv/MBq, with a maximum impurity content of 0.05% at the expiry date.
Absorbed dose per unit of administered activity via lumbar injection

The effective equivalent dose induced by the administration of an activity of 20 MBq (maximum recommended activity) in a 70 kg adult is approximately 2.8 mSv.
This value includes the effective equivalent dose related to the presence of In impurities (with a half-life of 49.51 days), which is 1.8 mSv/MBq, with a maximum impurity content of 0.05% at the expiry date.