Neurolite 900 micrograms radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NEUROLITE 900 micrograms reagent kit for radiopharmaceutical preparation

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Neurolite is and what it is used for
2. What you need to know before using Neurolite
3. How Neurolite is used
4. Possible adverse effects
5. How to store Neurolite
6. Contents of the pack and other information

1. What Neurolite is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

Neurolite is used to visualize blood flow through the brain. This information is important in certain diseases affecting the brain.

Neurolite is injected into the bloodstream and subsequently circulates throughout the body. It can be detected using special cameras that produce an image (or scan). This scan will show precisely the distribution of radioactivity in the area of the body being examined.

Administration of Neurolite involves exposure to a small amount of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using Neurolite

Neurolite must not be used:

• if you are allergic (hypersensitive) to technetium Tc-99m bicisate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with Neurolite:

• If you are pregnant or think you may be pregnant
• If you are breastfeeding

Neurolite is not recommended for children under 18 years of age or for patients with impaired renal function.

Before administration of Neurolite you should:

• Drink plenty of water before the examination and urinate as frequently as possible during the first hours after the study.

Your nuclear medicine physician will inform you if you need to take any special precautions after using this product.

Other medicines and Neurolite

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines.

Use of Neurolite with food and drink

Your physician will ask you to drink plenty of fluids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may 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 Neurolite if there is any possibility you could be pregnant, if you have missed your 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

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

If you are breastfeeding

Inform your physician if you are breastfeeding, as he or she may consider postponing the investigation until after the breastfeeding period, or may advise you to stop breastfeeding for 12 hours until radioactivity is no longer present in your body. Breast milk expressed during this time must be discarded. Ask your nuclear medicine physician when you may resume breastfeeding.

Driving and using machines:

Neurolite is considered unlikely to affect your ability to drive or operate machinery.

Neurolite contains sodium

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

3. How Neurolite is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Neurolite must 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 pay special attention to the safe use of this product and will keep you informed of their actions.

Neurolite must be reconstituted with sodium pertechnetate (99mTc) solution prior to administration.

The nuclear medicine physician supervising the procedure will determine the amount of Neurolite to be used in your case. This will be the minimum amount necessary to obtain the required information. The generally recommended dose for administration in adults is 740 MBq (megabecquerels, the unit used to express radioactivity).

Administration of Neurolite and performance of the procedure

Neurolite is administered by intravenous injection by qualified personnel.

A single injection is sufficient to perform the procedure required by your physician. The scintigraphy must be performed within 6 hours after administration of the product.

Duration of the procedure

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

After administration of Neurolite, you should:

• Avoid contact with children and pregnant women during the first 12 hours after injection
• 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 medicine. Consult your nuclear medicine physician if you have any doubts.

If you have been given more Neurolite than you need:

An overdose is unlikely, as you will receive a single dose of Neurolite precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered.

In case of overdose, the physician will instruct you to drink plenty of fluids and to urinate and defecate frequently to accelerate the elimination of radioactivity from your body.

If you have any further questions about the use of Neurolite, 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.

This radiopharmaceutical will deliver small amounts of ionizing radiation, which is associated with a low risk of cancer and hereditary abnormalities.

The following are the possible adverse effects listed in order of frequency:

Reporting of adverse reactions

If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Neurolite

You will not be responsible for storing this medicine. This medicine is stored under the responsibility of a specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations concerning radioactive materials.

The following information is intended for specialists only.

Neurolite must not be used after the expiry date stated on the vial and carton following EXP. The expiry date refers to the last day of the month indicated.

The packaged product should be kept below 25°C. Do not refrigerate or freeze.

The reconstituted solution for injection may be stored for up to 8 hours at below 25°C.

Do not refrigerate or freeze.

Neurolite must not be used if particles and/or discoloration are observed.

6. Package contents and additional information

Composition of Neurolite:

Vial A: Powder for injectable solution

The active substance is:

900 micrograms of biciastat dihydrochloride.

The other components are:

Stannous chloride dihydrate, disodium edetate, mannitol, hydrochloric acid.

Vial B: Solvent for injectable solution

The active substance is:

Does not contain active substances.

The other components are:

Disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, and water for injections.

Appearance of Neurolite and contents of the pack

Neurolite consists of two vials: a powder (vial A) and a solvent (vial B).

Before use, the powder is mixed with the solvent and with a solution of the radioactive substance sodium pertechneate (99mTc) to obtain the injectable technetium (99mTc) biciastat solution.

The mixed solution is clear and free from visible particles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Lantheus EU Limited
Rocktwist House
Block 1, Western Business Park
Shannon
Co. Clare
V14 FW97
Ireland

Manufacturer

Millmount Healthcare Limited
Block 7
City North Business Campus
Stamullen, Co. Meath K32Y D60
Ireland

This summary of product characteristics was last approved in 11/2018

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<This information is intended for medical or healthcare professionals only :>>

Dosage and method of administration

The recommended dose for an average patient (70 kg) administered intravenously after reconstitution with injectable sodium pertechneate (99mTc), Ph.Eur., is 740 MBq.

Scintigraphy should be performed within 6 hours after administration of the product.

If necessary, a maximum recommended activity of up to 1700 MBq may be administered, ensuring that the patient is able to urinate at least every two hours.

The patient's dose should be measured using an appropriate radioactivity calibration system immediately before administration. Radiochemical purity should be checked prior to administration (see below).

Precautions to be followed by family members, caregivers, and hospital staff when administering doses from unsealed sources

The administration of radiopharmaceuticals poses risks to other individuals due to external radiation or contamination from spills of urine, vomit, etc. Therefore, radiation protection measures must be taken in accordance with national regulations.

Preparation of the NEUROLITE Reagent Kit

The preparation of technetium (99mTc) biciastat from the NEUROLITE reagent kit must be carried out using the following aseptic procedure:

• Before adding injectable sodium pertechneate (99mTc) to vial B (the buffer vial), record the estimated activity, date, and time of preparation in the space provided on the vial label. Then cut out a radioactive material symbol and affix it to the neck of the vial.
• Wear impermeable gloves during the preparation procedure. Remove the plastic disk from both vials and disinfect the top of each vial stopper with alcohol.
• Place vial B into an appropriate radiation shield, properly labeled with the date, time of preparation, volume, and activity.
• Using a sterile, shielded syringe, aseptically add 3.70 GBq (100 mCi) of sterile, pyrogen-free, oxidant-free injectable sodium pertechneate (99mTc) in approximately 2.0 ml to vial B. Without removing the needle, withdraw an equal volume of air to maintain pressure within the vial.
• Using another sterile, shielded syringe, rapidly inject 3.0 ml of Intravenous Sodium Chloride Injection, B.P. (0.9% NaCl, without bacteriostatics) into vial A (the lyophilized vial) to dissolve its contents. Without removing the needle, withdraw an equal volume of air to maintain pressure within the vial. Shake the vial contents for a few seconds.
• Using another sterile, shielded syringe, immediately transfer (within 30 seconds) 1.0 ml of the solution from vial A to vial B. Immediately discard vial A.
• Shake the contents of vial B for a few seconds, then allow the mixture to stand for thirty (30) minutes at room temperature.
• Before administration to the patient, inspect the vial contents for particles and discoloration. If particles or discoloration are observed, DO NOT USE.
• Measure the reaction vial using an appropriate radioactivity measuring system (dose calibrator or activimeter). Record the technetium (99mTc) concentration, total volume, date and time of measurement, expiry date, and batch number on the vial shield label and affix the label to the shield.
• Store the reaction vial containing technetium (99mTc) biciastat below 25°C until use. At the time of use, the product must be aseptically withdrawn. Do not freeze or refrigerate. The vial contains no preservatives.
• Waste must be disposed of in accordance with national regulations for radioactive materials.

The product must be used within 8 hours after preparation.

Determination of radiochemical purity

Quality control of the radiopharmaceutical must follow the procedure described below:

Materials for thin-layer chromatography (TLC) procedure

• Silica gel IB-F Baker-Flex, 2.5 x 7.5 cm, Baker No. 2/4463/03, or equivalent
• Solvent system: Ethyl acetate, HPLC grade
• Dose calibrator or gamma counter for measuring radioactivity
• Small chromatographic development chamber
• Shielded syringes and vials, as needed

TLC Procedure

Determine the radiochemical purity of the final solution by thin-layer chromatography (TLC) using silica gel IB-F Baker-Flex plates or equivalent and ethyl acetate as the solvent system.

Procedure – Using fresh ethyl acetate, pour sufficient solvent into the development chamber to a depth of 3 to 4 mm. Seal the chamber with Parafilm and allow equilibration for 15 to 40 minutes. It is essential to pre-equilibrate and maintain the integrity of the headspace in the chromatographic chamber; otherwise, irreproducible TLC results may occur.

Note: Ethyl acetate is a skin and mucous membrane irritant and should be handled in a fume hood whenever possible.

Using a pencil, draw a light line across the TLC plate at 2 cm, 4.5 cm, and 7 cm from the bottom edge. Apply approximately 5 μL of the final solution at the center of the 2 cm mark. This can be achieved using a syringe fitted with a 25G or 27G needle, allowing a drop to form while holding the syringe vertically. The spot diameter should not exceed 10 mm. Allow the spot to dry for 5 to 10 minutes, but no longer.

Place the plate into the pre-equilibrated TLC chamber and allow development until the solvent front reaches the 7.0 cm line (approximately 15 minutes). Remove the plate and allow it to dry in a ventilated area.

Quantification

Cut the TLC plate at the 4.5 cm mark using scissors. Measure the radioactivity of each piece using a dose calibrator or gamma counter. The upper portion contains technetium (99mTc) biciastat, while the lower portion contains all radiochemical impurities.

Calculate the radiochemical purity using the following equation:

AS
% of 99mTc Biciastat = ——————— × 100
AS + Ai

Where:
AS = activity of the upper piece
Ai = activity of the lower piece

Criteria

Technetium (99mTc) biciastat has an Rf of 0.9 (± 0.1); colloids, TcO4-, and 99mTc-EDTA remain at the origin. If the radiochemical purity is less than 90%, do not use the reagent kit and discard the preparation.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.