PATIENT INFORMATION LEAFLET

NEUROLITE 900 micrograms kit for radiopharmaceutical preparation

Read this leaflet carefully before you receive this medicine, as 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 doctor who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

1. What is Neurolite and how is it used

2. What you need to know before starting to use Neurolite

3. How to use Neurolite

4. Possible side effects

5. Storage of Neurolite

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Neurolite is used to see how much blood circulates through the brain. This is an important piece of information for some brain diseases.

Neuroliteis injected into the blood and then circulates throughout the body. It can be detected using special cameras, which can obtain an image (or scan). This scan will show exactly the distribution of radioactivity in the area of the body being investigated.

The administration of Neurolite involves receiving a small amount of radiation. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Neurolite should not be used:

- if you are allergic (hypersensitive) to technetium Tc-99m pertechnetate or to any of the other components of this medication. (listed in section 6).

Warnings and precautions

You should be especially careful 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 must:

• Drink a large amount of water before the examination to urinate as often as possible during the first hours after the study.

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

Other medications and Neurolite

Inform your nuclear medicine doctor if you are taking, or have taken, recently or may need to take any other medication.

Use of Neurolite with food and beverages

Your doctor will ask you to drink plenty of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before this medication is administered.

You must inform your nuclear medicine doctor before administration of Neurolite if there is any possibility you may be pregnant, if you experience a delay in your period, or if you are breastfeeding. In case of doubt, it is essential that you consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

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

If you are breastfeeding

Inform your doctor if you are breastfeeding, as they may consider delaying the investigation until you have finished breastfeeding or ask you to stop breastfeeding for 12 hours until there is no more radioactivity in your body. Expressed breast milk must be discarded. Ask your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machines:

It is unlikely that Neurolite will affect your ability to drive or use machines.

Neurolite contains sodium

This product contains less than1mmolof sodium(23mg)per dose; this is, essentially “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Neurolite should only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to ensure 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 a sodium pertecnetate (99mTc) solution before administration.

The nuclear medicine physician overseeing the procedure will determine the amount of Neurolite to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult is 740MBq (Megabequerel, the unit used to express radioactivity).

Administration of Neurolite and Procedure Performance

Neurolite is administered via intravenous injection by qualified personnel.

One injection is sufficient to perform the procedure your doctor needs.The gamma scan should be performed before 6 hours have elapsed since the product's administration.

Procedure Duration

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

After Neurolite Administration, You Must:

• Avoid contact with children and pregnant women during the first 12 hours after injection
• Urinate frequently to eliminate the product from your body

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

If You Have Been Administered More Neurolite Than Needed:

It is unlikely to experience an overdose because you will receive a single, precisely controlled dose of Neurolite from the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment.

In the event of an overdose, the physician will ask you to drink plenty of liquid and urinate and defecate frequently to accelerate the elimination of radioactivity from your body.

If you have any other questions about the use of Neurolite, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

This radiopharmaceutical will administer small amounts of ionizing radiation associated with lower risks of cancer and hereditary anomalies.

The following possible adverse effects are presented in order of frequency:

Notification of Adverse Effects

If you experience adverse effects, consult your nuclear medicine doctor, even if they are adverse effects not listed in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

You will not need to store this medication. This medication will be stored under the responsibility of a specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Neurolite should not be used after the expiration date appearing on the vial and on the carton after CAD. The expiration date is the last day of the month indicated.

The packaged product must be stored below 25°C. Do not refrigerate or freeze.

The reconstituted and prepared solution for injection can be stored for 8 hours below 25°C.

Do not refrigerate or freeze.

Neurolite should not be used if particles and/or color alteration are observed.

Composition ofNeurolite:

Vial A: Powder for injectable solution

The active ingredient is:

900 micrograms of bicisatate dichlorhydrate.

The other components are:

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

Vial B: Diluent for injectable solution

The active ingredient is:

No active ingredients.

The other components are:

Dihydrated disodium phosphate heptahydrate, monohydrated sodium phosphate dihydrogen and water for injectable preparations.

Aspect of Neurolite and contents of the package

Neurolite is composed of two vials, a powder (vial A) and a diluent (vial B).

Before its use, the powder is mixed with the diluent and with a solution of the radioactive substance, pertecnetate (99mTc) of sodium, to obtain the injectable solution of bicisatate (99mTc).

The mixed solution is transparent and does not present visible particles.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

Lantheus EU Limited

Rocktwist House

Block 1, Western Business Park

Shannon

Co. Clare

V14 FW97

Ireland

Responsible for the manufacture

Millmount Healthcare Limited

Block 7

City North Business Campus

Stamullen, Co. Meath K32Y D60

Ireland

This leaflet was approved in 11/2018

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

Dosage and method of administration

The recommended dose for a medium-sized patient (70 kg) by intravenous administration after reconstitution with pertecnetate (99mTc) of sodium injectable, Ph.Eur., is 740 MBq.

The gammagraphy should be performed before 6 hours have elapsed since the administration of the product.

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

The dose for the patient should be measured using an appropriate radioactivity calibration system immediately before its administration. It is recommended to check the radiochemical purity beforehand (see below).

Precautions to be taken by family members, caregivers, hospital staff when administering a dose from non-sealed sources.

The administration of radiopharmaceuticals creates risks for other people by external radiation or contamination by urine, vomiting, etc. Measures of radiological protection should be adopted in accordance with national regulations.

Preparation of the NEUROLITE reactive equipment

The preparation of Bicisatate (99mTc) from the NEUROLITE reactive equipment is carried out by the following aseptic procedure:

- Before adding the pertecnetate (99mTc) of sodium injectable to vial B (the vial tampon), note the estimated activity, date and time of preparation on the space provided on the vial label. Then cut a symbol of radioactive material and attach it to the vial neck.

- During the preparation procedure, impermeable gloves should be used. Remove the plastic disc from both vials and clean the top of each vial cap with alcohol to disinfect the surface.

- Place vial B in an appropriate radiation shield, properly labeled with the date, time of preparation, volume and activity.

- With a sterile and shielded syringe, add aseptically approximately 3.70 GBq (100 mCi) of pertecnetate (99mTc) of sodium injectable, sterile, apyrogenic and without oxidants in approximately 2.0 ml, to vial B. Without removing the needle, eliminate an equal volume of air to maintain the pressure inside the vial.

- With a sterile and shielded syringe, inject rapidly 3.0 ml of Sodium Chloride Injectable Intravenous, B.P. (ClNa 0.9%, without bacteriostatics) into vial A (the lyophilized vial) to dissolve the content. Without removing the needle, eliminate an equal volume of air to maintain the pressure inside the vial. Shake the content of the vial for a few seconds.

- With another sterile and shielded syringe, transfer immediately (before 30 seconds have elapsed) 1.0 ml of the solution from vial A to vial B. Discard vial A immediately.

- Shake the content of vial B for a few seconds, and let the mixture rest for thirty (30) minutes at room temperature.

- Before administering the patient, examine the content of the vial to determine if there are particles and color alteration. If particles or color change are observed, DO NOT USE.

- Measure the reaction vial using an appropriate radioactivity measurement system (dose calibrator or activity meter). Note the technetium (99mTc) concentration, total volume, date and time of activity measurement, expiration date and batch number on the vial label and attach the label to the shield.

- Keep the reaction vial containing the bicisatate (99mTc) below 25°C until it is used; at that time, the product must be extracted aseptically. Do not freeze or refrigerate. The vial does not contain preservatives.

- Residues should be eliminated in accordance with national regulations for radioactive materials.

The product must be used before 8 hours have elapsed since the moment of preparation.

Determination of radiochemical purity

The quality control of the radiopharmaceutical should follow the procedure indicated below:

Materials for the TLC procedure

• Gel of silica IB-F Baker-Flex, 2.5 x 7.5 cm, Baker nº 2/4463/03, or equivalent.
• Solvent system: Acetate of ethyl, quality HPLC
• Calibrator of dose or gamma counter for measuring radioactivity
• Chamber of small-scale chromatographic development
• Syringe and shielded 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 or equivalent plates and a solvent system of acetate of ethyl.

Procedure- Using recent acetate of ethyl, pour enough solvent into the chromatographic development chamber to a depth of 3 to 4 mm. Seal the tank with Parafilm and let it stand for 15 to 40 minutes until the solvent is equilibrated. It is essential to pre-equilibrate and preserve the integrity of the headspace in the chromatographic chamber, otherwise, TLC results will be irreproducible.

Nota: Acetate of ethyl is a skin and mucous membrane irritant, so it should be handled in a fume hood whenever possible.

With a pencil, draw a faint line that crosses the TLC plate at a height of two (2) cm, four and a half (4.5) cm and seven (7) cm from the base of the plate. Place approximately 5 μl of the final solution in the center of the 2 cm mark. This can be achieved using a syringe fitted with a 25G or 27G needle and allowing a drop to form while holding the syringe in a vertical position. The diameter of the spot should not exceed 10 mm. Let the spot dry for 5 to 10 minutes, but no longer.

Place the plate in the pre-equilibrated TLC chamber and let it develop to the 7.0 cm line (approximately 15 minutes). Remove the plate and dry it in a well-ventilated area.

Cuantification

Cut the TLC plate at the 4.5 cm mark with scissors. Count the activity of each piece using a dose calibrator or gamma counter. The upper part contains the bicisatate (99mTc) and the lower part contains all the radioimpurities.

Calculate the radiochemical purity using the following equation:

AS

% of Bicisatate (99mTc) = x 100

AS+ AI

Where:AS= activity of the upper piece

andAI= activity of the lower piece

Criterios

Bicisatate (99mTc) has an Rf of 0.9 (± 0.1); the colloid, TcO4-y EDTA99mTc remain at the origin. If the radiochemical purity is less than 90%, do not use the reactive equipment and reject the preparation.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.