Product Information for the User

Luminity 150 microliters/mL gas and solvent for injectable dispersion and for infusion

perflutren

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information as you may need to refer to it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1. Adverse Effects
2. Storage of Luminity

1. Additional Information

Luminity is an ultrasound contrast agent that contains microspheres (small bubbles) of perflutren gas as the active substance.

Luminity is for diagnostic use only. It is a contrast agent (a medication that helps internal body structures be visible in imaging tests).

Luminity is used in adults to obtain a clearer image of the heart chambers, particularly the left ventricle, during echocardiography (a diagnostic test in which an image of the heart is obtained using ultrasound). Luminity is used in patients suspected or known to have coronary artery disease (obstruction of blood vessels that supply the heart muscle), when the image obtained with echocardiography without contrast is not optimal.

Do not use Luminity

• if you are allergic to perflutren or any of the other components of Luminity (listed in section 6).

Inform your doctor if in the past you have had an allergic reaction to Luminity or to another contrast medium.

Warnings and precautions

Consult your doctor before starting to use Luminity

• if you know you have an intracardiac shunt
• if you have any serious heart or lung disease or if you need mechanical assistance for breathing

• if you are a carrier of an artificial heart valve
• if you have acute severe inflammation/sepsis

• if you have been diagnosed with hyperactive coagulation system (blood clotting problem) or recurrent thromboembolism (blood clots)
• if you have liver insufficiency

• if you have kidney insufficiency

• if you have previously had any allergic reaction to polyethylene glycol

Children and adolescents

Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied for these groups.

Other medications and Luminity

Inform your doctor if you are taking or have recently taken any other medication.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or breastfeeding and ask your doctor or pharmacist for advice before Luminity is administered.

Driving and operating machinery

Luminity has no effect on the ability to drive or operate machinery.

Luminity contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per dose, making it essentially "sodium-free".

Luminity contains propylenglycol.

This medication contains 103.5 mg of propylenglycol per ml, equivalent to 182.2 mg in each vial.

Luminity is administered by experienced doctors before or during the ultrasound examination. The person administering the medication will calculate the exact dose you need.

Luminity is administered intravenously (direct injection into the vein). Before use, the medication must be activated by agitation using a mechanical device called Vialmix, which is supplied to doctors who must prepare the medication. This ensures the correct agitation of the medication and for a sufficient time to produce the "dispersion" of the perflutren microspheres with the correct dimensions to obtain a high-quality image.

Luminity is administered as a bolus injection (the entire dose at once) or as an infusion (solution) after dilution in a 9 mg/ml (0.9%) sodium chloride solution or a 50 mg/ml (5%) glucose injectable solution. In some cases, your doctor may decide to use two injections to complete the ultrasound examination. The method of administration of Luminity and its dose also depend on the technique used for echocardiography.

If you use more Luminity than you should

It is unlikely that an overdose will occur since the medication is administered by a doctor.

In the event of an overdose, the doctor will take the necessary measures.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some patients may experience allergic reactions such as facial swelling. However, there is a risk that these allergic reactions may evolve into a more serious situation, including anaphylactic shock (a severe, potentially life-threatening allergic reaction). On the other hand, some patients may experience seizures that may be associated with these allergic reactions.

In some patients, cardiac or respiratory problems, including cardiac arrest, have appeared. In clinical studies, these reactions were observed infrequently, and the frequency of their observation in the post-marketing period is unknown.

Frequent side effects(may affect up to 1 in 10 people)

Headache, facial flushing.

Less frequent side effects(may affect up to 1 in 100 people)

• Dizziness,

• Alteration of taste,

• Low blood pressure,

• Difficulty breathing, throat irritation,

• Abdominal pain, diarrhea, nausea (urge to vomit), vomiting,

• Itching,

• Increased sweating,

• Lower back pain, chest pain,

• Fatigue,

• Sensation of heat and

• Pain at the injection site.

Rare side effects(may affect up to 1 in 1,000 people).

• Sensation of numbness, tingling, or burning,

• Alteration of heart rhythm, palpitations (may be felt as if the heart is beating more strongly or irregularly),

• Dizziness,

• Increased blood pressure,

• Sensation of cold in extremities,

• Difficulty breathing, cough, dry throat, difficulty swallowing,

• Skin rash, redness of the skin,

• Joint pain, kidney pain (on one or both sides), neck pain, muscle cramps, fever, muscle stiffness

• and abnormal electrocardiogram.

• Unknown frequency(its frequency cannot be estimated from the available data)

• Loss of consciousness,

• Numbness of the face,

• Dilation of the eye,

• and abnormal vision.

These side effects usually disappear without the need for treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendixVBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use Luminity after the expiration date that appears on the packaging after CAD.

Before activation (shaking), store in refrigerator (between 2°C and 8°C). After activation (shaking), do not store at a temperature above 30°C.

The dispersion must be injected before 12 hours of its activation (shaking) have elapsed.

The product can be reactivated up to 48 hours after the initial activation and can be used up to 12 hours after the second activation.

Composition of Luminity

The active ingredient is perflutren. Each ml contains a maximum of 6.4 x 109lipid microspheres containing perflutren, with a mean diameter between 1.1 and 2.5 micrometers. The approximate amount of perflutren gas in each ml of Luminity is 150 microliters.

The other components are 1,2-dipalmitoyl-sn-glicero-3-fosfatidilcolina (DPPC);ácido 1,2-dipalmitoyl-sn-glicero-3-fosfatídico, sal monosódica (DPPA);N-(metoxipolietilenglicol5000carbamoil)-1,2-dipalmitoyl-sn-glicero-3-

fosfatidiletanolamina, sal monosódica (MPEG5000 DPPE), fosfato monosódico monohidrato, fosfatodisódico heptahidrato, cloruro sódico, propilenglicol, glicerol and water for injection.

Aspect of the product and content of the packaging

Luminity is a gas and solvent for injectable dispersion and for perfusion. Before activation (agitation) of the content of the vial, Luminity appears as a colorless and uniform liquid, clear to translucent. After its activation (agitation), the product appears as a white milky liquid.

It is presented in containers of 1 or 4 vials of 1.5 ml for single use.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Lantheus EU Limited

Rocktwist House,

Block 1, Western Business Park

Shannon, Co. Clare V14 FW97

Ireland

Phone:+353 1 223 3542

Responsible for manufacturing

Penn Pharmaceutical Services Ltd

23-24 Tafarnaubach Ind. Est.

Tredegar, Wales NP22 3AA.

United Kingdom

Millmount Healthcare Limited

Block 7, City North Business Campus

Stamullen, Co. Meath K32 YD60

Ireland

Date of the last review of this leaflet:

Other sources of information

The detailed information of this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

This leaflet can be found on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.

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This information is intended solely for healthcare professionals:

It is essential to follow the instructions for use and handling of Luminity and observe strict aseptic procedures during its preparation. Like all parenteral products, the vials must be visually examined for particles and to check their integrity. Before administering the product, it must be activated using the Vialmix, a mechanical agitation device. The Vialmix is not included in the Luminity packaging, but it will be provided to healthcare professionals once they request the product.

Luminity is activated using the Vialmix, which has a programmed agitation time of 45 seconds. The Vialmix will alert the user if the agitation frequency differs by 5% or more from the desired frequency. It has also been programmed to turn off and emit visual and auditory warnings if the agitation frequency exceeds the desired frequency by 5% or decreases by 10%.

Activation and administration process

• The vial must be activated using the Vialmix. Immediately after its activation, Luminity appears as a white milky dispersion.

Nota: If the product is left to rest for more than 5 minutes after its activation, it must be resuspended by manual agitation for 10 seconds before extraction with a syringe from the vial. Luminity must be used within 12 hours of its activation. The product can be reactivated up to 48 hours after its initial activation and used within 12 hours of this second activation, whether it is stored in the refrigerator or at room temperature. After activation, do not store the vial above 30°C.

• Before extracting the dispersion, the air must be expelled from the vial with a sterile syringe with a needle or a non-siliconized sterile minipunzón.

• The dispersion must be extracted from the vial using a sterile syringe with a needle of caliber 18 to 20 or a non-siliconized sterile minipunzón. If a needle is used, it must be positioned to extract the material from the middle of the liquid with the vial inverted. Do not inject air into the vial. The product must be used immediately after extraction from the vial.

• Luminity can be diluted with a 9 mg/ml (0.9%) sodium chloride injection solution or a 50 mg/ml (5%) glucose injection solution.

The content of the vial is for single use.

The unused product or waste material must be disposed of in accordance with local regulations.