LUMINITY 150 MICROLITERS/ML GAS AND SOLVENT FOR SOLUTION FOR DISPERSIBLE INJECTION AND FOR PERFUSION

Introduction

Package Leaflet: Information for the User

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

perflutren

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Luminity and what is it used for
2. What you need to know before you use Luminity
3. How to use Luminity

1. Possible side effects
2. Storage of Luminity

1. Additional information

1. What is Luminity and what is it used for

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 medicine that helps to make the body's internal structures visible during 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 that uses ultrasound to produce images of the heart). Luminity is used in patients who are suspected of or known to have coronary artery disease (obstruction of the blood vessels that supply the heart muscle), when the image obtained with echocardiography without contrast is not optimal.

2. What you need to know before you use Luminity

Do not use Luminity

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

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

Warnings and precautions

Talk to your doctor before using Luminity

• if you have an intracardiac shunt
• if you have severe heart or lung disease or if you need mechanical assistance to breathe

• if you have an artificial valve in your heart
• if you have severe acute inflammation/sepsis

• if you have been diagnosed with an overactive blood coagulation system (blood clotting problem) or recurrent thromboembolism (blood clots)
• if you have liver failure

• if you have kidney failure

• if you have had an allergic reaction to polyethylene glycol in the past

Children and adolescents

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

Other medicines and Luminity

Tell your doctor if you are taking or have recently taken any other medicines.

Pregnancy and breastfeeding

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

Driving and using machines

Luminity has no effect on the ability to drive or use machines.

Luminity contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is considered to be essentially "sodium-free".

Luminity contains propylene glycol.

This medicine contains 103.5 mg of propylene glycol per ml, which is equivalent to 182.2 mg in each vial.

3. How to use Luminity

Luminity is administered before or during echocardiography by doctors with experience in this type of diagnostic test. The doctor will calculate the exact dose you need.

Luminity is administered intravenously (directly into a vein). Before use, this medicine must be activated by shaking using a mechanical device called Vialmix, which is provided to doctors who prepare the medicine. This ensures the correct shaking of the medicine and for a sufficient time to produce the "dispersion" of the perflutren gas microspheres with the correct dimensions to obtain a good-quality image.

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

If you use more Luminity than you should

Overdose is unlikely since the medicine is administered by a doctor.

In case of overdose, the doctor will take the necessary measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

In some patients, cardiac or respiratory problems have occurred, including cardiac arrest. In clinical studies, these reactions were observed infrequently and their frequency is not known in the post-marketing period.

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

Headache, facial flushing.

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

• Dizziness,

• altered taste,

• decreased blood pressure,

• difficulty breathing, throat irritation,

• abdominal pain, diarrhea, nausea (feeling sick), vomiting,

• itching,

• increased sweating,

• lower back pain, chest pain,

• fatigue,

• feeling of heat and

• pain at the injection site.

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

• Numbness, tingling, or burning sensation,

• abnormal heart rhythm, palpitations (may feel like the heart is beating stronger or irregularly),

• dizziness,

• increased blood pressure,

• feeling of cold in extremities,

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

• skin rash, skin redness,

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

• and abnormal electrocardiogram.

• Frequency not known(frequency cannot be estimated from the available data)

• loss of consciousness,

• facial numbness,

• pupil dilation,

• and abnormal vision.

These side effects usually disappear without the need for treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Luminity

Keep out of the sight and reach of children.

Do not use Luminity after the expiry date stated on the carton after EXP.

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

The dispersion should be injected within 12 hours of activation.

The product can be reactivated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored in a refrigerator or at room temperature. After activation, do not store the vial above 30°C.

6. Contents of the pack and additional information

Composition of Luminity

The active substance is perflutren. Each ml contains a maximum of 6.4 x 10^9 liposomal 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 ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC); 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA); N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), monosodium phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, and water for injectable preparations.

Appearance and pack contents

Luminity is an injectable dispersion and infusion gas and solvent. Before activation (shaking) of the vial contents, Luminity appears as a clear to translucent, colorless liquid. After activation (shaking), the product appears as a white, milky liquid.

It is available in packs of 1 or 4 vials of 1.5 ml for single use.

Not all pack sizes may be marketed.

Marketing authorization holder

Lantheus EU Limited

Rocktwist House,

Block 1, Western Business Park

Shannon, Co. Clare V14 FW97

Ireland

Tel: +353 1 223 3542

Manufacturer

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 last revision of this leaflet:

Other sources of information

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

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

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This information is intended only for healthcare professionals:

It is essential to follow the instructions for use and handling of Luminity and to observe strict aseptic procedures during its preparation. As with all parenteral products, the vials should be visually inspected for particles and to check their integrity. Before administration of the product, it must be activated using the Vialmix, a mechanical shaking device. The Vialmix is not included in the pack of Luminity but will be provided to healthcare professionals upon request.

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

Activation and administration process

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

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

• Before extraction of the dispersion, the air must be expelled from the vial using a sterile syringe with a needle or a non-siliconized sterile minipunctor.

• The dispersion must be extracted from the vial using a sterile syringe with a 18-20 gauge needle or a non-siliconized sterile minipunctor. If a needle is used, it should be positioned to extract the material from the middle of the liquid with the vial inverted. Air must not be injected 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 solution or a 50 mg/ml (5%) glucose solution for injection.

The contents of the vial are for single use.

Unused product or waste material should be disposed of in accordance with local regulations.