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Luminity (perflutren) – Package leaflet - V08DA04

Updated on site: 08-Oct-2017

Medication nameLuminity
ATC CodeV08DA04
Substanceperflutren
ManufacturerLantheus MI UK Ltd.

Package leaflet: Information for the user

Luminity 150 microlitres/ml gas and solvent for dispersion for injection/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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Luminity is and what it is used for

2.What you need to know before you use Luminity

3.How to use Luminity

4.Possible side effects

5.How to store Luminity

6.Further information

1.What Luminity is and what it is used for

Luminity is an ultrasound contrast agent that contains microspheres (tiny 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 internal body structures visible during imaging tests).

Luminity is used in adults to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound). Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained with non- contrast echocardiography 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).

If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.

Warnings and precautions

Talk to your doctor before using Luminity

-if you have been told you have a heart shunt

-if you have severe heart or lung diseases or if you need mechanical help to breathe

-if you have an artificial valve in your heart

-if you have an acute severe inflammation/sepsis

-if you have known hyperactive coagulation system (blood clotting issues) or recurrent thromboembolism (blood clots)

-if you have a liver disease

- if you have a kidney disease

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 breast-feeding

Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.

Driving and using machines

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

Luminity contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3.How to use Luminity

Luminity is given to you before or during your ultrasound examination by healthcare professionals such as doctors who are experienced in this type of examination. They will calculate the right dose for you.

Luminity is for intravenous use (direct injection into the vein). Before use, this medicine must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine. This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion’ of microspheres of perflutren gas of the right size to get a good quality image.

Luminity is then given into a vein either as a ‘bolus’ injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. In some cases, your doctor may choose to use two injections to complete the ultrasound examination. The way Luminity is given and the dose depend on the technique used for the echocardiography.

If you are given more Luminity than you should

Overdose is not likely to happen since the medicine is administered by a doctor. In the case of overdose the doctor will take appropriate action.

4.Possible side effects

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

Some patients may experience allergic type reactions such as swelling of the face. There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response). In addition, some patients may experience convulsions, which may be associated with these allergic reactions.

Heart or breathing problems including cardiac arrest have occurred in some patients. In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known.

Common side effects (may affect up to 1 in 10 people) Headache, flushing.

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

Dizziness,

altered taste,

reduced blood pressure,

difficulty in breathing, throat irritation,

abdominal pain, diarrhoea, nausea (feeling sick), vomiting,

itching,

increased sweating,

back pain, chest pain,

fatigue,

feeling hot and

pain at the site of injection.

Rare side effects (may affect up to 1 in 1000 people)

Numbness, tingling and or burning sensation,

altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),

feeling faint,

increased blood pressure,

peripheral coldness,

breathing problems, cough, dry throat, difficulty in swallowing,

rash, redness of the skin,

joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness

and abnormal electrocardiogram.

Not known (frequency cannot be estimated from the available data)

loss of consiousness,

numbness of the face,

eye swelling,

and abnormal vision.

These side effects usually go away quickly without any treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.How to store Luminity

Keep out of the sight and reach of children.

Do not use Luminity after the expiry date which is stated on the carton and label after EXP.

Before activation (shaking), store in a refrigerator (2°C - 8°C).

After activation (shaking), do not store above 30°C.

The dispersion should be given to you within 12 hours of activation (shaking).

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

6. Contents of the pack and other information

What Luminity contains

-The active substance is perflutren. Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres. The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.

-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), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.

What Luminity looks like and contents of the pack

Luminity is a gas and solvent for dispersion for injection or infusion. Before activation (shaking) the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid. After activation (shaking), the product appears as a milky white liquid.

It is available in a pack containing one or four single-use 1.5 ml vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Lantheus MI UK Limited

Festival House

39 Oxford Street

Newbury, Berkshire, RG14 1JG

United Kingdom

Tel: 44 1635 573 048

Manufacturer

Penn Pharmaceutical Services Ltd

23-24 Tafarnaubach Ind. Est.

Tredegar, Wales NP22 3AA.

United Kingdom

This leaflet was last revised in

Other sources of information

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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The following information is intended for healthcare professionals only:

It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation. Like all parenteral products, the vials must be inspected visually for particulates and vial integrity. Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device. The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.

Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds. The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency. It also has been programmed to shut down and will provide visual and audio warnings if the shaking frequency exceeds the target frequency by 5%, or falls below the target frequency by 10%.

Activation process and administration

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

Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial. Luminity should be used within 12 hours following activation. The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation, whether stored under refrigeration or at room temperature. Do not store the vial above 30°C following activation.

-The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before withdrawing the dispersion.

-The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike. When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial. No air should be injected into the vial. The product should be used immediately after its withdrawal from the vial.

-Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose

50 mg/ml (5%) solution for injection.

The contents of the vial are intended for single use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

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