Luminity 150 microlitres/ml solution for dispersion forinjection or infusion

Luminity is an ultrasound contrast agent that contains tiny gas bubbles.

It enhances the images seen with ultrasound and helps your doctor to get a clearer picture (scan) of your heart.

This medicine is for diagnostic use only.

Do not use Luminity

• if you are allergic (hypersensitive) to perflutren or any of the other ingredients of Luminity.

Luminity should not be used in children and adolescents as it has not been studied in these groups.

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

Take special care with Luminity

• if you have been told you have a heart shunt
• if you have severe heart or lung diseases
• if you have an artificial valve in your heart
• if you have acute severe inflammation/sepsis
• if you have known hyperactive coagulation system/or recurrent thromboembolism
• if you have liver disease
• if you have kidney disease

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

The ability to drive and use machines is not affected.

Important information about some of the ingredients of Luminity

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium-free?.

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 and the prepared dispersion is either diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection and given by infusion over a period of time (drip solution), or given undiluted as an intravenous injection (direct injection into the vein).

For heart ultrasound examination, the recommended dose is multiple intravenous injections of 0.1 to 0.4 ml of Luminity, followed by an intravenous injection of 3 to 5 ml sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. The maximum total dose is 1.6 ml. The product can also be given at a dose of 10 microlitre/kg by intravenous injection followed by an intravenous injection of 10 ml sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection, depending on which ultrasound technique your doctor has chosen to use. In some cases, your doctor may choose to use two injections to complete the ultrasound examination. Your doctor may also choose to give Luminity via an intravenous infusion of 1.3 ml added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. Your doctor will decide on the speed at which the infusion should be given.

If you are given more Luminity than you should

It is not known what the effect of an overdose is.

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

Common side effects (greater than 1 patient out of 100, less than 1 patient out of 10) Headache, flushing.

Uncommon side effects (greater than 1 patient out of 1,000, less than 1 patient out of 100) 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 (greater than 1 patient out of 10,000, less than 1 patient out of 1,000) 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.

These side effects usually go away quickly without any treatment.

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. In addition, some patients may experience convulsions, which may be associated with these allergic reactions.

In very rare instances, severely ill patients have experienced circulatory or respiratory arrest (their heart or breathing has stopped) after receiving Luminity. A very small number of these patients subsequently died. It is quite possible that the deaths were related to the underlying severe disease but a relationship to the administration of Luminity cannot be ruled out.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

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

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

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

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

What Luminity contains

The active substance is perflutren. Each ml contains a maximum of 6.4 x 10 9 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 solution for dispersion for injection or infusion and is available in a pack containing one or four single-use 1.5 ml vials.

Not all pack sizes may be marketed.

Before activating the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid. After activation, the product appears as a milky white liquid.

Marketing Authorisation Holder

Lantheus MI UK Limited
One South Place
London EC2M 2WG
United Kingdom

Tel: 44 1635 573 059

Manufacturer

Penn Pharmaceutical Services Ltd
23-24 Tafarnaubach Ind. Est.
Tredegar, Wales NP22 3AA.
United Kingdom

This leaflet was last approved in

--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or 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 amilky 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 beforewithdrawing the dispersion.
• The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterileneedle 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 glucose50 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.