Luminity
perflutren
perflutren
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 Luminity is and what it is used for
What you need to know before you use Luminity
How to use Luminity
Possible side effects
How to store Luminity
Further information
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.
If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
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
if you have sickle cell disease
if you have had an allergic reaction in the past with polyethylene glycol
Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups
Tell your doctor if you are taking or have recently taken any other medicines.
Tell your doctor if you are pregnant or breast-feeding and ask your doctor or pharmacist for advice before you are given Luminity.
Luminity has no effect on the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
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.
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.
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). Some patients have experienced heart problems including heart attack and cardiac arrest following allergic type reactions, 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.
Patients with sickle cell disease have reported sickle cell crises, commonly reported as severe back pain, after receiving Luminity..
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.
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.
sickle cell crisis
loss of consiousness,
numbness of the face,
eye swelling,
and abnormal vision.
These side effects usually go away quickly without any treatment.
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.
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.
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.
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.
Lantheus EU Limited Rocktwist House,
Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Tel:+353 1 223 3542
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
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.