Luminity – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Luminity, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 a ny further questions, ask your doctor , pharmacist or nurse .
- If you get any side effects, talk to your d octor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 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 ec hocardiography (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 c lots)
- if you have a liver disease
- if you have a kidney disease 20 – if you have sickle cell disease
- if you have had an allergic reaction in the past with 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 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.
Lum inity contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium -free’.
Luminity contains propylene glycol .
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial .
💊 3. H ow to use Luminity
Luminity is given to you before or during your ul trasound 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 Lumin ity 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. P ossible side effects
Like all medicines, this medicine can cause side effects, alth ough 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 -threa tening 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 react ions.
21 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 s ickle cell crises, commonly reported as severe back pain, after receiving Luminity .
Common side effects (may affect up to 1 in 10 people )
Headache, flushing.
Uncommon side effects (may affect up to 1 in 100 people )
- Dizzine ss,
- altered taste,
- reduced b lood 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 o f injection.
Rare side effect s (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,
- peripher al coldness,
- breathing prob lems, 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 e stimated from the available da ta)
- 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.
Reporting of side effects
If you get any side effect s, talk to your doctor or nur se. 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 inf ormation on the safety of this medicine.
🌡️ 5. H ow 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 refriger ator (2°C – 8°C).
22 After activa tion (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. Cont ents of the pack and other information
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 micromet res. The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
- The other ingredients are 1,2- dipalmitoyl- sn-glycero -3-phosphatidyl choline (DPPC), 1,2 – dipalmitoyl -sn-glycero -3-phosphatidic acid, monosodium salt (DPPA), N -(methox ypolyethylene glycol 5000 carbamoyl)-1,2- dipalmitoyl- sn-glycero -3-phosphatidyl ethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and wa ter 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 tra nslucent liquid. After activat ion (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 EU Limited Rocktwist House , Block 1, Wester n Business Park Shannon, Co. Clare V14 FW97 Ireland Tel:+353 1 223 3542
Manufacturer
Millmount Healthcare Limited Block 7 , City North Business Campus Stamullen , Co. Meath K32 YD60 Ireland This leaflet was last revis ed in Other sources of infor mation 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.
23 <———————————- ————————————————————————————–> The following information is intended for healthcare professi onals only:
It is essential to follow instructions for use and handling of Luminity and to adhere to st rict 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 th e 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 bel ow 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 s hould 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 activ ation 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 -silicon ised mini -spike before withdra wing 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%) so lution 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.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Luminity (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/06/361).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.