LUMINITY 1,5 ML Injectable solution
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Інструкція із застосування LUMINITY
Зміст інструкції
Luminity 150 microliters/ml gas and solvent for injectable dispersion/ for infusion
perflutrene
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Luminity is and what it is used for
- 2. What you need to know before using Luminity
- 3. How to use Luminity
- 4. Possible side effects
- 5. How to store Luminity
- 6. Further information
1. What is Luminity and what is it used for
Luminity is an ultrasound contrast agent containing tiny microspheres (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 structures of the body visible during imaging diagnostic tests).
Luminity is used in adults to obtain a clearer scan of the heart chambers, in
particular the left ventricle, during echocardiography (a diagnostic test aimed at
obtaining an image of the heart using ultrasound). Luminity is used in patients with coronary artery disease
(blockage of the blood vessels that supply the heart muscle) suspected or confirmed,
when the image obtained with echocardiography without contrast agent is not optimal.
2. What you need to know before using Luminity
Do not use Luminity
- if you are allergic to perflutren or any of the excipients of Luminity (listed in section 6).
If you have previously had an allergic reaction with Luminity or with another ultrasound contrast agent, inform your doctor.
Warnings and precautions
Talk to your doctor before using Luminity
- if your doctor has told you that you have a cardiac shunt
- if you have severe heart or lung disorders or if you require mechanical assistance to breathe.
- if you have an artificial heart valve
- if you have a severe acute inflammation/sepsis
- if you suffer from a known condition of hyperactivity of the coagulation system (blood clotting problems) or recurrent thromboembolism (blood clots)
- if you have liver damage
- if you have kidney damage
- if you have previously had an allergic reaction to 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 patient 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 you are given Luminity.
Driving and operating machinery
Luminity has no effect on the ability to drive vehicles and operate machinery.
Luminity contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means that
it practically contains no sodium.
Luminity contains propylene glycol.
This medicine contains 103.5 mg/ml of propylene glycol, which is equivalent to 182.2 mg in each
vial.
3. How to use Luminity
Luminity is administered before or during the ultrasound examination by healthcare professionals such as doctors experienced in this type of investigation. They will calculate the correct dose for you.
Luminity is for intravenous use (direct injection into the vein). Before use, this medicine must be activated by shaking it with a mechanical device called Vialmix, which is provided to doctors who need to prepare the medicine. This ensures that the medicine is shaken correctly and for the time necessary to produce a “dispersion” of perflutren gas microbubbles of the right size to obtain a good quality image.
Luminity is then administered into a vein with a “bolus” injection (all at once) or by infusion (drip solution) once diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injectable solution. In some cases, the doctor may choose to use two injections to complete the ultrasound examination. The route of administration and the dose of Luminity will depend on the technique used for the echocardiogram.
If you are given too much Luminity
Since the medicine is administered by a doctor, an overdose is unlikely. In such an event, the doctor will take appropriate measures.
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. However, there is a
risk that these allergic-type reactions become serious and include anaphylactic shock (a serious allergic
reaction that is potentially life-threatening). Some patients may then experience convulsions, which may be
associated with these allergic reactions.
In some patients, heart or breathing problems have occurred, including cardiac arrest. In clinical trials
these reactions have been reported rarely, while regarding post-marketing reports the frequency is not
known.
Common side effects(may affect more than 1 in 10 people)
Headache, flushing.
Uncommon side effects(may affect more than 1 in 100 people)
- Dizziness,
- taste alteration,
- blood pressure reduction,
- difficulty breathing, throat irritation,
- abdominal pain, diarrhoea, nausea (feeling unwell), vomiting,
- itching,
- increased sweating,
- back pain, chest pain,
- fatigue,
- feeling of warmth and
- pain at the injection site.
Rare side effects(may affect more than 1 in 1000 people)
- Numbness, tingling and/or burning sensation,
- altered heartbeat, palpitations (feeling your heart beating faster or irregularly),
- feeling faint,
- increased blood pressure,
- coldness in the extremities,
- breathing problems, cough, dry throat, difficulty swallowing,
- rash, skin redness,
- joint pain, flank pain (hips), neck pain, muscle cramps, fever, muscle stiffness
- and abnormal electrocardiogram. Not known(the frequency cannot be estimated from the available data)
- loss of consciousness,
- numbness of the face,
- eye swelling,
- and altered vision.
Normally these side effects disappear quickly without any treatment.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also
report side effects directly through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.
5. How to store Luminity
Keep Luminity 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 the words
Exp.
Before activation (shaking), store in a refrigerator (2 °C - 8 °C)
After activation (shaking), do not store at a temperature above 30 °C.
The dispersion must be administered within 12 hours of activation (shaking).
The medicine can be reactivated up to 48 hours after the initial activation and can be used up to 12
hours after the second activation.
6. Package contents and other information
What Luminity contains
The active ingredient is perflutren. Each ml contains lipid bubbles containing a maximum of 6.4
x 10 of perflutren, with an average diameter between 1.1 and 2.5 microns. The approximate amount of
gaseous perflutren in each ml of Luminity is about 150 microliters.
The excipients are 1,2- di palmitoyl- sn-glycero-3- fosphatidyl choline (DPPC), acid 1,2- di palmitoyl- sn-
glycero-3- fosphatidic monosodium salt (DPPA), N-( methoxy polyethylene 5000carbamoyl)-1,2-
di palmitoyl- sn-glycero-3- fosphatidyle thanolamine monosodium salt (MPEG5000 DPPE), sodium dihydrogen
phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and
water for injections.
Description of the appearance of Luminity and contents of the pack
Luminity is a gas and solvent for injectable dispersion or for infusion. Before activation
(shaking), Luminity appears as a colorless liquid, uniformly from clear to translucent. After
activation (shaking), the product appears as a milky white liquid.
It is supplied in packs containing one or four single-dose vials of 1.5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Lantheus EU Limited
Rocktwist House,
Block 1, Western 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
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency (EMA): http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.
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The following information is intended exclusively for healthcare professionals:
It is essential to follow the instructions for the use and handling of Luminity and to comply with careful aseptic procedures during preparation.
As with all parenteral medicines, vials must be visually inspected for particles and to check the integrity
of the vial. Before administration, the medicine must be activated using Vialmix,
a mechanical shaker device. Vialmix is not included in the Luminity pack but will be
supplied to healthcare personnel together with the pack order.
Luminity is activated using Vialmix which has a programmed shaking time of 45 seconds.
Vialmix will warn the operator if the shaking frequency decreases by 5% or more from the set frequency.
Vialmix is also programmed to shut down and will provide audible and visual warnings if the
shaking frequency should be more than 5% or fall more than 10% below
the set frequency.
Activation and administration process
- The vial must be activated using Vialmix. Immediately after activation, Luminity appears as a milky white dispersion.
Note: if the medicine remains stationary for more than 5 minutes after activation, it must be resuspended with
manual shaking for 10 seconds before withdrawing the syringe from the vial. Luminity must
be used within 12 hours of activation. The medicine can be reactivated up to 48 hours after the
first activation and can be used up to 12 hours after the second activation, depending on whether it is
stored in the refrigerator or at room temperature. After activation, do not store the vial at
temperatures above 30 °C.
- The vial must be pierced with a sterile syringe needle or with a sterile, non-siliconized mini-spike adapter before aspirating the dispersion.
- The dispersion must be withdrawn from the vial using a syringe with an 18 to 20 G sterile needle or connected to a sterile, non-siliconized mini-spike adapter. If using a needle, it must be positioned to aspirate material from the center of the liquid with the vial inverted. Do not inject air into the vial. The medicine must be used immediately after being withdrawn from the vial.
- Luminity can be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or with glucose 50 mg/ml (5%) solution for injection.
The contents of the vial are intended for a single administration.
Unused medicine and waste materials derived from such medicine must be disposed of in accordance with
local legal requirements.
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- Країна реєстрації
- Лікарська формаInjectable solution, 1,5 ML
- Код АТХV08DA04
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до LUMINITYЛікарська форма: Injectable suspension, 5-8X108/ML, 0.22MGДіюча речовина: perflutren, human albumin microspheresВиробник: GE HEALTHCARE ASРецепт не потрібенЛікарська форма: Powder and solvent for injectable suspension, 8 MCG/MLДіюча речовина: sulfur hexafluoride, phospholipid microspheresВиробник: BRACCO INTERNATIONAL B.V.Рецепт не потрібенЛікарська форма: Injectable solution, 0,5 MMOL/MLДіюча речовина: Гадотеровая кислотаВиробник: GE HEALTHCARE ASПотрібен рецепт
Аналоги LUMINITY в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LUMINITY у Іспанія
Лікарі онлайн щодо LUMINITY
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на LUMINITY онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LUMINITY потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у LUMINITY — perflutren, phospholipid microspheres. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
LUMINITY виробляється компанією LANTHEUS EU LIMITED. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування LUMINITY з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати LUMINITY у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (perflutren, phospholipid microspheres) включають OPTISON, SONOVUE, KLARIKYKLIK. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
