Luminity

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 

1 



 
1. NAME OF THE MEDICINAL PRODUCT 
 
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean 
diameter range of 1.1-2.5 micrometres (μm). The approximate amount of perflutren gas in each ml is 
150 microlitres (μl). 
 
Excipient(s) with known effect 
Each ml contains 2.679 mg sodium 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Gas and solvent for dispersion for injection/infusion 
 
Colourless, uniformly clear to translucent liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
This medicinal product is for diagnostic use only. 
 
Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast 
echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six 
segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have 
suspected or established coronary artery disease, to provide opacification of cardiac chambers and 
improvement of left ventricular endocardial border delineation at both rest and stress. 
 
4.2 Posology and method of administration 
 
Luminity should only be administered by trained physicians with technical expertise in performing 
and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be 
available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4). 
 
Posology 
 
Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: 
 
The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml 
bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain 
optimal contrast enhancement. The total dose of perflutren should not exceed 1.6 ml. 
 
Bolus intravenous injection using fundamental imaging technique at rest: 
 
The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed 
by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. 
If necessary, a second 10 microlitre dispersion/kg dose followed by a second 10 ml bolus of sodium 

2 



chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection may be administered 
5 minutes after the first injection to prolong contrast enhancement. 
 
Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental 
imaging technique at rest: 
 
The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium 
chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection. The rate of infusion should 
be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to 
exceed 10 ml/minute. 
 
Paediatric population 
The safety and efficacy of Luminity in children and adolescents below 18 years have not been 
established. No data are available. 
 
Patients with hepatic impairment   
Luminity has not been specifically studied in patients with hepatic impairment. Use in this patient 
group should be on the basis of a benefit risk assessment by the physician. 
 
Patients with renal impairment 
Luminity has not been specifically studied in patients with renal impairment. Use in this patient group 
should be on the basis of a benefit risk assessment by the physician. 
 
Elderly patients 
Luminity has not been specifically studied in elderly patients. Use in this patient group should be on 
the basis of a benefit risk assessment by the physician. 
 
Method of administration  
 
Intravenous use. 
 
Before administering Luminity, the medicinal product must be activated by using a mechanical 
shaking device, the Vialmix, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1  
 
4.4 Special warnings and precautions for use 
 
This product must only be administered intravenously. 
 
Luminity should not be used with fundamental imaging technique for stress echocardiography since 
efficacy and safety have not been established. 
 
Patients with unstable cardiopulmonary status 
During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, 
have occurred during or within 30 minutes of Luminity administration in patients including those with 
severe cardiac and pulmonary diseases (see section 4.8). Extreme caution should be used when 
considering the administration of Luminity to patients with unstable cardiopulmonary status, for 
example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart 
failure (NYHA IV) or respiratory failure. Luminity should only be administered to such patients after 
careful risk/benefit assessment. 
 
Contrast-enhanced echocardiography should only be considered in such patients if the results are 
likely to produce a change in individual patient management. 
 

3 



Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes 
following Luminity administration. For such patients monitoring should include vital sign 
measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation. 
Resuscitation equipment and trained personnel must always be readily available. 
Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic 
inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism 
Luminity should be used only after careful consideration and such use should be monitored closely 
during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with 
prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive 
coagulation and/or recurrent thromboembolism. 
 
Hypersensitivity reactions 
Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid 
reactions, hypotension and angioedema) have been reported following the administration of Luminity. 
Patients should be closely monitored and administration should be under the direction of a physician 
experienced in the management of hypersensitivity reactions including severe allergic reactions, which 
might require resuscitation. Emergency equipment and personnel trained in its use must be readily 
available. 
 
Pulmonary disease 
Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse 
interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have 
been performed in these patients. 
 
Patients with Cardiac Shunts 
The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac 
shunts has not been studied. In these patients, phospholipid encapsulated microspheres can bypass the 
lung and directly enter the arterial circulation. Caution must be exercised when considering the 
administration of Luminity to these patients. 
 
Patients on mechanical ventilation  
The safety of microspheres in patients on mechanical ventilation has not been established. Caution 
should be exercised when considering the administration of Luminity to these patients. 
 
Administration and mechanical activation procedure 
Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial 
injection). 
 
If Luminity is administered directly to the patient without undergoing the mechanical activation 
procedure using the Vialmix (see section 6.6), the product will not produce its intended effect. 
 
Sodium Content 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- 
free’ . 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed and no other forms of interaction have been identified. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
For perflutren, no clinical data on exposed pregnancies are available. Animal studies do not indicate 
direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition 
or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant 
women. 

4 



 
Breast-feeding 
It is not known whether Luminity is excreted in human breast milk. Therefore, caution should be 
exercised when Luminity is administered to breast-feeding women. 
 
Fertility 
Animal studies do not indicate direct or indirect harmful effects on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
As Luminity has no pharmacologic effect, and on the basis of its pharmacokinetic and 
pharmacodynamic profiles, no or negligible influence is expected with the use of this product on the 
ability to drive or use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 
2,526 patients) occur within minutes after administration and usually resolve without therapeutic 
intervention within 15 minutes. The most frequently reported adverse reactions are: headache (2.0%), 
flushing (1.0%) and back pain (0.9%). 
 
Tabulated list of adverse reactions 
Adverse reactions were reported with the following frequencies (Very common ≥ 1/10; Common 
≥ 1/100 to < 1/10; Uncommon ≥ 1/1,000 to < 1/100; Rare ≥ 1/10,000 to < 1/1,000; Very rare 
< 1/10,000), not known (cannot be estimated from the available data). Within each frequency 
grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Immune system disorders Not known: Allergic type reactions, anaphylaxis, anaphylactic 

shock and anaphylactoid type reactions, hypotension, angioedema, 
lip swelling, bronchospasm, rhinitis, upper airway swelling, throat 
tightness, facial swelling, eye swelling 

Nervous system disorders Common: Headache 
 
Uncommon: Dizziness, dysgeusia 
 
Rare: Paraesthesia  
 
Not known: seizures, facial hypoaesthesia, loss of consciousness 

Eye disorders Not known: Abnormal vision 
Cardiac disorders Rare: Bradycardia, Tachycardia, Palpitations 

 
Not known: Cardiac arrest, ventricular arrhythmias (ventricular 
fibrillation, ventricular tachycardia, premature ventricular 
contactions), asystole, atrial fibrillation, cardiac ischaemia, 
supraventricular tachycardia, supraventricular arrhythmia 

Vascular disorders  Common: Flushing 
 
Uncommon: Hypotension 
 
Rare: Syncope, hypertension, peripheral coldness  

Respiratory, thoracic and 
mediastinal disorders 

Uncommon: Dyspnoea, Throat Irritation 
 
Rare: Respiratory Distress, Cough, Dry Throat 
 
Not known: Respiratory arrest, decreased oxygenation, hypoxia,  

Gastrointestinal disorders  Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,  

5 



 
Rare: Dyspepsia 
 
Not known: Tongue disorder  

Skin and subcutaneous 
tissue disorders 

Uncommon: Pruritus, increased sweating 
 
Rare: Rash, urticaria, erythema, erythematous rash 

Musculoskeletal and 
connective tissue disorders 

Uncommon: Back pain 
 
Rare: Arthralgia, flank pain, neck pain, muscle cramp 
 
Not known: Muscle spasm, musculoskeletal pain,  
musculoskeletal discomfort, myalgia, hypertonia 

General disorders and 
administration site 
conditions 

Uncommon: Chest Pain, fatigue, feeling hot, injection site pain 
 
Rare: Pyrexia, rigors 
 

Investigations Rare: Abnormal electrocardiogram 
 

 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The clinical consequences of overdose with Luminity are not known. Single doses of up to 
100 microlitres dispersion/kg and multiple doses up to 150 microlitres dispersion/kg were tolerated 
well in Phase I clinical trials. Treatment of an overdose should be directed towards the support of all 
vital functions and prompt institution of symptomatic therapy. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, 
ATC Code: V08DA04 
 
The product consists of lipid encapsulated perflutren microspheres. Microspheres in the 1 to < 10 µm 
diameter size range contribute to the contrast effect by generating strongly enhanced echoes. 
 
The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at 
interfaces due to small differences in the ultrasonic properties of the tissues. The ultrasonic properties 
of the product are very different from those of soft tissue and will generate strong echoes. 
 
As Luminity consists of microspheres that are stable and small enough for transpulmonary passage, 
enhanced echo signals in the left heart and systemic circulation are obtained. 
 
A strict dose/response relationship cannot be defined, although higher doses have been shown to 
produce a contrast effect of longer duration. 
 
5.2 Pharmacokinetic properties 
 

6 



The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects 
with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 
50 µl/kg dose of the product. 
 
The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs. 
The percentage of the perflutren dose excreted in expired air was approximately 50% of the 
administered dose due to the small quantities of perflutren given and the inability to quantify low 
levels of perflutren by gas chromatography. In most subjects after 4-5 minutes, perflutren was 
undetectable in blood and expired air. Perflutren concentrations in blood were shown to decline in a 
mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in 
COPD subjects. The systemic clearance of perflutren was similar in healthy and COPD subjects. Total 
lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to 
COPD subjects. CLlung was found to be significantly reduced (51%) in females compared to males (all 
subjects). These results suggest that overall perflutren systemic elimination is rapid and is not 
significantly reduced in COPD patients compared to healthy subjects. Doppler ultrasound 
measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of 
perflutren. Doppler signal intensity corresponded well with measured and extrapolated perflutren 
concentrations in blood. The time to maximum Doppler signal intensity tmax was shown to be similar to 
the perflutren blood tmax (1.13 versus 1.77 minutes). The observed 99% drop in Doppler signal 
intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in 
measurable blood levels of perflutren. 
 
Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/or amplitude 
modulation) using both continuous and triggered acquisition were utilised in clinical studies with 
Luminity. 
 
The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous 
lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been 
shown to be excreted in the urine in preclinical studies. All lipids are metabolised to free fatty acids. 
The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans. 
 
Pharmacokinetics in special population groups 
 
Elderly 
Pharmacokinetics has not been specifically studied in the elderly. 
 
Renal impairment 
Pharmacokinetics has not been specifically studied in the renal disease patients. 
 
Hepatic impairment 
Pharmacokinetics has not been specifically studied in the hepatic disease patients. 
 
5.3 Preclinical safety data 
 
Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, 
fertility, embryo/foetal development, parturition or post-natal development, and local tolerance. 
 
Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous 
injection of Luminity at doses ≥ 0.3 ml/kg in single and repeat-dose toxicity studies in rats and 
monkeys. Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including 
unresponsiveness and occasionally death. These levels are substantially above the recommended 
maximal clinical dose. Rats treated with Luminity for 1 month exhibited dose-related, reversible 
perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and 
increased goblet cell size and number in the lungs. These effects were observed at exposure levels in 
excess of the maximum human exposure indicating little relevance to clinical use. 
 
 

7 



6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
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 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
2 years. 
 
The product should be used 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. 
After activation: Do not store above 30°C. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C) 
For storage conditions after activation of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container  
 
1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric 
lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button. 
 
Pack sizes of 1 or 4 vials. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
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 
 

8 



- 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. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Lantheus EU Limited 
Rocktwist House, 
Block 1, Western Business Park 
Shannon, Co. Clare V14 FW97 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/361/001 - 002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 September 2006 
Date of latest renewal: 15 July 2016 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

9 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 

10 



A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Penn Pharmaceutical Services Ltd 
23-24 Tafarnaubach Ind. Est. 
Tredegar, Wales NP22 3AA. 
United Kingdom 
 
Millmount Healthcare Limited 
Block 7, City North Business Campus 
Stamullen, Co. Meath K32 YD60 
Ireland 

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.  

 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
 
 
 
 
 

11 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

12 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

13 



 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion 
perflutren 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter 
range of 1.1-2.5 μm (approximately 150 microlitres perflutren gas per ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: 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, water for injections 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gas and solvent for dispersion for injection/infusion 
 
1 x 1.5 ml single-dose vial 
4 x 1.5 ml single-dose vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use 
 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
After activation: use within 12 hours 
 

14 



9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
After activation: Do not store above 30°C 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Lantheus EU Limited 
Rocktwist House 
Block 1, Western Business Park 
Shannon, Co. Clare V14 FW97 
Ireland  
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/361/001 4 single-dose vials 
EU/1/06/361/002 1 single-dose vial 
 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
Not applicable. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
Not applicable. 

15 



 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion 
perflutren 
Intravenous use 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use 
 
3. EXPIRY DATE 
 
EXP: 
 
4. BATCH NUMBER<, DONATION AND PRODUCT CODES> 
 
LOT: 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.5 ml 
 
6. OTHER 
 
 

16 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 

17 



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 

18 



 
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’. 
 
Luminity contains propylene glycol. 
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial. 
 
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) 

19 



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. 
 
 

20 



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 EU Limited 
Rocktwist House,  
Block 1, Western Business Park 
Shannon, Co. Clare V14 FW97 
Ireland 
 
Tel:+353 1 223 3542 
 
Manufacturer 
Penn Pharmaceutical Services Ltd 
23-24 Tafarnaubach Ind. Est. 
Tredegar, Wales NP22 3AA. 
United Kingdom 
 
Millmount Healthcare Limited 
Block 7, City North Business Campus 
Stamullen, Co. Meath K32 YD60 
Ireland 
 
  
 
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. 
 
<------------------------------------------------------------------------------------------------------------------------> 
 

21 



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. 
 
 
 

22 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET