FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Prirodni fosfolipidi u Luminityju (vidjeti dio 6.1) raspodijeljeni su u endogenim nakupinama lipida u tijelu (primjerice, jetri), dok se za sintetičku komponentu (MPEG5000) u nekliničkim ispitivanjima pokazalo da se izlučuje u mokraću.
English: 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).
Croatian: Tijekom kontrastne ehokardiografije javile su se ozbiljne kardiopulmonalne reakcije, uključujući smrtne slučajeve, za vrijeme ili u roku od 30 minuta od primjene Luminityja u bolesnika, uključujući one s teškim srčanim ili plućnim bolestima (vidjeti dio 4.8).
English: 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.
Croatian: Potreban je oprez kod bolesnika s klinički značajnom plućnom bolešću, uključujući difuznu intersticijsku fibrozu pluća i tešku kroničnu opstruktivnu plućnu bolest, budući da nisu provedena nikakva ispitivanja u tih bolesnika.
English: Pulmonary disease
Croatian: Plućna bolest
English: Before activation (shaking) the contents of the vial, Luminity appears as a colourless, uniformly clear to translucent liquid.
Croatian: Prije aktivacije (miješanja) sadržaja bočice Luminity izgleda kao bezbojna, jednolično bistra do prozirna tekućina.
English: For such patients monitoring should include vital sign measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation.
Croatian: Za takve bi bolesnike praćenje trebalo uključivati mjerenje vitalnih znakova, elektrokardiografiju te, ako je klinički primjereno, perkutano zasićenje kisikom.
English: The safety of microspheres in patients on mechanical ventilation has not been established.
Croatian: Bolesnici na mehaničkoj ventilaciji Sigurnost mikrosfera u bolesnika na mehaničkoj ventilaciji nije utvrđena.
English: 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.
Croatian: Budući da se Luminity sastoji od mikrosfera koje su stabilne i dovoljno malene za prolaz kroz pluća, dobivaju se pojačani odjeci signala u lijevom dijelu srca i sistemskom krvotoku.
English: 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.
Croatian: Prije primjene ovaj lijek mora se aktivirati miješanjem pomoću mehaničkog uređaja pod nazivom Vialmix, koji dobivaju liječnici koji moraju pripremiti lijek.
English: In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known.
Croatian: U kliničkim ispitivanjima te su nuspojave bile rijetko zabilježene, a njihova učestalost nakon stavljanja lijeka u promet nije poznata.
English: Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Croatian: Luminity se ne smije primjenjivati metodama koje nisu navedene u dijelu 4.2 (npr. injekcijom u arteriju).
English: The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs.
Croatian: Komponenta perflutrena u Luminityju brzo se uklonila iz sistemskog krvotoka putem pluća.
English: 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.
Croatian: Jednokratne doze do 100 mikrolitara disperzije/kg i višestruke doze do 150 mikrolitara disperzije/kg dobro su se podnosile u kliničkim ispitivanjima faze I.
English: The clinical consequences of overdose with Luminity are not known.
Croatian: Kliničke posljedice predoziranja Luminityjem nisu poznate.
English: 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).
Croatian: Luminity se koristi u odraslih osoba da bi se dobila jasnija slika srčanih komora, osobito lijeve klijetke, tijekom ehokardiografije (dijagnostičke pretrage tijekom koje se korištenjem ultrazvuka dobiva snimka srca).
English: 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.
Croatian: Poremećeno disanje, promjene srčane frekvencije i smanjena aktivnost bili su uočeni ubrzo nakon intravenske injekcije Luminityja u dozama od ≥ 0,3 ml/kg u ispitivanjima toksičnosti jednokratnih i opetovanih doza provedenima na štakorima i majmunima.
English: - The vial should be vented with a sterile syringe needle or a sterile non-siliconised mini-spike before withdrawing the dispersion.
Croatian: - Bočicu treba odzračiti pomoću sterilne igle za štrcaljku ili sterilnog nesilikoniziranog mini šiljka prije izvlačenja disperzije.
English: 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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja genotoksičnosti, plodnosti, embriofetalnog razvoja, porođaja, postporođajnog razvoja i lokalne podnošljivosti.
English: It is not known whether Luminity is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se Luminity u majčino mlijeko.
English: EXP After activation: use within 12 hours
Croatian: Nakon aktivacije: upotrijebiti u roku od 12 sati
English: Luminity should be used within 12 hours following activation.
Croatian: Luminity se mora upotrijebiti u roku od 12 sati nakon aktivacije.
English: Activation process and administration
Croatian: Proces aktivacije i primjena
English: 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).
Croatian: Luminity smiju primjenjivati samo osposobljeni liječnici koji posjeduju stručno znanje o provođenju i tumačenju kontrastnih ehokardiograma, a pritom treba biti dostupna odgovarajuća oprema za reanimaciju za slučaj kardiopulmonalnih reakcija ili reakcija preosjetljivosti (vidjeti dio 4.4).
English: Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Croatian: Luminity se ne smije koristiti uz osnovnu tehniku snimanja za ehokardiografiju pod opterećenjem budući da njegova djelotvornost i sigurnost primjene nisu utvrđene.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su navedene od najozbiljnijih prema manje ozbiljnima.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Priog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Croatian: Lijek se može reaktivirati do 48 sati nakon početne aktivacije te koristiti do 12 sati nakon druge aktivacije.
English: Caution must be exercised when considering the administration of Luminity to these patients.
Croatian: Potreban je oprez kada se razmatra primjena Luminityja tim bolesnicima.
English: 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.
Croatian: 1,5 ml tekućine u prozirnoj bočici od borosilikatnog stakla tipa I, zatvorena klorobutilnim elastomernim liofilizacijskim čepom te zapečaćena aluminijskim prstenom s plastičnom „flip-off”
English: Rare: Abnormal electrocardiogram
Croatian: Rijetko: poremećeni elektrokardiogram
English: The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Croatian: Sigurnost primjene Luminityja u bolesnika s desno-lijevim, dvosmjernim ili prolaznim desno-lijevim srčanim spojevima nije ispitivana.
English: 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.
Croatian: Bolesnici s adultnim sindromom respiratornog distresa, endokarditisom, protetskim srčanim zaliscima, sistemskom upalom, sepsom, hiperaktivnom koagulacijom i/ili rekurentnom tromboembolijom Luminity se smije koristiti tek nakon pažljivog razmatranja, a njegovu uporabu treba pažljivo pratiti tijekom primjene u bolesnika s adultnim sindromom respiratornog distresa, endokarditisom, srcem s protetskim zaliscima, akutnim stanjima sistemske upale ili sepse, poznatim stanjima hiperaktivne koagulacije i/ili rekurentne tromboembolije.
English: - 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.
Croatian: - Disperziju treba izvlačiti iz bočice pomoću štrcaljke sa sterilnom iglom od 18G do 20G ili pričvršćenom na sterilni nesilikonizirani mini šiljak.
English: Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Croatian: Ozbiljne neposredne reakcije preosjetljivosti (npr. anafilaksa, anafilaktički šok i anafilaktoidne reakcije, hipotenzija i angioedem) zabilježeni su nakon primjene Luminityja.
English: 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.
Croatian: Štakori koji su primali Luminity tijekom 1 mjeseca imali su s dozom povezanu, reverzibilnu perivaskularnu i peribronhiolarnu infiltraciju eozinofila, alveolarno nakupljanje makrofaga te povećanu veličinu i broj vrčastih stanica u plućima.
English: Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Croatian: Intravenska infuzija uz korištenje nelinearne tehnike kontrastnog snimanja (pri mirovanju i pod opterećenjem) ili osnovne tehnike snimanja u mirovanju:
English: Excipient(s) with known effect Each ml contains 2.679 mg sodium
Croatian: Jedan ml sadržava 2,679 mg natrija
English: Heart or breathing problems including cardiac arrest have occurred in some patients.
Croatian: U nekih bolesnika javili su se problemi sa srcem ili disanjem, uključujući srčani zastoj.
English: 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.
Croatian: Izniman oprez potreban je kada se razmatra primjena Luminityja u bolesnika s nestabilnim kardiopulmonalnim statusom, primjerice: s nestabilnom anginom, akutnim infarktom miokarda, teškim ventrikularnim aritmijama, teškim srčanim zatajenjem (NYHA IV) ili respiratornim zatajenjem.
English: This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
Croatian: Ovaj lijek sadržava 103,5 mg propilenglikola, što odgovara 182,2 mg u svakoj bočici.
English: After activation (shaking), the product appears as a milky white liquid.
Croatian: Nakon aktivacije (miješanja) lijek izgleda kao mliječno bijela tekućina.
English: These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Ti su učinci zapaženi pri izloženosti dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Croatian: Približna količina plina perflutrena u svakom ml je 150 mikrolitara (μl).
English: - The vial should be activated using the Vialmix.
Croatian: - Bočica se mora aktivirati korištenjem Vialmixa.
English: Luminity is a gas and solvent for dispersion for injection or infusion.
Croatian: Luminity je plin i otapalo za disperziju za injekciju ili infuziju.
English: The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
Croatian: Približna količina plina perflutrena u svakom ml Luminityja je 150 mikrolitara.
English: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Croatian: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co.
English: The dispersion should be given to you within 12 hours of activation (shaking).
Croatian: Disperzija Vam se mora primijeniti u roku od 12 sati od aktivacije (miješanja).
English: Total lung clearance (CLlung) of perflutren was shown to be no different in healthy subjects compared to COPD subjects.
Croatian: Pokazalo se da se ukupni klirens perflutrena iz pluća (CLpluća) ne razlikuje u zdravih ispitanika u usporedbi s ispitanicima s KOPB-om.
English: Not known: Abnormal vision
Croatian: Nepoznato: poremećen vid
English: Rare: Paraesthesia
Croatian: Rijetko: dispepsija
English: 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.
Croatian: Uočeni pad od 99% u intenzitetu Doppler signala u roku od 10 minuta (t1/2 otprilike
English: 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.
Croatian: 2526 bolesnika) javljale su se u roku od nekoliko minuta od primjene i obično se povukle uz terapijsku intervenciju u roku od 15 minuta.
English: Not known: Cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia
Croatian: Nepoznato: srčani arest, ventrikularne aritmije (fibrilacija ventrikula, ventrikularna tahikardija, preuranjene kontrakcije ventrikula), asistola, fibrilacija atrija, srčana ishemija,
English: Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration.
Croatian: Bolesnike s nestabilnim kardiopulmonalnim statusom potrebno je pratiti tijekom te najmanje 30
English: Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Croatian: Kao što je slučaj sa svim parenteralnim lijekovima, bočice se moraju vizualno pregledati da bi se provjerilo ima li čestica i je li bočica neoštećena.
English: The systemic clearance of perflutren was similar in healthy and COPD subjects.
Croatian: Sistemski klirens perflutrena bio je sličan u zdravih ispitanika i u ispitanika s KOPB-om.
English: • altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),
Croatian: • Utrnulost, trnci i/ili osjećaj peckanja, • promijenjena srčana frekvencija, palpitacije (osjećate da Vam srce kuca jače ili nepravilno),
English: CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Croatian: Uočeno je da je CLpluća bio značajno smanjen (51%)
English: This product must only be administered intravenously.
Croatian: Ovaj se lijek smije primjenjivati samo intravenski.
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Croatian: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co.
English: • loss of consiousness,
Croatian: • gubitak svijesti,
English: After activation: Do not store above 30°C.
Croatian: Nakon aktivacije: Ne čuvati na temperaturi iznad 30°C.
English: Do not store the vial above 30°C following activation.
Croatian: Ne čuvati bočicu na temperaturi iznad 30°C nakon aktivacije.
English: Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness
Croatian: Rijetko: sinkopa, hipertenzija, periferna hladnoća
English: 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.
Croatian: U kliničkim ispitivanjima s Luminityjem korištene su osnovne i nelinearne tehnike snimanja („second harmonic”, „multipulse phase” i/ili „amplitude modulation”) koje koriste i kontinuirane i pulsirajuće signale.
English: Therefore, caution should be exercised when Luminity is administered to breast-feeding women.
Croatian: Stoga je potreban oprez kada se Luminity primjenjuje ženama koje doje.
English: - if you are allergic to perflutren or any of the other ingredients of Luminity.
Croatian: Nemojte primiti Luminity ako ste alergični na perflutren ili neki drugi sastojak Luminityja (naveden u dijelu 6).
English: Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
Croatian: Prije primjene Luminity se mora aktivirati pomoću uređaja za mehaničko miješanje Vialmix (vidjeti dio 6.6).
English: Uncommon: Back pain
Croatian: Manje često: bol u leđima
English: How to use Luminity
Croatian: Kako primjenjivati Luminity
English: 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.
Croatian: Farmakokinetička svojstva Luminityja bila su ocijenjena u normalnih zdravih ispitanika i u ispitanika s kroničnom opstruktivnom plućnom bolešću (KOPB) nakon intravenske primjene doze lijeka od
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree' .
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Bolus intravenous injection using fundamental imaging technique at rest:
Croatian: Intravenska bolus injekcija uz korištenje nelinearne tehnike kontrastnog snimanja pri mirovanju i pod opterećenjem:
English: 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.
Croatian: Pokazalo se da koncentracije perflutrena u krvi padaju monoeksponencijalno uz srednji poluvijek od 1,3 minute u zdravih ispitanika te od 1,9 minuta u ispitanika s KOPB-om.
English: • Dizziness,
Croatian: • svrbež,
English: Rare side effects (may affect up to 1 in 1000 people)
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba)
English: How to store Luminity
Croatian: Kako čuvati Luminity
English: Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia
Croatian: Rijetko: artralgija, bol u boku, bol u vratu, grčevi mišića Nepoznato: mišićni spazam, mišićno-koštana bol, mišićno koštana nelagoda, mijalgija, hipertonija
English: The product should be used within 12 hours of activation.
Croatian: Lijek se mora iskoristiti u roku od 12 sati od aktivacije.
English: Not known: seizures, facial hypoaesthesia, loss of consciousness
Croatian: Rijetko: parestezija Nepoznato: napadaji, hipoestezija lica, gubitak svijesti
English: The total dose of perflutren should not exceed 1.6 ml.
Croatian: Ukupna doza perflutrena ne smije premašivati
English: 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
Croatian: Nepoznato: alergijske reakcije, anafilaksa, anafilaktički šok i anafilaktoidne reakcije, hipotenzija, angioedem, oticanje usana, bronhospazam, rinitis, oticanje gornjih dišnih puteva, stezanje grla, oticanje lica, oticanje oka
English: If necessary, a second 10 microlitre dispersion/kg dose followed by a second 10 ml bolus of sodium 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.
Croatian: Ako je potrebno, druga doza od 10 mikrolitara disperzije/kg nakon koje slijedi drugi bolus od 10 ml 9 mg/ml (0,9%) otopine natrijevog klorida ili 50 mg/ml (5%) otopine glukoze za injekciju može se primijeniti 5 minuta nakon prve injekcije kako bi se produljilo pojačanje kontrasta.
English: Before administering the product, it must be activated by using the Vialmix, a mechanical shaking device.
Croatian: Prije primjene lijek se mora aktivirati korištenjem Vialmixa, uređaja za mehaničko miješanje.
English: After activation (shaking), do not store above 30°C.
Croatian: Nakon aktivacije (miješanja) ne čuvati na temperaturi iznad 30°C.
English: 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).
Croatian: Svaki ml sadrži najviše 6,4 x 109 lipidnih mikrosfera koje sadrže perflutren sa srednjim promjerom u rasponu od 1,1-2,5 μm (otprilike 150 mikrolitara plina perflutrena po ml).
English: 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
Croatian: Obratite se svom liječniku prije primjene Luminityja - ako Vam je rečeno da imate srčani spoj (šant) - ako imate tešku bolest srca ili pluća ili ako Vam je potrebna mehanička pomoć da biste disali
English: Package leaflet: Information for the user Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Croatian: Uputa o lijeku: Informacije za korisnika Luminity 150 mikrolitara/ml plin i otapalo za disperziju za injekciju/infuziju perflutren
English: Elderly Pharmacokinetics has not been specifically studied in the elderly.
Croatian: Starije osobe Farmakokinetika nije posebno ispitivana u starijih bolesnika.