FrancophonIA/ELRC3.0 huggingface dataset:
English: The subcutaneous formulation of tildrakizumab showed an absolute bioavailability ranging from 73% (90% CI: 46% - 115%, 200 mg SC vs. 3 mg/kg IV) to 80% (90% CI: 62% - 103%, 50 mg SC vs. 0.5 mg/kg IV) in healthy subjects, as a result of cross study single dose comparison.
Croatian: Formulacija tildrakizumaba za potkožnu primjenu imala je apsolutnu bioraspoloživost u rasponu od 73% (90% CI: 46% - 115%, 200 mg s.c. naspram 3 mg/kg i.v.) do 80% (90% CI: 62% - 103%, 50 mg s.c. naspram 0,5 mg/kg i.v.) u zdravih ispitanika, kao rezultat usporedbe jedne doze u ukriženim ispitivanjima.
English: The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg.
Croatian: Otopina je bistra do blago zamućena i bezbojna do žućkasta. pH raspon otopine je 5,7 - 6,3, a osmolalnost je između 258 i 311 mOsm/kg.
English: Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Croatian: Jedna napunjena štrcaljka sadrži 100 mg tildrakizumaba u 1 ml.
English: Tildrakizumab is catabolized into component amino acids by general protein degradation processes.
Croatian: Tildrakizumab se razgrađuje u sastavne aminokiseline uobičajenim procesima degradacije proteina.
English: The geometric mean exposure (AUC0-τ at steady state) in adult patients weighing >90 kg following a 100 mg or 200 mg SC dose was predicted to be about 30% lower than in an adult patient weighing ≤90 kg (see section 4.2).
Croatian: Predviđena geometrijska srednja vrijednost izloženosti (AUC0-τ u stanju dinamičke ravnoteže) u odraslih bolesnika tjelesne težine > 90 kg nakon supkutane doze od 100 ili 200 mg je oko 30 % niža nego u odraslih bolesnika tjelesne težine ≤ 90 kg (vidjeti dio 4.2).
English: p-values calculated using the Cochran-Mantel-Haenszel (CMH) test stratified by body weight (≤90 kg, >90 kg) and prior exposure to biologic therapy for psoriasis (yes/no).
Croatian: n = broj bolesnika u potpunom skupu podatak za analizu za koji su bili dostupni podaci, nakon imputacije kad je bilo primjenjivo. p-vrijednosti izračunate testom Cochran-Mantel-Haenszel (CMH) sa stratifikacijom prema tjelesnoj težini (≤90kg, >90kg) i prethodnoj izloženosti terapiji biološkim lijekovima za psorijazu (da/ne).
English: a Long-term response in patients who were responders (had achieved at least PASI 75) to tildrakizumab at week 28. b No imputation for missing data.
Croatian: a Dugoročni odgovor u bolesnika koji su s odgovorom (postigli su najmanje PASI 75) na terapiju tildrakizumabom u 28. tjednu.
English: In cynomolgus monkeys, there was negligible secretion of the product into breast milk.
Croatian: U makaki majmuna došlo je do zanemarivog izlučivanja lijeka u majčino mlijeko.
English: Excipients: L-Histidine, L-Histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections.
Croatian: Pomoćne tvari: L-histidin, L-histidinklorid hidrat, polisorbat 80, saharoza i voda za injekcije.
English: Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.
Croatian: Tildrakizumab inhibira oslobađanje citokina i kemokina koji uzrokuju upalu.
English: At steady state, following administration of 100 mg of tildrakizumab in subjects with moderate to severe plaque psoriasis geometric means (% CV) of AUC0-τ and Cmax values were respectively 305 μg·day/mL (41%) and 8.1 μg/mL (34%), whereas they were 612 μg·day/mL (40%) and 16.3 μg/mL (33%) following administration of 200 mg.
Croatian: U stanju dinamičke ravnoteže, nakon primjene 100 mg tildrakizumaba u ispitanika s umjerenom do teškom plak psorijazom geometrijske srednje vrijednosti (% CV) AUC0-τ i Cmax bile su 305 µg·dan/ml (41%) odnosno 8,1 µg/ml (34%), dok su nakon primjene 200 mg vrijednosti iznosile 612 µg·dan/ml (40%) odnosno 16,3 µg/ml (33 %).
English: INJECTION
Croatian: INJEKCIJA
English: Almirall N.V. Tél/Tel: +32 (0)2 771 86 37
Croatian: Tél/Tel: +32 (0)2 771 86 37
English: PC: SN:
Croatian: PC:
English: Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Croatian: Ilumetri je namijenjen za primjenu pod vodstvom i nadzorom liječnika koji je iskusan u dijagnostici i liječenju psorijaze.
English: SUN Pharmaceuticals Industries (Europe) B.V. Polarisavenue 87
Croatian: SUN Pharmaceuticals Industries (Europe) B.V.
English: The multicentre, randomised, double-blind, placebo-controlled trials reSURFACE 1 and reSURFACE 2 studies enrolled a total of 1,862 patients 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a Physician Global Assessment (PGA) score of ≥3 in the overall assessment (plaque thickness, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a
Croatian: Multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja reSURFACE 1 i reSURFACE 2 uključivala su ukupno 1862 bolesnika u dobi od 18 godina i starijih, s plak psorijazom, koji su imali minimalnu zahvaćenost površine tijela od 10%, rezultat opće procjene liječnika (engl.
English: SUN Pharmaceutical Industries (Europe) B.V. Polarisavenue 87
Croatian: SUN Pharmaceutical Industries (Europe) B.V.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Ilumetri.
Croatian: Ako niste sigurni da se bilo što od navedenog odnosi na Vas, prije primjene lijeka Ilumetri razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: N.V. Organon Veersemeer 4
Croatian: N.V. Organon Veersemeer 4 5347 JN Oss Nizozemska
English: Ilumetri contains the active substance tildrakizumab.
Croatian: Ilumetri sadrži djelatnu tvar tildrakizumab.
English: How to use Ilumetri
Croatian: Kako primjenjivati Ilumetri
English: Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Croatian: Ilumetri je namijenjen za primjenu pod vodstvom i nadzorom liječnika koji je iskusan u dijagnostici i liječenju plak psorijaze.
English: Solution for injection 2 pre-filled syringes
Croatian: Otopina za injekcije 2 napunjene štrcaljke
English: Each pre-filled syringe contains 100 mg of tildrakizumab.
Croatian: Jedna napunjena štrcaljka sadrži 100 mg tildrakizumaba.
English: Ilumetri is a sterile solution for injection in pre-filled syringe.
Croatian: Ilumetri je sterilna otopina za injekciju u napunjenoj štrcaljki.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE
English: • Hold the pre-filled syringe steady.
Croatian: • Mirno držite napunjenu štrcaljku.
English: - If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs.
Croatian: - ako ste alergični na tildrakizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate infekciju koju Vaš liječnik smatra značajnom, primjerice, aktivnu tuberkulozu koja je zarazna bolest koja uglavnom zahvaća pluća.
English: Solution for injection 1 pre-filled syringe
Croatian: Otopina za injekcije 1 napunjena štrcaljka
English: Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Croatian: Prije uvođenja lijeka Ilumetri bolesnicima s anamnezom prethodnog latentnog ili aktivnog TBC-a, u kojih se ne može potvrditi odgovarajući tijek liječenja, potrebno je razmotriti primjenu terapije protiv TBC-a.
English: Maintenance of Response in Studies reSURFACE 1 and reSURFACE 2
Croatian: Tablica 3. Održanost kliničkih odgovora u ispitivanjima reSURFACE 1 i reSURFACE 2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK SIZE 2 PRE-FILLED SYRINGES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - PAKIRANJE S 2 NAPUNJENE ŠTRCALJKE
English: The pre-filled syringes are for single use only.
Croatian: Napunjena štrcaljka je namijenjena samo za jednokratnu primjenu.
English: Your symptoms may return upon discontinuation.
Croatian: Nakon prekida primjene moguća je ponovna pojava simptoma.
English: • Insert the entire needle into the pinched skin between your fingers, straight up and down at a
Croatian: • U kožni nabor, koji ste napravili između dva prsta, umetnite cijelu iglu uvodeći je okomito i dolje,
English: Preferred term
Croatian: Preporučeni pojam
English: Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Croatian: Ne koristiti ako tekućina sadrži lako vidljive čestice, zamućena je ili izrazito smeđa.
English: It is unknown whether tildrakizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se tildrakizumab u majčino mlijeko.
English: How to store Ilumetri
Croatian: Kako čuvati Ilumetri
English: Ilumetri 100 mg injection tildrakizumab SC
Croatian: Ilumetri 100 mg injekcija tildrakizumab s.c.
English: Tildrakizumab is catabolized into component amino acids by general protein degradation processes and is not eliminated by renal or hepatic pathways.
Croatian: Tildrakizumab se katabolizira na sastavne aminokiseline procesima uobičajene razgradnje proteina i ne eliminira se putem bubrega ili jetre.
English: W4 W8 W12 W16 W22 W28 W32 W36 W40 W44 W48 W52 W56 W60 W64 Ilumetri 100 mg --> Placebo**
Croatian: TJ4 TJ8 TJ12 TJ16 TJ22 TJ28 TJ32 TJ36 TJ40 TJ44 TJ48 TJ52 TJ56 TJ60 TJ64
English: Ilumetri 100 mg solution for injection in pre-filled syringe.
Croatian: Ilumetri 100 mg otopina za injekciju u napunjenoj štrcaljki.
English: 200 m g
Croatian: 200 mg
English: - The active substance is tildrakizumab.
Croatian: - Djelatna tvar je tildrakizumab.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK SIZE 1 PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE S 1 NAPUNJENOM
English: You must look out for signs of these conditions while you are taking Ilumetri.
Croatian: Tijekom primjene lijeka Ilumetri morate paziti na znakove tih stanja.
English: Keep the pre-filled syringes in the outer carton in order to protect from light until the time of use.
Croatian: Napunjene štrcaljke čuvati u vanjskom pakiranju radi zaštite od svjetlosti do trenutka uporabe.
English: Description of selected adverse reaction Immunogenicity
Croatian: Opis odabranih nuspojava
English: L-Histidine hydrochloride monohydrate Polysorbate 80
Croatian: L-histidinklorid hidrat polisorbat 80 saharoza voda za injekcije
English: Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab
Croatian: Ilumetri 100 mg otopina za injekciju u napunjenoj štrcaljki tildrakizumab
English: 39.4c a Co-primary efficacy endpoint at week 12. b Non responder imputation for missing data.
Croatian: 39,4c a Koprimarna mjera ishoda djelotvornosti u 12. tjednu.
English: • Choose an injection site with clear skin and easy access such as abdomen, thighs or upper arm. - DO NOT administer 5 cm around the navel or where the skin is tender, bruised, abnormally red, hardened or affected by psoriasis.
Croatian: - NEMOJTE primjenjivati injekciju 5 cm oko pupka ili na mjestima osjetljive kože ili kože prekrivene modricama, abnormalno crvene, otvrdnule ili zahvaćene psorijazom.
English: - Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
Croatian: - Ilumetri je bistra do blago opalescentna i bezbojna do žućkasta otopina.
English: - The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80,
Croatian: - Drugi sastojci su: L-histidin, L-histidinklorid hidrat, polisorbat 80, saharoza i voda za injekcije.
English: Comprehensive instructions for administration are given in the package leaflet.
Croatian: Detaljne upute za primjenu navedene su u uputi o lijeku.
English: Do not use if the liquid contains visible particles, is cloudy or is distinctly brown.
Croatian: Nemojte koristiti ako tekućina sadrži vidljive čestice, ako je zamućena ili izrazito smeđe boje.
English: You should not be given certain types of vaccines (live vaccines) while using Ilumetri.
Croatian: Tijekom primjene lijeka Ilumetri ne smijete primati neke vrste cjepiva (živa cjepiva).
English: o DO NOT use if pre-filled syringe or needle is bent.
Croatian: o Još NEMOJTE dodirivati plavi klip. o NEMOJTE koristiti napunjenu štrcaljku ako su štrcaljka ili igla savijene.
English: Summary of Response Rates in Studies reSURFACE 1 and reSURFACE 2
Croatian: Tablica 2. Sažetak stopa odgovora u ispitivanju psorijaze reSURFACE 1 i reSURFACE 2
English: Maintenance and durability of PASI 90 response over time is presented in Figure 1.
Croatian: Održanost odgovora u ispitivanjima reSURFACE 1 i reSURFACE 2 prikazana je u tablici 3. Održanost i trajnost odgovora PASI 90 tijekom vremena prikazani su na slici 1.
English: Package leaflet: Information for the user Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Ilumetri 100 mg otopina za injekciju u napunjenoj štrcaljki tildrakizumab
English: Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
Croatian: Ilumetri je bistra do blago opalescentna (sedefasta) i bezbojna do žućkasta otopina.
English: Keep the product in the original carton in order to protect from light until the time of use.
Croatian: Lijek čuvajte u originalnom pakranju kako bi do trenutka primjene bio zaštićen od svjetlosti.
English: Long term responsea,b 200 mg
Croatian: Dugoročni odgovora,b
English: Common side effects (may affect up to 1 in 10 people): - Gastroenteritis - Nausea - Diarrhoea - Injection site pain - Back pain - Headache
Croatian: - proljev - bol na mjestu injekcije - bol u leđima - glavobolja
English: Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease.
Croatian: Ilumetri se koristi za liječenje kožne bolesti pod nazivom plak psorijaza.
English: Talk to your doctor, pharmacist or nurse before using Ilumetri: - If you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips or throat do not inject more Ilumetri and contact your doctor immediately.
Croatian: - ako dobijete alergijske reakcije popraćene simptomima poput stezanja u prsima, zviždanja pri disanju, oticanja lica, usana ili grla.
English: Clean injection site
Croatian: 7. Očistite mjesto ubrizgavanja
English: Inject
Croatian: Ubrizgajte
English: • Inspect Ilumetri visually for particulate matter and discoloration prior to administration.
Croatian: • Prije primjene pregledajte Ilumetri kako biste provjerili da nije promjenio boju i ne sadrži čestice.
English: 200 mg 100 mg Etanercep t reSURFACE1
Croatian: Tjedan 28 (3 doze)* 200 mg 100 mg Placebo Etanercept 200 mg 100 mg Etanercept reSURFACE1 Broj bolesnika PASI 75a (%)
English: List of adverse reactions MedDRA System Organ Class
Croatian: Popis nuspojava MedDRA
English: Renal and Hepatic impairment
Croatian: Oštećenje bubrega i jetre
English: The full EPAR for Luminity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Luminity nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 06-2016.
Croatian: Sažetak je posljednji put ažuriran: 06. 2016.
English: There have been five main studies of Luminity, involving a total of 401 patients.
Croatian: Provedeno je pet glavnih ispitivanja lijeka Luminity na ukupno 401 bolesniku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Luminity na snazi u Europskoj uniji od 20. rujna 2006.
English: As all five original studies were carried out with a technique known as ‘fundamental' ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘harmonic' and ‘non linear'.
Croatian: Budući da je svih pet izvornih ispitivanja provedeno s pomoću tehnike poznate kao „temeljno” ultrazvučno snimanje, tvrtka je predstavila i rezultate nekih ispitivanja kako bi dokazala da se rezultati dobiveni temeljnim snimanje mogu dobiti i uporabom tehnika snimanja poznatih kao „harmonic” i „non linear”.
English: The gas is then cleared through the lungs.
Croatian: Plin se zatim filtrira kroz pluća.
English: What measures are being taken to ensure the safe and effective use of Luminity?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Luminity?
English: Other information about Luminity
Croatian: Ostale informacije o lijeku Luminity
English: Luminity is for diagnostic use only.
Croatian: Luminity se koristi samo u dijagnostičke svrhe.
English: This is a summary of the European public assessment report (EPAR) for Luminity.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Luminity.
English: When Luminity is injected, it travels in the veins to the heart.
Croatian: Kada se Luminity ubrizga, venama putuje do srca.
English: Before use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Croatian: Luminity se prije uporabe mora aktivirati tako da se protrese s pomoću mehaničkog uređaja koji se naziva Vialmix i koji se isporučuje liječnicima koji trebaju pripremiti lijek.
English: This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue.
Croatian: Tako se dobiva bolji kontrast između područja u kojima se nalaze mjehurići plina (kao što su srčane komore) i okolnog tkiva.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Luminity.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Luminity.
English: It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).
Croatian: To je kontrastno sredstvo (lijek koji pomaže u dobivanju boljih snimki organa i tkiva prilikom snimanja).
English: The medicine can only be obtained with a prescription.
Croatian: Lijek se izdaje se samo na liječnički recept.
English: 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.
Croatian: Time se jamči da se lijek protrese na ispravan način i dovoljno dugo kako bi se postigla disperzija mikrosfera plina perflutrena odgovarajuće veličine za dobivanje snimaka dobre kvalitete.
English: Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Croatian: Lijek Luminity smiju davati samo liječnici osposobljeni za snimanje i tumačenje snimaka dobivenih kontrastnom ehokardiografijom u bolnicama ili klinikama u kojima je dostupna odgovarajuća oprema za oživljavanje u slučaju problema sa srcem ili plućima ili alergijskih reakcija.
English: For more information about treatment with Luminity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist
Croatian: Više informacija o terapiji lijekom Luminity pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
Croatian: Najčešće su nuspojave lijeka Luminity (zabilježene u između 1 do 10 na 100 bolesnika) glavobolja i rumenilo (crvenjenje kože).
English: In two of these studies, Luminity was compared with placebo (a dummy treatment).
Croatian: U dvama ispitivanjima, lijek Luminity uspoređen je s placebom (slijepo liječenje).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luminity have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati radi sigurne i učinkovite uporabe lijeka Luminity nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The last two studies were set up primarily to look at the ability of Luminity to improve the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat).
Croatian: Posljednja dva ispitivanja provedena su ponajprije kako bi se ocijenila sposobnost lijeka Luminity da poboljša točnost mjerenja ejekcijske frakcije (postotak volumena krvi koji se u jednom otkucaju istisne iz srca).
English: Luminity perflutren-containing lipid microspheres
Croatian: Luminity lipidne mikrosfere koje sadrže perflutren
English: This is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion after being diluted.
Croatian: Ta se disperzija zatim daje u venu kao „bolus” injekcija (cijela količina odjednom) ili kao infuzija nakon što se razrijedi.
English: What is the risk associated with Luminity?
Croatian: Koji su rizici povezani s lijekom Luminity?
English: The CHMP decided that Luminity's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Luminity nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
English: Luminity is used in adults to obtain a clearer image 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 za dobivanje jasnije snimke srčanih komora, osobito lijeve klijetke, tijekom ehokardiografije (dijagnostičke pretrage prilikom koje se ultrazvukom dobiva snimka srca).
English: Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Croatian: Lijek Luminity otopina je za injekciju ili intravensku infuziju (drip) koja sadrži mikrosfere (sitne mjehuriće) ili plin perflutren kao djelatnu tvar.
English: The way Luminity is given and the dose depend on the technique being used for the echocardiography.
Croatian: Način davanja lijeka Luminity i doza ovise o tehnici ehokardiografije koja se primjenjuje.
English: During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues.
Croatian: Mikrosfere perflutrena u lijeku Luminity različito reflektiraju ultrazvučne valove od okolnih tkiva tijekom ehokardiografije.
English: Why has Luminity been approved?
Croatian: Zašto je Luminity odobren?
English: 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 without a contrast agent is not good enough.
Croatian: Luminity se koristi u bolesnika kod kojih se sumnja na bolest koronarnih arterija (opstrukcije krvnih žila koje opskrbljuju srčani mišić) ili kod kojih je ta bolest potvrđena kada snimka dobivena bez kontrastnog sredstva nije dovoljno dobra.
English: For full details, see the summary of product characteristics (also part of the EPAR).
Croatian: Za potpune informacije vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).