natgillin/translations-raw huggingface dataset:
Route of Administration 
Farmacevtska oblika Pot uporabe Stična ovojnina
EU Procedure number Invented name Strength Pharmaceutical Form 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
Package size 
Številka EU
Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016 
Datum pridobitve dovoljenja za promet: 20. september 2006 Datum zadnjega podaljšanja: 15. julij 2016
They will calculate the right dose for you. 
Izračunal bo za vas primeren odmerek.
No interaction studies have been performed and no other forms of interaction have been identified. 
Študij medsebojnega delovanja niso izvedli niti niso ugotovili drugih oblik interakcij.
• altered taste, 
• spremenjen okus,
In the case of overdose the doctor will take appropriate action. 
V primeru prevelikega odmerjanja bo zdravnik uvedel ustrezne ukrepe.
Pack sizes of 1 or 4 vials. 
Pakiranji z 1 ali 4 vialami.
Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups 
Zdravilo Luminity se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let), saj se ni preučevalo pri teh skupinah.
The safety and efficacy of Luminity in children and adolescents below 18 years have not been established. 
Učinkovitost in varnost zdravila Luminity pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The contents of the vial are intended for single use only. 
Vsebina viale je namenjena le za enkratno uporabo.
In some cases, your doctor may choose to use two injections to complete the ultrasound examination. 
V nekaterih primerih se lahko zdravnik za dokončanje ultrazvočne preiskave odloči za uporabo dveh injiciranj.
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. 
S tem se zagotovi, da se zdravilo stresa na pravilen način in dovolj dolgo, da nastane »disperzija« mikrosfer s plinom perflutrenom ustrezne velikosti, da se pridobi kakovostna slika.
Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy. 
Zdravljenje prevelikega odmerjanja mora biti usmerjeno v podporo vseh vitalnih funkcij in takojšnjo uvedbo simptomatskega zdravljenja.
EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial 
EU/1/06/361/001 4 viale z enim odmerkom EU/1/06/361/002 1 viala z enim odmerkom
Patients on mechanical ventilation 
Bolniki na mehanični ventilaciji
These levels are substantially above the recommended maximal clinical dose. 
Te koncentracije so bistveno nad priporočenim največjim kliničnim odmerkom.
It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests). 
Je kontrastno sredstvo (zdravilo, ki pomaga pri pregledovanju struktur v telesu med preiskavami s slikanjem).
EXP After activation: use within 12 hours 
EXP: Po aktiviranju: uporabite v 12 urah.
The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%). 
Najpogosteje opisani neželeni učinki so glavobol (2,0 %), zardevanje (1,0 %) in bolečine v hrbtu (0,9 %).
In addition, some patients may experience convulsions, which may be associated with these allergic reactions. 
Razen tega se pri nekaterih bolnikih lahko pojavijo tudi epileptični krči, ki so lahko povezani s temi alergijskimi reakcijami.
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%. 
Prav tako je programiran, da se izključi in odda vidno in slišno opozorilo, če frekvenca stresanja preseže ciljno frekvenco za 5 % ali se zmanjša za 10 % pod njo.
In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known. 
V kliničnih preskušanjih so o teh reakcijah poročali redko, pri poročilih po pridobitvi dovoljenja za promet pa pogostnost ni znana.
Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including unresponsiveness and occasionally death. 
Večji odmerki zdravila, praviloma ≥ 1 ml/kg, so povzročili hujše znake, vključno z neodzivnostjo in, občasno, s smrtjo.
No air should be injected into the vial. 
V vialo ne smete injicirati zraka.
Fertility Animal studies do not indicate direct or indirect harmful effects on fertility. 
Plodnost Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost.
Emergency equipment and personnel trained in its use must be readily available. 
Oprema za nujne primere in osebje, usposobljeno za njeno uporabo, mora biti vedno nemudoma na voljo.
Pharmacokinetics in special population groups 
Farmakokinetika pri posebnih skupinah bolnikov
A strict dose/response relationship cannot be defined, although higher doses have been shown to produce a contrast effect of longer duration. 
Natančnega razmerja med odmerkom in odzivom ni mogoče opredeliti, je pa ugotovljeno, da imajo veliki odmerki dolgotrajnejši kontrasten učinek.
These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use. 
Te učinke so opazili samo pri izpostavljenostih, ki so presegale največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency. 
Vialmix operaterja opozori, če je frekvenca stresanja 5 % ali več pod ciljno frekvenco.
For perflutren, no clinical data on exposed pregnancies are available. 
Za perflutren ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood. 
Intenzivnost dopplerskega signala se je dobro ujemala z izmerjenimi in ekstrapoliranimi koncentracijami perflutrena v krvi.
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). 
< 1/10; občasni ≥ 1/1.000 do < 1/100; redki ≥ 1/10.000 do < 1/1.000; zelo redki < 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
It is not known whether Luminity is excreted in human breast milk. 
Ni znano, ali se zdravilo Luminity pri človeku izloča v materinem mleku.
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. 
Opomba: če izdelek stoji več kot 5 minut po aktiviranju, ga morate resuspendirati tako, da ga 10 sekund ročno tresete, preden ga z brizgo potegnete iz viale.
Other medicines and Luminity 
Druga zdravila in zdravilo Luminity
• reduced blood pressure, 
• znižan krvni tlak,
Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration. 
Bolnike z nestabilnim kardiopulmonalnim stanjem je treba nadzirati med in še najmanj 30 minut po uporabi zdravila Luminity.
CLlung was found to be significantly reduced (51%) in females compared to males (all subjects). 
Izkazalo pa se je, da je CLpljučni bistveno manjši (51 %) pri ženskah kot pri moških (vsi preiskovanci).
Some patients may experience allergic type reactions such as swelling of the face. 
Pri nekaterih bolnikih se lahko pojavijo alergijske reakcije, npr. otekanje obraza.
There is however a risk that these allergic type reactions become severe and may include anaphylactic shock (a serious, potentially life-threatening allergic response). 
Te alergijske reakcije lahko postanejo resne in lahko vključujejo tudi anafilaktični šok (resen, morebitno smrtno nevaren alergijski odziv).
The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes). 
Čas do največje intenzivnosti dopplerskega signala tmax je bil podoben tmax perflutrena v krvi (1,13 minute v primerjavi z 1,77 minute).
These side effects usually go away quickly without any treatment. 
• sprememba vida Ti neželeni učinki ponavadi minejo hitro brez kakršnegakoli zdravljenja.
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. 
Opaženi 99 % padec intenzivnosti dopplerskega signala v 10 minutah (t1/2 približno 2 minuti) se sklada z upadanjem merljive koncentracije perflutrena v krvi.
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland 
Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Irska
The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs. 
Perflutrenska sestavina zdravila Luminity se je iz sistemskega obtoka hitro odstranila skozi pljuča.
Use in this patient group should be on the basis of a benefit risk assessment by the physician. 
Uporaba pri tej skupini bolnikov mora temeljiti na zdravnikovi oceni razmerja med tveganji in koristmi.
The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans. 
Farmakokinetika in presnova MPEG5000 DPPE pri človeku nista ugotovljeni.
These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects. 
Ti izsledki kažejo, da je celokupna sistemska eliminacija perflutrena hitra in da pri bolnikih s KOPB ni bistveno manjša kot pri zdravih preiskovancih.
Pulmonary disease 
Pljučna bolezen
Resuscitation equipment and trained personnel must always be readily available. 
Ves čas mora biti nemudoma na voljo oprema za oživljanje in ustrezno usposobljeno osebje.
The safety of microspheres in patients on mechanical ventilation has not been established. 
Varnost mikrosfer pri bolnikih na mehanični ventilaciji ni ugotovljena.
If you are given more Luminity than you should 
Če ste dobili večji odmerek zdravila Luminity, kot bi smeli
Excipient(s) with known effect Each ml contains 2.679 mg sodium 
Pomožna(e) snov(i) z znanim učinkom: En ml vsebuje 2,679 mg natrija.
Luminity is for intravenous use (direct injection into the vein). 
Zdravilo Luminity je namenjeno intravenski uporabi (neposrednemu injiciranju v veno).
The product should be used immediately after its withdrawal from the vial. 
Zdravilo morate uporabiti takoj, ko ga potegnete iz viale.
Luminity has no effect on the ability to drive and use machines. 
Zdravilo Luminity nima vpliva na sposobnost vožnje in upravljanja s stroji.
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. 
Odstotek odmerka perflutrena, ki se je izločil v izdihanem zraku, je bil približno 50 % apliciranega odmerka; to je posledica majhne količine apliciranega perflutrena in nemožnosti za kvantificiranje nizkih koncentracij perflutrena s plinsko kromatografijo.
Luminity is activated by using the Vialmix which has a programmed shaking time of 45 seconds. 
Zdravilo Luminity aktivirate z Vialmixom, ki ima programiran čas stresanja 45 sekund.
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. 
Naravni fosfolipidi, ki jih vsebuje zdravilo Luminity (glejte poglavje 6.1), se porazdelijo v endogenih zbirih lipidov v telesu (npr. v jetrih), za sintetično sestavino (MPEG5000) pa so v predkliničnih študijah ugotovili, da se izloči v urinu.
What you need to know before you use Luminity Do not use Luminity 
Kaj morate vedeti, preden boste uporabili zdravilo Luminity Ne uporabljajte zdravila Luminity
It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation. 
Nujno morate upoštevati navodila za uporabo in ravnanje z zdravilom Luminity, med pripravo pa strogo skrbeti za aseptičnost postopka.
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. 
Ultrazvočni odboji od krvi in bioloških mehkih tkiv, npr. maščevja in mišic, nastanejo na mejni površini zaradi majhnih razlik v ultrazvočnih lastnostih teh tkiv.
What Luminity is and what it is used for 
Kaj je zdravilo Luminity in za kaj ga uporabljamo
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland 
Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Irska
Contents of the pack and other information What Luminity contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Luminity
The way Luminity is given and the dose depend on the technique used for the echocardiography. 
Način dajanja zdravila Luminity in njegov odmerek sta odvisna od tehnike, ki se uporabi pri ehokardiografiji,
- The active substance is perflutren. 
Učinkovina je perflutren.
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. 
Previdnost je potrebna pri bolnikih s klinično pomembno boleznijo pljuč, vključno z difuzno intersticijsko pljučno fibrozo in hudo kronično obstruktivno pljučno boleznijo, saj študije pri teh bolnikih niso bile izvedene.
It is available in a pack containing one or four single-use 1.5 ml vials. 
Na voljo je v pakiranjih, ki vsebujejo eno in štiri 1,5-ml viale za enkratno uporabo.
The clinical consequences of overdose with Luminity are not known. 
Klinične posledice prevelikega odmerka zdravila Luminity niso znane.
The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack. 
Vialmix ni priložen pakiranju zdravila Luminity, a ga bodo zdravniki dobili, ko bodo naročili pakiranje.
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. 
Potem jo prilagodite, kot je potrebno za optimalno ojačitev slike, ne sme pa preseči 10 ml/minuto.
Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren. 
Dopplerske ultrazvočne meritve z zdravilom Luminity so opravili hkrati s farmakokinetično analizo perflutrena.
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. 
To zdravilo je treba aktivirati s stresanjem v mehaničnem pripomočku, imenovanem Vialmix, ki se dobavi zdravnikom, ki ga potrebujejo za pripravo zdravila.
This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial. 
To zdravilo vsebuje 103,5 mg/ml propilenglikola, kar ustreza 182,2 mg propilenglikola na vialo.
Immediately after activation, Luminity appears as a milky white dispersion. 
Takoj po aktiviranju je zdravilo Luminity videti kot mlečno bela disperzija.
Rare: Abnormal electrocardiogram 
Preiskave redki: nenormalen elektrokardiogram
Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established. 
Zdravilo Luminity se ne sme uporabljati pri osnovnih načinih slikanja med obremenitveno ehokardiografijo, saj učinkovitost in varnost nista bili dokazani.
Luminity contains propylene glycol. 
Luminity vsebuje propilenglikol.
In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation. 
Pri takšnih bolnikih lahko fosfolipidno inkapsulirane mikrosfere obidejo pljuča in pridejo neposredno v arterijski obtok.
Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management. 
Kontrastna ehokardiografija se sme izvesti le pri bolnikih, pri katerih bi rezultati tovrstne preiskave lahko bistveno vplivali na potek zdravljenja posameznega bolnika.
Activation process and administration 
Postopek aktiviranja in apliciranja
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. 
1,5 ml tekočine v viali iz bistrega borosilikatnega stekla tipa I, zaprti s klorobutilnim elastomernim liofilizacijskim zamaškom, zapečateni z aluminijsko obrobo in pokriti s plastičnim dvižnim gumbom.
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. 
Če zdravilo Luminity aplicirate, ne da bi ga pred tem mehanično aktivirali z Vialmixom (glejte poglavje 6.6), ne bo imel želenega učinka.
• and abnormal electrocardiogram. 
• nenormalen elektrokardiogram.
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. 
Zdravilo lahko reaktivirate do 48 ur po prvem aktiviranju in ga uporabite do 12 ur po drugem aktiviranju, ne glede na to, ali je shranjeno v hladilniku ali pri sobni temperaturi.
Heart or breathing problems including cardiac arrest have occurred in some patients. 
Pri nekaterih bolnikih so se pojavile težave s srcem ali dihanjem, vključno z zastojem srca.
- The vial should be activated using the Vialmix. 
- Vialo morate aktivirati z Vialmixom.
When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial. 
Če uporabljate iglo, mora biti zabodena tako, da disperzijo vlečete iz sredine tekočine v viali, obrnjeni na glavo.
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). 
Zdravilo Luminity se uporablja pri odraslih za jasnejše slikanje srčnih votlin, predvsem levega prekata, med ehokardiografijo (diagnostično preiskavo, pri kateri se slika srca pridobi z ultrazvokom).
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 
- če so vam povedali, da imate srčni spoj (šant), - če imate hudo bolezen srca ali pljuč ali če za dihanje potrebujete mehanično podporo, - če imate umetno srčno zaklopko, - če imate hujše akutno vnetje/sepso, - če je znano, da imate hiperaktivni koagulacijski sistem (težave s strjevanjem krvi) ali ponavljajočo se trombembolijo (krvne strdke),
- 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. 
- Disperzijo morate izvleči iz viale z brizgo, ki ima nameščeno sterilno iglo številka 18 do 20 ali sterilno nesilikonizirano mini-konico.
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. 
Pri podganah, ki so 1 mesec dobivale Zdravilo Luminity, so ugotovili z odmerkom povezano, reverzibilno perivaskularno in peribronhiolarno infiltracijo z eozinofilci, alveolarno kopičenje makrofagov ter povečanje velikosti in števila čašastih celic v pljučih.
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. 
Zdravilo Luminity boste dobili pred preiskavo z ultrazvokom ali med njo; dal vam ga bo zdravstveni delavec, npr. zdravnik, ki ima izkušnje s takšnimi preiskavami.
• increased sweating, 
• srbenje, • močnejše znojenje,
The ultrasonic properties of the product are very different from those of soft tissue and will generate strong echoes. 
Luminity se zelo razlikujejo od lastnosti mehkih tkiv in povzročijo močan odboj.
The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation. 
Zdravilo lahko reaktivirate do 48 ur po prvem aktiviranju in ga uporabite do 12 ur po drugem aktiviranju.
How to use Luminity 
Kako uporabljati zdravilo Luminity
Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest: 
Intravensko infundiranje z uporabo nelinearnega načina kontrastnega slikanja (mirovanje in obremenitev) ali osnovnih načinov slikanja v mirovanju:
This product must only be administered intravenously. 
To zdravilo se sme dajati samo intravensko.
Luminity is for diagnostic use only. 
Zdravilo Luminity je samo za diagnostične namene.
Luminity should only be administered to such patients after careful risk/benefit assessment. 
Pri teh bolnikih se sme zdravilo Luminity uporabljati le po skrbnem ovrednotenju razmerja med koristjo in tveganjem.
• loss of consiousness, 
• izguba zavesti,
Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance. 
Zdravilo Luminity je kontrastno sredstvo za ultrazvočne preiskave, ki vsebuje mikrosfere (drobne mehurčke) s plinom perflutren kot učinkovino.
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. 
V kliničnih študijah z zdravilom Luminity so bile uporabljene osnovne in nelinearne preiskovalne metode (“second harmonic”, “multipulse phase” in/ali “amplitude modulation”) pri čemer je bil uporabljen tako kontinuiran kot pulzirajoč signal.
The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied. 
Varnost zdravila Luminity ni raziskana pri bolnikih z desno-levimi, dvosmernimi ali prehodnimi desno-levimi srčnimi spoji (šanti).
• pain at the site of injection. 
• občutek vročine in • bolečina na mestu injiciranja.
Like all parenteral products, the vials must be inspected visually for particulates and vial integrity. 
Kot velja za vsa parenteralna zdravila, morate viale pred uporabo pregledati in preveriti glede delcev in nepoškodovanosti viale.
All lipids are metabolised to free fatty acids. 
Vsi lipidi se presnovijo v proste maščobne kisline.
Luminity is a gas and solvent for dispersion for injection or infusion. 
Zdravilo Luminity je plin in vehikel za disperzijo za injiciranje ali infundiranje.
What Luminity looks like and contents of the pack 
Izgled zdravila Luminity in vsebina pakiranja
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). 
Bolniki z nestabilnim kardiopulmonalnim stanjem Med izvajanjem kontrastne ehokardiografije ali v 30 minutah po uporabi zdravila Luminity so pri bolnikih, vključno z bolniki s hudo boleznijo srca in pljuč, poročali o pojavu hudih kardiopulmonalnih reakcij, tudi s smrtnimi izidi (glejte poglavje 4.8).
The dispersion should be given to you within 12 hours of activation (shaking). 
Disperzijo morate dobiti v 12 urah po aktiviranju (stresanju).