natgillin/translations-raw huggingface dataset:
The efficacy of SonoVue for detection/exclusion of vesicoureteral reflux was studied in two published open label single centre studies. 
Učinkovitost zdravila SonoVue za odkrivanje/izključitev vezikoureternega refluksa je bila proučevana v dveh objavljenih odprtih enocentričnih kliničnih študijah.
Do not use if the liquid obtained is clear and/or if solid parts of the lyophilisate are seen in the suspension. 
Ne uporabljajte disperzije, če je nastala tekočina jasna in/ali če so v njej vidni trdi delci liofilizata.
Remove the protective disk from the vial. 
Z viale odstranite zaščitno ploščico.
Most of the side effects to SonoVue are rare and usually not serious. 
Večina neželenih učinkov na zdravilo SonoVue je redkih, običajno pa niso resni.
The microbubbles have a mean diameter of about 2.5 µm, with 90% having a diameter less than 6 µm and 99% having a diameter less than 11 µm. 
Mikromehurčki imajo povprečni premer okrog 2,5 µm, pri tem ima 90% premer manjši od 6 µm in 99% premer manjši od 11 µm.
The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. 
Varnost zdravila SonoVue po intravenski uporabi so ocenili pri 4653odraslih bolnikih, vključenih v 58 kliničnih preskušanjih.
SonoVue should only be administered to such patients after careful risk/benefit assessment and a closely monitoring of vital signs should be performed during and after administration. 
Pri teh bolnikih se sme zdravilo SonoVue lahko uporabljati le po temeljiti oceni tveganja/koristi in ob pozornem spremljanju vitalnih znakov med in po uporabi.
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstrukciji zdravila, glejte poglavje 6.3.
In one study including 183 patients (366 kidney-ureter units), SonoVue ultrasound was correctly positive in 89 out 103 units with reflux and correctly negative in 226 out of 263 units without reflux. 
V eni študiji, ki vključuje 183 bolnikov (366 enot ledvica-sečevod), je bil ultrazvok s SonoVue pravilno pozitiven v 89 od 103 enot z refluksom in pravilno negativen pri 226 od 263 enot brez refluksa.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user. 
Če pripravka ne uporabimo takoj, je uporabnik odgovoren za način in pogoje njegovega shranjevanja pred uporabo.
** In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported. 
** Pri nekaterih primerih preobčutljivosti, pri bolnikih z osnovno boleznijo koronarnih arterij, so poročali tudi o miokardni ishemiji in/ali miokardnemu infarktu.
4.6 Pregnancy, lactation, and fertility 
4.6 Nosečnost, dojenje in plodnost
What you need to know before you are given SonoVue 
Kaj morate vedeti, preden boste prejeli zdravilo SonoVue
Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours. 
Kemijska in fizikalna obstojnost disperzije mikromehurčkov je 6 ur.
Post-authorisation efficacy study (PAES): In order to further evaluate the sensitivity and specificity of SonoVue to detect vesicoureteral reflux through its impact on patient's management, the MAH should conduct and submit the results of a prospective observational cohort study (according to an agreed protocol). 
Študija o učinkovitosti zdravila po pridobitvi dovoljenja za promet (PAES): Da bi se še dodatno ocenilo učinkovitost in specifičnost zdravila SonoVue za odkrivanje vezikoureternega refluksa preko njegovega vpliva na vodenje zdravljenja pacienta, bo imetnik dovoljenja izvajal in oddal izide prospektivne opazovalne kohortne študije (na podlagi sprejetega protokola).
It is not known if SonoVue passes into breast milk. 
Ni znano, ali zdravilo SonoVue prehaja v materino mleko.
In the second study including 228 patients (463 kidney-ureter units), SonoVue ultrasound was correctly positive in 57 out of 71 units with reflux and correctly negative in 302 out of 392 units without reflux. 
V drugi študiji, ki vključuje 228 bolnikov (463 enot ledvica-sečevod), je bil ultrazvok z zdravilom SonoVue pravilno pozitiven pri 57 od 71 enot z refluksom in pravilno negativen pri 302 od 392 enot brez refluksa.
If you are given SonoVue together with a medicine, exercise or a device that stimulates the heart in order to visualise your heart under stress work, your heart activity, your blood pressure and rhythm will be monitored. 
Če ste prejeli zdravilo SonoVue skupaj z zdravilom, vajo ali napravo, ki stimulira srce za vizualizacijo delovanja vašega srca pod obremenitvijo, je treba spremljati dejavnost vašega srca, vaš krvni tlak in ritem srca.
SonoVue is given to you by medical or healthcare professionals who are experienced in this type of examination. 
Zdravilo SonoVue vam bo dal medicinski ali zdravstveni delavec, ki ima izkušnje s pregledi te vrste.
After a single intravenous injection of 0.03 or 0.3 mL of SonoVue/kg (approximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly. 
Po enkratnem intravenskem injiciranju 0,03 ali 0,3 ml zdravila SonoVue/kg (približno 1 do 10 kratnik maksimalnega kliničnega odmerka) prostovoljcem, se je žveplov heksafluorid hitro izločil.
Please tell your doctor if in the past 2 days you have: - had frequent and/or repeated angina or chest pain, especially if you have history of heart disease, - had recent electrocardiography changes. 
Povejte svojemu zdravniku, če ste imeli v preteklih 2 dneh: - pogosto in/ali ponavljajočo se angino ali bolečine v prsih, zlasti če imate anamnezo bolezni srca, - nedavno poslabšanje v ehokardiogramu.
It should be emphasised that stress echocardiography not only can induce an ischaemic episode but also the stressors may induce predictable, dose-dependent effects on the cardiovascular system (e.g., increase in heart rate, blood pressure and ventricular ectopic activity for dobutamine, or decrease in blood pressure for adenosine and dipyridamole) as well as unpredictable, hypersensitivity reactions. 
Potrebno je poudariti, da ne samo da lahko obremenitveno testiranje srca povzroči ishemične epizode, ampak lahko tudi stresorji povzročijo predvidljive, od odmerka odvisne učinke na kardiovaskularni sistem (npr. povečanje srčnega utripa, krvnega tlaka in ventrikularne ektopične aktivnosti pri dobutaminu ali znižanje krvnega tlaka pri adenozinu in dipiridamolu), kot tudi nepredvidljive, preobčutljivostne reakcije.
decrease in blood pressure, breathlessness, loss of consciousness, cardiac/cardio-respiratory arrest or more severe reaction with difficulties in breathing and dizziness) 
znižanjem krvnega tlaka, oteženim dihanjem, izgubo zavesti, srčnim/kardio-respiratornim zastojem ali hujšo reakcijo s težavami z dihanjem in omotico).
Other medicines and SonoVue 
Druga zdravila in zdravilo SonoVue
What SonoVue is and what it is used for 
Kaj je zdravilo SonoVue in za kaj ga uporabljamo
Final study report to be submitted by 2Q 2020 
Oddaja Končnega poročila Drugo četrtletje 2020
No clinical data are available. 
Plodnost Klinični podatki niso na razpolago.
Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions. 
Žveplov heksafluorid je inerten, neškodljiv plin, slabo topen v vodnih raztopinah.
It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue. 
Priporočljivo je, da je bolnik pod strogim zdravniškim nadzorom med in še vsaj 30 minut po prejetju zdravila SonoVue.
• In paediatric patients the recommended dose of SonoVue is 1mL. 
• pri pediatričnih bolnikih je priporočen odmerek zdravila SonoVue 1 ml. Način uporabe
A single-dose study and a repeat-dose study, both followed by a treatment-free period, were performed in female rats with local toxicity evaluated through macroscopic and histopathological examination of both kidneys, ureters, the urinary bladder and urethra. 
Študiji z enim odmerkom in študiji z večkratnimi odmerki, katerima je sledilo obdobje brez zdravljenja, sta bili izvedeni na podganjih samicah, pri katerih je bila lokalna toksičnost ocenjena na podlagi makroskopskih in histopatoloških preiskav obeh ledvic, sečevodov, sečnega mehurja in uretre.
- The active substance is sulphur hexafluoride in the form of microbubbles. 
- Zdravilna učinkovina je žveplov heksafluorid v obliki mikromehurčkov.
For ultrasound scan of heart or your blood vessels and/or tissues of the liver and breast in adults:the dose to be administered into a vein will be calculated for you depending on which part of your body is being examined. 
Ultrazvok srca ali krvnih žil in/ali tkiva jeter in dojk pri odraslih: odmerek, ki se ga daje v veno bo za vas izračunan na podlagi dela telesa, ki bo pregledan.
Reconstitution instructions: 
Navodilo za rekonstitucijo:
SonoVue is for diagnostic use only. 
Zdravilo SonoVue je samo za diagnostične namene.
Shake vigorously for 20 seconds to mix all the contents in the vial to obtain a white milky homogeneous liquid. 
Močno stresajte 20 sekund, da se vsebina viale premeša in nastane mlečna, homogena tekočina.
• B-mode imaging of cardiac chambers, at rest or with stress: 2 mL. 
• preiskava srčnih prekatov način-B, pri mirovanju ali pri obremenitvi: 2 ml,
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
After reconstitution, SonoVue is a homogeneous white milky dispersion. 
Po rekonstituciji je zdravilo SonoVue homogena belomlečna disperzija.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 25 mg powder 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 25 mg praška
The undesirable effects reported with SonoVue after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects. 
Neželeni učinki, poročani pri zdravilu SonoVue po intravenski aplikaciji, so bili na splošno neresni, prehodni in so izginili spontano brez učinkov.
The sulphur hexafluoride dissolves in the blood and is subsequently exhaled. 
Žveplov heksafluorid se raztopi v krvi in se pozneje izloči v izdihanem zraku.
SonoVue does not affect the ability to drive and use machines. 
Zdravilo SonoVue ne vpliva na sposobnost vožnje in upravljanja s stroji.
The safety and efficacy of SonoVue in patients under 18 years of age has not been established for intravenous administration and use in echocardiography and vascular Doppler imaging. 
Varnost in učinkovitost zdravila SonoVue pri bolnikih mlajših od 18 let ni bila ugotovljena za intravensko uporabo in uporabo pri ehokardiografskem in vaskularnem dopplerskem slikanju.
SonoVue must not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated. 
Zdravilo SonoVue se ne sme uporabljati v kombinaciji z dobutaminom pri bolnikih, ki kažejo na kardiovaskularno nestabilnost, kjer je dobutamin kontraindiciran.
At the proposed clinical doses for intravenous administration, SonoVue has been shown to provide marked increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature. 
Pri predlaganih kliničnih odmerkih za intravensko uporabo izkazuje zdravilo SonoVue znaten porast jakosti signala za več kot 2 minuti pri ehokardiografiji z B-načinom slikanja in za 3 do 8 minut pri dopplerskem slikanju velikih žil in mikrovaskularizacije.
Not known (frequency cannot be estimated from the available data): - Faintness - In some of the cases of allergic reactions, in patients with cardiac blood vessel disease, lack of oxygen supply of the heart or cardiac arrest were reported - Vomiting 
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - omedlevica, - pri nekaterih primerih alergijskih reakcij, pri bolnikih s koronarno srčno boleznijo so poročali tudi o slabi oskrbi srca s kisikom ali srčnemu infarktu, - bruhanje.
The product is for a single examination only. 
Zdravilo je namenjeno za uporabo pri samo enem pregledu.
The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows: 
Nato vialo močno stresajte 20 sekund, nato pa z injekcijsko brizgo odvzemite želeni volumen disperzije po sledečem postopku:
In particular, please tell your doctor if you are taking beta-blockers (medicines for heart disease and hypertension or for glaucoma in eye drops). 
Zlasti obvestite zdravnika, če jemljete zaviralce adrenergičnih receptorjev beta (zdravila za bolezni srca in hipertenzijo ali za glavkom v kapljicah za oči).
After introduction of a sterile 6F-8F urinary catheter into the bladder under sterile conditions, the bladder is emptied of urine and then filled with saline (normal sterile 0.9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL. 
Po vstavitvi sterilnega 6F-8F urinskega katetra v mehur pod sterilnimi pogoji, se mehur izprazni in nato napolni s fiziološko raztopino (normalno sterilno 0,9 % raztopino natrijevega klorida) do približno ene tretjine ali polovice predvidenega celotnega volumna [(starost v letih + 2) x 30] ml. Nato se zdravilo SonoVue aplicira preko urinskega katetra.
SonoVue has no or negligible influence on the ability to drive and use machines. 
Zdravilo SonoVue nima vpliva ali ima zanemarljivi vpliv na sposobnost vožnje in upravljanja s stroji.
In animal studies, the application of echo-contrast agents revealed biological adverse reactions (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. 
Študije na živalih so pokazale, da je aplikacija eho-kontrastnega sredstva privedla do bioloških neželenih reakcij (npr. poškodba endotelijskih celic, ruptura kapilar) pri interakciji z ultrazvočnimi valovi.
The safety of SonoVue after intravesical administration was based on evaluation of published literature involving use of SonoVue in over 6000 paediatric patients (age range 2 days to 18 years). 
Varnost zdravila SonoVue po intravezikalni uporabi temelji na oceni objavljene literature, ki vključuje uporabo zdravila SonoVue pri več kot 6000 pediatričnih bolnikih (starih od 2 dni do 18 let).
Once reconstituted, chemical and physical stability has been demonstrated for 6 hours. 
Ko je kontrastno sredstvo pripravljeno, je njegova kemijska in fizikalna obstojnost 6 ur.
The total amount of sulphur hexafluoride administered in a clinical dose is extremely small, (in a 2 mL dose the microbubbles contain 16 µl of gas). 
Celokupna količina žveplovega heksafluorida v kliničnem odmerku je izredno majhna (2 ml odmerek vsebuje 16 µl plina v obliki mikromehurčkov).
Clear, colourless solvent 
Bister, brezbarven vehikel
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, to v bistvu pomeni 'brez natrija'.
Tell your doctor straight away if you notice any of the following side effects, you may need medical treatment: swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe; skin rash; hives; swelling of the hands, feet or ankles. 
Takoj obvestite zdravnika, če opazite katerega od naslednjih neželenih učinkov, saj boste morda potrebovali zdravljenje: - otekanje obraza, ustnic, ust ali žrela, kar lahko oteži požiranje ali dihanje, kožni izpuščaj,
Method of administration For instructions on reconstitution of the medicinal product before administration see section 6.6 . 
Za navodila o rekonstrukciji zdravila pred uporabo glejte poglavje 6.6.
SonoVue dispersion should be administered within six hours of its preparation. 
Disperzijo zdravila SonoVue je treba porabiti v roku šestih ur po pripravi.
SonoVue should only be used in patients where study without contrast enhancement is inconclusive. 
Zdravilo SonoVue lahko uporabljamo samo pri bolnikih, kjer je preiskava brez kontrastnega sredstva neuspešna.
Powder: 
Prašek:
Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the label. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
If you have a serious pulmonary or cardiac condition you will be under close medical supervision during and for at least 30 minutes after the injection of SonoVue. 
Če imate hudo pljučno ali srčno stanje, boste med injiciranjem zdravila SonoVue in vsaj 30 minut po njem pod strogim zdravniškim nadzorom.
Therefore, if SonoVue is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days. 
Če se zdravilo SonoVue uporablja v povezavi z obremenitvenim testiranjem srca, morajo biti bolniki v preteklih dveh dneh v stabilnem stanju; s preverjeno odsotnostjo bolečine v prsnem košu ali brez EKG sprememb.
Myocardial infarction** Myocardial ischemia** 
Srčne bolezni miokardni infarkt** miokardna ishemija**
Doppler of microvasculature 
Doppler mikrovaskularizacije
Each millilitre of SonoVue contains 8 µL of the microbubbles. 
En mililiter zdravila SonoVue vsebuje 8 µl mikromehurčkov.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous or intravesical use Read the package leaflet before use. 
POSTOPEK IN POT UPORABE ZDRAVILA Intravenska ali intravezikalna uporaba Pred uporabo preberite priloženo navodilo.
Use caution when treating anaphylaxis with epinephrine in patients on beta blockers since response may be poor or promote undesired alpha-adrenergic and vagotonic effects (hypertension, bradycardia). 
Bodite previdni pri zdravljenju anafilaksije z adrenalinom pri bolnikih, ki jemljejo antagoniste adrenergičnih receptorjev beta, saj je odziv lahko slab ali pospeši alfa-adrenergične in vagotonične učinke (hipertenzija, bradikardija).
The filling and emptying of the bladder with saline solution may be repeated if needed. 
Polnjenje in praznjenje mehurja s fiziološko raztopino, se lahko po potrebi ponovi.
* Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock. 
* Primeri, ki kažejo na preobčutljivost, lahko vključujejo: kožni eritem, bradikardija, hipotenzija, težko dihanje, izguba zavesti, srčni/kardio-respiratorni zastoj, anafilaktične reakcije, anafilaktični šok.
In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue. 
V zelo redkih primerih so bili zabeleženi smrtni izidi ob dajanju zdravila SonoVue.
In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers without serious adverse events being reported. 
V fazi I kliničnega preskušanja so zdravi prostovoljci prejeli do 52 ml zdravila SonoVue in niso poročali o resnih neželenih učinkih.
PHARMACEUTICAL FORM AND CONTENTS 1 powder vial, 1 pre-filled syringe of solvent, 1 transfer system 
FARMACEVTSKA OBLIKA IN VSEBNOST 1 viala s praškom, 1 napolnjena injekcijska brizga z vehiklom, sistem za prenos.
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) 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le na recept s posebnim režimom (Glej Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Ultrasound imaging of the bladder and kidneys is performed during filling and voiding of the bladder. 
Ultrazvok mehurja in ledvic se izvaja med polnjenjem in praznjenjem mehurja.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu . 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid, Solvent: sodium chloride 9 mg/mL 
Makrogol 4000, distearilfosfatidilholin, natrijev fosfatidilglicerildipalmitat, palmitinska kislina Vehikel: 9 mg/ml raztopina natrijevega klorida
Rare (may affect up 1 in 1,000 people): - Blurred vision - Decrease in blood pressure - Itching - Back pain - Pain in general - Chest pain - Fatigue - Severe and less severe allergic reaction (including redness of the skin, decrease in heart rate, 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 ljudi): - zamegljen vid, - znižanje krvnega tlaka, - srbenje, - bolečina v hrbtu, - splošna bolečina, - bolečina v prsnem košu, - utrujenost, - hude in manj hude alergijske reakcije (vključno s pordelo kožo, znižanjem srčnega utripa,
METHOD OF ADMINISTRATION Intravenous or intravesical use 
POSTOPEK UPORABE Intravenska ali intravezikalna uporaba.
Talk to your doctor before you are given SonoVue if: - you had a recent myocardial infarction or a recent surgery on your coronary arteries, - you suffer from angina or chest pain or severe cardiac disease, - you suffer from severe heart rhythm disorders, - your cardiac disease has worsened recently, - you have an acute inflammation of the cardiac envelope (endocarditis), - you have artificial heart valves, - you have an acute general inflammation or infection, - you have known blood clotting problem, - you have severe kidney or liver diseases, 
Preden prejmete zdravilo SonoVue, se pogovorite z zdravnikom, če: - ste imeli nedavno miokardni infarkt ali kirurški poseg na koronarnih arterijah, - imate angino ali bolečine v prsih ali hudo srčno bolezen, - trpite za hudimi motnjami srčnega ritma, - se je vaša srčna bolezen v zadnjem času poslabšala, - imate akutno vnetje srčne ovojnice (endokarditis), - imate umetne srčne zaklopke, - imate akutno sistemsko vnetje ali okužbo, - imate znano težavo s strjevanjem krvi, - imate hudo bolezen ledvic ali jeter,
The MAH shall complete, within the stated timeframe, the below measures: 
Imetnik dovoljenja za promet bo izvedel sledeče ukrepe v predvidenem roku:
SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. 
Zdravilo SonoVue je indicirano za uporabo pri ultrazvoku sečnih izvodil pri pediatričnih bolnikih od novorojenčka do 18. leta, za odkrivanje vezikoureternega refluksa.
What SonoVue is and what it is used for What you need to know before you are given SonoVue How SonoVue is given 
Kaj je zdravilo SonoVue in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo SonoVue Kako uporabljati zdravilo SonoVue Možni neželeni učinki
SonoVue is an ultrasound contrast agent that contains tiny bubbles filled with a gas called sulphur hexafluoride. 
Zdravilo SonoVue je kontrastno sredstvo za ultrazvočni pregled, ki vsebuje drobne mehurčke, napolnjene s plinom, imenovanim žveplov heksafluorid.