FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Det bør understreges, at stressekkokardiografi, ikke kun kan fremkalde en iskæmisk tilstand, men også stressorerne kan fremkalde forudsigelige dosisafhængige effekter på det kardiovaskulære system (fx stigning i hjertefrekvens, blodtryk og ventrikulær ektopisk aktivitet for dobutamin eller nedsat blodtryk for adenosion og dipyridamol) samt uforusigelige overfølsomhedsreaktioner.
English: After emptying the bladder, a saline solution will be introduced into the bladder via a thin tube.
Danish: Efter tømning af blæren vil der blive sprøjtet en saltvandsopløsning ind i blæren gennem en tynd slange.
English: SonoVue does not affect the ability to drive and use machines.
Danish: SonoVue påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The undesirable effects reported with SonoVue after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects.
Danish: De bivirkninger, der er indberettet ved brug af SonoVue efter intravenøs administration, var generelt set ikke alvorlige, forbigående og svandt spontant uden sequelae.
English: 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.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten.
English: 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).
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For at kunne evaluere SonoVues følsomhed og specificitet i forhold til detektion af vesikoureteral refluks og den deraf følgende indflydelse på patientbehandling skal indehaveren af markedsføringstilladelsen udføre et prospektivt observationskohortestudie (ifølge en aftalt protokol) og indsende resultaterne heraf
English: In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers without serious adverse events being reported.
Danish: I et fase I-studie blev der givet op til 52 mL SonoVue til raske forsøgspersoner, uden at der blev rapporteret om alvorlige bivirkninger.
English: Chest pain, pain, fatigue
Danish: Smerter i brystet, smerter, træthed
English: Chest discomfort, injection site reaction, feeling hot
Danish: Ubehag i brystet, reaktioner på injektionsstedet, varmefølelse
English: In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.
Danish: I kliniske studier er de mest almindelige bivirkninger efter intravenøs administration: hovedpine, reaktioner på injektionsstedet og kvalme.
English: Immediately following the first voiding, the bladder may be refilled with saline for a second cycle of voiding and imaging, without the need of a second SonoVue administration.
Danish: Umiddelbart efter den første tømning kan blæren fyldes med saltvand igen for at udføre endnu en cyklus med tømning og scanning uden behov for endnu en administration af SonoVue.
English: Shake vigorously for 20 seconds to mix all the contents in the vial to obtain a white milky homogeneous liquid.
Danish: Ryst kraftigt i 20 sekunder for at blande hele indholdet i hætteglasset, således at der fremkommer en hvid, mælkeagtig homogen væske.
English: decrease in blood pressure, breathlessness, loss of consciousness, cardiac/cardio-respiratory arrest or more severe reaction with difficulties in breathing and dizziness)
Danish: nedsat blodtryk, stakåndethed, bevidsthedstab, hjerte-/hjerte-lungestop eller en mere alvorlig reaktion med vejrtrækningsbesvær og svimmelhed).
English: A low mechanical index (≤ 0.4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.
Danish: Der anbefales et lavt mekanisk indeks (≤ 0,4) til scanning af blære, ureter og nyrer under ultralydsundersøgelse af urinvejene med kontrastmiddel.
English: Ultrasound imaging of the bladder and kidneys is performed during filling and voiding of the bladder.
Danish: Ultralydscanning af blæren og nyrerne udføres under fyldning og tømning af blæren.
English: If your are an adult SonoVue helps to obtain clearer ultrasound pictures of your heart, your blood vessels and/or tissues of the liver and breast.
Danish: Hos voksne anvendes SonoVue til at få et tydeligere ultralydsbillede af dit hjerte, dine blodkar og/eller væv i leveren og brystet.
English: 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
Danish: Ikke kendt (hyppigheden kan ikke fastlægges ud fra de tilgængelige data): - Bevidsthedstab, - I nogle tilfælde med allergiske reaktioner hos patienter med sygdom i hjertets blodkar, er der rapporteret om manglende iltforsyning til hjertet eller hjertestop.
English: It was therefore concluded that SonoVue is well tolerated in the urinary tract in the rat.
Danish: Det blev derfor konkluderet, at SonoVue er veltolereret i urinvejene hos rotter.
English: SonoVue has no or negligible influence on the ability to drive and use machines.
Danish: SonoVue påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: 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.
Danish: SonoVues sikkerhed og virkning hos patienter i alderen under 18 år er ikke klarlagt for intravenøs administration og anvendelse i forbindelse med ekkokardiografi og Doppler vaskular scanning.
English: It is not known if SonoVue passes into breast milk.
Danish: Det vides ikke, om SonoVue udskilles i mælken.
English: * Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock.
Danish: * Tilfælde, der tyder på overfølsomhed, kan omfatte: huderythema, bradykardi, hypotension, dyspnø, bevidsthedstab, hjerte/hjerte-lungestop, anafylaktisk reaktion, anafylaktisk shock.
English: Caecal lesions observed in some repeat-dose studies with rats, but not in monkeys, are not relevant for humans under normal conditions of administration.
Danish: Der blev fundet coecum læsioner i nogle rottestudier med gentagne doser, men ikke hos aber, og disse fund har ingen betydning ved normal anvendelse hos mennesker.
English: 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.
Danish: Ved anvendelsen af ekko-kontraststoffer i dyrestudier afsløres biologiske bivirkninger (f.eks. skade på endothel celler, kapillær ruptur) ved interaktion med ultralyds bølger.
English: Remove the protective disk from the vial.
Danish: Fjern beskyttelsesskiven fra hætteglasset.
English: SonoVue is a kit which includes a glass vial containing white powder, a glass syringe containing the solvent and a transfer system.
Danish: SonoVue er et sæt med et hætteglas af glas indeholdende hvidt pulver, en injektionssprøjte af glas indeholdende opløsningsvæske og et overføringssystem.
English: Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.
Danish: Efter administration af SonoVue fyldes blæren helt op med saltvand, indtil patienten får vandladningstrang, eller det første svage tegn på modtryk mod infusionen viser sig.
English: Paediatric Patients
Danish: Pædiatrisk population
English: Bracco International B.V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, The Netherlands
Danish: Bracco International B.V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, Holland
English: No clinical data on exposed pregnancies are available.
Danish: Der er ikke udført kliniske studier med gravide kvinder.
English: Use extreme caution when considering the administration of Sonvue in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders because in these patients allergy like and/or vasodilatory reactions may lead to life threatening conditions.
Danish: Udvis yderste forsigtighed, når det overvejes at give SonoVue til patienter med nyligt akut koronarsyndrom eller klinisk ustabil iskæmisk hjertesygdom, inklusive udvikling af eller igangværende myokardieinfarkt, typisk angina i hvile, indenfor de seneste 7 dage, signifikant forværring af hjertesymptomer indenfor de seneste 7 dage, nylig koronararterie-intervention eller andre faktorer, der tyder på klinisk ustabilitet (f.eks. nylig forværring i EKG, laboratoriemæssige eller kliniske fund), akut hjertesvigt, klasse III/IV-hjertesvigt eller alvorlige rytmeforstyrrelser, da allergilignende og/eller vasodilatoriske reaktioner kan føre til livstruende tilstande hos disse patienter.
English: dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Danish: dipalmitoylphosphatidylglycerolnatrium, palmitinsyre.
English: Paediatric population-Intravesical use
Danish: Pædiatrisk population - intravesikal anvendelse
English: No clinical data are available.
Danish: Fertilitet Der er ingen kliniske data.
English: For ultrasonography of the excretory urinary tract in paediatric patients, after intravesical administration, SonoVue increases the signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis, and facilitates the detection of reflux of fluid from the bladder into the ureters.
Danish: Til ultralydsundersøgelse af nyrer og urinveje hos pædiatriske patienter efter intravesikal administration øger SonoVue signalstyrken for væsker i uretra, blæren, uretere og pelvis og muliggør detektion af refluks af væske fra blæren ind i uretere.
English: SonoVue is then administered through the urinary catheter.
Danish: SonoVue administreres dernæst gennem blærekateteret.
English: Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
Danish: Lad hætteglasset glide ind i den gennemsigtige slæde i overføringssystemet og pres med at fast tryk for at sætte hætteglasset på plads.
English: Uncommon side effects (may affect up to 1 in 100 people): - Headache - Numbness - Dizziness - Strange taste in the mouth - Redness - Chest discomfort - Feeling sick (nausea) - Abdominal pain - Skin rash - Feeling hot - Local reactions where the injection was given such as: pain or an unusual sensation at the injection site
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - Hovedpine, - Følelsesløshed, - Svimmelhed, - Mærkelig smag i munden, - Rødme, - Brystgener, - Kvalme, - Mavesmerter, - Hududslæt, - Varmefølelse, - Lokale reaktioner, hvor injektionen blev givet, såsom: smerter eller en unormal følelse.
English: Other medicines and SonoVue
Danish: Brug af anden medicin sammen med SonoVue
English: For patients under 18 years of age SonoVue can be used only for ultrasound of the urinary tract.
Danish: Til patienter under 18 år kan SonoVue kun anvendes til ultralydsundersøgelse af urinvejene.
English: PHARMACEUTICAL FORM AND CONTENTS 1 powder vial, 1 pre-filled syringe of solvent, 1 transfer system
Danish: 1 hætteglas med pulver, 1 fyldt sprøjte med solvens, 1 overføringssystem
English: Each millilitre of SonoVue contains 8 µL of the microbubbles.
Danish: 1 mL SonoVue indeholder 8 µL mikrobobler.
English: Echocardiography
Danish: Ekkokardiografi
English: Doppler of microvasculature
Danish: Mikrovaskular Doppler
English: Caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease, as the numbers of patients with those conditions who were exposed to SonoVue in the clinical trials were limited.
Danish: Der tilrådes forsigtighed, når præparatet gives til patienter med: akut endocarditis, kunstige hjerteklapper, akut systemisk inflammation og/eller sepsis, hyperaktiv koagulations tilstand og/eller nylig thromboemboli og slut stadie af renal eller hepatisk sygdom, idet kun et begrænset antal patienter med disse tilstande har været eksponeret for SonoVue i de kliniske studier.
English: If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Danish: Hvis SonoVue ikke anvendes umiddelbart efter rekonstitution, skal dispersionen omrystes igen, inden den trækkes op i sprøjten.
English: If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Danish: Hvis SonoVue ikke bruges umiddelbart efter rekonstitution bør mikroboble dispersionen rystes igen, før den trækkes op i en injektionssprøjte.
English: SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.
Danish: SonoVue forbedrer fremstilling af vaskularisering af lever og bryst læsioner under Doppler sonografi hos voksne patienter, hvilket fører til en mere specifik karakterisering af læsioner.
English: SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux.
Danish: SonoVue er indiceret til anvendelse ved ultralydscanning af nyrer og urinveje hos pædiatriske patienter i alderen nyfødt til 18 år til detektion af vesikoureteral refluks.
English: SonoVue dispersion should be administered within six hours of its preparation.
Danish: SonoVue opløsningen vil blive givet inden for 6 timer efter tilberedelsen.
English: In particular, please tell your doctor if you are taking beta-blockers (medicines for heart disease and hypertension or for glaucoma in eye drops).
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du tager betablokkere (medicin mod hjertesygdom og højt blodtryk eller i øjendråber mod grøn stær).
English: No adverse reactions were reported.
Danish: Der er ikke indberettet nogen bivirkninger.
English: Invert the system and carefully withdraw SonoVue into the syringe.
Danish: Vend systemet om og træk forsigtigt SonoVue tilbage i sprøjten.
English: SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Doppler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients.
Danish: SonoVue skal injiceres umiddelbart i en perifer vene ved anvendelse til ekkokardiografi og ved Doppler vaskular scanning hos voksne eller ved intravesikal administration til anvendelse ved ultralydsundersøgelse af nyrer og urinveje hos pædiatriske patienter.
English: Unscrew the syringe from the transfer system.
Danish: Skru sprøjten af overføringssystemet.
English: - If you are allergic to sulphur hexafluoride or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for sulphurhexafluorid eller et af de øvrige indholdsstoffer i SonoVue
English: Doppler of macrovasculature
Danish: Makrovaskular Doppler
English: Nausea, Abdominal pain
Danish: Mave-tarm-kanalen Kvalme, abdominal smerte
English: Distearoylphosphatidylcholine Dipalmitoylphosphatidylglycerol Sodium Palmitic acid
Danish: Distearoylphosphatidylcholin Dipalmitoylphosphatidylglycerolnatrium Palmitinsyre
English: SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients.
Danish: SonoVue øger kvaliteten af Doppler scanning og varigheden af en klinisk anvendelig forstærkning af signalet ved undersøgelser af vena portae hos voksne patienter.
English: SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.
Danish: SonoVue øger nøjagtigheden, hvormed man kan detektere eller udelukke abnormiteter i hjernens blodkar og extrakraniel carotis eller perifere arterier hos voksne patienter ved at accentuere Doppler signal støjforholdet.
English: Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a flip-off disc. A transfer system ( MiniSpike ).
Danish: Farveløst hætteglas af type I glas med 25 mg tørt, frysetørret pulver i en atmosfære af sulphurhexafluorid med en grå butylgummiprop med en krympeforsegling af aluminium med en afrivningshætte.
English: SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
Danish: SonoVue er et transpulmonært ekkokardiografisk kontrastmiddel til voksne patienter med formodet eller kendt kardiovaskulær sygdom for at give ekkografisk skygge af hjertekamrene og forstærke aftegningen af venstre ventrikels endokardie.
English: 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,
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): - Sløret syn, - Blodtryksfald, - Kløe, - Rygsmerter, - Almene smerter, - Brystsmerter, - Træthed, - Alvorlige eller mindre alvorlige allergiske reaktioner (herunder rødmen, nedsat hjerterytme,
English: SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
Danish: SonoVue bør indgives umiddelbart efter, det er trukket op i sprøjten, i en perifer vene.
English: PHARMACEUTICAL FORM Powder and solvent for dispersion for injection.
Danish: Pulver og solvens til injektionsvæske, dispersion.
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Marketing authorisation holder Bracco International B.V.
Danish: Bracco International B.V.
English: SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.
Danish: SonoVue bruges i forbindelse med ultralyd scanning for at accentuere ekko fra blod eller fra væske i urinvejene, hvilket giver et bedre signal støjforhold.
English: Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Hver injektion bør efterfølges af en skyllestrøm med 5 mL natriumchlorid 9 mg/mL (0,9%) injektionsvæske.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2001
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Adverse Drug Reactions Frequency Category
Danish: Bivirkninger Hyppighed
English: METHOD OF ADMINISTRATION Intravenous or intravesical use
Danish: Intravenøs eller intravesikal anvendelse.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the dispersion contains 8 µL sulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Danish: Hver mL af dispersionen indeholder 8 µL sulphurhexafluorid mikrobobler, svarende til 45 mikrogram.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER INJEKTIONSSPRØJTE
English: Empty the contents of the syringe into the vial by pushing on the plunger rod.
Danish: Tøm indholdet af sprøjten ned i hætteglasset ved at trykke på stempelstangen.
English: MARKETING AUTHORISATION HOLDER
Danish: MARKEDSFØRINGSTILLADELSESNUMMER
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER FOR BATCHFRIGIVELSE
English: SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial.
Danish: SonoVue skal fremstilles før brug ved at tilsætte 5 mL af natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning til indholdet i hætteglasset ved injektion gennem membranen.
English: If you are given more SonoVue than you should
Danish: Hvis du har fået for meget SonoVue
English: Final study report to be submitted by 2Q 2020
Danish: Endelig studierapport skal indsendes senest
English: Adult population-Intravenous use
Danish: Voksne - intravenøs anvendelse
English: Ultrasonography of excretory urinary tract
Danish: Ultralydscanning af nyrer og urinveje
English: 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)
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
English: There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.The addition of sodium chloride 9 mg/mL (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
Danish: Tilsætning af natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning til det frysetørrede pulver efterfulgt af kraftig rystning resulterer i dannelse af mikrobobler bestående af sulphurhexafluorid.
English: Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Solvens: Natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning
English: For the limitation in the interpretation of a negative urosonography, see section 4.4. and 5.1.
Danish: For oplysninger om begrænsninger ved fortolkning af negativ ultralydscanning af urinvejene, se pkt.
English: How SonoVue is given
Danish: Sådan bliver SonoVue indgivet
English: - If you have further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride
Danish: SonoVue 8 mikroliter/mL pulver og solvens til injektionsvæske, dispersion sulphurhexafluorid
English: Open the MiniSpike transfer system blister and remove syringe tip cap. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Danish: Åbn blisteren med MiniSpike overføringssystemet og fjern beskyttelseshætten på spidsen af sprøjten.
English: NL - 1077 ZX Amsterdam The Netherlands
Danish: Strawinskylaan 3051 NL - 1077 ZX Amsterdam Holland
English: This leaflet was last revised on
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: What you need to know before you are given SonoVue
Danish: Det skal du vide, før du begynder at bruge SonoVue Du må ikke få SonoVue: