FrancophonIA/ELRC3.0 huggingface dataset:
English: The ultrasonic properties of the product are very different from those of soft tissue and will generate strong echoes.
Danish: Produktets ultrasoniske egenskaber er meget forskellige fra bløddelsvævs egenskaber og vil generere stærke ekkoer.
English: In addition, some patients may experience convulsions, which may be associated with these allergic reactions.
Danish: Derudover kan nogle patienter opleve kramper, som kan forbindes med disse allergiske reaktioner.
English: • altered heart rate, palpitations (you feel your heart beats harder or in an irregular way),
Danish: • Ændret hjerteslag, hjertebanken (dit hjerte banker hårdere eller uregelmæssigt)
English: Tell your doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Luminity should only be administered to such patients after careful risk/benefit assessment.
Danish: Luminity skal kun administreres til disse patienter efter omhyggelig afvejning af risici/fordele.
English: Patients with unstable cardiopulmonary status
Danish: Patienter med ustabil kardiopulmonal status
English: 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).
Danish: til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000) ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Heart or breathing problems including cardiac arrest have occurred in some patients.
Danish: Der er forekommet hjerte- og åndedrætsproblemer, herunder hjertestop, hos nogle patienter.
English: EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial
Danish: EU/1/06/361/001 4 enkeltdosis-hætteglas EU/1/06/361/002 1enkeltdosis-hætteglas
English: The product should be used immediately after its withdrawal from the vial.
Danish: Produktet skal anvendes straks efter det er trukket op fra hætteglasset.
English: Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions, which might require resuscitation.
Danish: Patienter skal monitoreres omhyggeligt og administration skal ske under ledelse af en læge, der har erfaring i behandling af overfølsomhedsreaktioner inklusive allergiske reaktioner, som kan kræve genoplivning.
English: Emergency equipment and personnel trained in its use must be readily available.
Danish: Genoplivningsudstyr og personale, der er trænet i dets anvendelse, skal være umiddelbart tilgængeligt.
English: The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Danish: Tid til maksimal intensitet af Doppler-signal tmax vistes at svare til perflutren blod, tmax (1,13 versus 1,77 minutter).
English: Luminity should not be used in children and adolescents (under 18 years of age) as it has not been studied in these groups
Danish: Luminity må ikke bruges til børn eller unge (under 18 år), fordi Luminitys virkning på disse aldersgrupper er ikke undersøgt.
English: Some patients may experience allergic type reactions such as swelling of the face.
Danish: Nogle patienter kan opleve allergilignende reaktioner, som f.eks. hævet ansigt.
English: The way Luminity is given and the dose depend on the technique used for the echocardiography.
Danish: Dosis og den måde, Luminity gives på, afhænger af den teknik, der bruges til ekkokardiografien.
English: Luminity is for intravenous use (direct injection into the vein).
Danish: Luminity er til intravenøs anvendelse (direkte indsprøjtning i en vene).
English: Higher doses of the product, typically ≥ 1 ml/kg, resulted in more severe signs including unresponsiveness and occasionally death.
Danish: Højere doser, typisk ≥ 1 ml/kg, resulterede i sværere tegn, inklusiv passivitet og i visse tilfælde død.
English: In some cases, your doctor may choose to use two injections to complete the ultrasound examination.
Danish: Lægen kan undertiden vælge at give to indsprøjtninger i forbindelse med ultralydsundersøgelsen.
English: It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests).
Danish: Det er et kontraststof (et lægemiddel, der gør kroppens indre nemmere at se i forbindelse med billedundersøgelser).
English: It is not known whether Luminity is excreted in human breast milk.
Danish: Det vides ikke, om Luminity udskilles i modermælk.
English: In clinical trials these reactions were reported rarely and for post-marketing reports the frequency is not known.
Danish: Disse bivirkninger blev indberettet sjældent i kliniske forsøg, og hyppigheden kendes ikke i forbindelse med rapporter efter markedsføring.
English: Doppler signal intensity corresponded well with measured and extrapolated perflutren concentrations in blood.
Danish: Doppler-signalets intensitet svarede godt overens med de målte og ekstrapolerede perflutrenkoncentrationer i blodet.
English: Rare: Abnormal electrocardiogram
Danish: Sjælden: Abnormt elektrokardiogram
English: If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor.
Danish: Hvis du tidligere har haft en allergisk reaktion, efter at du har fået Luminity eller et andet kontraststof til ultralydsundersøgelser, skal du fortælle det til din læge.
English: Luminity has no effect on the ability to drive and use machines.
Danish: Luminity påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: • altered taste,
Danish: • Ændret smagssans
English: Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Danish: Luminity er et kontraststof til ultralydsundersøgelser, som indeholder mikrosfærer (bittesmå bobler) af perflutrengas som det aktive stof.
English: The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Danish: De hyppigst indberettede bivirkninger er: hovedpine (2,0 %), rødme (1,0 %) og rygsmerter (0,9 %).
English: The safety of Luminity in patients with right-to-left, bi-directional or transient right-to-left cardiac shunts has not been studied.
Danish: Luminitys sikkerhed hos patienter med højre-til-venstre, dobbeltsidig eller transitorisk højre-til-venstre hjerteshunt er ikke undersøgt.
English: No air should be injected into the vial.
Danish: Der må ikke lukkes luft ind i hætteglasset.
English: Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren.
Danish: Der er udført Doppler-ultralydsmålinger med Luminity i forbindelse med den farmakokinetiske evaluering af perflutren.
English: 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.
Danish: Hvis Luminity administreres direkte til patienten uden den mekaniske aktiveringsprocedure ved hjælp af Vialmixeren (se afsnit 6.6), vil produktet ikke have den forventede effekt.
English: Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established.
Danish: Luminity bør ikke anvendes med grundlæggende billeddiagnostiske teknikker til stressekkokardiografi eftersom virkning og sikkerhed er ikke undersøgt.
English: Luminity contains sodium.
Danish: Luminity indeholder natrium.
English: As Luminity consists of microspheres that are stable and small enough for transpulmonary passage, enhanced echo signals in the left heart and systemic circulation are obtained.
Danish: Da Luminity består af mikrosfærer, der er stabile og små nok til transpulmonær passage, forstærkes ekkosignaler i venstre hjertehalvdel og det systemiske kredsløb.
English: These results suggest that overall perflutren systemic elimination is rapid and is not significantly reduced in COPD patients compared to healthy subjects.
Danish: Disse resultater tyder på, at den overordnede systemiske elimination af perflutren er hurtig og ikke betydeligt reduceret hos KOL-patienter sammenlignet med raske frivillige.
English: The product consists of lipid encapsulated perflutren microspheres.
Danish: Produktet består af lipidindkapslede perflutrenmikrosfærer.
English: Pack sizes of 1 or 4 vials.
Danish: Pakningsstørrelser: 1 eller 4 hætteglas.
English: The Vialmix is not included in the Luminity pack but will be provided to healthcare professionals upon ordering the pack.
Danish: Vialmixeren er ikke inkluderet i Luminity-pakken, men leveres til lægen ved bestilling af pakken.
English: Immediately after activation, Luminity appears as a milky white dispersion.
Danish: Umiddelbart efter aktivering vil Luminity fremstå som en mælket, hvid dispersion.
English: Not known: Abnormal vision
Danish: Ikke kendt: Unormalt syn
English: What you need to know before you use Luminity Do not use Luminity
Danish: Det skal du vide, før du begynder at bruge luminity Du må ikke få Luminity
English: In these patients, phospholipid encapsulated microspheres can bypass the lung and directly enter the arterial circulation.
Danish: Hos disse patienter kan fosfolipidindkapslede mikrosfærer gå uden om lungerne og direkte i det arterielle kredsløb.
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Danish: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Irland
English: For such patients monitoring should include vital sign measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation.
Danish: Hos disse patienter skal overvågningen inkludere måling af vitale parametre, elektrokardiografi og - hvis klinisk relevant - kutan oxygenmætning.
English: The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Danish: Bivirkninger indberettet i hovedforsøgene og de understøttende forsøg (i alt 2526 patienter) efter brug af Luminity er opstået indenfor minutter efter administration og er sædvanligvis svundne uden terapeutisk intervention indenfor 15 minutter..
English: The safety and efficacy of Luminity in children and adolescents below 18 years have not been established.
Danish: Luminitys sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Use in this patient group should be on the basis of a benefit risk assessment by the physician.
Danish: Anvendelse til denne patientgruppe bør ske på basis af en læges vurdering af benefit/risk-forholdet.
English: Single doses of up to 100 microlitres dispersion/kg and multiple doses up to 150 microlitres dispersion/kg were tolerated well in Phase I clinical trials.
Danish: Enkeltdoser på op til 100 mikroliter dispersion/kg og gentagne doser på op til 150 mikroliter dispersion/kg har været veltolererede i kliniske Fase I forsøg.
English: • reduced blood pressure,
Danish: • Lavt blodtryk
English: Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.
Danish: Der bør udvises forsigtighed hos patienter med klinisk signifikant lungesygdom, inklusive diffus interstitiel lungefibrose og svær kronisk obstruktiv lungesygdom, eftersom der har ikke været udført studier med disse patienter.
English: This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
Danish: Dette lægemiddel indeholder 103,5 mg/ml propylenglycol, hvilket svarer til 182,2 mg i hvert hætteglas.
English: Store in a refrigerator (2°C - 8°C) For storage conditions after activation of the medicinal product, see section 6.3.
Danish: Opbevares i køleskab (2°C - 8°C) Opbevaringsforhold efter aktivering af lægemidlet, se pkt.
English: These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Disse virkninger sås ved optagelsesniveauer ud over den maksimale humane optagelse, og er ikke relevant for klinisk brug.
English: Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, fertility, embryo/foetal development, parturition or post-natal development, and local tolerance.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af genotoksicitet, fertilitet, embryo-/føtaludvikling, fødsel eller post-natal udvikling samt lokal tolerance.
English: 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.
Danish: NB: hvis produktet står længere end 5 minutter efter aktivering, skal det genopløses ved at rystes 10 sekunder i hånden, inden det trækkes fra hætteglasset op i sprøjten.
English: Luminity is for diagnostic use only.
Danish: Luminity er til diagnostisk brug.
English: The perflutren component of Luminity was rapidly cleared from the systemic circulation via the lungs.
Danish: Luminitys perflutren-bestanddel clearedes hurtigt fra det systemiske kredsløb via lungerne.
English: 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.
Danish: Ultralydsekkoer fra blod og biologiske bløddelsvæv, fx fedt og muskler, genereres på grund af små forskelle i vævenes ultrasoniske egenskaber ved grænsefladerne.
English: When using a needle, it should be positioned to withdraw the material from the middle of the liquid in the inverted vial.
Danish: Hvis der anvendes nål, skal den placeres således at materialet trækkes fra midten af hætteglasset, der er vendt om.
English: For perflutren, no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for perflutren under graviditet.
English: Talk to your doctor before using Luminity - if you have been told you have a heart shunt - if you have severe heart or lung diseases or if you need mechanical help to breathe - if you have an artificial valve in your heart - if you have an acute severe inflammation/sepsis - if you have known hyperactive coagulation system (blood clotting issues) or recurrent thromboembolism (blood clots) - if you have a liver disease - if you have a kidney disease
Danish: Kontakt lægen, før du bruger Luminity - hvis du har fået at vide, at du har en hjerteshunt - hvis du lider af en svær hjerte- eller lungesygdom, eller hvis du har brug for mekanisk hjælp til at trække vejret - hvis du har kunstige hjerteklapper - hvis du har akut inflammation/blodforgiftning - hvis du har hyperaktivt koaguleringssystem (problemer med blodets koagulering) eller tilbagevendende blodpropper - hvis du har en leversygdom - hvis du har en nyresygdom
English: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Danish: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Irland
English: Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Danish: Intravenøs infusion ved non-lineær kontrastbilledteknik (hvile og stress) eller grundlæggende billedteknik ved hvile:
English: Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure.
Danish: Der bør udvises ekstrem forsigtighed, hvis man overvejer at administrere Luminity til patienter med ustabil kardiopulmonal status som for eksempel: ustabil angina, akut myokardieinfarkt, alvorlige ventrikulære arytmier, alvorlig hjerteinsufficiens (NYHA IV) eller respirationssvigt.
English: Store in a refrigerator After activation: Do not store above 30°C
Danish: Opbevares i køleskab Efter aktivering: Må ikke opbevares over 30 °C
English: Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code: V08DA04
Danish: Farmakoterapeutisk klassifikation: ultralydskontraststof, mikrosfærer af fosfolipider ATC-kode: V08D A04
English: Luminity should be used within 12 hours following activation.
Danish: Luminity skal anvendes inden for 12 timer efter aktivering.
English: 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.
Danish: Produktet kan reaktiveres i op til 48 timer efter initial aktivering og anvendes i op til 12 timer efter anden aktivering, uanset om det er opbevaret i køleskab eller ved stuetemperatur.
English: Luminity is used in adults to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Danish: Luminity anvendes til at få et bedre billede (scanning) af hjertets kamre, især af venstre hjertekammer (ventrikel), under ekkokardiografien (en diagnostisk test, hvor hjertet fotograferes ved hjælp ad ultralyd).
English: 1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
Danish: 1,5 ml væske i klar borosilicat Type I hætteglas, lukket med chlorbutyl elastomerisk lyofiliseringsstopper og forseglet med aluminiumkrave, der trækkes af med plastikknap.
English: Rats treated with Luminity for 1 month exhibited dose-related, reversible perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and increased goblet cell size and number in the lungs.
Danish: Rotter behandlet med Luminity i 1 måned viste dosisrelateret, reversibel perivaskulær og peribronkiolær eosinofilinfiltration, akkumulering af alveolære makrofager og øget størrelse og antal af bægerceller i lungerne.
English: Luminity is a gas and solvent for dispersion for injection or infusion.
Danish: Luminity er en gas og solvens til dispersion til indsprøjtning eller infusion.
English: They will calculate the right dose for you.
Danish: Lægen eller sygeplejersken vil beregne den rigtige dosis.
English: It is essential to follow instructions for use and handling of Luminity and to adhere to strict aseptic procedures during preparation.
Danish: Det er af yderste vigtighed at brugsvejledningen følges ved anvendelse af Luminity, og at aseptiske procedurer overholdes omhyggeligt ved tilberedning.
English: Rare side effects (may affect up to 1 in 1000 people)
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1000 personer)
English: Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Danish: Alvorlige akutte overfølsomhedsreaktioner (f.eks. anafylaksi, anafylaktisk shock og anafylaktoide reaktioner, hypotension og angioødem) er blevet indberettet efter administration af Luminity.
English: Caution should be exercised when considering the administration of Luminity to these patients.
Danish: Der bør udvises forsigtighed, når Luminity overvejes til disse patienter.
English: Gas and solvent for dispersion for injection/infusion Colourless, uniformly clear to translucent liquid.
Danish: Gas og opløsningsmiddel til dispersion til injektion/infusion Farveløs, ensartet klar til gennemskinnelig væske.
English: During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes of Luminity administration in patients including those with severe cardiac and pulmonary diseases (see section 4.8).
Danish: Under kontrastforstærket ekkokardiografi er der forekommet alvorlige, inklusive fatale, kardiopulmonale reaktioner hos patienter under eller inden for 30 minutter efter administration af Luminity, heriblandt hos patienter med alvorlige hjerte- og lungesygdomme (se pkt.
English: Like all parenteral products, the vials must be inspected visually for particulates and vial integrity.
Danish: Som alle parenterale produkter, skal hætteglassene gennemses for partikler, og det skal tjekkes, at de er ubeskadigede.
English: 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.
Danish: Procentdelen af perflutrendosis udskilt i ekspirationsluften var, på grund af de små mængder der blev givet og den manglende evne til at kvantificere lave niveauer af perflutren ved gas-chromatografi, ca. 50 % af den administrerede dosis.
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 with noncontrast echocardiography is not optimal.
Danish: Luminity anvendes til patienter med mistanke om eller bekræftet koronar hjertesygdom (blokering af de blodkar, der fører blodet til hjertemusklen), når billedet med ekkokardiografi uden kontraststof ikke er optimalt.
English: Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism.
Danish: Patienter med ARDS (adult respiratory distress syndrome), endokarditis, kunstige hjerteklapper, systemisk inflammation, sepsis, øget koagulationstendens og/eller recidiverende tromboembolisme Luminity bør kun anvendes efter omhyggelig overvejelse, og en sådan anvendelse bør monitoreres tæt ved administration til patienter med ARDS (adult respiratory distress syndrome), endokarditis, kunstige hjerteklapper, akutte tilstande med systemisk inflammation eller sepsis, øget koagulationstendens og/eller recidiverende tromboembolisme.
English: Not known: seizures, facial hypoaesthesia, loss of consciousness
Danish: Ikke kendt: Kramper, facial hypæstesi, bevidsthedstab
English: The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 50 µl/kg dose of the product.
Danish: Luminitys farmakokinetiske egenskaber er undersøgt hos raske frivillige og patienter med kronisk obstruktiv lungesygdom (KOL) efter intravenøs administration af en dosis på 50 µl/kg.
English: The product should be used within 12 hours of activation.
Danish: Dette produkt bør anvendes inden for 12 timer efter aktivering.
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Danish: Produktet kan reaktiveres i op til 48 timer efter initial aktivering og anvendes i op til 12 timer efter anden aktivering.
English: Luminity contains propylene glycol.
Danish: Luminity indeholder propylenglycol.
English: Before use, this medicine must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Danish: Før brug skal dette lægemiddel aktiveres ved at omryste det i et mekanisk udstyr, Vialmixeren, der leveres til de læger, som skal klargøre lægemidlet.