FrancophonIA/ELRC3.0 huggingface dataset:
English: Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified.
Danish: Da der på nuværende tidspunkt ikke er indberettet tilfælde af overdosering, er der hverken blevet identificeret tegn på eller symptomer på overdosering.
English: Not known Cannot be estimated from available data
Danish: Ikke kendt, (kan ikke estimeres ud fra forhåndenværende data)
English: Emergency equipment and personnel trained in its use must be readily available.
Danish: Genoplivningsudstyr og personale der er trænet i brug af dette skal være tilgængelig.
English: The mean terminal half-life was 12 minutes (range 2 to 33 minutes).
Danish: Den gennemsnitlige terminale halveringstid var på 12 minutter (2-33 minutter).
English: In the event of overdose occurring, the patient should be observed and treated symptomatically.
Danish: I tilfælde af overdosering bør patienten observeres og behandles symptomatisk.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis ikke præparatet bruges med det samme, er opbevaringstiden og betingelserne brugerens ansvar.
English: The recommended dose is 2 or 2.4 mL per patient.
Danish: Den anbefalede dosis er 2 mL eller 2,4 mL pr. patient.
English: Patients with unstable cardiopulmonary status
Danish: Patienter med ustabil kardiopulmonær status
English: In the case of overdose the doctor will take appropriate action.
Danish: I tilfælde af overdosering vil lægen træffe de nødvendige foranstaltninger.
English: However, some patients may experience serious side effects and may require treatment.
Danish: Nogle patienter kan dog opleve alvorlige bivirkninger, der kan kræve behandling.
English: In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
Danish: Alle disse patienter havde en høj underliggende risiko for alvorlige kardiale komplikationer, som kan have været årsag til dødsfaldene.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: - If you have uncontrolled hypertension.
Danish: - Hvis du har ukontrolleret hypertension (for højt blodtryk).
English: However you must stop breastfeeding for two to three hours after your ultrasound examination.
Danish: Du skal dog stoppe med at amme i 2-3 timer efter ultralydsundersøgelsen.
English: • Vascular Doppler imaging: 2.4 mL.
Danish: • Vaskular Doppler scanning: 2,4 mL.
English: 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.
Danish: SonoVue må kun gives til sådanne patienter efter omhyggelig vurdering af benefit/risk-forholdet, og der skal foretages tæt monitorering af vitale tegn under og efter administrationen.
English: - If you have been told you have a right-to-left heart shunt.
Danish: - Hvis du har fået at vide, at du har en højre til venstre shunt (unormal forbindelse) i hjertet.
English: The product is for a single examination only.
Danish: Produktet må kun anvendes til en enkelt undersøgelse.
English: Clear, colourless solvent
Danish: Klar, farveløs solvens.
English: More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.
Danish: Mere end 80% af det indgivne sulphurhexafluorid blev genfundet i udåndingsluften inden for 2 minutter efter injektionen og næsten 100% efter 15 minutter.
English: Most of the side effects to SonoVue are rare and usually not serious.
Danish: De fleste bivirkninger ved SonoVue er sjældne og som regel ikke alvorlige.
English: Myocardial infarction** Myocardial ischemia**
Danish: Myokardieinfarkt** Myokardieiskæmi**
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < /100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data)
Danish: Bivirkningerne er klassificeret efter systemorganklasse og hyppighed efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 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: Before use examine the product to ensure that the container and closure have not been damaged.
Danish: Præparatet skal undersøges før brug for at sikre, at beholder og lukke ikke er skadet.
English: The dose recommendations for intravenous administration also apply to elderly patients.
Danish: Ældre patienter Dosisanbefalingerne for intravenøs administration gælder også ældre patienter.
English: Overdose is not likely to happen since SonoVue is given by a doctor.
Danish: Overdosering er usandsynligt, da du får SonoVue af en læge.
English: Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).
Danish: Dyrestudier har ikke påvist skadelige virkninger i forbindelse med graviditet, embryonal udvikling/fosterudvikling, fødsel eller postnatal udvikling (se punkt 5.3 Prækliniske sikkerhedsdata).
English: • B-mode imaging of cardiac chambers, at rest or with stress: 2 mL.
Danish: • B-mode scanning af hjertekamre, i hvile eller med stress: 2 mL.
English: After reconstitution, SonoVue is a homogeneous white milky dispersion.
Danish: Efter rekonstitution er SonoVue en homogen, hvid, mælkeagtig dispersion.
English: During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician.
Danish: Under en enkelt undersøgelse kan der gives endnu en injektion af den anbefalede dosis ske, hvis lægen skønner, at dette er nødvendigt.
English: Vasovagal reaction
Danish: Vasovagal reaktion
English: 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.
Danish: Mikroboblerne har en gennemsnitlig diameter på ca. 2,5 µm; 90% af boblerne har en diameter under 6 µm og 99% af boblerne har en diameter under 11 µm.
English: - If you have been told not to take dobutamine (medicine that stimulates the heart) due to your severe heart disease.
Danish: - Hvis du har fået at vide, at du ikke må tage dobutamin (medicin, der stimulerer hjertet) på grund en alvorlig hjertesygdom.
English: SonoVue is given to you by medical or healthcare professionals who are experienced in this type of examination.
Danish: Du vil få SonoVue af en læge eller andet sundhedspersonale med erfaring i denne type undersøgelser.
English: 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.
Danish: Hvis du får SonoVue sammen med et lægemiddel, en øvelse eller et apparat, der stimulerer hjertet for at se, hvordan dit hjerte arbejder under stress, vil din hjerteaktivitet, dit blodtryk og din hjerterytme blive overvåget.
English: - The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
Danish: - Øvrige indholdsstoffer: macrogol 4000, distearoylphosphatidylcholin,
English: Date of latest renewal: 24 April 2006
Danish: Dato for første markedsføringstilladelse: 26. marts 2001 Dato for seneste fornyelse: 24. april 2006
English: SonoVue should only be used in patients where study without contrast enhancement is inconclusive.
Danish: SonoVue bør kun anvendes til patienter, hvor undersøgelse uden forstærkning ved hjælp af kontrast er inkonklusiv.
English: However, based on its rapid elimination from the body via the expired air, it is considered that the breastfeeding can be resumed two to three hours after administration of SonoVue.
Danish: Baseret på den hurtige udskillelse fra kroppen gennem udåndingsluften antages det dog, at amning kan genoptages to-tre timer efter administration af SonoVue.
English: Reconstitution instructions:
Danish: Vejledning i rekonstitution:
English: • In paediatric patients the recommended dose of SonoVue is 1mL.
Danish: • Til pædiatriske patienter er den anbefalede dosis af SonoVue 1 mL.
English: Once reconstituted, chemical and physical stability has been demonstrated for 6 hours.
Danish: Efter rekonstitution er den kemiske og fysiske stabilitet dokumenteret i 6 timer.
English: It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue.
Danish: Det anbefales at sikre en tæt medicinsk monitorering af patienterne under og i mindst 30 minutter efter administration af SonoVue.
English: Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions.
Danish: Sulphurhexafluorid er en inaktiv, uskadelig gas, svært opløselig i vandige opløsninger.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og reproduktionstoksicitet.
English: - This medicine has been prescribed for you.
Danish: Lægen har ordineret dette lægemiddel til dig personligt.
English: SonoVue is for diagnostic use only.
Danish: SonoVue er kun til diagnostisk brug.
English: The presence or absence of vesicoureteral reflux with SonoVue ultrasound was compared to the radiographic reference standard.
Danish: Tilstedeværelse eller fravær af vesikoureteral refluks med SonoVue ultralyd blev sammenlignet med en radiografisk referencestandard.
English: The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials.
Danish: SonoVues sikkerhed efter intravenøs administration blev evalueret hos 4.653 voksne patienter, som indgik i 58 kliniske studier.
English: In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue.
Danish: Der er i meget sjældne tilfælde rapporteret dødsfald i tidsmæssig sammenhæng med anvendelse af SonoVue.
English: - If you have severe pulmonary hypertension (pulmonary artery pressure > 90mmHg).
Danish: - Hvis du har alvorlig pulmonal hypertension (blodtryk i lungekredsløbet > 90 mmHg).
English: Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours.
Danish: Mikroboble dispersionens kemiske og fysiske stabilitet er bevist i 6 timer.
English: The following side effects have been reported with SonoVue:
Danish: Følgende bivirkninger er indberettet i forbindelse med SonoVue:
English: Do not use if the liquid obtained is clear and/or if solid parts of the lyophilisate are seen in the suspension.
Danish: Må ikke anvendes, hvis den fremkomne væske er klar og/eller hvis der ses partikler fra det frysetørrede pulver i suspensionen.
English: White powder
Danish: Hvidt pulver.
English: ** In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.
Danish: ** I nogle tilfælde af overfølsomhed, hos patienter med underliggende koronar-arteriesygdom, blev der også rapporteret om myokardieiskæmi og/eller myokardieinfarkt.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/177/002
Danish: EU/1/01/177/002
English: The efficacy of SonoVue for detection/exclusion of vesicoureteral reflux was studied in two published open label single centre studies.
Danish: SonoVues virkning ved detektion/udelukkelse af vesikoureteral refluks blev studeret i to publicerede, åbne enkeltcenterstudier.
English: This product should only be used by physicians experienced in diagnostic ultrasound imaging.
Danish: Dette produkt bør kun anvendes af læger med erfaring i diagnostisk ultralyd scanning.
English: 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:
Danish: Hætteglasset rystes herefter kraftigt i 20 sekunder, hvorefter det ønskede volumen af dispersionen kan trækkes op i en injektionssprøjte på følgende måde:
English: The recommended doses of SonoVue in adults are:
Danish: De anbefalede doser af SonoVue til voksne er:
English: ECG monitoring should be performed in high-risk patients as clinically indicated.
Danish: EKG-monitorering bør kun udføres i høj risiko patienter på klinisk indikation.
English: Headache, paraesthesia, dizziness, dysgeusia
Danish: Hovedpine, paræstesi, svimmelhed, dysgeusi
English: The sulphur hexafluoride dissolves in the blood and is subsequently exhaled.
Danish: Sulphurhexafluorid opløses i blodet, hvorefter det udåndes.
English: 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).
Danish: Den totale mængde af sulphurhexafluorid givet i en klinisk dosis er ekstremt lille (i en 2 mL dosis indeholder mikroboblerne 16 µL gas).
English: It did not reveal any test item-related lesions in any of the examined organs, in particular in the urinary bladder, in both the single-dose and the repeat-dose studies.
Danish: Dette afslørede ikke nogen testenhedsrelaterede læsioner i nogen af de undersøgte organer, især i urinblæren, hverken i studiet af enkeltdoser eller studiet af gentagne doser.
English: SonoVue helps to obtain clearer pictures of the urinary tract in children .
Danish: SonoVue hjælper med at få tydeligere billeder af urinvejene hos børn.
English: 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.
Danish: Efter anlæggelse af et sterilt 6F-8F blærekateter i blæren under sterile betingelser tømmes blæren for urin og fyldes derefter med saltvand (normal steril 0,9% natriumchloridopløsning) til cirka en tredjedel eller halvdelen af det forventede totalvolumen [(alder i år + 2) x 30) i mL.
English: Any unused liquid remaining at the end of an examination must be discarded.
Danish: Ikke anvendt væske, der er til overs efter undersøgelsen, skal kasseres.
English: 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.
Danish: I det andet studie, som omfattede 228 patienter (463 nyre-ureter-enheder) var SonoVue ultralyd korrekt positiv i 57 ud af 71 enheder med refluks og korrekt negativ i 302 ud af 392 enheder uden refluks.
English: 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.
Danish: I ét studie, der omfattede 183 patienter (366 nyre-ureter-enheder) var SonoVue ultralyd korrekt positiv i 89 ud af 103 enheder med refluks og korrekt negativ i 226 ud af 263 enheder uden refluks.
English: 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).
Danish: SonoVues sikkerhed efter intravesikal administration er baseret på en evaluering af publiceret litteratur, som dækkede anvendelse af SonoVue til over 6.000 pædiatriske patienter (i alderen 2 dage til 18 år).
English: In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100% and the terminal half-life was similar to that measured in healthy volunteers.
Danish: I patienter med diffus interstitiel pulmonal fibrose var procenten af dosen, som blev genfundet i udåndingsluften, 100% og den terminale halveringstid svarede til den, som blev målt på raske forsøgspersoner.
English: - The active substance is sulphur hexafluoride in the form of microbubbles.
Danish: - Aktivt stof: sulphurhexafluorid i form af mikrobobler.
English: 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).
Danish: Vær forsigtig ved behandling af anafylaksi med epinephrin hos patienter som modtager behandling med beta-blokkere, da respons kan være dårlig eller fremme uønskede alfa-adrenerge og vagotoniske virkninger (hypertension, bradykardi).
English: 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.
Danish: Et studie af enkeltdosis og et studie af gentagne doser, begge efterfulgt af en behandlingsfri periode, blev udført hos hunrotter, og lokal toksicitet blev evalueret gennem makroskopisk og histopatologiske undersøgelser af begge nyrer, ureter, urinblære og uretra.
English: 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.
Danish: Fortæl det straks til lægen, hvis du bemærker nogle af følgende bivirkninger; det kan være nødvendigt med øjeblikkelig behandling: Hævelse af ansigt, læber, mund eller svælg, som kan gøre det vanskeligt at synke eller trække vejret, hududslæt, nældefeber, hævede hænder, fødder eller ankler.
English: 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.
Danish: Hvis du har en alvorlig lunge- eller hjertelidelse, vil du blive holdt under tæt lægelig overvågning under injektionen af SonoVue og i mindst 30 minutter efter injektion af SonoVue.
English: Outer packaging
Danish: YDRE EMBALLAGE
English: 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.
Danish: Ved ultralydsundersøgelse af hjerte eller blodårer og/eller væv i leveren og brystet hos voksne: Den dosis, du skal have, vil blive beregnet alt efter hvilken del af kroppen, der skal undersøges.
English: SonoVue contains sodium
Danish: SonoVue indeholder natrium
English: SonoVue must not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
Danish: SonoVue må ikke anvendes i kombination med dobutamin hos patienter med tilstande, der tyder på kardiovaskulær ustabilitet, hvor dobutamin er kontraindiceret.
English: As a precautionary measure, it is preferable to avoid the use of SonoVue during pregnancy.
Danish: For en sikkerheds skyld bør SonoVue undgås under graviditeten.
English: Via Ribes 5, Bioindustry Park Colleretto Giacosa - 10010 (TO) Italy
Danish: Bracco Imaging S.p.A Via Ribes 5, Bioindustry Park Colleretto Giacosa, 10010 (TO) Italien
English: 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.
Danish: Efter en enkelt intravenøs injektion på 0,03 eller 0,3 mL SonoVue/kg (cirka 1 og 10 gange den maksimale kliniske dosis) til forsøgspersoner, var sulphurhexafluorid hurtigt udskilt fra kroppen.
English: Pharmacotherapeutic group: Ultrasound contrast media ATC code: VO8DA05.
Danish: Farmakoterapeutisk klassifikation: Ultralydskontrastmiddel ATC-kode: V08DA05
English: SonoVue is an ultrasound contrast agent that contains tiny bubbles filled with a gas called sulphur hexafluoride.
Danish: SonoVue er et kontrastmiddel til ultralydsundersøgelser, som indeholder små bobler fyldt med en gas, der hedder svovlhexafluorid.
English: 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.
Danish: Derfor, hvis SonoVue skal bruges i forbindelse med stressekkokardiografi, skal patienten være stabil, verificeret ved ingen brystsmerter eller EKGændringer de to foregående dage.
English: This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: For ultrasound scan of urinary tract in children the recommended dose is 1 mL per patient to be administered into the bladder as follows:
Danish: Ved ultralydsundersøgelse af urinvejene hos børn er den anbefalede dosis 1 mL pr. patient, som indgives i blæren som følger:
English: Method of administration For instructions on reconstitution of the medicinal product before administration see section 6.6 .
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Danish: Desuden skal EKG og blodtryk kontrolleres under SonoVueforstærket ekkokardiografi med samtidig brug af en farmakologisk stressor (for eksempel dobutamin).
English: It is not known if sulphur hexafluoride is excreted in human milk .
Danish: Amning Det vides ikke, om sulphurhexafluorid udskilles i human mælk.
English: - If you have adult respiratory distress syndrome (a severe, medical condition characterized by widespread inflammation in the lungs).
Danish: - Hvis du har shocklunge (en alvorlig medicinsk tilstand, der er kendetegnet ved omfattende betændelse i lungerne).
English: 4.6 Pregnancy, lactation, and fertility
Danish: 4.6 Fertilitet, graviditet og amning
English: Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
Danish: Inravenøs anvendelse af SonoVue er kontraindiceret til patienter som har højre-til-venstre shunt, svær pulmonal hypertension (pulmonalt arterietryk > 90 mmHg), ukontrolleret systemisk hypertension og til patienter med adult respiratorisk distress syndrom.
English: 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.
Danish: Ved de foreslåede kliniske doser til intravenøs anvendelse har SonoVue vist en markant stigning i signalintensitetenpå mere end 2 minutter for B-mode scanning for ekkokardiografi og på 3 til 8 minutter for Doppler makrovaskular og mikrovaskular scanning.