FrancophonIA/ELRC3.0 huggingface dataset:
English: Further to the approval Spain raised a major objection related to the wording of the indication as Spain considered that the approved indication neither reflected the studied population in the two pivotal studies submitted for this variation of Gadovist nor the clinical context for which Gadovist has demonstrated to have the same diagnostic accuracy than its comparator.
Danish: Efter godkendelsen rejste Spanien en væsentlig indvending vedrørende ordlyden af indikationen, idet Spanien fandt, at den godkendte indikation hverken afspejlede den undersøgte population i de to hovedundersøgelser, der var forelagt med henblik på denne ændring for Gadovist, eller den kliniske sammenhæng, i hvilken Gadovist er påvist at have samme diagnostiske præcision som sammenligningspræparatets.
English: This is equivalent to 0.1 ml/kg BW of the 1.0 M solution.
Danish: Dette svarer til 0,1 ml/kg legemsvægt af 1,0 M opløsningen.
English: Tell the MRI department staff immediately if you experience any of these signs or have difficulty in breathing.
Danish: Fortæl straks MR-scanningspersonalet, hvis du får nogen af disse symptomer eller får vejrtrækningsbesvær.
English: Gd-based contrast agents are frequently administered prior to contrast-enhanced dynamic liver MRI and may improve both detection and classification of focal liver lesions.
Danish: Gdbaserede kontraststoffer bliver ofte administreret før kontrastforøget dynamisk MRI af leveren og giver mulighed for bedre påvisning og klassificering af fokale leverforandringer.
English: Contrast enhancement in magnetic resonance angiography (CE-MRA).
Danish: Kontrastforstærkning ved magnetisk resonansangiografi (CE-MRA).
English: Tell your doctor if you are breast-feeding or intending to breast-feed.
Danish: Fortæl det til din læge, hvis du ammer eller påtænker at amme.
English: Like with other gadolinium containing contrast agents special precaution is necessary in patients with a low threshold for seizures.
Danish: Som ved andre kontraststoffer, der indeholder gadolinium, er det nødvendigt at tage særlige forholdsregler hos patienter med tendens til krampeanfald.
English: While injecting Gadovist into veins with a small lumen there is the possibility of adverse effects such as reddening and swelling.
Danish: Ved injektion af Gadovist i vener med ringe lumen er der mulighed for bivirkninger såsom rødmen og hævelse.
English: Gadovist consists of nonspecific, low-molecular-weight, extracellular gadolinium-chelates and is presented in the formulation l.0 mmol gadolinium/ml and an osmolality of 1603 mosmol/kg H2O at 37°C.
Danish: Gadovist består af uspecifikke, lavmolekylære, ekstracellulære gadoliniumkelater og leveres i styrken l,0 mmol gadolinium/ml med en osmolalitet på 1 603 mosmol/kg H2O ved 37°C.
English: In rare cases anaphylactoid reactions ranging to shock may occur.
Danish: Der kan i sjældne tilfælde forekomme anafylaktoide reaktioner, som kan udvikle sig til shock.
English: Referral Procedure
Danish: Indbringelsesprocedure
English: Take special care with GADOVIST - if you suffer or have suffered from allergy (e.g. hay fever, hives) or asthma - if you had a previous reaction to contrast media - if you have a very poor kidney function - if you have a serious disease of the heart and blood vessels - if you suffer from low potassium levels - if you, or someone in your family, has ever had problems with the electrical rhythm of the heart
Danish: Vær ekstra forsigtig med at bruge GADOVIST - hvis du lider eller har lidt af allergi (f.eks. høfeber, nældefeber) eller astma - hvis du tidligere har haft en reaktion over for kontraststoffer - hvis du har meget dårlig nyrefunktion - hvis du lider af en alvorlig hjerte- eller karsygdom - hvis dine kaliumniveauer er lave - hvis du eller nogen i din familie nogensinde har haft problemer med hjertets elektriske rytme (lang QT
English: MRI is a form of medical diagnostic imaging that uses the behaviour of water molecules in normal and abnormal tissues.
Danish: MR-scanning er en form for medicinsk diagnostisk scanning, som danner billeder efter påvisning af vandmolekylers adfærd i normalt og unormalt væv.
English: HOW TO USE GADOVIST
Danish: SÅDAN SKAL DU BRUGE GADOVIST
English: This leaflet was last approved in {MM/YYYY}.
Danish: Gadovist Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}.
English: Osmolality at 37°C: 1603 mOsm/kg H2O Viscosity at 37°C: 4.96 mPa·s
Danish: Osmolalitet ved 37 °C: 1603 mOsm/kg H2O
English: It is not clearly obvious that accurate diagnostic information per se is beneficial, so the application for authorisation should provide support that the information is clinically useful by direct evaluation of this aspect in the clinical trials provided or being drawn historically from published scientific evidence.
Danish: Præcise diagnostiske oplysninger er ikke nødvendigvis i sig selv værdifulde, hvorfor det i ansøgningen skal godtgøres, at oplysningerne har klinisk værdi, enten ved direkte vurdering af dette aspekt i de forelagte kliniske undersøgelser eller ved retrospektiv uddragning fra publicerede kliniske data.
English: 1) The current indication does neither reflect the studied population in the two pivotal studies submitted for this variation of Gadovist nor the clinical context for which Gadovist has demonstrated to have the same diagnostic accuracy than its comparator.
Danish: Den aktuelle indikation afspejler hverken den undersøgte population i de to hovedundersøgelser, der er forelagt med henblik på denne ændring for Gadovist, eller den kliniske sammenhæng, i hvilken Gadovist er påvist at have samme diagnostiske præcision som sammenligningspræparatets.
English: Cardiac arrest, Fast heart beat
Danish: Hjertestop, hurtigt hjerteslag
English: After first opening use immediately within 24 h (stored 2 - 8 °C).
Danish: Skal bruges inden 24 timer efter åbning (ved opbevaring ved 2 - 8 °C).
English: LIST OF EXCIPIENTS Excipients: Calcobutrol sodium, Trometamol, Hydrochloric acid, Water for injections
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: Calcobutrolnatrium, trometamol, saltsyre, vand til injektionsvæsker
English: Parosmia
Danish: Parosmi
English: Hypersensitivity reactions (e.g. urticaria, rash, vasodilitation) have been uncommonly reported and were mostly of mild to moderate intensity.
Danish: Overfølsomhedsreaktioner (f.eks. nældefeber, udslæt, vasodilatation) er ikke almindeligt forekommende og var mest milde til moderate.
English: Important information about some of the ingredients of Gadovist This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free'.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Gadovist Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis (baseret på den gennemsnitlige mængde givet til en person som vejer 70 kg), dvs. stort set ‘natriumfri'.
English: Short-lasting mild to moderate feelings of coldness, warmth or pain at the injection site have been uncommonly observed during or after the injection of Gadovist.
Danish: Kortvarig mild til moderat følelse af kulde, varme eller smerter ved injektionsstedet er blevet observeret under eller efter injektion af Gadovist, men dette var usædvanligt.
English: Small amounts of gadobutrol enter milk in animals (less than 0.01% of the dose administered).
Danish: Dyreforsøg har vist, at små mængder gadobutrol (mindre end 0,01 % af den indgivne dosis) findes i modermælken.
English: Gadovist (see “What Gadovist contains”)
Danish: “Gadovist indeholder”)
English: At 0.47 T (20 MHz), pH 7 and 40°C the paramagnetic effect (relaxivity), as determined from the effect on spin-lattice relaxation time (T1) - is about 3.6 l mmol sec and the spin-spin relaxation time (T2) is about 4 l mmol sec
Danish: Ved 0,47 T (20 MHz), pH 7 og 40 °C er den paramagnetiske effekt (relaksivitet) - bestemt på grundlag af effekten på spin-lattice relaksationstiden (T1) - er ca. 3,6 l mmol sek
English: Problems with sense of smell Breathing difficulties Vomiting
Danish: Problemer med lugtesansen Åndedrætsbesvær Opkastning
English: Numbness and tingling Problems with sense of taste Nausea (feeling sick) Widening of blood vessels Injection site pain Injection site reaction
Danish: Følelsesløshed og prikken Problemer med smagsfornemmelsen Kvalme (føler sig syg) Udvidelse af blodårerne Smerter ved injektionsstedet Reaktioner ved injektionsstedet
English: Additional safety information:
Danish: Yderligere sikkerhedsoplysninger
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 7.5 ml Vial
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER 7,5 ml hætteglas
English: Shelf life of the medicinal product as packaged for sale:
Danish: Lægemidlets opbevaringstid i salgsemballagen:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless opening has taken place in controlled and validated aseptic conditions.
Danish: Produktet bør anvendes inden for 24 timer og bør opbevares ved en temperatur mellem 2-8 °C, medmindre beholderen er blevet åbnet under kontrollerede og validerede aseptiske forhold.
English: After first opening use immediately within 24 h (stored 2 - 8 °C) or within 8 h (stored at r.t.)
Danish: Skal bruges inden 24 timer efter åbning (ved opbevaring ved 2 - 8 °C) eller inden 8 timer (ved opbevaring ved stuetemperatur)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Prefilled syringes (5 ml, 7.5 ml, 10 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER Fyldte injektionssprøjter (5 ml, 7,5 ml, 10 ml)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Intravenøs anvendelse
English: Neo Iraklio
Danish: Iraklio
English: The increase in specificity from precontrast to combined pre and postcontrast MRI was 9% in the liver study (patient based analysis) while there was no increase in specificity in the kidney study (patient-based analysis as well as lesion-based analysis).
Danish: Stigningen i specificiteten fra prækontrastforstærket til kombineret præ- og postkontrastforstærket scanning var 9 % i lever-studiet (patient-baseret analyse), mens der ikke var nogen stigning i specificiteten i nyre-studiet (patient-baseret analyse samt læsions-baseret analyse).
English: At a dose of 0.1 mmol gadobutrol/kg BW, an average of 100.3 ± 2.6% of the dose was excreted within 72 h after administration.
Danish: Ved en dosis på 0,1 mmol gadobutrol pr. kg legemsvægt udskiltes i gennemsnit 100,3 ±2,6 % af dosis inden for 72 timer efter indgift.
English: • Adults
Danish: • Børn:
English: BEFORE YOU ARE GIVEN GADOVIST
Danish: DET SKAL DU VIDE, FØR DU FÅR GADOVIST
English: D - 13342 Berlin, Germany Telephone: +49 30 468-1111
Danish: Telefon: +49 30 468-1111
English: Due to potential effects of Gadovist on cardiac repolarization in cases of overdose, disturbances of cardiac rhythm may be possible.
Danish: Forstyrrelser i hjerterytmen ved overdosering er mulige på grund af Gadovists potentielle indvirkning på den kardielle repolarisering.
English: The following applies to the use of the infusion bottle containing 65 ml: After opening of the infusion bottle under aseptic conditions Gadovist remains stable for at least 8 hours at room temperature.
Danish: Efter at infusionsflasken er blevet åbnet under aseptiske forhold, holder Gadovist sig stabilt i mindst 8 timer ved stuetemperatur.
English: Short-lasting mild to moderate feelings of coldness, warmth or pain at the injection site have been uncommonly observed in association with the venous puncture or contrast medium injection.
Danish: Kortvarig let til moderat fornemmelse af kulde, varme eller smerte ved injektionsstedet er ikke almindeligt forekommende i forbindelse med venepunktur eller injektion af kontraststoffet.
English: Rare: between 1 and 10 in every 10,000 patients are likely to get these.
Danish: Sjælden: Forekommer mellem 1 og 10 ud af 10.000 patienter.
English: Gadovist is a clear, colourless to pale yellow solution.
Danish: Gadovist er en klar, farveløs til lysegul opløsning.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
English: Headache, Dizziness, Paresthesia,
Danish: Hovedpine, svimmelhed, paræstesi,
English: This medicinal product is a clear, colourless to pale yellow solution.
Danish: Dette lægemiddel er en klar, farveløs til lysegul opløsning.
English: Dizziness, Paresthesia, Dysgeusia
Danish: Hovedpine, svimmelhed, paræstesi, dysgeusi
English: CE-MRA:
Danish: Kontrastforstærket MRA:
English: To be able to react immediately to an emergency, medicinal products and equipment (e.g. endotracheal tube and respirator) should be within hand reach.
Danish: Akut beredskab med relevant medicinering og instrumenter til behandling af respirations- og hjertestop skal være inden for rækkevidde.
English: PHARMACOLOGICAL PROPERTIES
Danish: Farmakokinetiske egenskaber
English: Severe allergy-like reaction (shock)
Danish: Følelse af at have det for varmt, generel utilpashed Alvorlige allergi-lignende reaktion (shock)
English: Rare (≥1/10,000 to <1/1,000)
Danish: Sjælden (≥1/10.000 til <1/1.000)
English: Breast-feeding should be stopped for at least 24 hours following Gadovist administration.
Danish: Amning skal stoppes i mindst 24 timer efter at du har fået Gadovist.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 ml
English: Not relevant.
Danish: Ikke almindelig
English: NLNetherlands
Danish: NLNederlandene
English: Gadovist should not be prepared until immediately before use.
Danish: Gadovist må ikke klargøres før lige inden brug.
English: 1 vial with 30 ml of the solution contains 18141 mg gadobutrol.
Danish: 1 hætteglas med 30 ml af opløsningen indeholder 18141 mg gadobutrol.
English: What GADOVIST looks like and contents of the pack
Danish: Gadovists udseende og pakningstørrelse
English: Respiratory arrest, Bronchospasm, Cyanosis, Oropharyngeal swelling, Cough, Sneezing
Danish: Respirationsstop, bronkospasmer, cyanose, hævelse af orofarynks, hoste, nysen
English: Any solution for injection not used in one examination must be discarded.
Danish: Eventuel injektionsopløsning, der ikke er anvendt til en undersøgelse, skal kasseres.
English: In a pivotal phase III kidney study average sensitivity was 91% (patient-based analysis) and 85% (lesion-based analysis) for classification of malignant and benign renal lesions.
Danish: I et centralt fase-III nyre-studie var den gennemsnitlige sensitivitet 91 % (patient-baseret analyse) og 85 % (læsions-baseret analyse) for klassificering af maligne og benigne nyrelæsioner.
English: Anaphylactoid reaction
Danish: Anafylaktoid reaktion
English: In rare cases delayed anaphylactoid reactions (after hours to days) have been observed.
Danish: Der er i sjældne tilfælde registreret forsinkede anafylaktoide reaktioner (efter timer eller dage).
English: - Handling
Danish: - Håndtering
English: 1 infusion bottle with 65 ml of the solution contains 39307 mg gadobutrol.
Danish: 1 infusionsflaske med 65 ml af opløsningen indeholder 39307 mg gadobutrol.
English: The increase of sensitivity from precontrast to combined pre and postcontrast MRI for Gadovisttreated patients was 33% in the liver study (patient-based analysis) and 18% in the kidney study (patient-based analysis as well as lesion-based analysis).
Danish: Stigningen i sensitivitet fra prækontrastforstærket til postkontrastforstærket MR-scanning for patienter behandlet med Gadovist var 33 % i lever-studiet (patient-baseret analyse), og 18 % i nyre-studiet (patientbaseret analyse samt læsions-baseret analyse).
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig.
English: In a pivotal phase III liver study average sensitivity in combined pre and postcontrast MRI for Gadovist-treated patients was 79% and specificity was 81% for lesion detection and classification of suspected malignant liver lesions (patientbased analysis).
Danish: I et central fase-III lever-studie var den gennemsnitlige sensitivitet ved kombineret præ- og postkontrastforstærket MR-scanning for patienter behandlet med Gadovist 79 % og specifikt 81 % for påvisning af læsioner og klassificering af mistænkte maligne leverlæsioner (patient-baseret analyse).
English: Loss of consciousness,
Danish: Tab af bevidsthed, krampe
English: Calcobutrol sodium
Danish: Calcobutrolnatrium
English: Section 4.2 (Posology): “Gadovist is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Danish: Afsnit 4.2 (dosering): "På grund af manglende dokumentation for sikkerhed og/eller virkning, bør Gadovist ikke anvendes til børn og unge under 18 år."
English: The MAH must include in section 4.2 the following sentence “Gadovist is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Danish: Indehaveren af markedsføringstilladelsen skal indsætte følgende sætning i afsnit 4.2: "På grund af manglende dokumentation for sikkerhed og/eller virkning, bør Gadovist ikke anvendes til børn og unge under 18 år."
English: Gadovist should be used with special care in patients - with known congenital long QT syndrome or a family history of congenital long QT syndrome - with known previous arrhythmias after taking medicinal products that prolong cardiac repolarisation - who are currently taking a medicinal product that is known to prolong cardiac repolarisation e.g. a Class III antiarrhythmic (e.g. amiodarone, sotalol).
Danish: Gadovist bør anvendes med speciel forsigtighed hos patienter - med kendt medfødt langt QT-syndrom eller langt QT-syndrom i familien - med kendte tidligere arytmier efter indtagelse af medicin, der forlænger den kardielle repolarisering.
English: 1 prefilled syringe with 20 ml of the solution contains 12094 mg gadobutrol.
Danish: 1 fyldt injektionssprøjte med 20 ml af opløsningen indeholder 12094 mg gadobutrol.
English: Important information about some of the ingredients of X This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis (baseret på den gennemsnitlige mængde givet til en person som vejer 70 kg), dvs. stort set ‘natriumfri'.
English: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI).
Danish: Kontrastforstærkning ved cranial og spinal magnetisk resonans (MR) scanning.
English: Max-Dohm-Strasse 8-10 D-10589 Berlin
Danish: D-10589 Berlin
English: Gadovist not used in one examination must be discarded.
Danish: Gadovist der ikke er anvendt til en undersøgelse skal kasseres.
English: Gadovist should not be drawn up into the syringe from the vial until immediately before use.
Danish: Gadovist må ikke opsuges i sprøjten fra hætteglasset før lige inden brug.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER) 1 ml indeholder 604,72 mg gadobutrol (svarende til 1,0 mmol gadobutrol indeholdende 157,25 mg gadolinium).
English: HOW TO STORE GADOVIST
Danish: SÅDAN OPBEVARER DU GADOVIST
English: Schering Deutchland GmbH
Danish: Schering Deutchland GmbH Max-Dohrn-Strasse 10
English: Feeling hot, Malaise
Danish: Varmefølelse, utilpashed
English: Respiratory, thoracic and mediastinal disorders
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum
English: - The active substance is gadobutrol 604.72 mg corresponding to 1 mmol/ml - The other ingredients are calcobutrol sodium, trometamol, hydrochloric acid and water for injections
Danish: - Det aktive stof er gadobutrol 604,72 mg svarende til 1 mmol/ml - De øvrige indholdsstoffer er calcobutrolnatrium, trometamol, saltsyre og vand til injektionsvæsker 1 fyldt injektionssprøjte med 5,0 ml af opløsningen indeholder 3023 mg gadobutrol.
English: Cardiovascular monitoring (including ECG) and control of renal function is recommended as a measure of precaution.
Danish: Som en sikkerhedsforanstaltning anbefales kardiovaskulær monitorering (inkl.
English: Adverse reactions are “rare (≥1/10,000 to <1/1,000)” to “uncommon (≥1/1,000 to <1/100)”.
Danish: Bivirkningerne er ”sjældne (≥1/10.000 til <1/1000)” til ”ikke almindelige (≥1/1000 til <1/100)” Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
English: 1 or 10 injection vials with 7.5, 15 or 30 ml solution for injection 1 or 10 infusion bottles with 65 ml solution for injection (in 100-ml infusion bottle)
Danish: Indholdet af pakningerne er: 1 eller 10 injektionshætteglas med 7,5, 15 eller 30 ml injektionsvæske, opløsning 1 eller 10 infusionsflasker med 65 ml injektionsvæske, opløsning (i 100-ml infusionsflaske) Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: PHARMACEUTICAL FORM Solution for injection in prefilled syringe Clear, colourless to pale yellow liquid.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning i fyldt injektionssprøjte Klar, farveløs til lysegul væske.
English: Contrast medium not used in one examination must be discarded.
Danish: Kontraststof, som ikke anvendes under en undersøgelse, skal bortskaffes.
English: Each ml contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml indeholder 604,72 mg gadobutrol (svarende til 1,0 mmol gadobutrol indeholdende 157,25 mg gadolinium)
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow liquid.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning Klar, farveløs til lysegul væske.
English: Injection site reaction
Danish: Smerter ved injektionsstedet, reaktioner ved injektionsstedet
English: - the CHMP recommended that the following additional indication: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.” can be granted for Gadovist.
Danish: CHMP anbefalede, at følgende supplerende indikation: "Kontrastforstærket MRI af lever og nyrer hos patienter, hos hvilke fokale forandringer i lever eller nyrer er stærkt sandsynlige eller er påvist, med henblik på klassificering af sådanne forandringer som benigne eller maligne."
English: 1 prefilled syringe with 7.5 ml of the solution contains 4535 mg gadobutrol.
Danish: 1 fyldt injektionssprøjte med 7,5 ml af opløsningen indeholder 4535 mg gadobutrol.
English: “Contrast-enhanced magnetic resonance imaging (MRI) in patients with high suspicion or evidence of having a focal disease of liver or kidneys, obtained by other diagnostic tests or histopathology, to correctly localise malignant lesions of liver or kidney.”
Danish: "Kontrastforstærket magnetic resonance imaging (MRI) med henblik på korrekt lokalisering af maligne forandringer i lever eller nyrer hos patienter, hos hvilke fokal sygdom i lever eller nyrer anses for stærkt sandsynlig eller er blevet påvist ved andre diagnostiske prøver eller histopatologiske fund."
English: 1 prefilled syringe with 10 ml of the solution contains 6047 mg gadobutrol.
Danish: 1 fyldt injektionssprøjte med 10 ml af opløsningen indeholder 6047 mg gadobutrol.
English: Breathing difficulties (bronchospasm, swelling of the throat), Breathing arrest, Blueness of the lips, Cough, Sneezing
Danish: Åndedrætsbesvær (bronkospasme, hævelse af halsen), åndedrætsstop, blålige læber, hosten, nysen Hævelse (ødem) i ansigtet, unormalt stor svedafsondring, kløe, rødme i huden Besvimelse, rødme