FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4: Summary of baseline patient and disease characteristics in the phase 3 previously untreated HL study
Danish: Tabel 4: Oversigt over patient- og sygdomskarakteristika ved baseline i ikke tidligere behandlet HL - fase 3-studiet
English: Patients with hepatic impairment should be closely monitored for adverse events.
Danish: Patienter med nedsat nyrefunktion skal nøje monitoreres for bivirkninger.
English: 1.92 vials
Danish: 1,92 hætteglas
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells upper respiratory tract infection decrease in weight infection nausea abdominal pain itching muscle pain joint pain or painful, swollen joints
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal hvide blodlegemer - infektion i de øvre luftveje - vægttab - infektion - kvalme - mavesmerter - kløe - muskelsmerter - ledsmerter eller smertende, hævede led
English: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Danish: Den anbefalede dosis er 1,8 mg/kg administreret som en intravenøs infusion over 30 minutter hver 3. uge.
English: Patients with renal impairment should be closely monitored for adverse events (see section 5.2).
Danish: Patienter med nedsat leverfunktion skal nøje monitoreres for bivirkninger (se pkt.
English: Patients with renal impairment should be closely monitored for adverse events.
Danish: Patienter med nedsat leverfunktion skal nøje monitoreres for bivirkninger.
English: Common side effects (may affect up to1 in 10 people) pneumonia sore, creamy-yellow, raised patches in the mouth (thrush) decreased level of blood platelets dizziness blisters which may crust or scab increased level of blood sugar increased liver enzyme levels unusual hair loss or thinning
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - lungebetændelse - ømme, cremegule hævede områder i munden (trøske) - nedsat antal blodplader - svimmelhed - blærer, der kan danne skorpe eller sår - forhøjet blodsukkerniveau - forhøjede leverenzymniveauer - usædvanligt hårtab eller udtynding
English: Each vial contains 50 mg of brentuximab vedotin.
Danish: Hvert hætteglas indeholder 50 mg brentuximab vedotin.
English: See Table 11 below for a summary of baseline patient and disease characteristics.
Danish: Se Tabel 11 nedenfor for en oversigt over patient- og sygdomskarakteristika ved baseline.
English: Excipients: Citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, polysorbate 80 See package leaflet for further information
Danish: Hjælpestoffer: Citronsyremonohydrat, natriumcitratdihydrat, α,α-trehalosedihydrat, polysorbat 80.
English: (95% CI [0.36, 0.70])b
Danish: (95 % CI [0,36; 0,70])
English: See Table 9 below for a summary of baseline patient and disease characteristics.
Danish: Se Tabel 9 nedenfor for en oversigt over patient- og sygdomskarakteristika ved baseline.
English: Study-C25007
Danish: Studie C25007
English: Bone pain, arthralgia, back pain, myalgia
Danish: Knoglesmerter, artralgi, rygsmerter, myalgi
English: total dose divided by reconstituted vial concentration [5 mg/mL])
Danish: Totalt volumen der skal fortyndes b = total dosis divideret med den rekonstituerede hætteglaskoncentration [5 mg/ml]
English: If peripheral sensory or motor neuropathy emerges or worsens during treatment see Table 2 below for appropriate dosing recommendations (see section 4.4).
Danish: Hvis en perifer sensorisk eller motorisk neuropati opstår eller forværres under behandlingen, se da
English: NA
Danish: IR
English: Table 4 provides a summary of the baseline patient and disease characteristics.
Danish: Tabel 4 indeholder en oversigt over patient- og sygdomskarakteristika ved baseline.
English: Tell your doctor straight away if you notice any of the following symptoms because some of them may be signs of a serious or possibly fatal condition: - progressive multifocal leukoencephalopathy (PML) symptoms such as confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance (for more detailed information, see section 2) (affects less than 1 in 100 people) - symptoms of inflammation of the pancreas (pancreatitis) such as severe and persistent stomach pain, with or without nausea and vomiting (may affect up to 1 in 100 people).
Danish: - progressiv multifokal leukoencefalopati (PML) så som konfusion, problemer med at tænke, hukommelsestab, uklart syn eller synstab, nedsat styrke, nedsat kontrol eller følelse i en arm eller et ben, en forandring i måden at gå på eller tab af balance (for nærmere informationer, se punkt 2) (forekommer hos færre end 1 ud af 100 personer).
English: 18.7 mo (6.1-204.0)
Danish: (6,1-204,0) 18,8 mdr.
English: Refractory
Danish: Rygsmerter
English: The recommended starting dose in patients with mild hepatic impairment is 0.9 mg/kg administered as an intravenous infusion over 30 minutes every 2 weeks.
Danish: Den anbefalede startdosis til patienter med let nedsat leverfunktion er 0,9 mg/kg administreret som en intravenøs infusion over 30 minutter hver 2. uge.
English: 2.4 vials
Danish: 2,4 hætteglas
English: Retreatment with ADCETRIS resulted in 6 CRs (55%) and 4 PRs (36%), for an ORR of 91%.
Danish: Af de 8 sALCL-patienter blev 3 genbehandlet to gange, hvilket giver 11 genbehandlinger i alt. Genbehandling med ADCETRIS medførte 6 CR (55 %) og 4 PR (36 %), dvs. en ORR på 91 %.
English: Table 13 provides a summary of the baseline patient and disease characteristics.
Danish: Tabel 13 viser en oversigt over patient- og sygdomskarakteristika ved baseline.
English: Dose adjustments
Danish: Dosisjustering
English: Number of Risk Factors
Danish: Antal hændelser
English: One patient had a baseline ECOG status of 2, which was prohibited by protocol and is captured as Inclusion Criteria Not Met. b. Primary refractory sALCL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Danish: Primær refraktær på førstelinjebehandling Refraktært på den seneste behandling Baseline B-symptomer Stadium III ved initiel diagnose Stadium IV ved initiel diagnose a. Primært refraktær HL defineres som manglende opnåelse af komplet remission efter primær behandling eller progression inden for 3 måneder efter afslutning af denne.
English: Figure 3: Kaplan-Meier Plot of PFS per IRF in Patients with ≥ 2 Risk Factors
Danish: Figur 3: Kaplan-Meier-plot af PFS iht.
English: Disease Characteristics
Danish: Sygdomskarakteristika
English: Febrile neutropenia Immune system disorders Uncommon:
Danish: Immunsystemet Ikke almindelig:
English: Tumour lysis syndrome
Danish: Tumorlyse-syndrom
English: An updated analysis conducted after 3 years of follow-up showed a sustained PFS improvement per IRF (HR = 0.58 [95% CI (0.41, 0.81)]).
Danish: IRF (HR = 0,58 [95 % CI (0,41; 0,81)]).
English: Each vial contains 50 mg of brentuximab vedotin
Danish: 6.6) indeholder hver ml 5 mg brentuximab vedotin.
English: The recommended starting dose in patients with severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Danish: Den anbefalede startdosis for patienter med svært nedsat nyrefunktion er 1,2 mg/kg administreret som intravenøs infusion over 30 minutter hver 3. uge.
English: In the pooled dataset of ADCETRIS as monotherapy across HL, sALCL and CTCL studies (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 and C25007, see section 5.1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.
Danish: I det puljede datasæt for ADCETRIS som monoterapi i studier af HL, sALCL og CTCL (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 og C25007, se pkt.
English: Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening experience a whistling sound during breathing (wheezing)/difficulty breathing, hives, itching, or swelling (signs of an infusion reaction).
Danish: Visse infektioner kan være alvorlige og kan skyldes virus, bakterier eller andet, der kan være livstruende.
English: 9/L) or Grade 2 (< 1500-1000/mm < 1.5-1.0 x 10
Danish: Grad 2 (<1500-1000/mm
English: What you need to know before you are given Adcetris
Danish: Det skal du vide, før du begynder at få Adcetris
English: 80 kg 144 mg
Danish: 144 mg
English: Hazard ratio (95% CI): 0.770 ( 0.603, 0.983)
Danish: investigator var 0,41 (95 % CI [0,29; 0,58]) (se fig. 3 og 4).
English: The recommended starting dose in patients with hepatic impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Danish: Den anbefalede startdosis for patienter med nedsat leverfunktion er 1,2 mg/kg administreret som intravenøs infusion over 30 minutter hver 3. uge.
English: Figure 4: Kaplan-Meier Plot of PFS per Investigator in Patients with ≥ 2 Risk Factors
Danish: Figur 4: Kaplan-Meier-plot af PFS iht.
English: have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity).
Danish: - har nyopstået eller forværret åndenød eller hoste, da disse kan være symptomer på en alvorlig og potentielt dødelig lungekomplikation (lungetoksicitet).
English: Grade 1 (< LLN-1500/mm < LLN-1.5 x 10
Danish: <nederste grænse af normalområdet (LLN)-1,5 x 10
English: Frequency not known: Progressive multifocal leukoencephalopathy Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: Common side effects (may affect up to 1 in 10 people) - an infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis);
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - infektion i blodet (blodforgiftning) og/eller septisk shock (en livstruende form for blodforgiftning) - lungebetændelse - blærer, der kan danne skorpe eller sår - ømme, cremegule, hævede pletter i munden (trøske) - kløe - forhøjet blodsukker
English: 60 kg 108 mg
Danish: 108 mg
English: This includes herbal medicines and other medicines you can obtain without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: Musculoskeletal and connective tissue disorders Very common:
Danish: Knogler, led, muskler og bindevæv Meget almindelig:
English: dizziness
Danish: Vægttab
English: 80 kg 96 mg
Danish: 96 mg
English: Metabolism
Danish: Levertoksicitet
English: Takeda AS
Danish: Takeda Italia S.p.A.
English: VIAL LABEL
Danish: Oversigt over indlægssedlen
English: Co-administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin.
Danish: Samtidig administration af brentuximab vedotin og rifampicin, en stærk CYP3A4-induktor, ændrede ikke plasma-eksponeringen for brentuximab vedotin; Skønt der er begrænsede PK-data, syntes samtidig administration af rifampicin at reducere plasmakoncentrationer af de MMAE-metabolitter, der kunne bestemmes.
English: At the time of the updated analysis (3 years of follow-up) for patients with 2 or more risk factors, the hazard ratio for PFS per IRF was 0.49 (95% CI [0.34, 0.71]) and the hazard ratio for PFS per investigator was 0.41 (95% CI [0.29, 0.58]) (see Figures 3 and 4).
Danish: IRF 0,49 (95 % CI [0,34; 0,71]), og hazard ratio for PFS iht.
English: 60 kg 72 mg
Danish: 72 mg
English: Dizziness
Danish: Hæn
English: Hepatotoxicity
Danish: Lungetoksicitet
English: Median per Investigator
Danish: investigator.
English: Pulmonary toxicity
Danish: Tumorlysesyndrom
English: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option.
Danish: ADCETRIS er indiceret til behandling af voksne patienter med recidiverende eller refraktært CD30+ Hodgkins lymfom (HL): 1.
English: Preparation of Infusion Solution
Danish: Klargøring af infusionsvæsken
English: 76M (46%)/89F (54%) 97M (59%)/67F (41%)
Danish: 97 M (59 %)/67 F
English: If you experience any one of these symptoms you must tell your doctor immediately.”
Danish: Hvis du oplever nogle af disse symptomer, skal du straks kontakte en læge.”
English: There is evidence that higher dose and/or cumulative exposure are risk factors for development of valvular pathology.
Danish: Der er evidens for, at højere doser og/eller kumulativ eksponering er risikofaktorer for udvikling af hjerteklappatologi.
English: All patients must undergo a cardiovascular evaluation, including echocardiogram, to assess the potential presence of asymptomatic valvular disease.
Danish: Alle patienter bør gennemgå en kardiovaskulær vurdering, herunder ekkokardiografi, for at vurdere eventuel tilstedeværelse af en asymptomatisk hjerteklaplidelse.
English: If fibrotic reactions occur treatment will have to be discontinued.”
Danish: Hvis der opstår fibrotiske reaktioner, skal behandlingen afbrydes."
English: 4.4 Special warnings and precautions for use:
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: 4.3 Contraindications:
Danish: 4.3 Kontraindikationer
English: However, valvulopathy and fibrotic reactions have been reported during treatment with pergolide at doses less than 0.5mg/day.
Danish: Imidlertid er hjerteklaplidelser og fibrotiske reaktioner også set ved behandling med pergolid i doser lavere en 0,5 mg daglig.
English: Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis.
Danish: Fibrotiske lidelser kan være langsomt indtrædende, og patienter bør monitoreres jævnligt for mulige manifestationer af progressiv fibrose.
English: Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder.”
Danish: Yderligere undersøgelser, som f.eks. erythrocyt sænkningsreaktion og måling af serumkreatinin bør om nødvendigt foretages for at understøtte en diagnose på fibrotisk lidelse”.
English: Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis.
Danish: Der er set abnorm forhøjelse af erythrocyt-sænkningsreaktion (ESR) hos patienter med pleuraeffision/fibrose.
English: The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, Xray, CT scan) should be determined on an individual basis.
Danish: Behovet for yderligere klinisk monitorering (f.eks. fysisk undersøgelse, hjertestetoskopi, røntgen, CT scanning) bør bestemmes efter en individuel vurdering.
English: Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur.
Danish: Hjerteklapfibrose (og konstriktiv pericarditis) skal udelukkes, hvis sådanne symptomer opstår.
English: He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started and at regular intervals during treatment.
Danish: Lægen vil også foretage et ekkokardiogram (en ultralydsundersøgelse af hjertet) både før behandlingen begyndes og med jævne mellemrum under behandlingen.
English: Before initiating long-term treatment:
Danish: Før iværksættelse af langtidsbehandling:
English: Section 4 “Possible side effects”:
Danish: Afsnit 4 Bivirkninger
English: The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs.
Danish: De tidlige symptomer på dette viser sig ved en eller flere af følgende tilstande: åndedrætsbesvær, åndenød, smerter i brystet eller ryggen og hævede ben.
English: Section 2 “Before you take [product name]”.
Danish: Afsnit 2 ”Det skal De vide, før De begynder at tage [produktnavn]”
English: 4.8 Undesirable effects:
Danish: 4.8 Bivirkninger
English: Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.
Danish: Herefter bør hyppigheden af ekkokardiografisk monitorering bestemmes efter en passende individuel klinisk vurdering med særlig opmærksomhed på de ovennævnte tegn og symptomer, men bør foretages mindst hver 6.-12. måned.
English: It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy.
Danish: Det kan være hensigtsmæssigt at udføre baseline monitorering af erythrocyt sænkningsreaktionen eller de andre inflammatoriske markører, lungefunktion/røntgen af thorax samt nyrefunktion inden behandlingen initieres
English: During long-term treatment:
Danish: Under langtidsbehandling:
English: The following should be included under Cardiac disorders: “Very common: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
Danish: Følgende tilføjes under Hjerte: ”Meget almindelig: Hjerteklapfibrose (inklusivt tilbageløb) og relaterede lidelser (pericarditis og pericardieekssudat).”
English: “Fibrosis and cardiac valvulopathy and possibly related clinical phenomena:
Danish: ”Fibrose og hjerteklaplidelser og relaterede kliniske fænomener
English: Before initiating treatment:
Danish: Før behandling initieres:
English: If fibrotic valvular disease is detected, the patient should not be treated with pergolide (see section 4.3).
Danish: Hvis en fibrotisk klaplidelse påvises, bør patienten ikke behandles med pergolid (se pkt.
English: During treatment:
Danish: Under behandling:
English: At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline.
Danish: Risk-benefit af cabergolin-behandling bør overvejes ved hvert lægebesøg, for at afgøre om behandlingen skal fortsætte.
English: Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as pergolide.
Danish: Fibrotiske og serøse inflammatoriske tilstande, såsom pleuritis, pleuraeffusion, pleural fibrose, lungefibrose, pericarditis, pericardieekssudat, hjerteklaplidelser, som involverer en eller flere hjerteklapper (aorta, mitral og trikuspidal) eller retroperitoneal fibrose er set efter længerevarende brug af ergolinderivater med agonistisk aktivitet på serotonin 5HT2B-receptorer, som f.eks. pergolid.
English: Take special care with [product name]”
Danish: Vær ekstra forsigtig med at tage [produktnavn]”
English: Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline.
Danish: Fibrotiske og serøse inflammatoriske tilstande, såsom pleuritis, pleuraeffusion, pleural fibrose, lungefibrose, pericarditis, pericardieekssudat og hjerteklaplidelser, som involverer en eller flere hjerteklapper (aorta, mitral og trikuspidal) eller retroperitoneal fibrose, er set efter længerevarende brug af sekalealkaloider med agonistisk aktivitet på serotonin 5HT2B-receptorer, som f.eks. cabergolin.
English: If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).
Danish: Hvis der påvises en fibrotisk klaplidelse, bør patienten ikke behandles med cabergolin (se pkt.
English: Before treatment your physician will check whether your heart, lungs and kidneys are in good condition.
Danish: Før behandling vil lægen normalt undersøge Deres hjerte, lunger og nyrer.
English: ANNEX III AMENDMENTS TO THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Danish: BILAG III ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential.
Danish: Klinisk diagnostisk monitorering med henblik på udvikling af fibrotiske lidelser anbefales efter behov.
English: “- If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.”
Danish: “- hvis du har eller tidligere har haft fibrotiske reaktioner (arvæv), der har påvirket dit hjerte, dine lunger eller dit underliv."
English: “Before administration of cabergoline pregnancy should be excluded.
Danish: Graviditet skal udelukkes inden behandling med cabergolin påbegyndes.
English: Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb oedema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis.
Danish: • Nyreinsufficiens eller obstruktion af kar i ureter/abdomen, som kan optræde med lænde-/sidesmerter og ødemer i underekstremiteterne samt evt. udfyldning eller ømhed i maven, som kan være tegn på retroperitoneal fibrose.
English: Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue product name] one month before intended conception.”
Danish: Pga. begrænset klinisk erfaring og cabergolins lange halveringstid bør kvinder, der ønsker, at blive gravide, seponere Dostinex mindst 4 uger før planlagt konception.
English: “For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Danish: “Ved langtidsbehandling: Tegn på hjerteklapbeskadigelse konstateret ved EKG før behandlingsstart.”
English: Cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
Danish: Hjerteklap- og perikardial fibrose manifesterer sig ofte som hjertesvigt.
English: Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values.
Danish: I tilfælde af uforklarlig stigning i ESR og abnorme værdier anbefales røntgenundersøgelse af thorax.
English: Valvulopathy has been associated with cumulative doses, therefore, patients should be treated with the lowest effective dose.
Danish: Derfor bør patienter behandles med den laveste effektive dosis.
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide.
Danish: I nogle tilfælde bedredes symptomerne eller manifestationerne på hjerteklaplidelsen efter seponering af pergoliod.
English: In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline.
Danish: I nogle tilfælde bedredes symptomerne eller manifestationerne på hjerteklaplidelsen efter seponering af cabergolin.
English: Clinical diagnostic monitoring for development of valvular disease or fibrosis, as appropriate, is essential.
Danish: Klinisk diagnostisk monitorering for udvikling af hjerteklaplidelse eller fibrose anbefales efter behov.
English: Pergolide should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Danish: Pergolid bør seponeres, hvis ekkokardiografi viser ny eller forværret tilbageløb pga. hjerteklaplidelse, klapfunktionsindskrænkning eller fortykkelse af hjerteklap (se pkt.