FrancophonIA/ELRC3.0 huggingface dataset:
English: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5).
Danish: Til voksne Den anbefalede dosis og behandlingsplan er: 0,8 mg/kg legemsvægt (BW) busulfan som 2 timers infusion hver 6. time 4 dage i træk, dvs. i alt 16 doser efterfulgt af cyclophosphamid 60 mg/kg/dag i to dage, som først indledes mindst 24 timer efter den 16. dosis af busulfan (se pkt.
English: Weight increased Abnormal breath sounds
Danish: Anormale vejrtrækningslyde Forhøjet kreatinin
English: Like all medicines, Busulfan Fresenius Kabi can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Busulfan will be administered every 6 hours during 4 consecutive days prior to transplant.
Danish: Busulfan Fresenius Kabi gives hver 6. time 4 dage i træk forud for transplantationen
English: Dimethylacetamide Macrogol 400
Danish: 6.1 Hjælpestoffer Dimethylacetamid Macrogol 400.
English: Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Busulfan Fresenius Kabi skal fortyndes før brug med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning.
English: The quantity of the diluent must be 10 times the volume of Busulfan Fresenius Kabi ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Danish: For at sikre, at den endelige koncentration af busulfan er ca. 0,5 mg/ml, skal mængden af fortyndingsvæske være 10 gange volumenet af Busulfan Fresenius Kabi.
English: Busulfan in combination with cyclophosphamide or melphalan
Danish: Dosering Busulfan i kombination med cyclophosphamid eller melphalan.
English: What Busulfan Fresenius Kabi is and what it is used for What you need to know before you use Busulfan Fresenius Kabi How to use Busulfan Fresenius Kabi Possible side effects
Danish: Det skal du vide, før du begynder at bruge Busulfan Fresenius Kabi Sådan skal du bruge Busulfan Fresenius Kabi Bivirkninger
English: Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood.
Danish: Mave-tarm: betændelse i spiserørets slimhinde, lammelse af tarmen, opkastning af blod.
English: Alveolar haemorrhages Asthma
Danish: Hyperventilation Respirationssvigt Alveolær hæmoragi Astma
English: Weight increased
Danish: Forhøjet GGT Vægtøgning
English: Ventricular Extrasystoles Bradycardia
Danish: Ventrikulære ekstrasystoler
English: Encephalopathy Cerebral haemorrhage
Danish: Hjerneblødning Encefalopati
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan
Danish: Busulfan Fresenius Kabi 6 mg/ml koncentrat til infusionsvæske, opløsning busulfan
English: Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion Busulfan
Danish: Busulfan Fresenius Kabi 6 mg/ml koncentrat til infusionsvæske, opløsning Busulfan
English: Diluted Busulfan Fresenius Kabi is a clear colourless solution.
Danish: Efter fortynding er Busulfan Fresenius Kabi en klar, farveløs opløsning.
English: Hepatomegaly Jaundice
Danish: Arytmi Atrieflimren
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Æske indeholdende 1 hætteglas
English: IV after dilution
Danish: efter fortynding.
English: How to store Busulfan Fresenius Kabi
Danish: Busulfan Fresenius
English: For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in {MM/YYYY} Other sources of information
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af markedsføringstilladelsen.
English: Busulfan Fresenius Kabi in combination with cyclophosphamide: - The recommended dose of Busulfan Fresenius Kabi is 0.8 mg/kg
Danish: Den anbefalede dosis af Busulfan Fresenius Kabi er 0,8 mg/kg .
English: • Quantity of diluent: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent
Danish: Y (kg) x D (mg/kg) = A ml Busulfan Fresenius Kabi, som skal fortyndes.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: FREMSTILLERENS BATCHNUMMER<, DONATIONS- OG PRODUKTKODER> Batch
English: PRESENTATION
Danish: TILLADELSEN
English: Busulfan Fresenius Kabi must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Kabi må kun overføres til en infusionspose, som indeholder 9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske.
English: Cataract Corneal thinning
Danish: Anale gener
English: What Busulfan Fresenius Kabi looks like and contents of the pack Busulfan Fresenius Kabi consists of a concentrate for solution for infusion.
Danish: Busulfan Fresenius Kabi er et koncentrat til infusionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion
Danish: Busulfan Fresenius Kabi 6 mg/ml koncentrat til infusionsvæske, opløsning
English: There are no precautions for the person, but it is recommended to wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Danish: Der skal ikke træffes nogen foranstaltninger af den pågældende person, men det anbefales at vaske og desinficere sine hænder og udstyret efter vaccinationen for at undgå spredning af virusset.
English: This will help protect them against infectious bronchitis.
Danish: Derved opnås bedre beskyttelse mod infektiøs bronkitis.
English: The vaccine virus may spread from vaccinated to non-vaccinated chickens, so care should be taken to separate vaccinated from non-vaccinated chickens.
Danish: Vaccinen kan sprede sig fra vaccinerede til ikke-vaccinerede kyllinger, så det er vigtig at holde vaccinerede kyllinger adskilt fra ikke-vaccinerede kyllinger.
English: In the future if the animals are exposed to the virus the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for virussen, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 on 9 June 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis IB 4-91 den 9. juni 1998.
English: It is also the time allowed after administration of the medicine before eggs may be used for human consumption.
Danish: Det er også den tid, der skal gå efter indgivelsen af lægemidlet, før æggene kan anvendes til menneskeligt konsum.
English: Avian infectious bronchitis vaccine (live attenuated)
Danish: Aviær infektiøs bronkitisvaccine (levende, svækket)
English: The vaccine was given by coarse spray to chicken of various ages.
Danish: Vaccinen blev givet via grov spray til kyllinger i forskellig alder.
English: The withdrawal period for Nobilis IB 4-91 for chickens is zero days.
Danish: Tilbageholdelsestiden for Nobilis IB 4-91 til kyllinger er nul dage.
English: In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.
Danish: I den ene undersøgelse havde 100 % af kyllingerne efter tre uger dannet antistoffer mod IB 4-91-virus sammenlignet med 17 % af kontrolkyllingerne.
English: Nobilis IB 4-91 vaccine has also been compared with controls, i.e. chickens that were not vaccinated.
Danish: Nobilis IB 4-91-vaccine er også blevet sammenlignet med kontrolkyllinger, dvs. kyllinger, som ikke var blevet vaccineret.
English: Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens.
Danish: Nobilis IB 4-91 kan forårsage milde respiratoriske symptomer på sygdom, som kan vare i nogle få dage, afhængigt af den enkelte kyllings helbred og tilstand.
English: The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray.
Danish: Vaccinen kan anvendes til kommende æglæggere og avlsfugle fra daggamle og frem via intranasal/okulær administration eller grov spray.
English: The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials.
Danish: Nobilis IB 4-91-vaccinen blev undersøgt i forskellige vaccinationsprogrammer i en række undersøgelser.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 exceed the risks for the approved indication and recommended that Nobilis IB 4-91 should be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Nobilis IB 4-91opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Nobilis IB 4-91.
English: The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease.
Danish: De primære effektmål omfattede dannelse af antistoffer mod IB 4-91-virus, den samlede dødelighed hos kyllingerne og den procentvise andel af kyllinger, som blev kasseret på grund af sygdom.
English: When Nobilis IB 4-91 is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når Nobilis IB 4-91 gives til kyllinger, registrerer dyrenes immunsystem virus som »fremmede« og reagerer ved at danne antistoffer mod dem.
English: Nobilis IB 4-91 is a vaccine.
Danish: Nobilis IB 4-91 er en vaccine.
English: Nobilis IB 4-91 can be given to 1-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration.
Danish: Nobilis IB 4-91 kan gives til daggamle eller ældre kyllinger via grov spray, intranasal (indåndet gennem næseborene) eller okulær (absorberet via øjnene) administration.
English: Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.
Danish: Nobilis IB 4-91 anvendes til immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs bronkitis, som forårsages af stammevarianten IB 4-91, som forårsager infektiøs bronkitis hos kyllinger.
English: The vaccine can be given to 7-day and older chickens in their drinking water.
Danish: Vaccinen kan gives til kyllinger, der er 7 dage gamle eller ældre, via deres drikkevand.
English: There was a clear immune response to Nobilis IB 4-91.
Danish: Der sås et tydeligt immunrespons mod Nobilis IB 4-91.
English: Nobilis IB 4-91 is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus.
Danish: Nobilis IB 4-91 er en dyrevaccine, der indeholder levende, svækket aviær infektiøs bronkitisvaccine.
English: The avian infectious bronchitis virus in Nobilis IB 4-91 has been attenuated (weakened) so that it does not cause disease.
Danish: Aviær infektiøs bronkitisvaccine i Nobilis IB 4-91 er svækket, så den ikke kan fremkalde sygdom.
English: Nobilis IB 4-91 is available as a lyophilisate (freeze-dried powder) which is to be made up into a suspension.
Danish: Nobilis IB 4-91 fås som et lyofilisat (en frysetørret pellet), der benyttes til at fremstille en suspension til indsprøjtning.
English: Other information about Nobilis IB 4-91:
Danish: Øvrige oplysninger om Nobilis IB 4-91:
English: What is the risk associated with Nobilis IB 4-91?
Danish: Hvilken risiko er der forbundet med Nobilis IB 4-91?
English: Why has Nobilis IB 4-91 been approved?
Danish: Hvorfor blev Nobilis IB 4-91 godkendt?
English: What is Nobilis IB 4-91?
Danish: Hvad er Nobilis IB 4-91?
English: How has Nobilis IB 4-91 been studied?
Danish: Hvordan blev Nobilis IB 4-91 undersøgt?
English: What is Nobilis IB 4-91 used for?
Danish: Hvad anvendes Nobilis IB 4-91 til?
English: How does Nobilis IB 4-91 work?
Danish: Hvordan virker Nobilis IB 4-91?
English: What benefit has Nobilis IB 4-91 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobilis IB 4-91?
English: 1 bottle + 30 syringes + 1 syringe adapter + 1 carrying case
Danish: 1 flaske + 30 doseringssprøjter + 1 sprøjteadapter + 1 transporthylster
English: Oral solution bottle (glass)
Danish: Oral opløsning flaske (glas)
English: 1 mg/ml
Danish: EU/1/01/171/001 Rapamune 1 mg/ml
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Qualimed to Qualimed on 23 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Qualimed til Qualimed den 23. september 2009.
English: The standard dose of Clopidogrel Qualimed is one 75 mg tablet once a day, taken with or without
Danish: Standarddosis af Clopidogrel Qualimed er én 75 mg -tablet én gang dagligt med eller uden et måltid.
English: This means that Clopidogrel Qualimed is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Qualimed er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: Clopidogrel Qualimed is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Qualimed anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: What are the benefit and risk of Clopidogrel Qualimed?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Qualimed?
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse den faglige
English: Clopidogrel Qualimed can be given to the following groups of
Danish: Clopidogrel Qualimed kan gives til følgende
English: The full EPAR for Clopidogrel Qualimed can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Qualimed findes her.
English: Clopidogrel Qualimed can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Qualimed kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Qualimed i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: The Committee recommended that Clopidogrel Qualimed be given marketing
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Qualimed.
English: Clopidogrel Qualimed is a ‘generic medicine'.
Danish: Det fås som Clopidogrel Qualimed er et ‘generisk lægemiddel'.
English: Clopidogrel Qualimed is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Qualimed er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Because Clopidogrel Qualimed is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Qualimed er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: How has Clopidogrel Qualimed been studied?
Danish: Hvordan blev Clopidogrel Qualimed undersøgt?
English: Because Clopidogrel Qualimed is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Qualimed er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Clopidogrel Qualimed, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Qualimed, clopidogrel, er en trombocytfunktionshæmmer.
English: Clopidogrel Qualimed can be started between seven days and six months after
Danish: Behandling med Clopidogrel Qualimed kan påbegyndes 7 dage
English: Content Package size
Danish: Indgivelsesvej Emballage Indhold Pakningsstør -relse
English: Packaging
Danish: Tilbageholdelsesti d
English: Your doctor will be able to decide what is suitable for you.
Danish: Din læge skal afgøre, hvad der er egnet til dig.
English: • if you are pregnant
Danish: • hvis du er gravid
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 19 June 2014
Danish: Dato for første markedsføringstilladelse: 3. august 2009 Dato for seneste fornyelse: 19. juni 2014
English: • Take the tablets once a day preferably in the morning with or without food.
Danish: • Tag tabletterne én gang dagligt, helst om morgenen, med eller uden mad.
English: • low blood pressure when standing up
Danish: • lavt blodtryk, når du rejser dig
English: • macrolide antibiotics,
Danish: • makrolide antibiotika,
English: The absolute bioavailability of tolvaptan is about 56 %.
Danish: Den absolutte biotilgængelighed af tolvaptan er ca. 56 %.
English: • Treatment with Samsca will be initiated in hospital.
Danish: • Behandling med Samsca indledes på et hospital.
English: Therefore, more precautionary limits apply during the early treatment phase.
Danish: Flere sikkerhedsgrænser er derfor gældende i den tidlige behandlingsfase.
English: That can lead to difficulties in concentration and memory, or in keeping your balance.
Danish: Det kan føre til koncentrations- og hukommelsesbesvær eller besvær med at holde balancen.
English: • other products which increase the salt in your blood or which contain large amounts of salt.
Danish: • andre produkter, der øger saltindholdet i dit blod, eller som indeholder store mængder salt.
English: Patients have to be carefully monitored during treatment.
Danish: Patienterne skal overvåges omhyggeligt under behandlingen.
English: • if you have a condition which is associated with a very low blood volume
Danish: • hvis du har en sygdom, der er forbundet med et meget lavt blodvolumen
English: • Patients who cannot perceive thirst
Danish: • Patienter, som ikke føler tørst
English: Administration preferably in the morning, without regard to meals.
Danish: Administreres fortrinsvis om morgenen uafhængigt af måltider.
English: Do not take this medicine if you are pregnant or breast-feeding.
Danish: Tag ikke dette lægemiddel, hvis du er gravid eller ammer.
English: The efficacy and safety in this population is not well established.
Danish: Effekten og sikkerheden hos denne population er ikke kendt.
English: Samsca is not suitable for children and adolescents (under age 18).
Danish: Samsca er ikke egnet til børn og unge (under 18 år).
English: • rifampicin (against tuberculosis).
Danish: • rifampicin (mod tuberkulose).
English: If you notice any of the following side effects, you may need urgent medical attention.
Danish: Hvis du bemærker en eller flere af følgende bivirkninger, kan du have brug for akut lægehjælp.
English: • if you cannot drink enough water or if you are fluid restricted
Danish: • hvis du ikke kan drikke nok vand, eller dit væskeindtag skal begrænses
English: Consequently, the frequency of these adverse reactions is qualified as "not known".
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som "ikke kendt".
English: Tolvaptan was superior to placebo (p < 0.0001) for both periods in both studies.
Danish: Tolvaptan var bedre i forhold til placebo (p< 0,0001) i begge perioder i begge studier.
English: These patients may be at higher risk for developing rapid correction of serum sodium during the first 1-2 days of treatment due to potential additive effects.
Danish: Disse patienter kan have højere risiko for at udvikle hurtig korrektion af serum-natrium i løbet af de første 1-2 dage af behandlingen på grund af potential additiv virkning.
English: These responses were seen in patients independent of the underlying disease.
Danish: Disse responser sås hos patienterne uanset underliggende sygdom.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, som står på pakningen og blisterpakken efter ”EXP”.
English: Lactose and galactose intolerance
Danish: Lactose- og galactoseintolerans
English: If you do not take your tablet on one day, take your normal dose on the next day.
Danish: Hvis du glemmer at tage din tablet den ene dag, skal du tage den normale dosis den følgende dag.
English: Samsca with food and drink
Danish: Brug af Samsca sammen med mad og drikke
English: The primary endpoint for these trials was the average daily AUC for change in serum sodium from baseline to Day 4 and baseline to Day 30.
Danish: Det primære endpoint for disse studier var den gennemsnitlige daglige AUC for ændring i serumnatrium fra baseline til dag 4 og fra baseline til dag 30.
English: The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established.
Danish: Tolvaptans sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Stop taking Samsca and immediately contact a doctor or go to the nearest hospital if you:
Danish: Hold straks op med at tage Samsca og kontakt en læge eller nærmeste hospital, hvis du:
English: Samsca causes water loss because it increases your urine production.
Danish: Samsca medfører vandtab, fordi det øger din urinproduktion.
English: If you forget to take your medicine you have to take the dose as soon as you remember on the same day.
Danish: Hvis du har glemt at tage din medicin, skal du tage dosis den samme dag, så snart du husker det.
English: This condition should be excluded prior and during treatment with tolvaptan.
Danish: Denne tilstand skal udelukkes inden og under behandling med tolvaptan.
English: There are no or limited amount of data from the use of tolvaptan in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af tolvaptan til gravide kvinder.
English: Elevated transaminases2
Danish: forhøjede transaminaser2
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Danish: Hvis du har taget flere tabletter end den ordinerede dosis, skal du straks drikke masser af vand og kontakte din læge eller nærmeste hospital.
English: Clearance of tolvaptan is not significantly affected by age.
Danish: Alder Tolvaptans clearance påvirkes ikke signifikant af alder.
English: A total of 111 patients started tolvaptan treatment in an open-label, extension trial, regardless of their previous randomisation.
Danish: I alt 111 patienter påbegyndte behandling med tolvaptan i et open label forlængelsesstudie, uanset deres tidligere randomisering.
English: These findings may suggest that tolvaptan has the potential to cause irreversible and potentially fatal liver injury.
Danish: Disse fund kan antyde, at tolvaptan muligvis kan forårsage irreversibel og potentielt dødelig leverskade.
English: The efficacy and safety of tolvaptan in those with a creatinine clearance < 10 mL/min has not been evaluated and is therefore unknown.
Danish: Virkningen og sikkerheden af tolvaptan hos patienter med kreatininclearance < 10 ml/min er ikke vurderet og er derfor ikke kendt.