FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased uric acid clearance by the kidney is a known effect of tolvaptan.
Danish: Nedsat clearance af urinsyre i nyrerne er en kendt bivirkning ved tolvaptan.
English: It may still be alright for you to take these medicines and Jinarc together.
Danish: Du kan måske alligevel godt tage disse lægemidler sammen med Jinarc.
English: The initial dose is to be titrated upward to a split-dose regimen of 90 mg tolvaptan (60 mg + 30 mg) per day and then to a target split-dose regimen of 120 mg tolvaptan (90 mg + 30 mg) per day, if tolerated, with at least weekly intervals between titrations.
Danish: Den indledende dosis skal titreres op til et delt dosisregime på 90 mg tolvaptan (60 mg + 30 mg) dagligt og derefter til et endeligt delt dosisregime på 120 mg tolvaptan (90 mg + 30 mg) dagligt, hvis det kan tolereres, med mindst ugentlige intervaller mellem titreringer.
English: The primary end point for TKV did not distinguish a difference in change (−1.7 %) over the 5 year treatment between early- and delayed-treated subjects at the pre-specified threshold of statistical significance (p = 0.3580).
Danish: Hvad angår det primære endepunkt for TKV, sås ingen forskel i ændring (−1,7 %) over denne 5-års periode mellem de patienter, der fik øjeblikkelig behandling, og de patienter, der fik udskudt behandling, ved den præspecificerede tærskel for statistisk signifikans (p = 0,3580).
English: Tolvaptan must not be taken with grapefruit juice (see section 4.5).
Danish: Tolvaptan må ikke tages sammen med grapefrugtjuice (se pkt.
English: These may increase the effect of Jinarc.
Danish: Disse kan øge virkningen af Jinarc.
English: Dehydration, Hypernatraemia, Decreased appetite, Hyperuricaemia, Hyperglycaemia, Gout
Danish: Dehydrering, Hypernatriæmi, Nedsat appetit, Hyperurikæmi, Hyperglykæmi, Arthritis urica
English: The initial dose is 60 mg tolvaptan per day as a split-dose regimen of 45 mg + 15 mg (45 mg taken upon waking and prior the morning meal and 15 mg taken 8 hours later).
Danish: Den indledende dosis er 60 mg tolvaptan dagligt som et delt dosisregime med 45 mg + 15 mg (45 mg tages ved opvågning og inden morgenmaden, og 15 mg tages 8 timer senere).
English: Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) stages 1 to 4 with evidence of rapidly progressing disease.
Danish: Jinarc anvendes til at behandle ADPKD hos voksne med kronisk nyresygdom (CKD) i stadium 1 til 4 med tegn på stor sygdomsaktivitet.
English: • treatments containing ketoconazole for fungal infections, macrolide antibiotics like clarithromycin, or diltiazem as a treatment for high blood pressure and chest pain.
Danish: • præparater, der indeholder ketoconazol mod svampeinfektioner, makrolidantibiotika som clarithromycin, eller diltiazem, der bruges mod forhøjet blodtryk og smerter i brystet.
English: CYP3A substrates
Danish: CYP3A-substrater
English: The key secondary endpoint was a comparison of the efficacy of tolvaptan treatment vs. placebo in reducing the decline of annualized eGFR slope across all measured time points in the trial.
Danish: Det vigtigste sekundære endepunkt var en sammenligning af effekten af tolvaptan versus placebo i forhold til at reducere faldet i eGFR-hældning på tværs af alle målte tidspunkter i studiet omregnet til årsbasis.
English: Co-administration with vasopressin analogues
Danish: Samtidig administration af vasopressinanaloger
English: • difficulty sleeping
Danish: • søvnproblemer
English: • full or bloated or uncomfortable feeling in the stomach
Danish: • følelse af mæthed eller ubehag i maven
English: The pharmacodynamic effects of tolvaptan have been determined in healthy subjects and subjects with ADPKD across CKD stages 1 to 4.
Danish: Tolvaptans farmakodynamiske virkninger er blevet fastlagt hos raske frivillige og forsøgspersoner med ADPKD med CKD-stadier 1 til 4.
English: • Pregnancy outcomes, in patients treated with Jinarc
Danish: • Graviditetsudfald hos patienter behandlet med Jinarc
English: In a population pharmacokinetic analysis in patients with hepatic oedema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.
Danish: I en farmakokinetisk populationsanalyse af patienter med hepatisk ødem var AUC for tolvaptan hos patienter med svært (Child-Pugh klasse C) og let eller moderat (Child-Pugh klasse A og B) nedsat leverfunktion 3,1 og 2,3 gange højere end hos raske forsøgspersoner.
English: In a double-blind, placebo-controlled trial of patients with ADPKD, potentially clinically significant increased uric acid (greater than 10 mg/dL) was reported at a higher rate in tolvaptan-patients (6.2 %) compared to placebo-treated patients (1.7 %).
Danish: I et dobbelt-blindet, placebo-kontrolleret studie af patienter med ADPKD blev der indberettet et potentielt klinisk signifikant øget indhold af urinsyre (mere end 10 mg/dl) med en højere forekomst hos tolvaptanpatienter (6,2 %) sammenlignet med placebo-behandlede patienter (1,7 %).
English: If a patient shows abnormal ALT, AST or BT levels prior to initiation of treatment which fulfil the criteria for permanent discontinuation (see below) the use of tolvaptan is contraindicated (see section 4.3).
Danish: Hvis en patient inden behandlingsstart har unormale ALT-, AST- eller BT-niveauer, som opfylder kriterierne for permanent seponering (se nedenfor), er brugen af tolvaptan kontraindiceret (se pkt.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opført efter, hvor alvorlige de er.
English: The results of the primary endpoint, the rate of change in TKV for subjects randomised to tolvaptan (normalised as percentage) to the rate of change for subjects on placebo, were highly statistically significant.
Danish: Resultaterne af det primære endepunkt: Ændringen af nyrevolumen målt ved TKV for forsøgspersoner, randomiseret til tolvaptan (normaliseret som procentdel) versus ændringen af nyrevolumen for forsøgspersoner på placebo var i høj grad statistisk signifikant.
English: The dose combinations are: 45 mg + 15 mg
Danish: Dosiskombinationerne er: 45 mg + 15 mg
English: (CKD stage 3) or less than
Danish: (CKD stadie 3) eller eGFR på mindre end 30,
English: Approximately 35 % of subjects were chronic kidney disease (CKD) stage 1, 48 % CKD stage 2, and 17 % CKD stage 3 (eGFRCKD-EPI).
Danish: Ca. 35 % af forsøgspersonerne havde kronisk nyresygdom (CKD) i stadium 1, 48 % havde CKD i stadium 2 og 17 % havde CKD i stadium 3 (eGFRCKD-EPI).
English: Idiosyncratic hepatic toxicity
Danish: Idiosynkratisk levertoksicitet
English: Two (2/957, 0.2 %) of these tolvaptan treatedpatients, as well as a third patient from an extension open label trial, exhibited increases in hepatic enzymes (> 3 × ULN) with concomitant elevations in BT (> 2 × ULN).
Danish: 2 (2/957, 0,2 %) af disse patienter, der blev behandlet med tolvaptan, samt en 3. patient fra et open-label forlængelsesstudie udviklede stigninger i leverenzymer (> 3 × ULN) med samtidigt forhøjet totalt bilirubin (BT) (> 2 × ULN).
English: In a double-blind, placebo-controlled trial in patients with ADPKD, elevation (> 3 × upper limit of normal [ULN]) of ALT was observed in 4.4 % (42/958) of patients on tolvaptan and 1.0 % (5/484) of patients on placebo, while elevation (> 3 × ULN) of AST was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Danish: I et dobbeltblindet, placebo-kontrolleret studie af patienter med ADPKD observeredes forhøjet (> 3 × øvre normalgrænse [ULN]) ALT hos 4,4 % (42/958) af patienter på tolvaptan og 1,0 % (5/484) af patienter på placebo, mens forhøjet (> 3 × ULN) AST observeredes hos 3,1 % (30/958) af patienter på tolvaptan og 0,8 % (4/484) af patienter på placebo.
English: While these concomitant elevations were reversible with prompt discontinuation of tolvaptan, they represent a potential for significant liver injury.
Danish: De samtidige forhøjede værdier var reversible ved hurtig seponering af tolvaptan, men udgør en risiko for signifikant leverskade.
English: Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration.
Danish: Lægemidler med højt natriumindhold, f.eks. analgetiske brusetabletter og visse natriumholdige præparater mod dyspepsi, kan også øge koncentrationen af serum-natrium.
English: Adverse reactions of gout were reported more frequently in tolvaptan-treated patients (28/961, 2.9 %) than in patients receiving placebo (7/483, 1.4 %).
Danish: Bivirkninger i form af podagra indberettedes hyppigere hos tolvaptan-behandlede patienter (28/961, 2,9 %) end hos patienter, der fik placebo (7/483, 1,4 %).
English: • if you have difficulties urinating or have an enlarged prostate.
Danish: • hvis du har besvær med at lade vandet eller har forstørret blærehalskirtel (prostata).
English: The primary endpoint of the trial was the change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline levels to post-treatment assessment.
Danish: Det primære endepunkt for studiet var ændringen i den estimerede glomerulære filtrationshastighed (eGFR) fra baseline (før behandling) til den afsluttende vurdering (efter behandling).
English: Concomitant use of medicinal products that are potent CYP3A inducers (e.g., rifampicin) will decrease tolvaptan exposure and efficacy.
Danish: Samtidig anvendelse af lægemidler, der er stærke CYP3A-inducere (f.eks. rifampicin) vil nedsætte eksponeringen for og virkningen af tolvaptan.
English: • if you suffer from liver disease.
Danish: • hvis du har en leversygdom.
English: While these criteria were useful in enriching the study population with patients who were rapidly progressing, subgroup analyses based on stratification criteria (age, TKV, GFR, Albuminuria, Hypertension) indicated the presence of such risk factors at younger ages predicts more rapid disease progression.
Danish: Samtidig indikerede undergruppeanalyser baseret på stratificeringskriterier (alder, TKV, GFR, albuminuri, hypertension), at tilstedeværelsen af sådanne risikofaktorer i yngre aldre prædikterer hurtigere sygdomsprogression.
English: The patient information pack should contain:
Danish: Informationspakken til patienter skal indeholde:
English: In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended.
Danish: Hos patienter, hvor der er mistanke om tolvaptanoverdosering, anbefales vurdering af blodtryk, puls og temperatur, elektrolytkoncentrationer, ekg og væskestatus.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Smid ikke medicinrester i afløbet eller skraldespanden.
English: • digoxin (a medicine for the treatment of irregular heart beat and heart failure), dabigatran (used to thin the blood), rosuvastatin or pitavastatin (used to lower blood cholesterol) methotrexate (used to treat cancer, arthritis), ciprofloxacin (an antibiotic), sulfasalazine (for treatment of inflammatory bowel disease or rheumatoid arthritis) or metformin (for treatment of diabetes).
Danish: • digoxin (et lægemiddel til behandling af uregelmæssigt hjerteslag og hjertesvigt), dabigatran (blodfortyndende middel), rosuvastatin eller pitavastatin (middel mod forhøjet kolesterol i blodet), methotrexat (middel mod kræft og artritis), ciprofloxacin (et antibiotisk middel), sulfasalazin (til behandling af betændelse i tyktarmen eller reumatoid artritis) eller metformin (til behandling af diabetes).
English: Co-administration of tolvaptan with a high-fat meal increased peak concentrations of tolvaptan up to 2-fold but left AUC unchanged.
Danish: Samtidig administration af tolvaptan og et måltid med højt fedtindhold øgede de maksimale koncentrationer af tolvaptan op til 2 gange, men ændrede ikke AUC.
English: The primary focus of the clinical program for development of tolvaptan tablets for the treatment of ADPKD is a single pivotal, multinational, phase 3, randomised, placebo controlled trial in which the long-term safety and efficacy of oral split dose tolvaptan regimens (titrated between 60 mg/day and 120 mg/day) were compared with placebo in 1,445 adult subjects with ADPKD.
Danish: Det primære fokus for det kliniske program til udvikling af tolvaptan-tabletter i behandlingen af ADPKD er et enkelt, pivotalt, multinationalt, fase-3, randomiseret, placebo-kontrolleret studie, hvor den langsigtede sikkerhed og virkning af regimer med orale delte doser af tolvaptan (titreret mellem 60 mg/dgl og 120 mg/dgl) blev sammenlignet med placebo hos 1.445 voksne forsøgspersoner med ADPKD.
English: Effect of other medicinal products on the pharmacokinetics of tolvaptan
Danish: Virkningen af andre lægemidler på tolvaptans farmakokinetik
English: In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported.
Danish: Efter markedsføringen er der ved brug af tolvaptan til behandling af ADPKD rapporteret om akut leversvigt, hvor levertransplantation var påkrævet.
English: The relative rate of ADPKD-related events was decreased by 13.5 % in tolvaptan-treated patients, (hazard ratio, 0.87; 95 % CI, 0.78 to 0.97; p = 0.0095).
Danish: Det relative antal af ADPKD-relaterede hændelser faldt med 13,5 % hos tolvaptan-behandlede patienter, (hazard ratio, 0,87; 95 % CI, 0,78 til 0,97; p = 0,0095).
English: The no observed adverse effect level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the maximum human recommended dose of 120 mg/day on a mg/m basis.
Danish: NOAEL-værdien (no observed adverse effect level) for virkning på reproduktionsevnen hos hunrotter (100 mg/kg/dgl) var ca. 8 gange den anbefalede maksimaldosis for mennesker på 120 mg/dgl, baseret på mg/m
English: Women of childbearing potential must use adequate contraceptive measures during Jinarc use.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med Jinarc.
English: • if you are breastfeeding (see “Pregnancy and breast-feeding).
Danish: • hvis du ammer (se “Graviditet og amning”).
English: (CKD stage 4), respectively.
Danish: (CKD stadie 2), eGFR på
English: The other ingredients are lactose monohydrate (see section 2), maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake.
Danish: Øvrige indholdsstoffer: laktosemonohydrat (se punkt 2), majsstivelse, mikrokrystallinsk cellulose, hydroxypropylcellulose, magnesiumstearat, indigocarmin aluminium lake (E 132).
English: The morning dose is to be taken at least 30 minutes before the morning meal.
Danish: Morgendosis skal tages mindst 30 minutter før morgenmaden.
English: Patients must be instructed to drink sufficient amounts of water or other aqueous fluids (see section 4.4).
Danish: Patienter skal opfordres til at drikke tilstrækkelige mængder vand eller andre vandholdige væsker (se pkt.
English: What Jinarc contains
Danish: Jinarc indeholder
English: The primary objective of this trial was to evaluate the long-term efficacy of tolvaptan in ADPKD through rate of total kidney volume (TKV) change (%) for tolvaptan-treated compared with placebo-treated subjects.
Danish: Det primære formål med dette studie var at evaluere den langsigtede virkning af tolvaptan til ADPKD ved at måle ændringen af den totale nyrevolumen (TKV) i % for tolvaptan-behandlede sammenlignet med placebo-behandlede forsøgspersoner.
English: Gastroesophageal reflux disease
Danish: Gastroøsofageal reflukssygdom
English: Steady state digoxin concentrations were increased (1.3-fold in maximum observed plasma concentration [Cmax] and 1.2fold in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when coadministered with multiple once daily 60 mg doses of tolvaptan.
Danish: Steady statedigoxinkoncentrationer er set øget (1,3 gange øgning i maksimal observeret plasmakoncentration [Cmax] og 1,2 gange øgning af arealet under tidskurven for plasmakoncentration over doseringsintervallet [AUCτ]) ved samtidig administration af flere doser tolvaptan på 60 mg én gang dagligt.
English: Since hypersensitivity is a contraindication (see section 4.3) treatment must never be restarted after an anaphylactic reaction or other serious allergic reactions.
Danish: 4.3), må behandlingen aldrig påbegyndes igen efter en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Swallow the tablets without chewing, with a glass of water.
Danish: Tabletterne sluges hele med et glas vand.
English: • Elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan (see section 4.4)
Danish: • Forhøjede leverenzymer og/eller tegn eller symptomer på leverskade før indledning af behandling, som opfylder kravene for permanent seponering af tolvaptan (se pkt.
English: * reported during post-marketing surveillance of tolvaptan approved for other indications observed in post-marketing with tolvaptan in ADPKD.
Danish: overvågning efter markedsføring af tolvaptan godkendt til andre indikationer observeret efter markedsføring ved brug af tolvaptan til behandling af ADPKD.
English: 4) worsening albuminuria
Danish: 4) forværret albuminuri
English: Both groups' TKV growth trajectory was slowed, relative to placebo in the first 3 years, suggesting both early- and delayed- tolvaptan treated subjects benefitted to a similar degree.
Danish: Begge gruppers TKV-vækstkurve blev bremset sammenholdt med placebo de første 3 år, hvilket tyder på, at de patienter, der fik øjeblikkelig behandling, og de patienter, der fik udskudt behandling, havde lige stor gavn af tolvaptan.
English: Jinarc may increase the effect of these medicines.
Danish: Jinarc kan øge virkningen af ovenstående lægemidler.
English: In a population pharmacokinetic analysis for patients with ADPKD, tolvaptan concentrations were increased, compared to healthy subjects, as renal function decreased below eGFR of 60 mL/min/1.73 m2. An eGFRCKD-EPI decrease from 72.2 to 9.79 (mL/min/1.73 m2) was associated with a 32 % reduction in total body clearance.
Danish: I en farmakokinetisk populationsanalyse af patienter med ADPKD var tolvaptankoncentrationer højere end hos raske forsøgspersoner, da nyrefunktionen faldt under eGFR på 60 ml/min/1,73 m2. Et fald i eGFRCKD-EPI fra 72,2 til 9,79 (ml/min/1,73 m 2) blev forbundet med en 32 % reduktion i total kropsclearance.
English: Therefore, concomitant administration of tolvaptan with potent CYP3A inducers (e.g., rifampicin, rifabutin, rifapentin, phenytoin, carbamazepine, and St. John's Wort) is to be avoided.
Danish: Derfor skal samtidig administration af tolvaptan og stærke CYP3A-inducere (f.eks. rifampicin, rifabutin, rifapentin, phenytoin, carbamazepin og prikbladet perikum) undgås.
English: Urinary output must be secured.
Danish: Det skal sikres, at der ikke er urinvejsobstruktion.
English: Effect of tolvaptan on the pharmacokinetics of other products
Danish: Tolvaptans virkning på andre lægemidlers farmakokinetik
English: • find it difficult to urinate.
Danish: • har svært ved at lade vandet.
English: Special care must be taken if you have a disease that reduces appropriate fluid intake or if you are at an increased risk of water loss e.g. in case of vomiting or diarrhoea.
Danish: Der skal udvises særlig forsigtighed, hvis du har en sygdom, som forhindrer tilstrækkeligt væskeindtag, eller hvis du er udsat for en øget risiko for vandtab, f.eks. i tilfælde af opkastning eller diarré.
English: Jinarc contains lactose
Danish: Jinarc indeholder laktose
English: In this trial a total of 1,445 adult patients (age 18-50 years) with evidence of rapidly-progressing, early ADPKD (meeting modified Ravine criteria, total kidney volume (TKV) ≥ 750 mL, estimated creatinine clearance ≥ 60 mL/min) were randomized 2:1 to treatment with tolvaptan or placebo.
Danish: I studiet blev i alt 1.445 voksne patienter (i alderen 18-50 år) med evidens på tidlig ADPKD med hurtig progression (der opfyldte modificerede Ravine-kriterier, totalt nyrevolumen (TKV) ≥ 750 ml, estimeret kreatininclearance ≥ 60 ml/min) randomiseret 2:1 til behandling med tolvaptan eller placebo.
English: Dose adjustment for patients taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors, tolvaptan doses have to be reduced as follows:
Danish: Dosisjustering for patienter, der tager moderate CYP3A-hæmmere Hos patienter, der tager moderate CYP3A-hæmmere, skal dosis af tolvaptan reduceres som følger:
English: To mitigate the risk of significant and/or irreversible liver injury, blood testing for hepatic transaminases and bilirubin is required prior to initiation of Jinarc, continuing monthly for 18 months and at regular 3-monthly intervals thereafter.
Danish: For at mindske risikoen for signifikant og/eller irreversibel leverskade, er det nødvendigt at tage blodprøver for hepatiske transaminaser og bilirubin før behandlingen påbegyndes, samt fortsætte hermed hver måned i 18 måneder derefter med 3-måneders intervaller.
English: If you forget to take Jinarc
Danish: Hvis du har glemt at tage Jinarc
English: • dehydration
Danish: • dehydrering
English: CYP3A inducers
Danish: CYP3A-inducere
English: Tolvaptan daily split-dose Reduced dose (once daily) 90+30 mg
Danish: Daglig delt dosis af tolvaptan Reduceret dosis (én gang dagligt) 90+30 mg
English: Consult your doctor if symptoms of nausea, vomiting, fever, tiredness, loss of appetite, pain in the abdomen, dark urine, jaundice (yellowing of skin or eyes), itching of your skin or joint and muscle pain with fever occur.
Danish: Kontakt din læge, hvis du oplever symptomer som kvalme, opkastning, feber, træthed, appetitløshed, mavesmerter, mørk urin, gulsot (gulfarvning af hud og øjne), kløende hud eller led- og muskelsmerter med feber.
English: Genotyping for PKD1 and PKD2 genes was conducted in a majority of patients entering the openlabel extension study (TEMPO 4:4) but the results are not yet known.
Danish: Hos størstedelen af de patienter, der deltog i det åbne forlængelsesstudie (TEMPO 4:4), er der foretaget genotypebestemmelse, hvad angår PKD1- og PKD2-generne, men resultaterne kendes endnu ikke.
English: • Hepatotoxicity associated with the use of Jinarc.
Danish: • Hepatotoksicitet i forbindelse med anvendelsen af Jinarc.
English: Dose reduction of tolvaptan is recommended for patients while taking moderate or strong CYP3A inhibitors (see section 4.2).
Danish: Det anbefales at reducere dosis af tolvaptan for patienter, mens de tager moderate eller stærke CYP3A-hæmmere (se pkt.
English: Aspartate aminotransferase increased,
Danish: Øget alaninaminotransferase, Øget aspartataminotransferase, Vægttab
English: Special care must be taken in patients having diseases that impair appropriate fluid intake or who are at an increased risk of water loss e.g. in case of vomiting or diarrhoea.
Danish: Der skal udvises særlig forsigtighed hos patienter, der har sygdomme, som forhindrer tilstrækkeligt væskeindtag eller som er udsat for større risiko for vandtab, f.eks. i tilfælde af opkastning eller diarré.
English: If you stop taking Jinarc
Danish: Hvis du holder op med at tage Jinarc
English: If dehydration or renal dysfunction becomes evident, appropriate action must be taken which may include the need to interrupt or reduce doses of tolvaptan and/or diuretics and increased fluid intake.
Danish: Hvis der konstateres dehydrering eller nyredysfunktion, skal der træffes passende foranstaltninger, hvilket kan gøre det nødvendigt at seponere tolvaptan eller reducere dosis af tolvaptan og/eller diuretika samt øge væskeindtaget.
English: Therapy must be interrupted if the ability to drink or the accessibility to water is limited (see section 4.4).
Danish: Hvis evnen til at drikke eller adgangen til vand er begrænset, skal behandlingen seponeres (se pkt.