FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients taking moderate or strong CYP3A inhibitors must be managed cautiously, in particular if the inhibitors are taken more frequently than once a day.
Danish: Patienter, der tager moderate eller stærke CYP3A-hæmmere, skal kontrolleres nøje, især hvis disse tages oftere end én gang om dagen.
English: A single oral dose of 2,000 mg/kg was lethal in mice and symptoms of toxicity in affected mice included decreased locomotor activity, staggering gait, tremor and hypothermia.
Danish: En enkelt oral dosis på 2.000 mg/kg var dødelig hos mus, og symptomer på toksicitet hos påvirkede mus omfattede nedsat bevægelsesmæssig funktion, vaklende gang, tremor og hypotermi.
English: In addition, increased use of allopurinol and other medicinal products used to manage gout were observed in the double-blind, placebo-controlled trial.
Danish: Endvidere observeredes øget brug af allopurinol og andre lægemidler til at behandle podagra i det dobbelt-blindede, placebo-kontrollerede studie.
English: Patients may down-titrate to lower doses based on tolerability.
Danish: Patienter kan nedtitreres til lavere doser baseret på tolerabilitet.
English: In contrast, there was no effect of tolvaptan on either progression of hypertension or albuminuria.
Danish: Tolvaptan havde ingen virkning på progression af hypertension og albuminuri.
English: • flu-like syndrome (joint and muscle pain with fever)
Danish: • influenzalignende syndrom (led- og muskelsmerter med feber)
English: The effect of mildly or moderately impaired hepatic function (Child-Pugh classes A and B) on the pharmacokinetics of tolvaptan was investigated in 87 patients with liver disease of various origins.
Danish: Virkningen af let eller moderat nedsat leverfunktion (Child-Pugh klasse A og B) på tolvaptans farmakokinetik blev undersøgt hos 87 patienter med leversygdom af forskellig oprindelse.
English: However, events of increased uric acid and/or gout were not serious and did not cause discontinuation of therapy in the double-blind, placebo-controlled trial.
Danish: Tilfældene af øget indhold af urinsyre og/eller af podagra var dog ikke alvorlige og bevirkede ikke seponering af behandling i det dobbelt-blindede, placebo-kontrollerede studie.
English: This water loss may result in side effects such as dry mouth and thirst or even more severe side effects like kidney problems (see section 4).
Danish: Dette vandtab kan medføre bivirkninger som mundtørhed og tørst eller endnu alvorligere bivirkninger som f.eks. nyreproblemer (se punkt 4).
English: Patients receiving digoxin or other narrow therapeutic P-gp substrates (e.g., dabigatran) must therefore be managed cautiously and evaluated for excessive effects when treated with tolvaptan.
Danish: Patienter, der får digoxin eller andre smalle terapeutiske P-gp substrater (f.eks. dabigatran), skal derfor kontrolleres nøje og evalueres for overdreven effekt, når de behandles med tolvaptan.
English: Taken with Jinarc these may increase the risk of low blood pressure when you stand up from sitting or lying down.
Danish: Hvis disse tages sammen med Jinarc, kan de øge risikoen for lavt blodtryk, når du rejser dig fra siddende eller liggende stilling.
English: Tablets must be swallowed without chewing and with a glass of water.
Danish: Tabletterne skal synkes hele uden at tygge sammen med et glas vand.
English: Jinarc must not be used during pregnancy (see section 4.3).
Danish: Jinarc må ikke anvendes under graviditet (se pkt.
English: Bilirubin increased
Danish: Øget bilirubin
English: • Patients who cannot perceive or respond to thirst
Danish: • Patienter, som ikke føler tørst.
English: Elimination
Danish: Eliminiation
English: Information in braille:
Danish: Information i brailleskrift:
English: Tolvaptan is extensively metabolised in the liver almost exclusively by CYP3A.
Danish: Tolvaptan metaboliseres i høj grad i leveren og næsten udelukkende af CYP3A.
English: Co-administration of tolvaptan with rifampicin reduces Cmax and AUC for tolvaptan by about 85 %.
Danish: Samtidig administration af tolvaptan og rifampicin reducerer Cmax og AUC for tolvaptan med ca. 85 %.
English: No clinical trials in subjects with a creatinine clearance < 10 mL/min or in patients undergoing dialysis have been conducted.
Danish: Der er ikke udført studier af patienter med kreatininclearance på < 10 ml/min eller hos patienter i dialyse.
English: Jinarc can only be prescribed by doctors who are specialised in the treatment of ADPKD.
Danish: Jinarc må kun ordineres af læger, som har specialkundskab inden for ADPKD.
English: • dark urine
Danish: • mørk urin
English: In healthy subjects, tolvaptan, a CYP3A substrate, had no effect on the plasma concentrations of some other CYP3A substrates (e.g. warfarin or amiodarone).
Danish: Hos raske forsøgspersoner havde tolvaptan, et CYP3A-substrat, ingen virkning på plasmakoncentrationer af andre CYP3A-substrater (f.eks. warfarin eller amiodaron).
English: After oral administration, tolvaptan is rapidly absorbed with peak plasma concentrations occurring about 2 hours after dosing.
Danish: Efter oral administration absorberes tolvaptan hurtigt med maksimale plasmakoncentrationer ca. 2 timer efter dosering.
English: • if you suffer from too high or too low blood sodium.
Danish: • hvis du har for højt eller for lavt saltindhold i blodet.
English: Tolvaptan is a weak CYP3A4 substrate and does not appear to have any inhibitory activity.
Danish: Tolvaptan er et svagt CYP3A4-substrat, som tilsyneladende ikke har nogen hæmmende aktivitet.
English: Dose adjustment is not required in patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: In females, abnormal oestrus cycles were seen in both studies.
Danish: Hos hunrotter blev der i begge studier observeret abnorme østralperioder.
English: At the onset of symptoms or signs consistent with hepatic injury or if clinically significant abnormal ALT or AST increases are detected during treatment, Jinarc administration must be immediately interrupted and repeat tests including ALT, AST, BT and alkaline phosphatase (AP) must be obtained as soon as possible (ideally within 48-72 hours).
Danish: Ved symptomer eller tegn, der svarer til leverskade, eller hvis der konstateres klinisk signifikante unormale ALT- eller AST-stigninger under behandlingen, skal administrationen af Jinarc øjeblikkeligt afbrydes, og gentagne blodprøver, herunder af ALT, AST, BT og alkalinfosfatase (AP), skal foretages hurtigst muligt (ideelt inden for 48-72 timer).
English: Final study report should be submitted by:
Danish: Den endelige studierapport skal indsendes senest:
English: Tolvaptan is a vasopressin antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2 receptors of the distal portions of the nephron.
Danish: Tolvaptan er en vasopressinantagonist, der specifikt blokerer bindingen af argininvasopressin (AVP) ved V2-receptorerne af de distale dele af nefronen.
English: For split-dose regimens of 30, 60 and 120 mg/day in ADPKD patients, tolvaptan exposure (AUC) increases linearly.
Danish: For delte dosisregimer med 30, 60 og 120 mg/dgl hos ADPKD-patienter øges tolvaptan-eksponeringen (AUC) lineært.
English: Effects on serum uric acid are attributable to the reversible renal hemodynamic changes that occur in response to tolvaptan effects on urine osmolality and may be clinically relevant.
Danish: Virkninger på urinsyre i serum tilskrives de reversible hæmodynamiske ændringer i nyrerne, der indtræder som reaktion på tolvaptans virkninger på urinosmolalitet, og kan være klinisk relevante.
English: Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition, have an increased risk of developing acute retention.
Danish: Patienter med partiel obstruktion af urinvejene, f.eks. patienter med prostatahypertrofi eller hæmning af miktion, har øget risiko for at udvikle akut retention.
English: Increasing age has no effect on tolvaptan plasma concentrations.
Danish: Alder har ingen virkning på koncentrationerne af tolvaptan i plasma.
English: Volume status must be monitored in patients taking tolvaptan because treatment with tolvaptan may result in severe dehydration which constitutes a risk factor for renal dysfunction.
Danish: Væskestatus skal monitoreres hos patienter, der tager tolvaptan, fordi behandling med tolvaptan kan medføre svær dehydrering, hvilket udgør en risikofaktor for nyredysfunktion.
English: Acute reductions in mean total kidney volume were also observed following 3 weeks of therapy in all CKD stages, ranging from -4.6 % for CKD stage 1 to -1.9 % for CKD stage 4.
Danish: Akutte reduktioner i gennemsnitligt totalt nyrevolumen er også blevet observeret efter 3 ugers behandling i alle CKD-stadier fra −4,6 % for CKD-stadium 1 til −1,9 % for CKD-stadium 4.
English: OUTER CARTON (blisters in wallet card)
Danish: YDRE ÆSKE (blistre i etui)
English: By blocking the effect of vasopressin, Jinarc slows the development of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production.
Danish: Ved at blokere virkningen af vasopressin bremser Jinarc udviklingen af nyrecyster hos patienter med ADPKD, reducerer sygdomssymptomer og øger urinproduktionen.
English: • if you are pregnant (see “Pregnancy and breast-feeding)
Danish: • hvis du er gravid (se “Graviditet og amning”).
English: Longer term data are not currently available to show whether long-term therapy with Jinarc continues to slow the rate of renal function decline and affect clinical outcomes of ADPKD, including delay in the onset of end-stage renal disease.
Danish: Der er på nuværende tidspunkt ingen langsigtede data, der viser, om lang tids behandling med Jinarc fortsætter med at bremse svækkelsen af nyrefunktionen og har indvirkning på de kliniske udfald af ADPKD, herunder udskydelse af terminal nyresygdoms indtræden.
English: • if you have been told you have high levels of a chemical called uric acid in your blood (which may have caused attacks of gout).
Danish: • hvis du har fået at vide, at du har høje niveauer af urinsyre i blodet (som kan have forårsaget podagra-anfald).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tolvaptan in one or more subsets of the paediatric population in polycystic kidney disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med tolvaptan i en eller flere undergrupper af den pædiatriske population med polycystisk nyresygdom (se pkt.
English: Measurements of urine osmolality are recommended to monitor the adequacy of vasopressin inhibition.
Danish: Det anbefales at måle urinosmolalitet for at monitorere, om vasopressin hæmmes tilstrækkeligt.
English: In case of abnormal baseline levels below the limits for permanent discontinuation treatment can only be initiated if the potential benefits of treatment outweigh the potential risks and liver function testing must continue at increased time frequency.
Danish: I tilfælde af baseline-niveauer under grænserne for permanent seponering må behandling kun indledes, hvis de estimerede fordele ved behandlingen vejer tungere end de potentielle risici.
English: The volume status of patients taking tolvaptan must be monitored to prevent dehydration (see section 4.4).
Danish: Volumenstatus hos patienter, der tager tolvaptan, skal monitoreres for at forebygge dehydrering (se pkt.
English: • if you have a condition which increases the sodium in your blood
Danish: • hvis du har en sygdom, der øger saltindholdet i dit blod.
English: Co-administration of tolvaptan and ketoconazole resulted in a 440 % increase in area under time-concentration curve (AUC) and 248 % increase in maximum observed plasma concentration (Cmax) for tolvaptan.
Danish: Samtidig administration af tolvaptan og ketoconazol medførte en 440 % stigning i arealet under tidskurven (AUC) og en 248 % stigning i den maksimale observerede plasmakoncentration (Cmax) for tolvaptan.
English: Diuretics or non-diuretic anti-hypertensive medicinal product(s) Standing blood pressure was not routinely measured in ADPKD trials, therefore a risk of orthostatic/postural hypotension due to a pharmacodynamic interaction with tolvaptan cannot be excluded.
Danish: Stående blodtryk er ikke blevet målt rutinemæssigt i ADPKD-studier, så derfor kan en risiko for ortostatisk/postural hypotension på grund af en farmakodynamisk interaktion med tolvaptan ikke udelukkes.
English: Jinarc may cause your liver to not work properly.
Danish: Jinarc kan bevirke, at din lever ikke fungerer rigtigt.
English: 30 but greater than 15 mL/min/1.73 m
Danish: men større end 15 ml/min/1,73 m
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake
Danish: Hydroxypropylcellulose Laktosemonohydrat Magnesiumstearat Mikrokrystallinsk cellulose Indigocarmin aluminium lake
English: A secondary endpoint testing the persistence of positive effects on renal function indicated that the preservation of eGFR observed by the end of the TEMPO 3:4 pivotal trial (3.01 to 3.34 mL/min/1.73 m at follow-up visits 1 and 2) could be preserved during open-label treatment.
Danish: Et sekundært endepunkt, hvor persistensen af den positive effekt på nyrefunktionen blev testet, tydede på, at den opretholdelse af eGFR, der sås ved afslutningen af hovedstudiet TEMPO 3:4 (3,013,34 ml/min/1,73 m ved opfølgende besøg 1 og 2), kunne fastholdes under den åbne behandling.
English: Jinarc contains the active substance tolvaptan which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of ADPKD patients.
Danish: Jinarc indeholder det aktive stof tolvaptan, som blokerer virkningen af vasopressin, et hormon, der medvirker til at danne cyster i nyrerne hos ADPKD-patienter.
English: If this happens to you, do not drive or use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle eller arbejde med værktøj eller maskiner, hvis dette er tilfældet for dig.
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Danish: Tolvaptan øgede lovastatins plasmaniveauer 1,3 til 1,5 gange.
English: Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Danish: Mavesmerter, Abdominal udspiling, Forstoppelse, Dyspepsi,
English: • raised levels of liver enzymes in the blood
Danish: • forhøjede niveauer af leverenzymer i blodet
English: However, when driving vehicles or using machines it has to be taken into account that occasionally dizziness, asthenia or fatigue may occur.
Danish: Der skal dog ved bilkørsel og betjening af maskiner tages højde for, at der kan forekomme svimmelhed, asteni eller træthed.
English: Taken with Jinarc these may increase the risk of side effects due to water loss.
Danish: Hvis disse tages sammen med Jinarc, kan de øge risikoen for bivirkninger på grund af vandtab.
English: Therefore, you should only stop taking Jinarc if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Danish: Derfor bør du kun holde op med at tage Jinarc, hvis du får bivirkninger, der kræver akut lægehjælp (se pkt.
English: In a peri- and post-natal study in rats, delayed ossification and reduced pup bodyweight were seen at the high dose of 1,000 mg/kg/day.
Danish: I et peri- og post-natalt studie med rotter sås forsinket ossifikation og reduceret kropsvægt hos ungerne ved den høje dosis på 1.000 mg/kg/dgl.
English: • itching of your skin
Danish: • kløe på huden
English: Uric acid concentrations are to be evaluated prior to initiation of Jinarc therapy, and as indicated during treatment based on symptoms.
Danish: Koncentrationer af urinsyre skal vurderes før behandling med Jinarc og under behandlingen baseret på symptomer.
English: In vitro studies indicated that tolvaptan has no inhibitory activity for CYP3A.
Danish: In vitro-studier indikerede, at tolvaptan ikke har nogen hæmmende aktivitet på CYP3A.
English: Patients have to be maintained on the highest tolerable tolvaptan dose.
Danish: Patienter skal vedligeholde den højeste tolvaptandosis, der kan tolereres.
English: Co-administration with medicinal products that increase serum sodium concentration There is no experience from controlled clinical trials with concomitant use of tolvaptan and hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Danish: Samtidig administration med lægemidler, der øger koncentrationen af serum-natrium Der er ingen erfaring fra kontrollerede kliniske studier med samtidig anvendelse af tolvaptan og hypertont natriumchloridopløsning, orale natriumformuleringer og lægemidler, der øger koncentrationen af serum-natrium.
English: The morning dose of Jinarc is to be taken at least 30 minutes before the morning meal.
Danish: Morgendosis af Jinarc skal tages mindst 30 minutter før morgenmaden.
English: This trial evaluated the effects of tolvaptan on safety, TKV and eGFR in subjects receiving active treatment for 5 years (early-treated), compared with subjects treated with placebo for 3 years, then switched to active treatment for 2 years (delayed-treated).
Danish: Dette studie vurderede tolvaptans effekt på sikkerheden, TKV og eGFR hos forsøgspersoner, der fik aktiv behandling i 5 år (øjeblikkelig behandling), sammenholdt med forsøgspersoner, der fik placebo i 3 år og derefter kom over på aktiv behandling i 2 år (udskudt behandling).
English: In addition to its renal aquaretic effect, tolvaptan is capable of blocking vascular vasopressin V2 receptors involved in the release of coagulation factors (e.g., von Willebrand factor) from endothelial cells.
Danish: Ud over dets virkning på reabsorptionen af vand i nyrerne er tolvaptan i stand til at blokere vaskulære vasopressin-V2-receptorer, der er involveret i frigivelsen af koagulationsfaktorer (f.eks. von Willebrands faktor) fra endotelceller.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Danish: Ingen dosisjustering er nødvendig hos patienter med let eller moderat nedsat leverfunktion (Child-Pugh klasse A og B).
English: Patients must be managed carefully and liver enzymes must be monitored regularly (see section 4.4).
Danish: Patienter skal kontrolleres nøje, og leverenzymer skal monitoreres jævnligt (se pkt.
English: Current clinical practice suggests that Jinarc therapy is to be interrupted upon confirmation of sustained or increasing transaminase levels and permanently discontinued if significant increases and/or clinical symptoms of hepatic injury persist.
Danish: Nuværende klinisk praksis antyder, at behandlingen skal pauseres ved bekræftelse af vedvarende eller stigende transaminaseniveauer og seponeres permanent, hvis signifikante stigninger og/eller kliniske symptomer på leverskade vedvarer.
English: Even though the clinical relevance of this finding is not known, to minimise the unnecessary risk of increasing the maximal exposure the morning dose should be taken under fasted conditions (see section 4.2).
Danish: Selvom den kliniske relevans af dette fund ikke er kendt, bør morgendosis tages under fastende forhold for at minimere den unødvendige risiko for at øge den maksimale eksponering (se pkt.
English: Therefore, patients must have access to water (or other aqueous fluids) and be able to drink sufficient amounts of these fluids (see section 4.2).
Danish: Derfor skal patienter have adgang til vand (eller andre vandholdige væsker) og være i stand til at drikke tilstrækkelige mængder af disse væsker (se pkt.
English: This disease causes growth of fluid-filled cysts in the kidneys which put pressure on surrounding tissues and reduce kidney function, possibly leading to kidney failure.
Danish: Denne sygdom forårsager vækst af væskefyldte cyster i nyrerne, trykker på det omgivende væv og nedsætter nyrefunktionen, hvilket muligvis kan medføre nyresvigt.
English: Following single oral doses of ≥ 300 mg, peak plasma concentrations appear to plateau, possibly due to saturation of absorption.
Danish: Efter orale enkeltdoser på  300 mg tyder det på, at maksimale plasmakoncentrationer bliver stabile, muligvis på grund af mættet absorption.
English: These data suggest that Jinarc can slow the rate of renal function decline, and that these benefits persist over the duration of therapy.
Danish: Disse data tyder på, at Jinarc kan bremse svækkelsen af nyrefunktionen, og at denne gavnlige effekt opretholdes under hele behandlingens varighed.
English: Therefore, serum creatinine, electrolytes and symptoms of electrolyte imbalances (e.g. dizziness, fainting, palpitations, confusion, weakness, gait instability, hyper-reflexia, seizures, coma) have to be assessed prior to and after starting tolvaptan to monitor for dehydration.
Danish: Serum-kreatinin, elektrolytter og symptomer på manglende elektrolytbalance (f.eks. svimmelhed, besvimelse, palpitationer, konfusion, svaghed, ustabil gang, hyperrefleksi, krampeanfald, koma) skal vurderes inden og efter start af tolvaptan for at kontrollere dehydrering.
English: Single oral doses up to 480 mg (4 times the maximum recommended daily dose) and multiple doses up to 300 mg once daily for 5 days have been well tolerated in trials in healthy subjects.
Danish: Orale enkeltdoser på op til 480 mg (4 gange den maksimale anbefalede daglige dosis) og flere doser på op til 300 mg én gang dagligt i 5 dage har været veltolererede i kliniske studier med raske frivillige.
English: Pre-treatment sodium abnormalities (hyponatraemia or hypernatraemia) must be corrected prior to initiation with tolvaptan therapy.
Danish: Natriumabnormiteter (hyponatriæmi eller hypernatriæmi) inden behandling skal korrigeres før indledning af behandling med tolvaptan.
English: Do not take Jinarc:
Danish: Tag ikke Jinarc:
English: • desmopressin (used to increase blood clotting factors or to control urine output or bedwetting).
Danish: • desmopressin (benyttes til at øge koagulationsfaktorerne i blodet eller regulere urinproduktionen eller ved ufrivillig natlig vandladning).
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: If OATP1B1 and OATP1B3 substrates (e.g., statins such as rosuvastatin and pitavastatin), OAT3 substrates (e.g., methotrexate, ciprofloxacin), BCRP substrates (e.g. sulfasalazine) or OCT1 substrates (e.g. metformin) are co-administered with tolvaptan, patients must be managed cautiously and evaluated for excessive effects of these medicinal products.
Danish: Hvis OATP1B1- og OATP1B3-substrater (f.eks. sådanne statiner som rosuvastatin og pitavastatin), OAT3-substrater (f.eks. methotrexat, ciprofloxacin), BCRP-substrater (f.eks. sulfasalazin) eller OCT1-substrater (f.eks. metformin) administreres sammen med tolvaptan, skal patienter kontrolleres nøje for overdreven effekt af disse lægemidler.
English: • experience swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Danish: • opdager hævelse i ansigtet, på læberne eller på tungen, hvis du har kløe, generaliseret udslæt eller hvæsende vejrtrækning eller åndenød (symptomer på en allergisk reaktion).
English: Only the oxobutyric acid metabolite is present at greater than 10 % of total plasma radioactivity; all others are present at lower concentrations than tolvaptan.
Danish: Kun oxobutylsyremetabolitten er til stede med mere end 10 % af total radioaktivitet i plasma.
English: In post-marketing experience, anaphylaxis (including anaphylactic shock and rash generalised) has been reported very rarely following administration of tolvaptan.
Danish: Ved erfaring efter markedsføring er der rapporteret meget sjældne tilfælde af anafylaksi (herunder anafylaktisk shock og generaliseret udslæt) efter administration af tolvaptan.