FrancophonIA/ELRC3.0 huggingface dataset:
English: According to these split dose regimens the total daily doses are 60, 90, or 120 mg.
Danish: I overensstemmelse med disse delte dosisregimer er den totale daglige dosis på 60, 90 eller 120 mg.
English: Anaphylactic shock,
Danish: Anafylaktisk shock,
English: In addition the study should also provide information on
Danish: Endvidere skal studiet også give oplysninger om:
English: reduction in reciprocal serum creatinine during treatment [from end of titration to last on medicinal product visit])
Danish: reduktion i gensidig serum-kreatinin under behandling [fra afslutningen af titrering til sidste besøg, hvor lægemidlet blev taget])
English: The table is based on adverse events reported during clinical trials and/or post-marketing use.
Danish: Tabellen er baseret på bivirkninger rapporteret under kliniske studier og/eller efter markedsføringen.
English: If you stop taking Jinarc your kidney cysts may grow as fast as they did before you started treatment with Jinarc.
Danish: Hvis du holder op med at tage Jinarc, kan dine cyster vokse lige så hurtigt, som de gjorde, før du begyndte at blive behandlet med Jinarc.
English: Pregnancy and breast-feeding Do not take this medicine if you are pregnant or breast-feeding.
Danish: Graviditet og amning Tag ikke dette lægemiddel, hvis du er gravid eller ammer.
English: The higher dose should be taken in the morning when you wake up, at least 30 minutes before the morning meal.
Danish: Den højeste dosis skal tages om morgenen, når du vågner, mindst 30 minutter før morgenmaden.
English: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Danish: Selvom denne øgning ikke er klinisk relevant, indikerer det, at tolvaptan potentielt kan øge eksponeringen for CYP3A4-substrater.
English: The key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent [reproduced over at least 2 weeks] 25 %
Danish: Det vigtigste sekundære kombinerede endepunkt (ADPKD-progression) var tiden til flere kliniske progressionstilfælde af: 1) forværret nyrefunktion (defineres som en vedvarende [reproduceret over mindst 2 uger] 25 %
English: Jinarc causes water loss because it increases your urine production.
Danish: Jinarc medfører vandtab, fordi det øger din urinproduktion.
English: • if you do not realise when you are thirsty
Danish: • hvis du ikke kan føle tørst.
English: • if you have a condition which is associated with a very low blood volume (e.g. severe dehydration or bleeding)
Danish: • hvis du har en sygdom, der er forbundet med et meget lavt blodvolumen (f.eks. svær dehydrering eller blødning).
English: Prior to launch of Jinarc in each Member State the Marketing Authorisation Holder must agree the content and format of the educational programme, including communication media and distribution modalities with each National Competent Authority.
Danish: Forud for lanceringen af Jinarc i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen og den nationale kompetente myndighed blive enige om indholdet og formatet af undervisningsprogrammet, herunder en kommunikations- og distributionsplan.
English: There is no specific antidote for tolvaptan intoxication.
Danish: Der findes ingen specifik antidot til forgiftning med tolvaptan.
English: Transporter substrates
Danish: Transportørsubstrater
English: Tolvaptan binds reversibly (98 %) to plasma proteins.
Danish: Tolvaptan binder sig reversibelt (98 %) til plasmaproteiner.
English: Dialysis may not be effective in removing tolvaptan because of its high binding affinity for human plasma protein (> 98 %).
Danish: Dialyse virker måske ikke med hensyn til at fjerne tolvaptan på grund af dets høje bindingsaffinitet for human plasmaprotein (> 98 %).
English: Patients have to be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration.
Danish: Patienter skal opfordres til at drikke vand eller andre vandholdige væsker ved det første tegn på tørst for at undgå for kraftig tørst eller dehydrering.
English: The MAH must ensure that all healthcare professionals and patients/carers who are expected to prescribe and/or use JINARC have access to/are provided with the following educational package
Danish: Indehaveren af markedsføringstilladelsen skal sørge for, at alle sundhedspersoner og patienter/plejere, som forventes at ordinere og/eller anvende JINARC, har adgang til/forsynes med følgende undervisningspakke:
English: Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces, where unchanged tolvaptan accounted for 32 % of radioactivity.
Danish: Forsøg med radioaktivt mærket tolvaptan viste, at 40 % af radioaktiviteten blev genfundet i urinen, og 59 % blev genfundet i fæces, hvor uomdannet tolvaptan udgjorde 32 % af radioaktiviteten.
English: Age Clearance of tolvaptan is not significantly affected by age.
Danish: Alder Tolvaptans clearance påvirkes ikke signifikant af alder.
English: A pre-specified subgroup analysis suggested that tolvaptan had less of an effect in patients older than 55 years of age, a small subgroup with a notably slower rate of eGFR decline.
Danish: En præspecificeret undergruppeanalyse indikerede, at tolvaptan havde en mindre virkning hos patienter over 55 år, som er en lille undergruppe med et markant langsommere fald i eGFR.
English: TEMPO 4:4 is an open-label extension study that included 871 subjects that completed TEMPO 3:4 from 106 centres across 13 countries.
Danish: TEMPO 4:4 er et åbent forlængelsesstudie, der omfatter 871 forsøgspersoner, som har gennemført TEMPO 3:4 på 106 centre i 13 lande.
English: Effect of tolvaptan on glomerular filtration rate (GFR)
Danish: Tolvaptans virkning på glomerulær filtrationsrate (GFR)
English: (CKD-Epidemiology formula) and historical TKV, available in 318 (23 %) of subjects, averaged 2,026 mL.
Danish: (CKD-epidemiologi-formel), og den historiske TKV, der var tilgængelig hos 318 (23 %) af forsøgspersonerne, var i gennemsnit 2.026 ml.
English: Data for patients in CKD stage 3 are more limited than for patients in stage 1 or 2 (see section 5.1).
Danish: Data for patienter med CKD stadium 3 er mere begrænsede end for patienter med stadium 1 eller 2 (se pkt.
English: The safety and efficacy of tolvaptan in children and adolescents has not yet been established.
Danish: Tolvaptans sikkerhed og virkning hos børn og unge er endnu ikke klarlagt.
English: ‘Tolvaptan (n = 961) and placebo (n = 484) groups were well matched in terms of gender with an average age of 39 years.
Danish: Tolvaptan- (n = 961) og placebo- (n = 484) grupperne var godt matchede med hensyn til køn med en gennemsnitsalder på 39 år.
English: • Signs or symptoms of liver toxicity and severe dehydration
Danish: • Tegn og symptomer på levertoksicitet og svær dehydrering
English: The educational programme is aimed at ensuring awareness about the potential risk of hepatotoxicity and providing guidance on how to manage this risk and the importance of pregnancy prevention prior to the initiation and during the treatment with Jinarc.
Danish: Undervisningsprogrammet har til formål at sikre, at der gøres opmærksom på den potentielle risiko for hepatotoksicitet og gives vejledning i, hvordan denne risiko håndteres, samt vigtigheden af graviditetsforebyggelse før og under behandlingen med Jinarc.
English: • ALT or AST > 3-times ULN and (BT > 2-times ULN or International Normalized Ratio
Danish: • ALT eller AST > 3 gange ULN og (BT > 2 gange ULN eller internationalt normaliseret ratio
English: In total, 14 clinical trials involving tolvaptan have been completed worldwide in support of the ADPKD indication, including 8 trials in the US, 1 in the Netherlands, 3 in Japan, 1 in Korea, and the multinational phase 3 pivotal trial.
Danish: I alt er der gennemført 14 kliniske studier med tolvaptan på verdensplan inden for ADPKDindikationen, herunder 8 studier i USA, 1 i Holland, 3 i Japan, 1 i Korea og det multinationale, fase-3 pivotalstudie.
English: Fluid and electrolyte balance
Danish: Væske- og elektrolytbalance
English: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Ireland
Danish: Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Irland
English: Jinarc with food and drink Do not drink grapefruit juice when taking Jinarc.
Danish: Brug af Jinarc sammen med mad og drikke Du må ikke drikke grapefrugtjuice, når du tager Jinarc.
English: The different strengths of Jinarc tablets have different shapes and embossing:
Danish: Jinarc tabletternes forskellige styrker har forskellige former og prægning:
English: Effects on free water clearance and urine volume are evident across all CKD stages with smaller absolute effects observed at later stages, consistent with the declining number of fully functioning nephrons.
Danish: Der er evidens på virkning på fritvandsclearance og urinvolumen i alle CKD-stadier med færre absolutte virkninger observeret i de senere stadier, hvilket svarer til det faldende antal af fuldt fungerende nefroner.
English: The aim of dose titration is to block activity of vasopressin at the renal V2 receptor as completely and constantly as possible, while maintaining acceptable fluid balance (see section 4.4).
Danish: Målet med dosistitrering er at blokere aktiviteten af vasopressin i den renale V2-receptor så fuldstændigt og konstant som muligt, samtidig med at der bibeholdes en acceptabel væskebalance (se pkt.
English: Following an additional 2 years of tolvaptan treatment, resulting in a total of 5 years on tolvaptan therapy no new safety signals were identified.
Danish: Efter yderligere 2 års tolvaptan-behandling, dvs. efter i alt 5 års behandling med tolvaptan, er der ikke observeret nye sikkerhedsrelaterede fund.
English: Following single oral doses, Cmax values show less than dose proportional increases from 30 to 240 mg and then a plateau at doses from 240 to 480 mg, AUC increases linearly.
Danish: Efter orale enkeltdoser viser Cmax værdier mindre end dosisproportionelle stigninger fra 30 til 240 mg og derefter et plateau ved doser fra 240 til 480 mg. AUC stiger lineært.
English: • diuretics (used to increase your urine production).
Danish: • diuretika (anvendes til at øge urinproduktionen).
English: The use of any of these medicines together with Jinarc is to be avoided because this may reduce the effects of Jinarc.
Danish: Anvendelsen af nogen af disse lægemidler sammen med Jinarc skal undgås, fordi de kan nedsætte virkningen af Jinarc.
English: • loss of appetite
Danish: • tab af appetit
English: • jaundice (yellowing of skin or eyes)
Danish: • gulsot (gulfarvning af hud eller øjne)
English: Jinarc has minor influence on the ability to drive or use machines.
Danish: Jinarc påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: The active substance is tolvaptan.
Danish: Aktivt stof: tolvaptan.
English: Contains lactose.
Danish: Indeholder laktose.
English: No mortality was observed in rats or dogs following single oral doses of 2,000 mg/kg (maximum feasible dose).
Danish: Der observeredes ingen mortalitet hos rotter og hunde efter orale enkeltdoser på 2.000 mg/kg (maksimalt mulig dosis).
English: Jinarc may reduce the effect of desmopressin.
Danish: Jinarc kan nedsætte virkningen af desmopressin.
English: 7 tablets 28 tablets
Danish: 7 tabletter 28 tabletter
English: During the first 18 months of treatment, Jinarc can only be supplied to patients whose physician has determined that liver function supports continued therapy.
Danish: I løbet af de første 18 måneders behandling må Jinarc kun gives til patienter, hvis deres læge har bestemt, at leverfunktionen kan klare fortsat behandling.
English: • medicines which increase the level of sodium in your blood or which contain large amounts of salt, like tablets that dissolve in water and indigestion remedies.
Danish: • lægemidler, der øger niveauet af natrium i blodet, eller som indeholder store mængder salt, f.eks. tabletter, der opløses i vand, og fordøjelsesmidler.
English: The phase 3 pivotal trial (TEMPO 3:4, 156-04-251) included subjects from 129 centres in the Americas, Japan, Europe and other countries.
Danish: Fase-3 pivotalstudiet (TEMPO 3:4, 156-04-251) omfattede forsøgspersoner fra 129 centre i Nord-, Syd- og Centralamerika, Japan, Europa og andre lande.
English: • ALT or AST > 3-times ULN with persistent symptoms of hepatic injury noted above.
Danish: • ALT eller AST > 3 gange ULN med vedvarende symptomer på leverskade, som angivet ovenfor.
English: Your doctor may gradually increase your dose up to a maximum combination of 90 mg on waking and 30 mg after 8 hours.
Danish: Din læge kan øge din dosis gradvist til en maksimal kombination på 90 mg, når du vågner og 30 mg efter 8 timer.
English: In patients treated with tolvaptan the reduction in eGFR was significantly less than in patients treated with placebo (p < 0.0001).
Danish: Hos de patienter, der fik tolvaptan, var reduktionen i eGFR signifikant mindre end hos de patienter, der fik placebo (p < 0,0001).
English: In patients with severe hepatic impairment the benefits and risks of treatment with Jinarc must be evaluated carefully.
Danish: Hos patienter med svært nedsat leverfunktion skal fordele og risici i forbindelse med behandling med Jinarc vurderes nøje.
English: Data related to smoking or alcohol history in ADPKD trials are too limited to determine possible interactions of smoking or alcohol with efficacy and safety of ADPKD treatment with tolvaptan.
Danish: Data vedrørende tidligere rygning eller alkoholforbrug i ADPKD-studier er for begrænsede til at afgøre mulige interaktioner af rygning eller alkoholforbrug med virkningen og sikkerheden af ADPKD-behandling med tolvaptan.
English: These data also showed significant benefit from tolvaptan vs. placebo (p < 0.0001).
Danish: Disse data viste også signifikante fordele ved tolvaptan versus placebo (p < 0,0001).
English: • high levels of sodium, uric acid and blood sugar
Danish: • højt indhold af natrium, urinsyre og sukker i blodet
English: Therefore, diabetic patients treated with tolvaptan must be managed cautiously.
Danish: Derfor skal diabetespatienter på tolvaptan behandles med forsigtighed.
English: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD United Kingdom
Danish: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD Storbritannien
English: Your treatment will normally start with a dose of 45 mg in the morning and 15 mg eight hours later.
Danish: Din behandling vil normalt begynde med en dosis på 45 mg om morgenen og 15 mg 8 timer senere.
English: A reversible reduction in GFR has been observed in ADPKD trials at the initiation of tolvaptan treatment.
Danish: En reversibel reduktion i GFR er blevet observeret i ADPKD-studier ved indledningen af behandling med tolvaptan.
English: Fluid and electrolyte status must be monitored in all patients.
Danish: Væske- og elektrolytbalancen skal monitoreres hos alle patienter.
English: Studies in rats have shown excretion of tolvaptan in milk.
Danish: Studier med rotter har vist, at tolvaptan udskilles i mælk.
English: In-vitro studies indicate that tolvaptan or its oxobutyric metabolite may have the potential to inhibit OATP1B1, OATP1B3, OAT3, BCRP and OCT1 transporters.
Danish: In-vitro-studier indikerer, at tolvaptan og dets oxobutylsyremetabolit kan have potentialet for at hæmme OATP1B1-, OATP1B3-, OAT3-, BCRP- og OCT1-transportører.
English: Subgroup analysis of the primary and secondary endpoints by CKD stage found similar, consistent treatment effects relative to placebo for subjects in stages 2, 3a, 3b and 4 at baseline.
Danish: Undergruppeanalyse af det primære og det sekundære endepunkt ud fra CKD-stadie viste en tilsvarende konsistent behandlingseffekt i forhold til placebo hos patienter i stadie 2, 3a, 3b og 4 ved baseline.
English: While there does not appear to be a synergistic or additive effect of concomitant use of tolvaptan with loop and thiazide diuretics, each class of agent has the potential to lead to severe dehydration, which constitutes a risk factor for renal dysfunction.
Danish: Selvom det ikke ser ud til, at der er en synergistisk eller additiv virkning ved samtidig anvendelse af tolvaptan og loop- og thiaziddiuretika, kan hver præparatklasse potentielt føre til svær dehydrering, hvilket udgør en risikofaktor for nyredysfunktion.
English: The result of the key secondary composite endpoint is primarily attributed to effects on worsening kidney function and medically significant kidney pain.
Danish: Resultatet af det vigtigste sekundære kompositte endepunkt tilskrives primært effekten på forværret nyrefunktion og medicinsk signifikante nyresmerter.
English: Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD).
Danish: Jinarc er medicin, der anvendes til at behandle en sygdom, der kaldes “autosomal dominant polycystisk nyresygdom” (ADPKD).
English: It is not recommended to administer Jinarc with vasopressin analogues.
Danish: Det frarådes at administrere Jinarc sammen med vasopressinanaloger.
English: • if you have been told that you have raised levels of liver enzymes in your blood which do not allow treatment with tolvaptan
Danish: • hvis du har fået at vide, at du har forhøjede niveauer af leverenzymer i blodet, som ikke tåler behandling med tolvaptan.
English: If you take other medicines which can increase the effects of Jinarc you may receive lower doses.
Danish: Hvis du tager andre lægemidler, som kan øge virkningen af Jinarc, kan du eventuelt få lavere doser.
English: The pharmacodynamically predictable and most commonly reported adverse reactions are thirst, polyuria, nocturia, and pollakiuria occurring in approximately 55 %, 38 %, 29 % and 23 % of patients, respectively.
Danish: De farmakodynamisk forudsigelige og mest almindeligt indberettede bivirkninger er tørst, polyuri, nykturi og pollakisuri, der forekommer hos ca. hhv. 55 %, 38 %, 29 % og 23 % af patienterne.
English: In this case your doctor may prescribe you Jinarc tablets with 30 mg or 15 mg tolvaptan which have to be taken once a day in the morning.
Danish: I dette tilfælde kan din læge ordinere Jinarc tabletter med 30 mg eller 15 mg tolvaptan, som skal tages én gang dagligt om morgenen.
English: It is unknown whether tolvaptan is excreted in human breast milk.
Danish: Det vides ikke, om tolvaptan udskilles i brystmælk hos mennesker.
English: It is therefore of greatest importance that patients have access to water and are able to drink sufficient amounts of fluids.
Danish: Det er derfor meget vigtigt, at patienter har adgang til vand og er i stand til at drikke tilstrækkelige mængder vand.
English: Dose titration has to be performed cautiously to ensure that high doses are not poorly tolerated through overly rapid up-titration.
Danish: Dosistitrering skal foretages med forsigtighed for at sikre, at høje doser ikke tolereres dårligt på grund af for hurtig optitrering.
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01.
Danish: Farmakoterapeutisk klassifikation: Diuretica, vasopressin antagonister, ATC-kode: C03XA01.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller karcinogenicitet.
English: • the importance of pregnancy prevention, before and during treatment with Jinarc
Danish: • vigtigheden af graviditetsforebyggelse før og under behandling med Jinarc
English: The trial utilized a randomized withdrawal design, to enrich for patients that were able to tolerate tolvaptan for a 5-week, single-blind pre-randomization period consisting of a 2-week titration period and 3-week run-in period.
Danish: Studiet anvendte et randomiseret seponeringsdesign for at tage højde for patienter, der var i stand til at tåle tolvaptan i en 5-ugers, enkeltblindet prærandomiseringsperiode bestående af en titreringsperiode på 2 uger og en indkøringsperiode på 3 uger.
English: • if you have diabetes.
Danish: • hvis du har sukkersyge.
English: Therefore, the effect of vasopressin analogues such as desmopressin may be attenuated in patients using such analogues to prevent or control bleeding when co-administered with tolvaptan.
Danish: Virkningen af vasopressinanaloger, som f.eks. desmopressin, kan derfor nedsættes hos patienter, som anvender disse analoger for at forhindre eller kontrollere blødning, når de administreres samtidigt med tolvaptan.
English: Prescribing physicians must comply fully with the safety measures required below.
Danish: Ordinerende læger skal overholde nedenstående sikkerhedsforanstaltninger.
English: Tolvaptan has not been extensively studied in ADPKD in combination with diuretics.
Danish: Tolvaptan er ikke blevet undersøgt grundigt i forbindelse med ADPKD i kombination med diuretika.
English: Diabetic patients with an elevated glucose concentration (e.g. in excess of 300 mg/dl) may present with pseudohyponatraemia.
Danish: Diabetespatienter med forhøjet glucosekoncentration (f.eks. over 300 mg/dl) kan have pseudohyponatriæmi.
English: You should always take the highest tolerable dose combination prescribed by your doctor.
Danish: Du skal altid tage den højeste dosiskombination, du kan tåle, og som din læge har ordineret.
English: If ALT and AST levels remain below 3-times the upper limit of normal (ULN), Jinarc therapy may be cautiously re-started, with frequent monitoring at the same or lower doses, as transaminase levels appear to stabilise during continued therapy in some patients.
Danish: Hvis ALT- og AST-niveauer forbliver under 3 gange den øvre normalgrænse (ULN), må behandlingen med Jinarc genstartes med forsigtighed, med hyppig kontrol ved den samme eller lavere doser, da transaminaseniveauer hos nogle patienter lader til at stabilisere sig ved fortsat behandling.
English: Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements (see section 4.4).
Danish: Behandling med tolvaptan skal indledes og monitoreres under supervision af læger med specialkundskab inden for ADPKD og fuld forståelse af risici ved behandling med tolvaptan, herunder hepatisk toksicitet og monitoreringskrav (se pkt.
English: Following multiple once daily dosing of 300 mg, tolvaptan exposure was only increased 6.4-fold when compared to a 30 mg dose.
Danish: Efter flere daglige doser på 300 mg én gang dagligt blev eksponeringen for tolvaptan kun øget 6,4-gange i sammenligning med en 30 mg dosis.
English: • ALT or AST > 8-times ULN
Danish: • ALT eller AST > 8 gange ULN
English: However, the safety and effectiveness of tolvaptan in ADPKD patients aged over 50 years has not yet been established.
Danish: Tolvaptans sikkerhed og virkning hos ADPKD-patienter over 50 år er endnu ikke klarlagt.
English: The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia.
Danish: Tegnene og symptomerne på en akut overdosis kan forventes at være følgende: overdrevne farmakologiske virkninger: en stigning i koncentrationen af serum-natrium, polyuri, tørst og dehydrering/hypovolæmi.
English: In-vitro studies indicate that tolvaptan is a substrate and competitive inhibitor of P-glycoprotein (P-gp).
Danish: In-vitro-studier indikerer, at tolvaptan er et substrat og en kompetitiv hæmmer af P-glykoprotein (P-gp).
English: If an anaphylactic reaction or other serious allergic reactions occur, administration of tolvaptan must be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, skal administrationen af tolvaptan straks seponeres, og passende behandling iværksættes.