natgillin/translations-raw huggingface dataset:
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.
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.
4.3), må behandlingen aldrig påbegyndes igen efter en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner.
Since hypersensitivity is a contraindication (see section 4.3) treatment must never be restarted after an anaphylactic reaction or other serious allergic reactions.
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tabletterne sluges hele med et glas vand.
Swallow the tablets without chewing, with a glass of water.
• Forhøjede leverenzymer og/eller tegn eller symptomer på leverskade før indledning af behandling, som opfylder kravene for permanent seponering af tolvaptan (se pkt.
• 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)
overvågning efter markedsføring af tolvaptan godkendt til andre indikationer observeret efter markedsføring ved brug af tolvaptan til behandling af ADPKD.
* reported during post-marketing surveillance of tolvaptan approved for other indications observed in post-marketing with tolvaptan in ADPKD.
4) forværret albuminuri
4) worsening albuminuria
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.
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.
Jinarc kan øge virkningen af ovenstående lægemidler.
Jinarc may increase the effect of these medicines.
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.
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.
Derfor skal samtidig administration af tolvaptan og stærke CYP3A-inducere (f.eks. rifampicin, rifabutin, rifapentin, phenytoin, carbamazepin og prikbladet perikum) undgås.
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.
Det skal sikres, at der ikke er urinvejsobstruktion.
Urinary output must be secured.
Tolvaptans virkning på andre lægemidlers farmakokinetik
Effect of tolvaptan on the pharmacokinetics of other products
• har svært ved at lade vandet.
• find it difficult to urinate.
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.
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.
Jinarc indeholder laktose
Jinarc contains lactose
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.
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.
Dosisjustering for patienter, der tager moderate CYP3A-hæmmere Hos patienter, der tager moderate CYP3A-hæmmere, skal dosis af tolvaptan reduceres som følger:
Dose adjustment for patients taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors, tolvaptan doses have to be reduced as follows:
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.
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.
Hvis du har glemt at tage Jinarc
If you forget to take Jinarc
• dehydrering
• dehydration
CYP3A-inducere
CYP3A inducers
Daglig delt dosis af tolvaptan Reduceret dosis (én gang dagligt) 90+30 mg
Tolvaptan daily split-dose Reduced dose (once daily) 90+30 mg
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.
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.
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.
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.
• Hepatotoksicitet i forbindelse med anvendelsen af Jinarc.
• Hepatotoxicity associated with the use of Jinarc.
Det anbefales at reducere dosis af tolvaptan for patienter, mens de tager moderate eller stærke CYP3A-hæmmere (se pkt.
Dose reduction of tolvaptan is recommended for patients while taking moderate or strong CYP3A inhibitors (see section 4.2).
Øget alaninaminotransferase, Øget aspartataminotransferase, Vægttab
Aspartate aminotransferase increased,
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.
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.
Hvis du holder op med at tage Jinarc
If you stop taking Jinarc
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.
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.
Hvis evnen til at drikke eller adgangen til vand er begrænset, skal behandlingen seponeres (se pkt.
Therapy must be interrupted if the ability to drink or the accessibility to water is limited (see section 4.4).
Patienter med kendt overfølsomhed over for benzazepiner eller benzazepinderivater (f.eks. benazepril, conivaptan, fenoldopammesylat eller mirtazepin) kan have en risiko for overfølsomhedsreaktioner over for tolvaptan (se pkt.
Patients with known hypersensitivity reactions to benzazepines or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) may be at risk for hypersensitivity reaction to tolvaptan (see section 4.3 Contraindications).
• hvis du tidligere har haft en allergisk reaktion over for benzazepin, tolvaptan eller andre benzazepinderivater (f.eks. benazepril, conivaptan, fenoldopammesylat eller mirtazapin) eller et af de øvrige indholdsstoffer (anført i pkt.
• if you had an allergic reaction in the past to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
Samtidig administration af tolvaptan og fluconazol, en moderat CYP3A-hæmmer, medførte en stigning i tolvaptans AUC og Cmax på hhv. 200 % og 80 %.
Co-administration of tolvaptan and fluconazole, a moderate CYP3A inhibitor, produced a 200 % and 80 % increase in tolvaptan AUC and Cmax, respectively.
Perioden inden debut af hepatocellulær skade (ved forhøjet ALT på > 3 × ULN) lå inden for 3 til 14 måneder efter indledning af behandling.
The period of onset of hepatocellular injury (by ALT elevations > 3 × ULN) was within 3 to 14 months after initiating treatment and these increases were reversible, with ALT returning to < 3 × ULN within 1 to 4 months.
Jinarcs sikkerhed og virkning i CKD stadium 5 er ikke blevet undersøgt tilstrækkeligt.
The safety and efficacy of Jinarc in CKD stage 5 have not been adequately explored and therefore tolvaptan treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
Der observeredes ingen teratogene virkninger hos kaniner ved 300 mg/kg/dgl (ca. 1,25 til 2,65 gange eksponeringen hos mennesker ved en dosis på 120 mg/dgl baseret på AUC).
No teratogenic effects were seen in rabbits at 300 mg/kg/day (about 1.25 to 2.65 times the exposure in humans at the 120 mg/day dose, based on AUC).
• phenytoin eller carbamazepin (lægemidler til behandling af epilepsi), rifampicin (et lægemiddel til behandling af tuberkulose) eller prikbladet perikum (traditionel urtemedicin til lindring af let depression og angst).
• phenytoin or carbamazepine (medicines for the treatment of epilepsy), rifampicin (a medicine for treatment of tuberculosis) or St. John's Wort (a traditional herbal medicinal product for the relief of slightly low mood and mild anxiety).
For randomiserede forsøgspersoner var den gennemsnitlige estimerede glomerulære filtrationshastighed (eGFR) ved baseline 41 ml/min/1,73 m
For subjects randomized, the baseline, average estimated glomerular filtration rate (eGFR) was 41 mL/min/1.73 m
Stigninger i urinsyre
Uric acid increases
For at mindske risikoen for signifikant eller irreversibel leverskade, er det nødvendigt at tage blodprøver for hepatiske transaminaser inden indledning af behandling med Jinarc og at fortsætte hver måned i 18 måneder derefter med 3-måneders intervaller (se pkt.
To mitigate the risk of significant or irreversible liver injury, blood testing for hepatic transaminases is required prior to initiation of Jinarc treatment, continuing monthly for 18 months and at regular 3-monthly intervals thereafter (see section 4.4).
Ændringen af TKV over 3 år var signifikant mindre for tolvaptan-behandlede forsøgspersoner end for forsøgspersoner, der fik placebo: Henholdsvis 2,80 %'s vækst pr. år versus 5,51 %'s vækst pr. år (ratio af geometrisk gennemsnit 0,974; 95 % CI 0,969 til 0,980; p < 0,0001).
The rate of TKV increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80 % per year vs 5.51 % per year, respectively (ratio of geometric mean 0.974; 95 % CI 0.969 to 0.980; p < 0.0001).
Hvis dehydrering konstateres, skal der træffes passende foranstaltninger, hvilket kan gøre det nødvendigt at seponere tolvaptan eller reducere dosis af tolvaptan og øge væskeindtaget.
If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake.
Samtidig administration af tolvaptan og grapefrugtjuice, en moderat til stærk CYP3A-hæmmer, medførte en fordobling af de maksimale koncentrationer af tolvaptan (Cmax).
Co-administration of tolvaptan with grapefruit juice, a moderate to strong CYP3A inhibitor, produced a doubling of peak tolvaptan concentrations (Cmax).
Alle metabolitter har ingen eller svag antagonistaktivitet på humane V2-receptorer i sammenligning med tolvaptan.
Tolvaptan metabolites have little to no contribution to the pharmacological effect of tolvaptan; all metabolites have no or weak antagonist activity for human V2 receptors when compared with tolvaptan.
ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Tolvaptan kan have bivirkninger, som er relateret til vandtab, f.eks. tørst, polyuri, nykturi og pollakisuri (se pkt.
Tolvaptan may cause adverse reactions related to water loss such as thirst, polyuria, nocturia, and pollakiuria (see section 4.8).
Daglig delt dosis af tolvaptan Reduceret delt dosis 90+30 mg
Tolvaptan daily split-dose Reduced split-dose 90+30 mg
• risikoen for hepatotoksicitet i forbindelse med anvendelsen af Jinarc
• the risk of hepatotoxicity associated with the use of Jinarc
Nyrefunktionshændelser var 61,4 % mindre sandsynlige for tolvaptan sammenlignet med placebo (hazard ratio, 0,39; 95 % CI, 0,26 to 0,57; nominel p < 0,0001), mens hændelser med nyresmerter var 35,8 % mindre sandsynlige hos tolvaptanbehandlede patienter (hazard ratio, 0,64; 95 % CI, 0,47 to 0,89; nominel p = 0,007).
The renal function events were 61.4 % less likely for tolvaptan compared with placebo (hazard ratio, 0.39; 95 % CI, 0.26 to 0.57; nominal p < 0.0001), while renal pain events were 35.8 % less likely in tolvaptan-treated patients (hazard ratio, 0.64; 95 % CI, 0.47 to 0.89; nominal p = 0.007).
Endvidere er tolvaptan blevet forbundet med idiosynkratisk forhøjet alanin- og aspartataminotransferaser (ALT og AST) i blodet med sjældne tilfælde af samtidigt forhøjet totalt bilirubin (BT).
Furthermore, tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
Jinarc er kontraindiceret til patienter med forhøjede leverenzymer og/eller tegn eller symptomer på leverskade før indledning af behandling, som opfylder kravene for permanent seponering af tolvaptan (se pkt.
Jinarc is contraindicated in patients with 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 sections 4.3 and 4.4).
• Bivirkninger i forbindelse med langtidsanvendelse af Jinarc
• ADRs associated with long term use of Jinarc
156-13-210-studiet (et internationalt, randomiseret, dobbeltblindet, placebokontrolleret seponeringsstudie i fase 3 på flere centre) sammenlignede effekten og sikkerheden ved tolvaptan (45120 mg/dag) med placebo hos patienter, der var i stand til at tåle tolvaptan under en titrerings- og indkøringsperiode på fem uger.
The phase 3, multi-centre, international, randomized-withdrawal, placebo-controlled, double-blind trial 156-13-210 compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo in patients able to tolerate tolvaptan during a five-week titration and run-in period on tolvaptan.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Kontakt lægen, før du tager Jinarc:
Talk to your doctor before taking Jinarc
Tolvaptan er blevet forbundet med idiosynkratisk forhøjet alanin- og aspartataminotransferase (ALT og AST) i blodet med sjældne tilfælde af samtidigt forhøjet totalt bilirubin (BT).
Tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
EU/1/15/1000/003 7 tabletter EU/1/15/1000/004 28 tabletter
EU/1/15/1000/003 7 tablets EU/1/15/1000/004 28 tablets
Brug af anden medicin sammen med Jinarc
Other medicines and Jinarc
Hvis patienter ikke kan tolerere de reducerede doser af tolvaptan, skal yderligere reduktioner overvejes.
Further reductions have to be considered if patients cannot tolerate the reduced tolvaptan doses.
Samtidig anvendelse af lægemidler, der er moderate CYP3A-hæmmere (f.eks. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazol,
Concomitant use of medicinal products that are moderate CYP3A inhibitors (e.g. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) or strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, ritonavir, clarithromycin) increase tolvaptan exposure.
Teratogenicitet sås hos kaniner, der fik 1.000 mg/kg/dgl (7,5 gange eksponeringen for den anbefalede humane dosis på 120 mg/dgl baseret på AUC).
Teratogenicity was noted in rabbits given 1,000 mg/kg/day (7.5 times the exposure from the 120 mg/day human dose on an AUC basis).
Tolvaptan kan forårsage hyperglykæmi (se pkt.
Tolvaptan may cause hyperglycaemia (see section 4.8).
Polydipsi
Polydipsia
EU/1/15/1000/001 7 tabletter EU/1/15/1000/002 28 tabletter
EU/1/15/1000/001 7 tablets EU/1/15/1000/002 28 tablets
• Patientadvarselskort
• A Patient Alert Card
• Undervisningsmateriale til sundhedspersoner
• Healthcare professionals training material
Det anbefales samtidigt at kontrollere for symptomer, som kan indikere leverskade (f.eks. træthed, anoreksi, kvalme, smerter i den øverste højre del af maven, opkastning, feber, udslæt, pruritus, mørk urin eller gulsot).
Concurrent monitoring for symptoms that may indicate liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, dark urine or jaundice) is recommended.
Endvidere skal patienter drikke 1-2 glas væske før sengetid uden hensyn til om de er tørstige.
Additionally, patients have to drink 1-2 glasses of fluid before bedtime regardless of perceived thirst and replenish fluids overnight with each episode of nocturia.
Jinarc er kontraindiceret under amning (se pkt.
Jinarc is contraindicated during breast-feeding (see section 4.3).
Det skal du vide, før du begynder at tage Jinarc
What you need to know before you take Jinarc
Monitoreringen fortsættes med større hyppighed, indtil symptomerne/tegnene/de unormale laboratorieprøver er stabiliseret eller forsvundet.
Testing must continue at increased time frequency until symptoms/signs/laboratory abnormalities stabilise or resolve, at which point Jinarc may be reinitiated.
Samtidig anvendelse af tolvaptan og andre lægemidler, der øger koncentrationen af serum-natrium, kan medføre en højere risiko for at udvikle hypernatriæmi (se pkt.
Concomitant use of tolvaptan with medicinal products that increase serum sodium concentration may result in a higher risk for developing hypernatraemia (see section 4.4) and is therefore not recommended.
• unormal leverfunktionstest
• liver function abnormal
Abnorm leverfunktion
Abnormal hepatic function
og/eller kropsvægt bør overvejes for at monitorere risikoen for dehydrering sekundært til den aquaretiske effekt af tolvaptan, i tilfælde af patientens vandindtag ikke er tilstrækkeligt.
Periodic monitoring of plasma osmolality or serum sodium (to calculate plasma osmolarity) and/or body weight should be considered to monitor the risk of dehydration secondary to the aquaretic effects of tolvaptan in case of patient's insufficient water intake.
Jinarc skal administreres to gange dagligt i delte dosisregimer med 45 mg + 15 mg, 60 mg + 30 mg eller 90 mg + 30 mg. Morgendosis skal tages mindst 30 minutter før morgenmaden.
Jinarc is to be administered twice daily in split dose regimens of 45 mg + 15 mg, 60 mg + 30 mg or 90 mg + 30 mg.
• Undervisningsmateriale til patienter/plejere
• Patient/Carer educational material
To fertilitetsstudier med rotter viste påvirkning på den parentale generation (nedsat fødeindtag, langsommere kropsvægtforøgelse, spytflåd).
Two fertility studies in rats showed effects on the parental generation (decreased food consumption and body weight gain, salivation), but tolvaptan did not affect reproductive performance in males and there were no effects on the foetuses.
Undervisningsmaterialet til sundhedspersoner skal indeholde følgende væsentlige elementer:
The healthcare professional training material shall contain the following key elements
• smerter i maven
• pain in the abdomen
Risikoen for leverskade hos patienter med svært nedsat nyrefunktion (dvs. eGFR < 20) kan øges.
The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR < 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Statiner, der var i almindelig brug i fase-3 pivotalstudiet med tolvaptan (f.eks. rosuvastatin og pitavastatin), er OATP1B1- eller OATP1B3-substrater.
Statins commonly used in the tolvaptan phase 3 pivotal trial (e.g., rosuvastatin and pitavastatin) are OATP1B1 or OATP1B3 substrates, however no difference in AE profile was observed during the phase 3 pivotal trial for tolvaptan in ADPKD.
• Graviditet (se pkt.
• Pregnancy (see section 4.6)
Administration af tolvaptan fremkalder rigelig aquaresis og kan forårsage dehydrering og stigninger i serum-natrium (se pkt.
Administration of tolvaptan induces copious aquaresis and may cause dehydration and increases in serum sodium (see section 4.8) and is contraindicated in hypernatraemic patients (see section 4.3).
Hovedpine, Svimmelhed
Headache, Dizziness
CKD stadie 3 kan yderligere underinddeles i stadie 3a 30 % (eGFR 45 ml/min/1,73 m til mindre end
The CKD stage 3 can be subdivided further to stage 3a 30 %, (eGFR 45 mL/min/1.73 m to less than 60 mL/min/1.73 m 2) and stage 3b 45 %, (eGFR between 30-45 mL/min/1.73 m
Ingen klinisk signifikante ændringer er blevet set i clearance for doser på fra 5 til 60 mg. Der foreligger meget begrænsede oplysninger om patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Disse patienter skal monitoreres nøje for levertoksicitet.
Patients have to be carefully monitored during treatment.
Undervisningsmaterialet til patienter/plejere skal indeholde følgende væsentlige elementer:
The Patient/Carer educational material shall contain the following key messages:
Tolvaptan er kontraindiceret til patienter med anuri (se pkt.
Tolvaptan is contraindicated in anuric patients (see section 4.3).
• større behov for at lade vandet eller oftere vandladning
• increased need to urinate, to urinate at night, or to urinate more frequently
1,462-4,836, p = 0,0003) samt i følsomhedsanalyser, hvor eGFR-dataene ved baseline blev fremført (2,64 ml/min/1,73 m2, 95 %-CI 0,672-4,603, p = 0,0086).
This difference was maintained in the pre-specified MMRM analysis (3.15 mL/min/1.73 m2, 95 %CI 1.462 to 4.836, p = 0.0003) and with sensitivity analyses where baseline eGFR data were carried forward (2.64 mL/min/1.73 m2, 95 %CI 0.672 to 4.603, p = 0.0086).
Steady state-koncentrationer af tolvaptan opnås efter første dosis.
The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Nedsat nyrefunktion
Weight decreased
Jinarc 15 mg tabletter: blistre med 7 eller 28 tabletter
Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Jinarc indeholder laktose som hjælpestof.
Jinarc contains lactose as an excipient.