FrancophonIA/ELRC3.0 huggingface dataset:
English: Results were highly variable with large overlap between dose groups; changes were not significantly correlated with tolvaptan exposure.
Danish: Resultaterne var stærkt varierende med store overlap mellem dosisgrupperne; ændringerne var ikke signifikant korreleret med tolvaptan-eksponering.
English: The following medicines may increase the effect of this medicine:
Danish: Følgende lægemidler kan øge virkningen af dette lægemiddel:
English: Most of the liver enzyme abnormalities were observed during the first 18 months of treatment.
Danish: De fleste leverenzymforstyrrelser blev observeret i løbet af de første 18 måneder af behandlingen.
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: Studier 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: Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Danish: Selvom denne øgning ikke har klinisk relevans, indikerer det, at tolvaptan potentielt kan øge eksponering for CYP3A4-substrater.
English: Avoid drinking grapefruit juice when taking Samsca.
Danish: Du må ikke drikke grapefrugtjuice, når du tager Samsca.
English: Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists.
Danish: Samsca, der indeholder det aktive stof tolvaptan, tilhører en gruppe lægemidler, der hedder vasopressin-antagonister.
English: It may still be alright for you to take these medicines and Samsca together.
Danish: Du kan sandsynligvis godt tage disse lægemidler sammen med Samsca.
English: During the first 1-2 days and until the tolvaptan dose is stabilised serum sodium and volume status must be monitored at least every 6 hours.
Danish: De første 1-2 dage og indtil tolvaptan-dosis er stabiliseret, skal serum-natrium og volumenstatus kontrolleres mindst hver 6. time.
English: In the setting of hyponatremia, the treatment duration is determined by the underlying disease and its treatment.
Danish: Ved hyponatriæmi bestemmes behandlingsvarigheden af den underliggende sygdom og behandlingen af denne.
English: • increased need to urinate, or to urinate more frequently
Danish: • større behov for at lade vandet eller for at lade vandet oftere
English: • if you have a condition which increases the salt in your blood (“hypernatremia”)
Danish: • hvis du har en sygdom, der øger saltindholdet i dit blod (”hypernatriæmi”)
English: The pharmaco-dynamically predictable and most commonly reported adverse reactions are thirst, dry mouth and pollakiuria occurring in approximately 18 %, 9 % and 6 % of patients.
Danish: De farmakodynamisk forudsigelige og mest almindeligt rapporterede bivirkninger er tørst, mundtørhed og pollakisuri, som forekommer hos ca. 18 %, 9 % og 6 % af patienterne.
English: Markedly higher doses of tolvaptan produce more sustained responses without affecting the magnitude of excretion, as active concentrations of tolvaptan are present for longer periods of time.
Danish: Mærkbart højere doser tolvaptan giver mere vedvarende respons uden at påvirke omfanget af udskillelsen, eftersom aktive koncentrationer af tolvaptan er til stede gennem længere perioder.
English: The following medicines may lower the effect of this medicine:
Danish: Følgende lægemidler kan reducere virkningen af dette lægemiddel:
English: Patients receiving digoxin should therefore be evaluated for excessive digoxin effects when treated with tolvaptan.
Danish: Patienter, der får digoxin, skal derfor evalueres for overdreven digoxineffekt, når de behandles med tolvaptan.
English: Tolvaptan treatment is expected to last until the underlying disease is adequately treated or until such time that hyponatremia is no longer a clinical issue.
Danish: Behandling med tolvaptan forventes at vare, indtil den underliggende sygdom er tilstrækkeligt behandlet, eller indtil hyponatriæmien ikke længere er et klinisk problem.
English: Antagonist means that it prevents vasopressin having its effect on water retention.
Danish: Antagonist betyder, at det forhindrer vasopressin i at tilbageholde vand.
English: Therefore, patients must have access to water and be able to drink sufficient amounts of water.
Danish: 4.8) Derfor skal patienter have adgang til vand og være i stand til at drikke tilstrækkeligt med vand.
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Danish: Den terminale eliminationshalveringstid er ca. 8 timer, og steady state-koncentrationer af tolvaptan opnås efter første dosis.
English: For all doses, urine excretion rates returned to baseline levels after 24 hours.
Danish: Ved alle doser vendte urinudskillelseshastigheden tilbage til baseline-niveauet efter 24 timer.
English: • rapid rise in level of sodium.
Danish: • hurtig stigning i natriumniveauet.
English: The elevations gradually improved after discontinuation of tolvaptan.
Danish: Stigningerne svandt gradvist efter seponering af tolvaptan.
English: This medicine may increase the effect of the following medicines: • digoxin (used for treatment of irregularities of heart beat and heart failure).
Danish: Dette lægemiddel kan øge virkningen af følgende andre lægemidler: • digoxin (anvendes til behandling af uregelmæssig hjerterytme og hjertesvigt).
English: Tolvaptan has to be initiated at a dose of 15 mg once daily.
Danish: Tolvaptan skal indledes med en dosis på 15 mg én gang dagligt.
English: Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP.
Danish: Tolvaptans affinitet for den humane V2-receptor er 1,8 gange større end for det native AVP.
English: • if you do not realise when you are thirsty
Danish: • hvis du ikke kan føle tørst
English: • barbiturates (used to treat epilepsy/seizures and some sleep disorders),
Danish: • barbiturater (anvendes til behandling af epilepsi/krampeanfald og visse søvnforstyrrelser),
English: Patients taking tolvaptan should avoid ingesting grapefruit juice.
Danish: Patienter, der tager tolvaptan, skal undlade at indtage grapefrugtjuice.
English: Improvements in serum sodium levels were observed as early as the first day after dosing and continued for on-treatment assessments up to Week 106.
Danish: Forbedringer i indholdet af serum-natrium blev observeret så tidligt som den første dag efter dosering og fortsatte ved vurderinger under behandlingen op til uge 106.
English: Elderly No dose adjustment is needed in elderly patients.
Danish: Ældre patienter Dosisjustering er ikke nødvendig hos ældre patienter.
English: Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers.
Danish: Enkeltdoser på op til 480 mg og gentagne doser på op til 300 mg dagligt i 5 dage har været tolereret i kliniske studier hos raske frivillige.
English: • ketoconazole (against fungal infections),
Danish: • ketoconazol (mod svampeinfektioner),
English: • diltiazem (treatment for high blood pressure and chest pain),
Danish: • diltiazem (behandling mod forhøjet blodtryk og brystsmerter),
English: • high levels of sodium, potassium, creatinine, uric acid and blood sugar
Danish: • højt indhold af natrium, kalium, kreatinin, urinsyre og sukker i blodet
English: Talk to your doctor or pharmacist before taking Samsca:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Samsca:
English: The mean serum sodium concentration at trial entry was 129 mEq/L (range 114-136).
Danish: Gennemsnitskoncentrationen af serum-natrium ved studiets start var 129 mEq/l (område 114-136).
English: If fluid restricted patients are treated with tolvaptan, extra caution has to be exercised to ensure that patients do not become overly dehydrated.
Danish: Hvis patienter, som er på væskerestriktion, behandles med tolvaptan, skal der udvises ekstra forsigtighed for at sikre, at patienterne ikke bliver for dehydrerede.
English: Tablets must be swallowed without chewing with a glass of water.
Danish: Tabletterne skal synkes hele sammen med et glas vand.
English: Co-administration with vasopressin analogues
Danish: Samtidig administration af vasopressin-analoger
English: This medicine may lower the effect of the following medicines: • desmopressin (used to increase blood clotting factors).
Danish: Dette lægemiddel kan reducere virkningen af følgende andre lægemidler: • desmopressin (bruges til at øge koagulationsfaktorerne i blodet).
English: Individual maximal increases in serum sodium were negatively correlated with fluid balance; mean change in fluid balance showed a dose dependent decrease.
Danish: De individuelle maksimale stigninger i serum-natrium var negativt korreleret med væskebalance; den gennemsnitlige ændring i væskebalance viste et dosisafhængigt fald.
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 vasopressin analoger, 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: • if you suffer from a kidney disease called autosomal dominant polycystic kidney disease
Danish: • hvis du har en nyresygdom, der kaldes autosomal dominant polycystisk nyresygdom (ADPKD)
English: • For treatment of your low sodium (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium.
Danish: • Hvis du behandles for for lidt salt i blodet (hyponatriæmi), vil din læge starte med at give dig en dosis på 15 mg og kan derefter øge den til maksimalt 60 mg for at opnå det ønskede serumnatriumniveau.
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 postnatalt studie med rotter sås forsinket ossifikation og reduceret kropsvægt hos ungerne ved den høje dosis på 1.000 mg/kg/dag.
English: Diabetic patients with an elevated glucose concentration (e.g. in excess of 300 mg/dL) may present with pseudo-hyponatremia.
Danish: Diabetespatienter med forhøjet glucosekoncentration (f.eks. over 300 mg/dl) kan have pseudohyponatriæmi.
English: In order to minimise the risk of too rapid correction of hyponatremia the increase of serum sodium should be less than 10-12 mmol/L/24 hours and less than 18 mmol/L/48 hours.
Danish: For at minimere risikoen for en for hurtig korrektion af hyponatriæmi bør øgningen af serum-natrium være under 10-12 mmol/l/døgn og under 18 mmol/l/48 timer.
English: • raised levels of creatinine in the blood.
Danish: • forhøjede niveauer af kreatinin i blodet.
English: In case of inadequate improvement in serum sodium levels, other treatment options have to be considered, either in place of or in addition to tolvaptan.
Danish: I tilfælde af utilstrækkelig øgning af serum-natrium skal andre behandlingsformer overvejes, enten i stedet for eller udover tolvaptan.
English: In addition, an increased incidence of significant elevations of ALT was observed in patients treated with tolvaptan [4.4 % (42/958)] compared to those receiving placebo [1.0 % (5/484)].
Danish: Der blev desuden observeret en øget forekomst af signifikante stigninger i ALAT hos patienter behandlet med tolvaptan [4,4 % (42/958)] sammenlignet med patienter, der fik placebo [1,0 % (5/484)].
English: Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output.
Danish: Vasopressin er et hormon, som medvirker til at forhindre væsketab i kroppen ved at mindske urinproduktionen.
English: However, when driving or using machines it should be taken into account that occasionally dizziness, asthenia or syncope may occur.
Danish: Dog skal der ved kørsel eller betjening af maskiner skal der tages højde for, at der kan forekomme svimmelhed, asteni eller synkope.
English: You have been prescribed this medicine because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water.
Danish: Du har fået ordineret dette lægemiddel, fordi du har et nedsat saltindhold i blodet, som skyldes en sygdom, der hedder SIADH (syndrome of inappropriate antidiuretic hormone secretion), hvor nyrerne tilbageholder for meget vand.
English: Data on the long-term safety and efficacy of tolvaptan were assessed for up to 106 weeks in a clinical trial in patients (any aetiology) who had previously completed one of the pivotal hyponatremia trials.
Danish: Data for den langvarige sikkerhed og effekt af tolvaptan blev vurderet i op til 106 uger i et klinisk studie hos patienter (alle ætiologier), som forinden havde gennemført et af de pivotale studier med hyponatriæmi.
English: This effect continued as on Day 30, when more tolvaptan than placebo patients still had normal concentrations (60 % vs. 27 %).
Danish: Denne virkning fortsatte til dag 30, hvor flere patienter på tolvaptan end på placebo stadig havde normale koncentrationer (60 % vs. 27 %).
English: Therefore, diabetic patients treated with tolvaptan should be managed cautiously.
Danish: Derfor skal diabetespatienter på tolvaptan behandles med forsigtighed.
English: Mean maximal changes in serum sodium were highest following the 15 mg dose (7.9 mmol/L) but median maximal changes were highest for the 7.5 mg dose (6.0 mmol/L).
Danish: De gennemsnitlige maksimale ændringer i serumnatrium var højest efter 15 mg-dosen (7,9 mmol/l), mens de mediane maksimale ændringer var højest for 7,5 mg-dosen (6,0 mmol/l).
English: Mechanism of action
Danish: Virkningsmekanism
English: In healthy subjects, tolvaptan, a CYP3A4 substrate, had no effect on the plasma concentrations of some other CYP3A4 substrates (e.g. warfarin or amiodarone).
Danish: Hos raske personer havde tolvaptan, et CYP3A4-substrat, ingen virkning på plasmakoncentrationerne af visse andre CYP3A4-substrater (f.eks. warfarin eller amiodaron).
English: The frequencies of the adverse reactions from clinical trials correspond with very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne for bivirkningerne i kliniske studier er angivet som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000
English: If liver injury is suspected, tolvaptan must be promptly discontinued, appropriate treatment has to be instituted, and investigations have to be performed to determine the probable cause.
Danish: Hvis der er mistanke om leverskade, skal tolvaptan omgående seponeres, passende behandling initieres og undersøgelser iværksættes for at bestemme den mulige årsag.
English: It is unknown whether tolvaptan is excreted in human milk.
Danish: Det vides ikke, om tolvaptan udskilles i brystmælk hos mennesker.
English: Tolvaptan is a selective vasopressin V2-receptor antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2-receptor of the distal portions of the nephron.
Danish: Tolvaptan er en selektiv vasopressin-V2-receptorantagonist, der specifikt blokerer bindingen af argininvasopressin (AVP) ved V2-receptorerne af de distale dele af nefronen.
English: Other side effects Very common (may affect more than 1 in 10 people)
Danish: Andre bivirkninger Meget almindelig (kan påvirke flere end 1 ud af 10 brugere)
English: The results of self-assessed health status using the SF-12 Health Survey for the mental scores showed statistically significant and clinically relevant improvements for tolvaptan treatment compared to placebo.
Danish: Resultaterne af selvvurderet helbredstilstand vha. SF-12 Health Survey (spørgeskema) om helbredstilstand ved de mentale scores viste statistisk signifikante og klinisk relevante forbedringer ved behandling med tolvaptan i sammenligning med placebo.
English: The adverse reaction profile of tolvaptan in SIADH is based on a clinical trials database of 3,294 tolvaptan-treated patients and is consistent with the pharmacology of the active substance.
Danish: Tolvaptans bivirkningsprofil ved behandling for SIADH er baseret på en database fra kliniske studier med 3.294 patienter, der blev behandlet med tolvaptan, og er i overensstemmelse med det aktive stofs farmakologi.
English: Contents of the pack and other information What Samsca contains
Danish: Pakningsstørrelser og yderligere oplysninger Samsca indeholder:
English: The dose could be increased to 30 and 60 mg/day depending on response using a 3 day titration scheme.
Danish: Dosis kunne øges til 30 og 60 mg dagligt afhængigt af respons ifølge en plan for titrering over 3 dage.
English: Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01
Danish: Farmakoterapeutisk klassifikation: Diuretika, vasopressin-antagonister, ATC-kode C03XA01
English: This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatremia).
Danish: Denne sygdom medfører en ureguleret produktion af hormonet vasopressin, som har medført, at saltindholdet i dit blod er for lavt (hyponatriæmi).
English: When treatment was discontinued, serum sodium concentrations decreased to approximately baseline values, despite the reinstatement of standard care therapy.
Danish: Da behandlingen blev seponeret, reduceredes koncentrationerne af serum-natrium til ca. baseline, på trods af genoptaget standardbehandling.
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 (profuse and prolonged aquaresis).
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 (kraftig og forlænget aquaresis).
English: Fluid and electrolyte status has to be monitored in all patients and particularly in those with renal and hepatic impairment.
Danish: Væske- og elektrolytbalancen skal kontrolleres hos alle patienter og især hos patienter med nedsat nyre- og leverfunktion.
English: Tolvaptan plasma concentrations have been decreased by up to 87 % (AUC) after the administration of CYP3A4 inducers.
Danish: Koncentrationer af tolvaptan i plasma er blevet reduceret med op til 87 % (AUC) efter administration af CYP3A4-inducere.
English: Based on the data available, no dose adjustment is required in those with mild to moderate renal impairment.
Danish: Baseret på de tilgængelige data er dosisjustering ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: • Swallow the tablet without chewing, with a glass of water.
Danish: • Synk tabletten hel sammen med et glas vand.
English: If sodium correction exceeds 6 mmol/L during the first 6 hours of administration or 8 mmol/L during the first 6-12 hours, respectively, the possibility that serum sodium correction may be overly rapid should be considered.
Danish: Hvis korrektion af natrium overstiger 6 mmol/l i løbet af de første 6 timer efter administration eller 8 mmol/l i løbet af de første 6-12 timer, bør det overvejes, om korrektionen af serum-natrium muligvis er for hurtig.
English: Samsca is unlikely to adversely affect your ability to drive or to operate machinery.
Danish: Det er usandsynligt, at Samsca vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Polydipsia, Dehydration, Hyperkalemia, Hyperglycemia, Hypoglycemia1, Hypernatremia1, Hyperuricemia1, Decreased appetite
Danish: Metabolisme og ernæring polydipsi, dehydrering, hyperkaliæmi, hyperglykæmi, hypoglykæmi1, hypernatriæmi1, hyperurikæmi1, nedsat appetit
English: Co-administration of a 60 mg dose with a high-fat meal increases peak concentrations 1.4 fold with no change in AUC and no change in urine output.
Danish: Administration af en dosis på 60 mg sammen med et fedtholdigt måltid øger den højeste koncentration med 1,4 gange uden ændring af AUC og urinvolumen.
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: Selv om det ikke ser ud til, at der er en synergistisk eller additiv virkning ved samtidig administration af tolvaptan og loop- og thiaziddiuretika, kan hver præparatklasse potentielt føre til svær dehydrering, hvilket udgør en risikofaktor for nyrefunktionsnedsættelse.
English: Samsca has no or negligible influence on the ability to drive or use machines.
Danish: Samsca påvirker ikke eller kun i ubetydelig grad i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
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 alle patienter, som tager tolvaptan, fordi behandling med tolvaptan kan resultere i svær dehydrering, hvilket udgør en risikofaktor for nyrefunktionsnedsættelse.
English: EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) was a long-term outcome, double-blind, controlled clinical trial in patients hospitalised with worsening HF and signs and symptoms of volume overload.
Danish: EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) var et langvarigt, dobbeltblindet, kontrolleret, klinisk studie med patienter indlagt med forværring af hjertesvigt og tegn og symptomer på volumenbelastning.
English: In the long-term outcome trial, a total of 2,072 patients received 30 mg tolvaptan with standard of care (SC) and 2,061 received placebo with SC.
Danish: I det langvarige studie blev i alt 2.072 patienter behandlet med 30 mg tolvaptan med standardbehandling, og 2.061 fik placebo med standardbehandling.
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 f.eks. mundtørhed og tørst eller mere alvorlige bivirkninger såsom nyreproblemer (se punkt 4).
English: Tolvaptan has not been studied in a setting of urgent need to raise serum sodium acutely.
Danish: Tolvaptan er ikke blevet undersøgt ved akut behov for øgning af serum-natrium.
English: Elevation (>3 × ULN) of serum aspartate aminotransferase (AST) was observed in 3.1 % (30/958) of patients on tolvaptan and 0.8 % (4/484) patients on placebo.
Danish: Der blev observeret en stigning (> 3 × ULN) i serumaspartataminotransferase (ASAT) hos 3,1 % (30/958) af patienterne på tolvaptan og hos 0,8 % (4/484) af patienterne på placebo.
English: Patients with very low baseline serum sodium concentrations may be at greater risk for too rapid correction of serum sodium.
Danish: Patienter med meget lave baseline-koncentrationer af serum-natrium kan have større risiko for en for hurtig korrektion af serum-natrium.
English: For patients with an appropriate increase in serum sodium, the underlying disease and serum sodium levels must be monitored at regular intervals to evaluate further need of tolvaptan treatment.
Danish: Hos patienter med passende øgning af serumnatrium skal den underliggende sygdom og serum-natrium kontrolleres jævnligt for at vurdere det videre behov for behandling med tolvaptan.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne angivet efter faldende sværhedsgrad.