FrancophonIA/ELRC3.0 huggingface dataset:
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 patients should be monitored more frequently regarding their serum sodium and administration of hypotonic fluid is recommended.
Danish: Serum-natrium skal kontrolleres hyppigere hos disse patienter, og administration af hypoton væske anbefales.
English: Therefore, you should only stop taking Samsca 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 Samsca, hvis du får bivirkninger, der kræver akut lægehjælp (se pkt.
English: In addition to its renal aquaretic effect, tolvaptan is capable of blocking vascular vasopressin V2receptors 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: Samsca is used to treat low serum sodium levels in adults.
Danish: Samsca bruges til at behandle meget lavt saltindhold i kroppen hos voksne.
English: Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Danish: Samsca er indiceret til behandling af voksne patienter med hyponatriæmi sekundært til SIADH (syndrome of inappropriate antidiuretic hormone secretion).
English: • sense of taste altered • kidney problems
Danish: • ændret smagssans • nyreproblemer.
English: Rapid correction of hyponatremia
Danish: Hurtig korrektion af hyponatriæmi
English: This effect was seen in all patients, the severe (serum sodium: < 130 mEq/L) and mild (serum sodium: 130 -< 135 mEq/L) subsets and for all disease aetiology subsets (e.g. HF, cirrhosis, SIADH/other).
Danish: Virkningen sås hos alle patienter, de alvorlige (serumnatrium: < 130 mEq/l) og lette (serum-natrium: 130 til < 135 mEq/l) undergrupper og for alle undergrupper af sygdomsætiologi (f.eks. hjertesvigt, cirrhose, SIADH m.fl.).
English: There is no experience from controlled clinical trials with concomitant use of Samsca and other treatments for hyponatremia such as hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Danish: Der er ingen erfaring fra kontrollerede kliniske studier med samtidig anvendelse af Samsca og andre behandlinger for hyponatriæmi, f.eks. hyperton natriumchloridopløsning, orale natriumpræparater og lægemidler, der øger serum-natrium.
English: The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium.
Danish: Dosis kan øges til maksimalt 60 mg én gang dagligt, afhængigt af tolerance, for at opnå det ønskede indhold af serum-natrium.
English: Samsca must not be taken with grapefruit juice (see section 4.5).
Danish: Samsca må ikke tages med grapefrugtjuice (se pkt.
English: At 7 days after discontinuing treatment, sodium values decreased to levels of placebo treated patients.
Danish: 7 dage efter seponering af behandlingen blev natriumindholdet reduceret til samme niveau som hos de placebobehandlede patienter.
English: In these clinical trials, clinically significant increases (greater than 3 × Upper Limit of Normal) in serum alanine aminotransferase (ALT), along with clinically significant increases (greater than 2 × Upper Limit of Normal) in serum total bilirubin were observed in 3 patients treated with tolvaptan.
Danish: I disse kliniske studier blev der observeret klinisk signifikante stigninger (større end 3 × den øvre normalgrænse) i serum-alaninaminotransferase (ALAT) samt klinisk signifikante stigninger (større end 2 × den øvre normalgrænse) i total-serum-bilirubin hos 3 patienter behandlet med tolvaptan.
English: Too rapid correction of hyponatremia (increase ≥ 12 mmol/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death.
Danish: En for hurtig korrektion af hyponatriæmi (øgning ≥ 12 mmol/l/døgn) kan forårsage osmotisk demyelinisering og resulterer i dysartri, mutisme, dysfagi, letargi, affektive symptomer, spastisk tetraparese, krampeanfald, koma eller død.
English: To monitor the effects of Samsca your doctor will do regular blood tests.
Danish: Din læge vil regelmæssigt tage blodprøver for at overvåge virkningen af Samsca.
English: Steady state digoxin concentrations have been increased (1.3-fold increase in maximum observed plasma concentration [Cmax] and 1.2-fold increase in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when co administered with multiple once daily 60 mg doses of tolvaptan.
Danish: Steady state-digoxinkoncentrationer er blevet øget (1,3 gange øgning i maksimal observeret plasmakoncentration [Cmax] og 1,2 gange øgning af arealet under tidskurven for plasmakoncentration over doseringsintervallet [AUCτ]) ved samtidig administration af flere doser tolvaptan på 60 mg én gang dagligt.
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).
Danish: • Øvrige indholdsstoffer: Lactosemonohydrat, majsstivelse, mikrokrystallinsk cellulose, hydroxypropylcellulose, magnesiumstearat, indigocarmin aluminium lake (E 132).
English: Too rapid correction of serum sodium
Danish: For hurtig korrektion af serum-natrium
English: Tolvaptan is extensively metabolised by the liver.
Danish: Tolvaptan metaboliseres i høj grad i leveren.
English: Tolvaptan increased plasma levels of lovastatin by 1.3- to 1.5-fold.
Danish: Tolvaptan øgede indholdet af lovastatin i plasma 1,3-1,5 gange.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tolvaptan in breast milk (for details see 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg har vist, at tolvaptan udskilles i brystmælk (se pkt.
English: In a pilot, randomized (1:1:1), double-blind trial in 30 patients with hyponatremia secondary to SIADH, the pharmacodynamics of tolvaptan following single doses of 3.75, 7.5 and 15 mg were assessed.
Danish: I et randomiseret (1:1:1), dobbeltblindet pilotstudie med 30 patienter med hyponatriæmi sekundært til SIADH blev tolvaptans farmakodynamik efter enkeltdoser a 3,75, 7,5 og 15 mg undersøgt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Samsca in one or more subsets of the paediatric population in treatment of dilutional hyponatremia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Samsca i en eller flere undergrupper af den pædiatriske population i behandling for fortyndingshyponatræmi (se pkt.
English: Adequate contraceptive measures must be used during use of this medicine.
Danish: Du skal anvende sikker kontraception under behandlingen med dette lægemiddel.
English: Tolvaptan must not be re-initiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to treatment with tolvaptan.
Danish: Tolvaptanbehandling bør ikke genstartes, medmindre det kan fastlægges med sikkerhed, at årsagen til den observerede leverskade ikke har relation til tolvaptan-behandlingen.
English: However, you may occasionally feel dizzy or weak or you may faint for a short period.
Danish: Samsca en gang imellem få dig til at føle dig svimmel eller svag, eller du kan besvime i kort tid.
English: In case serum sodium increases ≥ 12 mmol/L within 24 hours or ≥ 18 mmol/L within 48 hours, tolvaptan treatment is to be interrupted or discontinued followed by administration of hypotonic fluid.
Danish: Hvis serum-natrium stiger ≥ 12 mmol/l inden for 24 timer eller ≥ 18 mmol/l inden for 48 timer, skal behandling med tolvaptan afbrydes eller seponeres og hypoton væske administreres.
English: Women of childbearing potential have to use effective contraception during tolvaptan treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med tolvaptan.
English: This includes all medicines obtained without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept.
English: Liver function tests must be promptly performed in patients taking tolvaptan who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
Danish: Der bør straks tages leverfunktionsprøver hos patienter i behandling med tolvaptan, som rapporterer symptomer, der kan være tegn på leverskade, inklusive træthed, anoreksi, ubehag i øverste højre del af abdomen, mørk urin eller gulsot.
English: Following 3 days of treatment, the pooled analysis of the two trials revealed five-fold more tolvaptan than placebo patients achieved normalisation of serum sodium concentrations (49 % vs. 11 %).
Danish: Efter 3 dages behandling viste den samlede analyse fra de to studier, at fem gange så mange patienter, der fik tolvaptan, i forhold til antallet af placebobehandlede patienter, opnåede normaliserede koncentrationer af serum-natrium (49 % vs. 11 %).
English: In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) 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.
English: Tolvaptan has linear pharmacokinetics for doses of 7.5 to 60 mg.
Danish: Tolvaptan har lineær farmakokinetik ved doser på 7,5 til 60 mg.
English: • decrease in level of blood sugar
Danish: • nedsat blodsukker
English: The no observed adverse effects level (NOAEL) for effects on reproduction in females (100 mg/kg/day) was about 8-times the total daily dose of 60 mg/day on a mg/m2 basis.
Danish: NOAEL-niveauet (niveauet uden observeret negativ effekt) for indvirkning på reproduktionsevnen hos hunrotter (100 mg/kg/dag) var ca. 8 gange større end den samlede daglige dosis på 60 mg/dag baseret på mg/m2.
English: For single doses 60 mg to 480 mg, a mean of about 7 litres was excreted during 0 to 12 hours, independent of dose.
Danish: Ved enkeltdoser a 60480 mg blev der udskilt gennemsnitligt 7 liter i løbet af 0-12 timer uafhængigt af dosis.
English: After oral administration, tolvaptan is rapidly absorbed with peak plasma concentrations occurring about 2 hours after dosing.
Danish: Efter peroral administration absorberes tolvaptan hurtigt med maksimale plasmakoncentrationer ca. 2 timer efter dosering.
English: Mean change from baseline in cumulative urine volume and urine excretion rates was 2-fold higher for the 15 mg dose compared to the 7.5 and 3.75 mg doses, which showed similar responses.
Danish: Den gennemsnitlige ændring fra baseline i kumulativ urinvolumen og urinudskillelseshastighed var 2 gange højere for 15 mg-dosen sammenholdt med 7,5- og 3,75-dosen, hvis respons var omtrent den samme.
English: If you stop taking Samsca
Danish: Hvis du holder op med at tage Samsca
English: Samsca is contraindicated during pregnancy (see section 4.3).
Danish: Samsca er kontraindiceret under graviditet (se pkt.
English: If you stop taking Samsca this may lead to reoccurrence of your low sodium.
Danish: Hvis du holder op med at tage Samsca, kan det medføre, at du igen får for lidt salt i blodet.
English: Liver injury induced by tolvaptan was observed in clinical trials investigating a different indication (autosomal dominant polycystic kidney disease [ADPKD]) with long-term use of tolvaptan at higher doses than for the approved indication (see section 4.8).
Danish: Leverskade induceret af tolvaptan er observeret i kliniske studier, der undersøgte en anden indikation (autosomal dominant polycystisk nyresygdom [ADPKD]), ved langvarig anvendelse af tolvaptan i højere doser end for den godkendte indikation (se pkt.
English: Co-administration of grapefruit juice and tolvaptan resulted in a 1.8-fold increase in exposure to tolvaptan.
Danish: Samtidig brug af grapefrugtjuice og tolvaptan resulterede i en 1,8 gange større eksponering for tolvaptan.
English: No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion (Child-Pugh klasse A og B).
English: If you forget to take Samsca
Danish: Hvis du har glemt at tage Samsca
English: Tolvaptan plasma concentrations have been increased by up to 5.4-fold area under time-concentration curve (AUC) after the administration of strong CYP3A4 inhibitors.
Danish: Koncentrationer af tolvaptan i plasma er blevet øget med op til 5,4 gange arealet under tidskurven for plasmakoncentration (AUC) efter administration af stærke CYP3A4-hæmmere.
English: • Hypovolemic hyponatremia
Danish: • Hypovolæmisk hyponatriæmi
English: In a population pharmacokinetic analysis in patients with hepatic oedema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.
Danish: I en farmakokinetisk populationsanalyse af patienter med hepatisk ødem var AUC for tolvaptan hos patienter med svært (Child-Pugh klasse C) og mildt eller moderat (Child-Pugh klasse A og B) nedsat leverfunktion 3,1 og 2,3 gange højere end hos raske forsøgspersoner.
English: If dehydration or renal dysfunction becomes evident, take appropriate action which may include the need to interrupt or reduce doses of tolvaptan and/or diuretics, increase fluid intake, evaluate and address other potential causes of renal dysfunction or dehydration.
Danish: Hvis der konstateres dehydrering eller nedsat nyrefunktion, skal der træffes passende foranstaltninger, hvilket kan inkludere seponering af tolvaptan eller dosisnedsættelse af tolvaptan og/eller diuretika, øget væskeindtagelse samt evaluering og korrektion af andre mulige årsager til nyrefunktionsnedsættelse eller dehydrering.
English: What you need to know before you take Samsca Do not take Samsca
Danish: Det skal du vide, før du begynder at tage Samsca Tag ikke Samsca
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: BILAG III ETKETTERING OG INDLÆGSSEDDEL
English: • general feeling of being unwell
Danish: • generel følelse af utilpashed
English: 50 mL/min) impaired renal function were not significantly different to tolvaptan concentrations in patients with normal renal function (Ccr 80 to 150 mL/min).
Danish: nedsat nyrefunktion ikke signifikant anderledes end tolvaptankoncentrationer hos patienter med normal nyrefunktion (80 til 150 ml/min.).
English: Urgent need to raise serum sodium acutely
Danish: Akut behov for øgning af serum-natrium
English: Medicinal products with high sodium content such as effervescent analgesic preparations and certain sodium containing treatments for dyspepsia may also increase serum sodium concentration.
Danish: Lægemidler med højt natriumindhold, f.eks. analgetiske brusetabletter og visse natriumholdige præparater mod dyspepsi, kan også øge serum-natrium.
English: No information is available in patients with severe hepatic impairment (Child-Pugh class C).
Danish: Der er ingen oplysninger vedrørende patienter med alvorligt nedsat leverfunktion (Child-Pugh klasse C).
English: Samsca contains lactose
Danish: Samsca indeholder lactose.
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, including a high proportion of patients with tumours (especially Small Cell Lung Cancer), patients with low baseline serum sodium as well as patients with concomitant use of diuretics and/or sodium chloride solution the incidence of rapid correction of hyponatremia was found to be higher than in clinical trials.
Danish: I en undersøgelse af brugen af tolvaptan efter tilladelse til markedsføring hos patienter med hyponatriæmi sekundært til SIADH, herunder en stor andel af patienter med tumorer (især småcellet lungekræft), patienter med en lav natrium-værdi ved baseline og patienter med samtidig brug af diuretika og/eller natriumchloridopløsning var incidensen af hurtig korrektion af hyponatriæmi højere end i de kliniske studier.
English: No teratogenic effects were seen in rabbits at 300 mg/kg/day (up to 5 times the exposure in humans at the 60 mg dose, based on AUC).
Danish: Ingen teratogen effekt sås hos kaniner ved 300 mg/kg/dag (op til 5 gange eksponeringen hos mennesker ved 60 mg-dosen baseret på AUC).
English: If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake.
Danish: Hvis dehydrering konstateres, skal der træffes passende foranstaltninger, hvilket kan inkludere seponering af tolvaptan eller nedsættelse af tolvaptandosis og øget væskeindtagelse.
English: Co-administration with other treatments for hyponatremia and medicinal products that increase serum sodium concentration
Danish: Samtidig administration af anden behandling for hyponatriæmi og lægemidler, der øger serum-natrium
English: Caution has to be exercised in co-administering CYP3A4 inducers (e.g. rifampicin, barbiturates) with tolvaptan.
Danish: Der skal udvises forsigtighed ved samtidig administration af CYP3A4-inducere (f.eks. rifampicin, barbiturater) og tolvaptan.
English: Patients with known hypersensitivity reactions to benzazepine 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).
Danish: 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.
English: 10 tablets 30 tablets 10 × 1 tablet 30 × 1 tablet
Danish: 10 tabletter 30 tabletter 10 × 1 tablet 30 × 1 tablet
English: • if you suffer from liver disease
Danish: • hvis du har en leversygdom
English: Consult your doctor if symptoms of fatigue, loss of appetite, right upper abdominal discomfort, dark urine or jaundice (yellowing of skin or eyes) occur.
Danish: Søg læge, hvis du oplever symptomer som træthed, appetitløshed, smerter i den øvre, højre del af maven, mørk urin eller gulsot (gulfarvning af hud og øjne).
English: Tolvaptan has not been studied in patients with severe renal failure.
Danish: Tolvaptan er ikke undersøgt hos patienter med alvorligt nedsat nyrefunktion.
English: • Volume depletion
Danish: • Volumendepletering
English: Use of tolvaptan in combination with other options may increase the risk of overly rapid correction of serum sodium (see sections 4.4 and 4.5).
Danish: Brug af tolvaptan i kombination med andre muligheder kan øge risikoen for en for hastig korrektion af serum-natrium (se pkt.
English: Tolvaptan may cause hyperglycemia (see section 4.8).
Danish: Tolvaptan kan forårsage hyperglykæmi (se pkt.
English: For patients at risk of overly rapid correction of sodium e.g. patients with oncological conditions, very low baseline serum sodium, taking diuretics, or taking sodium supplementation a dose of 7.5 mg should be considered (see section 4.4).
Danish: Hos patienter med risiko for meget hurtig korrektion af natrium, f.eks. patienter med onkologiske tilstande, patienter med en meget lav baseline-værdi af serum-natrium, patienter som tager diuretika eller natriumtilskud, bør en dosis på 7,5 mg overvejes (se pkt.
English: Teratogenicity was noted in rabbits given 1,000 mg/kg/day (up to 15 times the exposure in humans at the 60 mg dose, based on AUC).
Danish: Teratogenicitet sås hos kaniner, der fik 1.000 mg/kg/dag (op til 15 gange eksponeringen hos mennesker ved 60 mg-dosen baseret på AUC).
English: In an analysis on population pharmacokinetics for patients with heart failure, tolvaptan concentrations of patients with mildly (creatinine clearance [Ccr] 50 to 80 mL/min) or moderately (Ccr 20 to
Danish: I en analyse af populationsfarmakokinetik hos patienter med hjertesvigt var tolvaptankoncentrationer hos patienter med let (kreatininclearance 50-80 ml/min.)
English: In healthy adult subjects, oral administration of 7.5 to 120 mg doses of tolvaptan produced a increase in urine excretion rate within 2 hours of dosing.
Danish: Oral administration af doser på 7,5 til 120 mg tolvaptan hos raske voksne forsøgspersoner medførte en øgning af urinudskillelseshastigheden inden for 2 timer efter dosering.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS AND PERFORATED UNIT DOSE BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER OG PERFORERET ENKELTDOSISBLISTER
English: In patients at higher risk of demyelination syndromes, for example those with hypoxia, alcoholism or malnutrition, the appropriate rate of sodium correction may be lower than that in patients without risk factors; these patients should be very carefully managed.
Danish: Hos patienter med højere risiko for demyeliniseringssyndrom, f.eks. patienter med hypoksi, alkoholisme eller fejlernæring, kan den hensigtsmæssige hastighed for korrektion af serum-natrium være lavere end hos patienter uden risikofaktorer.
English: • excessive drinking of water
Danish: • indtagelse af store mængder vand
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, dry mouth and dehydration (see section 4.8).
Danish: Tolvaptan kan have bivirkninger, der er relateret til vandtab, såsom tørst, mundtørhed og dehydrering (se pkt.
English: • Hypernatremia
Danish: • Hypernatriæmi
English: • patchy bleeding in the skin
Danish: • pletvis blødning i huden
English: Co-administration of Samsca with other treatments for hyponatremia, and medicinal products that increase serum sodium concentration, is not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations (see section 4.5).
Danish: Samtidig administration af Samsca og anden behandling for hyponatriæmi eller medicin, der øger serum-natrium, frarådes under den indledende behandling eller for andre patienter med meget lave baselinekoncentrationer af serum-natrium (se pkt.
English: In these patients dosing has to be managed cautiously and electrolytes and volume status must be monitored (see section 4.4).
Danish: Der skal udvises forsigtighed ved bestemmelse af dosis til disse patienter, og elektrolytbalance og volumenstatus skal kontrolleres (se pkt.
English: Following single oral doses of 7.5 to 60 mg, 24-hour urine volume increased dose dependently with daily volumes ranging from 3 to 9 litres.
Danish: Efter orale enkeltdoser på 7,5-60 mg steg døgnurinvolumenen dosisafhængigt med døgnvolumener fra 3 til 9 liter.
English: conivaptan, fenoldopam mesylate or mirtazapine)
Danish: (f.eks. benazepril, conivaptan, fenoldopammesylat eller mirtazapin)
English: Therefore after initiation of treatment, patients have to be closely monitored for serum sodium and volume status (see above).
Danish: Efter påbegyndelse af behandling skal serum-natrium og volumenstatus derfor monitoreres nøje (se ovenfor).
English: Samsca is not recommended in the paediatric age group.
Danish: Det frarådes at anvende Samsca til den pædiatriske population.
English: Rapid correction of hyponatremia, sometimes leading to neurological symptoms observed in clinical trials investigating other indications from post-authorisation safety study in hyponatremia secondary to SIADH observed in post-marketing with tolvaptan in ADPKD.
Danish: Kirurgiske og medicinske procedurer hurtig korrektion af hyponatriæmi, hvilket sommetider medfører neurologiske symptomer observeret i kliniske studier, der undersøgte andre indikationer data fra sikkerhedsstudie hos patienter med hyponatriæmi sekundært til SIADH