FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
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: • 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).
Danish: • 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.
English: Co-administration of tolvaptan and fluconazole, a moderate CYP3A inhibitor, produced a 200 % and 80 % increase in tolvaptan AUC and Cmax, respectively.
Danish: Samtidig administration af tolvaptan og fluconazol, en moderat CYP3A-hæmmer, medførte en stigning i tolvaptans AUC og Cmax på hhv. 200 % og 80 %.
English: 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.
Danish: Perioden inden debut af hepatocellulær skade (ved forhøjet ALT på > 3 × ULN) lå inden for 3 til 14 måneder efter indledning af behandling.
English: 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.
Danish: Jinarcs sikkerhed og virkning i CKD stadium 5 er ikke blevet undersøgt tilstrækkeligt.
English: 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).
Danish: 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).
English: • 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).
Danish: • 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).
English: For subjects randomized, the baseline, average estimated glomerular filtration rate (eGFR) was 41 mL/min/1.73 m
Danish: For randomiserede forsøgspersoner var den gennemsnitlige estimerede glomerulære filtrationshastighed (eGFR) ved baseline 41 ml/min/1,73 m
English: Uric acid increases
Danish: Stigninger i urinsyre
English: 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).
Danish: 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.
English: 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).
Danish: 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).
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 gøre det nødvendigt at seponere tolvaptan eller reducere dosis af tolvaptan og øge væskeindtaget.
English: Co-administration of tolvaptan with grapefruit juice, a moderate to strong CYP3A inhibitor, produced a doubling of peak tolvaptan concentrations (Cmax).
Danish: Samtidig administration af tolvaptan og grapefrugtjuice, en moderat til stærk CYP3A-hæmmer, medførte en fordobling af de maksimale koncentrationer af tolvaptan (Cmax).
English: 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.
Danish: Alle metabolitter har ingen eller svag antagonistaktivitet på humane V2-receptorer i sammenligning med tolvaptan.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Tolvaptan may cause adverse reactions related to water loss such as thirst, polyuria, nocturia, and pollakiuria (see section 4.8).
Danish: Tolvaptan kan have bivirkninger, som er relateret til vandtab, f.eks. tørst, polyuri, nykturi og pollakisuri (se pkt.
English: Tolvaptan daily split-dose Reduced split-dose 90+30 mg
Danish: Daglig delt dosis af tolvaptan Reduceret delt dosis 90+30 mg
English: • the risk of hepatotoxicity associated with the use of Jinarc
Danish: • risikoen for hepatotoksicitet i forbindelse med anvendelsen af Jinarc
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: 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).
Danish: 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.
English: • ADRs associated with long term use of Jinarc
Danish: • Bivirkninger i forbindelse med langtidsanvendelse af Jinarc
English: 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.
Danish: 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.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Talk to your doctor before taking Jinarc
Danish: Kontakt lægen, før du tager Jinarc:
English: 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).
Danish: Tolvaptan er blevet forbundet med idiosynkratisk forhøjet alanin- og aspartataminotransferase (ALT og AST) i blodet med sjældne tilfælde af samtidigt forhøjet totalt bilirubin (BT).
English: EU/1/15/1000/003 7 tablets EU/1/15/1000/004 28 tablets
Danish: EU/1/15/1000/003 7 tabletter EU/1/15/1000/004 28 tabletter
English: Other medicines and Jinarc
Danish: Brug af anden medicin sammen med Jinarc
English: Further reductions have to be considered if patients cannot tolerate the reduced tolvaptan doses.
Danish: Hvis patienter ikke kan tolerere de reducerede doser af tolvaptan, skal yderligere reduktioner overvejes.
English: 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.
Danish: Samtidig anvendelse af lægemidler, der er moderate CYP3A-hæmmere (f.eks. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazol,
English: 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).
Danish: 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).
English: Tolvaptan may cause hyperglycaemia (see section 4.8).
Danish: Tolvaptan kan forårsage hyperglykæmi (se pkt.
English: Polydipsia
Danish: Polydipsi
English: EU/1/15/1000/001 7 tablets EU/1/15/1000/002 28 tablets
Danish: EU/1/15/1000/001 7 tabletter EU/1/15/1000/002 28 tabletter
English: • A Patient Alert Card
Danish: • Patientadvarselskort
English: • Healthcare professionals training material
Danish: • Undervisningsmateriale til sundhedspersoner
English: 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.
Danish: 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).
English: 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.
Danish: Endvidere skal patienter drikke 1-2 glas væske før sengetid uden hensyn til om de er tørstige.
English: Jinarc is contraindicated during breast-feeding (see section 4.3).
Danish: Jinarc er kontraindiceret under amning (se pkt.
English: What you need to know before you take Jinarc
Danish: Det skal du vide, før du begynder at tage Jinarc
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Danish: Herikerbergweg 292
English: Testing must continue at increased time frequency until symptoms/signs/laboratory abnormalities stabilise or resolve, at which point Jinarc may be reinitiated.
Danish: Monitoreringen fortsættes med større hyppighed, indtil symptomerne/tegnene/de unormale laboratorieprøver er stabiliseret eller forsvundet.
English: 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.
Danish: Samtidig anvendelse af tolvaptan og andre lægemidler, der øger koncentrationen af serum-natrium, kan medføre en højere risiko for at udvikle hypernatriæmi (se pkt.
English: • liver function abnormal
Danish: • unormal leverfunktionstest
English: Abnormal hepatic function
Danish: Abnorm leverfunktion
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • Patient/Carer educational material
Danish: • Undervisningsmateriale til patienter/plejere
English: 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.
Danish: To fertilitetsstudier med rotter viste påvirkning på den parentale generation (nedsat fødeindtag, langsommere kropsvægtforøgelse, spytflåd).
English: The healthcare professional training material shall contain the following key elements
Danish: Undervisningsmaterialet til sundhedspersoner skal indeholde følgende væsentlige elementer:
English: • pain in the abdomen
Danish: • smerter i maven
English: 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.
Danish: Risikoen for leverskade hos patienter med svært nedsat nyrefunktion (dvs. eGFR < 20) kan øges.
English: 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.
Danish: Statiner, der var i almindelig brug i fase-3 pivotalstudiet med tolvaptan (f.eks. rosuvastatin og pitavastatin), er OATP1B1- eller OATP1B3-substrater.
English: • Pregnancy (see section 4.6)
Danish: • Graviditet (se pkt.
English: 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).
Danish: Administration af tolvaptan fremkalder rigelig aquaresis og kan forårsage dehydrering og stigninger i serum-natrium (se pkt.
English: Headache, Dizziness
Danish: Hovedpine, Svimmelhed
English: 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
Danish: CKD stadie 3 kan yderligere underinddeles i stadie 3a 30 % (eGFR 45 ml/min/1,73 m til mindre end
English: No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Danish: 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).
English: Patients have to be carefully monitored during treatment.
Danish: Disse patienter skal monitoreres nøje for levertoksicitet.
English: The Patient/Carer educational material shall contain the following key messages:
Danish: Undervisningsmaterialet til patienter/plejere skal indeholde følgende væsentlige elementer:
English: Tolvaptan is contraindicated in anuric patients (see section 4.3).
Danish: Tolvaptan er kontraindiceret til patienter med anuri (se pkt.
English: • increased need to urinate, to urinate at night, or to urinate more frequently
Danish: • større behov for at lade vandet eller oftere vandladning
English: 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).
Danish: 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).
English: The terminal elimination half-life is about 8 hours and steady-state concentrations of tolvaptan are obtained after the first dose.
Danish: Steady state-koncentrationer af tolvaptan opnås efter første dosis.
English: Weight decreased
Danish: Nedsat nyrefunktion
English: Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Danish: Jinarc 15 mg tabletter: blistre med 7 eller 28 tabletter
English: Jinarc contains lactose as an excipient.
Danish: Jinarc indeholder laktose som hjælpestof.
English: Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Danish: Jinarc 30 mg tabletter: blistre med 7 eller 28 tabletter
English: What Jinarc is and what it is used for What you need to know before you take Jinarc How to take Jinarc
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Jinarc Sådan skal du tage Jinarc Bivirkninger
English: Package leaflet: Information for the patient
Danish: Indlægsseddel Information til patienten
English: 1,692 mL (height adjusted 972 mL/m).
Danish: 79 % havde hypertension og et gennemsnitligt TKV på 1.692 ml (højdejusteret 972 ml/m).
English: Serum sodium abnormalities
Danish: Serum-natriumabnormiteter
English: Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister)
Danish: Jinarc 15 mg tabletter EU/1/15/1000/001-002 (blister)
English: narcotic and anti-nociceptive, radiologic or surgical interventions) 3) worsening hypertension
Danish: 2) medicinsk signifikante nyresmerter (defineres som krævende ordineret sygeorlov, last-resort analgetika, narkotika og antinociceptive, radiologiske eller kirurgiske interventioner) 3) forværret hypertension
English: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below.
Danish: Incidensen af bivirkninger forbundet med tolvaptan-behandling er angivet i tabellen nedenfor.
English: How to take Jinarc
Danish: Sådan skal du tage Jinarc
English: At baseline, patients had average estimated glomerular filtration rate (eGFR) of 82 mL/min/1.73 m2 (CKD-EPI) with 79 % having hypertension and a mean TKV of
Danish: Ved baseline havde patienter en gennemsnitlig estimeret glomerulær filtrationsrate (eGFR) på 82 ml/min/1,73 m
English: Nocturia, Pollakiuria, Polyuria
Danish: Nyrer og urinveje Nykturi, Pollakisuri,
English: Generalised rash
Danish: Generaliseret udslæt
English: The Patient Alert Card shall contain the following key messages:
Danish: Patientadvarselskortet skal indeholde følgende væsentlige elementer:
English: Fourteen metabolites have been identified in plasma, urine and faeces; all but one were also metabolised by CYP3A.
Danish: 14 metabolitter er blevet identificeret i plasma, urin og fæces.
English: Jinarc 30 mg tablets EU/1/15/1000/003-004 (blister)
Danish: Jinarc 30 mg tabletter EU/1/15/1000/003-004 (blister)
English: Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Danish: Jinarc 15 mg tabletter 7 eller 28 tabletter i PVC/aluminiumsfolieblister
English: Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Danish: Jinarc 30 mg tabletter 7 eller 28 tabletter i PVC/aluminiumsfolieblister
English: • The Patient information leaflet
Danish: • Information til patienten
English: • Patient information pack
Danish: • Informationspakke til patienter
English: 35 % reduction in the LS means of change in eGFR of -2.34 mL/min/1.73 m in tolvaptan group relative to a -3.61 mL/min/1.73 m in placebo group observed over the course of one year.
Danish: Den behandlingsforskel med hensyn til eGFR-ændring, der blev observeret i dette studie, er 1,27 ml/min/1,73 m2, hvilket svarer til en reduktion på 35 % i mindste kvadraters middelværdier for eGFR (-2,34 ml/min/1,73 m for tolvaptan-gruppen vs. -3,61 ml/min/1,73 m for placebogruppen) i løbet af et år.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Each 15 mg tablet contains 15 mg of tolvaptan.
Danish: Jinarc 15 mg tabletter + Jinarc 45 mg tabletter Hver 15 mg tablet indeholder 15 mg tolvaptan.
English: 15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Danish: 15 mm tablet: blå, trekantet, præget med “OTSUKA” og “15” på den ene side.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets
Danish: Jinarc 15 mg tabletter + Jinarc 45 mg tabletter Jinarc 30 mg tabletter + Jinarc 60 mg tabletter Jinarc 30 mg tabletter + Jinarc 90 mg tabletter
English: Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Danish: Jinarc 30 mg tabletter Blå, rund (diameter: 8 mm), flad, konveks, præget med “OTSUKA” og “30” på den ene side.
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Danish: Hver 60 mg tablet indeholder ca. 16 mg laktose (som monohydrat).
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Danish: Hver 45 mg tablet indeholder ca. 12 mg laktose (som monohydrat).
English: 45 mg tablet: blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side
Danish: 45 mg tablet: blå, firkantet (6,8 mm på den ene side, større akse 8,2 mm), flad, konveks, præget med “OTSUKA” and “45” på den ene side.
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Danish: Hver 90 mg tablet indeholder ca. 24 mg laktose (som monohydrat).
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister in wallet card)
Danish: Jinarc 15 mg tabletter + Jinarc 45 mg tabletter EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister i etui)
English: 30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Danish: 30 mm tablet: blå, rund, præget med “OTSUKA” og “30” på den ene side.
English: Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Danish: Jinarc 45 mg tabletter + Jinarc 15 mg tabletter: blistre med eller uden etui med 14 (7 tabletter i den højeste styrke + 7 tabletter i den laveste styrke), 28 (14 tabletter i den højeste styrke + 14 tabletter i den laveste styrke) eller 56 (28 tabletter i den højeste styrke + 28 tabletter i den laveste styrke) tabletter.
English: Each 15 mg tablet contains 15 mg tolvaptan.
Danish: Hver 15 mg tablet indeholder 15 mg tolvaptan.
English: This type of reaction occurred after the first administration of tolvaptan.
Danish: Denne type reaktion indtraf efter den første administration af tolvaptan.Patienterne skal overvåges omhyggeligt under behandlingen.
English: Each 90 mg tablet contains 90 mg tolvaptan.
Danish: Hver 90 mg tablet indeholder 90 mg tolvaptan.
English: Each 60 mg tablet contains 60 mg tolvaptan.
Danish: Hver 60 mg tablet indeholder 60 mg tolvaptan.
English: Jinarc 30 mg tablets
Danish: Jinarc 30 mg tabletter
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister in wallet card)
Danish: Jinarc 30 mg tabletter + Jinarc 90 mg tabletter EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister i etui)