FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of Neparvis in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Neparvis 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Danish: Sikkerheden af Neparvis hos patienter med kronisk hjertesvigt blev undersøgt i det pivotale fase 3studie PARADIGM-HF, hvor man sammenlignede patienter behandlet 2 gange daglig med enten 97 mg/103 mg Neparvis (n=4203) eller 10 mg enalapril (n=4229).
English: A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.
Danish: En startdosis på 24 mg/26 mg to gange daglig bør overvejes hos patienter med SBT ≥100-110 mmHg.
English: Therefore, monitoring of renal function is recommended when initiating or modifying treatment in patients on Neparvis who are taking NSAIDs concomitantly (see section 4.4).
Danish: Det anbefales derfor at overvåge nyrefunktionen ved start eller ved ændring af behandlingen hos patienter, der får Neparvis og samtidig tager NSAID (se pkt.
English: In the PARADIGM-HF study, Neparvis decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril.
Danish: I PARADIGM-HF-studiet mindskede Neparvis plasma NTproBNP og øgede plasma BNP og urin cGMP sammenlignet med enalapril.
English: Patients with mild and moderate renal impairment are more at risk of developing hypotension (see section 4.2).
Danish: Patienter med let til moderat nedsat nyrefunktion har større risiko for at udvikle hypotension (se pkt.
English: Sudden death accounted for 45% of cardiovascular deaths and was reduced by 20% in Neparvis-treated patients compared to enalapril-treated patients (HR 0.80, p=0.0082).
Danish: Pludselig død udgjorde 45 % af de kardiovaskulære dødsfald og blev reduceret med 20 % hos Neparvisbehandlede patienter sammenlignet med enalaprilbehandlede patienter (HR 0,80, p=0,0082).
English: Renal failure (renal failure, acute renal failure)
Danish: Nyresvigt (nyresvigt, akut nyresvigt)
English: A correlation was observed between renal function and systemic exposure to LBQ657 in patients with mild to severe renal impairment.
Danish: Der sås korrelation mellem nyrefunktion og systemisk optag for LBQ657 hos patienter med let til svært nedsat nyrefunktion.
English: More patients who were naïve to previous ACE inhibitor or ARB therapy or on low-dose therapy (equivalent to <10 mg enalapril/day) were able to achieve and maintain Neparvis 200 mg when up-titrated over 6 weeks (84.8%) versus 3 weeks (73.6%).
Danish: Flere patienter, som ikke tidligere havde været behandlet med ACE-hæmmer eller ARB, eller som var på lavdosisbehandling (svarende til <10 mg enalapril/dag), kunne opnå og vedligeholde 200 mg Neparvis ved optitrering over 6 uger (84,8 %) versus 3 uger (73,6 %).
English: Pump failure accounted for 26% of cardiovascular deaths and was reduced by 21% in Neparvis-treated patients compared to enalapril-treated patients (HR 0.79, p=0.0338).
Danish: Pumpesvigt udgjorde 26 % af de kardiovaskulære dødsfald og blev reduceret med 21 % hos Neparvisbehandlede patienter sammenlignet med enalaprilbehandlede patienter (HR 0,79, p=0,0338).
English: In vitro metabolism studies indicate that potential for CYP 450-based drug interactions is low since there is limited metabolism of Neparvis via CYP450 enzymes.
Danish: In-vitro-metaboliseringsstudier tyder på, at der kun er lille potentiale for CYP-baserede lægemiddelinteraktioner, da Neparvis kun i begrænset omfang metaboliseres via CYP-enzymer.
English: In the PARADIGM-HF study, subjects were previously treated with ACE inhibitors and/or ARBs and also had to successfully complete sequential enalapril and Neparvis run-in periods (median drug exposure of 15 and 29 days, respectively) prior to the randomised double-blind period.
Danish: I PARADIGM-HF-studiet var patienterne tidligere behandlet med ACE-hæmmere og/eller ARB og skulle også inden den randomiserede dobbeltblindede periode fuldføre en sekventiel enalapril og Neparvis run-in periode (gennemsnitlig lægemiddeleksponering var henholdsvis 15 og 29 dage).
English: Exposure to ARBs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Eksponering for behandling med ARB under andet og tredje trimester er kendt for at medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi).
English: The 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths are in some publications referred to as 50, 100 or 200 mg.
Danish: Styrkerne på 24 mg/26 mg, 49 mg/51 mg og 97 mg/103 mg henviser i nogle publikationer til 50, 100 og 200 mg.
English: Neparvis contains valsartan, and therefore should not be co-administered with another ARB containing product (see section 4.4).
Danish: Da Neparvis indeholder valsartan, bør det ikke anvendes sammen med et andet produkt indeholdende en ARB (se pkt 4.4).
English: Dizziness postural
Danish: Postural svimmelhed
English: Caution is therefore recommended when using it in these patients (see section 4.2 and 5.2).
Danish: Forsigtighed er derfor anbefalet ved anvendelse hos disse patienter (se pkt.
English: Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists (see section 4.2).
Danish: Det anbefales at monitorere serumkalium, især hos patienter, som har risikofaktorer som fx nedsat nyrefunktion, diabetes mellitus eller hypoaldosteronisme, eller som er på en diæt med højt kaliumindhold, eller som behandles med mineralokortikoidantagonister (se pkt.
English: TITRATION was a 12-week safety and tolerability study in 538 patients with chronic heart failure (NYHA class II-IV) and systolic dysfunction (left ventricular ejection fraction ≤35%) naïve to ACE inhibitor or ARB therapy or on varying doses of ACE inhibitors or ARBs prior to study entry.
Danish: TITRATION var et 12-ugers sikkerheds- og tolerabilitetsstudie hos 538 patienter med kronisk hjertesvigt (NYHA klasse II-IV) og systolisk dysfunktion (venstre ventrikel ejektionsfraktion ≤35 %), som ikke tidligere havde fået ACE-hæmmer eller ARB-behandling, eller som var på varierende doser af ACE-hæmmere eller ARB-er før studiestart.
English: Secondary endpoint
Danish: Sekundært endepunkt
English: In elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function, concomitant use of Neparvis and NSAIDs may lead to an increased risk of worsening of renal function.
Danish: Anvendelse af Neparvis sammen med NSAIDer kan hos ældre patienter, patienter med væskemangel (inklusive dem som er i diuretisk behandling) eller patienter med kompromitteret nyrefunktion medføre øget risiko for forværring af nyrefunktionen.
English: There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range.
Danish: Der er begrænset klinisk erfaring hos patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) eller med ASAT/ALAT-værdier mere end to gange den øvre grænse for normalværdier.
English: If hypotension occurs, temporary down-titration or discontinuation of Neparvis is recommended (see section 4.2).
Danish: Ved forekomst af hypotension anbefales midlertidig nedtitrering eller seponering af Neparvis (se pkt.
English: The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient (see section 5.1).
Danish: Dosis bør fordobles efter 2-4 uger til en måldosis på én tablet på 97 mg/103 mg to gange daglig, baseret på patientens toleranceevne (se pkt.
English: The clinical relevance of this finding is not known (see section 5.3).
Danish: Den kliniske relevans af dette fund er ukendt (se pkt.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Valsartan inhibits detrimental cardiovascular and renal effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
Danish: Valsartan hæmmer angiotensin IIs skadelige virkninger på hjerte-kar og nyrer ved en selektiv blokering af AT1-receptoren og ved også at hæmme angiotensin II-afhængig aldosteronfrigivelse.
English: Use of Neparvis may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Danish: Anvendelse af Neparvis kan være forbundet med en øget risiko for hyperkaliæmi, selvom hypokaliæmi også kan forekomme (se pkt.
English: In PARADIGM-HF study, Neparvis was administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB) (see section 5.1).
Danish: I PARADIGM-HF-studiet blev Neparvis administreret sammen med anden medicin til hjertesvigt, enten i stedet for en ACE-hæmmer eller andre angiotensin-II-receptorblokkere (ARB) (se pkt.
English: • painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 (Cox-2) inhibitors.
Danish: • smertestillende medicin af den type, der kaldes non-steroide antiinflammatoriske midler (NSAID) eller selektive cyclooxygenase-2 (Cox-2) hæmmere.
English: • if you have low blood pressure or are taking any other medicines that reduce your blood pressure (for example, a diuretic) or are suffering from vomiting or diarrhoea, especially if you are aged 65 years or more, or if you have kidney disease and low blood pressure.
Danish: • hvis du har et lavt blodtryk eller tager anden medicin, som kan nedsætte dit blodtryk (fx et vanddrivende middel) eller lider af opkastning eller diarré, især hvis du er 65 år eller derover,
English: Dose adjustment of diuretics, concomitant antihypertensives and treatment of other causes of hypotension (e.g. hypovolaemia) should be considered.
Danish: Det bør overvejes at justere dosis af diuretika, samtidigt administrerede antihypertensiva og hypotensionsbehandling af andre årsager (fx hypovolæmi).
English: If patients experience tolerability issues (systolic blood pressure [SBP] ≤95 mmHg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down-titration or discontinuation of Neparvis is recommended (see section 4.4).
Danish: Hvis patienten oplever tolerabilitetsproblemer (systolisk blodtryk [SBT] ≤95 mmHg, symptomatisk hypotension, hyperkaliæmi, nedsat nyrefunktion), er justering af samtidigt administrerede lægemidler, midlertidig nedtitrering eller seponering af Neparvis anbefalet (se pkt.
English: OATP1B1 and OATP1B3 substrates, e.g. statins
Danish: OATP1B1- og OATP1B3-substrater, fx statiner
English: Hyperkalaemia and serum potassium
Danish: Hyperkaliæmi og serum-kalium
English: Table 1 List of adverse reactions
Danish: Tabel 1 Liste over bivirkninger
English: • The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc and silica colloidal anhydrous.
Danish: • Øvrige indholdsstoffer i tabletkernen er mikrokrystallinsk cellulose, lavsubstitueret hydroxypropylcellulose, crospovidon, magnesiumstearat, talcum og silica, kolloid vandfri.
English: No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were coadministered.
Danish: Der blev ikke observeret nogen klinisk relevant interaktion ved kombinationsbehandling med simvastatin og Neparvis.
English: During the Neparvis run-in period, 10.4% of patients permanently discontinued, 5.9% because of an adverse reaction, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%).
Danish: Under Neparvis run-in perioden udgik 10,4 % af patienterne permanent, 5,9 % på grund af en bivirkning, hyppigst renal dysfunktion (1,8 %), hypotension (1,7 %) og hyperkaliæmi (1,3 %).
English: Other medicines and Neparvis Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Neparvis Fortæl altid lægen, apotekspersonalet eller sygeplejersken, hvis du bruger anden medicin eller har gjort det for nylig.
English: There is very limited clinical experience in patients with severe renal impairment (estimated GFR <30 ml/min/1.73m2) and these patients may be at greatest risk of hypotension (see section 4.2).
Danish: Der er meget begrænset klinisk erfaring hos patienter med svært nedsat nyrefunktion (estimeret GFR <30 ml/min/1,73m2), og disse patienter kan være i størst fare for hypotension (se pkt.
English: Interactions resulting in concomitant use not being recommended
Danish: Interaktioner som medfører at samtidig anvendelse frarådes
English: Overall, 76% of patients achieved and maintained the target dose of Neparvis 200 mg twice daily without any dose interruption or down-titration over 12 weeks.
Danish: Samlet nåede 76 % af patienterne op på Neparvis' måldosis 200 mg to gange daglig og kunne vedligeholde den uden afbrydelse eller nedtitrering i studieperioden på 12 uger.
English: A single dose of Neparvis 583 mg sacubitril/617 mg valsartan and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) were studied in healthy volunteers and were well tolerated.
Danish: En enkelt dosis Neparvis på 583 mg sacubitril/617 mg valsartan og gentagne doser på 437 mg sacubitril/463 mg valsartan (14 dage) blev undersøgt hos voksne frivillige forsøgspersoner og var veltolererede.
English: Black patients have an increased susceptibility to develop angioedema (see section 4.8).
Danish: Sorte patienter har øget følsomhed for udvikling af angioødem (se pkt.
English: The effects of Neparvis on amyloid-β concentrations in CSF and brain tissue were assessed in young (2-4 years old) cynomolgus monkeys treated with Neparvis (24 mg sacubitril/26 mg valsartan/kg/day) for two weeks.
Danish: Neparvis' virkning på koncentrationen af amyloid-β i CSF og hjernevæv blev undersøgt hos unge (2-4 år gamle) cynomolgus aber behandlet med Neparvis (24 mg sacubitril/26 mg valsartan/kg/dag) i to uger.
English: In the Neparvis group, 76% of patients remained on the target dose of 200 mg twice daily at the end of the study (mean daily dose of 375 mg).
Danish: I Neparvisgruppen var 76 % af patienterne stadigvæk på måldosis 200 mg 2 gange daglig ved afslutningen af forsøget (gennemsnitlig daglig dosis på 375 mg).
English: If patients experience clinically significant hyperkalaemia adjustment of concomitant medicinal products, or temporary down-titration or discontinuation is recommended.
Danish: Hvis patienter får klinisk signifikant hyperkaliæmi, anbefales justering af samtidigt administrerede lægemidler eller midlertidig nedtitrering eller seponering.
English: Neparvis should not be co-administered with an ACE inhibitor or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5).
Danish: Neparvis må ikke administreres sammen med en ACE-hæmmer eller en ARB. På grund af mulig risiko for angioødem, må behandling med Neparvis ikke startes før mindst 36 timer efter, at behandling med en ACE-hæmmer er afbrudt (se pkt.
English: The components of Neparvis, sacubitril and valsartan, were excreted in the milk of lactating rats (see section 5.3).
Danish: Neparvis' komponenter sacubitril og valsartan blev udskilt i mælk hos diegivende rotter (se pkt.
English: Patients with SBP <100 mmHg, severe renal impairment (eGFR <30 ml/min/1.73 m2) and severe hepatic impairment were excluded at screening and therefore not prospectively studied.
Danish: Patienter med SBT <100 mmHg, svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2) og svært nedsat leverfunktion blev ekskluderet ved screening og er derfor ikke studeret prospektivt.
English: • other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see “Do not take Neparvis”).
Danish: • anden medicin brugt til at behandle hjertesvigt eller til at sænke blodtrykket, som fx angiotensin-receptorblokker eller aliskiren (se ”Tag ikke Neparvis”).
English: Since CYP450-enzyme-mediated metabolism of sacubitril and valsartan is minimal, co-administration with medicinal products that impact CYP450 enzymes is not expected to impact the pharmacokinetics.
Danish: Da CYP-enzymmedieret metabolisering af sacubitril og valsartan er minimal, forventes administration sammen med CYP-enzymer ikke at influere på farmakokinetikken.
English: Monitoring of serum potassium is recommended if Neparvis is co-administered with these agents (see section 4.4).
Danish: Det anbefales at monitorere serumkalium, hvis Neparvis administreres sammen med disse stoffer (se pkt.
English: In a 21-day study in HFrEF patients, Neparvis significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1 compared to baseline.
Danish: I et 21-dages studie hos HFrEF-patienter øgede Neparvis urin ANP og cGMP, og plasma cGMP, og mindskede plasma NT-proBNP, aldosteron og endothelin-1 sammenlignet med baseline.
English: During the enalapril run-in period, 1,102 patients (10.5%) permanently discontinued from the study, 5.6% because of an adverse reaction, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%).
Danish: Under enalapril run-in perioden udgik 1102 patienter (10,5 %) permanent af studiet, 5,6 % på grund af bivirkninger, hyppigst renal dysfunktion (1,7 %), hyperkaliæmi (1,7 %) og hypotension (1,4 %).
English: • if you have diabetes or impaired kidney function and you are being treated with a blood pressure lowering medicine containing aliskiren (see “Other medicines and Neparvis”).
Danish: • hvis du har sukkersyge eller nedsat nyrefunktion, og du bliver behandlet med et blodtrykssænkende lægemiddel, der indeholder aliskiren (se ”Brug af anden medicin sammen med Neparvis”).
English: Talk to your doctor, pharmacist or nurse before taking Neparvis
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken før du tager Neparvis:
English: Pre- and postnatal development studies in rats conducted with sacubitril at high doses up to 750 mg/kg/day (2.2-fold the MRHD on the basis of AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment with Neparvis during organogenesis, gestation and lactation may affect pup development and survival.
Danish: Pre- og postnatale udviklingsstudier hos rotter udført med sacubitril i høje doser, op til 750 mg/kg/dag (2,2 gange MRHD vurderet ud fra AUC) og valsartan i doser op til 600 mg/kg/dag (0,86 gange MRHD vurderet ud fra AUC), tyder på, at behandling med Neparvis under organdannelse, gestation og laktation kan påvirke ungernes udvikling og overlevelse.
English: Concomitant use of potassium-sparing diuretics (triamterene, amiloride), mineralocorticoid antagonists (e.g. spironolactone, eplerenone), potassium supplements, salt substitutes containing potassium or other agents (such as heparin) may lead to increases in serum potassium, and to increases in serum creatinine.
Danish: Anvendelse sammen med kaliumbesparende diuretika (triamteren, amilorid), mineralokortikoidantagonister (fx spironolacton, eplerenon), kaliumtilskud, kaliumholdige salterstatninger eller andre stoffer (som fx heparin) kan føre til forhøjelse af serumkalium og forhøjelse af serumkreatinin.
English: In juvenile rats treated with valsartan (postnatal days 7 to 70), doses as low as 1 mg/kg/day produced persistent irreversible kidney changes consisting of tubular nephropathy (sometimes accompanied by tubular epithelial necrosis) and pelvic dilatation.
Danish: Hos unge rotter behandlet med valsartan (dag 7 til 70 postnatalt) i doser så lave som 1 mg/kg/dag gav irreversible nyreforandringer bestående af tubulær nefropati (sommetider ledsaget af tubulær epitelnekrose) og udvidelse af nyrebækkenet.
English: Neparvis is not recommended for mothers who are breastfeeding.
Danish: Neparvis frarådes til mødre, som ammer.
English: The tablets are supplied in PVC/PVDC/Aluminium blister packs of 14, 20, 28 tablets or 56 tablets and in multipacks of 196 tablets (7 packs of 28 tablets).
Danish: Tabletterne leveres i PVC/PVDC/Aluminiumsblisterpakninger med 14, 20, 28 eller 56 tabletter og multipakninger med 196 tabletter (7 pakninger med 28 tabletter).
English: The embryo-foetal no-observed adverse effect level (NOAEL) for sacubitril was at least 750 mg/kg/day in rats and 200 mg/kg/day in rabbits (2.2-fold the MRHD on the basis of LBQ657 AUC).
Danish: Den embryoføtale no observed adverse effect level (NOAEL) for sacubitril var mindst 750 mg/kg/dag hos rotter og 200 mg/kg/dag hos kaniner (2,2 gange MRHD baseret på LBQ657 AUC).
English: LBQ657 and valsartan exposure are increased in subjects over 65 years of age by 42% and 30%, respectively, compared to younger subjects.
Danish: Optagelsen af LBQ657 og valsartan er øget med henholdsvis 42 % og 30 % hos patienter over 65 år sammenlignet med yngre patienter.
English: In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of Neparvis resulted in an initial increase in natriuresis, increased urine cGMP, and decreased plasma levels of mid-regional pro-atrial natriuretic peptide (MR-proANP) and N-terminal prohormone brain natriuretic peptide (NT-proBNP) compared to valsartan.
Danish: I et 7-dages valsartankontrolleret studie hos patienter med nedsat uddrivningsfraktion (HFrEF), resulterede administration af Neparvis i en initial øgning i natriurese, øget urin cGMP og sænkede plasmakoncentrationer af MR-proANP (mid-regional proatrial natriuretic peptide) og NT-proBNP (N-terminal prohormone brain natriuretic peptide)
English: OUTER CARTON OF UNIT PACK
Danish: YDERKARTON TIL ENKELTPAKNING
English: Angioedema*
Danish: Angioødem*
English: Neparvis may be administered with or without food (see section 5.2).
Danish: Neparvis kan indtages med eller uden mad (se pkt.
English: In PARADIGM-HF, hypotension and clinically relevant low systolic blood pressure (<90 mmHg and decrease from baseline of >20 mmHg) were reported in 17.6% and 4.76% of Neparvis-treated patients compared with 11.9% and 2.67% of enalapril-treated patients, respectively.
Danish: I PARADIGM-HF forekom hypotension og klinisk relevant lavt systolisk blodtryk (<90 mmHg og reduktion fra baseline på >20 mmHg) hos henholdsvis 17,6 % og 4,76 % af patienter behandlet med Neparvis sammenlignet med henholdsvis 11,9 % og 2,67 % af patienter behandlet med enalapril.
English: Cardiovascular abnormalities (mainly cardiomegaly) were observed in rabbit foetuses at a maternally non-toxic dose (1.46 mg sacubitril/1.54 mg valsartan/kg/day).
Danish: Kardiovaskulære abnormaliteter (hovedsageligt kardiomegali) blev observeret hos kaninfostre ved en non-toksisk dosis for moderen (1,46 mg sacubitril/1,54 mg valsartan/kg/dag).
English: At steady state, sacubitril and valsartan do not accumulate significantly, while LBQ657 accumulates 1.6-fold.
Danish: Sacubitril og valsartan akkumuleres ikke signifikant under steady-state, mens LBQ657 akkumuleres 1,6 gange.
English: No dose adjustment is required when administering Neparvis to patients with mild hepatic impairment (Child-Pugh A classification).
Danish: Dosisjustering er ikke påkrævet, når Neparvis gives til patienter med let nedsat leverfunktion (ChildPugh klasse A).
English: In a thorough QTc clinical study in healthy male subjects, single doses of Neparvis 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarisation.
Danish: I et omhyggeligt QTc-studie hos raske, frivillige mænd havde enkeltdoser på Neparvis 194 mg sacubitril/206 mg valsartan og 583 mg sacubitril/617 mg valsartan ingen virkning på hjertets repolarisation.