FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Neparvis 194 mg sacubitril/206 mg valsartan once daily for two weeks to healthy subjects was associated with an increase in CSF Aβ1-38 compared to placebo; there were no changes in concentrations of CSF Aβ1-40 and 1-42.
Danish: Administration af Neparvis 194 mg sacubitril/206 mg valsartan en gang daglig i 2 uger til raske forsøgspersoner var forbundet med en øgning i CSF Aβ1-38 sammenlignet med placebo, der var ingen ændringer i koncentrationerne af CSF Aβ1-40 og 1-42.
English: Evaluation of patients with heart failure should always include assessment of renal function.
Danish: Vurdering af patienter med hjertesvigt bør altid inkludere måling af nyrefunktionen.
English: The oral absolute bioavailability of sacubitril and valsartan is estimated to be more than 60% and 23%, respectively.
Danish: Den absolutte orale biotilgængelighed af sacubitril og valsartan er bestemt til højere end hhv. 60 % og 23 %.
English: A similar effect on the heart rate may occur when Neparvis is co-administered with sublingual, oral or transdermal nitrates.
Danish: En lignende virkning på hjertefrekvensen kan forekomme, når Neparvis anvendes sammen med nitrater i sublingual, oral eller transdermal form.
English: Caution is required in patients with renal artery stenosis and monitoring of renal function is recommended.
Danish: Der skal iagttages forsigtighed hos patienter med renal arteriestenose, og det anbefales at monitorere nyrefunktionen.
English: ACE inhibitors are used to treat high blood pressure or heart failure.
Danish: ACE-hæmmere bruges til at behandle for højt blodtryk eller hjertesvigt.
English: Increases in CSF Aβ1-40 and 1-42 were not observed in a two-week healthy volunteer study in humans (see section 5.1).
Danish: Der sås ingen øgning i CSF Aβ1-40 og 1-42 i et 2-ugers studie hos raske forsøgspersoner (se pkt.
English: First heart failure hospitalisation
Danish: Første hospitalsindlæggelse ved hjertesvigt
English: Treatment should not be initiated if the serum potassium level is >5.4 mmol/l.
Danish: Behandling bør ikke initieres, hvis serum-kalium-niveauet er >5,4 mmol/l.
English: If you forget to take Neparvis
Danish: Hvis du har glemt at tage Neparvis
English: Microcrystalline cellulose Low-substituted hydroxypropylcellulose Crospovidone, type A Magnesium stearate
Danish: Mikrokrystallinsk cellulose Lavsubstitueret hydroxypropylcellulose Crospovidon, type A Magnesiumstearat
English: Sacubitril is further metabolised to the active metabolite LBQ657.
Danish: Sacubitril metaboliseres videre til den aktive metabolit LBQ657.
English: The recommended starting dose of Neparvis is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Danish: Den anbefalede startdosis af Neparvis er én tablet på 49 mg/51 mg to gange daglig, med undtagelse af de tilfælde, der er beskrevet herunder.
English: In general no dose adjustment is required.
Danish: Som udgangspunkt er dosisjustering ikke nødvendig.
English: The primary endpoint was the composite of cardiovascular (CV) death or hospitalisation for heart failure (HF).
Danish: Det primære endepunkt var en kombination af kardiovaskulær (CV) død eller hospitalsindlæggelse på grund af hjertesvigt (HF).
English: A decision should be made whether to abstain from breast-feeding or to discontinue Neparvis while breast-feeding, taking into account the importance of Neparvis to the mother.
Danish: Det skal besluttes, om amning eller behandling skal ophøre, idet der tages højde for vigtigheden af Neparvis for moderen.
English: • some types of antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted organs) or antivirals such as ritonavir (used to treat HIV/AIDS).
Danish: • visse typer antibiotika (rifamycingruppen), ciclosporin (bruges til at forebygge afstødning af transplanterede organer) eller antivirale midler, som fx ritonavir (bruges til behandling af
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: YDERKARTON TIL DELPAKNING (UDEN BLUE BOX)
English: No studies have been performed in patients undergoing dialysis.
Danish: Der er ikke udført studier hos patienter i dialyse.
English: This medicine does not require any special temperature storage conditions.
Danish: Der er ingen særlige temperaturmæssige opbevaringsforhold for dette lægemiddel.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakning og blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • low blood pressure (dizziness, light-headedness) when switching from sitting or lying to standing position
Danish: • lavt blodtryk (svimmelhed, uklarhed) ved skift fra siddende eller liggende til stående stilling
English: Co-administration of Neparvis and furosemide had no effect on the pharmacokinetics of Neparvis but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Danish: Samtidig indgift af Neparvis og furosemid har ingen indvirkning på Neparvis' farmakokinetik, men reducerede Cmax og AUC for furosemid med henholdsvis 50 % og 28 %.
English: • nitroglycerine, a medicine used to treat angina.
Danish: • nitroglycerin, som er et lægemiddel, der bruges til behandling af angina.
English: Neparvis is a medicine known as an angiotensin receptor neprilysin inhibitor.
Danish: Neparvis er et lægemiddel kendt som en angiotensinreceptor-neprilysinhæmmer.
English: Sacubitril, LBQ657 and valsartan are eliminated from plasma with a mean elimination half-life (T½) of approximately 1.43 hours, 11.48 hours, and 9.90 hours, respectively.
Danish: Sacubitril, LBQ657 og valsartan elimineres fra plasma med en gennemsnitlig halveringstid (T½) på henholdsvis omkring 1,43 timer, 11,48 timer og 9,90 timer.
English: You will usually start by taking 24 mg/26 mg or 49 mg/51 mg twice a day (one tablet in the morning and one tablet in the evening).
Danish: Du vil normalt skulle starte med at tage 24 mg/26 mg eller 49 mg/51 mg to gange daglig (én tablet om morgenen og én tablet om aftenen).
English: Sacubitril is readily converted to LBQ657 by carboxylesterases 1b and 1c; LBQ657 is not further metabolised to a significant extent.
Danish: Sacubitril omdannes nemt til LBQ657 af carboxylesterase 1b og 1c; LBQ657 metaboliseres ikke yderligere i signifikant udstrækning.
English: They were then randomised to the double-blind period of the study, during which they received either Neparvis 200 mg or enalapril 10 mg twice daily [Neparvis (n=4,209); enalapril (n=4,233)].
Danish: De blev derefter randomiseret til den dobbeltblindede studieperiode, i hvilken de fik enten 200 mg Neparvis 2 gange daglig eller 10 mg enalapril 2 gange daglig [Neparvis (n=4209); enalapril (n=4233)].
English: • if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take Neparvis”).
Danish: • hvis du bliver behandlet med en angiotensin-receptorblokker (ARB) eller aliskiren (se ”Tag ikke Neparvis”).
English: In juvenile rats treated with sacubitril (postnatal days 7 to 70), there was a reduction in age-related bone mass development and bone elongation.
Danish: Hos unge rotter behandlet med sacubitril (dag 7 til 70 postnatalt), var der en nedsættelse i aldersrelateret udvikling af knoglemasse og knoglelængdevækst.
English: Prior to study participation, patients were well treated with standard of care therapy which included ACE inhibitors/ARBs (>99%), beta blockers (94%), mineralocorticoid antagonists (58%) and diuretics (82%).
Danish: Forud for deltagelse i studiet var patienterne velbehandlede på standardbehandling, som inkluderede ACE-hæmmere/ARBer (>99 %), betablokkere (94 %), mineralokortikoidantagonister (58 %) og diuretika (82 %).
English: These kidney changes represent an expected exaggerated pharmacological effect of angiotensin converting enzyme inhibitors and angiotensin II type 1 blockers; such effects are observed if rats are treated during the first 13 days of life.
Danish: Disse nyreforandringer kan skyldes en forventet øget farmakologisk virkning af angiotensinkonverterende enzymhæmmere og angiotensin II type-1 blokkere; sådanne virkninger er set, hvis rotter behandles under de første 13 levedøgn.
English: Hypotension is the most likely symptom of overdose due to the blood pressure lowering effects of Neparvis.
Danish: Det mest sandsynlige symptom på overdosering er hypotension på grund af Neparvis' blodtrykssænkende virkning.
English: The exposure of valsartan was similar in patients with moderate and severe renal impairment compared to patients with mild renal impairment.
Danish: Eksponeringen for valsartan var sammenlignelig hos patienter med moderat og svært nedsat nyrefunktion sammenlignet med patienter med let nedsat nyrefunktion.
English: Caution should be exercised when co-administering Neparvis with statins.
Danish: Der skal udvises forsigtighed, når Neparvis anvendes sammen med statiner.
English: Tell your doctor if you are breastfeeding or about to start breastfeeding.
Danish: Tal med din læge, hvis du ammer eller skal til at starte amning.
English: Neparvis was superior to enalapril, reducing the risk of cardiovascular death or heart failure hospitalisations to 21.8% compared to 26.5% for enalapril treated patients.
Danish: Neparvis viste overlegenhed over for enalapril, idet risiko for kardiovaskulær død eller hospitalsindlæggelse på grund af hjertesvigt blev mindsket til 21,8 % sammenlignet med 26,5 % hos de enalaprilbehandlede patienter.
English: • feeling sick (nausea)
Danish: • føle sig syg (kvalme)
English: • furosemide, a medicine belonging to the type known as diuretics, which are used to increase the amount of urine you produce.
Danish: • furosemid, som er et vanddrivende lægemiddel, der bruges til forøge den mængde af urin, du producerer.
English: In vitro data indicate that sacubitril inhibits OATP1B1 and OATP1B3 transporters.
Danish: In vitro data tyder på, at sacubitril hæmmer OATP1B1- og OATP1B3-transportører.
English: If you think you may be allergic to any component of this medicine, talk to your doctor before taking Neparvis.
Danish: Hvis du tror, at du er allergisk over for noget af indholdet i denne medicin, skal du spørge lægen til råds, før du tager Neparvis.
English: Patients with renal artery stenosis
Danish: Patienter med renal arteriostenose
English: What you need to know before you take Neparvis
Danish: Det skal du vide, før du begynder at tage Neparvis
English: Elderly population The dose should be in line with the renal function of the elderly patient.
Danish: Ældre patienter Dosis skal tilpasses de ældre patienters nyrefunktion.
English: • Hereditary or idiopathic angioedema (see section 4.4).
Danish: • Hereditær eller idiopatisk angioødem (se pkt.
English: Should exposure to ARBs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis eksponering for ARB er sket fra andet trimester af graviditeten, anbefales det at udføre ultralydsundersøgelse af nyrefunktion og kranie.
English: Angioedema was reported in patients treated with Neparvis (see description of selected adverse reactions).
Danish: Angioødem blev rapporteret hos patienter behandlet med Neparvis (se beskrivelse af udvalgte bivirkninger).
English: These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines and heparin.
Danish: Disse omfatter kaliumtilskud, kaliumholdige salterstatninger, kaliumbesparende lægemidler og heparin.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors or angiotensin II receptor antagonists.
Danish: Der er rapporteret reversibelt forhøjede serumkoncentrationer og toksicitet af lithium ved administration af lithium sammen med ACE-hæmmere eller angiotensin II-receptorantagonister.
English: However, if you forget to take a dose, you should simply take the next one at the scheduled time.
Danish: Hvis du imidlertid har glemt at tage en dosis, skal du tage den næste på det planlagte tidspunkt for næste dosis.
English: The concomitant use of Neparvis with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Danish: Anvendelse af Neparvis sammen med ACE-hæmmere er kontraindiceret, da samtidig hæmning af neprilysin (NEP) og ACE kan øge risikoen for angioødem.
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Danish: De mest almindelige symptomer på hjertesvigt er åndenød, mathed, træthed og hævelse af ankler.
English: The risk may be further increased by dehydration or concomitant use of non-steroidal anti-inflammatory agents (NSAIDs) (see section 4.5).
Danish: Risikoen kan være forøget ved dehydrering eller brug sammen med non-steroide antiinflammatoriske midler (NSAIDer) (se pkt.
English: No clinically meaningful drug-drug interaction was observed when Neparvis was co-administered with digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol or a combination of levonorgestrel/ethinyl estradiol.
Danish: Der er ikke observeret klinisk relevant lægemiddelinteraktion, når Neparvis blev givet sammen med digoxin, warfarin, hydrochlortiazid, amlodipin, omeprazol, carvedilol, eller en kombination af levonorgestrel/ethinyl østradiol.
English: The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Neparvis is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Danish: Valsartan indeholdt i Neparvis har en højere biotilgængelighed end valsartan i andre markedsførte tabletformuleringer; 26 mg, 51 mg og 103 mg valsartan i Neparvis svarer til henholdsvis 40 mg, 80 mg og 160 mg valsartan i andre markedsførte tabletformuleringer.
English: Co-administration of Neparvis with metformin reduced both Cmax and AUC of metformin by 23%.
Danish: Samtidig indgift af Neparvis og metformin reducerede både Cmax og AUC for metformin med 23 %.
English: The active metabolite of sacubitril (LBQ657) and valsartan are OATP1B1, OATP1B3, OAT1 and OAT3 substrates; valsartan is also a MRP2 substrate.
Danish: Den aktive metabolit af sacubitril (LBQ657) og valsartan er OATP1B1, OATP1B3, OAT1 og OAT3 substrater; valsartan er også et MRP2-substrat.
English: However, LBQ657 and valsartan are highly bound to plasma protein and therefore unlikely to be effectively removed by dialysis.
Danish: Da LBQ657 og valsartan er bundet til plasmaprotein i høj grad, er det ikke sandsynligt, at det kan fjernes effektivt ved dialyse.
English: A higher incidence of angioedema was observed in Black patients treated with Neparvis (2.4%) and enalapril (0.5%) (see section 4.4).
Danish: Frekvensen af angioødem var højere hos sorte patienter behandlet med Neparvis (2,4 %) og enalapril (0,5 %) (se pkt.
English: 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets
Danish: 14 filmovertrukne tabletter 20 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter
English: It dissociates into two active substances, sacubitril and valsartan.
Danish: Det består af to aktive stoffer, sacubitril og valsartan.
English: This risk reduction was consistently observed across subgroups including: gender, age, race, geography, NYHA class (II/III), ejection fraction, renal function, history of diabetes or hypertension, prior heart failure therapy, and atrial fibrillation.
Danish: Risikoreduktionen var konstant på tværs af subgrupper inklusive: køn, alder, race, geografi, NYHAklasse (II/III), uddrivningsfraktion, nyrefunktion, tidligere diabetes eller hypertension, tidligere behandling for hjertesvigt og hjerteflimmer.
English: PARADIGM-HF was a multinational, randomised, double-blind study of 8,442 patients comparing Neparvis to enalapril, both given to adult patients with chronic heart failure, NYHA class II-IV and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%, amended later to ≤35%) in addition to other heart failure therapy.
Danish: PARADIGM-HF var et multinationalt, randomiseret, dobbeltblindet studie hos 8442 patienter, hvori Neparvis blev sammenlignet med enalapril, begge blev givet til voksne patienter med kronisk hjertesvigt NYHA klasse II-IV og nedsat uddrivningsfraktion (venstre ventrikel ejektionsfraktion [LVEF] ≤40 %, som senere blev ændret til ≤35 %) i tillæg til anden behandling for hjertesvigt.
English: Where there is involvement of the tongue, glottis or larynx likely to cause airway obstruction, appropriate therapy, e.g. adrenaline solution 1 mg/1 ml (0.3-0.5 ml), and/or measures necessary to ensure a patent airway, should be promptly administered.
Danish: Hvor tunge, glottis eller larynx er omfattet med risiko for luftvejsobstruktion, skal der straks iværksættes passende behandling, fx adrenalinopløsning 1 mg/1 ml (0,3-0,5 ml) og/eller foranstaltninger nødvendige for at sikre frie luftveje.
English: This finding is not considered adverse.
Danish: Dette fund er ikke vurderet som værende kritisk.
English: Worsening renal function
Danish: Forværring af nyrefunktionen
English: What Neparvis contains
Danish: Neparvis indeholder:
English: • if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril).
Danish: • hvis du bruger en anden type af medicin, som kaldes en angiotensin-konverteringsenzymhæmmer (ACE-hæmmer) (fx enalapril, lisinopril eller ramipril).
English: Following twice daily dosing of Neparvis, steady-state levels of sacubitril, LBQ657 and valsartan are reached in three days.
Danish: Efter indgift 2 gange daglig nås steady-state niveauer af sacubitril, LBQ657 og valsartan på 3 dage.
English: It must not be re-administered.
Danish: Neparvis må ikke gives igen.
English: Sacubitril, LBQ657 and valsartan are highly bound to plasma proteins (94-97%).
Danish: Sacubitril, LBQ657 og valsartan er bundet til proteiner i udstrakt grad (94-97 %).
English: Administration with food has no clinically significant impact on the systemic exposures of sacubitril, LBQ657 and valsartan.
Danish: Administration sammen med mad har ingen klinisk signifikant indflydelse på den systemiske optagelse af sacubitril, LBQ657 og valsartan.
English: Neparvis may therefore increase the systemic exposure of OATP1B1 and OATP1B3 substrates such as statins.
Danish: Neparvis kan derfor øge den systemiske eksponering af OATP1B1- og OATP1B3-substrater som fx statiner.
English: • The active substances are sacubitril and valsartan.
Danish: • Aktive stoffer: sacubitril og valsartan.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Danish: Epidemiologisk data vedrørende risikoen for teratogenicitet efter eksponering for ACE-hæmmere under graviditetens første trimester er ikke entydige.
English: • low blood pressure (dizziness, light-headedness)
Danish: • lavt blodtryk (svimmelhed, uklarhed)
English: The usual recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one tablet in the evening).
Danish: Den normalt anbefalede vedligeholdelsesdosis er 97 mg/103 mg to gange daglig (én tablet om morgenen og én tablet om aftenen).
English: In PARADIGM-HF, angioedema was reported in 0.5% of patients treated with Neparvis, compared with 0.2% of patients treated with enalapril.
Danish: I PARADIGM-HF blev angioødem rapporteret hos 0,5 % af patienter behandlet med Neparvis sammenlignet med 0,2 % hos patienter behandlet med enalapril.
English: Non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors
Danish: Non-steroide antiinflammatoriske midler (NSAIDer) inklusive selektive cyclooxygenase-2 (COX-2)hæmmere
English: Because of the potential risk for adverse reactions in breast-fed newborns/infants, it is not recommended during breast-feeding.
Danish: På grund af den potentielle risiko for bivirkninger hos de ammede nyfødte/spædbørn, bør Neparvis ikke anvendes under amning.
English: This prevents sustained activation of the renin-angiotensin-aldosterone system that would result in vasoconstriction, renal sodium and fluid retention, activation of cellular growth and proliferation, and subsequent maladaptive cardiovascular remodelling.
Danish: Dette forhindrer vedvarende aktivering af renin-angiotensin-aldosteronsystemet, som ville forårsage vasokonstriktion, renal natrium- og væskeretention, aktivering af cellevækst og proliferation med deraf følgende mangelfuld kardiovaskulær remodellering.
English: If serum potassium level is >5.4 mmol/l discontinuation should be considered.
Danish: Hvis serumkaliumniveauet er >5,4 mmol/l, bør seponering overvejes.
English: • if you are suffering from dehydration.
Danish: • hvis du er dehydreret
English: The pharmacodynamic effects of Neparvis were evaluated after single and multiple dose administrations in healthy subjects and in patients with heart failure, and are consistent with simultaneous neprilysin inhibition and RAAS blockade.
Danish: De farmakodynamiske virkninger af Neparvis blev evalueret efter administration af en enkeltdosis og gentagne doser hos raske forsøgspersoner og patienter med hjertesvigt, og stemmer overens med samtidig neprilysinhæmning og RAAS-blokade.
English: At the time of Commission Decision
Danish: Kommissionens afgørelse
English: The relative risk reduction was 20% versus enalapril (see Table 2).
Danish: Den relative risikoreduktion var 20 % versus enalapril (se Tabel 2).
English: In the enalapril group, 75% of patients remained on the target dose of 10 mg twice daily at the end of the study (mean daily dose of 18.9 mg).
Danish: I enalaprilgruppen var 75 % af patienterne stadigvæk på måldosis 10 mg 2 gange daglig ved afslutningen af forsøget (gennemsnitlig daglig dosis på 18,9 mg).
English: If any of the above applies to you, do not take Neparvis and talk to your doctor.
Danish: Hvis noget af ovenstående passer på dig, må du ikke tage Neparvis, før du har talt med din læge.
English: The 49 mg/51 mg and 97 mg/103 mg tablets are also supplied in multipacks of 168 tablets (3 packs of 56 tablets).
Danish: 49 mg/51 mg og 97 mg/103 mg tabletterne findes også i multipakninger med 168 tabletter (3 pakninger med 56 tabletter.
English: NPs exert their effects by activating membrane-bound guanylyl cyclase-coupled receptors, resulting in increased concentrations of the second messenger cyclic guanosine monophosphate (cGMP), which could result in vasodilation, natriuresis and diuresis, increased glomerular filtration rate and renal blood flow, inhibition of renin and aldosterone release, reduction of sympathetic activity, and anti-hypertrophic and anti-fibrotic effects.
Danish: NP'er udøver deres virkning ved at aktivere membranbundne guanylylcyclasekoblede receptorer, hvilket fører til øgede koncentrationer af den sekundære messenger cyklisk guanosinmonophosphat (cGMP), hvilket kan resultere i vasodilatation, natriurese og diurese, øget glomerulær filtrationshastighed og renal blodgennemstrømning, hæmning af renin- og aldosteronfrigivelse, reduktion af sympatisk aktivitet og anti-hypertrofisk og anti-fibrotisk virkning fremmes.
English: Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg (see section 4.4).
Danish: Behandling bør ikke initieres hos patienter med serum-kalium-værdier >5,4 mmol/l eller med SBT <100 mmHg (se pkt.
English: The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations (see section 5.2).
Danish: Biotilgængeligheden af valsartan-komponenten i Neparvis er højere end biotilgængeligheden af valsartan i andre markedsførte tabletformuleringer (se pkt.