FrancophonIA/ELRC3.0 huggingface dataset:
English: One blister contains either 10 or 14 film-coated tablets.
Danish: En blister indeholder enten 10 eller 14 filmovertrukne tabletter.
English: • dizziness when switching from sitting to standing position
Danish: • svimmelhed ved skift fra siddende til stående stilling
English: This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Danish: Denne periode svarer til 36 ugers graviditet hos mennesker, hvilket lejlighedsvis kan øges op til 44 uger efter befrugtning hos mennesker.
English: NT-proBNP is not a neprilysin substrate and is therefore a more suitable biomarker.
Danish: NT-proBNP er ikke et neprilysinsubstrat og er derfor bedre egnet som biomarkør.
English: • if you are more than 3 months pregnant (it is also better to avoid this medicine in early pregnancy, see “Pregnancy and breastfeeding”).
Danish: • hvis du er gravid og er mere end 3 måneder henne (det er også bedst at undgå denne medicin i den tidlige graviditet, se ”Graviditet og amning”).
English: Swallow the tablets with a glass of water.
Danish: Synk tabletten med et glas vand.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS)
English: Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Bivirkningerne er ordnet efter systemorganklasse og derefter efter frekvens med de hyppigste først baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
English: • Second and third trimester of pregnancy (see section 4.6).
Danish: • Andet og tredje trimester af graviditet (se pkt.
English: If you are taking one of these, your doctor may want to check your kidney function when starting or adjusting treatment (see “Warnings and precautions”).
Danish: Hvis du tager noget af dette, vil din læge måske ønske at kontrollere din nyrefunktion, når du starter eller ved justering af behandlingen (se ”Advarsler og forsigtighedsregler”).
English: The average daily dose of furosemide was unchanged from baseline until the end of the PARADIGM-HF study in patients treated with Neparvis.
Danish: Den gennemsnitlige daglige dosis af furosemid var uændret fra baseline til slutningen af PARADIGM-HF-studiet hos patienter behandlet med Neparvis.
English: It is not known whether Neparvis is excreted in human milk.
Danish: Det er ukendt, om Neparvis udskilles i human mælk.
English: Full analysis set
Danish: Fuldt analysesæt
English: Whilst there is no controlled epidemiological data on the risk with ARBs, similar risks may exist for this class of medicinal product.
Danish: Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af ARB, men lignende risici kan eksistere for denne gruppe af lægemidler.
English: These may be signs of angioedema (an uncommon side effect which may affect up to 1 in 100 people).
Danish: Dette kan være tegn på angioødem (en ikke almindelig bivirkning, der kan forekomme hos op til 1 ud af 100 personer).
English: Table 2 Treatment effect for the primary composite endpoint, its components and all-cause mortality over a median follow-up of 27 months
Danish: Tabel 2 Behandlingseffekt for det primære sammensatte endepunkt, dets komponenter og generel dødelighed over en gennemsnitlig opfølgningstid på 27 måneder
English: You can take Neparvis with or without food.
Danish: Du kan tage Neparvis med eller uden mad.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: YDRE KARTON TIL MULTIPAKNING (INKLUSIV BLUE BOX)
English: While there was no relevant change in urine volume, the urinary excretion of sodium was reduced within 4 hours and 24 hours after co-administration.
Danish: Mens der ikke var nogen relevant ændring i urinvolumen, var urinsekretionen af natrium reduceret i mellem 4 og 24 timer efter samtidig administration.
English: Valsartan is minimally metabolised, as only about 20% of the dose is recovered as metabolites.
Danish: Valsartan metaboliseres kun i ringe grad, kun omkring 20 % af dosis genfindes som metabolitter.
English: If you have accidentally taken too many Neparvis tablets, or if someone else has taken your tablets, contact your doctor immediately.
Danish: Hvis du ved et uheld har taget for mange Neparvis-tabletter, eller hvis nogen anden har taget dine tabletter, skal du kontakte din læge så hurtigt som muligt.
English: At randomisation, 70% of patients were NYHA class II, 24% were class III and 0.7% were class IV.
Danish: På randomiseringstidspunktet var 70 % af patienterne i NYHA klasse II, 24 % var i klasse III, og 0,7 % var i klasse IV.
English: 90429 Nuremberg Germany
Danish: 90429 Nürnberg
English: • if you have ever had angioedema (see “Do not take Neparvis” and section 4 “Possible side effects”).
Danish: • hvis du nogensinde har haft angioødem (se ”Tag ikke Neparvis” og punkt 4 ”Bivirkninger”).
English: Neparvis is used to treat a type of long-term heart failure in adults.
Danish: Neparvis anvendes til behandling af en langvarig type af hjertesvigt hos voksne.
English: As they may be at higher risk for angioedema, caution is recommended if Neparvis is used in these patients.
Danish: Da de kan have en højere risiko for angioødem, skal der udvises forsigtighed, hvis Neparvis anvendes til disse patienter.
English: In these patients, exposure may be increased and safety is not established.
Danish: Eksponering kan være forøget og sikkerheden er ikke kendt hos disse patienter.
English: Angioedema associated with laryngeal oedema may be fatal.
Danish: Angioødem forbundet med larynxødem kan være fatalt.
English: Stopping your treatment with Neparvis may cause your condition to get worse.
Danish: Hvis du stopper behandlingen med Neparvis, kan din tilstand forværres.
English: *See description of selected adverse reactions.
Danish: *Se beskrivelse af udvalgte bivirkninger.
English: PDE5 inhibitors including sildenafil
Danish: PDE-5-hæmmere inklusive sildenafil
English: Individual components of the primary composite endpoint CV death**
Danish: Individuelle komponenter af det primære endepunkt CV død**
English: If you experience severe dizziness and/or fainting, tell your doctor as quickly as possible and lie down.
Danish: Hvis du bliver voldsomt svimmel og/eller besvimer, skal du fortælle det til din læge hurtigst muligt og lægge dig ned.
English: Appropriate care should be exercised when initiating or ending concomitant treatment with such medicinal products.
Danish: Der skal udvises passende forsigtighed, når samtidig behandling med sådanne lægemidler startes eller afsluttes.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne ordnet efter faldende alvorlighed.
English: • if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for sacubitril, valsartan eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Neprilysin is one of multiple enzymes involved in the clearance of amyloid-β (Aβ) from the brain and cerebrospinal fluid (CSF).
Danish: Neprilysin er et af mange enzymer, som er involveret i udskillelsen af amyloid-β (Aβ) fra hjerne og cerebrospinalvæske (CSF).
English: Patients with NYHA functional classification IV
Danish: Patienter med NYHA klasse IV
English: These reach peak plasma concentrations in 2 hours, 1 hour, and 2 hours, respectively.
Danish: Peak plasmakoncentrationerne opnås efter henholdsvis 2 timer, 1 time og 2 timer.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N-nitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Danish: Indehaverne af markedsføringstilladelse skal sikre, at fremstillingsprocesserne for de stoffer, der anvendes i deres lægemidler, gennemgås for den mulige risiko for dannelse af Nnitrosaminer og ændres i nødvendigt omfang for at minimere nitrosamin-forureningen mest muligt.
English: Interactions requiring precautions
Danish: Interaktioner der kræver forsigtighed
English: Neparvis improved survival with a significant reduction in all-cause mortality of 2.8% (Neparvis, 17%, enalapril, 19.8%).
Danish: Neparvis forbedrede overlevelse med en signifikant reduktion i generel dødelighed på 2,8 % (Neparvis, 17 %, enalapril, 19,8 %).
English: • Stop taking Neparvis and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing.
Danish: • Stop med at tage Neparvis og søg straks læge, hvis du mærker hævelse af ansigt, læber, tunge og/eller hals, som kan give vejrtrækningsbesvær eller synkebesvær.
English: Time to occurrence of CV death in PARADIGM-HF
Danish: Tid til forekomst af CV død i PARADIGM-HF
English: • gastritis (stomach pain, nausea)
Danish: • gastritis (mavesmerter, kvalme)
English: Therefore, caution should be exercised when sildenafil or another PDE5 inhibitor is initiated in patients treated with Neparvis.
Danish: Der skal derfor udvises forsigtighed, når sildenafil eller anden PDE-5-hæmmer initieres hos patienter behandlet med Neparvis.
English: A study in adult rats showed only a minimal transient inhibitory effect on bone mineral density but not on any other parameters relevant for bone growth, suggesting no relevant effect of sacubitril on bone in adult patient populations under normal conditions.
Danish: Et studie på voksne rotter viste kun minimal forbigående hæmmende virkning på knoglemineraltæthed men ikke på nogen anden relevant parameter for knoglevækst, hvilket antyder at sacubitril ikke har nogen relevant virkning på knoglerne i den voksne patientpopulation under normale omstændigheder.
English: Therefore, when initiating therapy with Neparvis in patients receiving metformin, the clinical status of the patient should be evaluated.
Danish: Ved start af behandling med Neparvis hos patienter, der får metformin, skal patientens kliniske status derfor vurderes.
English: All-cause mortality 711 (16.98) 835 (19.82) 0.84 (0.76, 0.93) 16% 0.0005 *The primary endpoint was defined as the time to first event of CV death or hospitalisation for HF. **CV death includes all patients who died up to the cut-off date irrespective of previous hospitalisation.
Danish: Total dødelighed 711 (16,98) 835 (19,82) 0,84 (0,76, 0,93) 16% 0,0005 *Det primære endepunkt blev defineret som tid til første hændelse af CV død eller hospitalisering på grund af HF. ** CV død inkluderede alle patienter som døde op til cut-off dato uafhængigt af tidligere hospitalsindlæggelse.
English: Figure 1 Kaplan-Meier curves for the primary composite endpoint and the CV death component
Danish: Figur 1 Kaplan-Meier kurver for det primære samlede endepunkt og komponenten CV død
English: If a dose is missed, the patient should take the next dose at the scheduled time.
Danish: Hvis en dosis glemmes, skal patienten tage den efterfølgende dosis på det planlagte tidspunkt.
English: OATP and MRP2 transporters
Danish: OATP- og MRP2-transportproteiner
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis det vurderes, at kombinationen er nødvendig, anbefales omhyggelig monitorering af lithiumniveauet i blodet.
English: Caution should be exercised when initiating Neparvis in patients with NYHA functional classification IV due to limited clinical experience in this population.
Danish: Der skal udvises forsigtighed ved påbegyndelse af behandling med Neparvis hos patienter med NYHA klasse IV, da der er begrænset klinisk erfaring hos denne population.
English: No evidence of embryo-foetal toxicity or teratogenicity was observed in rats treated with sacubitril.
Danish: Der er ikke set tegn på embryoføtal toksicitet eller teratogenicitet hos rotter behandlet med sacubitril.
English: Due to discontinuations during the run-in period, the adverse reaction rates as presented in table below may be lower than the adverse reaction rates expected in clinical practice.
Danish: Med baggrund i afbrydelserne af studiet under run-in perioderne kan bivirkningsfrekvenserne, der er præsenteret i tabellen nedenfor, være lavere end de forventede bivirkningsfrekvenser i klinisk praksis.
English: Following oral administration, Neparvis dissociates into valsartan and the prodrug sacubitril.
Danish: Efter oral administration omdannes Neparvis til valsartan og prodruget sacubitril.
English: Interactions resulting in a contraindication
Danish: Interaktioner som fører til kontraindikation
English: Neparvis has a minor influence on the ability to drive and use machines.
Danish: Neparvis påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • allergic reaction with rash and itching
Danish: • allergisk reaktion med udslæt og kløe
English: If you stop taking Neparvis
Danish: Hvis du holder op med at tage Neparvis
English: The average apparent volume of distribution of valsartan and sacubitril were 75 litres to 103 litres, respectively.
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen for valsartan og sacubitril var henholdsvis 75 liter og 103 liter.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat behandling med ARB vurderes at være nødvendig, bør patienter, som planlægger at blive gravide, skiftes til en alternativ hypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug ved graviditet.
English: Infants whose mothers have taken ARBs should be closely observed for hypotension (see section 4.3).
Danish: Spædbørn hvis mødre har taget ARB bør observeres tæt for hypotension (se pkt.
English: Use of Neparvis may be associated with decreased renal function.
Danish: Brug af Neparvis kan være forbundet med nedsat nyrefunktion.
English: A slight generalised delay in ossification was observed at doses of >50 mg/kg/day.
Danish: En let generel forsinkelse i knogledannelse blev observeret ved doser på >50 mg/kg/dag.
English: The AT1-receptor was also blocked as evidenced by increased plasma renin activity and plasma renin concentrations.
Danish: AT1-receptoren blev også blokeret, vist ved øget plasmareninaktivitet og øgede plasmareninkoncentrationer.
English: Addition of a single dose of sildenafil to Neparvis at steady state in patients with hypertension was associated with a significantly greater blood pressure reduction compared to administration of Neparvis alone.
Danish: Tillæg af en enkelt dosis sildenafil til Neparvis ved steady state hos patienter med hypertension var forbundet med signifikant højere blodtrykssænkning sammenlignet med administration af Neparvis alene.
English: The absolute risk reductions were 4.7% for the composite of the CV death or HF hospitalisation, 3.1% for CV death alone, and 2.8% for first HF hospitalisation alone.
Danish: Den absolutte risikoreduktion var 4,7 % for samlet CV død eller hospitalsindlæggelse på grund af HF, 3,1 % for CV død alene og 2,8 % for første hospitalisering på grund af HF alene.
English: • if you or a member of your family have ever had a reaction called angioedema (swelling of the face, lips, tongue and/or throat, difficulties in breathing) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan).
Danish: • hvis du eller et familiemedlem nogensinde har haft en reaktion, som kaldes angioødem (hævelse af ansigt, læber, tunge og/eller hals, besvær med at trække vejret) når du har taget en ACEhæmmer eller en angiotensin-receptorblokker (ARB) (som fx valsartan, telmisartan eller irbesartan).
English: There was no drug-drug interaction between Neparvis and intravenously administered nitroglycerin with regard to blood pressure reduction.
Danish: Der var ingen interaktion mellem Neparvis og intravenøst indgivet nitroglycerin med hensyn til blodtryksnedsættelse.
English: The use of Neparvis is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Danish: Neparvis anbefales ikke i det første trimester af graviditet og er kontraindiceret i det andet og tredje trimester af graviditet (se pkt.
English: Non-clinical data (including studies with sacubitril and valsartan components and/or Neparvis) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Danish: Prækliniske data (inklusive studier med komponenterne sacubitril og valsartan og/eller Neparvis) viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt fertilitet.
English: There are no data from the use of Neparvis in pregnant women.
Danish: Der er ingen data vedrørende anvendelse af Neparvis hos gravide kvinder.
English: • lithium, a medicine used to treat some types of psychiatric illness.
Danish: • lithium, et lægemiddel som bruges til at behandle visse typer psykiatriske sygdomme.
English: Down-titration should be considered in patients who develop a clinically significant decrease in renal function.
Danish: Nedtitrering bør overvejes hos patienter, som udvikler klinisk signifikant fald i nyrefunktionen.
English: There are no data from the use of sacubitril in pregnant women.
Danish: Der er ingen data vedrørende anvendelse af sacubitril hos gravide kvinder.
English: The mean LVEF was 29% and there were 963 (11.4%) patients with a baseline LVEF >35% and ≤40%.
Danish: Den gennemsnitlige LVEF var 29 %, og der var 963 (11,4 %) patienter med LVEF >35 % og ≤40 % ved baseline.
English: • some medicines known as statins that are used to lower high cholesterol levels (for example atorvastatin).
Danish: • nogle lægemidler kendt som statiner, der bruges til at sænke høje kolesteroltal (fx atorvastatin).
English: If angioedema occurs, Neparvis should be immediately discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Ved forekomst af angioødem skal Neparvis straks seponeres, og der skal iværksættes passende behandling og monitorering, indtil der er opnået komplet og vedvarende ophør af symptomer.
English: Neparvis can be administered with or without food.
Danish: Neparvis kan gives sammen med eller uden mad.
English: When pregnancy is diagnosed, treatment with ARBs should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet skal behandlingen med ARB afbrydes med det samme, og om nødvendigt skal en anden behandling påbegyndes.
English: Patients taking Neparvis can develop low blood pressure (dizziness, light-headedness), a high level of potassium in the blood (which would be detected when your doctor performed a blood test) or decreased kidney function.
Danish: Patienter, der tager Neparvis, kan få lavt blodtryk (svimmelhed, uklarhed), et højt niveau af kalium i blodet (som bliver opdaget, når din læge tager en blodprøve) eller nedsat nyrefunktion.
English: Nitrates, e.g. nitroglycerine
Danish: Nitrater, fx nitroglycerin
English: Based on the comparison of plasma and CSF exposures, LBQ657 crosses the blood brain barrier to a limited extent (0.28%).
Danish: Vurderet ud fra sammenligning af plasma- og CSF-koncentrationer passerer LBQ657 blodhjernebarrieren i begrænset omfang (0,28 %).
English: When initiating therapy or during dose titration with Neparvis, blood pressure should be monitored routinely.
Danish: Ved behandlingsstart eller under dosistitrering med Neparvis bør blodtrykket monitoreres regelmæssigt.
English: Your doctor may check the amount of potassium in your blood at regular intervals during Neparvis treatment.
Danish: Din læge vil måske regelmæssigt undersøge mængden af kalium i dit blod i løbet af din behandling med Neparvis.
English: In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Danish: I de tilfælde af verificeret angioødem, hvor hævelsen var begrænset til ansigt og læber, ophørte tilstanden normalt uden behandling, men anvendelse af antihistaminer mildnede symptomerne.
English: However, a mild transient interference of sacubitril with the early phase of fracture healing in adults cannot be excluded.
Danish: Det kan dog ikke udelukkes, at sacubitril har en let forbigående påvirkning i den tidlige helingsfase af frakturer hos voksne.
English: B-type natriuretic peptide (BNP)
Danish: B-type natriuretisk peptid (BNP)
English: Neparvis may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Danish: Neparvis kan øge mængden af serumkreatinin og urinstof i blodet hos patienter med bilateral eller unilateral renal arteriestenose.
English: There is no experience in patients with end-stage renal disease and use of Neparvis is not recommended.
Danish: Der er ingen erfaring hos patienter med nyresygdom i slutstadiet og Neparvis anbefales ikke.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, other combinations, ATC code: C09DX04
Danish: Farmakoterapeutisk klassifikation: Midler med virkning på renin-angiotensin-systemet; angiotensin-IIantagonister, andre kombinationer, ATC-kode: C09DX04
English: CYP 450 interactions
Danish: CYP interaktioner
English: Patients randomised to the Neparvis group received treatment for a median duration of exposure of 24 months; 3,271 patients were treated for more than one year.
Danish: Den gennemsnitlige eksponeringsvarighed hos patienter randomiseret til Neparvisgruppen var 24 måneder; 3271 patienter blev behandlet i mere end et år.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Neparvis in one or more subsets of the paediatric population in the treatment of heart failure (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultater af studier med Neparvis i en eller flere undergrupper af den pædiatriske population ved behandling af hjertesvigt (se pkt.
English: Following oral administration, 52-68% of sacubitril (primarily as LBQ657) and ~13% of valsartan and its metabolites are excreted in urine; 37-48% of sacubitril (primarily as LBQ657) and 86% of valsartan and its metabolites are excreted in faeces.
Danish: Efter oral administration udskilles 52-68 % af sacubitril (primært som LBQ657) og ~13 % af valsartan og dets metabolitter i urinen; 37-48 % af sacubitril (primært som LBQ657) og 86 % af valsartan og dets metabolitter udskilles i fæces.
English: The relative risk reduction was 16% compared with enalapril (see Table 2).
Danish: Den relative risikoreduktion var 16 % sammenlignet med enalapril (se Tabel 2).
English: Do not take Neparvis with ACE inhibitors.
Danish: Tag ikke Neparvis sammen med ACE-hæmmere.