FrancophonIA/ELRC3.0 huggingface dataset:
English: • metformin, a medicine used to treat diabetes.
Danish: • metformin, som er et lægemiddel, der bruges til behandling af sukkersyge.
English: Co-administration of Neparvis increased the Cmax of atorvastatin and its metabolites by up to 2-fold and AUC by up to 1.3-fold.
Danish: Anvendelse sammen med Neparvis øgede Cmax af atorvastatin og dets metabolitter op til 2 gange og AUC op til 1,3 gange.
English: In this study CSF Aβ clearance in cynomolgus monkeys was reduced, increasing CSF Aβ1-40, 1-42 and 1-38 levels; there was no corresponding increase in Aβ levels in the brain.
Danish: I dette studie var CSF Aβ clearence hos cynomolgus aber reduceret, idet CSF Aβ1-40, 1-42 og 1-38 niveauer øgedes.
English: Multipack: 196 (7 packs of 28) film-coated tablets
Danish: Multipakning: 196 (7 pakninger med 28) filmovertrukne tabletter
English: Other possible side effects: If any of the side effects listed below becomes severe, tell your doctor or pharmacist.
Danish: Hvis nogle af de bivirkninger, som er angivet nedenfor, bliver alvorlige, så fortæl det til din læge eller apotekspersonalet.
English: Neparvis does not induce or inhibit CYP450 enzymes.
Danish: Neparvis hverken inducerer eller hæmmer CYP-enzymer.
English: In PARADIGM-HF, hyperkalaemia and serum potassium concentrations >5.4 mmol/l were reported in 11.6% and 19.7% of Neparvis-treated patients and 14.0% and 21.1% of enalapril-treated patients, respectively.
Danish: I PARADIGM-HF forekom hyperkaliæmi og serumkaliumkoncentrationer på >5,4 mmol/l hos henholdsvis 11,6 % og 19,7 % af patienter behandlet med Neparvis og henholdsvis 14,0 % og 21,1 % af patienter behandlet med enalapril.
English: Discontinuation of therapy due to an adverse reaction in the double-blind period of the PARADIGM-HF study occurred in 450 Neparvis-treated patients (10.7%) and 516 enalapril-treated patients (12.2%).
Danish: I den dobbeltblinde periode af PARADIGM-HF-studiet forekom afbrydelse af behandlingen hos 450 patienter behandlet med Neparvis (10,7 %) og 516 patienter behandlet med enalapril (12,2 %).
English: A hydroxyl metabolite of valsartan has been identified in plasma at low concentrations (<10%).
Danish: Der er fundet lave koncentrationer (<10 %) af en hydroxylmetabolit af valsartan i plasma.
English: Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Danish: Neparvis er indiceret til behandling af voksne patienter med symptomatisk kronisk hjertesvigt med nedsat uddrivningsfraktion (se pkt.
English: • (acute) renal failure (severe kidney disorder)
Danish: • (akut) nyresvigt (alvorlig nyresygdom)
English: You must tell your doctor if you think that you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid.
English: Time to first occurrence of CV death or heart failure hospitalisations in PARADIGM-HF
Danish: Tid til første forekomst af CV død eller indlæggelse ved hjertesvigt i PARADIGM-HF
English: The complementary cardiovascular benefits of Neparvis in heart failure patients are attributed to the enhancement of peptides that are degraded by neprilysin, such as natriuretic peptides (NP), by LBQ657 and the simultaneous inhibition of the effects of angiotensin II by valsartan.
Danish: Neparvis' komplementære kardiovaskulære fordele hos patienter med hjertesvigt forklares med, at peptider, som nedbrydes af neprilysin, som fx natriuretiske peptider (NP), øges ved hjælp af LBQ657 samtidigt med, at de virkninger, som forårsages af angiotensin II, hæmmes ved hjælp af valsartan.
English: Co-administration of nitroglycerin and Neparvis was associated with a treatment difference of 5 bpm in heart rate compared to the administration of nitroglycerine alone.
Danish: Samtidig indgift af nitroglycerin og Neparvis var ledsaget af en behandlingsforskel i hjertefrekvensen på 5 slag/minut sammenlignet med indgift af nitroglycerin alene.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer)
English: The adverse embryofoetal effects of Neparvis are attributed to the angiotensin receptor antagonist activity (see section 4.6).
Danish: De negative embryoføtale virkninger af Neparvis er relateret til angiotensinreceptor-antagonistvirkningen (se pkt.
English: SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Danish: SIA Novartis Blatics Eesti filiaal Tel: +372 66 30 810
English: Neparvis should be used with caution in these patients and the recommended starting dose is 24 mg/26 mg twice daily (see sections 4.4 and 5.2).
Danish: Neparvis skal derfor anvendes med forsigtighed hos disse patienter og den anbefalede startdosis er 24 mg/26 mg to gange daglig (se pkt.
English: The most commonly reported adverse reactions during treatment with Neparvis were hypotension, hyperkalaemia and renal impairment (see section 4.4).
Danish: De mest almindeligt rapporterede bivirkninger ved behandling med Neparvis var hypotension, hyperkaliæmi og nedsat nyrefunktion (se pkt.
English: Syncope
Danish: Synkope
English: Patients were required to discontinue their existing ACE inhibitor or ARB therapy and enter a sequential single-blind run-in period during which they received treatment with enalapril 10 mg twice daily, followed by single-blind treatment with Neparvis 100 mg twice daily, increasing to 200 mg twice daily (see section 4.8 for discontinuations during this period).
Danish: Patienterne skulle afbryde deres eksisterende ACE-hæmmer- eller ARB-behandling og indgå i en sekventiel enkeltblindet run-in periode, i hvilken de blev behandlet med 10 mg enalapril 2 gange daglig efterfulgt af enkeltblindet behandling med Neparvis 100 mg 2 gange daglig stigende til 200 mg 2 gange daglig (se pkt.
English: Symptomatic hypotension is more likely to occur if the patient has been volume-depleted, e.g. by diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Risiko for symptomatisk hypotension er størst, hvis patienten har hypovolæmi fx forårsaget af behandling med diuretika, saltfattig diæt, diarré eller opkastning.
English: Approximate tablet dimensions 15.1 mm x 6.0 mm.
Danish: Tabletdimensioner: ca. 15,1 mm x 6,0 mm.
English: Combination of Neparvis with aliskiren is potentially associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) (see sections 4.3 and 4.4).
Danish: Kombination af Neparvis med aliskiren er muligvis forbundet med en højere hyppighed af bivirkniner som fx hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) (se pkt.
English: Angioedema has been reported in patients treated with Neparvis.
Danish: Der er forekommet angioødem hos patienter behandlet med Neparvis.
English: A starting dose of 24 mg/26 mg twice daily should be considered in patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2).
Danish: En startdosis på 24 mg/26 mg to gange daglig bør overvejes hos patienter med modetat nedsat nyrefunktion (eGFR 30-60 ml/min/1,73m2).
English: Neparvis is contraindicated in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy or with hereditary or idiopathic angioedema (see section 4.3).
Danish: Neparvis er kontraindiceret hos patienter, som tidligere har oplevet angioødem relateret til ACE-hæmmere, til behandling med ARB eller med hereditær eller idiopatisk angioødem (se pkt.
English: Patients with SBP <100 mmHg were not studied (see section 5.1).
Danish: Der er ikke udført studier hos patienter med SBT <100 mmHg (se pkt.
English: The pharmacokinetics of Neparvis (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Danish: Neparvis' (sacubitril, LBQ657 og valsartan) farmakokinetik er den samme hos mænd og kvinder.
English: Interactions between Neparvis and lithium have not been investigated.
Danish: Interaktion mellem Neparvis og lithium er ikke undersøgt, denne kombination kan derfor ikke anbefales.
English: If you stop taking Neparvis, wait 36 hours after taking your last dose of Neparvis before starting an ACE inhibitor.
Danish: Hvis du stopper med at tage Neparvis, skal du vente i 36 timer efter at have taget din sidste dosis Neparvis, før du må begynde at tage en ACE-hæmmer.
English: In patients with mild to moderate hepatic impairment, the exposures of sacubitril increased by 1.5- and 3.4- fold, LBQ657 increased by 1.5- and 1.9-fold, and valsartan increased by 1.2-fold and 2.1-fold, respectively, compared to matching healthy subjects.
Danish: Hos patienter med let til moderat nedsat leverfunktion øgedes optagelsen af sacubitril med 1,5 og 3,4 gange, LBQ657 øgedes med 1,5 og 1,9 gange, og valsartan øgedes med henholdsvis 1,2 gange og 2,1 gange, sammenlignet med matchende raske forsøgspersoner.
English: BNP is not a suitable biomarker of heart failure in patients treated with Neparvis because BNP is a neprilysin substrate (see section 4.4).
Danish: BNP er ikke egnet som biomarkør for hjertesvigt hos patienter i behandling med Neparvis, da BNP er et neprilysinsubstrat (se pkt.
English: If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Neparvis.
Danish: Hvis noget af ovenstående passer på dig, skal du tale med din læge, apotekspersonalet eller sygeplejersken, før du tager Neparvis.
English: The exposure of LBQ657 in patients with moderate (30 ml/min/1.73 m
Danish: Eksponering for LBQ657 hos patienter med moderat (30 ml/min/1,73 m og svært nedsat nyrefunktion (15 ml/min/1,73 m
English: Colloidal anhydrous silica
Danish: Kolloid, vandfri silica
English: 168 film-coated tablets
Danish: 168 filmovertrukne tabletter
English: In PARADIGM-HF, renal impairment was reported in 10.1% of Neparvis-treated patients and 11.5% of enalapril-treated patients.
Danish: I PARADIGM-HF forekom nedsat nyrefunktion hos 10,1 % af patienter behandlet med Neparvis og hos 11,5 % af patienter behandlet med enalapril.
English: The pharmacokinetics of sacubitril, LBQ657 and valsartan were approximately linear over an Neparvis dose range of 24 mg sacubitril/26 mg valsartan to 97 mg sacubitril/103 mg valsartan.
Danish: Der er nogenlunde lineær farmakokinetik af sacubitril, LBQ657 og valsartan i et dosisinterval af Neparvis mellem 24 mg sacubitril/26 mg valsartan og 97 mg sacubitril/103 mg valsartan.
English: No dose adjustment is required in patients with mild (Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1.73 m2) renal impairment.
Danish: Dosisjustering er ikke påkrævet hos patienter med let (estimeret glomerulær filtrationshastighed [eGFR] 60-90 ml/min/1,73 m2) nedsat nyrefunktion.
English: Animal studies with Neparvis have shown reproductive toxicity (see section 5.3).
Danish: Dyrestuder med Neparvis har vist reproduktionstoksicitet (se pkt.
English: BNP is not a suitable biomarker of heart failure in patients treated with Neparvis because it is a neprilysin substrate (see section 5.1).
Danish: BNP er ikke egnet som markør for hjertesvigt hos patienter behandlet med Neparvis, da dette er et neprilysinsubstrat (se pkt.
English: A slight increase in two foetal skeletal variations (misshapen sternebra, sternebra bipartite ossification) was observed in rabbits at an Neparvis dose of 4.9 mg sacubitril/5.1 mg valsartan/kg/day.
Danish: En let øgning i to føtale, skeletale variationer (misdannet sternebra, tvedelt knogledannelse af sternebra) blev observeret hos kaniner ved en dosis af Neparvis på 4,9 mg sacubitril/5,1 mg valsartan/kg/dag.
English: Primary composite endpoint of CV death and heart failure hospitalisations*
Danish: Primært samlet endepunkt for CV død og hospitalsindlæggelse ved hjertesvigt*
English: ≤ eGFR <60 ml/min/1.73 m 2) and severe renal impairment (15 ml/min/1.73 m eGFR <30 ml/min/1.73 m2) was 1.4-fold and 2.2-fold higher compared to patients with mild renal impairment (60 ml/min/1.73 m
Danish: ≤ eGFR <30 ml/min/1,73 m 2) var 1,4 gange og 2,2 gange højere sammenlignet med patienter med let nedsat nyrefunktion (60 ml/min/1,73 m
English: Approximate tablet dimensions 13.1 mm x 5.2 mm. Neparvis 49 mg/51 mg film-coated tablets
Danish: Tabletdimensioner er ca. 13,1 mm x 5,2 mm. Neparvis 49 mg/51 mg filmovertrukne tabletter
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer):
English: Neparvis is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see section 4.3).
Danish: Neparvis er kontraindiceret hos patienter med svært nedsat leverfunktion, biliær cirrhose eller cholestase (Child-Pugh klasse C) (se pkt.
English: If any of the above applies to you, tell your doctor or pharmacist before you take Neparvis.
Danish: Hvis noget af ovenstående passer på dig, skal du tale med din læge eller apotekspersonalet før du tager Neparvis.
English: Neparvis 97 mg/103 mg film-coated tablets
Danish: Neparvis 97 mg/103 mg filmovertrukne tabletter
English: Neparvis exhibits the mechanism of action of an angiotensin receptor neprilysin inhibitor by simultaneously inhibiting neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and by blocking the angiotensin II type-1 (AT1) receptor via valsartan.
Danish: Neparvis udøver virkningsmekanismen af en angiotensinreceptor-neprilysin-hæmmer idet LBQ657, som er den aktive metabolit af prodruget sacubitril, hæmmer neprilysin (neutral endopeptidase; NEP) samtidig med, at valsartan blokerer angiotensin II type-1 (AT1) receptoren.
English: Approximate tablet dimensions 13.1 mm x 5.2 mm.
Danish: Tabletdimensioner: ca. 13,1 mm x 5,2 mm.
English: The medicinal product is unlikely to be removed by haemodialysis due to high protein binding.
Danish: På grund af høj proteinbinding er det usandsynligt, at lægemidlet kan fjernes ved hæmodialyse.
English: Patients with a prior history of angioedema were not studied.
Danish: Der er ikke udført studier hos patienter med angioødem i anamnesen.
English: Multipack: 168 (3 packs of 56) film-coated tablets Multipack: 196 (7 packs of 28) film-coated tablets
Danish: Multipakning: 168 (3 pakninger med 56) filmovertrukne tabletter Multipakning: 196 (7 pakninger med 28) filmovertrukne tabletter
English: Neparvis 24 mg/26 mg film-coated tablets
Danish: Neparvis 24 mg/26 mg filmovertrukne tabletter
English: There are no available data on the effect of Neparvis on human fertility.
Danish: Virkningen af Neparvis på human fertilitet er ikke undersøgt.
English: Neparvis 49 mg/51 mg film-coated tablets
Danish: Neparvis 49 mg/51 mg filmovertrukne tabletter
English: ≤ eGFR <90 ml/min/1.73 m2), the largest group of patients enrolled in
Danish: <90 ml/min/1,73 m2), som udgjorde den største gruppe af patienter, der deltog i PARADIGM-HF).
English: Patients received a starting dose of Neparvis of 50 mg twice daily and were up-titrated to 100 mg twice daily,
Danish: Patienterne fik en startdosis på 50 mg Neparvis 2 gange daglig, og blev titreret op til 100 mg 2 gange daglig, derefter til måldosis på 200 mg 2 gange daglig med enten et 3-ugers eller 6-ugers regime.
English: Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets.
Danish: Pakningsstørrelser: 14, 20, 28 eller 56 filmovertrukne tabletter og multipakninger indeholdende 168 (3x56) eller 196 (7x28) filmovertrukne tabletter.
English: Neparvis 24 mg/26 mg film-coated tablets Neparvis 49 mg/51 mg film-coated tablets Neparvis 97 mg/103 mg film-coated tablets
Danish: Neparvis 24 mg/26 mg filmovertrukne tabletter Neparvis 49 mg/51 mg filmovertrukne tabletter Neparvis 97 mg/103 mg filmovertrukne tabletter
English: Iron oxide black (E172)
Danish: Sort jernoxid (E172)
English: Approximate tablet dimensions 13.1 mm x 5.2 mm. Neparvis 97 mg/103 mg film-coated tablets
Danish: Tabletdimensioner er ca. 13,1 mm x 5,2 mm. Neparvis 97 mg/103 mg filmovertrukne tabletter
English: Neparvis 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side.
Danish: Neparvis 49 mg/51 mg filmovertrukne tabletter er svagt gule ovale tabletter med ”NVR” på den ene side og ”L1” på den anden side.
English: However, in patients with mild to moderate hepatic impairment, the exposures of free concentrations of LBQ657 increased by 1.47- and 3.08-fold, respectively, and the exposures of free concentrations of valsartan increased by 1.09-fold and 2.20-fold, respectively, compared to matching healthy subjects.
Danish: Optagelse af frit LBQ657 øgedes dog hos patienter med mildt til moderat nedsat leverfunktion henholdsvis 1,47 og 3,08 gange, og optagelse af frit valsartan øgedes med henholdsvis 1,09 gange og 2,20 gange sammenlignet med matchende raske forsøgspersoner.
English: • sildenafil, a medicine used to treat erectile dysfunction or lung hypertension.
Danish: • sildenafil, som er et lægemiddel, der bruges til at behandle rejsningsproblemer eller for højt blodtryk i lungerne.
English: If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Neparvis (see “Other medicines and Neparvis”).
Danish: Hvis du har taget en ACE-hæmmer, skal du vente i 36 timer efter at have taget den sidste dosis, før du begynder at tage Neparvis (se ”Brug af anden medicin sammen med Neparvis”).
English: Iron oxide red (E172)
Danish: Rød jernoxid (E172)
English: • if you have liver disease.
Danish: • hvis du har en leversygdom.
English: Neparvis 24 mg/26 mg film-coated tablets Neparvis 49 mg/51 mg film-coated tablets Neparvis 97 mg/103 mg film-coated tablets sacubitril/valsartan
Danish: Neparvis 24 mg/26 mg filmovertrukne tabletter Neparvis 49 mg/51 mg filmovertrukne tabletter Neparvis 97 mg/103 mg filmovertrukne tabletter sacubitril/valsartan
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Novartis Pharma GmbH
English: • if you have severe liver disease.
Danish: • hvis du har en alvorlig leversygdom.
English: The combination of Neparvis with direct renin inhibitors such as aliskiren is not recommended (see section 4.4).
Danish: Kombination af Neparvis med direkte reninhæmmere som fx aliskiren frarådes (se pkt.
English: Cases of symptomatic hypotension have been reported in patients treated with Neparvis during clinical studies (see section 4.8), especially in patients ≥65 years old, patients with renal disease and patients with low SBP (<112 mmHg).
Danish: 4.8), især hos patienter ≥65 år, patienter med nyresygdom og patienter med lavt SBT (<112 mmHg.).
English: ≥49 mg sacubitril/51 mg valsartan/kg/day (≤0.72-fold the maximum recommended human dose [MRHD] on the basis of AUC) and rabbits at doses ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively).
Danish: Behandling med Neparvis under organdannelsen resulterede i øget embryoføtal dødelighed hos rotter ved doser ≥49 mg sacubitril/51 mg valsartan/kg/dag (≤0,72 gange den maksimalt anbefalede dosis til mennesker [MRHD] vurderet ud fra AUC) og kaniner ved doser ≥4,9 mg sacubitril/5,1 mg valsartan/kg/dag (henholdsvis 2 gange og 0,03 gange MHRD vurderet ud fra AUC for valsartan og LBQ657).
English: Hyperkalaemia*
Danish: Hyperkaliæmi*
English: • Known history of angioedema related to previous ACE inhibitor or ARB therapy (see section 4.4).
Danish: • Kendt angioødem i anamnesen i forbindelse med tidligere behandling med ACE-hæmmer eller ARB (se pkt.
English: Very common Orthostatic hypotension Common
Danish: Meget almindelig Ortostatisk hypotension Almindelig Luftveje, thorax og mediastinum Hoste
English: Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 196 (7x28) film-coated tablets.
Danish: Pakningsstørrelser: 14, 20, 28 eller 56 filmovertrukne tabletter og multipakninger indeholdende 196 (7x28) filmovertrukne tabletter.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer)
English: Neparvis must not be started until 36 hours after taking the last dose of ACE inhibitor therapy.
Danish: Neparvis må ikke påbegyndes før 36 timer efter indtagelse af den sidste dosis ACE-hæmmer.
English: • The 24 mg/26 mg and the 97 mg/103 mg tablet coatings contain hypromellose, titanium dioxide (E171), Macrogol 4000,talc, iron oxide red (E172) and iron oxide black (E172).
Danish: • Overtrækket for 24 mg/26 mg og 97 mg/103 mg tabletterne indeholder hypromellose, titandioxid (E171), Macrogol 4000, talcum, rød jernoxid (E172), og sort jernoxid (E172).
English: 28 film-coated tablets.
Danish: 28 filmovertrukne tabletter.
English: NDEA Limit in ppm in API
Danish: Grænseværdi i ppm i det aktive stof
English: • The 49 mg/51 mg tablet coating contains hypromellose, titanium dioxide (E171), Macrogol 4000, talc, iron oxide red (E172) and iron oxide yellow (E172).
Danish: • Overtrækket for 49 mg/51 mg tabletten indeholder hypromellose, titandioxid (E171), Macrogol 4000, talcum, rød jernoxid (E172) og gul jernoxid (E172).
English: 20 film-coated tablets
Danish: 20 filmovertrukne tabletter
English: • low level of red blood cells (shown in a blood test)
Danish: • lavt niveau af røde blodlegemer (påvist i en blodprøve)
English: Additionally, in a toxicology study in cynomolgus monkeys treated with Neparvis at 146 mg sacubitril/154 mg valsartan/kg/day for 39 weeks, there was no evidence for the presence of amyloid plaques in the brain.
Danish: Ydermere var der ingen tegn på forekomst af amyloid plaques i hjernen hos cynomolgus aber, der blev behandlet med Neparvis 146 mg sacubitril/154 mg valsartan/kg/dag i 39 uger i et toksikologisk studie.
English: It is teratogenic based on a low incidence of foetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Neparvis dose of ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day.
Danish: Med baggrund i en lille forekomst af føtal hydrocephali relateret til maternelle toksiske doser, som sås hos kaniner ved en Neparvisdosis ≥4,9 mg sacubitril/5,1 mg valsartan/kg/dag, er
English: Preferred term
Danish: Foretrukken betegnelse Hyppighed
English: Possible side effects
Danish: Andre bivirkninger:
English: If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Neparvis (see “Do not take Neparvis”).
Danish: Hvis du har taget en ACEhæmmer, skal du vente i 36 timer efter at have taget den sidste dosis ACE-hæmmer, før du kan starte med at tage Neparvis (se ”Tag ikke Neparvis”).
English: 56 film-coated tablets.
Danish: 56 filmovertrukne tabletter.
English: Do not throw away any medicines via wastewater.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Sodium and/or volume depletion should be corrected before starting treatment with Neparvis, however, such corrective action must be carefully weighed against the risk of volume overload.
Danish: Hyponatriæmi og/eller hypovolæmi bør korrigeres før behandling med Neparvis påbegyndes.
English: • Neparvis contains valsartan, and therefore should not be co-administered with another ARB containing product (see sections 4.2 and 4.5).
Danish: • Neparvis indeholder valsartan og må derfor ikke gives sammen med et andet produkt indeholdende en ARB.
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: Sacubitril treatment during organogenesis resulted in embryo-foetal lethality and embryo-foetal toxicity (decreased foetal body weights and skeletal malformations) in rabbits at doses associated with maternal toxicity (500 mg/kg/day; 5.7-fold the MRHD on the basis of LBQ657 AUC).
Danish: Behandling af kaniner med sacubitril i doser relateret til maternel toksicitet (500 mg/kg/dag; 5,7 gange MRHD baseret på LBQ657 AUC) under organdannelse resulterede i embryoføtal dødelighed og embryoføtal toksicitet (nedsat føtal legemsvægt og derform knogledannelse) hos kaniner med doser relateret til maternel toksicitet (500 mg/kg/dag; 5,7 gange MRHD) baseret på LBQ657 AUC).