FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions rigors, pyrexia, pain and discomfort, fatigue fatigue aggravated, feeling hot, feeling cold, asthenia, chest pain, chest tightness, influenza like illness, injection site rash, malaise
Danish: Almene symptomer og reaktioner på administrationsstedet kulderystelser, pyreksi, smerter og ubehag, træthed forværring af træthed, feberfornemmelse, kuldefornemmelse, asteni, bryst-smerter, trykken for brystet, influenza-lignende sygdom, udslæt på injektionsstedet, ildebefindende
English: Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
Danish: Natriumdihydrogenphosphatmonohydrat polysorbat 20 natriumchlorid natriumhydroxid vand til injektionsvæsker
English: After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients.
Danish: Efter 6 måneders behandling reducerede Replagal signifikant patienternes smerter sammenlignet med smerterne hos patienter, der blev behandlet med placebo (uvirksomt stof).
English: NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Replagal 1 mg/ml koncentrat til infusionsvæske, opløsning.
English: Respiratory, thoracic and mediastinal disorders cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea oxygen saturation decreased
Danish: Luftveje, thorax og mediastinum hoste, hæshed, snørende fornemmelse omkring halsen, dyspnø, nasopharyngitis, pharyngitis, øget produktion af slim i halsen, rinoré reduceret oxygenmætning
English: Patients with renal impairment
Danish: Patienter med svækket nyrefunktion
English: Your medicine is available in vials containing 3.5 mg/ 3.5 ml of agalsidase alfa.
Danish: Lægemidlet leveres i hætteglas (glasflasker) indeholdende 3,5 mg/3,5 ml agalsidase alfa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Replagal 1 mg/ml sterile concentrate agalsidase alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Replagal 1 mg/ml koncentrat, sterilt
English: Skin and subcutaneous tissue disorders acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema,
Danish: Hud og subkutane væv acne, erytem, pruritus, udslæt, livedo reticularis angioødem, urticaria hyperhidrose
English: What Replagal is and what it is used for The active substance in Replagal is agalsidase alfa (1mg/ml).
Danish: Det aktive stof er agalsidase alfa (1 mg/ml).
English: Replagal reduced left ventricle mass in treated patients compared to placebo treated patients.
Danish: Replagal reducerede patienternes venstre hjertekammer sammenlignet med hjertekammeret hos placebobehandlede patienter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 3.5 mg of agalsidase alfa
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 3,5 mg agalsidase alfa
English: Infusion related reactions reported in the postmarketing setting (also see section 4.4) may include cardiac events such as cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischemia, and heart failure in patients with Fabry disease involving the heart structures.
Danish: 4.4), kan omfatte kardielle hændelser såsom arytmier (atrieflimren, ventrikulære ekstrasystoler, takyarytmi), myokardieiskæmi og hjerteinsufficiens hos patienter med Fabrys sygdom, hvor hjertestrukturen er involveret.
English: Eye disorders corneal reflex decreased, lacrimation increased
Danish: Øjne nedsat cornearefleks, tåreflåd
English: Gastrointestinal disorders nausea diarrhoea , vomiting, abdominal pain/discomfort
Danish: Mave-tarm-kanalen kvalme diare, opkastning, mavesmerter/ubehag
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: This pain reduction persisted through 4 years of Replagal therapy in 9 patients (in patients 7 - 18 years of age).
Danish: Hos 9 patienter (7-18 år) varede denne reduktion i smerter ved i 4 år med behandling med Replagal.
English: The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue.
Danish: De hyppigste symptomer er kulderystelser, hovedpine, kvalme, pyreksi, ansigtsrødme og træthed.
English: Musculoskeletal, connective tissue and bone disorders musculoskeletal discomfort, myalgia, back pain, limb pain, peripheral swelling, arthralgia, joint swelling sensation of heaviness
Danish: Knogler, led, muskler og bindevæv muskuloskeletale gener, myalgi, rygsmerter, smerter i ekstremiteter, perifer hævelse, artralgi, hævede led tyngdefornemmelse
English: 4.7 Undesirable effects
Danish: 4.8 Bivirkninger
English: In male paediatric patients ≥ 7 years of age, heart rate variability was abnormal at baseline and improved after 6 months of Replagal therapy in 15 boys and the improvement was sustained through 6.5 years of Replagal 0.2 mg/kg therapy in an open-label long-term extension study in 9 boys.
Danish: Hos mandlige pædiatriske patienter i alderen 7 år og derover var variabiliteten i hjertefrekvens unormal ved baseline og forbedredes efter 6 måneders behandling med Replagal hos 15 drenge.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - Enzymes.ATC code: A16AB03.
Danish: Farmakoterapeutisk klassifikation: Andre produkter vedrørende fordøjelseskanal og metabolismeEnzymer.
English: - The active substance is agalsidase alfa.
Danish: Replagal indeholder: - Aktivt stof: agalsidase alfa.
English: What Replagal looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Within 2 years after Commission Decision.
Danish: Senest to år efter Kommissionens afgørelse
English: Do not take Entresto:
Danish: Tag ikke Entresto:
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Entresto affects you.
Danish: Før du kører bil, bruger værktøj eller betjener maskiner eller udfører andre aktiviteter, som kræver koncentration, skal du sikre dig, at du ved, hvordan Entresto påvirker dig.
English: The safety and efficacy of Entresto in children and adolescents aged below 18 years have not been established.
Danish: Entrestos sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Entresto.
Danish: Din læge vil normalt råde dig til at stoppe med at tage denne medicin, før du bliver gravid, eller så snart du ved, at du er gravid og vil råde dig til at tage en anden medicin end Entresto.
English: Do not use any Entresto pack that is damaged or shows signs of tampering.
Danish: Brug ikke en Entresto-pakning, som er beskadiget eller viser tegn på at have været åbnet.
English: If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Entresto dose, or stop your Entresto treatment completely.
Danish: Hvis dette sker, kan din læge vælge at nedsætte dosis af eventuel anden medicin, du tager, nedsætte dosis af Entresto midlertidigt, eller fuldstændigt stoppe din behandling med Entresto.
English: It is not known whether Entresto is excreted in human milk.
Danish: Det er ukendt, om Entresto udskilles i human mælk.
English: The average daily dose of furosemide was unchanged from baseline until the end of the PARADIGM-HF study in patients treated with Entresto.
Danish: Den gennemsnitlige daglige dosis af furosemid var uændret fra baseline til slutningen af PARADIGM-HF-studiet hos patienter behandlet med Entresto.
English: Stopping your treatment with Entresto may cause your condition to get worse.
Danish: Hvis du stopper behandlingen med Entresto, kan din tilstand forværres.
English: Entresto has a minor influence on the ability to drive and use machines.
Danish: Entresto påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
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 N-nitrosaminer og ændres i nødvendigt omfang for at minimere nitrosamin-forureningen mest muligt.
English: If you have accidentally taken too many Entresto tablets, or if someone else has taken your tablets, contact your doctor immediately.
Danish: Hvis du ved et uheld har taget for mange Entresto-tabletter, eller hvis nogen anden har taget dine tabletter, skal du kontakte din læge så hurtigt som muligt.
English: • if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
Danish: • hvis du nogensinde har haft angioødem (se ”Tag ikke Entresto” og punkt 4 ”Bivirkninger”).
English: Entresto is used to treat a type of long-term heart failure in adults.
Danish: Entresto anvendes til behandling af en langvarig type af hjertesvigt hos voksne.
English: Caution should be exercised when co-administering Entresto with statins.
Danish: Der skal udvises forsigtighed, når Entresto anvendes sammen med statiner.
English: • Stop taking Entresto 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 Entresto og søg straks læge, hvis du mærker hævelse af ansigt, læber, tunge og/eller hals, som kan give vejrtrækningsbesvær eller synkebesvær.
English: Entresto improved survival with a significant reduction in all-cause mortality of 2.8% (Entresto, 17%, enalapril, 19.8%).
Danish: Entresto forbedrede overlevelse med en signifikant reduktion i generel dødelighed på 2,8 % (Entresto, 17 %, enalapril, 19,8 %).
English: Therefore, caution should be exercised when sildenafil or another PDE5 inhibitor is initiated in patients treated with Entresto.
Danish: Der skal derfor udvises forsigtighed, når sildenafil eller anden PDE-5-hæmmer initieres hos patienter behandlet med Entresto.
English: The use of Entresto 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: Entresto anbefales ikke i det første trimester af graviditet og er kontraindiceret i det andet og tredje trimester af graviditet (se pkt.
English: Use of Entresto may be associated with decreased renal function.
Danish: Brug af Entresto kan være forbundet med nedsat nyrefunktion.
English: Therefore, when initiating therapy with Entresto in patients receiving metformin, the clinical status of the patient should be evaluated.
Danish: Ved start af behandling med Entresto hos patienter, der får metformin, skal patientens kliniske status derfor vurderes.
English: As they may be at higher risk for angioedema, caution is recommended if Entresto is used in these patients.
Danish: Da de kan have en højere risiko for angioødem, skal der udvises forsigtighed, hvis Entresto anvendes til disse patienter.
English: Caution should be exercised when initiating Entresto 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 Entresto hos patienter med NYHA klasse IV, da der er begrænset klinisk erfaring hos denne population.
English: There is no experience in patients with end-stage renal disease and use of Entresto is not recommended.
Danish: Der er ingen erfaring hos patienter med nyresygdom i slutstadiet og Entresto anbefales ikke.
English: Addition of a single dose of sildenafil to Entresto at steady state in patients with hypertension was associated with a significantly greater blood pressure reduction compared to administration of Entresto alone.
Danish: Tillæg af en enkelt dosis sildenafil til Entresto ved steady state hos patienter med hypertension var forbundet med signifikant højere blodtrykssænkning sammenlignet med administration af Entresto alene.
English: There are no data from the use of Entresto in pregnant women.
Danish: Der er ingen data vedrørende anvendelse af Entresto hos gravide kvinder.
English: Following oral administration, Entresto dissociates into valsartan and the prodrug sacubitril.
Danish: Efter oral administration omdannes Entresto til valsartan og prodruget sacubitril.
English: Your doctor may check the amount of potassium in your blood at regular intervals during Entresto treatment.
Danish: Din læge vil måske regelmæssigt undersøge mængden af kalium i dit blod i løbet af din behandling med Entresto.
English: Non-clinical data (including studies with sacubitril and valsartan components and/or Entresto) 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 Entresto) viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt fertilitet.
English: If angioedema occurs, Entresto 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 Entresto straks seponeres, og der skal iværksættes passende behandling og monitorering, indtil der er opnået komplet og vedvarende ophør af symptomer.
English: Patients taking Entresto 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 Entresto, 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: Entresto may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis.
Danish: Entresto kan øge mængden af serumkreatinin og urinstof i blodet hos patienter med bilateral eller unilateral renal arteriestenose.
English: Patients randomised to the Entresto 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 Entrestogruppen var 24 måneder; 3271 patienter blev behandlet i mere end et år.
English: If you stop taking Entresto
Danish: Hvis du holder op med at tage Entresto
English: You can take Entresto with or without food.
Danish: Du kan tage Entresto med eller uden mad.
English: Entresto is a medicine known as an angiotensin receptor neprilysin inhibitor.
Danish: Entresto er et lægemiddel kendt som en angiotensinreceptor-neprilysinhæmmer.
English: Entresto is not recommended for mothers who are breastfeeding.
Danish: Entresto frarådes til mødre, som ammer.
English: A similar effect on the heart rate may occur when Entresto is co-administered with sublingual, oral or transdermal nitrates.
Danish: En lignende virkning på hjertefrekvensen kan forekomme, når Entresto anvendes sammen med nitrater i sublingual, oral eller transdermal form.
English: When initiating therapy or during dose titration with Entresto, blood pressure should be monitored routinely.
Danish: Ved behandlingsstart eller under dosistitrering med Entresto bør blodtrykket monitoreres regelmæssigt.
English: Administration of Entresto 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 Entresto 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: There was no drug-drug interaction between Entresto and intravenously administered nitroglycerin with regard to blood pressure reduction.
Danish: Der var ingen interaktion mellem Entresto og intravenøst indgivet nitroglycerin med hensyn til blodtryksnedsættelse.
English: The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, except in the situations described below.
Danish: Den anbefalede startdosis af Entresto er én tablet på 49 mg/51 mg to gange daglig, med undtagelse af de tilfælde, der er beskrevet herunder.
English: A decision should be made whether to abstain from breast-feeding or to discontinue Entresto while breast-feeding, taking into account the importance of Entresto to the mother.
Danish: Det skal besluttes, om amning eller behandling skal ophøre, idet der tages højde for vigtigheden af Entresto for moderen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Entresto 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 resultaterne af studier med Entresto i en eller flere undergrupper af den pædiatriske population ved behandling af hjertesvigt (se pkt.
English: Hypotension is the most likely symptom of overdose due to the blood pressure lowering effects of Entresto.
Danish: Det mest sandsynlige symptom på overdosering er hypotension på grund af Entrestos blodtrykssænkende virkning.
English: Entresto can be administered with or without food.
Danish: Entresto kan gives sammen med eller uden mad.
English: Co-administration of Entresto and furosemide had no effect on the pharmacokinetics of Entresto but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Danish: Samtidig indgift af Entresto og furosemid har ingen indvirkning på Entrestos farmakokinetik, men reducerede Cmax og AUC for furosemid med henholdsvis 50 % og 28 %.
English: Patients received a starting dose of Entresto of 50 mg twice daily and were up-titrated to 100 mg twice daily, then to the target dose of 200 mg twice daily, with either a 3-week or a 6-week regimen.
Danish: Patienterne fik en startdosis på 50 mg Entresto 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: Angioedema was reported in patients treated with Entresto (see description of selected adverse reactions).
Danish: Angioødem blev rapporteret hos patienter behandlet med Entresto (se beskrivelse af udvalgte bivirkninger).
English: Entresto 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: Entresto 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: They were then randomised to the double-blind period of the study, during which they received either Entresto 200 mg or enalapril 10 mg twice daily [Entresto (n=4,209); enalapril (n=4,233)].
Danish: De blev derefter randomiseret til den dobbeltblindede studieperiode, i hvilken de fik enten 200 mg Entresto 2 gange daglig eller 10 mg enalapril 2 gange daglig [Entresto (n=4209); enalapril (n=4233)].
English: The valsartan contained within Entresto is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Entresto is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Danish: Valsartan indeholdt i Entresto har en højere biotilgængelighed end valsartan i andre markedsførte tabletformuleringer; 26 mg, 51 mg og 103 mg valsartan i Entresto svarer til henholdsvis 40 mg, 80 mg og 160 mg valsartan i andre markedsførte tabletformuleringer.
English: Entresto may therefore increase the systemic exposure of OATP1B1 and OATP1B3 substrates such as statins.
Danish: Entresto kan derfor øge den systemiske eksponering af OATP1B1- og OATP1B3-substrater som fx statiner.
English: No clinically meaningful drug-drug interaction was observed when Entresto 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 Entresto blev givet sammen med digoxin, warfarin, hydrochlortiazid, amlodipin, omeprazol, carvedilol, eller en kombination af levonorgestrel/ethinyl østradiol.
English: Following twice daily dosing of Entresto, 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: The concomitant use of Entresto with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Danish: Anvendelse af Entresto sammen med ACE-hæmmere er kontraindiceret, da samtidig hæmning af neprilysin (NEP) og ACE kan øge risikoen for angioødem.
English: Co-administration of Entresto with metformin reduced both Cmax and AUC of metformin by 23%.
Danish: Samtidig indgift af Entresto og metformin reducerede både Cmax og AUC for metformin med 23 %.
English: PARADIGM-HF was a multinational, randomised, double-blind study of 8,442 patients comparing Entresto 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 Entresto 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: What you need to know before you take Entresto
Danish: Det skal du vide, før du begynder at tage Entresto
English: A higher incidence of angioedema was observed in Black patients treated with Entresto (2.4%) and enalapril (0.5%) (see section 4.4).
Danish: Frekvensen af angioødem var højere hos sorte patienter behandlet med Entresto (2,4 %) og enalapril (0,5 %) (se pkt.
English: If hypotension occurs, temporary down-titration or discontinuation of Entresto is recommended (see section 4.2).
Danish: Ved forekomst af hypotension anbefales midlertidig nedtitrering eller seponering af Entresto (se pkt.
English: The pharmacodynamic effects of Entresto 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 Entresto 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: 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).