FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Enviage if you are pregnant.
Danish: Du må ikke tage Enviage, hvis du er gravid.
English: Do not use Enviage after the expiry date which is stated on the carton and blister.
Danish: Brug ikke Enviage efter den udløbsdato, der står på pakningen og blisterkortet.
English: Like all medicines, Enviage can cause side effects, although not everybody gets them.
Danish: Enviage kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If any of these apply to you, tell your doctor before you take Enviage.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, før du tager Enviage.
English: Enviage has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Danish: Enviage er evalueret med henblik på sikkerhed hos mere end 7.800 patienter, herunder over 2.300, som var i behandling i mere end 6 måneder, og mere end 1.200, som var i behandling i over 1 år.
English: If you have accidentally taken too many Enviage tablets, consult a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af Enviage, skal du straks kontakte en læge.
English: If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage Enviage, skal du tage det så snart, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: Your doctor may prescribe Enviage together with other medicines used to treat high blood pressure.
Danish: Din læge kan ordinere Enviage sammen med anden medicin, der bruges til at behandle forhøjet blodtryk.
English: - if you have impaired kidney function.
Danish: - hvis du har nedsat nyrefunktion.
English: Angioedema has occurred during treatment with Enviage.
Danish: Angioødem er forekommet under behandling med Enviage.
English: Enviage belongs to a new class of medicines called renin inhibitors.
Danish: Enviage tilhører en ny klasse af medicin, kaldet reninhæmmere.
English: Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Danish: Enviage er undersøgt i 1.864 patienter i alderen 65 år eller derover og i 426 patienter
English: If angioedema occurs, Enviage should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis angioødem opstår, skal Enviage seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende resolution af tegn og symptomer indtræffer.
English: Enviage helps to lower high blood pressure.
Danish: Enviage hjælper med at sænke et forhøjet blodtryk.
English: Always take Enviage exactly as your doctor has told you.
Danish: Tag altid Enviage nøjagtigt efter lægens anvisning.
English: This condition should be corrected prior to administration of Enviage, or the treatment should start under close medical supervision.
Danish: Denne tilstand bør korrigeres før administration af Enviage, eller behandlingen skal indledes under nøje
English: However, in one study where Enviage was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Danish: I et studie, hvor Enviage blev anvendt sammen med en ACE-hæmmer i en diabetisk population, var stigningerne i serumkalium dog mere hyppige (5,5 %).
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Enviage and placebo, respectively.
Danish: Andelen af patienter, som fik UACR reduceret med mindst 50 fra baseline ved forsøgets slutning var henholdsvis 24,7 % for Enviage og 12,5 % for placebo.
English: Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines: - medicines that increase the amount of potassium in your blood.
Danish: Det kan være nødvendigt for din læge at ændre din dosis og/eller tage andre forsigtighedsregler, hvis - medicin, der kan øge mængden af kalium i dit blod.
English: You should not take Enviage together with grapefruit juice.
Danish: Du må ikke tage Enviage sammen med grapefrugt juice.
English: In the event of severe and persistent diarrhoea, Enviage therapy should be stopped.
Danish: I tilfælde af alvorlig og vedvarende diarré bør behandling med Enviage stoppes.
English: In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Danish: I forsøgsdyr er det blevet vist a P-gp har stor indflydelse på Enviages biotilgængelighed.
English: As a result no dose adjustment for Enviage or these co-administered medicinal products is necessary.
Danish: Dosisjustering for Enviage eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Enviage.
Danish: I kontrollerede kliniske forsøg blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af Enviage.
English: Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Danish: Når blodtrykket sænkes til normalt niveau, mindskes risikoen for at få
English: Digoxin bioavailability may be slightly decreased by Enviage.
Danish: Biotilgængeligheden af digoxin kan blive lettere nedsat af Enviage.
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Enviage 150 mg was well tolerated.
Danish: I et 3-måneders studie med 302 patienter med let stabilt hjertesvigt, som alle var i standardbehandling for stabilt hjertesvigt blev tillæg af Enviage 150 mg godt tolereret.
English: Slovenija es Inc.
Danish: România ces Inc.
English: Grapefruit juice should not be taken together with Enviage.
Danish: Grapefrugt juice må ikke tages sammen med Enviage.
English: Enviage has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Danish: Enviage har ingen kendte klinisk relevante interaktioner med lægemidler, som typisk bruges til behandling af hypertension eller diabetes.
English: Enviage was secreted in the milk of lactating rats.
Danish: Enviage udskilles i mælken hos diegivende rotter.
English: Take special care with Enviage - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Danish: Vær ekstra forsigtig med at tage Enviage - hvis du tager et diuretikum (kaldes også vanddrivende tabletter, som øger den mængde urin, du producerer).
English: Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Danish: Enviage bør ikke anvendes til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning (se pkt.
English: Enviage may be used alone or in combination with other antihypertensive agents (see sections 4.4 and
Danish: Enviage kan anvendes alene eller kombineres med andre antihypertensiva (se pkt 4.4 og 5.1).
English: It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of volume overload.
Danish: Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumen
English: Warfarin The effects of Enviage on warfarin pharmacokinetics have not been evaluated.
Danish: Effekten af Enviage på warfarins farmakokinetik er ikke blevet evalueret.
English: Food intake Meals with a high fat content have been shown to reduce the absorption of Enviage substantially.
Danish: Måltider med højt fedtindhold reducerer absorptionen af Enviage betragteligt.
English: The recommended dose of Enviage is 150 mg once daily.
Danish: Den anbefalede dosis af Enviage er 150 mg én gang dagligt.
English: Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
Danish: Foreløbige data tyder på at irbesartan kan nedsætte AUC og Cmax for Enviage.
English: Not all pack sizes may be marketed.
Danish: ke alle pakningsstørrelser er nødvendigvis markedsført.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i ansøgningen om markedsføringstilladelsen (version 8.0, Modul 1.8.1), er på plads og fungerer, før og
English: Enviage was not teratogenic in rats or rabbits (see section 5.3).
Danish: Enviage var ikke teratogent i rotter eller kaniner (se pkt.
English: Serum potassium: Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Enviage alone (0.9% compared to 0.6% with placebo).
Danish: Serumkalium: Stigningerne i serumkalium var minimale og ikke hyppige hos patienter med essentiel hypertension, som blev behandlet med Enviage alene (0,9 % kontra 0,6 % med placebo).
English: Enviage should be taken with a light meal once a day, preferably at the same time each day.
Danish: Enviage bør tages med et let måltid mad én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: If pregnancy is detected during therapy, Enviage should be discontinued accordingly.
Danish: Hvis der opstår graviditet under behandlingen, skal Enviage seponeres som konsekvens heraf.
English: No controlled clinical data are available on the use of Enviage in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Danish: Der er ingen tilgængelige kontrollerede kliniske data om brug af Enviage til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Enviage til patienter med stenose i en enkelt nyre.
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Danish: Inducere af P-gp (prikbladet perikum, rifampicin) kan derfor nedsætte biotilgængeligheden af Enviage.
English: Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than with the initial dose.
Danish: Steady state-plasmakoncentrationerne nås inden for 5-7 dage efter adm max inistration en t, og steady state-niveauerne er ca. 2 gange større end ved initialdosen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/406/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/406/001-010
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Enviage alone.
Danish: Kraftig hypotension var usædvanlig (0,1 % hos patienter med ukompliceret hypertension, som blev behandlet med Enviage alene.
English: Enviage has negligible influence on the ability to drive and use machines.
Danish: Enviage har en ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Enviage 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Danish: Sammenlignet med et diuretikum (hydrochlortiazid - HCTZ) sænkede Enviage 300 mg det systoliske/diastoliske blodtryk med 17,0/12,3 mmHg sammenlignet med 14,4/10,5 mmHg for HCTZ 25 mg efter 12 ugers behandling.
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Danish: Samtidig administration af aliskiren med enten valsartan (↓28 %), metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i en ændring af Cmax eller AUC for Enviage på mellem 20 % og 30 %.
English: In controlled clinical trials, angioedema occurred rarely during treatment with Enviage with rates comparable to treatment with placebo or hydrochlorothiazide.
Danish: I kontrollerede kliniske studier forekom angioødem sjældent under behandling med Enviage, og havde sammenlignelig hyppighed med placebo eller hydrochlorthiazid.
English: You should take Enviage with a light meal once a day, preferably at the same time each day.
Danish: Du bør tage Enviage sammen med et let måltid mad, én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Danish: Sjældne bivirkninger (forekommer hos mellem 1 og 10 ud af 10.000 patienter): Angioødem (besvær med at trække vejret eller med at synke eller hævet ansigt, hænder og fødder, øjenomgivelser, læber
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Danish: Måltider med højt fedtindhold reducerer C med 85 % og
English: In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Enviage 300 mg achieved a 20% reduction versus placebo in urinary albumin:creatinine ratio (UACR), i.e. from 58 mg/mmol to 46 mg/mmol.
Danish: I et 6 måneders studie med 599 hypertensionspatienter med type 2 diabetes mellitus og nefropati, der alle fik 100 mg losartan sammen med optimal antihypertensiv standardbehandling, opnåede ved tillæg af Enviage 300 mg en 20 % reduktion i forhold til placebo i urin-albumin-kreatininforholdet (UACR), dvs. fra 58 mg/mmol til 46 mg/mmol.
English: Novartis Ireland Limite el: +353 1 260 12 55
Danish: Novartis Ireland Limited el: +353 1 260 12 55
English: The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Danish: Den antihypertensive effekt er til stede i betydelig grad inden for to uger (85-90 %) efter initiering af
English: Enviage induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Danish: Enviage inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid og ramipril.
English: Absorption
Danish: Indtagelse
English: In clinical studies Enviage has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Enviage er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret glomerulær filtrationsrate (GFR) < 30 ml/min.
English: Vistor hf. ími: +354 535 7000
Danish: ími: +354 535 7000
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svær hjertesvigt (New York Heart
English: Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/or those with reduced kidney function and/or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Danish: Patienter, som anvender andre lægemidler der hæmmer renin-angiotensin systemet (RAS), og/eller har nedsat nyrefunktion og/eller diabetes mellitus har en øget risiko for hyperkalæmi under behandling
English: In hypertensive patients, once-daily administration of Enviage at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Danish: Hos hypertensive patienter gav administration af Enviage en gang dagligt i doser på 150 mg og 300 mg dosisafhængige reduktioner i både det systoliske og det diastoliske blodtryk, som blev opretholdt over hele dosisintervallet på 24 timer (med vedvarende gavnlig virkning tidligt om morgenen) med en gennemsnitlig peak/trough ratio for diastolisk respons på op til 98 % for 300-mgdosen.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Du må ikke amme, hvis du tager pørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Danish: Aliskiren er en effektiv en gang daglig antihypertensiv behandling til voksne patienter uanset køn,
English: Novartis Europharm Limited Wimblehurst Road Horsham
Danish: Novartis E Wimblehurst Road Horsham
English: Ελλάδα
Danish: Det kan
English: Combination therapy studies are available for Enviage added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Danish: Der er undersøgelser af kombinationsbehandling tilgængelige hvor Enviage er kombineret med diuretikaet hydrochlorthiazid, ACE-hæmmeren ramipril, calciumkanal-blokkeren amlodipin og angiotensinreceptor-antogonisten valsartan og betablokeren atenolol.
English: Coadministration of Enviage had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Danish: Samtidig administration af Enviage havde ingen signifikant indvirkning på atorvastatins, valsartans, metformins eller amlodipins farmakokinetik.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Enviage 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Danish: Hos adipøse patienter med utilstrækkelig respons på HCTZ 25 mg gav tillægsbehandling med Enviage 300 mg en yderligere blodtryksnedsættende effekt, som var sammenlignelig med tillægsbehandling irbesartan 300 mg eller amlodipin 10 mg.
English: Тел.
Danish: organet.
English: Do not take Enviage - if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Enviage.
Danish: - hvis du er overfølsom (allergisk) over for aliskiren eller et af de øvrige indholdsstoffer i Enviage.
English: Enviage monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Danish: Undersøgelser af Enviage-monoterapi har vist en blodtrykssænkende effekt, som er sammenlignelig med andre klasser af antihypertensiva, herunder ACE-hæmmere og angiotension-II-antagonister.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Enviage til dig personligt.
English: In clinical studies in hypertensive patients, Enviage had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Danish: I kliniske studier af hypertensive patienter havde Enviage ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider,
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Enviage 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Danish: Hos patienter, som ikke responderede tilstrækkeligt på 5 mg af calciumantagonisten amlodipin, havde kombinationen med Enviage 150 mg en blodtrykssænkende virkning, som svarede til den opnåede virkning ved at amlodipindosen blev øget til 10 mg, men med en lavere incidens af ødem (aliskiren 150 mg/amlodipin 5 mg 2,1 % kontra amlodipin 10 Enviage i kombination med angiotensinreceptor-antagonisten valsartan viste en add blodtrykssænkende effe mg 11,2 %).
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Danish: Enviage påvirkede ikke serumkoncentrationen af kreatinin men blev forbundet med en øget frekv ngen effekt på QT-intervallet blev rapporteret i et randomiseret, dobbeltblin det, placebo og aktivt kontrolleret studie ved anvendelse af standard og Holter elektrokardiografi.
English: No adjustment of the initial dosage of Enviage is required in patients with mild to severe renal impairment, however caution should be exercised in patients with severe renal impairment.
Danish: Det er ikke nødvendigt at justere initialdosen af Enviage hos patienter med mildt til svært nedsat nyrefunktion, men der skal udvises forsigtighed hos patienter med svært nedsat nyrefunktion.
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Enviage.
Danish: Symptomatisk hypotension kan forekomme hos patienter med markant væske- og/eller natriummang (f.eks. patienter, som får høje doser af diuretika) efter initiering af behandling med Enviage.
English: Enviage is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Enviage er tilgængelig i pakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: The incidence of cough was similar in placebo (0.6%) and Enviage treated (0.9%) patients.
Danish: For patienter, der blev behandlet med placebo (0,6 %) svarede incidensen af hoste til incidensen for patienter, der blev behandlet med Enviage (0,9 %).
English: Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Danish: Novartis Farma - Produt Tel: +351 21 000 8600
English: When administered with atorvastatin, steady-state Enviage AUC and Cmax increased by 50%.
Danish: Ved samtidig administration med atorvastatin steg AUC og Cmax for Enviage ved steady state med 50 %.
English: Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Danish: Derfor er justering af initialdosen af aliskiren ikke nødvendig hos patienter med let til svært nedsat
English: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),
Danish: - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol, mikrokrystallinsk cellulose, povidon, kolloid vandfri silica, talcum, titandioxid (E171), sort
English: As for any medicine that acts directly on the RAS, Enviage should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Danish: Enviage bør, som andre præparater, der virker direkte på RAS, ikke anvendes under 1. trimester i graviditeten (se pkt.
English: Enviage 150 mg film-coated tablets Aliskiren
Danish: Enviage 150 mg filmovertrukne tabletter Aliskiren
English: Enviage 300 mg film-coated tablets Aliskiren
Danish: Enviage 300 mg filmovertrukne tabletter Aliskiren
English: S
Danish: c
English: In diabetic hypertensive patients, Enviage provided additive blood pressure reductions when added to ramipril, while the combination of Enviage and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
Danish: af ombination af Enviage og mipril havde en lavere incidens af hoste (1,8 %) end ramipril (4,7 %).
English: NAME OF THE MEDICINAL PRODUCT Enviage 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Enviage 150 mg filmovertrukne tabletter
English: Novartis Europharm Limited
Danish: uropharm Limited