FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because the safety and benefits of this medicine are not known in this population.
Danish: Det er fordi lægemidlets sikkerhed og virkning hos denne population ikke kendes.
English: The AUC is 50% higher in elderly (> 65 years) than in young subjects.
Danish: AUC er 50 % højere hos ældre (> 65 år) end hos yngre individer.
English: - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).
Danish: - hvis du har alvorlig hjertesvigt (en hjertesygdom, hvor dit hjerte ikke kan pumpe nok blod rundt i din krop).
English: Do not take this medicine if you are pregnant (see section “Do not take Rasilez”).
Danish: Du må ikke tage dette lægemiddel hvis du er gravid (se afsnittet ”Tag ikke Rasilez”).
English: This helps to lower high blood pressure in adult patients.
Danish: Dette hjælper til at sænke forhøjet blodtryk hos voksne patienter.
English: It is unknown whether aliskiren/metabolites are excreted in human milk.
Danish: Det er ukendt, om aliskiren/metabolitter udskilles i human mælk.
English: Via Provinciale Schito 131 80058 Torre Annunziata (NA) Italy
Danish: Via Provinciale Schito 131 80058 Torre Annunziata (NA) Italien
English: It is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Denne medicin frarådes i den tidlige periode af graviditeten, og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje måned af graviditeten.
English: - during the last 6 months of pregnancy or if you are breast-feeding, see section “Pregnancy and breastfeeding”.
Danish: - de sidste 6 måneder af graviditeten eller hvis du ammer, se afsnittet om ”Graviditet og amning”.
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Danish: Middelforskellen mellem aliskiren og placebo i lav- og middeldosisgrupperne var <0,2 mmHg.
English: Date of latest renewal: 22 May 2017
Danish: Dato for første markedsføringstilladelse: 22. august 2007 Dato for seneste fornyelse: 22. maj 2017
English: If you have severe and persistent diarrhoea you should stop taking Rasilez.
Danish: Hvis du har kraftig og vedvarende diarré skal du stoppe med at tage Rasilez.
English: The most common adverse reaction is diarrhoea.
Danish: Den mest almindelige bivirkning er diarré.
English: The treatment with aliskiren was well tolerated in this study.
Danish: Behandlingen med aliskiren var veltolereret i studiet.
English: - if you have impaired kidney function, your doctor will carefully consider whether this medicine is suitable for you and may wish to monitor you carefully.
Danish: - hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om denne medicin er egnet til dig, og kan vælge at følge dig nøje.
English: The blood pressure lowering effect is present within two weeks after beginning treatment.
Danish: Den blodtrykssænkende virkning ses inden for to uger efter behandlingsstart.
English: Table 1 Immune system disorders Rare:
Danish: Tabel 1 Immunsystemet Sjælden:
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant and will advise you to take another medicine instead of this medicine.
Danish: Normalt vil din læge råde dig til at stoppe med at tage denne medicin, inden du bliver gravid og råde dig til at tage anden medicin i stedet.
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with aliskiren.
Danish: På grund af risiko for terapeutisk svigt bør frugtjuice ikke tages sammen med aliskiren.
English: If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage en dosis af denne medicin, skal du tage det så snart, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: You may need to stop Rasilez.
Danish: Det kan være nødvendigt at stoppe behandlingen med Rasilez.
English: If this happens, stop taking this medicine and contact your doctor.
Danish: Hvis det sker, skal du stoppe med at tage denne medicin og kontakte din læge.
English: Your doctor may prescribe this medicine together with other medicines used to treat high blood pressure.
Danish: Din læge kan ordinere denne medicin sammen med anden medicin, der bruges til at behandle forhøjet blodtryk.
English: See also section “Do not take Rasilez”.
Danish: Se også information under punktet ”Tag ikke Rasilez”.
English: Microcrystalline cellulose Povidone, K-30
Danish: Cellulose, mikrokrystallinsk Povidon, K-30
English: The starting dose in each group was assigned depending on weight with three groups: ≥20 to <50 kg, ≥50 to <80 kg, and ≥80 to ≤150 kg.
Danish: Startdosis i hver gruppe blev tildelt i tre grupper ud fra vægt: ≥20 til <50 kg, ≥50 til <80 kg og ≥80 til ≤150 kg.
English: When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez.
Danish: Når man fører motorkøretøj eller betjener maskiner, skal man være opmærksom på, at der lejlighedsvis kan optræde svimmelhed eller døsighed under behandlingen med Rasilez.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Danish: Muligheden for interaktioner med lægemidler ved P-gp's bindingssted vil sandsynligvis afhænge af, i hvor stor udstrækning denne transportør hæmmes.
English: This medicine contains an active substance called aliskiren.
Danish: Denne medicin indeholder et aktivt stof, som kaldes aliskiren.
English: Overall, the mean age of the patients was 11.8 years with 48.6% of patients being in the 6-11 years age group and 51.4% in the 12-17 years age group.
Danish: Samlet set var gennemsnitsalderen af patienterne 11,8 år med 48,6% af patienter i aldersgruppen 611 år og 51,4% i aldersgruppen 12-17 år.
English: If you forget to take Rasilez
Danish: Hvis du har glemt at tage Rasilez
English: Aliskiren 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: Aliskiren er evalueret med henblik på sikkerhed hos mere end 7.800 patient, 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: Do not take Rasilez - if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Rasilez - hvis du er allergisk over for aliskiren eller et af de øvrige indholdsstoffer i Rasilez (angivet i punkt 6).
English: In addition, due to the possibility of up-titration if medically necessary to control the msSBP, no conclusion can be drawn on the appropriate posology of aliskiren in patients aged 6 to 17 years.
Danish: På grund af muligheden for optitrering, hvis det var medicinsk nødvendigt for at kontrollere msSBT, er det desuden ikke muligt at drage nogen konklusion om passende dosering af aliskiren til patienter i alderen 6 til 17 år.
English: The volume or salt depletion should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision.
Danish: Væske- og natriummangel bør korrigeres før administration af Rasilez, eller behandlingen skal indledes under nøje klinisk overvågning.
English: If you have accidentally taken too many tablets of this medicine, consult a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af denne medicin, skal du straks kontakte en læge.
English: As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
Danish: Dosisjustering for Rasilez eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: Medicinal products affecting serum potassium levels
Danish: Lægemidler, som påvirker serumkalium
English: Hyponatraemia *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Danish: Hyponatriæmi *Isolerede tilfælde af leverforstyrrelser med kliniske symptomer og laboratorie-dokumentation for mere markant leverdysfunktion.
English: Colloidal anhydrous silica Hypromellose substitution type 2910 (3 mPa·s) Macrogol 4000
Danish: Hypromellose substitutionstype 2910 (3 mPa-s) Macrogol 4000
English: (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Rasilez.
Danish: (↑19 %) resulterede i en ændring af Cmax eller AUC for Rasilez på mellem 20 % og 30 %.
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine
Danish: Samtidig administration af aliskiren med enten metformin (↓28 %), amlodipin (↑29 %) eller cimetidin
English: Rasilez is contraindicated in children from birth to less than 2 years.
Danish: Rasilez er kontraindiceret til børn fra fødslen og op til 2 år.
English: This medicine must not be used in babies from birth to less than 2 years of age.
Danish: Dette lægemiddel må ikke bruges til behandling af babyer fra fødslen og op til 2 år.
English: If anaphylactic reactions or angioedema occur, treatment should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis anafylaktiske reaktioner eller angioødem opstår, skal behandlingen seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende ophævelse af tegn og symptomer er indtrådt.
English: - Hereditary or idiopathic angioedema.
Danish: - Arvelig eller idiopatisk angioødem.
English: In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability.
Danish: I forsøgsdyr er det blevet vist a P-gp har stor indflydelse på Rasilez' biotilgængelighed.
English: PA/Alu/PVC - Alu blisters:
Danish: PA/Alu/PVC - Alu-blister:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with aliskiren in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med aliskiren i en eller flere undergrupper af den pædiatriske population med hypertension (se pkt.
English: Dizziness Ear and labyrinth disorders Not known:
Danish: Øre og labyrinth Ikke kendt:
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0-tau by 67% in hypertensive patients.
Danish: Ved steady state reducerer måltider med lavt fedtindhold Cmax med 76 % og AUC0-tau med 67 % hos hypertensive patienter.
English: Mean weight was 68.0 kg with 57.7% of patients having BMI greater than or equal to the 95th percentile for age and gender.
Danish: Gennemsnitsvægten var 68,0 kg, hvor 57,7% af patienterne havde et BMI ≥ 95 %-percentilen for alder og køn.
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Danish: Ved afslutningen af forlængelsesstudiet var ændringerne i msSBT fra baseline sammenlignelige for aliskiren og enalapril (-7,63 mmHg mod7,94 mmHg) i det fulde analysesæt.
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Danish: Rifampicin, som er en P-gp-induktor, nedsatte aliskirens biotilgængelighed med omkring 50 % i kliniske studier.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Ydeligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The safety and efficacy of Rasilez in children aged 6 to 17 years have not yet been established.
Danish: Rasilez' sikkerhed og virkning hos børn i alderen 6 til 17 år er endnu ikke klarlagt.
English: In patients treated with both aliskiren and oral furosemide or torasemide, it is therefore recommended that the effects of furosemide or torasemide be monitored when initiating and adjusting furosemide, torasemide or aliskiren therapy to avoid changes in extracellular fluid volume and possible situations of volume overload (see section 4.4).
Danish: Hos patienter, der behandles med både aliskiren og oral furosemid eller torasemid, anbefales det derfor at monitorere virkningen af furosemid eller torasemid ved initiering og justering af furosemid- , torasemid- eller aliskirenbehandling for at undgå ændringer i det ekstracellulære væskevolumen og potentielle situationer med volumen-overload (se pkt.4.4).
English: In addition, an increased incidence of adverse events was observed with aliskiren compared to placebo (38.2% versus 30.3%).
Danish: Desuden blev der observeret en øget forekomst af bivirkninger ved aliskiren sammenlignet med placebo (38,2 % vs.
English: The safety and efficacy of aliskiren in children aged 6 to 17 years have not yet been established.
Danish: Aliskirens sikkerhed og virkning hos børn i alderen 6 - 17 år er endnu ikke klarlagt.
English: However, the efficacy of aliskiren was similar when taken with a light meal or under fasted state.
Danish: Dog var effekten af aliskiren den samme, uanset om det blev taget med et let måltid eller fastende.
English: However, the significance of the non-inferiority testing was not maintained when the analysis was performed on the per-protocol set in which the least square mean change in msSBP from baseline was -7.84 mmHg with aliskiren and -9.04 mmHg with enalapril.
Danish: Signifikansen af non-inferiority-testen blev dog ikke opretholdt, når analysen blev udført på pr. protokol sættet, hvor ændringen i msSBT fra baseline (beregnet ved mindste kvadraters metode) var -7,84 mmHg for aliskiren og -9,04 mmHg for enalapril.
English: What you need to know before you take Rasilez
Danish: Det skal du vide, før du begynder at tage Rasilez
English: Digoxin and verapamil bioavailability may be slightly decreased by Rasilez.
Danish: Biotilgængeligheden af digoxin og verapamil kan blive lettere nedsat af Rasilez.
English: The recommended dose of Rasilez is 150 mg once daily.
Danish: Den anbefalede dosis af Rasilez er 150 mg én gang dagligt.
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Danish: Studier af sikkerhedsfarmakologi med aliskiren afslørede ingen negative virkninger på centralnervesystem, respiration eller kardiovaskulær funktion.
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular re-modelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Danish: I et 36-ugers studie med 820 patienter med iskæmisk venstre ventrikeldysfunktion blev der ikke påvist forandringer i ventrikel-remodellering, vurderet ved det systoliske slutvolumen i venstre ventrikel, med aliskiren sammenlignet med placebo som tillægsbehandling.
English: Pharmacokinetic interaction with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: Farmakokinetiske interaktioner med andre lægemidler Stoffer, som er undersøgt i kliniske farmakokinetiske studier inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: Patients should establish a convenient daily schedule of medicinal product intake and maintain a steady temporal relationship with food intake.
Danish: Patienter bør indføre en passende daglig rutine for medicinindtagelsen og fastholde en rutine i forhold til madindtagelse.
English: The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Danish: Startdosis for aliskiren var henholdvis 37,5/75/150 mg i grupperne med lav, middel og høj vægt.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for bortskaffelse Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped (see section 4.8).
Danish: Ved alvorlig og vedvarende diarré bør behandling med Rasilez stoppes (se pkt.
English: Talk to your doctor before taking Rasilez: - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Rasilez: - hvis du tager et diuretikum (kaldes også vanddrivende tabletter, som øger den mængde urin, du producerer).
English: The other ingredients are crospovidone type A, hypromellose substitution type 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Danish: Øvrige indholdsstoffer: crospovidon type A, hypromellose substitutionstype 2910 (3 mPa s), magnesiumstearat, macrogol 4000, mikrokrystallinsk cellulose, povidon K-30, kolloid vandfri silica, talcum, titandioxid (E171), sort jernoxid (E172), rød jernoxid (E172).
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9-month non-inferiority study in 901 elderly patients (≥ 65 years) with essential systolic hypertension.
Danish: Virkningen og sikkerheden af aliskiren-baseret behandling blev sammenlignet med ramipril-baseret behandling i et 9-måneders non-inferioritetsstudie med 901 ældre patienter (≥ 65 år) med essentiel systolisk hypertension.
English: The starting doses for enalapril were 2.5/5/10 mg in the low, mid and high weight groups, respectively.
Danish: Startdosis af enalapril var henholdsvis 2,5/5/10 mg i grupperne med lav, middel og høj vægt.
English: However, in the subsequent 4 week randomised withdrawal phase of the study (Phase 2), the effect of aliskiren overlapped with the effects observed in patients switched to placebo in all dose groups (low, p=0.8894; mid, p=0.9511; high, p=0.0563).
Danish: I studiets efterfølgende 4-ugers randomiserede seponeringsfase (fase 2) overlappede virkningen af aliskiren imidlertid i alle dosisgrupper med virkningen, som sås hos patienter, der blev skiftet til placebo (lav: p=0,8894; middel: p=0,9511; høj: p=0,0563).
English: Rasilez should be taken once a day, always with or always without food, preferably at the same time each day.
Danish: Rasilez bør tages én gang daglig, altid med eller uden mad, fortrinsvis på samme tidspunkt hver dag.
English: The available clinical data did not indicate that higher doses of torasemide were used after co-administration with aliskiren.
Danish: De kliniske data indikerede ikke, at der blev anvendt højere doser af torasemid ved samtidig behandling med aliskiren.
English: Hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Hypotension Luftveje, thorax og mediastinum Ikke almindelig:
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svært hjertesvigt (New York Heart Association [NYHA] klasse III-IV) (se pkt.
English: If pregnancy is detected during therapy, treatment should be discontinued accordingly.
Danish: Hvis der opstår graviditet under behandlingen, skal behandlingen seponeres som konsekvens heraf.
English: No controlled clinical data are available on the use of aliskiren 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 aliskiren til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Rasilez til patienter med stenose i en enkelt nyre.
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Danish: Dette studie blev forlænget med et 52 ugers dobbeltblindt, randomiseret studie for at evaluere sikkerhed, tolerabilitet og effekt af aliskiren sammenlignet med enalapril hos 208 pædiatriske hypertensive patienter i alderen 6 til 17 år (ved baseline i det foregående studie).
English: Therefore, Rasilez is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years (see sections 4.2 and 4.3).
Danish: Derfor er Rasilez kontraindiceret hos børn fra fødslen og op til 2 år og bør ikke anvendes til børn i alderen fra 2 år og op til 6 år (se pkt.
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6-fold increase in AUC and Cmax, respectively.
Danish: Efter administration af en enkelt dosis i intervallet 75 til 600 mg, resulterede en fordobling i dosis i en ~2,3 og 2,6 fold stigning i respektivt AUC og Cmax.
English: In a pooled analysis of efficacy and safety data from clinical studies up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years).
Danish: I en samlet analyse af data for effekt og sikkerhed fra kliniske studier af op til 12 måneders varighed var der ikke statistisk signifikant forskel mellem aliskiren 300 mg og aliskiren 150 mg i blodtryksreduktionen hos ældre patienter (≥ 65 år).
English: Aliskiren should not be used during breast-feeding.
Danish: Aliskiren bør ikke bruges under amning.
English: It induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Danish: Aliskiren inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid.
English: Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with aliskiren (see section 4.2)
Danish: Derfor bør drikkevarer indeholdende planteekstrakter, inklusive urteteer, ikke indtages sammen med aliskiren (se pkt.
English: Rasilez 150 mg film-coated tablets PA/Alu/PVC - Alu blisters:
Danish: Rasilez 150 mg filmovertrukne tabletter PA/Alu/PVC - Alu-blister:
English: After multiple doses of furosemide (60 mg/day) co-administered with aliskiren (300 mg/day) to patients with heart failure the urinary sodium excretion and the urine volume were reduced during the first 4 hours by 31% and 24%, respectively, as compared to furosemide alone.
Danish: Efter gentagne furosemiddoser (60 mg/dag), administreret samtidig med aliskiren (300 mg/dag) til patienter med hjertesvigt, var udskillelsen af natrium i urinen og urinvoluminet reduceret med henholdsvis 31 % og 24 % i løbet af de første 4 timer, sammenlignet med furosemid alene.
English: There was a greater LS mean increase from Baseline in height after 104 weeks (at LT Visit 19 [Week 156], secondary hypertension patients) compared to the increase observed after 52 weeks (at LT Visit 18 [Week 104], primary hypertension patients), which is expected in these growing paediatric patients.
Danish: Der var en større stigning i mindste kvadraters gennemsnit for højde efter 104 uger i forhold til baseline (ved langsigtet opfølgningsbesøg 19 [uge 156], patienter med sekundær hypertension) sammenlignet med stigningen observeret efter 52 uger (ved langsigtet opfølgningsbesøg 18 [uge 104], patienter med primær hypertension), hvilket forventes hos disse voksende pædiatriske patienter.