FrancophonIA/ELRC3.0 huggingface dataset:
English: No controlled clinical data are available on the use of Rasitrio 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 Rasitrio til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Rasitrio til patienter med stenose i en enkelt nyre.
English: Torasemide renal excretion is known to be mediated by organic anion transporters (OATs).
Danish: Den renale udskillelse af torasemid vides at være medieret af organisk anion-transportere (OAT).
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Danish: Derfor forventes ingen interaktioner på grund af hæmning eller induktion af CYP-isoenzymer.
English: - medicines to increase blood pressure, such as noradrenaline or adrenaline.
Danish: medicin, som bruges til at øge blodtrykket, som fx noradrenalin og adrenalin.
English: The blood-pressure-lowering effect in patients with moderate to severe hypertension was independent of age, gender, race, body mass index and overweight-associated disorders (metabolic syndrome and diabetes).
Danish: Den blodtrykssænkende effekt hos patienter med moderat til svær hypertension var uafhængig af alder, køn, race, body mass index og sygdomme forbundet med overvægt (metabolisk syndrom og diabetes).
English: Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.
Danish: Der skal derfor udvises forsigtighed, når aliskiren ordineres til patienter med angioødem i anamnesen, og disse patienter skal følges tæt under behandlingen, især i begyndelsen af behandlingen (se pkt.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Danish: Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen med ketoconazol, verapamil eller andre moderate P-gp-hæmmere (clarithromycin, telithromycin, erythromycin, amiodaron).
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Danish: Thiaziders virkningsmåde er gennem hæmning af Na+Cl- symporteren ved at konkurrere om Cl-bindingsstedet, hvorved elektrolytreabsorptionsmekanismerne påvirkes: ved direkte at øge natrium- og kloridudskillelse i omtrent lige omfang og indirekte ved, at denne diuretiske virkning reducerer plasmavolumen med efterfølgende stigninger i plasmareninaktivitet, aldosteronudskillelse og urinkaliumtab samt en reduktion i serumkalium.
English: Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide.
Danish: Rasitrio indeholder tre aktive stoffer, der hedder aliskiren, amlodipin og hydrochlorthiazid.
English: Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Danish: Administration af thiaziddiuretika samtidig med andre midler, som også har en blodtrykssænkende virkning (fx ved at reducere aktiviteten i det sympatiske centralnervesystem eller ved direkte vasodilatation) kan forstærke ortostatisk hypotension.
English: These doses of hydrochlorothiazide in mice and rats represent 19 and 1.5 times, respectively, the maximum recommended human dose on a mg/m basis.
Danish: Disse doser hydrochlorthiazid til mus og rotter repræsenterer henholdsvis 19 og 1,5 gange den maksimale dosis, der anbefales til mennesker baseret på mg/m2.
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling 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 dysfunktion af venstre ventrikel blev der ikke påvist ændringer i remodellering vurderet ved venstresidig systolisk ventrikulær slutvolumen for aliskiren sammenlignet med placebo, givet som tillæg til normalbehandling.
English: - Medicinal products used in the treatment of gout Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: - Lægemidler, der anvendes til behandling af arthritis urica Dosisjustering af urikosuriske lægemidler kan være nødvendig, da hydrochlorthiazid kan øge serumurinsyre.
English: • bruising and frequent infections (aplastic anaemia)
Danish: • blå mærker og hyppige infektioner (aplastisk anæmi)
English: These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Danish: Dette omfatter kaliumtilskud eller salterstatninger, der indeholder kalium, samt kaliumbesparende medicin og heparin.
English: Rasitrio is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Danish: Rasitrio er kontraindiceret til patienter med hyperkalcæmi og bør kun anvendes efter korrektion af præeksisterende hyperkalcæmi.
English: Rasitrio is available in packs containing 30 or 90 tablets in blisters.
Danish: Rasitrio er tilgængelig i pakninger, der indeholder 30 eller 90 tabletter i blister.
English: Rasitrio was associated with a significant reduction in plasma renin activity (PRA) (-34%) from baseline while the dual combination of amlodipine with hydrochlorothiazide increased PRA (+170%).
Danish: Rasitrio medførte en signifikant reduktion af plasmareninaktiviteten (PRA) (-34 %) i forhold til baseline, mens kombinationen af amlodipin og hydrochlorthiazid forhøjede PRA (+170 %).
English: Patients receiving aliskiren, amlodipine and hydrochlorothiazide from separate tablets given concurrently at the same time of the day may be switched to a fixed combination tablet of Rasitrio containing the same component doses.
Danish: Patienter, der får aliskiren, amlodipin og hydrochlorthiazid som separate tabletter, der gives sideløbende på samme tid på dagen, kan skiftes over til en kombinationstablet af Rasitrio, der indeholder de samme komponentdoser.
English: Side effects reported for Rasitrio are:
Danish: Bivirkninger indberettet med Rasitrio:
English: Do not take Rasitrio - if you are allergic to aliskiren, to amlodipine, to other dihydropyridine-derived medicines (known as calcium channel blockers), to hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Rasitrio - hvis du er allergisk over for aliskiren, over for amlodipin eller over for anden medicin med dihydropyridinderivater (kendt som calciumantagonister), over for hydrochlorthiazid, sulfonamidafledt medicin (medicin, der anvendes til at behandle bryst- eller urinvejsinfektioner) eller over for et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: • bleeding, tender or enlarged gums
Danish: • blødende, ømme eller hævede gummer
English: As a result no dose adjustment for aliskiren or these co-administered medicinal products is necessary.
Danish: Dosisjustering af aliskiren eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: • Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high doses of diuretics) or
Danish: • Patienter med markant væskemangel eller patienter med natriummangel (fx patienter, der får høje doser diuretika) eller
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.
Danish: Akut nyresvigt, som var reversibel ved seponering af behandlingen, er efter markedsføring rapporteret hos risikopatienter, som fik aliskiren.
English: Renal clearance of lithium is reduced by thiazides, therefore the risk of lithium toxicity may be increased with hydrochlorothiazide.
Danish: Lithiums nyreclearance nedsættes af thiazider; derfor kan risikoen for lithiumtoksicitet øges med hydrochlorthiazid.
English: With aliskiren, the most likely manifestation of overdose would be hypotension, related to the antihypertensive effect of aliskiren.
Danish: For aliskiren vil den mest sandsynlige manifestation af overdosering være hypotension relateret dets antihypertensive virkning.
English: Symptomatic hypotension could occur after initiation of treatment with Rasitrio in the following cases:
Danish: Symptomatisk hypotension kan forekomme hos patienter i behandling med Rasitrio i følgende tilfælde:
English: - Warfarin The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Danish: - Warfarin Effekten af aliskiren på warfarins farmakokinetik er ikke blevet evalueret.
English: Rasitrio was studied in a double-blind, randomised, active-controlled study in 1,181 patients of which 773 were classified as moderately hypertensive (msSBP 160-180 mmHg) and 408 as severely hypertensive (msSBP >180 mmHg) at baseline.
Danish: Rasitrio er blevet undersøgt i et dobbeltblindet, randomiseret, aktivt kontrolleret studie hos 1.181 patienter, hvoraf 773 var klassificeret som moderat hypertensive (msSBP 160-180 mmHg) og 408 som svært hypertensive (msSBP > 180 mmHg) ved baseline.
English: - cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood).
Danish: colestyramin og colestipol eller andre ionbytterresiner (medicin, der primært bruges til behandling af forhøjet fedtniveau i blodet).
English: Peripheral oedema is a known, dose-dependent adverse reaction of amlodipine and has also been reported with aliskiren therapy in post-marketing experience.
Danish: Perifert ødem er en kendt, dosisafhængig bivirkning ved amlodipin, og er også indberettet ved behandling med aliskiren efter markedsføring.
English: Effects of amlodipine on other medicinal products - The blood pressure lowering effects of amlodipine add to the blood pressure lowering effects of other antihypertensive medicinal products.
Danish: Amlodipins virkning på andre lægemidler - Amlodipins blodtrykssænkende virkning øger den blodtrykssænkende virkning af andre antihypertensive lægemidler.
English: - medicines for the treatment of diabetes (oral agents such as metformin or insulins).
Danish: medicin til behandling af sukkersyge (diabetes mellitus) (oral medicin såsom metformin, eller insulin).
English: The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule.
Danish: Thiaziddiuretikas virkningspunkt er primært i nyrens tubulus contortus distalis.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Danish: Respiratorisk distress (herunder pneumonitis og lungeødem)
English: Treatment with Rasitrio was well tolerated at doses up to 300 mg/10 mg/25 mg with an overall incidence of adverse events similar to the corresponding dual combinations, except for symptomatic hypotension.
Danish: Behandling med Rasitrio tolereredes godt ved doser op til 300 mg/10 mg/25 mg med en samlet forekomst af bivirkninger svarende til forekomsten ved behandling med kombinationerne af to præparater, bortset fra symptomatisk hypotension.
English: Grapefruit juice should not be taken together with Rasitrio (see section 4.5).
Danish: Grapefrugtjuice må ikke tages sammen med Rasitrio (se pkt.
English: Information on Rasitrio
Danish: Information om Rasitrio
English: Haemoglobin decreased, haematocrit decreased, blood creatinine increased *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Danish: Fald i hæmoglobinværdi, fald i hæmatokritværdi, forhøjet blodkreatinin *Isolerede tilfælde af leverforstyrrelser med kliniske symptomer og laboratorie-dokumentation for mere markant leverdysfunktion.
English: - cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
Danish: cytotoksisk medicin (anvendes til behandling af kræft), som fx methotrexat og cyclophosphamid.
English: Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% vs. 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Danish: Blandt de sekundære endepunkter var incidensen af hjertesvigt (del af et sammensat kombineret kardiovaskulært endepunkt) signifikant højere for amlodipin-gruppen sammenlignet med chlorthalidon-gruppen (10,2 % vs 7,7 %, RR 1,38, 95 % KI [1,25-1,52] p<0,001).
English: General In the event of severe and persistent diarrhoea, Rasitrio therapy should be stopped (see section 4.8).
Danish: Generelt I tilfælde af alvorlig og vedvarende diarré bør Rasitrio seponeres (se pkt.
English: As for any medicinal product that acts directly on the renin-angiotensin-aldosterone system, aliskiren should not be used during the first trimester of pregnancy and is contraindicated during the second and third trimesters (see section 4.3).
Danish: Aliskiren bør, som andre lægemidler, der virker direkte på renin-angiotensin-aldosteron-systemet, ikke anvendes under 1. trimester i graviditeten og er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt.
English: Haemodynamically unstable heart failure after acute myocardial infarction.
Danish: Hæmodynamisk ustabil hjertesvigt efter akut myokardie infarkt.
English: Metabolism and nutrition disorders Very rare
Danish: Metabolisme og ernæring Meget sjælden:
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 de første 4 timer, sammenlignet med furosemid alene.
English: Medicinal products affecting serum potassium levels: The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of aliskiren.
Danish: Lægemidler, som påvirker serumkalium: Hydrochlorthiazids kaliumudtømmende virkning dæmpes ved aliskirens kaliumbesparende virkning.
English: However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Danish: Hos patienter, som fik aliskiren var der dog en signifikant højere hyppighed af hyperkaliæmi, hypotension og nyreproblemer sammenlignet med gruppen, der fik placebo.
English: Vomiting, dyspepsia, altered bowel habits (including diarrhoea and
Danish: Opkastning, dyspepsi, ændrede afføringsvaner (inklusive diarré og
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Danish: I prækliniske studier er det vist, at MDR1/Mdr1a/1b (P-gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og biliære udskillelse.
English: Amlodipine elimination from plasma is biphasic with a terminal elimination half-life of approximately 30 to 50 hours.
Danish: Amlodipin udskilles bifasisk fra plasma med en terminal halveringstid på ca. 30 til 50 timer.
English: BLISTERS (PVC/PCTFE OR PA/Alu/PVC)
Danish: BLISTER (PVC/PCTFE ELLER PA/Alu/PVC)
English: However, as with other medicinal products acting on the renin-angiotensin-aldosterone system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Danish: Der er dog ligesom for andre lægemidler, der virker på renin-angiotensin-aldosteron-systemet, en øget risiko for nyreinsufficiens, inklusive akut nyresvigt, når patienter med nyrearteriestenose behandles med aliskiren.
English: NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Danish: NSAID kan også svække hydrochlorthiazids diuretiske og antihypertensive effekt.
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (<2% of oral clearance).
Danish: I et studie udført hos hæmodialyse-patienter med nyresygdom i slutstadie (end stage renal disease, ESRD) var clearencedialyse af aliskiren lav (< 2 % oral clearence).
English: The use of Rasitrio in patients aged 75 years or older should be restricted to patients for whom blood pressure control has been established for the free combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently without accompanying safety concerns, in particular hypotension.
Danish: Brugen af Rasitrio til patienter på 75 år eller ældre skal begrænses til de patienter, hvis blodtrykskontrol er fastlagt for den frie kombination af aliskiren, amlodipin og hydrochlorthiazid givet samtidigt uden tilhørende sikkerhedsproblemer, specielt hypotension.
English: • severe allergic reaction (anaphylactic reaction)
Danish: • alvorlige allergiske reaktioner (anafylaktisk reaktion)
English: Untreated acute angle-closure glaucoma can lead to permanent vision loss.
Danish: Ubehandlet lukketvinklet glaukom kan føre til permanent synstab.
English: - Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of aliskiren.
Danish: - Administration af aliskiren sammen med enten metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i ændring af Cmax eller AUC for aliskiren på mellem 20 % og 30 %.
English: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilatation resulting in a reduction of supine and standing blood pressures.
Danish: Efter administration af terapeutiske doser til patienter med hypertension giver amlodipin en vasodilation, som resulterer i nedsat blodtryk i liggende og stående stilling.
English: Aliskiren/amlodipine/hydrochlorothiazide combination Following oral administration of a fixed combination tablet of aliskiren, amlodipine and hydrochlorothiazide, peak concentrations were achieved for aliskiren within 1-2 hours, for amlodipine within 8 hours and for hydrochlorothiazide within 2-3 hours.
Danish: Aliskiren/amlodipin/hydrochlorthiazid-kombination Efter oral indgivelse af en kombinationstablet med aliskiren, amlodipin og hydrochlorthiazid opnåedes maksimale koncentrationer for aliskiren inden for 1-2 timer, for amlodipin inden for 8 timer og for hydrochlorthiazid inden for 2-3 timer.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
Danish: Hos hypertensive patienter med normal nyrefunktion resulterede terapeutiske doser af amlodipin i en nedat renal vaskulær modstand med øget glomerulær filtrationshastighed og effektivt renal plasma flow, uden ændring i filtrationsfraktionen eller proteinuri.
English: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1,500 mg/kg/day were not statistically significant.
Danish: Der er registreret et tilfælde af adenom i kolon og et tilfælde af adenocarcinom i coecum hos rotter ved dosen 1500 mg/kg/dag, hvilket ikke var statistisk signifikant.
English: Rasitrio is available in packs containing 14, 28, 56, 98 tablets in calendar blisters.
Danish: Rasitrio er tilgængelig i pakninger, der indeholder 14, 28, 56, 98 tabletter i kalenderpakninger.
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Danish: Samtidig brug af aliskiren med ciclosporin eller itraconazol, to yderst potente P-glykoprotein(P-gp)-hæmmere, eller andre potente P-gp-hæmmere (fx. quinidin), er kontraindiceret (se pkt.
English: Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Danish: Derfor kan kan P-gpinduktorer muligvis øge vævskoncentrationen mere end plasmakoncentrationen.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl det til din læge, hvis du ammer, eller hvis du skal starte med at amme.
English: When Rasitrio is used in patients with renal impairment, periodic monitoring of serum electrolytes including potassium, creatinine and uric acid serum levels is recommended.
Danish: Når Rasitrio anvendes hos patienter med nedsat nyrefunktion, anbefales regelmæssig monitorering af serum-elektrolytter herunder kalium, samt serum-kreatinin og serum-urinsyre.
English: The amlodipine component of Rasitrio inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Rasitrio hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients (aged 6-17 years) given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
Danish: I et farmakokinetisk studie af aliskirenbehandling hos 39 pædiatriske patienter (i alderen 6-17 år), som fik en daglig dosis aliskiren på 2 mg/kg eller 6 mg/kg, administreret som granulat (3,125 mg/tablet), svarede de farmakokinetiske parametre til dem, der er set hos voksne.
English: Rasitrio is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Danish: Rasitrio tages en gang dagligt og er et effektivt antihypertensivt middel til behandling af voksne patienter uanset køn, alder, body mass indeks og etnicitet.
English: • mood changes (including anxiety)
Danish: • humørsvingninger (inklusive angst)
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, corticosteroids, laxatives, adrenocoricotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives).
Danish: Denne virkning af hydrochlorthiazid på serumkalium ville imidlertid forventes at blive gjort mere virkningsfuld af andre lægemidler forbundet med kaliumtab og hypokaliæmi (fx andre kaliuretiske diuretika, kortikosteroider, afføringsmidler, adrenokortikotropt hormon (ACTH), amphotericin, carbenoxolon, benzylpenicillin (G-penicillin), salicylsyrederivater).
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Danish: Hydrochlorthiazid øger mængden af urin, hvilket også hjælper med at sænke blodtrykket.
English: Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium is recommended when Rasitrio is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Danish: Lægemidler, der påvirkes af serumkaliumforstyrrelser: Regelmæssig overvågning af serumkalium anbefales, når Rasitrio administreres sammen med lægemidler, der påvirkes af serumkaliumforstyrrelser (fx digitalisglykosider, antiarytmika).