FrancophonIA/ELRC3.0 huggingface dataset:
English: If photosensitivity reaction occurs during treatment with Rasitrio, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Rasitrio, anbefales det at seponere behandlingen.
English: When combined, the consolidated effects of inhibition of the reninangiotensin-aldosterone system, calcium channel-mediated vasodilatation and sodium chloride excretion result in a reduction of blood pressure to a greater degree than the corresponding dual combinations.
Danish: Når de kombineres, resulterer den samlede virkning af hæmning af renin-angiontensin-aldosteronsystem, calciumkanal medieret vasodilation og natriumchlorid udskillelse i en blodtryksnedsættelse, som er større end den tilsvarende kombinationsbehandling af to præparater.
English: Food had no effect on the pharmacokinetics of amlodipine or hydrochlorothiazide in the fixed combination tablet.
Danish: Mad havde ingen effekt på farmakokinetikken af amlodipin eller hydrochlorthiazid i kombinationstabletten.
English: In diabetic patients dose adjustments of insulin or oral hypoglycaemic medicinal products may be required during Rasitrio therapy.
Danish: Hos diabetespatienter kan dosisjustering af insulin og orale antidiabetika være påkrævet under behandling med Rasitrio.
English: A population pharmacokinetic analysis in patients with hypertension did not indicate any clinically relevant changes in the steady-state exposure (AUC) and Cmax of aliskiren, amlodipine and hydrochlorothiazide compared to the corresponding dual therapies.
Danish: En farmakokinetisk analyse af en patientpopulation med hypertension tydede ikke på klinisk relevante ændringer i steady state-eksponeringen (AUC) og Cmax for aliskiren, amlodipin og hydrochlorthiazid sammenlignet med de tilsvarende behandlinger med to præparater.
English: Risk factors for developing acute angle-closure glaucoma may include a history of sulphonamide or penicillin allergy.
Danish: Risikofaktorer for at udvikle akut lukketvinklet glaukom kan inkludere sulfonamid- eller penicillinallergi i anamnesen.
English: What you need to know before you take Rasitrio
Danish: Det skal du vide, før du begynder at tage Rasitrio
English: The safety and efficacy of Rasitrio in children and adolescents below age 18 have not been established.
Danish: Rasitrios sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder).
Danish: • Kvalme, manglende appetit, mørk-farvet urin eller gulfarvning af hud og øjne (tegn på leversygdom).
English: Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Danish: Hydrochlorthiazid udskilles hovedsageligt uomdannet.
English: The results from a food effect study using a standard high-fat meal with the 300/10/25 mg fixed combination tablet showed that food reduced the rate and extent of absorption of aliskiren in the fixed combination tablet with a similar magnitude of effect as for aliskiren monotherapy.
Danish: Resultaterne af et fødevareeffektstudie med anvendelse af et standardmåltid med højt fedtindhold sammen med kombinationstabletten på 300/10/25 mg viste, at maden for aliskirens vedkommende medførte en reduktion af absorptionshastighed og -grad af samme størrelsesorden som ved monoterapi med dette stof.
English: • increased sensitivity of skin to the sun
Danish: • øget følsomhed i huden over for solen
English: Thiazide-induced hypokalaemia or hypomagnesaemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4).
Danish: Thiazid-induceret hypokaliæmi eller hypomagnesiæmi fremmer start af digitalis-inducerede hjertearytmier (se pkt.
English: Severe renal impairment (GFR <30 ml/min/1.73 m Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
Danish: Stærkt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m Hyponatriæmi, hyperkalcæmi, symptomatisk hyperurikæmi og refraktorisk hypokaliæmi.
English: BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)
Danish: BLISTER (KALENDERPAKNING) (PVC/PCTFE ELLER PA/Alu/PVC)
English: 4.4 and 5.1).
Danish: 4.3 og 5.2).
English: Due to the hydrochlorothiazide component, Rasitrio is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Danish: På grund af indholdet af hydrochlorthiazid er Rasitrio kontraindiceret ved symptomatisk hyperurikæmi (se pkt.
English: The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Danish: Risikoen for hypokaliæmi er størst hos patienter med levercirrhose, hos patienter, der oplever kraftig diurese, hos patienter, der har mangelfuld oral indtagelse af elektrolytter, og hos patienter, der samtidigt modtager behandling med kortikosteroider eller adrenocorticotropt hormon (ACTH) (se pkt.
English: - Furosemide and torasemide
Danish: - Furosemid og torasemid
English: Aliskiren induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Danish: Aliskiren inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid.
English: - Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Danish: - Antikolinerge lægemidler og andre lægemidler, som påvirker den gastrointestinale motilitet Antikolinerge midler (fx atropin, biperiden) kan øge biotilgængeligheden af diuretika af thiazidtypen, tilsyneladende ved at reducere den gastrointestinale motilitet og mavetømningshastigheden.
English: Very limited efficacy and safety data are available on the use of Rasitrio in patients aged 75 years or older.
Danish: Der er meget begrænset effekt- og sikkerhedsdata tilgængeligt for brug af Rasitrio til patienter på 75 år eller ældre.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated when using amlodipine in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved andre vasodilatorer skal der udvises særlig forsigtighed, når amlodipin anvendes til patienter, der lider af aorta- eller mitralklapstenose eller hypertrofisk obstruktiv kardiomyopati.
English: The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Danish: Patienterne havde mindst én ekstra risikofaktor for koronar hjertelidelse, inklusive: tidligere myokardie infarkt eller slagtilfælde (> 6 måneder før inkludering) eller dokumenteret anden aterosklerotisk kardiovaskulær sygdom (tilsammen 51,5 %), type 2 diabetes (36,1 %), høj-densitet-lipoprotein - kolesterol < 35 mg/dl eller < 0,906 mmol/l (11,6 %), venstresidig ventrikulær hypertrofi diagnosticeret ved elektrokardiogram eller ekkokardiografi (20,9 %), aktiv rygning (21,9 %).
English: - Medicinal products affecting serum sodium level The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Danish: Den hyponatriæmiske virkning af diuretika kan forstærkes ved samtidig administration af lægemidler som antidepressiva, antipsykotika, antiepileptika osv.
English: Rasitrio is available in packs containing 56x1 tablet in perforated unit dose blister.
Danish: Rasitrio er tilgængelig i pakninger, der indeholder 56x1 tabletter i perforerede enkeltdosisblisterpakninger.
English: - medicines that may increase blood sugar level, such as beta blockers and diazoxide.
Danish: medicin, som kan øge blodsukkeret, som fx betablokkere og diazoxid.
English: As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume.
Danish: Som med andre calciumantagonister har hæmodynamiske undersøgelser af hjertefunktionen i hvile og ved fysisk aktivitet (eller vedvarende aktivitet) hos patienter med normal ventrikelfunktion og i behandling med amlodipin, generelt vist en lille forøgelse i hjerteindekset uden signifikant indflydelse på dP/dt eller venstre ventrikels slutdiastoliske tryk eller volumen.
English: Hypercalcaemia, hyperglycaemia, worsening of diabetic metabolic
Danish: Hyperkalcæmi, hyperglykæmi, forværring af den metaboliske tilstand ved diabetes
English: As with other medicinal products acting on the renin-angiotensinaldosterone system (RAAS), angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Danish: Som ved andre lægemidler, der virker på renin-angiotensin-aldosteron-systemet, er angioødem eller symptomer, som tyder på angioødem (hævet ansigt, læber, svælg og/eller tunge), blevet rapporteret hos patienter, som behandles med aliskiren.
English: No data on cardiovascular mortality and morbidity are available for Rasitrio in patients with heart failure (see section 5.1).
Danish: Der er ingen tilgængelige data med hensyn til mortalitet og morbiditet for Rasitrio til patienter med hjertesvigt ( se pkt.
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Danish: Metformin skal anvendes med forsigtighed pga. risikoen for laktatacidose fremkaldt af muligt funktionelt nyresvigt forårsaget af hydrochlorthiazid.
English: - Beta blockers and diazoxide
Danish: - Betablokkere og diazoxid
English: The fertility of rats was unaffected at doses of up to aliskiren 250 mg/kg/day and hydrochlorothiazide 4 mg/kg/day (see section 5.3).
Danish: Rotters fertilitet var upåvirket ved doser op til 250 mg/kg/dag aliskiren og 4 mg/kg/dag hydrochlorthiazid (se pkt.
English: - diltiazem, a medicine used to treat heart problems.
Danish: diltiazem, medicin, som bruges til behandling af hjerteproblemer.
English: - alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures).
Danish: alkohol, sovemedicin og narkosemedicin (medicin, der bruges ved operationer og andre procedurer).
English: Asthenia, pyrexia
Danish: Asteni, pyreksi
English: In particular there was an increased incidence of renal dysfunction (14.0% versus 12.1%), hyperkalaemia (38.9% versus 28.8%), hypotension-related events (19.7% versus 16.2%) and adjudicated stroke endpoints (3.4% versus 2.6%).
Danish: Der var især en øget forekomst af nedsat nyrefunktion (14,0 % vs. 12,1 %), hyperkaliæmi (38,9 % vs. 28,8 %), hypotension-relaterede tilfælde (19,7 % vs. 16,2 %) og bekræftede apopleksiendepunkter (3,4 % vs. 2,6 %).
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidonebased therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Danish: Der var dog ingen signifikant forskel på mortalitet af alle årsager mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling, RR 0,96 95 % KI [0,89-1,02] p=0,20.
English: Impotence General disorders and administration site conditions Not known
Danish: Impotens Almene symptomer og reaktioner på administrationsstedet Ikke kendt:
English: - P-gp substrates or weak inhibitors
Danish: - P-gp-substrater og svage P-gp-hæmmere
English: Co-administration with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and coadministration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Danish: Indtagelse sammen med 150 mg aliskiren resulterede i en reduktion i AUC for aliskiren på 61 %, og indtagelse sammen med 300 mg aliskiren resulterede i en reduktion i AUC for aliskiren på 38 %.
English: Reproductive studies in rats have shown no toxicity except for delayed date of delivery and prolonged duration of labour at dosages 50 times greater than the maximum recommended dosage for humans (see section 5.3).
Danish: Reproduktionsstudier i rotter har ikke vist toksicitet bortset fra udsat fødselstidspunkt og forlænget varighed af fødsel ved doser 50 gange større end den maksimale anbefalede dosis til human brug (se pkt.
English: • liver disorders which can occur together with yellow skin and eyes
Danish: • leversygdomme, der kan optræde sammen med gulfarvning af hud og øjne
English: Aliskiren monotherapy studies have shown blood-pressure-lowering effects comparable to other classes of antihypertensive medicinal products including selected ACEI and ARB.
Danish: Undersøgelser af aliskiren-monoterapi har vist en blodtrykssænkende effekt, som er sammenlignelig med andre klasser af antihypertensive lægemidler, herunder ACE-hæmmere og angiotension-IIantagonister.
English: The most frequent adverse reactions observed with Rasitrio are hypotension and dizziness.
Danish: Den hyppigste bivirkning set med Rasitrio er hypotension og svimmelhed.
English: • severely decreased urine output (possible signs of renal disorder or renal failure), weakness
Danish: • stærkt nedsat urinmængde (kan være tegn på nyresygdom eller nyresvigt), svaghed (asteni)
English: Treatment with Rasitrio should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Danish: Behandling med Rasitrio bør kun påbegyndes efter korrektion af hypokaliæmi og eventuel samtidigt forekommende hypomagnesiæmi.
English: • decreased skin sensitivity
Danish: • nedsat følsomhed i huden
English: In an 8-week study in 754 hypertensive geriatric patients aged 65 years or older and geriatric patients aged 75 years or older (30%) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Danish: I et 8-ugers studie med 754 hypertensive geriatriske patienter på 65 år eller ældre og geriatriske patienter på 75 år eller ældre (30 %) gav aliskiren i doser på 75 mg, 150 mg og 300 mg statistisk signifikant større blodtryksreduktioner (både systolisk og diastolisk) sammenlignet med placebo.
English: Rasitrio is contraindicated during the second and third trimesters (see section 4.3).
Danish: Rasitrio er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt.
English: The concomitant use of CYP3A4 inducers (e.g. rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine.
Danish: Samtidig administration af CYP3A4-induktorer (fx rifampicin, perikon) kan medføre lavere plasmakoncentration af amlodipin.
English: If pregnancy is detected during therapy, Rasitrio should be discontinued accordingly as soon as possible.
Danish: Hvis der opstår graviditet under behandlingen, skal Rasitrio således seponeres omgående.
English: In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Danish: Hos de fleste patienter på 65 år og derover giver en dosis på 300 mg aliskiren ikke yderligere blodtryksnedsættelse sammenlignet med en dosis på 150 mg.
English: Thiazides reduce urinary calcium excretion and may cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Danish: Thiazider nedsætter calciumudskillelsen i urinen og kan forårsage en intermitterende og let stigning i serumcalcium uden tilstedeværelse af kendt forstyrrelse i calciummetabolismen.
English: Aliskiren is a substance that belongs to a group of medicines called renin inhibitors.
Danish: Aliskiren tilhører en klasse af medicin, kaldet reninhæmmere.
English: Tremor, dysgeusia, syncope, hypoesthesia, paraesthesia
Danish: Tremor, smagsforstyrrelser, synkope, hypoæstesi, paræstesi
English: In clinical studies in hypertensive patients, aliskiren 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 aliskiren ingen klinisk signifikant virkning på total kolesterol, HDLkolesterol, fastende triglycerider, fastende glukose eller urinsyre.
English: In patients with mild to moderate renal impairment, a 3-fold increase in hydrochlorothiazide AUC has been observed.
Danish: Hos patienter med let til moderat nedsat nyrefunktion er en 3 gange større AUCværdi for hydrochlorthiazid observeret.
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by grapefruit juice in the gastrointestinal tract.
Danish: Det er sandsynligt, at denne reduktion skyldes hæmning af organisk anion-transport-polypeptidmedieret optagelse af aliskiren, forårsaget af grapefrugtjuice i mave-tarm-kanalen.
English: No data is available 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/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Der foreligger ingen data om hypertensive patienter med stærkt 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 en skønnet glomerulær filtrationsrate (GFR) < 30 ml/min/1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
English: A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Danish: Et interaktionsstudie med raske personer, hvor dosis blev administreret en gang, viste, at ciclosporin (200 og 600 mg) øger Cmax af 75 mg aliskiren cirka 2,5 gange og AUC cirka 5 gange.
English: The toxicity profiles of the combination of aliskiren/hydrochlorothiazide and aliskiren/amlodipine have been well characterised in preclinical studies.
Danish: Toksicitetsprofilerne for aliskiren/hydrochlorthiazid-kombinationen og aliskiren/amlodipinkombinationen er veldokumenterede i prækliniske undersøgelser.
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing, or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Danish: Ved tegn tydende på en overfølsomhedsreaktion/angioødem (specielt besvær med vejrtrækning eller synkning, udslæt, kløe, urticaria eller hævelse i ansigt, ekstremiteter, øjne, læber og/eller tunge, svimmelhed) skal patienten afbryde behandlingen og kontakte lægen (se pkt.
English: Information on Rasitrio interactions
Danish: Information om interaktioner med Rasitrio
English: Anaphylactic reactions, hypersensitivity reactions
Danish: Anafylaktisk reaktion, overfølsomhedsreaktioner
English: Ear and labyrinth disorders Uncommon
Danish: Øre og labyrint Ikke almindelig:
English: • abnormal liver function test
Danish: • unormale resultater i leverfunktionstest
English: • liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine
Danish: • lidelser i leveren, som kan opstå sammen med gulfarvning af hud og øjne eller mørk farvet urin
English: - atorvastatin, a medicine used to treat high cholesterol.
Danish: atorvastatin, medicin, der bruges til behandling af forhøjet kolesterol.
English: Rare (may affect up to 1 in 1,000 people) • confusion.
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) • forvirring
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicinal products known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
Danish: Et antal af disse patienter havde en anamnese med angioødem eller symptomer, der tydede på angioødem, som i nogle tilfælde havde efterfulgt brug af anden medicin, der er kendt for at forårsage angioødem, inklusive RAAS-blokkere (ACE-hæmmere eller ARB'er).
English: Due to hydrochlorothiazide contained in Rasitrio, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Danish: Hvis du drikker alkohol, mens du behandles med dette lægemiddel, kan du på grund af hydrochlorthiazid-indholdet i Rasitrio opleve øget svimmelhed, når du rejser dig fra siddende stilling.
English: • breast enlargement in men
Danish: • forstørrede bryster hos mænd
English: Very limited safety data are available for patients aged >75 years or patients with major cardiovascular co-morbidities.
Danish: De tilgængelige sikkerhedsdata for patienter > 75 år eller patienter med større kardiovaskulære komorbiditeter er meget begrænsede.
English: There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95% CI (0.90-1.07) p=0.65.
Danish: Der var ingen signifikant forskel mellem amlodipin-baseret behandling og chlorthalidonbaseret behandling på det primære endepunkt: Risikoratio (RR) 0,98 95 % KI (0,90-1,07) p=0,65.
English: Aliskiren/amlodipine/hydrochlorothiazide combination In hypertensive patients, once-daily administration of Rasitrio provided clinically meaningful reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval.
Danish: Aliskiren/amlodipin/hydrochlorthiazid-kombination Hos hypertensive patienter gav Rasitrio én gang dagligt klinisk betydningsfulde reduktioner af både systolisk og diastolisk blodtryk, som opretholdtes i hele dosisintervallet på 24 timer.
English: Concomitant use of thiazide type diuretics may lead to hypercalcaemia in patients pre-disposed for hypercalcaemia (e.g. hyperparathyroidism, malignancy, or vitamin-D-mediated conditions) by increasing tubular calcium reabsorption.
Danish: Samtidig brug af thiaziddiuretika kan medføre hyperkalcæmi hos patienter, som er prædisponerede for hyperkalcæmi (fx hyperparathyroidisme, maligne sygdomme eller D-vitamin-medierede forhold) ved at øge den tubulære reabsorption af calcium.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Danish: Øget aliskiren-eksponering ved samtidig administration af CYP3A4-hæmmere, som også hæmmer P-gp, kan derfor forventes (se også P-glycoprotein interaktioner i pkt.
English: Rasitrio combines three antihypertensive active substances with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the direct renin inhibitor class, amlodipine to the calcium channel blocker class and hydrochlorothiazide to the thiazide diuretics class.
Danish: Rasitrio kombinerer tre antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: Aliskiren tilhører klassen kaldet direkte reninhæmmere, amlodipin tilhører klassen kaldet calciumantagonister og hydrochlorthiazid tilhører klassen kaldet thiaziddiuretika.
English: Photosensitivity reactions
Danish: Lysfølsomhedsreaktioner