FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Danish: Der er ingen ændring i hydrochlorthiazids kinetik efter gentagen dosering, og akkumulation er minimal ved dosering en gang daglig.
English: (Calculations assume an oral dose of 25 mg/day and a 60-kg patient.)
Danish: (Beregningerne forudsætter en oral dosis på 25 mg/dag og en patient på
English: Effects of aliskiren on mortality and cardiovascular morbidity are currently unknown.
Danish: Virkninger af aliskiren på mortalitet og kardiovaskulær morbiditet er for nærværende ikke kendt.
English: If you have accidentally taken too many Rasitrio tablets, talk to a doctor immediately.
Danish: Hvis du er kommet til at tage for mange Rasitrio-tabletter, skal du straks kontakte en læge.
English: Caution required with concomitant use - P-gp interactions
Danish: Forsigtighed ved samtidig brug - Interaktioner med P-gp
English: Hereditary or idiopathic angioedema.
Danish: Arveligt eller idiopatisk angioødem.
English: Hypromellose Titanium dioxide (E171) Macrogol
Danish: Filmovertræk Hypromellose Titandioxid (E 171) Macrogol
English: Therefore, because of the risk of therapeutic failure, grapefruit juice should not be taken together with Rasitrio.
Danish: På grund af risiko for terapisvigt bør grapefrugtjuice ikke tages sammen med Rasitrio.
English: Very rare
Danish: Meget sjælden:
English: There are no specific data regarding the effect of hydrochlorothiazide in elderly patients.
Danish: Der foreligger ingen specifikke data for effekten af hydrochlorthiazid hos ældre patienter.
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Danish: Thiazider bør seponeres før udførelse af test for parathyroidea-funktion.
English: In patients taking amlodipine alone, the following have been reported: Common (may affect up to 1 in 10 people)
Danish: Hos patienter, der tager amlodipin alene, er følgende blevet indberettet: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter)
English: - if the level of calcium in your blood is too high.
Danish: - hvis niveauet af calcium i dit blod er for højt.
English: - one of the following classes of medicines used to treat high blood pressure:
Danish: en af følgende typer medicin, som anvendes til at behandle for højt blodtryk:
English: Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Danish: Da amlodipin er stærkt proteinbundet, er det ikke sandsynligt at dialyse har gavnlig virkning.
English: The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction.
Danish: Det primære endepunkt var en sammensætning af fatal koronarsygdom eller ikke-fatalt myokardie infarkt.
English: • headache (especially at the beginning of treatment)
Danish: • hovedpine (især i begyndelsen af behandlingen)
English: Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A).
Danish: Aliskiren hæmmer ikke CYP-isoenzymer (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A).
English: The available data did not suggest that age, body weight or gender have any significant effect on aliskiren systemic exposure (see section 4.2).
Danish: De tilgængelige data tyder ikke på, at alder, kropsvægt eller køn har nogen signifikant effekt på den systemiske eksponering af aliskiren (se pkt.
English: A switch to a suitable alternative antihypertensive treatment should be carried out in advance of a planned pregnancy since Rasitrio should not be used in women planning to become pregnant.
Danish: Et skift til en passende hypertensionsbehandling skal ske inden planlagt graviditet, da Rasitrio ikke må anvendes af kvinder, som planlægger at blive gravide.
English: Somnolence, headache (especially at the beginning of treatment)
Danish: Somnolens, hovedpine (især i begyndelsen af behandling)
English: Aliskiren was not teratogenic in rats or rabbits (see section 5.3).
Danish: Aliskiren var ikke teratogent i rotter eller kaniner (se pkt.
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 et klinisk studie.
English: In patients ≥65 years the incidence was 10.2% with Rasitrio versus up to 5.4% with dual combinations.
Danish: Hos patienter ≥ 65 år var forekomsten 10,2 % med Rasitrio mod op til 5,4 % med kombinationer af to præparater.
English: Aliskiren has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Danish: Aliskiren er undersøgt i 1.864 patienter i alderen 65 år eller derover og i 426 patienter i alderen 75 år eller derover.
English: Investigations: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Danish: Undersøgelser: I kontrollerede kliniske studier blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af aliskiren.
English: The safety of amlodipine in human pregnancy has not been established.
Danish: Amlodipins sikkerhed ved human graviditet er ikke fastslået.
English: Gastric lavage may be worthwhile in some cases.
Danish: Maveskyldning kan være af værdi i nogle tilfælde.
English: - clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections.
Danish: clarithromycin, telithromycin, erythromycin, der er antibiotika og bruges til behandling af infektioner.
English: The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9month 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: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en periodisk, opdateret sikkerhedsindberetning (PSUR) og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: There is no evidence that Rasitrio would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er intet, der tyder på, at Rasitrio ville reducere eller forhindre diuretikainduceret hyponatriæmi.
English: Additional information on individual components Other adverse reactions previously reported with one of the individual components may occur with Rasitrio even if not observed in clinical trials.
Danish: Yderligere information om de individuelle komponenter Andre bivirkninger, som tidligere er indberettet for de individuelle komponenter kan også opstå for Rasitrio, selv, hvor de ikke er set i kliniske studier.
English: Co-administration of lithium and hydrochlorothiazide is not recommended.
Danish: Kombinationen af lithium og hydrochlorthiazid anbefales ikke.
English: The mean weight of patients concomitantly treated with furosemide and 300 mg aliskiren (84.6 kg) was higher than the weight of patients treated with furosemide alone (83.4 kg).
Danish: Gennemsnitsvægten af patienter i samtidig behandling med furosemid og 300 mg aliskiren (84,6 kg) var højere end vægten af patienter behandlet med furosemid alene (83,4 kg).
English: The adverse reactions for aliskiren, amlodipine and hydrochlorothiazide are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne for aliskiren, amlodipin og hydrochlorthiazid er opstillet efter frekvens med den hyppigste først ved anvendelse af følgende definition: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10): ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If Rasitrio is used during breastfeeding, doses should be kept as low as possible.
Danish: Hvis Rasitrio anvendes under amning, bør dosis holdes så lav som muligt.
English: Very common Increases in cholesterol and triglycerides Rare
Danish: Meget almindelig: Stigning i kolesterol og triglycerider Sjælden:
English: - lithium (a medicine used to treat some types of depression).
Danish: lithium (medicin til behandling af visse typer depression).
English: You should tell your doctor if you are 65 years of age or older because you may be more susceptible to side effects related to low blood pressure (see section 4 on possible side effects).
Danish: Du skal fortælle din læge, hvis du er 65 år eller derover, da du muligvis er mere følsom for bivirkninger, som er relateret til lavt blodtryk (se punkt 4 om bivirkninger).
English: If patients taking amlodipine suffer from dizziness, drowsiness, headache, fatigue or nausea, the ability to react may be impaired.
Danish: Hvis patienter, der får amlodipin, lider af svimmelhed, sløvhed, hovedpine, træthed eller kvalme kan evnen til at reagere være nedsat.
English: Therefore dialysis is not adequate to treat aliskiren over-exposure.
Danish: Dialyse er derfor ikke tilstrækkeligt til behandling af aliskiren-overdosering.
English: Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients).
Danish: Alvorlige bivirkninger omfatter anafylaktiske reaktioner og angioødem, som efter markedsføring er blevet rapporteret med frekvensen sjælden (mindre end 1 tilfælde ud af 1.000 patienter).
English: • Combined use of aliskiren with other agents acting on the RAAS.
Danish: • Anvendelse af aliskiren sammen med andre stoffer, der virker på RAAS.
English: Tell your doctor if you are using the following medicines: - medicines or substances that increase the amount of potassium in your blood.
Danish: Fortæl det til din læge, hvis du bruger nogen af følgende lægemidler: medicin eller andre stoffer, der øger indholdet af kalium i dit blod.
English: Aliskiren Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Danish: Aliskiren Aliskiren er en oral aktiv, non-peptid, potent og selektiv direkte hæmmer af humant renin.
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 stateplasmakoncentrationerne nås inden for 5-7 dage efter administration en gang dagligt, og steady stateniveauerne er ca. 2 gange større end ved initialdosen.
English: Rasitrio should be taken with a light meal once a day, preferably at the same time each day.
Danish: Rasitrio bør tages med et let måltid én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: No data are available on systemic exposure after administration of Rasitrio in geriatric patients.
Danish: Der foreligger ingen data om systemisk eksponering efter administration af Rasitrio til geriatriske patienter.
English: However, staggering the dosage of hydrochlorothiazide and resin such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimise the interaction.
Danish: Forskydning af doseringen af hydrochlorthiazid og anionbytterresin således, at hydrochlorthiazid gives mindst 4 timer før eller 4-6 timer efter indgift af anionbytterresin, kan dog muligvis minimere interaktionen.
English: Women of childbearing potential/contraception in males and females Healthcare professionals prescribing Rasitrio should counsel women of childbearing potential about the potential risk during pregnancy.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Læger, som ordinerer Rasitrio, bør rådgive kvinder i den fertile alder om den potentielle risiko under graviditet.
English: Paediatric population: Based on the limited amount of safety data available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children 6-17 years of age, the frequency, type and severity of adverse reactions in children are expected to be similar to that seen in hypertensive adults.
Danish: Pædiatrisk population: Baseret på de begrænsede sikkerhedsdata, der er tilgængelige fra et farmakokinetisk studie af aliskirenbehandling hos 39 hypertensive børn i alderen 6-17 år, forventes frekvensen, typen og alvorligheden af bivirkninger hos børn at svare til det, der ses hos hypertensive voksne.
English: If you think you may be allergic, do not take Rasitrio and ask your doctor for advice.
Danish: Hvis du mener, at du er allergisk, skal du ikke tage Rasitrio og kontakte lægen for vejledning.
English: Fertility There are no clinical data on fertility with the use of Rasitrio.
Danish: Fertilitet Der er ingen kliniske data vedrørende påvirkning af fertiliteten ved brug af Rasitrio.
English: IT-80058 Torre Annunziata
Danish: I-80058 Torre Annunziata/NA
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase in AUC of approximately 40-60%.
Danish: Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca. 40-60 %.
English: The usual dose of Rasitrio is one tablet a day.
Danish: Den sædvanlige dosis af Rasitrio er en tablet daglig.
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with aliskiren alone.
Danish: Udtalt hypotension var usædvanlig (0,1 %) hos patienter med ukompliceret hypertension, som blev behandlet med aliskiren alene.
English: - vitamin D and calcium salts.
Danish: D-vitamin og calciumsalte.
English: As expected for a compound which is cleared almost exclusively via the kidneys, renal function has a marked effect on the kinetics of hydrochlorothiazide.
Danish: Som forventet af en forbindelse, der udskilles næsten udelukkende via nyrerne, har nyrefunktionen imidlertid en markant virkning på hydrochlorthiazids kinetik.
English: • increased muscle stiffness and inability to stretch
Danish: • øget muskelstivhed og svært ved at strække ud
English: The pharmacokinetics of Rasitrio have not been investigated.
Danish: Rasitrios farmakokinetik er ikke undersøgt.
English: Other substances that act directly on the renin-angiotensin-aldosterone system have been associated with serious foetal malformations and neonatal death.
Danish: Andre stoffer, som virker direkte på renin-angiotensin-aldosteronsystemet, associeres med alvorlige fostermisdannelser og dødsfald hos nyfødte.
English: Close monitoring of blood pressure, renal function and electrolytes should be exercised if co-administration is considered absolutely necessary.
Danish: Blodtryk, nyrefunktion og elektrolytter skal monitoreres tæt, hvis samtidig administration vurderes at være absolut nødvendig.
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of treatment initiation.
Danish: Symptomerne omfatter akut nedsat syn og øjensmerter og opstår typisk inden for timer til uger efter behandlingsstart.
English: - Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Danish: - Samtidig administration af gentagne doser af 10 mg amlodipin sammen med 80 mg simvastatin resulterede i en 77 % stigning i eksponeringen for simvastatin sammenlignet med simvastatin alene.
English: This effect is also seen with other medicinal products acting on the RAAS, such as ACEIs and ARBs.
Danish: Denne virkning ses også for andre lægemidler, som virker på RAAS, fx ACE-hæmmere og ARB'er.
English: In addition, an increased incidence of adverse events was observed with aliskiren compared to placebo (37.9% versus 30.2%).
Danish: Desuden blev der observeret en øget forekomst af bivirkninger ved aliskiren sammenlignet med placebo (37,9 % vs. 30,2 %).
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Danish: Selvom det ikke er blevet undersøgt for aliskiren, er det kendt, at P-gp også kontrollerer optagelsen af et stort udvalg af substrater i væv, og P-gp kan øge væv:plasma-koncentrationsforholdet.
English: Use in patients with heart failure
Danish: Anvendelse til patienter med hjerteinsufficiens
English: No interactions - In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,
Danish: Ingen interaktioner - I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin,
English: Swallow the tablet whole with some water.
Danish: Synk tabletten hel sammen med vand.
English: Patients 65 years of age or older are more susceptible to side effects related to low blood pressure.
Danish: Patienter på 65 år eller derover er mere følsomme for bivirkninger, der er relateret til lavt blodtryk.
English: There is evidence of an increased risk of adverse events related to hypotension in patients aged 65 years or older treated with Rasitrio.
Danish: Der er beviser for en øget risiko for bivirkninger relateret til hypotension hos patienter på 65 år eller ældre behandlet med Rasitrio.
English: Mutagenicity studies revealed no effects related to the medicinal product at either the gene or chromosome levels.
Danish: Mutagenicitetsstudier viste ingen lægemiddelrelaterede virkninger på hverken gen- eller kromosomniveau.
English: • ringing noise in ears
Danish: • ringen for ørene
English: If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Danish: Hvis denne kombination viser sig at være væsentlig, anbefales nøje monitorering af serumlithiumniveaet under samtidig brug.
English: Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30% (the effect of aliskiren on furosemide administered intramuscularly or intravenously has not been investigated).
Danish: Samtidig oral administration af aliskiren og furosemid havde ingen effekt på aliskirens farmakokinetik, men reducerede eksponeringen af furosemid med 20-30 % (effekten af aliskiren på furosemid, administreret intramuskulært eller intravenøst, er ikke blevet undersøgt).
English: In experimental animals, it has been shown that P-gp is a major determinant of aliskiren bioavailability.
Danish: I forsøgsdyr er det blevet vist, at P-gp har stor indflydelse på aliskirens biotilgængelighed.
English: - muscle relaxants (medicines to relax the muscles which are used during operations).
Danish: muskelrelaksantia (medicin, som bruges under operationer til at afslappe musklerne).
English: - amantadine (a medicine used to treat Parkinson's disease, also used to treat or prevent certain illnesses caused by viruses).
Danish: amantadin (medicin til behandling af Parkinsons sygdom, bruges også til behandling af eller for at forebygge visse virus-infektioner).
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, vasculitis necrotising and toxic epidermal necrolysis
Danish: Kutan lupus erythematosus-lignende reaktioner, reaktivering af kutan lupus erythematosus, nekrotiserende vaskulitis og toksisk epidermal nekrolyse
English: - if you have problems to produce urine (anuria).
Danish: - hvis du ikke producerer urin (anuri).
English: When administered alone, the AUC of aliskiren in geriatric subjects (>65 years) is 50% higher than in young subjects.
Danish: Når aliskiren gives alene, er AUC for aliskiren hos geriatriske patienter (> 65 år) 50 % højere end hos unge patienter.
English: Information on amlodipine interactions
Danish: Information om interaktioner med amlodipin
English: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites, with 10% of the parent compound and 60% of the metabolites excreted in the urine.
Danish: Amlodipin bliver i udstrakt grad (ca. 90 %) metaboliseret i leveren til inaktive metabolitter, og 10 % uomdannet amlodipin og 60 % af metabolitterne udskilles i urinen.
English: Aliskiren is minimally excreted via the renal route, and only 0.6% of the aliskiren dose is recovered in urine following oral administration (see section 5.2).
Danish: Aliskiren udskilles minimalt gennem nyrerne, og kun 0,6 % af aliskirendosis genfindes i urinen efter oral administration (se pkt.
English: - verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.
Danish: verapamil, medicin, der bruges til at sænke forhøjet blodtryk, til at korrigere hjerterytmen eller til at behandle hjertekrampe (angina pectoris).
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products.
Danish: I tilfælde af diuretikuminduceret dehydrering er der en øget risiko for akut nyresvigt, særlig ved høje doser af iodpræparat.
English: If anaphylactic reactions or angioedema occur, Rasitrio 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 Rasitrio seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende ophævelse af tegn og symptomer er indtrådt.
English: You may need to stop Rasitrio.
Danish: Det kan være nødvendigt at stoppe behandlingen med Rasitrio.
English: Hypokalaemia may develop with the use of thiazide diuretics.
Danish: Hypokaliæmi kan udvikle sig ved brug af thiaziddiuretika.
English: The time to reach peak plasma concentrations of amlodipine is similar in elderly and younger subjects.
Danish: Tiden til maksimal plasmakoncentration af amlodipin er den samme for ældre og yngre patienter.
English: • kidney problems including acute renal failure (severely decreased urine output)
Danish: • nyreproblemer, inklusive akut nyresvigt (svært nedsat urinproduktion)
English: • vision disorder (including double vision)
Danish: • synsforstyrrelse (inklusive dobbeltsyn)
English: - CYP3A4 inducers
Danish: - CYP3A4-inducere
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Danish: En sammentrækning af hjertemusklens og karvæggens glatte muskulatur er afhængig af ekstracellulære calciumioners vandring ind i disse celler gennem specifikke ionkanaler.
English: In children 6 to 12 years and in adolescents 13-17 years of age the typical oral clearance (CL/F) was 22.5 and 27.4 l/hr respectively in males and 16.4 and 21.3 l/hr respectively in females.
Danish: Hos børn i alderen 6 til 12 år og hos teenagere i alderen 13-17 år var den typiske oral clearance (CL/F) henholdsvis 22,5 og 27,4 l/time hos drenge og henholdsvis 16,4 og 21,3 l/time hos piger.
English: Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
Danish: Obstruktion af venstre ventrikels udløb (fx høj grad af aortastenose).
English: Following intravenous administration, mean plasma clearance is approximately 9 l/h.
Danish: Efter intravenøs administration er den gennemsnitlige plasmaclearance ca. 9 l/time.
English: The most common adverse reaction is diarrhoea.
Danish: Den hyppigste bivirkning er diarré.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC 0tau 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.