FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of aliskiren and amlodipine does not cause meaningful changes in the steady-state pharmacokinetic exposure (AUC) and the maximum concentration (Cmax) of either component in
Danish: Samtidig administration af aliskiren og amlodipin viser ikke betydningsfulde ændringer i den farmakokinetiske eksponering (AUC) og maksimale koncentration (Cmax) ved steady state for nogle af
English: These studies indicate that excessive aliskiren exposure (>400-fold higher in 8-day old rats compared with adult rats) and high acute toxicity in juvenile rats are caused by immature MDR1, which suggests that in paediatric patients with immature MDR1, there is a potential for aliskiren overexposure (see sections 4.2, 4.3 and 5.2).
Danish: Disse studier indikerer, at ekstremt høj aliskiren-eksponering (>400 gange højere hos 8 dage gamle rotter samenlignet med voksne rotter) og høj akut toksicitet hos unge rotter skyldes umodent MDR1, hvilket antyder, at der hos pædiatriske patienter med umodent MDR1 muligvis kan forekomme overeksponering for aliskiren (se pkt.
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: The most frequently reported adverse reaction for Rasilamlo in clinical trials was peripheral oedema, which occurred at a frequency lower than or equal to that of the corresponding amlodipine doses, but higher than with aliskiren; ** Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked
Danish: Den hyppigste indberettede bivirkning for Rasilamlo i kliniske studier var perifert ødem, der opstod med en hyppighed, der var mindre end eller den samme som for de tilsvarende amlodipindoser, men større end for aliskiren: **Isolerede tilfælde af leverforstyrrelser med kliniske symptomer og laboratorie-dokumentation for
English: Taking into account the PRAC Assessment Report on the PSUR for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en for aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid er CHMP nået frem til følgende videnskabelige konklusioner:
English: No controlled clinical data are available on the use of Rasilamlo 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 Rasilamlo til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Rasilamlo til patienter med stenose i en enkelt nyre.
English: Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilamlo.
Danish: Derfor bør drikkevarer indeholdende planteekstrakter, inklusive urteteer, ikke indtages sammen med Rasilamlo.
English: Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially
Danish: Måltider (med højt eller lavt fedtindhold) reducerer absorptionen af aliskiren betragteligt (se pkt.
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: At steady state meals with low fat content reduce Cmax by 76% and AUC 0-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: General In the event of severe and persistent diarrhoea, Rasilamlo therapy should be stopped (see section 4.8).
Danish: Generelt Ved alvorlig og vedvarende diarré bør Rasilamlo seponeres (se pkt.
English: - In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,
Danish: I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin,
English: The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Danish: Rasilamlos sikkerhedsprofil vist herunder er baseret på kliniske studier udført med Rasilamlo og de kendte sikkerhedsprofiler for de individuelle komponenter, aliskiren og amlodipin.
English: Rasilamlo combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the class of direct renin inhibitors and amlodipine belongs to the calcium antagonist class.
Danish: Rasilamlo kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: Aliskiren tilhører klassen kaldet direkte reninhæmmere og amlodipin tilhører klassen kaldet calciumantagonister.
English: • Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high
Danish: • Patienter med markant væskemangel eller patienter med natriummangel (fx patienter, der får
English: - Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: Stoffer, som er undersøgt i kliniske farmakokinetiske studier med aliskiren, inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: In a double-blind, randomised placebocontrolled study in 1,688 patients with mild or moderate hypertension, discontinuation of therapy due to a clinical adverse event occurred in 1.7% of patients treated with Rasilamlo versus 1.5% of
Danish: I et dobbeltblindet, randomiseret placebokontrolleret studie med 1.688 patienter med mildt til moderat hypertension blev behandlingen seponeret pga. en klinisk bivirkning hos 1,7 % af patienterne behandlet med Rasilamlo versus 1,5 % af patienterne, der fik
English: Rasilamlo is available in packs containing 14, 28, 56 or 98 tablets (in calendar blisters), 30 or 90 tablets (in normal blisters) and 56x1 tablet (as perforated unit dose blisters).
Danish: Rasilamlo er tilgængelig i pakninger, der indeholder 14, 28, 56 eller 98 tabletter (i kalenderpakninger), 30 eller 90 tabletter (i normale blisterpakninger) og 56x1 tabletter (som
English: When given to patients whose blood pressure was not adequately controlled by either aliskiren or amlodipine, Rasilamlo results in greater blood pressure reductions after one week of treatment than the component monotherapies and a near-maximal effect is achieved after four weeks of therapy.
Danish: Når Rasilamlo gives til patienter, hvis blodtryk ikke var tilstrækkeligt kontrolleret med hverken aliskiren eller amlodipin, resulterede i større blodtryksreduktion efter en uges behandling end de enkelte stoffers behandling alene, og næsten maksimal virkning opnås efter fire ugers behandling.
English: The rate and extent of absorption of Rasilamlo are similar in fasting state to those of aliskiren and amlodipine when administered as individual monotherapies.
Danish: Hastigheden og omfanget af absorptionen af Rasilamlo i fastende tilstand er lig dem for aliskiren og amlodipin, når det indgives som individuelle monoterapier.
English: Therefore, Rasilamlo 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.
Danish: Derfor er Rasilamlo 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.
English: Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Danish: Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
English: Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Danish: Amlodipin har vist gavnlig klinisk effekt til patienter med kronisk stabil angina, vasospastisk angina
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the
Danish: Inducere af P-gp (perikon, rifampicin) kan derfor nedsætte
English: As for any medicine that acts directly on the RAAS, 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 præparater, der virker direkte på RAAS, ikke anvendes under 1. trimester i graviditeten og er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt.
English: There are no clinical data on fertility with the use of Rasilamlo.
Danish: Der er ingen kliniske data vedrørende påvirkning af fertiliteten ved brug af Rasilamlo.
English: The combination at a dose of 300 mg/5 mg also showed statistically significantly greater blood pressure reduction than aliskiren 300 mg monotherapy.
Danish: Kombinationen med dosis 300 mg/5 mg viste også statistisk signifikant større blodtryksreduktioner end aliskiren 300 mg monoterapi.
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
Danish: Samtidig brug af aliskiren med ciclosporin eller itraconazol, to yderst potente P-glykoprotein(P-gp)-hæmmere, eller andre potente P-gp-hæmmere (f. eks. quinidin), er kontraindiceret (se
English: Safety information for Rasilamlo in patients aged 75 years and older is limited.
Danish: Der er begrænset sikkerhedsinformation for Rasilamlo til patienter på 75 år og ældre.
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Danish: I kliniske undersøgelser, hvor amlodipin blev givet i kombination med betablokkere til patienter med enten hypertension eller angina, er der ikke set bivirkninger på de
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of
Danish: Indgift af aktivt kul op til 2 timer efter administration af 10 mg amlodipin har vist, at det nedsætter absorptionshastigheden af amlodipin.
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (may be signs of
Danish: • Kvalme, manglende appetit, mørk-farvet urin eller gulfarvning af hud og øjne (tegn på
English: Plasma aliskiren exposure (AUC) in rats aged 8 days was nearly 4-fold higher than that in rats aged 14 days at 100 mg/kg/day.
Danish: Plasma aliskiren-eksponering (AUC) hos 8 dage gamle rotter var næsten fire gange højere end hos 14 dage gamle rotter ved 100 mg/kg/dag.
English: - Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Danish: Hæmmere af organisk anion-transporterende polypeptid (OATP) Prækliniske studier tyder på, at aliskiren kan være et substrat for organisk anion-transporterende polypetider.
English: Plasma aliskiren exposure in rats aged 14 days was between 85- and 387fold higher than that in adult rats aged 64 days.
Danish: Plasma-eksponeringen for aliskiren hos 14 dage gamle rotter var mellem 85 og 387 gange højere end hos voksne rotter på 64 dage.
English: A patient who experiences dose limiting adverse reactions on either component alone may be switched to Rasilamlo containing a lower dose of that component to achieve similar blood pressure
Danish: Hvis en patient får dosisbegrænsende bivirkninger af en af komponenterne alene, kan patienten skiftes til Rasilamlo, der indeholder en lavere dosis af denne komponent, for at opnå samme blodtrykssænkning.
English: BLISTERS (PVC/PCTFE OR PA/Alu/PVC) CALENDAR BLISTERS ONLY
Danish: BLISTER (PVC/PCTFE ELLER PA/Alu/PVC) KUN TIL KALENDERPAKNING
English: The most likely manifestation of overdose for Rasilamlo would be hypotension, related to the antihypertensive effect of aliskiren and amlodipine.
Danish: De mest sandsynlige manifestationer for Rasilamlo vil være hypotension relateret til aliskiren og amlodipins antihypertensive virkning.
English: On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid er CHMP af den opfattelse, at benefit/risk-forholdet for de lægemidler, der indeholder de aktive stoffer aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: - if you have impaired kidney function, your doctor will carefully consider whether Rasilamlo is suitable for you and may wish to monitor you carefully - if you suffer from liver problems (impaired liver function)
Danish: - hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om Rasilamlo er egnet til dig, og kan vælge at følge dig nøje
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
English: Therefore, particular caution should be exercised in these patients.
Danish: Der skal derfor udvises særlig forsigtighed over for disse patienter.
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: - Fruit juice and drinks containing plant extracts Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Danish: Frugtjuice og drikkevarer indeholdende planteekstrakter Indtagelse af frugtjuice sammen med aliskiren resulterede i en reduktion i AUC og Cmax for aliskiren.
English: Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
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: Rasilamlo may be administered with other antihypertensive medicinal products with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate
Danish: Rasilamlo kan administreres sammen med andre antihypertensive lægemidler dog ikke i kombination med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin-II receptorblokkere (ARB) hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationsrate (GFR)
English: No interaction studies with other medicinal products were performed with Rasilamlo.
Danish: Der er ikke udført interaktionsstudier for Rasilamlo med andre lægemidler.
English: There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human basis).
Danish: Der sås ingen effekt på fertiliteten hos rotter behandlet med amlodipin (hanner i 64 dage og hunner i 14 dage før parring) ved doser op til 10 mg/kg/dag (8 gange* den maksimalt anbefalede dosis til
English: The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment; therefore, caution should be exercised when administering Rasilamlo to patients with
Danish: Amlodipins farmakokinetik er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion; der skal derfor udvises forsigtighed, hvis Rasilamlo administreres til patienter med nesat leverfunktion.
English: Rasilamlo is not recommended in patients with severe renal impairment
Danish: Rasilamlo frarådes til patienter med stærkt nedsat
English: , dyspepsia
Danish: , dyspepsi
English: The volume or salt depletion should be corrected prior to administration of Rasilamlo, or the treatment should start under close medical supervision.
Danish: Væske- og natriummangel bør korrigeres før administration af Rasilamlo, ellers skal behandlingen indledes under nøje klinisk overvågning.
English: In a 8-week study in 754 hypertensive elderly (≥65 years) and very elderly patients (30% ≥75 years) 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 ældre patienter (≥ 65 år) og gamle patienter (30 % ≥ 75 år) gav aliskiren i doser på 75 mg, 150 mg og 300 mg statistisk signifikant større blodtryksreduktioner (både systolisk og diastolisk) sammenlignet med placebo.
English: The pharmacokinetics of aliskiren was evaluated in rats aged from 8 to 28 days after intravenous administration of aliskiren 3 mg/kg.
Danish: Aliskirens farmakokinetik blev undersøgt hos 8 til 28 dage gamle rotter ved intravenøs indgift af aliskiren på 3 mg/kg.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated 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 over for patienter, der lider af aortaeller mitralklapstenose eller hypertrofisk obstruktiv kardiomyopati.
English: The results from a food effect study using a standard high fat meal with the 300 mg/10 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 fra et studie med føde, hvor der blev givet et standardmåltid med højt fedtindhold sammen med 300 mg/10 mg fast dosiskombinationstablet viste, at føde reducerede hastigheden og omfanget af aliskirens absorption i den faste kombinationstablet svarende til størrelsen af virkningen ved aliskiren monoterapi.
English: Rasilamlo must not be used in children from birth to less than 2 years of age.
Danish: Rasilamlo må ikke bruges til behandling af børn fra fødslen og op til 2 år.
English: An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
Danish: Der blev observeret en øget forekomst af hyperkaliæmi (20,9 % versus 17,5 %), nedsat nyrefunktion/nyresvigt (16,6 % versus 12,1 %) og hypotension (17,1 % versus 12,6 %) i aliskiren-gruppen sammenlignet med placebo-gruppen; hyppigheden var højere hos patienter med
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Danish: YDRE KARTON TIL MULTPAKNING (INKLUSIVE BLÅ BOKS)
English: No data on cardiovascular mortality and morbidity are available for aliskiren in patients with heart
Danish: Der er ingen tilgængelige data med hensyn til mortalitet og morbiditet for aliskiren til patienter med
English: The incidence of adverse events did not show any association with gender, age, body mass index, race or ethnicity.
Danish: Incidensen af bivirkninger var ikke forbundet med køn, alder, BMI, race eller etnicitet.
English: The amlodipine component of Rasilamlo inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Rasilamlo hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: Treatment with Rasilamlo at doses up to 300 mg/10 mg had an overall incidence of adverse experiences similar to the component monotherapies.
Danish: Ved behandling med Rasilamlo i doser op til 300 mg/10 mg var den samlede incidens af bivirkninger enslydende med stoffernes monoterapi.
English: Rasilamlo is contraindicated during the second and third trimesters (see section 4.3).
Danish: Rasilamlo er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt.
English: , mood changes (including anxiety)
Danish: , humørsvingninger (inklusive angst)
English: , skin decolouration hyperhidrosis
Danish: , misfarvning af huden hyperhidrose
English: A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild
Danish: Et dobbeltblindet morbiditet-mortalitets studie kaldet ”Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calcium-antagonist) eller lisinopril 10-40 mg/dag (ACEhæmmer) som førstevalgsbehandling i tillæg til thiaziddiuretikummet chlorthalidon 12,5-25 mg/dag
English: - Haemodynamically unstable heart failure after acute myocardial infarction.
Danish: Hæmodynamisk ustabil hjertesvigt efter akut myokardie infarkt.
English: In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥150 μmol/l or 1.70 mg/dl in women and ≥177 μmol/l or 2.00 mg/dl in men and/or estimated GFR <30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Aliskiren er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret GFR < 30 ml/min/1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension.
English: High acute mortality (within hours) and severe morbidity were observed at 100 and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended basis assuming a 60 kg adult patient) with no cause of death established and occurring without signs or prodromal symptoms.
Danish: Der blev observeret høj akut mortalitet (inden for timer) og svær morbiditet ved 100 og 300 mg/kg/dag (2,3 og 6,8 gange den maksimale anbefalede humane dosis (MRHD) baseret på mg/m antaget for en voksen patient på 60 kg), hvor dødsårsagen ikke kunne fastslås og skete uden tegn eller prodromale symptomer.
English: • skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects
Danish: • hududslæt (dette kan også være symptomer på en overfølsomhedsreaktion eller angioødem - se