FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Danish: Efter oral absorption nås de maksimale plasmakoncentrationer af aliskiren efter 1-3 timer.
English: If angioedema occurs, Sprimeo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis angioødem opstår, skal Sprimeo seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende resolution af tegn og symptomer indtræffer.
English: The increase may be higher with higher aliskiren doses.
Danish: Forøgelsen kan være større for højere aliskirendoser.
English: The clinical implications of the differences in effect on PRA are not known at the present time.
Danish: Den kliniske betydning af forskellene i effekt på PRA er ikke kendt på nuværende tidspunkt.
English: It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload.
Danish: Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumenoverload.
English: The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Danish: Den antihypertensive effekt er til stede i betydelig grad inden for to uger (85-90 %) efter initiering af behandling med 150 mg en gang dagligt.
English: Second and third trimesters of pregnancy (see section 4.6).
Danish: 2. og 3. trimester af graviditet (se pkt.
English: If you have accidentally taken too many Sprimeo tablets, consult a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af Sprimeo, skal du straks kontakte en læge.
English: Carcinogenic potential was assessed in a 2-year rat study and a 6-month transgenic mouse study.
Danish: Det karcinogene potentiale blev vurderet i et 2-årigt rottestudie og i et 6-måneders studie af transgene mus.
English: Other substances that act directly on the RAAS have been associated with serious foetal malformations and neonatal death.
Danish: Andre stoffer, som virker direkte på RAAS, associeres med alvorlige fostermisdannelser og dødsfald hos nyfødte.
English: Sprimeo is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Danish: Sprimeo bør ikke anvendes til børn og unge under 18 år pga. manglende dokumentation for sikkerhed og virkning (se pkt.
English: If symptomatic hypotension should occur, supportive treatment should be initiated.
Danish: Hvis der skulle opstå symptomatisk hypotension, bør der iværksættes støttende behandling.
English: These observed changes, however, did not correlate with the severity of renal impairment.
Danish: Disse observerede ændringer korrelerede imidlertid ikke med graden af nedsat nyrefunktion.
English: Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A).
Danish: Aliskiren hæmmer ikke CYP450-isoenzymer (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A).
English: PA/Alu/PVC - Alu blisters:
Danish: PA/Alu/PVC - Alu blister:
English: With cessation of treatment, blood pressure gradually returned towards baseline levels over a period of several weeks, with no evidence of a rebound effect for blood pressure or PRA.
Danish: Ved ophør af behandlingen vendte blodtrykket gradvist tilbage mod basisniveauet over flere uger, og der var ingen tegn på reboundeffekt for blodtrykket eller PRA.
English: Sprimeo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Danish: Sprimeo er undersøgt i 1.864 patienter i alderen 65 år eller derover og i 426 patienter i alderen 75 år eller derover.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Hvis du mener, at du er allergisk, skal du bede lægen om vejledning.
English: The doses in rats and rabbits provided systemic exposures of 1 to 4 and 5 times higher, respectively, than the maximum recommended human dose (300 mg).
Danish: Doserne hos rotter og kaniner gav en systemisk eksponering, der var henholdsvis 1-4 og 5 gange højere end den maksimale anbefalede humane dosis (300 mg).
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Danish: Kombination af aliskiren og NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: The primary endpoint was a composite of cardiovascular and renal complications.
Danish: Det primære endepunkt var en kombination af hjertekar- og nyrekomplikationer.
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (78%).
Danish: Aliskiren udskilles hovedsageligt som et uændret stof i fæces (78 %).
English: Sprimeo belongs to a new class of medicines called renin inhibitors.
Danish: Sprimeo tilhører en ny klasse af medicin, kaldet reninhæmmere.
English: There has been no evidence of first-dose hypotension and no effect on pulse rate in patients treated in controlled clinical studies.
Danish: Der er ingen tegn på hypotension efter første dosis og ingen indvirkning på pulsen hos patienter, som er blevet behandlet i kontrollerede kliniske undersøgelser.
English: The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
Danish: De mest sandsynlige manifestationer af overdosering vil være hypotension relateret til aliskirens antihypertensive virkning.
English: The MAH shall submit an updated risk management plan (RMP) that adequately describes all the safety concerns, the pharmacovigilance activities and the interventions designed to identify, characterise, prevent or minimise the risks.
Danish: Inden for en risikostyringsprogram (RMP), som på tilstrækkelig vis beskriver alle sikkerhedsproblemer, lægemiddelovervågningsaktiviteter og tiltag, som er udformet med henblik på at identificere, karakterisere, forebygge eller minimere risici.
English: - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Danish: - visse typer af smertestillende medicin kaldet ikke-steroide antiinflammatoriske lægemidler (NSAID).
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 state-plasmakoncentrationerne nås inden for 5-7 dage efter administration en gang dagligt, og steady state-niveauerne er ca. 2 gange større end ved initialdosen.
English: Exposure to aliskiren increased more than in proportion to the increase in dose.
Danish: Eksponeringen med aliskiren øgedes mere end proportionelt sammenlignet med stigningen i dosis.
English: Beneficial effects of Sprimeo on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Danish: Gavnlige virkninger af Sprimeo med hensyn til mortalitet, kardiovaskulær morbiditet og organskade er for nærværende ikke kendt.
English: The MAH shall submit the final results and study report for the active treatment phase of the ALTITUDE study when available
Danish: Indehaveren af markedsføringstilladelsen skal indsende de endelige resultater og studierapporten for den aktive behandlingsfase fra ALTITUDE-studiet, når de foreligger.
English: Therefore dialysis is not adequate to treat aliskiren over-exposure.
Danish: Dialyse er derfor ikke tilstrækkeligt til behandling af aliskiren-overeksponering.
English: Your doctor may prescribe Sprimeo together with other medicines used to treat high blood pressure.
Danish: Din læge kan ordinere Sprimeo sammen med anden medicin, der bruges til at behandle forhøjet blodtryk.
English: High blood pressure increases the workload of the heart and arteries.
Danish: Forhøjet blodtryk øger belastningen på hjerte og blodkar.
English: There are no data on the use of aliskiren in pregnant women.
Danish: Der foreligger ikke data om brugen af hos gravide kvinder.
English: Therefore, because of the risk of therapeutic failure, grapefruit juice should not be taken together with Sprimeo.
Danish: På grund af risiko for terapeutisk svigt bør grapefrugtjuice ikke tages sammen med Sprimeo.
English: In most patients arterial blood pressure was well controlled at baseline.
Danish: Blodtrykket var velkontrolleret ved baseline hos de fleste patienter.
English: Food intake Meals with a high fat content have been shown to reduce the absorption of Sprimeo substantially.
Danish: Fødeindtag Måltider med højt fedtindhold reducerer absorptionen af Sprimeo betragteligt.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Danish: Muligheden for interaktioner med lægemidler ved P-gp's bindingssted vil sandsynligvis afhænge af i hvor stor udstrækning denne transportør hæmmes.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: However, CYP3A4 inhibitors often also affect Pgp.
Danish: CYP3A4-hæmmere påvirker dog ofte også P-gp.
English: Do not take Sprimeo - if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Sprimeo.
Danish: Tag ikke Sprimeo - hvis du er overfølsom (allergisk) over for aliskiren eller et af de øvrige indholdsstoffer i Sprimeo.
English: Sprimeo was not teratogenic in rats or rabbits (see section 5.3).
Danish: Sprimeo var ikke teratogent i rotter eller kaniner (se pkt.
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Danish: Ingen effekt på QT-intervallet blev rapporteret i et randomiseret, dobbeltblindet, placebo og aktivt kontrolleret studie ved anvendelse af standard og Holter elektrokardiografi.
English: Preliminary study results indicated a hazard ratio for the primary endpoint of 1.09 in favour of placebo (95% Confidence Interval: 0.97, 1.22, 2-sided p=0.17).
Danish: Præliminære resultater fra studiet indikerede en hazard ratio for det primære endepunkt på 1,09 til fordel for placebo (95% konfidensinterval: 0,97-1,22, 2-sidet p=0,17).
English: In the event of severe and persistent diarrhoea, Sprimeo therapy should be stopped.
Danish: Ved alvorlig og vedvarende diarré bør behandling med Sprimeo stoppes.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Sprimeo.
Danish: I kontrollerede kliniske forsøg blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af Sprimeo.
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne (tabel 1) er ordnet i frekvensgrupper med den mest almindelige først og 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, when driving vehicles or operating machinery it must be borne in mind that dizziness or weariness may occasionally occur when taking any antihypertensive therapy.
Danish: Når man fører motorkøretøjer eller betjener maskiner, skal man være opmærksom på, at der lejlighedsvis kan optræde svimmelhed eller træthed under hvilken som helst antihypertensiv behandling.
English: P-glycoprotein interactions
Danish: Interaktioner med P-glykoprotein
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Ydeligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive agents.
Danish: Hypotension var også usædvanlig (< 1 %) under kombinationsbehandling med andre antihypertensiva.
English: The most common adverse drug reaction is diarrhoea.
Danish: Den mest almindelige bivirkning er diarré.
English: Following intravenous administration, the mean volume of distribution at steady state is approximately 135 litres, indicating that aliskiren distributes extensively into the extravascular space.
Danish: Efter intravenøs administration er det gennemsnitlige distributionsvolumen omkring 135 liter, hvilket indikerer, at aliskiren distribueres omfattende i det ekstravaskulære rum.
English: Renin inhibitors reduce the amount of angiotensin II the body can produce.
Danish: Reninhæmmere nedsætter den mængde angiotensin-II, kroppen kan producere.
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: Hereditary or idiopathic angioedema.
Danish: Arvelig eller idiopatisk angioødem.
English: Similar reductions were found when aliskiren was combined with other antihypertensive agents.
Danish: Tilsvarende reduktioner blev fundet, når aliskiren blev kombineret med andre antihypertensive stoffer.
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 vævsoptagelsen af et stort udvalg af substrater, og P-gp kan øge koncentrationsforholdet mellem væv og plasma.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svært hjertesvigt (New York Heart Association [NYHA] klasse III-IV).
English: In experimental animals, it has been shown that P-gp is a major determinant of Sprimeo bioavailability.
Danish: I forsøgsdyr er det blevet vist a P-gp har stor indflydelse på Sprimeos biotilgængelighed.
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Danish: Måltider med højt fedtindhold reducerer Cmax med 85 % og AUC med 70 %.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under markedsføringen af lægemidlet.
English: Healthcare professionals prescribing any agents acting on the RAAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Danish: Læger, som ordinerer præparater, der virker på RAAS, bør rådgive kvinder i den fertile alder om den potentielle risiko ved disse stoffer under graviditet.
English: Sprimeo helps to lower high blood pressure.
Danish: Sprimeo hjælper med at sænke et forhøjet blodtryk.
English: Aliskiren does not induce CYP3A4.
Danish: Aliskiren inducerer ikke CYP3A4.
English: The usual dose of Sprimeo for patients aged 65 years or older is 150 mg.
Danish: Den sædvanlige dosis til patienter på 65 år og derover er 150 mg.
English: Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Danish: Køn, vægt og etnicitet har ingen klinisk relevant indflydelse på aliskirens farmakokinetik.
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: If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure.
Danish: Hvis det fortsætter i lang tid, kan det beskadige blodkarrene i hjernen, hjertet og nyrerne, som kan føre til slagtilfælde, hjertesvigt, hjerteanfald eller nyresvigt.
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: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Danish: Fertiliteten og den præ- og postnatale udvikling blev ikke påvirket hos rotter ved doser på op til 250 mg/kg/dag.
English: You should not take Sprimeo together with grapefruit juice.
Danish: Du må ikke tage Sprimeo sammen med grapefrugtjuice.
English: This effect is also seen with other agents acting on the reninangiotensin system, such as ACEI and ARBs.
Danish: Denne virkning ses også med andre stoffer, som virker på renin-angiotensin-systemet, f.eks. ACE-hæmmere og ARB'er.
English: You may need to stop Sprimeo.
Danish: Det kan være nødvendigt at stoppe behandlingen med Sprimeo.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local irritation potential or the expected pharmacological effects of aliskiren.
Danish: Hændelser under gentagen-dosis toksicitetsstudier i dyr var i overensstemmelse med det kendte potentiale for lokalirritation eller de forventede farmakologiske effekter af aliskiren.
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme afslutte følgende foranstaltninger/tiltag:
English: Hypersensitivity reactions have also been reported in post-marketing experience.
Danish: Der er også blevet indberettet overfølsomhedsreaktioner efter markedsføring.
English: 4.4 and 5.1).
Danish: 4.4 og 5.2).
English: Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Danish: Tolerabiliteten var sammenlignelig for de to behandlingsarme, men hoste blev oftere rapporteret med ramipril-regimet end med aliskiren-regimet (14,2 % vs. 4,4 %), mens diarré var mere almindelig med aliskiren-regimet end med ramipril-regimet (6,6 % vs. 5,0 %).
English: As a result no dose adjustment for Sprimeo or these co-administered medicinal products is necessary.
Danish: Dosisjustering for Sprimeo eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: Following intravenous administration, the mean plasma clearance is approximately 9 l/h.
Danish: Efter intravenøs administration er den gennemsnitlige plasmaclearance ca. 9 l/time.
English: Silica, colloidal anhydrous Hypromellose Macrogol
Danish: Silica, kolloid vandfri Hypromellose Macrogol
English: Crospovidone Magnesium stearate Cellulose, microcrystalline Povidone
Danish: Magnesiumstearat Cellulose, mikrokrystallinsk Povidon
English: In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily.
Danish: Hos patienter med utilstrækkeligt kontrolleret blodtryk kan dosis øges til 300 mg én gang dagligt.
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Danish: Rifampicin, som er en P-gp-induktor, nedsatte aliskirens biotilgængelighed med omkring 50 % i kliniske forsøg.
English: Pharmacotherapeutic group: Renin inhibitor, ATC code: C09XA02
Danish: Farmakoterapeutisk klassifikation: Reninhæmmer, ATC-kode: C09XA02
English: Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Danish: Aliskiren er en oral aktiv, non-peptid, potent og selektiv direkte hæmmer af humant renin.
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Sprimeo alone.
Danish: Kraftig hypotension var usædvanlig (0,1 %) hos patienter med ukompliceret hypertension, som blev behandlet med Sprimeo alene.
English: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Danish: Der er ikke observeret nogen relevante interaktioner med atenolol, digoxin, amlodipin eller cimetidin.
English: Take special care with Sprimeo - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Danish: Vær ekstra forsigtig med at tage Sprimeo - hvis du tager et diuretikum (kaldes også vanddrivende tabletter, som øger den mængde urin, du producerer).
English: Reproductive toxicity studies with aliskiren did not reveal any evidence of embryofoetal toxicity or teratogenicity at doses up to 600 mg/kg/day in rats or 100 mg/kg/day in rabbits.
Danish: Studier af aliskirens reproduktive toksicitet viste ingen tegn på embryoføtal toksicitet eller teratogenicitet ved doser på op til 600 mg/kg/dag hos rotter eller 100 mg/kg/dag hos kaniner.
English: Sprimeo induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Danish: Sprimeo inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid.
English: No additional blood pressure lowering effect was detected with 300 mg aliskiren compared to 150 mg aliskiren.
Danish: Der blev ikke påvist yderligere blodtrykssænkende effekt med 300 mg aliskiren sammenlignet med 150 mg aliskiren.
English: Sprimeo was secreted in the milk of lactating rats.
Danish: Sprimeo udskilles i mælken hos diegivende rotter.
English: Grapefruit juice should not be taken together with Sprimeo.
Danish: Grapefrugtjuice må ikke tages sammen med Sprimeo.
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: Warfarin The effects of Sprimeo on warfarin pharmacokinetics have not been evaluated.
Danish: Warfarin Effekten af Sprimeo på warfarins farmakokinetik er ikke blevet evalueret.
English: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Danish: Aliskiren er en effektiv en gang daglig antihypertensiv behandling til voksne patienter uanset køn, alder, BMI og etnicitet.
English: Whereas other agents that inhibit the RAAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Danish: Mens andre stoffer, som hæmmer RAAS (ACE-hæmmere og angiotensin-IIantagonister (ARB)) forårsager en kompensatorisk stigning i plasmareninaktiviteten (PRA), mindsker behandling med aliskiren PRA hos hypertensive patienter med ca. 50-80 %.