FrancophonIA/ELRC3.0 huggingface dataset:
English: Since there is insufficient/limited information on the excretion of aliskiren and amlodipine in human or animal breast milk, a risk to the newborns/infants cannot be excluded.
Danish: Da der er utilstrækkelig/manglende information om udskillelse af aliskiren og amlodipin i human mælk eller brystmælk fra dyr, kan en risiko for nyfødte/spædbørn ikke udelukkes.
English: The use of combined treatment with aliskiren and amlodipine arises from the actions of these two medicinal products on different but complementary systems that regulate blood pressure.
Danish: Anvendelsen af kombinationsbehandling med aliskiren og amlodipin kommer fra disse to lægemidlers virkning på forskellige, men komplementære systemer, som regulerer blodtrykket.
English: Clearance in rats aged 8 or 14 days was similar, but at these ages the clearance was only about 23% of clearance in rats aged 21 days and 16% of clearance in rats aged 28 days.
Danish: Clearance hos 8 eller 14 dage gamle rotter var sammenlignelige, men ved disse aldre var clearance kun omkring 23 % af clearance hos 21 dage gamle rotter og 16 % af clearance hos 28 dage gamle rotter.
English: What you need to know before you take Rasilamlo
Danish: Det skal du vide, før du begynder at tage Rasilamlo
English: These were statistically significant versus placebo and aliskiren for all doses.
Danish: Disse værdier var statistisk signifikante versus placebo og aliskiren, gældende for alle doser.
English: Amlodipine, one of the active substances in Rasilamlo, may make you feel dizzy and drowsy.
Danish: Amlodipin, et af de aktive stoffer i Rasilamlo, kan gøre dig svimmel og sløv.
English: When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilamlo.
Danish: Når man fører motorkøretøj eller betjener maskiner, skal man være opmærksom på, at der lejlighedsvis kan optræde svimmelhed eller træthed under behandlingen med Rasilamlo.
English: You should take this medicine with a light meal once a day, preferably at the same time each day.
Danish: Du skal tage dette lægemiddel sammen med et let måltid mad, én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasilamlo.
Danish: Besvimelse og/eller uklarhed i forbindelse med lavt blodtryk kan opstå i begyndelsen af behandlingen med Rasilamlo.
English: Increases in AUC and elimination half-life in patients with congestive heart failure were as expected for the patient age group in this study (see section 4.4).
Danish: Stigninger i AUC og eliminationshalveringstid hos patienter med hjerteinsufficiens var som forventet for patientgruppen i dette studie (se pkt.
English: A mechanistic study was conducted to investigate the relationship between age, aliskiren exposure and MDR1 and OATP2 expression maturation in rats.
Danish: Et mekanistisk studie blev udført for at undersøge forholdet mellem alder, aliskiren-eksponering og MDR1- og OATP2-ekspressionsmodning hos rotter.
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with Rasilamlo.
Danish: På grund af risiko for terapisvigt bør frugtjuice ikke tages sammen med Rasilamlo.
English: Therefore, information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Danish: Information om interaktionsstudier med andre lægemidler kendt fra de individuelle aktive substanser, er derfor
English: Amlodipine can have minor or moderate influence on the ability to drive and use machines.
Danish: Amlodipin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: A single dose study was conducted in juvenile rats aged 14, 21, 24, 28, 31 or 36 days post-partum.
Danish: Et enkeltdosisstudie blev udført hos unge rotter i alderen 14, 21, 24, 28, 31 eller 36 dage.
English: • kidney problems including acute renal failure (severely decreased urine output)
Danish: • nyreproblemer inklusive akut nyresvigt (svært nedsat urinproduktion)
English: There is limited experience with Rasilamlo, in particular in patients aged 75 years or older.
Danish: Der er begrænset erfaring med Rasilamlo specielt til patienter på 75 år eller ældre.
English: Diarrhoea a, abdominal pain
Danish: Diarré a, abdominalsmerter
English: There were no new adverse reactions which occurred specifically with Rasilamlo in addition to those known to be associated with the individual monotherapies.
Danish: Der var ingen nye bivirkninger, som opstod specifikt med Rasilamlo i tillæg til de kendte, som er forbundet med de individuelle monoterapier.
English: The recommended dose of Rasilamlo is one tablet per day.
Danish: Den anbefalede dosis af Rasilamlo er én tablet daglig.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rasilamlo in all subsets of the paediatric population in essential hypertension (see section 4.2 for
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rasilamlo i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: In patients with uncomplicated hypertension treated with Rasilamlo in short-term controlled trials, the incidence of hypotension was low (0.2%).
Danish: Hos patienter med ukompliceret hypertension, behandlet med Rasilamlo i korttids-, kontrollerede undersøgelser, var forekomsten af hypotension lav (0,2 %).
English: Women of child-bearing potential/contraception in males and females Healthcare professionals prescribing Rasilamlo 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 Rasilamlo, bør rådgive kvinder i den fertile alder om den potentielle risiko under graviditet.
English: Do not take a double dose (two tablets at once) to make up for a
Danish: Du må ikke tage en dobbeltdosis (to tabletter samtidig) som erstatning for den glemte tablet.
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering
Danish: Administration af amlodipin sammen med grapefrugt eller grapefrugtjuice kan ikke anbefales, da biotilgængeligheden kan øges hos nogen patienter, hvilket kan resultere i en øget blodtrykssænkende
English: Preclinical safety studies have demonstrated that the combination of aliskiren and amlodipine was well tolerated in rats.
Danish: Prækliniske sikkerhedsstudier har vist, at kombinationen af aliskiren og amlodipin er veltolereret hos rotter.
English: In 3 additional cases where severe hyponatremia was associated with neurological symptoms such as brain oedema or major confusion and cerebral oedema,
Danish: I yderligere 3 tilfælde, hvor svær hyponatriæmi var forbundet med neurologiske symptomer, så som hjerneødem eller svær forvirring, og cerebralt ødem,
English: If anaphylactic reactions or angioedema occur, Rasilamlo 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 Rasilamlo 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 can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information
English: During the reporting a number of serious and non-serious adverse drug reactions (ADRs) from postmarketing data sources regarding “hyponatraemia” raised a concern that led to the submission of a cumulative review from the Marketing Authorisation Holder (MAH).
Danish: I rapporteringsperioden har et antal alvorlige og ikke-alvorlige bivirkninger (ADRs) i form af ”hyponatriæmi” i datakilder for tiden efter markedsføring givet anledning til bekymring, og ført til, at indehaveren af markedsføringstilladelsen (MAH) har indsendt en kumulativ oversigt.
English: The clearance of aliskiren increased in an age-dependent manner.
Danish: Aliskiren-clearance steg aldersafhængigt.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Danish: I kontrollerede kliniske studier blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af aliskiren.
English: If blood pressure remains uncontrolled after 4 to 6 weeks of therapy, the dose may be titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine.
Danish: Hvis blodtrykket forbliver ukontrolleret efter 4 til 6 ugers behandling, kan dosis øges til den maksimale dosis på 300 mg aliskiren/10 mg amlodipin.
English: The MAH submitted an analysis with 1407 cases of “dyspnoea”, in 13 of them there was positive dechallenge and three cases with positive rechallenge.
Danish: MAH indsendte en analyse af 1407 tilfælde af ”dyspnø”, i 13 af disse tilfælde forsvandt bivirkningen efter seponering, og i 3 tilfælde opstod den igen efter reeksponering.
English: Anaphylactic reactions a, hypersensitivity reactions a
Danish: Anafylaktiske reaktioner a, overfølsomhedsreaktioner a
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with aliskiren alone.
Danish: Kraftig hypotension var usædvanlig (0,1 %) hos patienter med ukompliceret hypertension, som blev behandlet med aliskiren alene.
English: The results of this study did not suggest that age, body weight or gender have any significant effect on aliskiren
Danish: Studiets resultater tyder ikke på, at alder, kropsvægt eller køn har nogen signifikant effekt på den systemiske
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger, vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Danish: Det anbefales at begrænse dosis af simvastatin til 20 mg dagligt til patienter, som er i
English: Rasilamlo is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Danish: Rasilamlo frarådes i den tidlige periode af graviditeten, og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages
English: Rasilamlo contains two active substances, called aliskiren and amlodipine.
Danish: Rasilamlo indeholder to aktive stoffer, som kaldes aliskiren og amlodipin.
English: If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea, the ability to react may
Danish: Hvis patienter, der får amlodipin, lider af svimmelhed, hovedpine, træthed eller kvalme kan evnen til
English: Intravenous calcium gluconate may be beneficial in reversing the
Danish: Intravenøs calciumglyconat kan være gavnlig til ophævelse af
English: The effect on blood pressure is seen within 1 week and maximum effect is reached at around 4 weeks.
Danish: Virkningen på blodtrykket ses inden for 1 uge og maksimal virkning opnås efter ca. 4 ugers behandling.
English: Additional information on individual components Adverse reactions previously reported with one of the individual components may occur with Rasilamlo even if not observed in clinical trials.
Danish: Yderligere information om de individuelle komponenter Bivirkninger, som tidligere er indberettet for de individuelle komponenter kan også opstå for Rasilamlo, selv, hvor de ikke er set i kliniske undersøgelser.
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
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: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see interaction with fruit juice).
Danish: Der er derfor risiko for interaktion mellem hæmmere af OATP og aliskiren, hvis de administreres samtidigt (se interaktion med frugtjuice).
English: , gingival hyperplasia
Danish: , gingival hyperplasi
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: Limited safety data are available from a pharmacokinetic study of aliskiren treatment in 39 hypertensive children aged 6 to less than 18 years (see sections 4.8 and 5.2).
Danish: Begrænsede sikkerhedsdata er tilgængelige fra et farmakokinetisk studie med aliskirenbehandling hos 39 hypertensive børn i alderen fra 6 år og op til 18 år (se pkt.4.8 og 5.2).
English: , thrombocytopenia
Danish: , trombocytopeni
English: Keep your appointments with the doctor even if
Danish: Overhold dine aftaler med lægen, også selvom du føler dig rask.
English: There were no new toxicities or increased severity of the toxicities which were associated with either
Danish: Der blev ikke set nye toksiciteter eller øget alvorlighed af toksiciteterne, som kunne forbindes med nogle af stofferne.
English: - if your urine flow has decreased markedly for 24 hours or more and/or if you have serious kidney problems (e.g. require dialysis) or a narrowing or blockage of the arteries that supply
Danish: - hvis din urinmængde er markant nedsat i 24 timer eller længere tid, og/eller hvis du har alvorlige nyreproblemer (fx hvis dialyse er nødvendig) eller en forsnævring eller blokade af
English: Thus, amlodipine directly inhibits vasoconstriction and reduces vascular resistance, while aliskiren, by controlling Ang II production, can also inhibit vasoconstriction but additionally shifts water and sodium balance toward levels necessary for normotensive conditions.
Danish: Herved hæmmer amlodipin direkte vasokonstriktion og nedsat vaskulær modstand, mens aliskiren ved at kontrollere Ang II dannelsen, også kan hæmme vasokonstriktion, og yderligere vender vand og saltbalancen til niveauer, der er nødvendige ved normotensive tilstande.
English: If symptomatic hypotension should occur with Rasilamlo, supportive treatment should be initiated.
Danish: Hvis der skulle opstå symptomatisk hypotension med Rasilamlo, bør der iværksættes støttende
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON TIL DELPAKNING (UDEN BLÅ BOKS)
English: The combined action of aliskiren and amlodipine on these two central blood pressure-regulating factors (vasoconstriction and RAAS-mediated hypertensive effects) results in more effective antihypertensive effects than seen with monotherapy.
Danish: Den kombinerede virkning af aliskiren og amlodipin på disse to centrale blodtryksregulerende faktorer (vasokonstriktion og RAAS-medierede hypertensiv virkning) giver en mere effektiv antihypertensiv virkning, end set med monoterapi.
English: - Non-steroidal anti-inflammatory drugs (NSAIDs) As with other medicinal products acting on the renin-angiotensin-aldosterone system, NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID) Som for andre lægemidler, der virker på renin-angiotensin-aldosteron-systemet, kan NSAID reducere aliskirens antihypertensive effekt.
English: Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering med amlodipin kræver aktiv kardiovaskulær støttebehandling inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hæve ekstremiteter og opmærksomhed på cirkulerende blodvolumen og urinproduktion.
English: 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: 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: The safety and efficacy of Rasilamlo in children below age 18 have not been established.
Danish: Rasilamlos sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: There is no experience of overdose with Rasilamlo.
Danish: Der er ikke erfaring med tilfælde af overdosering med Rasilamlo.
English: A switch to a suitable alternative antihypertensive treatment should be carried out in advance of a planned pregnancy since Rasilamlo should not be used in
Danish: Et skift til en passende hypertensionsbehandling skal ske inden planlagt graviditet, da Rasilamlo ikke må anvendes af kvinder, som planlægger at blive gravide.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterforlien efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Following oral administration of Rasilamlo, the median peak plasma concentration time is within 3 hours for aliskiren and 8 hours for amlodipine.
Danish: Efter oral indgivelse af Rasilamlo er tiden til middel peak-plasmakoncentrationen inden for 3 timer for aliskiren og 8 timer for amlodipin.
English: , arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Danish: , arytmi (inklusive bradykardi, ventrikulær takykardi og atrieflimmer)
English: - if you have renal artery stenosis (narrowing of the blood vessels to one of both kidneys) - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body)
Danish: - hvis du har leverproblemer (nedsat leverfunktion) - hvis du har nyrearteriestenose (forsnævring af blodkarrene til en eller begge nyrer) - hvis du har alvorligt hjertesvigt (en hjertesygdom, hvor dit hjerte ikke kan pumpe tilstrækkeligt blod rundt i kroppen)
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in
Danish: Kombination af aliskiren og NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: Not all pack sizes or strengths may be available in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i dit land.
English: Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome a, toxic epidermal necrolysis (TEN)
Danish: Svære kutane bivirkninger inklusive StevensJohnsons syndrom a, toksisk epidermal nekrolyse
English: If pregnancy is detected during therapy, Rasilamlo should be discontinued accordingly as soon as
Danish: Hvis der opstår graviditet under behandlingen, skal Rasilamlo således seponeres omgående.
English: The findings from the 2- and 13-week oral toxicity studies in rats were consistent with those of aliskiren and amlodipine when both active substances are administered alone.
Danish: Hændelserne fra et 2- og 13 ugers oral toksicitetstudie i rotter var tilsvarende dem set med aliskiren og amlodipin, når begge stoffer gives alene.
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in postmarketing experience.
Danish: Akut nyresvigt, som var reversibel ved seponering af behandlingen, er efter markedsføring rapporteret hos risikopatienter, som fik aliskiren.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose basis) was close to the maximum tolerated dose for mice but not for rats.
Danish: Den højeste dosis (for mus lig med og for rotter 2 gange* den maksimalt anbefalede kliniske dosis på 10 mg baseret på mg/m2) var tæt på den maksimalt tolererede dosis for mus, men ikke for rotter.
English: The usual dose of Rasilamlo is one tablet a day.
Danish: Den sædvanlige dosis af Rasilamlo er en tablet daglig.
English: The most frequent adverse reactions for Rasilamlo are hypotension and peripheral oedema.
Danish: De hyppigste bivirkninger ved Rasilamlo er hypotension og perifert ødem.
English: The adverse reactions observed with Rasilamlo or with monotherapy with one or both of the two components are included in the table below.
Danish: Bivirkninger, der er observeret ved Rasilamlo eller ved monoterapi af en eller begge komponenter, er inkluderet i tabellen herunder.
English: There is a potential for aliskiren overexposure in children with an immature MDR1 (P-gp) system (see “Transporters” above
Danish: Der kan muligvis ske en overeksponering for aliskiren hos børn med umodent MDR1 (P-gp)-system (Se ”Transportere” ovenfor og pkt.
English: • increased muscle stiffness and inability to stretch • sensation of numbness or tingling with sensation of burning in fingers and toes
Danish: • øget muskelstivhed og svært ved at strække ud • følelse af snurren og følelsesløshed med fornemmelse af brændende fingre og tæer
English: • vision disorder (including double vision)
Danish: Synsforstyrrelser (inklusive dobbeltsyn)
English: Linearity Amlodipine exhibits linear pharmacokinetics between the therapeutic dose range of 5 mg and 10 mg.
Danish: Amlodipin udviser linær farmakokinetik i det terapeutiske dosisinterval på 5 mg og 10 mg.
English: Renin inhibitors suppress the enzymatic activity of renin, and thereby block the formation of Angiotensin II, the major effector molecule of the renin-angiotensin-aldosterone system (RAAS).
Danish: Reninhæmmere holder renins enzymatiske aktivitet nede, og blokerer derved dannelsen af Angiotensin II, der er renin-angiotensin-aldosteron systemets (RAAS) største effektfaktor.
English: The plasma exposure was approximately 100-fold higher in rats aged 14 days and 3-fold higher in rats aged 21 days compared to adult rats.
Danish: Plasma-eksponeringen var ca. 100 gange højere hos 14 dage gamle rotter og 3 gange højere hos 21 dage gamle rotter sammenlignet med voksne rotter.
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
English: If you take more Rasilamlo than you should If you have accidentally taken too many Rasilamlo tablets, talk to a doctor immediately.
Danish: Hvis du er kommet til at tage for mange Rasilamlo-tabletter, skal du straks kontakte en læge.