FrancophonIA/ELRC3.0 huggingface dataset:
English: For the combination of aliskiren and enalapril there were statistically significant differences in the rate of angina unstable compared to enalapril.
Danish: For kombinationen af aliskiren og enalapril var der statistisk signifikante forskelle i forekomsten af ustabil angina sammenlignet med enalapril alene.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking this medicine.
Danish: Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller uger efter indtagelse af lægemidlet.
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 lægemiddelinteraktioner ved P-gp's bindingssted vil sandsynligvis afhænge af, i hvor stor udstrækning denne transportør hæmmes.
English: Results from a mechanistic study showed that the MDR1 (P-gp) gene expression in juvenile rats was significantly lower when compared to adult rats.
Danish: Resultater af et mekanistisk studie viste, at ekspressionen af MDR1- (P-gp) genet hos juvenile rotter var signifikant lavere sammenlignet med voksne rotter.
English: Hepatic MDR1 mRNA expression was statistically significantly lower in samples from foetuses, neonates and infants up to 23 months.
Danish: Hepatisk MDR1-mRNA-ekspression var statistisk signifikant lavere i prøver fra fostre, nyfødte og børn op til 23 måneder.
English: This helps to lower high blood pressure in adult patients.
Danish: Dette hjælper med at sænke blodtrykket hos voksne patienter.
English: If any of the above applies to you, do not take Rasilez HCT and talk to your doctor.
Danish: Hvis noget af dette gælder for dig, skal du ikke tage Rasilez HCT og fortælle det til lægen.
English: Fertility There are no clinical data on fertility.
Danish: Fertilitet Der er ingen kliniske data vedrørende påvirkning af fertiliteten.
English: • Increased sensitivity of skin to the sun
Danish: • Øget hudfølsomhed over for sol
English: There are no data on the use of aliskiren in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af aliskiren hos gravide kvinder.
English: • Sad mood (depression)
Danish: • Nedtrykthed (depression)
English: Dosing should be individualised and adjusted according to the patient's clinical response.
Danish: Dosis børe være individuel og tilpasses patientens kliniske respons.
English: • Low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Danish: • Lavt antal blodplader (sommetider med blødning eller blå mærker under huden)
English: It is not known whether aliskiren is excreted in human milk.
Danish: Det er ukendt, om aliskiren udskilles i human mælk.
English: It is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Det frarådes under graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
English: The results of this study did not suggest that age, body weight or gender have any significant effect on aliskiren systemic exposure (see section 4.2).
Danish: Studiets resultater tyder ikke på, at alder, kropsvægt eller køn har nogen signifikant effekt på den systemiske eksponering af aliskiren (se pkt.
English: Overall, the mean age of the patients was 11.8 years with 48.6% of patients being in the 6-11 years age group and 51.4% in the 12-17 years age group.
Danish: Samlet var gennemsnitsalderen af patienter 11,8 år med 48,6 % af patienter i aldersgruppen 6-11 år og 51,4 % i aldersgruppen 12-17 år.
English: Other substances that act directly on the RAAS have been associated with serious foetal malformations and neonatal death when used during second and third trimesters.
Danish: Andre stoffer, som virker direkte på RAAS, associeres imidlertid med alvorlige fostermisdannelser og dødsfald hos nyfødte, når det anvendes i andet og tredje trimester.
English: Use of Rasilez HCT is not recommended in this population.
Danish: Brug af Rasilez anbefales ikke til denne population.
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 langt ind i det ekstravaskulære rum.
English: Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Danish: Efter oral absorption nås maksimale plasmakoncentrationer af aliskiren efter 1-3 timer.
English: When driving vehicles or using machines, it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez HCT.
Danish: Når man fører motorkøretøj eller bruger maskiner, skal man være opmærksom på, at der lejlighedsvis kan forekomme svimmelhed eller træthed under behandlingen med Rasilez HCT.
English: The safety of the combination therapy was similar to the respective monotherapies regardless of severity of hypertension or of the presence or absence of additional cardiovascular risk.
Danish: Sikkerheden af kombinationsbehandlingen svarede til de respektive monoterapier uanset alvorligheden af hypertension eller af tilstedeværelsen eller fraværet af yderligere kardiovaskulær risiko.
English: In addition, due to the possibility of up-titration if medically necessary to control the msSBP, no conclusion can be drawn on the appropriate posology of aliskiren in patients aged 6 to 17 years.
Danish: Endvidere kan der på grund af muligheden for optitrering, når det er medicinsk nødvendigt for at regulere msSBP, ikke drages nogen konklusion med hensyn til passende dosering af aliskiren hos patienter i alderen 6-17 år.
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (oral radioactive dose recovery = 91%).
Danish: Aliskiren udskilles hovedsageligt som et uændret stof i fæces (oral radioaktiv dosisgenfinding = 91 %).
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Danish: Når det er klinisk relevant, kan et direkte skift fra monoterapi til den faste kombination overvejes.
English: The mechanism of this effect has not been established.
Danish: Virkningsmekanismen er ikke klarlagt.
English: The increased aliskiren exposure in juvenile rats appears to be attributed mainly to lack of maturation of P-gp in the gastrointestinal tract.
Danish: Den forøgede aliskiren-eksponering hos juvenile rotter synes hovedsageligt at kunne tilskrives manglende modning af P-gp i gastrointestinalkanalen.
English: Although meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially, the efficacy of aliskiren was shown to be similar when taken either with a light meal or without a meal (see section 4.2).
Danish: Selvom måltider (med højt eller lavt fedtindhold) har vist sig at reducere absorptionen af aliskiren betragteligt, har effekten af aliskiren vist sig at være den samme uanset om det tages med et let måltid eller uden et måltid (se pkt.4.2).
English: This medicine must not be used in babies from birth to less than 2 years of age.
Danish: Dette lægemiddel må ikke bruges til behandling af spædbørn fra fødslen og op til 2 år.
English: Hypotension and related adverse events were uncommon with the combination treatment, with no increased incidence in elderly patients.
Danish: Hypotension og relaterede bivirkninger var ualmindelige med kombinationsbehandlingen og uden øget incidens hos ældre patienter.
English: The greater blood pressure reductions with these combination doses were also significantly greater than the respective doses of aliskiren and hydrochlorothiazide when used alone.
Danish: De større blodtryksreduktioner med disse kombinationsdoser var også signifikant større end de respektive doser af aliskiren og hydrochlorthiazid, når disse blev anvendt alene.
English: High blood pressure increases the workload of the heart and arteries.
Danish: Forhøjet blodtryk øger belastningen på hjerte og blodårer.
English: One dosage unit contains no more than 100 micrograms of gluten.
Danish: Én dosisenhed indeholder højst 100 mikrogram gluten.
English: There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Danish: Der var ingen statistisk signifikante forskelle i de gennemsnitlige ændringer i vægt, højde eller BMI mellem behandlingsgrupperne fra baseline til langsigtet opfølgningsbesøg 18 (uge 104) (primær analyse).
English: Increased cellular vacuolation of the adrenal gland zona glomerulosa was observed during the 13-week toxicity study in rats.
Danish: Der er observeret øget cellulær vakuoledannelse i binyrens zona glomerulosa i 13-ugers toksicitetsstudiet hos rotter.
English: There is no evidence that Rasilez HCT would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er ingen dokumentation for, at Rasilez HCT vil reducere eller forhindre diuretikainduceret hyponatriæmi.
English: The adverse reactions listed in the table above, which are marked with the reference “h”, have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide.
Danish: Bivirkningerne, der er anført i listen ovenfor, som er markeret med referencen ”h”, er blevet rapporteret hos patienter behandlet med thiazid-diuretika alene, inklusive hydrochlorthiazid.
English: Hypromellose substitution type 2910 (3 mPa·s) Macrogol 4000
Danish: Hypromellose substitutionstype 2910 (3 mPa·s) Macrogol 4000
English: Transporters
Danish: Transportere
English: Respiratory distress (including pneumonitis and pulmonary oedema) h
Danish: Respirationsbesvær (herunder pneumonitis og lungeødem)h
English: Safety pharmacology studies with aliskiren did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Danish: Studier af sikkerhedsfarmakologi med aliskiren afslørede ingen negative virkninger på centralnervesystem, respiration eller kardiovaskulær funktion.
English: However, staggering the dose 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 dosen af hydrochlorthiazid og anionbytter således, at hydrochlorthiazid gives mindst 4 timer før eller 4-6 timer efter indgift af anionbytter kan dog muligvis minimere interaktionen.
English: The finding was observed in animals treated with hydrochlorothiazide but not in those animals receiving aliskiren alone or vehicle.
Danish: Resultaterne blev observeret hos dyr behandlet med hydrochlorthiazid, men ikke hos dyr, som fik aliskiren alene eller vehikel.
English: Palpitationsa, oedema peripherala
Danish: Palpitationera, perifert ødema
English: In addition, an increased incidence of adverse events was observed with aliskiren compared to placebo (38.2% versus 30.3%).
Danish: Desuden blev der observeret en øget forekomst af bivirkninger ved aliskiren sammenlignet med placebo (38,2 % vs. 30,3 %).
English: • Liver disorders which can occur together with yellow skin and eyes
Danish: • Leversygdomme, der kan optræde sammen med gulfarvning af hud og øjne
English: The effect of drinks containing plant extracts (including herbal teas) on the absorption of aliskiren has not been investigated.
Danish: Virkningen af drikkevarer indeholdende planteekstrakter (inklusive urteteer) på absorptionen af aliskiren er ikke undersøgt.
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 blodårerne i hjernen, hjertet og nyrerne, som kan føre til slagtilfælde, hjertesvigt, hjerteanfald eller nyresvigt.
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with Rasilez HCT.
Danish: På grund af risiko for terapisvigt bør frugtjuice ikke tages sammen med Rasilez HCT.
English: The most likely manifestation of overdose 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 increase in mean AUC is linear and dose proportional in the therapeutic range.
Danish: Stigning i middelAUC er lineær og proportional med dosis i det terapeutiske område.
English: In controlled clinical study, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
Danish: I kontrollerede, kliniske studier var incidensen af diarré hos Rasilez HCT-behandlede patienter 1,3 %, sammenlignet med 1,4 % for aliskiren- eller 1,9 % for hydrochlorthiazidbehandlede patienter.
English: • Kidney problems including acute renal failure (severely decreased urine output)
Danish: • Nyreproblemer inklusive akut nyresvigt (svært nedsat urinproduktion)
English: At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Danish: Ved afslutningen af forlængelsesstudiet var ændringer i msSBP i forhold til baseline tilsvarende for aliskiren når sammenlignet med enalapril (7,63 mmHg vs. -7,94 mmHg) i det samlede analysesæt.
English: − Hereditary or idiopathic angioedema.
Danish: − Arvelig eller idiopatisk angioødem.
English: Excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: En for stor reduktion af blodtrykket kan hos patienter med iskæmisk kardiomyopati eller iskæmisk kardiovaskulær sygdom føre til myokardieinfarkt eller slagtilfælde.
English: The antihypertensive effect of Rasilez HCT may be increased with the concomitant use of other antihypertensive agents.
Danish: Rasilez HCT's antihypertensive virkning kan øges ved samtidig brug af andre antihypertensiva.
English: Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation.
Danish: Resultater fra et in vitro MDR1-studie med humant væv antydede et alders- og vævsafhængigt mønster for MDR1 (P-gp)-transportermodning.
English: Therefore, dialysis is not adequate to treat aliskiren over-exposure.
Danish: Dialyse er derfor ikke tilstrækkeligt til behandling af aliskiren-overdosering.
English: • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder) (frequency not known: frequency cannot be estimated from the available data).
Danish: • Kvalme, manglende appetit, mørk-farvet urin eller gulfarvning af hud og øjne (tegn på leversygdom) (hyppighed ikke kendt: hyppighed kan ikke estimeres ud fra forhåndenværende data).
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-gpinduktor, nedsatte aliskirens biotilgængelighed med omkring 50 % i kliniske studier.
English: Rasilez HCT contains lactose and wheat starch (containing gluten) This medicine contains lactose (milk sugar).
Danish: Rasilez HCT indeholder lactose og hvedestivelse (indeholder gluten) Dette lægemiddel indeholder lactose (mælkesukker).
English: By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Danish: Ved at hæmme enzymet renin hæmmer aliskiren RAAS ved aktiveringspunktet og blokerer konverteringen af angiotensinogen til angiotensin I og mindsker niveauet af angiotensin I og angiotensin II.
English: You should establish a convenient daily schedule to take the medicine the same way each day, in a regular pattern with respect to the timing of your meals.
Danish: Du bør indføre en praktisk daglig rutine, så du tager lægemidlet på samme måde hver dag i et regelmæssigt mønster i forhold til dine måltider.
English: Adverse reactions previously reported with one of the individual components may occur with Rasilez HCT even if not observed in clinical study.
Danish: Bivirkninger, der tidligere er blevet indberettet for en af de individuelle komponenter, kan forekomme med Rasilez HCT, selvom de ikke er blevet observeret i kliniske studier.
English: Diarrhoeac,a,h, decreased appetiteh, nausea and vomitinga,h
Danish: Diarréc,a,h, nedsat appetith, kvalme og opkastninga,h
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PVC/PCTFE OR PA/ALU/PVC) BLISTER (CALENDAR) (PVC/PCTFE OR PA/ALU/PVC)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (PVC/PCTFE ELLER PA/ALU/PVC) BLISTER (KALENDERPAKNING) (PVC/PCTFE ELLER PA/ALU/PVC)
English: No carcinogenic potential for aliskiren was detected in a 2-year rat study and a 6-month transgenic mouse study.
Danish: Der blev ikke observeret karcinogent potentiale i et 2-årigt rottestudie og i et 6-måneders studie hos transgene mus.
English: Therefore, the use of Rasilez HCT with an NSAID requires caution, especially in elderly patients.
Danish: Anvendelse af Rasilez HCT sammen med et NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: Cutaneous lupus erythematosus-like reactionsh, reactivation of cutaneous lupus erythematosush, vasculitis necrotising and toxic epidermal necrolysish
Danish: Kutan lupus erythematosus-lignende reaktionerh, reaktivering af kutan lupus erythematosush, nekrotiserende vaskulitis og toksisk epidermal nekrolyseh
English: However, in the subsequent 4 week randomised withdrawal phase of the study (Phase 2), the effect of aliskiren overlapped with the effects observed in patients switched to placebo in all dose groups (low, p=0.8894; mid, p=0.9511; high, p=0.0563).
Danish: I den efterfølgende 4-ugers nedtrapningsfase af studiet (fase 2) overlappede effekten af aliskiren imidlertid med effekterne set hos patienter, der skiftede til placebo, i alle dosisgrupper (lav, p=0,8894; middel, p=0,9511; høj, p=0,0563).
English: This medicine contains two active substances, called aliskiren and hydrochlorothiazide.
Danish: Dette lægemiddel indeholder to aktive stoffer, som kaldes aliskiren og hydrochlorthiazid.
English: Aliskiren is a P-glycoprotein (P-gp) substrate, and there is a potential for aliskiren overexposure in children with an immature P-gp drug transporter system.
Danish: Aliskiren er et P-glykoprotein (P-gp)-subtrat, og der kan muligvis forekomme overeksponering for aliskiren hos børn med umodent P-gp-lægemiddeltransportsystem.
English: The primary endpoint was a composite of cardiovascular death and first hospitalisation for heart failure.
Danish: Det primære endepunkt var en sammensætning af kardiovaskulær død og første hospitalsindlæggelse med hjertesvigt.
English: • Decrease in vision or pain in your eyes due to high pressure (possible signs of acute-angle closure glaucoma)
Danish: • Nedsat syn eller øjensmerter på grund af højt tryk i øjet (kan være tegn på akut lukketvinklet glaukom)
English: The study showed no benefit of aliskiren when administered on top of standard therapy for acute heart failure and an increased risk of cardiovascular events in patients with diabetes mellitus.
Danish: Studiet viste ingen fordel ved aliskiren, når det blev lagt oveni standardbehandling af akut hjertesvigt, og en øget risiko for kardiovaskulære tilfælde hos patienter med diabetes mellitus.
English: Following oral administration of Rasilez HCT tablets, the median peak plasma concentration time is within 1 hour for aliskiren and 2.5 hours for hydrochlorothiazide.
Danish: Efter oral indgivelse af Rasilez HCT-tabletter er tiden for middel peak-plasmakoncentrationen under 1 time for aliskiren og 2,5 timer for hydrochlorthiazid.
English: Swallow the tablet whole with some water.
Danish: Slug tabletten hel med vand.
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,selektiv og direkte hæmmer af humant renin.
English: Microcrystalline cellulose Crospovidone, type A
Danish: Mikrokrystallinsk cellulose Crospovidon, type A
English: Rasilez HCT is contraindicated in children from birth to less than 2 years.
Danish: Rasilez HCT er kontraindiceret til børn fra fødslen og op til 2 år.
English: However, the significance of the non-inferiority testing was not maintained when the analysis was performed on the per-protocol set in which the least square mean change in msSBP from baseline was -7.84 mmHg with aliskiren and -9.04 mmHg with enalapril.
Danish: Signifikansen af non-inferioritetstestning vedblev dog ikke ved analyse af et per-protokol-sæt, hvor den gennemsnitlige ændring i mindste kvadrat for msSBP i forhold til baseline var -7,84 mmHg med aliskiren og -9,04 mmHg med enalapril.
English: However the efficacy of aliskiren was similar when taken with a light meal or under fasted state.
Danish: Dog var effekten af aliskiren den samme, uanset om det blev taget med et let måltid eller fastende.
English: It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Danish: Det kan også anvendes til patienter, hvor blodtrykket er tilstrækkelig kontrolleret med aliskiren og hydrochlorthiazid, taget som separate tabletter, for at erstatte den samme dosis af de to aktive stoffer.
English: Urticaria and other forms of rasha,h
Danish: Urticaria og andre former for udslæta,h
English: Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA Italy
Danish: Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA Italien
English: If Rasilez HCT is used during breast-feeding, doses should be kept as low as possible.
Danish: Hvis Rasilez HCT anvendes under amning, bør dosis holdes så lav som muligt.
English: Astheniah, pyrexiah
Danish: Astenih, pyreksih
English: Treatment effects were similar in patients with diabetes and with renal insufficiency.
Danish: Behandlingseffekter var ens hos patienter med diabetes og patienter med nyreinsufficiens.
English: Mean weight was 68.0 kg with 57.7% of patients having BMI greater than or equal to the 95th percentile for age and gender.
Danish: Gennemsnitsvægten af patienter var 68,0 kg og 57,7 % af patienter havde et kropsmasseindeks højere end eller svarende til 95-percentilen for alder og køn.
English: Rasilez HCT should be discontinued if hypercalcaemia develops during treatment.
Danish: Rasilez HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: The findings observed in the 2-week and 13-week toxicity studies were consistent with those observed previously with aliskiren or hydrochlorothiazide monotherapies.
Danish: De observerede resultater i 2-ugers og 13-ugers toksicitetsstudier er i overensstemmelse med de resultater, som tidligere er observeret for aliskiren og hydrochlorthiazid monoterapi.
English: This medicine is used to treat high blood pressure in adult patients.
Danish: Dette lægemiddel anvendes til behandling af for højt blodtryk hos voksne.
English: Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly (see section “Fruit juice and drinks containing plant extracts” above).
Danish: Der er derfor risiko for interaktion mellem hæmmere af OATP og aliskiren, hvis de administreres samtidigt (se punktet ”Frugtjuice og drikkevarer indeholdende planteekstrakter” ovenfor).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA52
Danish: Farmakoterapeutisk klassifikation: Stoffer, der virker på renin-angiotensin-systemet, reninhæmmer ATC-kode: C09XA52