FrancophonIA/ELRC3.0 huggingface dataset:
English: • Fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)
Danish: • Feber, ondt i halsen eller sår i munden, øget hyppighed af infektioner (manglende eller lavt antal hvide blodlegemer)
English: Upon withdrawal of the aliskiren treatment (aliskiren with or without hydrochlorothiazide add-on), the return of blood pressure towards baseline was gradual (3-4 weeks) with no evidence of the rebound effect.
Danish: Ved ophør af aliskirenbehandlingen (aliskiren med eller uden tillæg af hydrochlorthiazid) vendte blodtrykket gradvist tilbage til udgangspunktet (over 3-4 uger) uden tegn på reboundeffekt.
English: Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Danish: Yderligere information om interaktioner med hydrochlorthiazid Ved samtidig administration kan følgende lægemidler interagere med thiaziddiuretika:
English: The rate and extent of absorption of Rasilez HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Danish: Hastigheden og omfanget af absorptionen af Rasilez HCT svarer til biotilgængeligheden for aliskiren og hydrochlorthiazid, når det indgives som individuelle monoterapier.
English: Some side effects can be serious: A few patients have experienced these serious side effects.
Danish: Nogle bivirkninger kan være alvorlige: Nogle få patienter har oplevet disse alvorlige bivirkninger Kontakt din læge med det samme, hvis du oplever noget af følgende:
English: General disorders and administration site conditions Not known
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke kendt
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local (gastrointestinal tract) irritation potential or the expected pharmacological effects of aliskiren.
Danish: Fund i toksicitetsstudier med gentagne doser hos dyr var i overensstemmelse med det kendte potentiale for lokalirritation (gastrointestinalkanalen) eller de forventede farmakologiske virkninger af aliskiren.
English: Rasilez HCT is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section “Pregnancy”).
Danish: Rasilez HCT frarådes i den tidlige periode af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det tages på dette tidspunkt (se punktet om Graviditet).
English: Rasilez HCT combines two antihypertensive active substances to control blood pressure in patients with essential hypertension: Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics.
Danish: Rasilez HCT kombinerer to antihypertensive aktive indholdsstoffer til kontrol af blodtryk hos patienter med essentiel hypertension: Aliskiren tilhører klassen af direkte reninhæmmere og hydrochlorthiazid tilhører klassen af thiaziddiuretika.
English: Dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is therefore not recommended.
Danish: Dobbelt hæmning af RAAS ved kombination af aliskiren med en ACE-hæmmer eller en ARB frarådes derfor.
English: Symptomatic hypotension could occur after initiation of treatment with Rasilez HCT in the following cases:
Danish: Symptomatisk hypotension kan forekomme hos patienter i behandling med Rasilez HCT i følgende tilfælde:
English: Rasilez HCT should be taken once a day, always with or always without food, preferably at the same time each day.
Danish: Rasilez HCT bør tages én gang daglig, altid med eller altid uden mad, fortrinsvis på samme tidspunkt hver dag.
English: Rasilez HCT contains lactose.
Danish: Rasilez HCT indeholder lactose.
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Danish: Det er blevet påvist, at der er en højaffinitetsreceptor i renal cortex som det primære bindingssted for den thiaziddiuretiske virkning og hæmning af NaC1-transport i tubulus contortus distalis.
English: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/25 mg daily.
Danish: Hvis blodtrykket ikke er under kontrol efter 2-4 ugers behandling kan dosis titreres op til en maksimal daglig dosis på 300 mg/25 mg Rasilez HCT.
English: The final results of the study did not demonstrate statistically that aliskiren was non-inferior to enalapril on the primary endpoint, however there was essentially no difference in the observed incidence rates between aliskiren and enalapril (hazard ratio of 0.99 with 95% Confidence Interval: 0.90-1.10).
Danish: De endelige resultater af studiet viste ikke statistisk, at aliskiren ikke var ringere end enalapril på det primære endepunkt, men der var i det væsentlige ingen forskel i den observerede incidensrate mellem aliskiren og enalapril (Hazard Ratio på 0,99 med 95 % konfidensinterval: 0,90-1,10).
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Danish: Hypokaliæmi kan resultere i muskelspasmer og/eller forstærke hjertearytmier forbundet med samtidig brug af digitalis glykosider eller visse antiarytmiske lægemidler.
English: The European Medicines Agency has waived the obligation to submit results of studies with Rasilez HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rasilez HCT i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: The most common adverse reaction observed with Rasilez HCT is diarrhoea.
Danish: Den mest almindelige bivirkning set for Rasilez HCT er diarré.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svært hjertesvigt (New York Heart Association (NYHA) klasse III-IV) (se pkt.
English: Medicinal products that could induce torsades de pointes Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Danish: Lægemidler som kan forårsage torsades de pointes På grund af risiko for hypokaliæmi bør hydrochlorthiazid gives med forsigtighed sammen med lægemidler, der kan forårsage torsades de pointes især Klasse Ia og Klasse III antiarytmika og visse antipsykotika.
English: Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Danish: Administration af thiaziddiuretika samtidig med midler, som også har en blodtrykssænkende virkning (fx ved at reducere aktiviteten i det sympatiske centralnervesystem eller ved direkte vasodilatation) kan forstærke ortostatisk hypotension.
English: − Severe renal impairment (GFR < 30 ml/min/1.73 m2).
Danish: − Stærkt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2).
English: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Danish: Der blev observeret små fald i hæmoglobin og hæmatokritværdi (gennemsnitligt fald på henholdsvis ca. 0,05 mmol/l og 0,16 volumenprocent).
English: Increases in cholesterol and triglyceridesh
Danish: Stigning i kolesterol og triglyceriderh
English: Warnings and precautions Talk to your doctor before taking Rasilez HCT: - if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Danish: Kontakt lægen, før du tager Rasilez HCT - hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: The absorption of hydrochlorothiazide, after an oral dose, is rapid (Tmax about 2 h).
Danish: Efter en oral dosis absorberes hydrochlorthiazid hurtigt (Tmax omkring 2 timer).
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 blisterpakken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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: 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: One colonic adenoma and one caecal adenocarcinoma recorded in rats at the dose of 1500 mg/kg/day were not statistically significant.
Danish: Der er registreret et tilfælde af adenom i colon og et tilfælde af adenokarcinom i coecum hos rotter ved dosen 1.500 mg/kg/dag, hvilket ikke var statistisk signifikant.
English: Name and address of the manufacturer(s) responsible for batch release Noden Pharma DAC
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Noden Pharma DAC
English: The combination of aliskiren and hydrochlorothiazide neutralised the reactive increase of PRA caused by hydrochlorothiazide.
Danish: Kombinationen af aliskiren og hydrochlorthiazid neutraliserede den reaktive øgning af PRA forårsaget af hydrochlorthiazid.
English: This effect is also seen with other agents acting on the renin-angiotensin system, such as ACEIs and ARBs.
Danish: Denne virkning ses også med andre stoffer, som virker på renin-angiotensin-systemet, fx ACE-hæmmere og ARB'er.
English: Patients should establish a convenient daily schedule of medicinal product intake and maintain a steady temporal relationship with food intake.
Danish: Patienter bør indføre en passende daglig rutine for lægemiddelindtagelsen og fastholde en rutine i forhold til madindtagelse.
English: However, compounds potentially inhibiting organic anion transporting polypeptide-mediated uptake of aliskiren are widely present in fruits, vegetables, and many other plant products.
Danish: Imidlertid er stoffer, der potentielt kan hæmme organisk anion-transport-polypeptid-medieret optagelse af aliskiren, i vid udstrækning til stede i frugt, grøntsager og mange andre planteprodukter.
English: The safety and efficacy of aliskiren in children aged 6 to 17 years have not yet been established.
Danish: Aliskirens sikkerhed og virkning hos børn i alderen 6-17 år er endnu ikke klarlagt.
English: The usual dose of Rasilez HCT is one tablet a day.
Danish: Den sædvanlige dosis af Rasilez HCT er én tablet daglig.
English: Where there is involvement of the tongue, glottis or larynx, adrenaline should be administered.
Danish: Hvis tunge, glottis eller svælg er involveret, skal der gives adrenalin.
English: You may need to stop Rasilez HCT.
Danish: Det kan være nødvendigt at stoppe behandlingen med Rasilez HCT.
English: Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medicines: - furosemide or torasemide, medicines belonging to the type known as diuretics, or water tablets,
Danish: Det kan være nødvendigt for din læge at ændre din dosis og/eller tage andre forholdsregler, hvis du tager et af følgende lægemidler: - furosemid eller torasemid, er medicin, der tilhører gruppen diuretika, også kaldet vanddrivende tabletter og bruges til at øge urinproduktionen.
English: Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilez HCT.
Danish: Derfor bør drikkevarer indeholdende planteekstrakter, inklusive urteteer, ikke indtages sammen med Rasilez HCT.
English: If pregnancy is detected during therapy, Rasilez HCT should be discontinued as soon as possible.
Danish: Hvis der opstår graviditet under behandlingen, skal Rasilez HCT seponeres så hurtigt som muligt.
English: − The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent
Danish: − Brug af aliskiren sammen med ciclosporin eller itraconazol, to yderst potente P-glykoprotein
English: • Bruising and frequent infections (aplastic anaemia)
Danish: • Blå mærker og hyppige infektioner (aplastisk anæmi)
English: Digoxine or other digitalis glycosides
Danish: Digoxin og andre digitalisglykosider
English: Whereas other agents that inhibit the RAAS (angiotensin converting enzyme inhibitors (ACEI) and angiotension 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 angiotension-II receptorblokkere (ARB)), forårsager en kompensatorisk stigning i plasmareninaktiviteten (PRA), mindsker behandling med aliskiren PRA hos hypertensive patienter med ca. 50-80 %.
English: No pharmacokinetic data on Rasilez HCT are available in the paediatric population.
Danish: Der er ingen tilgængelige farmakokinetiske data for Rasilez HCT hos den pædiatriske population.
English: The incidence of atrial fibrillation was 11.1%, 13.3%, and 11.0% in the combination, aliskiren, and enalapril groups, respectively.
Danish: Incidensen af atrieflimren var henholdsvis 11,1 %, 13,3 % og 11,0 % hos patienterne der fik henholdsvis kombinationen, aliskiren og enalapril.
English: No clinically relevant differences in efficacy or safety results were observed in the subpopulation of elderly patients with a history of hypertension and chronic heart failure Class I-II compared to the overall study population.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i resultater for effekt eller sikkerhed hos undergruppen af ældre patienter, der tidligere havde haft hypertension og kronisk hjertesvigt klasse I-II sammenlignet med den samlede studiepopulation.
English: After single dose administration in the dose range of 75 to 600 mg, a 2-fold increase in dose results in a ~2.3 and 2.6-fold increase in AUC and Cmax, respectively.
Danish: Efter administration af en enkelt dosis i intervallet 75 til 600 mg, resulterede en fordobling i dosis i en ~2,3 og 2,6 gange stigning i respektivt AUC og Cmax.
English: See also section “Do not take Rasilez HCT”.
Danish: Se ogsåpunktet ”Tag ikke Rasilez HCT”.
English: The volume or salt depletion should be corrected prior to administration of Rasilez HCT, or the treatment should start under close medical supervision.
Danish: Væske- og natriummangel bør korrigeres før administration af Rasilez HCT, eller behandlingen skal indledes under nøje klinisk overvågning.
English: If photosensitivity reaction occurs during treatment with Rasilez HCT, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Rasilez HCT, anbefales det at seponere behandlingen.
English: Pharmacokinetic interactions with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: Farmakokinetiske interaktioner med andre lægemidler - Stoffer, som er undersøgt i kliniske farmakokinetiske studier, inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: However, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Danish: Der er dog en øget risiko for nyreinsufficiens, inklusive akut nyresvigt, når patienter med nyrearteriestenose behandles med aliskiren.
English: You should take this medicine once a day, always with or always without food, preferably at the same time each day.
Danish: Du skal tage dette lægemiddel én gang daglig, altid med eller altid uden mad, og helst på samme tidspunkt hver dag.
English: − Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
Danish: − Hyponatriæmi, hyperkalcæmi, symptomatisk hyperurikæmi og refraktær hypokaliæmi.
English: In the subgroup of patients with diabetes mellitus the hazard ratio was 1.64 in favour of placebo (95% Confidence Interval: 1.15-2.33), whereas the hazard ratio in the subgroup of patients without diabetes was 0.69 in favour of aliskiren (95% Confidence Interval: 0.50-0.94); p-value for interaction = 0.0003.
Danish: I undergruppen af patienter med diabetes mellitus var hazard ratio 1,64 til fordel for placebo (95 % konfidensinterval: 1,15-2,33), hvorimod hazard ratio i undergruppen af patienter uden diabetes var 0,69 til fordel for aliskiren (95 % konfidensinterval: 0,50-0,94); p-værdi for interaktion=0,0003.
English: Information on Rasilez HCT interactions
Danish: Information om interaktioner med Rasilez HCT
English: Rasilez HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Danish: Rasilez HCT har vist sig effektiv som antihypertensiv behandling en gang daglig til voksne patienter uanset køn, alder, BMI og etnicitet.
English: The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Danish: Risikoen for hypokaliæmi er størst hos patienter med levercirrhose, hos patienter, der oplever kraftig diurese, hos patienter, der har mangelfuld oral indtagelse af elektrolytter, og hos patienter, der samtidig modtager behandling med kortikosteroider eller adrenocorticotropt hormon (ACTH) (se pkt.
English: Therefore, Rasilez HCT 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 (see section 4.2 and 4.3).
Danish: Derfor er Rasilez HCT 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 (se pkt.
English: The adverse reactions observed with Rasilez HCT or with monotherapy with one or both of the two components are included in the table below.
Danish: Bivirkninger, der er observeret ved Rasilez HCT eller ved monoterapi af en eller begge komponenter, er inkluderet i tabellen herunder.
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Danish: Studiet blev forlænget med et 52-ugers dobbeltblindet, randomiseret studie for at evaluere sikkerheden, tolerabiliteten og effekten af aliskiren sammenlignet med enalapril hos 208 pædiatriske hypertensive patienter i alderen 6-17 år (ved baseline i det tidligere studie).
English: Angioedemaa, erythemaa, photosensitivity reactionsh
Danish: Angioødema, erytema, lysfølsomhedsreaktionerh
English: In the event that any signs of renal failure occur, aliskiren should be promptly discontinued.
Danish: I tilfælde af at der opstår tegn på nyresvigt, skal aliskirenbehandling afbrydes med det samme.
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
Danish: I et studie udført hos hæmodialyse-patienter med nyresygdom i slutstadie (end stage renal disease, ESRD) var clearencedialyse af aliskiren lav (< 2 % oral clearence).
English: Depressionh, sleep disturbancesh
Danish: Depressionh, søvnforstyrrelser h
English: • Dizziness, fainting on standing up
Danish: • Svimmelhed eller besvimelse, når man rejser sig
English: Aliskiren/hydrochlorothiazide
Danish: Aliskiren/hydrochlorthiazid
English: Non-depolarising skeletal muscle relaxants
Danish: Ikke-depolariserende muskelrelaksantia
English: Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Danish: Derfor kan P-gp-induktorer muligvis øge vævskoncentrationen mere end plasmakoncentrationen.
English: Although aliskiren has known local (gastrointestinal tract) irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Danish: Selvom aliskiren har et kendt irritationspotentiale (gastrointestinalkanalen) blev de opnåede sikkerhedsmargener i et studie på raske frivillige forsøgspersoner hos mennesker ved en dosis på 300 mg anset for at være passende ved 9-11 gange baseret på fækale koncentrationer eller 6 gange baseret på koncentrationerne i mucosa, sammenlignet med 250 mg/kg/dag i karcinogenitetsstudiet hos rotter.
English: There was a greater LS mean increase from Baseline in height after 104 weeks (at LT Visit 19 [Week 156], secondary hypertension patients) compared to the increase observed after 52 weeks (at LT Visit 18 [Week 104], primary hypertension patients), which is expected in these growing paediatric patients.
Danish: Der var en større stigning i mindste kvadrants gennemsnit for højde efter 104 uger i forhold til baseline (ved langsigtet opfølgningsbesøg 19 [uge 156], patienter med sekundær hypertension) sammenlignet med stigningen observeret efter 52 uger (ved langsigtet opfølgningsbesøg 18 [uge 104], patienter med primær hypertension), hvilket forventes hos disse voksende pædiatriske patienter.
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: Orthostatic hypotensionh
Danish: Ortostatisk hypotensionh
English: • Sleep disturbances
Danish: • Søvnforstyrrelser
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Danish: Der blev påvist en kumulativ dosis/respons relation med en justeret OR-værdi på 2,1 (95 %-KI: 1,7-2,6), der steg til OR 3,9 (3,0-4,9) ved et stort forbrug (~25.000 mg) og OR 7,7 (5,7-10,5) ved den højeste kumulative dosis (~100.000 mg) (se også pkt.
English: Not recommended (see section 4.2)
Danish: Anbefales ikke (se pkt.
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.
Danish: Akut nyresvigt, som er reversibel ved behandlingsophør, er efter markedsføring rapporteret hos risikopatienter, som fik aliskiren.
English: In hypertensive patients, once-daily administration of Rasilez HCT provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval.
Danish: Hos hypertensive patienter gav administration af Rasilez HCT én gang dagligt dosis-afhængige reduktioner i både systolisk og diastolisk blodtryk, som blev vedligeholdt i hele 24-timers dosisintervallet.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Noden Pharma DAC
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Noden Pharma DAC