FrancophonIA/ELRC3.0 huggingface dataset:
English: With amlodipine, available data suggest that gross overdose could result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Danish: Tilgængelige data vedrørende amlodipin antyder, at kraftig overdosering kan resultere i udtalt perifer vasodilatation og muligvis refleks-takykardi.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, renin-inhibitors; ATC code C09XA54
Danish: Farmakoterapeutisk klassifikation: Stoffer, der virker på renin-angiotensin-systemet, renin-hæmmere; ATC-kode: C09XA53
English: Study results indicated a hazard ratio for the primary endpoint of 1.11 in favour of placebo (95% Confidence Interval: 1.00, 1.23, 2-sided p=0.05).
Danish: Resultater fra studiet indikerede en hazard ratio for det primære endepunkt på 1,11 til fordel for placebo (95 % konfidensinterval: 1,00-1,23, 2-sidet p=0,05).
English: Amlodipine can have minor or moderate influence on the ability to drive and use machines.
Danish: Amlodipin kan have indflydelse på evnen til at føre motorkøretøj eller betjene maskiner i mindre eller moderat grad.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brug i andet og tredje trimester kompromittere den føto-placentale perfusion og forårsage føtale og neonatale virkninger såsom icterus, forstyrrelse i elektrolytbalancen og trombocytopeni.
English: Whereas other medicinal products 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 lægemidler, som hæmmer RAAS (ACE-hæmmere og angiotensin-II-antagonister (ARB)) forårsager en kompensatorisk stigning i plasmareninaktiviteten (PRA), mindsker behandling med aliskiren PRA hos hypertensive patienter med ca. 50-80 %.
English: There is no experience regarding the administration of Rasitrio in patients who have recently undergone kidney transplantation, therefore caution should be exercised in these patients.
Danish: Der er ingen erfaringer med brug af Rasitrio til patienter, som for nylig har gennemgået en nyretransplantation; der skal derfor udvises forsigtighed over for disse patienter.
English: The combined rates of cardiovascular death, hospitalisation for heart failure, recurrent heart attack, stroke and resuscitated sudden death were similar in the aliskiren group and the placebo group.
Danish: De kombinerede hyppigheder for kardiovaskulær død, hospitalsindlæggelser pga. hjertesvigt, tilbagevendende hjerteanfald, slagtilfælde og genoplivning ved pludselig død var de samme for grupperne givet aliskiren og placebo.
English: Dose adjustment of the antidiabetic medicinal product may be necessary (see section 4.4).
Danish: Det kan være nødvendigt at justere dosis af antidiabetika (se pkt.
English: Serum levels of calcium should be periodically monitored during treatment with thiazides.
Danish: Serumcalcium-niveauet bør monitoreres regelmæssigt under behandling med thiazider.
English: Rasitrio should be discontinued if hypercalcaemia develops during treatment.
Danish: Rasitrio skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rasitrio 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 Rasitrio i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: If you forget to take Rasitrio
Danish: Hvis du har glemt at tage Rasitrio
English: Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Danish: Amlodipin har vist gavnlig klinisk effekt til patienter med kronisk stabil angina, vasospastisk angina og angiografisk dokumenteret koronarterielidelse.
English: Pancreatitis, gastritis, gingival hyperplasia
Danish: Pankreatitis, gastritis, gingival hyperplasi
English: Single pack containing 30, 90 tablets
Danish: Enkeltpakninger indeholdende 30, 90 tabletter.
English: Smaller changes in furosemide pharmacokinetics and efficacy were observed with aliskiren 150 mg/day.
Danish: Der blev observeret mindre ændringer i furosemids farmakokinetik og effekt ved aliskiren 150 mg/dag.
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' aktiveringspunkt og blokerer konverteringen af angiotensinogen til angiotensin I og mindsker niveauet af angiotensin I og angiotensin II.
English: - if you have serious liver problems.
Danish: - hvis du har svære leverproblemer.
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: Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during treatment with aliskiren.
Danish: Overfølsomhedsreaktioner inklusive anafylaktiske reaktioner og angioødem er forekommet under behandling med aliskiren.
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 NaCl-transport i tubulus contortus distalis.
English: Insomnia, mood changes (including anxiety), depression
Danish: Søvnløshed, humørsvingninger (inklusive angst), depression
English: The fixed dose combination should only be used after a stable effect on the monocomponents, given concurrently, has been established after dose titration.
Danish: Den faste dosiskombination må kun anvendes, når en stabil virkning af monokomponenttabletterne, der gives sideløbende, er etableret efter dosistitrering.
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: • low level of white blood cells and blood platelets
Danish: • lavt niveau af hvide blodlegemer og blodplader
English: In patients treated with both aliskiren and oral furosemide or torasemide, it is therefore recommended that the effects of furosemide or torasemide be monitored when initiating and adjusting furosemide, torasemide or aliskiren therapy to avoid changes in extracellular fluid volume and possible situations of volume overload (see section 4.4).
Danish: Hos patienter, der behandles med både aliskiren og oral furosemid eller torasemid, anbefales det derfor at monitorere virkningen af furosemid eller torasemid ved initiering og justering af furosemid-, torasemid- eller aliskirenbehandling for at undgå ændringer i det ekstracellulære væskevolumen og potentielle situationer med volumen-overload (se pkt.
English: Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure.
Danish: Amlodipin tilhører en gruppe stoffer, som hedder calcium-antagonister, der hjælper til med at kontrollere forhøjet blodtryk.
English: Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg,/day respectively, prior to mating and throughout gestation.
Danish: Hydrochlorthiazid havde ingen uønskede virkninger på fertiliteten hos mus og rotter af begge køn i studier, hvor disse arter via deres kost blev eksponeret for doser på op til henholdsvis 100 og 4 mg/kg/dag forud for parring og gennem hele drægtighedsperioden.
English: - rifampicin, a medicine used to prevent or treat infections.
Danish: rifampicin, medicin, der bruges til at forebygge eller behandle infektioner.
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid and non-selective NSAIDs: As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Danish: Non-steroide-anti-inflammatoriske lægemidler (NSAID), inklusive selektive cyclooxygenase-2hæmmere (COX-2-hæmmere), acetylsalicylsyre og ikke-selektive NSAID: Som for andre stoffer, der påvirker renin-angiotensin-systemet, kan NSAID reducere aliskirens antihypertensive effekt.
English: The greater blood pressure reduction for Rasitrio over each dual combination was seen at every hour including the early morning hours with the 24-hour ambulatory blood pressure monitoring.
Danish: Den større reduktion af blodtrykket med Rasitrio i forhold til hver af kombinationerne af to præparater blev set ved hver time, herunder også i de tidlige morgentimer, ved hjælp af ambulatant døgnmonitorering af blodtrykket.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisterfolien efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome, have been reported with amlodipine.
Danish: Der er rapporteret markant og sandsynligvis forlænget systemisk hypotension op til og inklusive shock med dødelig udgang med amlodipin.
English: Rasitrio 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 Pregnancy section).
Danish: Rasitrio 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 afsnittet om Graviditet).
English: The available clinical data did not indicate that higher doses of torasemide were used after coadministration with aliskiren.
Danish: De kliniske data indikerede ikke, at der blev anvendt højere doser af torasemid ved samtidig behandling med aliskiren.
English: Aliskiren was secreted in the milk of lactating rats.
Danish: Aliskiren udskilles i mælken hos diegivende rotter.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Danish: Indgift af aktivt kul op til 2 timer efter administration af 10 mg amlodipin har vist, at det nedsætter absorptionshastigheden af amlodipin.
English: Linearity Amlodipine exhibits linear pharmacokinetics between the therapeutic dose range of 5 mg and 10 mg.
Danish: Linearitet Amlodipin udviser linær farmakokinetik i det terapeutiske dosisinterval på 5 mg og 10 mg.
English: Rasitrio 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: Rasitrio 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 dit barn, hvis det tages efter tredje måned af graviditeten.
English: The adverse reactions previously reported with one of the individual components of Rasitrio (aliskiren, amlodipine and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Rasitrio.
Danish: Bivirkningerne, der tidligere er indberettet for en af de individuelle komponenter i Rasitrio (aliskiren, amlodipin og hydrochlorthiazid), og præsenteret i de respektive afsnit for de individuelle komponenter kan forekomme med Rasitrio.
English: As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: Som med andre antihypertensive lægemidler kan kraftig sænkning af blodtrykket hos patienter med iskæmisk kardiopati eller iskæmisk kardiovaskulær sygdom resultere i et myokardieinfarkt eller slagtilfælde.
English: PVC/polychlorotrifluoroethylene (PCTFE) - Alu calendar blisters: Single pack containing 14, 28, 56, 98 tablets
Danish: PVC/polychlortrifluorethylen (PCTFE) - Alu-kalenderblister: Enkeltpakninger indeholdende 14, 28, 56, 98 tabletter.
English: Preclinical evaluations to support the administration of hydrochlorothiazide in humans included in vitro genotoxicity assays and reproductive toxicity and carcinogenicity studies in rodents.
Danish: Prækliniske evalueringer, der støtter administrationen af hydrochlorthiazid til mennesker, omfattede in vitro- genotoksicitetsanalyser og reproduktionstoksicitets- og carcinogenicitetsstudier af gnavere.
English: The following adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide:
Danish: Følgende bivirkninger er blevet rapporteret hos patienter behandlet med thiazid-diuretika alene, inklusive hydrochlorthiazid:
English: Children and adolescents The use of Rasitrio in children and adolescents up to 18 years of age is not recommended.
Danish: Børn og teenagere Rasitrio bør ikke bruges til børn og teenagere op til 18 år.
English: Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue.
Danish: Patienter skal informeres om at kontakte læge, hvis de udvikler tegn på allergiske reaktioner, specielt vejrtrækningsproblemer eller synkebesvær, hævelse i ansigt, ekstremiteter, øjne, læber eller tunge.
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Danish: Calciumkanalblokkere, inklusive amlodipin, bør anvendes med forsigtighed til patienter med hjerteinsufficiens, da de kan øge risikoen for fremtidige kardiovaskulære hændelser og mortalitet.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
Danish: Overdosering med hydrochlorthiazid er forbundet med elektrolytmangel (hypokaliæmi, hypokloriæmi, hyponatriæmi) og dehydrering, der er forårsaget af overdreven diurese.
English: Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)
Danish: Myokardie infarkt, arytmi (inklusive bradykardi, ventrikulær takykardi og atrieflimmer)
English: Clinically significant hypotension due to amlodipine overdose 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, hævning af ekstremiteterne og opmærksomhed på cirkulerende blodvolumen og urinproduktion.
English: - Vitamin D and calcium salts
Danish: - D-vitamin og calciumsalte
English: Investigations Uncommon
Danish: Undersøgelser Ikke almindelig:
English: As for other RAAS blockers, headache is a common adverse event in children treated with aliskiren.
Danish: Som for andre RAAS-hæmmere er hovedpine en almindelig bivirkning hos børn, der behandles med aliskiren.
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Danish: I kliniske undersøgelser, hvor amlodipin blev givet i kombination med betablokkere til patienter med enten hypertension eller angina, er der ikke set bivirkninger på de elektrokardiografiske parametre.
English: The volume or salt depletion should be corrected prior to administration of Rasitrio, or the treatment should start under close medical supervision.
Danish: Væske- og natriummangel bør korrigeres før administration af Rasitrio, eller behandlingen skal indledes under nøje klinisk overvågning.
English: No interactions - Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
Danish: Ingen interaktioner - Stoffer, som er undersøgt i kliniske farmakokinetiske studier med aliskiren inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25 and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Danish: I studier med rotter og mus, der fik amlodipin i foderet i to år ved koncentrationer beregnet til at give daglige dosisniveauer på 0,5, 1,25 og 2,5 mg/kg, sås ingen tegn på karcinogenicitet.
English: Impotence, gynaecomastia
Danish: Impotens, gynækomasti
English: Treatment If symptomatic hypotension should occur with Rasitrio, supportive treatment should be initiated.
Danish: Hvis der skulle opstå symptomatisk hypotension med Rasitrio, bør der iværksættes støttende behandling.
English: • swelling mainly of the face and throat
Danish: • hævelse især af ansigt og svælg
English: Information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Danish: Information om interaktioner med hydrochlorthiazid Ved samtidig administration kan følgende lægemidler interagere med thiaziddiuretika:
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: Hypersensitivity reactions to hydrochlorothiazide may occur in patients, but are more likely in patients with allergy and asthma.
Danish: Overfølsomhedsreaktioner over for hydrochlorthiazid kan forekomme, men ses hyppigst hos patienter med allergi eller astma.
English: In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren and hydrochlorothiazide given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Hos visse patienter med svækket nyrefunktion (dehydrerede patienter eller ældre patienter) kan administration af aliskiren og hydrochlorthiazid sammen med NSAID medføre en yderligere forværring af nyrefunktion, inklusive risiko for akut nyresvigt, som sædvanligvis er reversibel.
English: Posology The recommended dose of Rasitrio is one tablet per day.
Danish: Dosering Den anbefalede dosis af Rasitrio er én tablet daglig.
English: Cellulose microcrystalline Crospovidone Povidone
Danish: Cellulose, mikrokrystallinsk Crospovidon
English: - digoxin or other digitalis glycosides (medicines used to treat heart problems).
Danish: digoxin og andre digitalisglykosider (medicin, som bruges til behandling af hjerteproblemer).
English: Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.
Danish: Hydrochlorthiazid tilhører en klasse af medicin, som kaldes thiaziddiuretika.
English: • sensation of numbness or tingling with sensation of burning in fingers and toes
Danish: • følelse af snurren og følelsesløshed med fornemmelse af brændende fingre og tæer
English: Anaphylactic reactions and angioedema
Danish: Anafylaktisk reaktioner og angioødem
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 digitalisglykosider eller visse antiarytmiske lægemidler.
English: Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in geriatric patients.
Danish: Der er en tendens til, at amlodipin-clearance aftager, hvilket medfører stigninger i AUC og forlængelse af elimineringshalveringstiden hos geriatriske patienter.
English: The incidence of adverse events did not show any association with gender, age (with the exception of symptomatic hypotension), body mass index, race or ethnicity.
Danish: Hyppigheden af bivirkninger viste ingen forbindelse med køn, alder (bortset fra symptomatisk hypotension),body mass index, race eller etnicitet.
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Danish: Administration af en enkelt oral dosis på 300 mg aliskiren viste minimale ændringer i aliskirens farmakokinetik (ændring i Cmax på mindre end 1,2 gange; AUC forøget op til 1,6 gange) sammenlignet med tilsvarende raske personer.
English: A population pharmacokinetic study has been conducted in 74 hypertensive children aged from 1 to 17 years (with 34 patients aged 6 to 12 years and 28 patients aged 13 to 17 years) receiving amlodipine between 1.25 and 20 mg given either once or twice daily.
Danish: Et farmakokinetisk populationsstudie er blevet udført med 74 hypertensive børn i alderen 1 til 17 år (med 34 patienter i alderen 6 til 12 år og 28 patienter i alderen 13 til 17 år), der fik amlodipin mellem 1,25 og 20 mg enten en eller to gange daglig.
English: The following, possibly serious, side effects have been reported with medicines containing aliskiren, amlodipine or hydrochlorothiazide alone.
Danish: De følgende, muligvis alvorlige, bivirkninger er blevet indberettet med lægemidler, der kun indeholder aliskiren, amlodipin eller hydrochlorthiazid.
English: Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially (see section 4.2).
Danish: - Fødeindtagelse Måltider (med højt eller lavt fedtindhold) reducerer absorptionen af aliskiren betragteligt (se pkt.
English: 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters)
Danish: 98 tabletter (2x49x1, PVC/PCTFE enkeltdosisblister)
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Danish: Hydrochlorthiazid bør ikke anvendes ved graviditetsødem, gestational hypertension eller præeklampsi på grund af risiko for nedsat plasmavolumen og placental hypoperfusion uden gavnlig effekt på tilstanden.