FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
Danish: Den maksimale reduktion i blodtryk opnås generelt 4 til 8 uger efter behandlingsstart og fastholdes gennem langtidsbehandling.
English: • Simvastatin to treat elevated levels of cholesterol.
Danish: • Simvastatin til behandling af forhøjet kolesterol.
English: Absolute bioavailability has been estimated to be between 64 and 80%.
Danish: Den absolutte biotilgængelighed er mellem 64% og 80%.
English: • if you suffer from severe low blood pressure (including shock).
Danish: • hvis du lider af svært nedsat blodtryk (herunder shock).
English: Onduarp with food and drink
Danish: Brug af Onduarp sammen med mad og drikke
English: The volume of distribution of amlodipine is approximately 21 l/kg.
Danish: Fordelingsvolumen for amlodipin er ca. 21 l/kg.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Danish: Total plasma-clearance (Cltot) er høj (ca. 1.000 ml/min) sammenlignet med hepatisk blodgennemstrømning (omkring 1.500 ml/min).
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Der var ingen tegn på mutagenicitet og relevant klastogen aktivitet i in vitro-studier og heller ingen tegn på karcinogenicitet hos rotter og mus.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Danish: Den gennemsnitlige absolutte biotilgængelighed for telmisartan er ca. 50%.
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer har en additiv antihypertensiv virkning ved at nedsætte blodtrykket i større grad end hver komponent alene.
English: Therefore, caution should be recommended when driving a car or using machines.
Danish: Derfor skal det anbefales, at der udvises forsigtighed, når patienten fører et motorkøretøj eller betjener maskiner.
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Danish: Den hæmmende virkning vedvarer i mere end 24 timer og er stadig målbar i op til 48 timer.
English: Serum electrolytes and creatinine should be monitored frequently.
Danish: Serumelektrolytter og -kreatinin skal monitoreres hyppigt.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Danish: Den maksimale plasmakoncentration (Cmax) og i mindre grad arealet under plasmakoncentrationskurven (AUC) stiger disproportionalt med dosis.
English: If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Danish: Hvis samtidig brug er indiceret på grund af dokumenteret hypokaliæmi, skal de bruges med forsigtighed og med hyppig monitorering af serumkalium.
English: Little information is available in the very elderly patients.
Danish: Der er kun meget begrænset viden om behandling af meget ældre patienter.
English: If patients experience these adverse reactions, they should avoid potentially hazardous tasks such as driving or using machines.
Danish: Patienter, der oplever disse bivirkninger, skal undgå at foretage sig ting, der er potentielt farlige, såsom at føre et motorkøretøj eller betjene maskiner.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Danish: Mens der ikke findes nogen kontrollerede epidemiologiske data for risikoen med angiotensin IIreceptorantagonister, kan der eksistere lignende risici for denne lægemiddelklasse.
English: • Severe hypotension
Danish: • Svær hypotension
English: The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Danish: Den samlede incidens af bivirkninger ved Onduarp i det kliniske studieprogram var lav, idet kun 12,7% af de behandlede patienter oplevede bivirkninger.
English: Contraindicated (see section 4.3)
Danish: Kontraindiceret (se pkt.4.3)
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Danish: Tilsyneladende er der en tendens mod dosisafhængighed i forholdt til tid til tilbagevenden til baseline for det systoliske blodtryk (SBP).
English: • Lithium-containing medicines to treat some types of depression.
Danish: • Lithiumholdige lægemidler til behandling af visse typer depression.
English: Grapefruit juice and grapefruit should not be consumed when you take Onduarp.
Danish: Du må ikke indtage grapefrugtjuice og grapefrugt, mens du tager Onduarp.
English: Experimental data indicate that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Danish: Dyrestudier antyder, at amlodipin binder til både dihydropyridin- og ikke-dihydropyridin-bindingssteder.
English: The pharmacokinetics of telmisartan do not differ in young and elderly patients.
Danish: For telmisartan er der ingen forskel i farmakokinetik hos unge og ældre patienter.
English: If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Danish: Hvis du ved et uheld tager for mange tabletter, skal du med det samme kontakte din læge, apoteket eller den nærmeste skadestue.
English: Concomitant use requiring caution
Danish: Samtidig brug, der kræver forsigtighed
English: If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day.
Danish: Hvis din lever ikke fungerer korrekt, bør den sædvanlige dosis ikke overstige én 40 mg/5 mg-tablet eller én 40 mg/10 mg-tablet pr. dag.
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Danish: Diabetespatienter, som behandles med insulin eller antidiabetika Hos disse patienter kan hypoglykæmi forekomme under behandling med telmisartan.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Danish: Hos begge arter sås øget plasma-reninaktivitet og hypertrofi/hyperplasi af de renale juxtaglomerulære celler.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Danish: Når telmisartan tages sammen med mad, varierer reduktion i arealet under plasmakoncentrationskurven (AUC0-∞) fra ca. 6% (40 mg-dosis) til ca. 19% (160 mg-dosis).
English: If you have the impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Onduarp er for kraftig eller for svag, bør du tale med din læge eller dit apotek herom.
English: Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination.
Danish: Individuel dosistitrering med komponenterne (dvs. amlodipin og telmisartan) anbefales, før der skiftes til den faste dosiskombination.
English: Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium receptor antagonists have a harmful effect on the health of the fetus.
Danish: Data fra et begrænset antal graviditeter med eksponering indikerer ikke, at amlodipin eller andre calciumantagonister har nogen skadelig virkning på fosterets helbred.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Danish: I et studie medførte samtidig administration af telmisartan og ramipril en stigning i AUC0-24 og Cmax for ramipril og ramiprilat på op til 2,5 gange.
English: Method of administration Onduarp can be taken with or without food.
Danish: Administration Onduarp kan tages sammen med mad eller uden mad.
English: • Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
Danish: • Hjerte-relaterede smerter i brystet, også i hvile eller ved meget lav aktivitet (ustabil angina pectoris).
English: Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Danish: Ved pludseligt ophør af behandling med telmisartan vil blodtrykket over en periode på flere dage gradvist vende tilbage til værdierne fra før behandling uden der ses tegn på ”rebound”-hypertension.
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Danish: I tilfælde, hvor det er klinisk relevant, kan det overvejes at skifte direkte fra monoterapi til den faste kombination.
English: This has been confirmed in a subchronic (13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of telmisartan and amlodipine were tested.
Danish: Dette er bekræftet i et subkronisk (13-ugers) toksikologisk studie i rotter, hvor dosisniveauer på 3,2/0,8, 10/2,5 og 40/10 mg/kg telmisartan og amlodipin blev testet.
English: • Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals).
Danish: • Ophobning af vand i kroppen forårsaget af forhøjede aldosteronniveauer (som medfører ophobning af vand og salt i kroppen sammen med ubalance af forskellige mineraler i blodet).
English: Serious syncope may occur rarely (less than 1 case per 1,000 patients).
Danish: Alvorlig synkope er set i sjældne tilfælde (mindre end 1 tilfælde pr. 1.000 patienter).
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours consistent with once daily dosing.
Danish: Amlodipin elimineres bifasisk fra plasma med en terminal eliminationshalveringstid på ca. 30 til 50 timer konsistent med dosering én gang dagligt.
English: * Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Danish: * De fleste tilfælde af unormal leverfunktion og leversygdom, som er set, efter telmisartan er blevet markedsført, forekom hos japanske patienter.
English: Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects.
Danish: Tegn og symptomer på overdosering forventes at være som ved unormal høj farmakologisk virkning.
English: Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of amlodipine.
Danish: 240 ml grapefrugtjuice givet samtidig med en enkelt oral dosis på 10 mg amlodipin til 20 raske frivillige viste ikke nogen signifikant virkning på de farmakokinetiske egenskaber for amlodipin.
English: • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
Danish: • Obstruktion i udløbet fra venstre ventrikel (f.eks. aortastenose i svær grad)
English: Japanese patients are more likely to experience these adverse reactions.
Danish: Japanske patienter har større sandsynlighed for at opleve disse bivirkninger.
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 blisterkortet.
English: Close monitoring of renal function is advisable if co-administration is considered necessary.
Danish: Tæt monitorering af nyrefunktionen anbefales, hvis kombinationsbehandling vurderes nødvendig.
English: No pharmacological activity has been shown for the conjugate.
Danish: Der er ikke set nogen farmakologisk aktivitet fra konjugatet.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Fortæl det til lægen, hvis du tror, du er (eller kan blive) gravid.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onduarp in all subsets of the paediatric population in 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 Onduarp i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: The majority of the antihypertensive effect was attained within 2 weeks after initiation of therapy.
Danish: Størst antihypertensiv virkning sås inden for 2 uger efter behandlingsstart.
English: ketoconazole).
Danish: (f.eks. ketoconazol).
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Danish: Telmisartan er en peroralt aktiv og specifik angiotensin II-receptor (type AT1)-antagonist.
English: Management depends on the time since ingestion and the severity of the symptoms.
Danish: Behandlingen afhænger af den tid, der er gået siden indtagelse, samt af symptomernes sværhedsgrad.
English: If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis det viser sig nødvendigt at bruge kombinationen, anbefales det at monitorere serumlitiumniveauerne nøje.
English: Amlodipine In patients taking amlodipine alone the following additional side effects have been reported:
Danish: Amlodipin Hos patienter, der tager amlodipin alene, er følgende yderligere bivirkninger blevet rapporteret:
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke "angiotensin-converting-enzyme" (kininase II), som også nedbryder bradykinin.
English: Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Danish: For telmisartan blev set forskelle i plasmakoncentrationer, idet Cmax og AUC for kvinder var henholdsvis ca. 3 og 2 gange højere end for mænd.
English: Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of spinning (vertigo) when they are treated for high blood pressure.
Danish: Nogle mennesker kan opleve bivirkninger som besvimelse, søvnighed, svimmelhed eller en fornemmelse af at dreje rundt (vertigo), når de behandles for højt blodtryk.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Danish: Amlodipin er undersøgt hos patienter med kronisk stabil angina, vasospastisk angina og angiografisk dokumenteret koronararteriesygdom.
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Danish: Telmisartan metaboliseres ved konjugation til glucuronidet af modersubstansen.
English: Interactions linked to amlodipine
Danish: Interaktioner associeret til amlodipin
English: Amlodipine exhibits linear pharmacokinetics.
Danish: Amlodipin udviser lineær farmakokinetik.
English: Preclinical data available for the components of this fixed dose combination are reported below.
Danish: Prækliniske data for stofferne i denne fastdosiskombination er angivet nedenfor.
English: If you stop taking Onduarp
Danish: Hvis du holder op med at tage Onduarp
English: With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % respectively.
Danish: Ved brug sammen med henholdsvis CYP3A4-hæmmeren erythromycin hos unge patienter og diltiazem hos ældre patienter steg plasmakoncentrationen af amlodipin med henholdsvis 22% og 50%.
English: Ten per cent of original amlodipine and 60 % of amlodipine metabolites are excreted in urine.
Danish: 10% uomdannet amlodipin og 60% af amlodipin-metabolitterne udskilles i urinen.
English: Similarly, no effects on male and female fertility were reported for amlodipine (see section 5.3).
Danish: Tilsvarende er der heller ikke rapporteret om virkninger af amlodipin på fertiliteten hos hanner eller hunner (se afsnit 5.3).
English: Since the non-clinical toxicity profiles of telmisartan and amlodipine are not overlapping, no exacerbation of toxicity was expected for the combination.
Danish: Da de præ-kliniske toksicitetsprofiler for telmisartan og amlodipin ikke er overlappende, forventedes ingen forværring i toksiciteten ved kombinationsbehandling.
English: As a result, the blood vessels relax and blood pressure is lowered.
Danish: Resultatet er, at blodkarrene bliver slappere, og blodtrykket sænkes.
English: Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
Danish: Der er ikke gennemført separate reproduktionstoksicitetsstudier med kombination af telmisartan og amlodipin.
English: The safety and efficacy of Onduarp in children aged below 18 years have not been established.
Danish: Onduarps sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia.
Danish: Overdosering med amlodipin kan resultere i udtalt perifer vasodilatation og risiko for reflekstakykardi.
English: Because no information is available regarding the use of telmisartan and/or amlodipine during breastfeeding, Onduarp is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant.
Danish: Da der ikke er nogen viden vedrørende brugen af telmisartan og/eller amlodipin under amning, frarådes brug af Onduarp, og alternative behandlinger med bedre dokumenterede sikkerhedsprofiler under amning foretrækkes, særligt under amning af en nyfødt eller et for tidligt født spædbarn.
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Danish: Der er ingen viden om virkningen af CYP3A4-induktorer på amlodipin.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness.
Danish: Ubehandlet højt blodtryk kan medføre skader på blodkarrene i flere organer, hvilket betyder, at der er risiko for alvorlige hændelser hos patienten såsom hjerteanfald, hjerte- eller nyresvigt, slagtilfælde eller blindhed.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Der er ikke afgørende epidemiologisk bevis for risikoen for teratogenicitet efter eksponering over for ACE-hæmmere i graviditetens første trimester, men en let øget risiko kan ikke udelukkes.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated.
Danish: Før initiering af samtidig brug af lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, skal risk-benefit-forholdet vurderes.
English: • if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller amlodipin eller et af de øvrige indholdsstoffer i Onduarp (angivet i punkt 6).
English: Children and adolescents The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og teenagere Behandling af børn og unge under 18 år med Onduarp frarådes.
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Danish: Intravenøst calciumglyconat kan have en gavnlig effekt på ophævelsen af calciumkanalblokaden.
English: To be taken into account with concomitant use
Danish: Bør tages i betragtning ved samtidig brug.
English: Blood creatine phosphokinase increased, haemoglobin decreased 1: the event may be a chance finding or related to a mechanism currently not known 2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Danish: Forhøjet kreatinkinase i blodet, nedsat hæmoglobin 1: hændelsen kan være en tilfældighed eller relateret til en endnu ukendt mekanisme 2: de fleste tilfælde af unormal leverfunktion/leversygdom rapporteret for telmisartan efter markedsføringen forekom hos japanske patienter.
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Danish: Forekomsten af tør hoste var signifikant lavere hos patienter, der blev behandlet med telmisartan, end hos patienter, der fik angiotensin-konverterende enzymhæmmere i kliniske studier med direkte sammenligning af de to antihypertensive behandlinger.
English: No clinical relevance has been established.
Danish: Der er ikke påvist nogen klinisk relevans.
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of telmisartan was observed.
Danish: Hos patienter med let til moderat og svært nedsat nyrefunktion, blev der observeret fordobling af plasmakoncentrationen af telmisartan.
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Danish: Telmisartan udviser ikke nogen delvis agonistaktivitet på AT1-receptoren.
English: Dual blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other blockers of the renin-angiotensin-aldosterone system) is therefore not recommended.
Danish: Dobbelthæmning af renin-angiotensin-aldosteronsystemet (f.eks. ved at administrere telmisartan sammen med andre blokkere af renin-angiotensin-aldosteronsystemet) kan derfor ikke anbefales.
English: Therefore, the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
Danish: Til patienter i behandling med amlodipin bør dosis af simvastatin derfor begrænses til 20 mg dagligt.
English: Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required when indicated.
Danish: Passende monitorering af blodglucose bør overvejes, og dosisjustering af insulin eller antidiabetika kan være påkrævet.
English: Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Danish: Skader på ventrikelslimhinder (erosion, ulcus eller inflammation) sås hos rotter og hunde.
English: Telmisartan/Amlodipine
Danish: Telmisartan/amlodipin
English: Psychiatric disorders depression, anxiety, insomnia
Danish: Psykiske forstyrrelser depression, angst, insomni
English: The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Danish: Den antihypertensive virkning holder sig konstant i 24 timer efter dosering, hvilket også gælder de sidste 4 timer forud for næste dosis som vist ved døgnblodtryksmåling.
English: • Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g.
Danish: • Lægemidler, der bruges til behandling af hiv/aids (f.eks. ritonavir) eller svampeinfektioner