FrancophonIA/ELRC3.0 huggingface dataset:
English: The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Danish: Den nøjagtige virkningsmekanisme ved hvordan lægemidlets diuretiske og natriuretiske effekt medvirker til dets hypotensive aktivitet, er ikke fuldstændig klarlagt.
English: Concomitant use to be taken into account
Danish: Samtidig brug, der skal tages i betragtning
English: Interactions common to the combination No drug interaction studies have been performed.
Danish: Kendte interaktioner ved kombinationen Der er ikke udført interaktionsstudier.
English: • Haemodynamically unstable heart failure after acute myocardial infarction
Danish: • Hæmodynamisk ustabil hjerteinsufficiens efter akut myokardieinfarkt
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 November 2011
Danish: Dato for første markedsføringstilladelse: 24. november 2011 Dato for seneste fornyelse:
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensiva, der virker ved hæmning af renin-angiotensinsystemet.
English: Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure.
Danish: Angiotensin II er et stof, der produceres i kroppen, og som får blodkarrene til at trække sig sammen, hvilket øger blodtrykket.
English: Activated charcoal may be useful in the treatment of overdose of both telmisartan and amlodipine.
Danish: Aktivt kul kan være nyttigt til behandling af overdosering med både telmisartan og amlodipin.
English: No dose adjustment is necessary for elderly patients.
Danish: Dosisjustering er ikke nødvendig hos den ældre population.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.
Danish: Hvis du skal opereres eller bedøves, skal du fortælle din læge, at du tager Onduarp.
English: Microcrystalline cellulose Povidone K25
Danish: Mikrokrystallinsk cellulose Povidon K25
English: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Sepsis including fatal outcome1
Danish: Infektion i de øvre luftveje, herunder faryngitis og sinuitis, urinvejsinfektion, herunder cystitis Sepsis, herunder med fatal udgang1
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Danish: Patienter i behandling med 10 mg amlodipin, som oplever en hvilken som helst dosisbegrænsende bivirkning såsom ødem, kan skiftes til Onduarp 40 mg/5 mg én gang dagligt og dermed få reduceret amlodipin-dosen, uden at det samlede forventede antihypertensive respons reduceres.
English: • if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez.
Danish: • hvis du har sukkersyge (diabetes mellitus) eller nedsat nyrefunktion, og du også tager Rasilez.
English: When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Danish: Ved kombination af amlodipin og sildenafil udviste hvert stof deres egen uafhængige blodtrykssænkende virkning.
English: Reproductive system, and breast disorders erectile dysfunction
Danish: Det reproduktive system og mammae erektil dysfunktion
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Danish: Telmisartan har en bieksponentiel faldende farmakokinetik med en terminal eliminationshalveringstid på >20 timer.
English: The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
Danish: Brugen af lægemidler, der kan påvirke renin-angiotensin-aldosteronsystemet, kan medføre hyperkaliæmi.
English: Amlodipine is relatively vessel-selective, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Danish: Amlodipin er relativt kar-selektiv og har en større virkning på vaskulære glatte muskelceller end på hjertemuskelceller.
English: Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range.
Danish: Onduarp én gang dagligt giver en effektiv og konsistent nedsættelse af blodtrykket i hele dosisintervallet på 24 timer.
English: In this same population amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Danish: I den samme population blev amlodipin associeret med et øget antal indberetninger af lungeødem, selvom der ikke var nogen signifikant forskel på incidensen af forværring af hjerteinsufficiens sammenlignet med placebo.
English: In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Danish: En dosis på 80 mg telmisartan hæmmer næsten fuldstændigt en angiotensin II-fremkaldte blodtryksstigning.
English: Leukocytopenia, thrombocytopenia
Danish: Leukocytopeni, trombocytopeni
English: If you forget to take Onduarp
Danish: Hvis du har glemt at tage Onduarp
English: Amlodipine should be used with caution together with CYP3A4 inhibitors.
Danish: Der skal udvises forsigtighed ved anvendelse af amlodipin sammen med CYP3A4hæmmere.
English: Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.
Danish: Amlodipin har ikke forårsaget metaboliske bivirkninger eller forandringer i plasmalipider og er egnet til patienter med astma, diabetes og urinsyregigt.
English: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, hvis du har eller tidligere har haft en af de følgende tilstande eller lidelser:
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Danish: Disse forandringer, som også udgør en klassevirkning af ACE-hæmmere og andre angiotensin II-receptorantagonister, synes ikke at have klinisk betydning.
English: No data from controlled clinical studies with the Fixed Dose Combination or with the individual components are available.
Danish: Der er ingen data fra kontrollerede kliniske studier for fastdosiskombinationen eller for de enkelte aktive stoffer.
English: Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77 % compared to simvastatin alone.
Danish: Samtidig behandling med 80 mg simvastatin og gentagne doser amlodipin resulterede i en øget eksponering for simvastatin med op til 77% sammenlignet med simvastatin alene.
English: Onduarp has not been studied in any patient population other than hypertension.
Danish: Onduarp er kun undersøgt i patientpopulationer med hypertension.
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Danish: Behandling med angiotensin II-receptorantagonister bør ikke påbegyndes under graviditet.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp.
Danish: Hvis et eller flere af disse punkter gælder for dig, så tal med din læge eller apoteket, før du tager Onduarp.
English: Infections and infestations cystitis
Danish: Infektioner og parasitære sygdomme cystitis
English: Hypersensitivity, anaphylactic reaction
Danish: Overfølsomhed, anafylaktisk reaktion
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat behandling med angiotensin II-receptorantagonister anses for at være af afgørende betydning, bør patienter, der planlægger at blive gravide, skiftes til en alternativ antihypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug under graviditet.
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on an mg/m2 basis).
Danish: Der var ingen effekt på fertiliteten hos rotter, der blev behandlet peroralt med amlodipinmaleat (hanner i 64 dage og hunner i 14 dage før parring) i doser på op til 10 mg amlodipin/kg/dag (ca. 10 gange den maksimalt anbefalede humane dosis på 10 mg/dag udtrykt i mg/m2).
English: Telmisartan does not inhibit human plasma renin or block ion channels.
Danish: Telmisartan hæmmer ikke humant plasmarenin og blokerer heller ikke ionkanaler.
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Onduarp:
Danish: Følgende bivirkninger er observeret med henholdsvis telmisartan og amlodipin taget alene og kan også forekomme med Onduarp:
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Danish: Telmisartan flytter angiotensin II med meget høj affinitet fra dets proteinbindingssted på AT1-receptorundertypen, som er ansvarlig for de kendte virkninger af angiotensin II.
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets').
Danish: • Medicin, der kan øge kaliumniveauet i blodet, såsom salterstatninger indeholdende kalium, kaliumbesparende diuretika (visse vanddrivende tabletter).
English: For telmisartan the posology should not exceed 40 mg once daily (see section 4.4).
Danish: Dosis af telmisartan bør ikke overstige 40 mg én gang dagligt (se pkt.
English: Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier med telmisartan har vist reproduktionstoksicitet (se pkt.
English: If hypotension occurs with Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Ved hypotension i forbindelse med Onduarp bør patienten placeres i liggende stilling, og om nødvendigt gives intravenøs infusion af isotonisk saltvand.
English: It cannot be ruled out that strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem.
Danish: Det kan ikke udelukkes, at stærke CYP3A4-hæmmere (f.eks. ketoconazol, itraconazol, ritonavir) kan øge plasmakoncentrationerne af amlodipin i højere grad end ved diltiazem.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Onduarp.
Danish: Sepsis er kun set efter telmisartan alene, men kan ikke udelukkes for Onduarp.
English: The reduction in diastolic blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively.
Danish: Reduktion af det diastoliske blodtryk til < 90 mmHg sås hos henholdsvis 71,6%, 74,8%, 82,1% 85,3% af patienterne.
English: This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine in some patients and may increase the blood pressure lowering effect of Onduarp.
Danish: Det skyldes, at grapefrugt og grapefrugtjuice kan medføre øgede blodkoncentrationer af det aktive stof amlodipin hos nogle patienter, hvilket kan øge den blodtrykssænkende virkning af Onduarp.
English: However, the clinical relevance of this finding is uncertain.
Danish: Den kliniske relevans heraf er usikker.
English: Caution is advised when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section
Danish: Der skal udvises forsigtighed ved brug af Onduarp til sådanne patienter, da amlodipin og telmisartan ikke kan fjernes ved dialyse (se også pkt.
English: Suggested measures include induction of emesis and/or gastric lavage.
Danish: De anbefalede forholdsregler omfatter provokeret emesis og/eller ventrikelskylning.
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Danish: Clearance af amlodipin hos patienter med nedsat leverfunktion er nedsat, hvilket medfører en stigning i AUC på ca. 40-60%.
English: The concomitant use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma concentration of amlodipine.
Danish: Samtidig brug af CYP3A4induktorer (dvs. rifampicin, Hypericum perforatum) kan medføre lavere plasmakoncentration af amlodipin.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists and calcium channel blockers; ATC Code: C09DB04.
Danish: Farmakoterapeutisk klassifikation: Midler med virkning på renin-angiotensin-systemet, angiotensin IIantagonister og calciumantagonister; ATC-kode: C09DB04.
English: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis
Danish: Hepatitis, gulsot, forhøjede leverenzymtal (i reglen konsistent med kolestase)
English: The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, leading to reductions in peripheral vascular resistance and in blood pressure.
Danish: Amlodipins antihypertensive virkning skyldes den direkte afslappende effekt på karvæggens glatte muskulatur, hvilket fører til nedsat perifer vaskulær modstand og nedsat blodtryk.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Danish: Der er rapporteret om reversibel forøgelse af serumlitiumkoncentrationer og toksicitet ved administration af litium samtidig med angiotensinkonverterende enzymhæmmere og med angiotensin II-receptorantagonister, herunder telmisartan.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Danish: Hos hypertensive patienter med normal nyrefunktion resulterede terapeutiske amlodipin-doser i en nedsat renal vaskulær modstand med øget glomerulær filtrationshastighed og effektivt renal plasma flow, uden ændring i filtrationsfraktionen eller proteinuri.
English: Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Tidligere rapporterede bivirkninger for hvert af de aktive stoffer (telmisartan eller amlodipin) kan ligeledes være mulige bivirkninger ved Onduarp, selvom de ikke er observeret i kliniske studier eller efter markedsføring.
English: The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Danish: Telmisartans antihypertensive virkning er sammenlignelig med effekten af andre klasser af antihypertensiva (påvist i kliniske studier ved sammenligning af telmisartan med amlodipin, atenolol, enalapril, hydrochlorthiazid og lisinopril).
English: The most common adverse reactions include dizziness and peripheral oedema.
Danish: De almindeligste uønskede hændelser omfatter svimmelhed og perifere ødemer.
English: Dyspnoea, rhinitis
Danish: Dyspnø, rinitis
English: If hypotension occurs, the patient should be placed in a supine position with elevation of extremities, with salt and volume replacement given quickly.
Danish: Hvis hypotension indtræder, skal patienten placeres i liggende stilling med hævede ekstremiteter, og der skal hurtigt gives salt- og væskeerstatning.
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea,
Danish: • Lavt blodtryk (hypotension), som kan opstå, hvis du er dehydreret (overdrevent væsketab fra kroppen) eller har saltmangel på grund af diuretikabehandling (”vanddrivende tabletter”),
English: Animal reproductive toxicity studies with Onduarp have not been performed.
Danish: Der er ikke udført undersøgelser af reproduktionstoksicitet i dyrestudier med Onduarp.
English: Pharmacokinetic of the fixed dose combination (FDC) The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and amlodipine when administered as individual tablets.
Danish: Farmakokinetik for fastdosiskombination (FDC) Absorptionshastighed og -grad for Onduarp er ækvivalent med telmisartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.
Danish: På grund af den langsomt indsættende virkning er akut hypotension ikke et problem ved behandling med amlodipin.
English: • if you suffer from low heart output because of a serious heart problem.
Danish: • hvis dit hjerte ikke pumper nok blod på grund af et alvorligt hjerteproblem.
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Danish: Amlodipin metaboliseres i vid udstrækning til inaktive metabolitter (ca. 90%) i leveren.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Giv din læge besked, hvis du ammer, eller hvis du skal begynde at amme.
English: • if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
Danish: • hvis du er overfølsom over for andre lægemidler af dihydropyridintypen (en type calciumantagonist).
English: In reproductive toxicity studies in rats, delayed parturition, difficult labour and impaired fetal and pup survival were seen at high doses.
Danish: I reproduktionstoksicitetsstudier i rotter blev der ved høje doser set forsinket fødsel, vanskelig fødsel og nedsat føtal overlevelse samt nedsat overlevelse af unger.
English: Concomitant use not recommended
Danish: Samtidig brug, der frarådes
English: Telmisartan selectively binds the AT1 receptor.
Danish: Telmisartan binder AT1-receptoren selektivt.
English: Other antihypertensive medicinal products
Danish: Nonsteroide antiinflammatoriske lægemidler
English: Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
Danish: Amlodipin forhindrer calcium i at bevæge sig ind i blodkarrenes vægge, hvilket forhindrer blodkarrene i at trække sig sammen.
English: In elderly patients, amlodipine clearance tends to decline with resulting increases in AUC and elimination half-life.
Danish: Amlodipins clearance har tendens til at falde hos ældre patienter, hvilket resulterer i øget AUC og øget eliminationshalveringstid.
English: • Liver disease.
Danish: • Leversygdom.
English: The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day.
Danish: Den maksimale anbefalede dosis er én Onduarp 80 mg/10 mg tablet pr. dag.
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget angiotensin II-antagonister, skal observeres nøje for hypotension (se pkt.
English: After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Danish: Telmisartan udskilles efter peroral (og intravenøs) administration næsten udelukkende med fæces, hovedsageligt som uomdannet stof.
English: The blood pressure lowering effect of Onduarp can be increased by concomitant use of other antihypertensive medicinal products.
Danish: Andre antihypertensiva Den blodtrykssænkende virkning ved Onduarp kan øges ved samtidig brug med andre antihypertensiva.
English: Onduarp combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine.
Danish: Onduarp kombinerer to antihypertensive stoffer med komplementære virkningsmekanismer, som kontrollerer blodtrykket hos patienter med essentiel hypertension: en angiotensin IIreceptorantagonist, telmisartan, og en dihydropyridin-calciumantagonist, amlodipin.
English: In preclinical studies, no effects of telmisartan on male and female fertility were observed.
Danish: I de prækliniske studier blev der ikke observeret nogen virkninger af telmisartan på fertiliteten hos hanner eller hunner.
English: Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Danish: Kaliumbesparende diuretika f.eks. spironolacton, eplerenon, triamteren eller amilorid, kaliumtilskud eller kaliumholdige salterstatninger kan medføre en signifikant stigning i serumkalium.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Danish: Patienterne bør være tilstrækkeligt hydrerede, og nyrefunktionen bør monitoreres, ved initiering og under samtidig behandling.
English: Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently over the entire 24-hours dosing period.
Danish: Automatiseret døgnblodtryksmåling (ABPM) hos en delgruppe på 562 patienter bekræftede de resultater, der blev set for reduktion af systolisk og diastolisk blodtryk på klinikken som konsistente over hele dosisintervallet på 24 timer.
English: The concomitant use of amlodipine and grapefruit or grapefruit juice is still not recommended in patients as the bioavailability of amlodipine may increase in some and may result in increased hypotensive effects.
Danish: Samtidig indtagelse af amlodipin og grapefrugt eller grapefrugtjuice anbefales fortsat ikke til patienter, da biotilgængeligheden af amlodipin kan øges hos nogen og resultere i forstærket hypotensiv virkning.
English: Furthermore as with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations have not been established.
Danish: For amlodipin, som for alle andre calciumantagonister, er halveringstiden forlænget hos patienter med nedsat leverfunktion uden der er fastsat nogen dosisanbefalinger.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Hos nogle patienter med kompromitteret nyrefunktion (f.eks. dehydrerede patienter eller ældre patienter med kompromitteret nyrefunktion) kan samtidig administration af angiotensin IIreceptorantagonister og lægemidler, der hæmmer cyklooxygenase, resultere i yderligere forværring af nyrefunktionen, herunder muligvis akut nyresvigt, hvilket sædvanligvis er reversibelt.