FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror, at virkningen af Telmisartan Teva er for stærk eller svag, så sig det til lægen eller på apoteket.
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Danish: Der er en tydelig trend mod en dosisafhængighed i forhold til tid til tilbagevenden til baseline for det systoliske blodtryk (SBT).
English: Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients.
Danish: De fleste tilfælde af unormal leverfunktion/leversygdom fra post-marketing erfaring forekom hos japanske patienter.
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Danish: Denne hæmmende effekt vedvarer i mere end 24 timer og kan måles i op til 48 timer.
English: • If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva” and “Warnings and precautions”).
Danish: • Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Telmisartan Teva” og ”Advarsler og forsigtighedsregler”).
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Danish: Telmisartan er karakteriseret ved en farmakokinetisk bieksponentiel udskillelse med en terminal eliminationshalveringstid på >20 timer.
English: Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Teva.
Danish: Volumen- og/eller natriumdepletering bør korrigeres før behandling med Telmisartan Teva.
English: 1, 2, 3, 4: for further descriptions, please see sub-section ”Description of selected adverse reactions”.
Danish: 1,2, 3, 4: For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger”.
English: By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Danish: Tre timer efter indgiften er plasmakoncentrationerne ens, hvad enten telmisartan tages fastende eller med føde.
English: Therefore it is not expected to potentiate bradykininmediated adverse effects.
Danish: Derfor forventes det ikke, at bradykininmedierede bivirkninger potenseres.
English: Elderly The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Danish: Telmisartans farmakokinetiske egenskaber er ikke anderledes hos ældre patienter i forhold til de der er under 65 år.
English: Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Danish: Telmisartan udviser ikke affinitet til andre receptorer, herunder AT2 og andre mindre karakteriserede AT-receptorer.
English: These patients can be expected to have reduced hepatic clearance for telmisartan.
Danish: Hos disse patienter kan man forvente at se nedsat hepatisk clearance af telmisartan.
English: It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Danish: Det vides ikke, om lavere doser end 80 mg telmisartan reducerer kardiovaskulær morbiditet.
English: Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it
Danish: Adskil én blisterlomme fra resten af blisterkortet ved forsigtigt at rive langs perforeringerne omkring den
English: Patients with rare hereditary problems of fructose intolerance should not take Telmisartan Teva.
Danish: Patienter med sjælden arvelig fruktoseintolerans bør ikke tage Telmisartan Teva.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaprotein (>99,5 %), hovedsagelig til albumin og Alfa I-syreglycoprotein.
English: Carefully peel off the top paper layer
Danish: Træk forsigtigt det øverste papirlag af
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Danish: Efter administration af den første dosis telmisartan indtræder den antihypertensive effekt gradvist inden for 3 timer.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Danish: Tabletten bør synkes hel med vand eller anden væske uden alkohol.
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Danish: Funktionen af disse receptorer er ikke kendt, dette gælder også effekten af deres mulige overstimulering af angiotensin II, hvis niveau øges af telmisartan.
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Danish: Hos begge dyrearter fandt man forøget plasma-reninaktivitet og hypertrofi/hyperplasi af de renale juxtaglomerulære celler.
English: Your doctor can tell you if you are at high risk for such events.
Danish: Din læge kan informere dig, om du er i risikogruppen.
English: See also information under the heading “Do not take Telmisartan Teva”.
Danish: Se også information under overskriften ”Tag ikke Telmisartan Teva”.
English: In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Danish: Hos patienter med hypertension reducerer telmisartan både det systoliske og det diastoliske blodtryk uden at påvirke pulsen.
English: If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take Telmisartan Teva in combination with:
Danish: Hvis du lider af en tilstand, der kaldes "ortostatisk hypotension" (et fald i blodtrykket, når du rejser dig op fra siddende eller liggende stilling, hvilket gør dig svimmel eller mat), kan din tilstand forværres, hvis du tager Telmisartan Teva sammen med:
English: Management depends on the time since ingestion and the severity of the symptoms.
Danish: Behandlingen afhænger af den tid, der er forløbet siden indtagelse og af symptomernes sværhedsgrad.
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 blodtrykket opnås generelt 4-8 uger, efter behandlingen er påbegyndt og fastholdes gennem langtidsbehandling.
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 påvist ved døgnblodtryksmålinger.
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 op til 2,5 gange øgning af AUC0-24 og Cmax af ramipril og ramiprilat.
English: Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Danish: Der er observeret forskelle i plasmakoncentrationen med Cmaks og AUC hhv. 3 og 2 gange højere hos kvinder end hos mænd.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Danish: Forekomsten af hændelser svarende til det primære endepunkt var ens for telmisartan (16,7 %) og ramipril (16,5 %).
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Danish: De tilsvarende data for det diastoliske blodtryk (DBT) var modstridende.
English: If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis denne kombination skønnes nødvendig, tilrådes tæt monitorering af serum-lithiumniveauet.
English: Japanese patients are more likely to experience these adverse reactions.
Danish: Japanske patienter er mere udsatte for at få sådanne bivirkninger.
English: It is important that you take Telmisartan Teva every day until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage Telmisartan Teva hver dag, så længe lægen ikke har givet dig besked på andet.
English: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
Danish: Teva Denmark A/S Tlf: +45 44 98 55 11
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Danish: Selvom der ikke findes kontrollerede epidemiologiske data for angiotensin II-receptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse.
English: The safety of long term treatment of telmisartan in children and adolescents was not evaluated.
Danish: Sikkerheden ved langtidsbehandling med telmisartan hos børn og unge blev ikke evalueret.
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 med føde, sker der en reduktion i arealet under plasmakoncentrationskurven (AUC0-∞) på ca. 6 % (40 mg dosis) til ca. 19 % (160 mg dosis).
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke “angiotensinconvertingenzyme” (kininase-II enzymet), som også nedbryder bradykinin.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
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 pludselig seponering af telmisartan, vil blodtrykket gradvist returnere til værdierne fra før behandlingsstart over en periode på flere dage, uden at der ses tegn på "rebound"-hypertension.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes or blindness.
Danish: Hvis forhøjet blodtryk ikke behandles, kan der ske skader på blodkarrene i flere organer, som i nogle tilfælde kan føre til hjerteanfald, hjerte- eller nyresvigt, slagtilfælde eller blindhed.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet (se pkt.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Danish: Abdominalsmerter, diarré, dyspepsi, flatulens, opkastning
English: When initiating, adjusting, and discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic range.
Danish: Ved opstart, justering og seponering af telmisartan skal digoxinniveauet monitoreres for at holde plasmakoncentrationen inden for det terapeutiske område.
English: Plasma aldosterone levels are decreased by telmisartan.
Danish: Plasma-aldosteronniveauet sænkes med telmisartan.
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 displacerer angiotensin II med meget høj affinitet fra dets bindingssted på AT1receptorsubtypen, som er ansvarlig for de kendte virkninger af angiotensin II.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelige, ATC-kode: C09CA07
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Danish: Telmisartan er en oralt aktiv og specifik angiotensin II-receptor (AT1)-antagonist.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Danish: Dette bekræftes ved, at trough/peak ratios konstant over 80 % er set efter dosering af 40 mg og 80 mg telmisartan i placebokontrollerede kliniske studier.
English: Close monitoring of serum potassium in at risk patients is recommended (see section 4.5).
Danish: Det anbefales at monitorere serumkalium nøje hos patienter i risikogruppen (se pkt.4.5).
English: By inclusion the presence of secondary hypertension was not investigated.
Danish: Eventuel tilstedeværelse af sekundær hypertension blev ikke undersøgt før inklusion.
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 i forbindelse med telmisartan-terapi.
English: Serum electrolytes and creatinine should be monitored frequently.
Danish: Serumelektrolytter og kreatinin skal bestemmes regelmæssigt.
English: No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offsprings such as lower body weight and delayed eye opening was observed.
Danish: Der er ingen tegn på teratogenisitet, men ved toksiske doser sås en påvirkning af den postnatale udvikling af afkommet såsom lavere legemsvægt og forsinket åbning af øjnene.
English: Investigations Uncommon:
Danish: Undersøgelser Ikke almindelig:
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Danish: Telmisartan udviser ingen partiel agonistaktivitet ved AT1-receptoren.
English: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
Danish: • manifest arteriotrombotisk kardiovaskulær sygdom (koronar hjertesygdom, apopleksi eller perifer arteriesygdom i anamnesen) eller
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Danish: Telmisartan metaboliseres ved konjugation til glucuronidet til moderstoffet.
English: Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Danish: Desuden blev der fundet ventrikel-slimhindelæsioner (erosion, ulcus eller inflammation) i rotter og hunde.
English: • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
Danish: • Andet og tredje trimester af graviditeten (se pkt.
English: Always take Telmisartan Teva exactly as your doctor has told you.
Danish: Tag altid Telmisartan Teva nøjagtigt efter lægens anvisning.
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 vil generelt ikke respondere på antihypertensiva, som virker ved at hæmme renin-angiotensinsystemet.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100);
English: The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Danish: Den blodtryksnedsættende virkning af telmisartan kan øges ved samtidig behandling med andre antihypertensive lægemidler.
English: Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Danish: Bemærk, at vejledning i, hvordan tabletten tages ud af blisterkortet, findes på den ydre æske med blisterkortene med aftrækkeligt folie.
English: - The active substance is telmisartan.
Danish: Aktivt stof: Telmisartan.
English: Therefore, the use of telmisartan is not recommended.
Danish: Derfor frarådes brug af telmisartan.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Storbritannien
English: Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients treated with ramipril, whereas hypotension was more frequently reported with telmisartan.
Danish: Hoste og angioødem blev sjældnere rapporteret af patienter behandlet med telmisartan end af patienter behandlet med ramipril, mens hypotension oftere blev rapporteret af patienter behandlet med telmisartan.
English: Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone.
Danish: Kombinationen af telmisartan og ramipril havde ikke nogen additiv virkning i forhold til ramipril og telmisartan alene.
English: Deutschland Teva GmbH Tel: (49) 731 40208
Danish: Teva GmbH Tel: (49) 731 40208
English: As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: Som ved andre antihypertensiva, kan en for kraftig reduktion af blodtrykket hos patienter med iskæmisk kardiopati eller iskæmisk kardiovaskulær sygdom resultere i myokardieinfarkt eller apopleksi.
English: - if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva in early pregnancy
Danish: 6) hvis du er mere end 3 måneder henne i graviditeten - (du skal desuden helst undgå at bruge Telmisartan Teva tidligt i graviditeten - se afsnittet om Graviditet).
English: Anaphylactic reaction, hypersensitivity
Danish: Anafylaktisk reaktion, overfølsomhed
English: Therefore the use of a combination of telmisartan and ramipril is not recommended in this population.
Danish: Kombination af ramipril og telmisartan kan derfor ikke anbefales til denne patientpopulation.
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Danish: Død af alle årsager var 11,6% henholdsvis 11,8% for telmisartan- og ramiprilbehandlede patienter.
English: Telmisartan Teva belongs to a class of medicines known as angiotensin-II receptor antagonists.
Danish: Telmisartan Teva tilhører en klasse af lægemidler, der kaldes angiotensin II-receptorantagonister.
English: Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Administration Telmisartan-tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: Aluminium-Aluminium blisters : pack size of 30 tablets
Danish: Aluminium-aluminiumblistere: pakningsstørrelse a 30 tabletter.
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Danish: Angiotensin II-receptorantagonister bør ikke anvendes under graviditet.
English: When Telmisartan Teva is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Telmisartan Teva anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniveauerne for kalium og kreatinin.
English: If you forget to take Telmisartan Teva
Danish: Hvis du har glemt at tage Telmisartan Teva
English: Telmisartan selectively binds the AT1 receptor.
Danish: Telmisartan bindes selektivt til AT1-receptoren.
English: The recommended dose of Telmisartan Teva is one tablet a day.
Danish: Den anbefalede dosis af Telmisartan Teva er 1 tablet daglig.
English: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Danish: Ud fra de farmakologiske egenskaber må det forventes, at den hypotensive virkning af alle antihypertensiva inklusive telmisartan vil forstærkes af følgende lægemidler: Baclofen, amifostine.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Danish: Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5% CI 0,93-1,10, p (noninferioritet) =0,0019 ved en margin på 1,13).
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Danish: Der er øget risiko for alvorlig hypotension og nyreinsufficiens, når patienter med bilateral nyrearteriestenose eller stenose af arterien til en enkelt fungerende nyre behandles med lægemidler, som påvirker renin-angiotensin-aldosteronsystemet.
English: CV mortality and all cause mortality were numerically higher with the combination.
Danish: Kardiovaskulær død eller død af andre årsager var numerisk højere ved administration af kombinationen.
English: Microcrystalline cellulose (Avicel PH 102) Sodium starch glycolate (Type A) Poloxamers
Danish: Mikrokrystallinsk cellulose (Avicel PH 102) Natriumstivelsesglycolat (Type A) Poloxamerer
English: Telmisartan Teva is used to treat essential hypertension (high blood pressure) in adults.
Danish: Telmisartan Teva bruges til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne.
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Danish: I PRoFESS-forsøget blev der set en øget incidens af sepsis hos patienter behandlet med telmisartan sammenlignet med placebo.
English: • Baclofen (a muscle relaxant)
Danish: • Baclofen (en medicin med afslappende effekt på musklerne)
English: A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Danish: Derimod er kombinationer med ACE-hæmmere eller NSAID mindre risikable, forudsat at de foreskrevne forholdsregler følges.
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Danish: I listningen af bivirkninger er også medtaget alvorlige hændelser og hændelser, som førte til behandlingsstop, i tre kliniske langtidsstudier med i alt 21.642 patienter, behandlet med telmisartan i op til 6 år for at reducere kardiovaskulær morbiditet.
English: The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports.
Danish: Bivirkningsreaktionerne vist nedenfor er indsamlet fra kontrollerede kliniske forsøg med hypertensionspatienter og fra post marketing rapporter.
English: Date of the latest renewal: 19 December 2014
Danish: Dato for første tilladelse: 26. januar 2010 Dato for seneste fornyelse: 19/12/2014
English: Telmisartan Teva 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: Telmisartan Teva frarådes tidligt i graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader, hvis det bruges på det tidspunkt (se afsnittet om graviditet).
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Danish: Angioødem (også med letalt udfald), eksem, erythema, urticaria, medikamentalt udløst udslæt, toksisk hududslæt
English: <1/1,000); very rare (<1/10,000).
Danish: sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000).
English: In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm.
Danish: Derudover fandtes en signifikant højere insidens af hyperkaliæmi, nyresvigt, hypotension og synkope med kombinationsbehandlingen.