FrancophonIA/ELRC3.0 huggingface dataset:
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: In these patients hypoglycaemia may occur under telmisartan treatment.
Danish: Hos disse patienter kan hypoglykæmi forekomme i forbindelse med telmisartan-terapi.
English: Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box.
Danish: Pakningsstørrelser: 14, 28, 30, 56, 84, 90, 98 og 100 tabletter i en æske.
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21642 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: Tolura may be less effective in lowering the blood pressure in black patients.
Danish: Tolura kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: Tolura is available in blister packs containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Danish: Tolura fås i blisterpakninger, der indeholder 14, 28, 30, 56, 84, 90, 98 og 100 tabletter.
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Danish: Telmisartan er en peroral aktiv og specifik angiotensin II-receptor (type AT1)-antagonist.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Danish: Hvis forhøjet blodtryk ikke behandles, kan der ske skade på blodkarrene i flere organer, som i nogen tilfælde kan medføre hjerteanfald, hjerte- eller nyresvigt, slagtilfælde eller blindhed.
English: - Heart trouble.
Danish: - hjerteproblemer.
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 NSAIDere mindre risikable, forudsat at de foreskrevne forholdsregler følges nøje.
English: - The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate,
Danish: - De øvrige indholdsstoffer er povidon, meglumin, natriumhydroxid, lactosemonohydrat,
English: - if you are more than 3 months pregnant.
Danish: - hvis du er gravid i andet eller tredje trimester.
English: Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Telmisartan-tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis
Danish: urinvejsinfektion herunder cystitis, infektion i øvre luftveje herunder pharyngitis og sinusitis
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Danish: Telmisartan metaboliseres ved konjugation til glucuronidet til af moderstoffet.
English: Because no information is available regarding the use of Tolura during breast-feeding, Tolura is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Da der ikke er tilgængelig information vedrørende anvendelse af Tolura under amning, frarådes det at anvende Tolura, og andre behandlinger med en kendt sikkerhedsprofil vedrørende brug under amning foretrækkes, især hvis barnet er nyfødt eller præmaturt.
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) hos rotter og hunde.
English: Tolura belongs to a class of medicines known as angiotensin II receptor antagonists.
Danish: Tolura tilhører en type lægemidler, der kaldes angiotensin II-receptorantagonister.
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Danish: I PRoFESS-studiet blev set en øget incidens af sepsis hos patienter behandlet med telmisartan sammenlignet med placebo.
English: - if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems, - aliskiren.
Danish: - hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge - aliskiren.
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Danish: hypoglykæmi (hos diabetes patienter)
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Danish: angioødem (også med letalt udfald), eksem, erythem, urticaria, medikamentelt udløst udslæt, toksisk hududslæt
English: The adjusted DBP changes from baseline were -8.4 (1.5) mmHg, -4.5 (1.6) mmHg and -3.5 (2.1) mmHg respectively.
Danish: De justerede DBP-ændringer fra baseline var henholdsvis -8,4 (1,5) mmHg; -4,5 (1,6) mmHg og -3,5 (2,1) mmHg.
English: In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Danish: Hos mennesket hæmmer en dosis på 80 mg telmisartan næsten fuldstændigt en angiotensin IIprovokeret blodtryksforhøjelse.
English: * The event may have happened by chance or could be related to a mechanism currently not known.
Danish: *Observationen kan være en tilfældighed eller kan være relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt.
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 en sådan samtidig behandling er nødvendig på grund af dokumenteret hypokaliæmi, bør der udvises forsigtighed og med hyppig kontrol af serumkalium.
English: Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Telmisartan skal forblive i den forseglede blister pga. hygroskopiske egenskaber.
English: sorbitol (E420) and magnesium stearate.
Danish: sorbitol (E420) og magnesiumstearat.
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: Children and adolescents The use of Tolura in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og teenagere Det frarådes at anvende Tolura til børn og unge i alderen op til 18 år.
English: To be taken into account with concomitant use
Danish: Overvejelser ved samtidig brug med nedenstående
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstillere ansvarlige for batchfrigivelse
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 studier med hypertensionspatienter og fra post marketing rapporter.
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Børn, hvis mødre har taget angiotensin II-receptorantagonister, bør observeres nøje for hypotension (se pkt.
English: In dogs, renal tubular dilation and atrophy were observed.
Danish: Hos hunde fandt man renal tubulær dilatation og atrofi.
English: Tolura blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Tolura blokerer angiotensin IIs virkning, så blodkarrene afslappes og blodtrykket falder.
English: The recommended dose is 80 mg once daily.
Danish: Den anbefalede dosis er 80 mg én gang daglig.
English: Anaphylactic reaction, hypersensitivity
Danish: anafylaktisk reaktion, overfølsomhed
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Danish: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) var et studie, der skulle undersøge fordelen ved at tilføje aliskiren til standardbehandling med en ACE-hæmmer eller en angiotensin II-receptorantagonist hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
English: The antihypertensive efficacy of telmisartan is comparable to that of agents 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 virkningen af andre klasser af antihypertensive lægemidler (påvist i kliniske studier, der sammenlignede telmisartan med amlodipin, atenolol, enalapril, hydrochlorthiazid og lisinopril).
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, amifostin.
English: The event may be a chance finding or related to a mechanism currently not known (see also section 5.1).
Danish: Observationen kan være en tilfældighed eller relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt (se også pkt.
English: Pruritus, hyperhidrosis, rash
Danish: pruritus, hyperhidrose, udslæt
English: Tolura 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: Tolura frarådes i de første 3 måneder af graviditeten og må ikke tages i 4.-9. måned af graviditeten, da det kan medføre alvorlig skade på dit barn, hvis det anvendes i dette stadie (se afsnittet om graviditet).
English: Povidone (K30) Meglumine Sodium hydroxide Lactose monohydrate Sorbitol (E420) Magnesium stearate
Danish: Povidon (K30) Meglumin Natriumhydroxid Lactosemonohydrat Sorbitol (E420) Magnesiumstearat
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Danish: Patienterne blev randomiseret til én af de tre følgende behandlingsgrupper: Telmisartan 80 mg (n = 8.542), ramipril 10 mg (n = 8.576) eller en kombination af telmisartan 80 mg og ramipril 10 mg (n = 8.502).
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 brugere) Tiltagende arvævsdannelse i lungerne (interstitiel lungesygdom)**
English: Tolura 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 used after the third month of pregnancy.
Danish: Tolura frarådes i de første 3 måneder af graviditeten og må ikke tages i 4.-9. måned af graviditeten, da det kan medføre alvorlig skade for dit barn, hvis det anvendes efter graviditetens 3. måned.
English: Reduction of cardiovascular morbidity in adults with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or - type 2 diabetes mellitus with documented target organ damage.
Danish: Reduktion af kardiovaskulær morbiditet hos voksne med: - manifest arteriotrombotisk kardiovaskulær sygdom (koronar hjertesygdom, apopleksi eller perifer arteriesygdom i anamnesen) eller - type 2-diabetes med dokumenteret påvirkning af målorgan.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1receptor 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: The concomitant use of Tolura with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: Samtidig brug af Tolura og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati
English: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Danish: Angotensin II-receptorantagonister, såsom telmisartan, mindsker diuretisk fremkaldt kaliumtab.
English: Other medicines and Tolura
Danish: Brug af anden medicin sammen med Tolura
English: If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
Danish: Hvis du har nedsat leverfunktion, bør dosis normalt ikke overskride 40 mg én gang dagligt.
English: Your doctor has recommended a lower dose of one 20 mg tablet daily.
Danish: Din læge har anbefalet en lavere dosis på 20 mg til dig.
English: ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Danish: **Tilfælde af tiltagende arvævsdannelse i lungerne er blevet rapporteret ved indtagelse af telmisartan.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Tolura.
Danish: Hvis du skal opereres eller bedøves, skal du fortælle lægen, at du tager Tolura.
English: There is no experience regarding the administration of Tolura in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Tolura til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: Tolura may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Danish: Tolura kan øge den blodtryksnedsættende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: - Diuretics ('water tablets'), especially if taken in high doses together with Tolura, may lead to excessive loss of body water and low blood pressure (hypotension).
Danish: - vanddrivende medicin (diuretika), især i høje doser sammen med Tolura, kan medføre udpræget tab af kropsvæske og for lavt blodtryk (hypotension).
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Danish: NSAIDere (f.eks. acetylsalicylsyre i doser beregnet til antiinflammatorisk behandling, COX-2hæmmere og ikke-selektive NSAIDere) kan muligvis nedsætte den antihypertensive virkning af angiotensin II-receptorantagonister.
English: Blood creatinine increased
Danish: forhøjet kreatinin
English: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Som ved brug af andre vasodilatatorer, bør særlig forsigtighed udvises hos patienter, der lider af aorta- eller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati.
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 som spironolakton, eplerenon, triamteren eller amilorid, kaliumtilskud eller kaliumholdige saltsubstitutter kan medføre en signifikant stigning i serumkalium.
English: Visual disturbance
Danish: synsforstyrrelser
English: were -14.5 (1.7) mmHg in the telmisartan 2 mg/kg group, -9.7 (1.7) mmHg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group.
Danish: 14,4 (1,7) mmHg i telmisartan 2 mg/kg gruppen; -9,7 (1,7) mmHg i telmisartan 1 mg/kg gruppen og-6,0 (2,4) mmHg i placebogruppen.
English: Anaemia Eosinophilia, thrombocytopenia
Danish: eosinofili, trombocytopeni
English: Tablets should be taken out of the blister shortly before administration (see section 6.6).
Danish: Tabletterne skal tages ud af blisteren kort før indtagelse (se pkt.
English: What you need to know before you take Tolura
Danish: Det skal du vide, før du begynder at tage Tolura
English: Manufacturers
Danish: Fremstiller
English: - if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Danish: - hvis du har alvorlige leverproblemer, såsom kolestase eller galdevejsobstruktion (problem med udskillelse af galde fra leveren og fra galdeblæren) eller anden alvorlig leversygdom.
English: Telmisartan does not exhibit any partial agonist activity at the AT1receptor.
Danish: Telmisartan udviser ingen partiel agonistaktivitet ved AT1-receptoren.
English: However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Tolura may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Tolura.
Danish: Nogle patienter får anbefalet en lavere dosis på 20 mg eller en højere dosis på 80 mg. Tolura kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig yderligere at øge den blodtryksnedsættende virkning af Tolura.
English: Metabolism and nutrition disorders Uncommon:
Danish: Metabolisme og ernæring Ikke almindelig:
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Danish: Disse farmakologisk betingede bivirkninger, som er kendt fra prækliniske forsøg med både ACE-hæmmere og angiotensin II-receptorantagonister, kunne forebygges ved oral salttilførsel.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Danish: nedsat hæmoglobin, forhøjet urinsyre, forhøjede leverenzymer, forhøjet kreatininphosphokinase i blodet
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 (non-inferioritet) =0,0019 ved en margin på 1,13).
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Danish: Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af renin-angiotensinaldosteronsystemets aktivitet (f.eks. patienter med alvorlig kongestivt hjertesvigt eller tilgrundliggende nyresygdom, herunder nyrearteriestenose), har behandling med lægemidler, som påvirker dette system, såsom telmisartan, været forbundet med akut hypotension, hyperazotæmi, oliguri eller i sjældne tilfælde akut nyresvigt (se pkt.
English: Diuretics (thiazide or loop diuretics)
Danish: Vanddrivende lægemidler (thiazider eller loop-diuretika)
English: Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure.
Danish: Angiotensin II er et naturligt stof i kroppen, som får blodkarrene til at snævre ind.
English: - Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).
Danish: - tilstødende komplikationer, især dehydrering, akut hjertedekompensation, metabolsk acidose, forværring af nyrefunktionen, pludselig forværring af nyrernes tilstand (f.eks. ved infektiøse sygdomme), cellenedbrydning (f.eks. ved akut ekstremitetiskæmi, rhabdomyolyse, større traumer).
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years).
Danish: - diabetes mellitus, nedsat nyrefunktion, alder (> 70 år).
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul.
Danish: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien KRKA-POLSKA Sp. z o.o., Ul.
English: For reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once a day.
Danish: Til nedsættelse af risikoen for hjerte-kar-tilfælde er den sædvanlige dosis Tolura 80 mg én gang dagligt.
English: The usually effective dose is 40 mg once daily.
Danish: Den normale dosis er 40 mg én gang dagligt.
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 er bekræftet ved målinger, der blev foretaget på tidspunktet for maksimal effekt og umiddelbart forud for den næste dosis (trough/peak ratio var over 80% efter dosering af 40 mg og 80 mg telmisartan i placebokontrollerede kliniske studier).
English: - Liver disease.
Danish: - leversygdom.
English: Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure.
Danish: Telmisartan havde samme virkning som ramipril mht. reduktion i det primære sammensatte endepunkt (kardiovaskulær død, ikke-fatalt myokardieinfarkt, ikke-fatal apopleksi eller hospitalsindlæggelse pga. hjertesvigt).
English: Blood and the lymphatic system disorders Uncommon:
Danish: Blod og lymfesystem Ikke almindelig:
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 reversible stigninger i serum-lithiumkoncentrationerne samt toksicitet ved samtidig behandling med lithium og ACE-hæmmere, og ved behandling med angiotensin IIreceptorantagonister, herunder telmisartan.