FrancophonIA/ELRC3.0 huggingface dataset:
English: Telmisartan Actavis tablets are used to treat essential hypertension (high blood pressure) in adults.
Danish: Telmisartan Actavis bruges til behandling af essential hypertension (forhøjet blodtryk) hos voksne.
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 kan føre til hjerteanfald, hjerte- eller nyresvigt, slagtilfælde eller blindhed.
English: Telmisartan Actavis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Telmisartan Actavis blokerer angiotensin II´s virkning, så blodkarrene afslappes og blodtrykket falder.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Actavis.
Danish: Hvis du har nogen af ovenstående tilstande, så fortæl det til lægen eller på apoteket før du tager Telmisartan Actavis.
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-angiotensin-aldosteronsystemet.
English: If you take more Telmisartan Actavis than you should It is important to keep to the dose as prescribed by your doctor.
Danish: Hvis du har taget for mange Telmisartan Actavis tabletter Det er vigtigt at følge den dosering din læge har ordineret dig.
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 nyreinsufficens, når patienter med bilateral nyrearteriestenose eller stenose af arterien til en enkelt fungerende nyre behandles med lægemidler, som påvirker renin-angiotensin-aldosteronsystemet.
English: Magnesium stearate Croscarmellose sodium Mannitol
Danish: Magnestiumstearat Croscarmellosenatrium Mannitol
English: Bulebel Industrial Estate Zejtun
Danish: Bulebel Industrial Estate Zetjun
English: Your doctor will normally advise you to stop taking Telmisartan Actavis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Actavis.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Telmisartan Actavis, før du bliver gravid eller så snart du ved, du er gravid.
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.
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: At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, blood pressure should be frequently monitored.
Danish: I den første periode af behandlingen med Telmisartan Actavis 80 mg, skal blodtrykket kontrolleres regelmæssigt.
English: You can take Telmisartan Actavis with or without food.
Danish: Du kan tage tabletten med eller uden mad.
English: Hypotension2, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Hypotension2, ortostatisk hypotension Luftveje, thorax og mediastinum Ikke almindelig:
English: The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports.
Danish: Bivirkningsreaktionerene vist nedenfor er indsamlet fra kontrollerede kliniske studier med hypertensionspatienter og fra post marketing rapporter.
English: It is important that you take Telmisartan Actavis every day until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage Telmisartan Actavis hver dag, så længe lægen ikke har givet dig besked på andet.
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 virkningern af andre klasser af antihypertensive lægemidler (påvist) i kliniske studier, der sammenlignede telmisartan med amlodipin, atenolol, enalapril, hydrochloritiazid og lisinopril).
English: The concomitant use of Telmisartan Actavis 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
Danish: Samtidig brug af Telmisartan Actavis og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: HDPE tablet container with LDPE lid: Keep the container tightly closed in order to protect from light.
Danish: HDPE-tabletbeholder med LDPE-låg: Hold tabletbeholderen tæt tillukket for at beskytte mod lys.
English: Concomitant use requiring caution
Danish: Nedenstående kombinationer kræver forsigtighed
English: Do not take Telmisartan Actavis - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Telmisartan Actavis - hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i denne medicin (angivet i pkt.
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 resultatere i myokarieninfarkt eller apopleksi (slagtilfælde).
English: What Telmisartan Actavis contains - The active substance is telmisartan.
Danish: Telmisartan Actavis indeholder: - Det aktive stof er telmisartan.
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Danish: Telmisartan er en oralt administereret aktiv specifik angiotensin II-receptorsubtype 1 (AT1)-antagonsit.
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 dem, del blev behandlet med ACE-hæmmere i kliniske studier, som direkte sammenlignede disse to antihypertensive behandlinger.
English: The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast heart beat (tachycardia).
Danish: De almindligste symptomer på overdosering af telmisartan er lavt blodtryk (hypotension) og hurtig hjerterytme (tarkykadi).
English: The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
Danish: Sikkerhedsprofilen for telmisartan for patienter i behandling for at reducere kardiovaskulær morbiditet er i oveensstemmelse med, hvad der tidligere er fundet for patienter med hypertension.
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 langtisstudier med i alt 21642 patienter, behandlet med telmisartan i op til 6 år for at reducere kardiovaskulær morbiditet.
English: Interstitial lung disease4
Danish: Interstitiel lungesygdom4
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningeren opstillet efter, hvor alvorlige de er.
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100);
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.
English: HDPE tablet container:
Danish: HDPE-tabletbeholder:
English: - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: • hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren.
English: In dogs renal tubular dilation and atrophy were observed.
Danish: I hunde fandt man tubulær dilation og atrofi af nyrerne.
English: If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
Danish: Ved hypotension skal patienten lægges i rygleje, der skal hurtigt gives salt- og væskesubstitution.
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, triametern eller amilorid, kaliumtilskud eller kaliumholdige saltsubstitutter kan medføre en signifikant stigning i serumkalium.
English: Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
Danish: Telmisartan Actavis kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Danish: En dosis på 80 mg telmisartan givet til raske frivillige hæmmer næsten fuldstændigt en angiotensin II-provokeret blodtryksforhøjelse.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl din læge eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
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: Telmisartan Actavis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Din læge vil vælge en anden behandling til dig, hvis du ønsker at amme, specielt hvis dit barn er nyfødt eller er født for tidligt.
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 antihypertensiva inklusive telmisartan vil forstærkes af følgende lægemidler: baclofen, amifostin.
English: If you forget to take Telmisartan Actavis
Danish: Hvis du har glemt at tage Telmisartan Actavis
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 eller fra galdeblæren) eller anden alvorlig leversygdom.
English: TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n = 2954) or placebo (n = 2972), both given on top of standard care.
Danish: I TRANSCEND-studiet randomiseredes patienter, der var intolerante over ACE-hæmmere, men i øvrigt med de samme inklusionskriterier som i ONTARGET studiet, til enten 80 mg telmisartan (n=2954) eller placebo (n=2972).
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, apoleksi eller perifer arteriesygdom i anamnesen) eller - type 2-diabetes med dokumenteret organpåvirkning.
English: Talk to your doctor before taking Telmisartan Actavis:
Danish: Kontakt lægen, før du tager Telmisartan Actavis:.
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: De tre randomiseringsgrupper var følgende: Telmisartan 80 mg (n=8542), ramipril 10 mg (n=8576) eller en kombination af telmisartan 80 mg og ramipril 10 mg(n=8502).
English: There is no experience regarding the administration of Telmisartan Actavis in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Telmisartan Actavis til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines known as angiotensin II receptor antagonists.
Danish: Telmisartan Actavis indeholder det aktive stof telmisartan som tilhører en gruppe af medicin som kaldes angiotensin II-receptorantagonister.
English: Telmisartan Actavis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes.
Danish: Telmisartan Actavis bruges også til at nedsætte risikoen for kardiovaskulære hændelser (f.eks. hjerteanfald eller salgtilfælde) hos voksne, der har nedsat eller blokeret blodtilførsel til hjertet eller benene, eller har haft et slagtilfælde eller har høj risiko for diabetes.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved brug af andre vasodilatatorer, bør særlig forsigthed udvises hos patienter, der lider af aortaeller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati.
English: For reduction of cardiovascular events, the usual dose of Telmisartan Actavis is one 80 mg tablet once a day.
Danish: Til nedsættelse af risikoen for hjerte-kar-hændelser er den sædvanlige dosis Telmisartan Actavis 80 mg én gang daglig.
English: The risk is particularly high in combination with potassium sparing-diuretics and when combined with salt substitutes containing potassium.
Danish: Risikoen er i særdelshed høj ved samtidig behandling med kaliumbesparende diuretika, og med kaliumholdige saltsubstitutter.
English: The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
Danish: Hyperkaliæmi Medicin, som påvirker renin-angiotensin-aldosteronsystemet, kan forårsage hyperkaliæmi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
English: NAME OF THE MARKETING AUTHORISATION HOLDER Actavis logo
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis logo
English: Serum electrolytes and creatinine should be monitored frequently.
Danish: Serumelektrolytter og kreatinin skal bestemmes regelmessigt.
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 anvendt angiotensin II-receptorantagonister, bør obseveres for hypertension (se pkt.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system 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: Andre tilstande med stimulering af renin-angiotensin-aldosteronsystemet Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af renin-angiotensinaldosteronsystemets aktivitet (f.eks. patienter med svær højresidig hjerteinsufficiens eller tilgrundliggende nyresygdom, herunder nyrearteriestenose), har behandling med lægemidler, som påvirker dette system, såsom telmisartan, været forbundet med akut hypotension, hyperzotæmi, oliguri eller i sjældne tilfælde akut nyresvigt (se pkt.
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: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses: - Kidney disease or kidney transplant.
Danish: Kontakt lægen, hvis du har eller har haft nogen af de nedenstående sygdomme eller tilstande:
English: Potassium Hydroxide Pellets
Danish: Kaliumhydroxid pellets
English: Eosinophilia , thrombocytopenia
Danish: Eosinofili, trombocytopeni
English: Telmisartan Actavis 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: Telmisartan Actavis kan øge den blodtryksnedsættende virkning af andre blodtryksnedsættende lægemidler og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton til blister
English: Keep the container tightly closed in order to protect from light.
Danish: Hold beholderen tæt tillukket for at beskytte mod lys..
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Danish: Angioødem (også med letalt udfald), eksem, erythema, urticaria, mediakamentelt udløst udslæt, toksisk hududslæt,
English: The tablet container contains a desiccant, do not eat the desiccant.
Danish: Tabletbeholderen indeholder en tørrekapsel, den må ikke spises.
English: For treatment of high blood pressure, the usual dose of Telmisartan Actavis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Danish: Til behandling af for højt blodtryk, er den sædvanlige dosis af Telmisartan Actavis 40 mg én gang dagligt til kontrol af dit blodtryk i 24 timer.
English: *The event may have happened by chance or could be related to a way that telmisartan works that is currently not known.
Danish: *Observationen kan være en tilfældighed eller kan være relateret til den måde telmisartan virker som på nuværende tidspunkt ikke er kendt.
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 pimære sammensatte endepunkt (kardiovaskulær død, ikke-fatalt myokardieninfarkt, ikke-fatal apopleksi eller hospitalsindlæggelse pga. hjertesvigt).
English: Non-steroidal anti-inflammatory medicinal products 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: NSAID (f.eks. acetylsalicylsyre) i doser beregnet til antiinflammatorisk behandling, (COX-2-hæmmere og ikke-selektive NSAID) kan muligvis nedsætte den antihypertensive virkning af angiotensin II-receptorantagonister.
English: SPECIAL STORAGE CONDITIONS Keep the container tightly closed in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i tætlukket beholder for at beskytte mod lys.
English: To be taken into account with concomitant use
Danish: Vær opmærksom ved samtidig brug med nedenstående
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 hjertekompensation, metabolsk acidose, forværring af nyrefunktionen, akut forværring af nyrernes tilstand ( f.eks. ved infektiøse sygdomme), cellenedbrydning (f.eks. ved akut ekstremitetsæmi, rabdomylyse, større traumer).
English: If you accidentally take too many tablets ask your doctor what to do or contact your nearest hospital emergency department immediately.
Danish: Hvis du ved en fejl kommer til at tage for mange tabletter, så kontakt straks lægen eller skadestue.
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 alle placebokontrollerede kliniske studier).
English: Store in the original package in order to protect from light.
Danish: Opbevares i originalpakning for at beskytte mod lys.
English: Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70% vs. 0.49% [RR 1.43 (95% confidence interval 1.00- 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33%) vs. patients taking placebo (0.16%) [RR 2.07 (95% confidence interval 1.14 3.76)].
Danish: I studiet ”Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) hos patienter på 50 år og ældre, som for nylig har oplevet stroke, blev der observeret en øget incidens af sepsis hos patienter behandlet med telmisartan sammenlignet med placebo, 0,70% vs. 0,49% [RR 1,43 (95% sikkerhedsinterval 1,00-2,06)]; incidensen af fatale tilfælde af sepsis var øget hos patienter, som fik telmisartan (0,33%) vs. patienter, som fik placebo (0,16%) [RR 2,07 (95% sikkerhedsinterval 1,14-3,76)].