natgillin/translations-raw huggingface dataset:
Se også information under overskriften ”Tag ikke Telmisartan Actavis” 
See also information under the heading “Do not take Telmisartan Actavis”.
Telmisartan er i høj grad bundet til plasmaprotein (>99,5%), hovedsagelig til albumin og Alfa I-syreglycoprotein. 
Telmisartan is largely bound to plasma protein (> 99.5%), mainly albumin and alpha-1 acid glycoprotein.
Corticosteroid (systemisk administration) Reducerer den antihypertensive virkning. 
Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Det tilsyneladende fordelingsvolumen, (Vdss), ved ”steady state” er ca. 500 l. 
The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Tabletten bør synkes med vand eller anden væske uden alkohol. 
The tablets should be swallowed with some water or other non-alcoholic drink.
Der foreligger ikke tilstrækkelige data om brugen af Telmisartan Actavis hos gravide kvinder. 
There are no adequate data from the use of Telmisartan Actavis in pregnant women.
Den maksimale plasmakoncentration (Cmaks) og, i mindre grad, arealet under plasmakoncentrationtidskurven (AUC) stiger disproportionalt med dosis. 
The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC) increase disproportionately with dose.
Telmisartan udviser ikke affinitet til andre receptorer, herunder AT2 og andre mindre karakteriserede AT receptorer. 
Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Den totale plasmaclearenace, (Cltot), er høj (ca. 1000 ml/min) sammenlignet med den hepatiske blodgennemstrømning (ca. 1500 ml/min). 
Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Der var ingen tegn på mutagenicitet eller relevant klasteogen aktivitet ved et in-vitro forsøg og ingen tegn på karcinogenicitet i rotter og mus. 
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
I farmakokinetiske studier med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100%. 
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler. 
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Behandling af essential hypertension 
Treatment of essential hypertension
Volumen- og/eller natriumdepletering bør korrigeres før behandling med Telmisartan Actavis. 
Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Actavis .
Hypertension Behandling af essential hypertension hos voksne. 
Hypertension Treatment of essential hypertension in adults.
Denne hæmmende effekt vedvarer i mere en 24 timer og kan måles i op til 48 timer. 
The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Selvom der ikker findes kontrollerede epidemiologiske data for angiotensin II-receptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse. 
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Tre timer efter indgiften er plasmakoncentrationerne ens, hvad enten telmisartan tages fastende eller med føde. 
By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Endvidere kan ortostatisk hypotension blive forværret af alkohol, barbiturater, narkotika eller antidepressiv. 
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Telmisartan er karatkeriseret ved en farmakokinetisk bieksponentiel udskillelse med en terminal eliminationshalveringstid på >20 timer. 
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of > 20 hours.
Den maksimale reduktion i blodtrykket opnås generelt 4-8 uger efter behandlingen er påbegyndt og fastholdes gennem langtidsbehandling. 
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.
'Essentiel' betyder, at det ikke er nogen sygdom, der er årsag til, at blodtrykket er forhøjet. 
‘Essential' means that the high blood pressure is not caused by any other condition.
Japanske patienter er mere udsatte for at få disse bivirkninger. 
Japanese patients are more likely to experience these adverse reactions.
Hos begge dyrearter fandt man forøget plasma-reninakvtivitet og hypertrofi/hyperplasi af de renale juxtaglomerulære celler. 
In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Den observerede øgede forekomst af sepsis forbundet med brugen af telmisartan kan enten være en tilfældighed eller relateret til en mekanisme, som på nuværenede tidspunkt ikke er kendt. 
The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Forekomsten af hændelser svarende til det primære endepunkt var ens for telmisartan (16,7%) og ramipril (16,5%). 
The incidence of the primary endpoint was similar in the telmisartan (16.7%) and ramipril (16.5%) groups.
Det vises ikke, om lavere doser end 80 mg telmisartan reducerer kardiovaskulær morbiditet. 
It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Der er observeret kønsforskelle i plasmakoncentrationen med Cmaks og AUC hhv. 3 og 2 gange højere hos kvinder end hos mænd. 
Gender differences in plasma concentrations were observed, Cmax and AUC being approximately 3-and 2-fold higher, respectively, in females compared to males.
Hvis du tror virkningen af Telmisartan Actavis er for stærk eller svag, så sig det til din læge eller på apoteket. 
If you have the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or pharmacist.
Telmisartan hæmmer ikke ”angiotensin-converting-enzyme”(kininase-II enzymet), som også nedbryder bradykinin. 
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
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). 
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).
Al/Al blister: Opbevares i den originale yderpakning for at beskytte mod lys. 
Al/Al blisters: Store in the original package in order to protect from light.
Reykjavikurvegi 76-78 
Reykjavíkurvegi 76-78
Dato for første markedsføringstilladelse: 30.09.2010 Dato for fornyelse af tilladelsen: 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30.09.2010
Kontakt lægen, før du tager Telmisartan Actavis: - hvis du tager digoxin. 
Talk to your doctor before taking Telmisartan Actavis: - if you are taking digoxin.
Sådanne tilstande bør korrigeres før behandling med Telmisartan Actavis. 
Such conditions should be corrected before the administration of Telmisartan Actavis .
A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE 
A. MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE
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. 
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.
Død af alle årsager var 11,6% henholdsvis 11,8% for telmisartan og ramiprilbehandlede patienter. 
The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Diabetespatienter, som behandles med insulin eller andiabetika Hos disse patienter kan hypoglykæmi forekomme i forbindelse med telmisartan-terapi. 
Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Tabletbeholder: 30 og 250 tabletter. 
Tablet container: 30 and 250 tablets.
De fleste tilfælde af insufficient leverfunktion/-lidelse fra post-marketing erfaring forekom hos japanske patienter. 
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients.
Når Telmisartan Actavis anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniverauerne for kalium og kreatinin. 
When Telmisartan Actavis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Administration Telmisartan tabletter administreres oralt én gang daglig med væske, med eller uden mad. 
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Behandling: Telmisartan kan ikke fjernes ved hæmodialyse. 
Treatment: Telmisartan is not removed by haemodialysis.
Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelige, ATC kode: C09CA07 
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
- De øvrige indholdsstoffer er magnestiumstearat, croscarmellosenatrium, mannitol, povidon, 
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone,
Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5% CI 0,93-1,10, p (non-inferiorietet) = 0,0019 ved en margin på 1,13). 
The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Telmisartan Actavis bruges til behandling af essential hypertension (forhøjet blodtryk) hos voksne. 
Telmisartan Actavis tablets are used to treat essential hypertension (high blood pressure) in adults.
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. 
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.
Telmisartan Actavis blokerer angiotensin II´s virkning, så blodkarrene afslappes og blodtrykket falder. 
Telmisartan Actavis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Hvis du har nogen af ovenstående tilstande, så fortæl det til lægen eller på apoteket før du tager Telmisartan Actavis. 
If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Actavis.
Patienter med primær aldosteronisme vil generelt ikke respondere på antihypertensiva, som virker ved at hæmme renin-angiotensin-aldosteronsystemet. 
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Hvis du har taget for mange Telmisartan Actavis tabletter Det er vigtigt at følge den dosering din læge har ordineret dig. 
If you take more Telmisartan Actavis than you should It is important to keep to the dose as prescribed by your doctor.
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. 
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.
Magnestiumstearat Croscarmellosenatrium Mannitol 
Magnesium stearate Croscarmellose sodium Mannitol
Bulebel Industrial Estate Zetjun 
Bulebel Industrial Estate Zejtun
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. 
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.
- 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 
- 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.
I den første periode af behandlingen med Telmisartan Actavis 80 mg, skal blodtrykket kontrolleres regelmæssigt. 
At the beginning of the preventive therapy with Telmisartan Actavis 80 mg, blood pressure should be frequently monitored.
Du kan tage tabletten med eller uden mad. 
You can take Telmisartan Actavis with or without food.
Hypotension2, ortostatisk hypotension Luftveje, thorax og mediastinum Ikke almindelig: 
Hypotension2, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon:
Bivirkningsreaktionerene vist nedenfor er indsamlet fra kontrollerede kliniske studier med hypertensionspatienter og fra post marketing rapporter. 
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports.
Du skal fortsætte med at tage Telmisartan Actavis hver dag, så længe lægen ikke har givet dig besked på andet. 
It is important that you take Telmisartan Actavis every day until your doctor tells you otherwise.
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). 
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).
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. 
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
HDPE-tabletbeholder med LDPE-låg: Hold tabletbeholderen tæt tillukket for at beskytte mod lys. 
HDPE tablet container with LDPE lid: Keep the container tightly closed in order to protect from light.
Nedenstående kombinationer kræver forsigtighed 
Concomitant use requiring caution
Tag ikke Telmisartan Actavis - hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i denne medicin (angivet i pkt. 
Do not take Telmisartan Actavis - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
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). 
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.
Telmisartan Actavis indeholder: - Det aktive stof er telmisartan. 
What Telmisartan Actavis contains - The active substance is telmisartan.
Telmisartan er en oralt administereret aktiv specifik angiotensin II-receptorsubtype 1 (AT1)-antagonsit. 
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
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. 
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.
De almindligste symptomer på overdosering af telmisartan er lavt blodtryk (hypotension) og hurtig hjerterytme (tarkykadi). 
The most common symptoms of telmisartan overdose are low blood pressure (hypotension) and fast heart beat (tachycardia).
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. 
The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
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. 
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.
Interstitiel lungesygdom4 
Interstitial lung disease4
Inden for hver enkelt frekvensgruppe er bivirkningeren opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); 
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).
Det anbefales at monitorere serumkalium nøje hos patienter i risikogruppen (se pkt. 
Close-monitoring of serum potassium in at risk patients is recommended (see section 4.5).
HDPE-tabletbeholder: 
HDPE tablet container:
• hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren. 
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
I hunde fandt man tubulær dilation og atrofi af nyrerne. 
In dogs renal tubular dilation and atrophy were observed.
Ved hypotension skal patienten lægges i rygleje, der skal hurtigt gives salt- og væskesubstitution. 
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
Kaliumbesparende diuretika som spironolakton, eplerenon, triametern eller amilorid, kaliumtilskud eller kaliumholdige saltsubstitutter kan medføre en signifikant stigning i serumkalium. 
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.
Telmisartan Actavis kan have en mindre blodtrykssænkende virkning hos sorte patienter. 
Telmisartan Actavis may be less effective in lowering the blood pressure in black patients.
En dosis på 80 mg telmisartan givet til raske frivillige hæmmer næsten fuldstændigt en angiotensin II-provokeret blodtryksforhøjelse. 
In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Fortæl din læge eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 brugere): Tiltagende arvævsdannelse i lungerne (interstitiel lungesygdom)** 
Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**.
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. 
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.
Ud fra de farmakologiske egenskaber må det forventes, at den hypotensive virkning af antihypertensiva inklusive telmisartan vil forstærkes af følgende lægemidler: baclofen, amifostin. 
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.
Hvis du har glemt at tage Telmisartan Actavis 
If you forget to take Telmisartan Actavis
- hvis du har alvorlige leverproblemer, såsom kolestase eller galdevejsobstruktion (problem med udskillelse af galde fra leveren eller fra galdeblæren) eller anden alvorlig leversygdom. 
- 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.
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). 
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.
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. 
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.
Kontakt lægen, før du tager Telmisartan Actavis:. 
Talk to your doctor before taking Telmisartan Actavis:
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). 
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.
Der er ingen erfaring med anvendelse af Telmisartan Actavis til patienter, der kort tid forinden har fået foretaget en nyretransplantation. 
There is no experience regarding the administration of Telmisartan Actavis in patients with recent kidney transplantation.
Telmisartan Actavis indeholder det aktive stof telmisartan som tilhører en gruppe af medicin som kaldes angiotensin II-receptorantagonister. 
Telmisartan Actavis contains the active substance telmisartan which belongs to a class of medicines known as angiotensin II receptor antagonists.