FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Actavis.
Danish: Hvis du skal opereres eller have anden form for bedøvelse, så fortæl lægen , at du tager Telmisartan Actavis.
English: Symptomatic hypotension, especially after the first dose of Telmisartan Actavis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Specielt efter den første dosis af Telmisartan Actavis kan der forekomme symptomatisk hypotension hos patienter, som har for lavt volumen i blodbanen eller natriummangel på grund af kraftig diuretisk behandling, saltfattig diæt, diarré eller opkastning.
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 farmakologiske betingede bivirkninger, som er kendt fra prækliniske forsøg med både ACE-hæmmere og angiotensin II-receptorantagonister, kunne forhindres/afhjælpes ved peroral salttilførsel.
English: Possible side effects of telmisartan:
Danish: Bivirkninger ved Telmisartan Actavis:
English: Telmisartan Actavis 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: Det frarådes at anvende Telmisartan Actavis tidligt i graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Danish: Indehaver af markedsføringstilladelsen Actavis Group PTC ehf.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains desiccant, do not eat.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Indeholder tørrekapsel, må ikke sluges.
English: The effect of Telmisartan Actavis may be reduced when you take NSAIDs (non steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Danish: Den blodtrykssænkende virkning med Telmisartan Actavis kan blive mindre, hvis du samtidig tager NSAID'er (non-steroid antiinflammatorisk medicin såsom aspirin eller ibuprofen) eller kortikosteroider.
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Danish: I prækliniske sikkerhedsforsøg i normotensive dyr med doser, der gav en eksponering sammenlignelig med den i det kliniske terapeutiske område, fandt man en reduktion af røde blodcelleparametre (erytocyter, hæmoglobin, hæmatokrit), og ændringer i den renale hæmodynamik (forhøjet BUN og kreatinin) såvel som forhøjet serumkalium.
English: HDPE container with LDPE lid and desiccant Pack sizes: 30 or 250 tablets.
Danish: HDPE-tabletbeholder med LDPE-låg og tørrekapsel: Pakningstørrelser: 30 eller 250 tabletter.
English: Slow heart beat (bradycardia), dizziness, higher levels of creatinine in the blood and sudden kidney failure have also been reported.
Danish: Der er også forekommet langsom hjerterytme (bradykardi), svimmelhed, forhøjet kreatinniveau i blodet og pludselig nyresvigt.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Danish: Abdominalsmerter, diarré, dysepsi, flautulens, opkastning
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger Indehaveren af markedsføringstilladelsen skal fremsende periodiske,
English: Telmisartan Actavis is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Telmisartan Actaviss er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis Sepsis including fatal outcome1
Danish: Urinvejsinfektion herunder cystitis, infektion i øvre luftveje herunder fayngitis og sinutis
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4% vs 43.9%) in placebo controlled trials in patients treated for hypertension.
Danish: I kontrollerede studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs 43,9%).
English: In patients with liver problems 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 om dagen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis logo
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis logo
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7% in the telmisartan and 17.0% in the placebo groups with a hazard ratio of 0.92 (95% CI 0.81-1.05, p = 0.22)].
Danish: Der blev ikke fundet statiskisk forskelle i det primære sammensatte endepunkt (kardiovaskulær død, , ikke-fatalt myokardieninfarkt, ikke-fatal apopleksi eller hospitalsindlæggelse pga. hjertesvigt) [15,7% i telmisartangruppen og 17,0% i placebogruppen med en hazard ratio på 0,92 (95% CI 0,81-1,05; p=0,22)].
English: The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Danish: Lægemidlets diuretiske og natriuretiske virkningsmekaniske, som andel af den blodtrykssænkende effekt, er endnu ikke klarlagt.
English: Telmisartan Actavis should be used only with caution in patients with mild to moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når Telmisartan Actavis bruges til patienter med let til moderat nedsat leverfunktion.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis angiotensin II-receptorantagonister har været anvendt efter start af anden trimester, bør nyrefunktionen og kraniet kontrolleres ved hjælp af ultralyd.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and
Danish: I tilfælde af konstateret graviditet skal behandling med angiotensin II-receptorantagonist straks seponeres, og alternativ behandling påbegyndes (se pkt.
English: In patients with kidney problems a lower starting dose of 20 mg is recommended.
Danish: Hvis du har nedsat nyrefunktion anbefales en lavere startdosis på 20 mg.
English: Telmisartan Actavis 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 telmisartan.
Danish: Telmisartan Actavis kan også bruges sammen med vanddrivende medicin, såsom hydrochlortiazid, der har vist sig at øge den blodtryksnedsættende virkning af telmisartan.
English: Hepatic function abnormal / liver disorder
Danish: Abnormal leverfunktion/leversydom3
English: Manufacturer Actavis Hf.
Danish: Actavis hf.
English: In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.
Danish: Hyperkaliæmi kan være fatal for ældre, for patienter med nyreinsufficiens, for diabetespatienter, for patienter i bahndling med andre lægemidler, der kan øge kaliumniveauet og/eller for patienter med tilstødende komplikationer.
English: Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Danish: Al/AL blister: 14, 28, 30, 56, 84, 90, 98 og 100 tabletter.
English: Al/Al blisters: Pack sizes: 14, 28, 30, 56, 84, 90, 98 or 100 tablets.
Danish: Al/Al blister: Pakningstørrelser: 14 , 28 , 30 , 56 , 84 , 90 , 98 eller 100 tabletter.
English: PUREN Pharma GmbH & Co. KG Tel.: +49-89-558-9090
Danish: KG Tel.: +49-89-558-9090
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Danish: Nedsat hæmoglobin, forhøjet urinsyre, forhøjede leverenzymer forhøjet kreatininfosfokinase,
English: What Telmisartan Actavis looks like and contents of the pack 20 mg tablets are white, round, flat with logo T on one side
Danish: Telmisartan Actavis udseende og pakningsstørrelser 20 mg tabletter er hvide, runde, flade med logoet T på en side
English: What you need to know before you take Telmisartan Actavis
Danish: Det skal du vide, før du begynder at tage Telmisartan Actavis
English: As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in nonblacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Danish: Som ved ACE-hæmmere synes telmisartan og andre angiotensin II-receptorantagonister at virke mindre blodtrykssænkende hos neogroide end hos ikke-negroide personer.
English: If you feel dizzy or tired, do not drive or use machines.
Danish: Kør ikke bil eller motorcykel eller cykel, hvis du føler dig svimmel eller træt.
English: The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.
Danish: Telmisartan Actavis sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Reykjavikurvegi 76-78, IS-220 Hafnafjordur ICELAND
Danish: Reykjavikurvegur 76-78, IS-220 Hafnarfjordur Island
English: What Telmisartan Actavis looks like and contents of the pack 40 mg tablets are white, oval, biconvex, with a break line and logo T on one side.
Danish: Telmisartan Actavis udseende og pakningsstørrelser 40 mg tabletter er hvide, ovale, bikonvekse, med delekærv og logoet T på en side.
English: Alternatively, telmisartan may be used in combination with thiazidetype diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan.
Danish: Alternativt kan Telmisartan Actavis også bruges sammen med vanddrivende medicin, såsom hydrochlortiazid, der har vist sig at øge den blodtryksnedsættende virkning af telmisartan.
English: Other medicines and Telmisartan Actavis
Danish: Brug af anden medicin sammen med Telmisartan Actavis
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Danish: Hvis du sammen med Telmisartan Actavis tager visse andre typer medicin, kan det være nødvendigt at ændre dosis eller tage andre forholdsregler.
English: Telmisartan Actavis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Danish: Telmisartan Actavis må ikke gives til patienter med kolestase, obstruktive galdelidelser, eller svært nedsat leverfunktion (se pkt.
English: White, round, flat tablets with logo T on one side.
Danish: Hvide, runde, flade tabletter, med logo T på den ene side.
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76-1.00, p = 0.048)], There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95% CI 0.85-1.24).
Danish: Der var evidens for en fordel ved telmisartan i forhold til placebo i det præspecificerede sekundære sammensatte endepunkt (kardiovaskulær død, , ikke-fatalt myokardieninfarkt, ikke-fatal apopleksi) ) [0,87 (95% CI 0,761,00; p = 0,048)].
English: PHARMACEUTICAL FORM Tablet
Danish: Label til tabletbeholder
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Ud fra epidemiologiske data, kan man ikke konkludere, at behandling med ACE-hæmmer i første trimester medfører en risiko for teratogenicotet.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash,
Danish: Sepsis* (ofte kaldet “blodforgiftning”, en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan føre til døden), øget antal hvide blodlegemer (eosinofili), for få blodplader
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss.
Danish: Angiotensin II-receptorantagonister, såsom telmisartan, mindsker diuretisk fremkaldt kaliumtab.
English: White, oval, biconvex tablets with a break line and logo T on one side.
Danish: Hvide, ovale, bikonvekse tabletter med delekærv og logo T på den ene side.
English: INFORMATION IN BRAILLE Telmisartan Actavis 40 mg
Danish: INFORMATION I BRAILLE-SKRIFT Telmisartan Actavis 40 mg
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Telmisartan Actavis.
Danish: Du skal derfor tale med din læge om eventuelt at få ændret doseringen af din medicin.
English: What Telmisartan Actavis is and what it is used for What you need to know before you take Telmisartan Actavis How to take Telmisartan Actavis Possible side effects
Danish: Det skal du vide, før du begynder at tage Telmisartan Actavis Sådan skal du tage Telmisartan Actavis Bivirkninger
English: Because no information is available regarding the use of Telmisartan Actavis during breast-feeding, Telmisartan Actavis 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: Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
English: Telmisartan Actavis 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: Hvis Telmisartan Actavis tages mere end 3 måneder henne i graviditeten, kan det forårsage alvorlige fosterskader (se afsnit Graviditet).
English: Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Danish: Reykjavikurvegur 76-78 220 Hafnarfjordur Island
English: INFORMATION IN BRAILLE Telmisartan Actavis 20 mg
Danish: INFORMATION I BRAILLE-SKRIFT Telmisartan Actavis 20 mg
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (> 70 years)
Danish: De væsentligste risikofaktorer, hvor hyperkaliæmi kan forekomme, er: - Diabetes mellitus, nedsat nyrefunktion, alder (> 70 år) - Samtidig anvendelse af lægemidler, der påvirker renin-angiotensin-aldosteronsystemet og/eller kaliumtilskud.
English: How to take Telmisartan Actavis
Danish: Sådan skal du tage Telmisartan Actavis
English: INFORMATION IN BRAILLE Telmisartan Actavis 80 mg
Danish: INFORMATION I BRAILLE-SKRIFT Telmisartan Actavis 80 mg
English: Medicinal products or therapeutic class of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Danish: Lægemidler, der kan udløse hyperkaliæmi er kaliumholdige saltsubstitutter, kaliumbesparende diuretika, ACE-hæmmere,angiotensin II-receptorantagonister, non steroide antiinflammatoriske lægamidler (NSAIDs, herunder selekvtive COX-2-hæmmere), heparin, immunosuppressiva ( cyclosporin eller tacrolimus) og trimethoprim.
English: PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: Telmisartan Actavis 40 mg tablets Telmisartan
Danish: Telmisartan Actavis 40 mg tabletter telmisartan
English: Telmisartan Actavis 20 mg tablets Telmisartan
Danish: Telmisartan Actavis 20 mg tabletter telmisartan
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Danish: Vanddrivende lægemidler(thiazider eller loop diuretika) Der kan opstå volumendepletion og risiko for hypotension ved initiering af behandling med telmisartan, hvis patienten forudegående har modtaget behandling med høje doser af diuretika såsom furosemid (loop diuretika) og hydrochorthiazid (thiazid diuretika).
English: potassium hydroxide pellets.
Danish: kaliumhydroxid kugler
English: White, oval, biconvex tablets with logo T1 on one side.
Danish: Hvide, ovale, bikonvekse tabletter med logo T på den ene side.
English: Telmisartan Actavis 80 mg tablets Telmisartan
Danish: Telmisartan Actavis 80 mg tabletter telmisartan
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Danish: 6.1 - Andet og tredje trimester af graviditeten (se pkt.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Danish: Sepsis* (ofte kaldet “blodforgiftning”, en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan føre til døden), øget antal hvide blodlegemer (eosinofili), for få blodplader (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos sukkersygepatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelser (dysgeusi), unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), hurtigt indsættende hævelse af hals og slimhinder (angioødem), som kan være dødelig, eksem, hudrødme, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, nedsat hæmoglobin samt forhøjet urinsyre, forhøjede leverenzymer eller forhøjet kreatinkinase i blodet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 40 mg telmisartan Alle hjælpestoffer er anført under pkt.
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Danish: De var 55 år eller ældre og havde en anamnese med koronararteriesygdom, apopleksi, transitorisk cerebral iskæmi (TCI),perifer arteriel sygdom eller diabetes mellitus type 2 med en organpåvirkning (f.eks. retinopati, venstre ventrikel hypertrofi, makro- eller mikroalbuminuri).
English: If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Danish: Der bør udvises forsigtighed og hyppigt udføres monitorering af serumkalium, hvis en sådan samtidig behandling er nødvendig på grund af dokumteret hypokaliæmi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 80 mg telmisartan Alle hjælpestoffer er anført under pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg telmisartan For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 20 mg telmisartan Alle hjælpestoffer er anført under pkt.
English: Anaphylactic reaction , hypersensitivity Metabolism and nutrition disorders Uncommon: Rare:
Danish: Metabolisme og ernæring Ikke almindelig:
English: In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
Danish: Dosis bør ikke overskride 40 mg hos patienter med let til moderat nedsat levefunktion (se pkt.
English: Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your blood pressure controlled.
Danish: Hvis du holder op med at tage Telmisartan Actavis For at holde dit blodtryk under kontrol, skal du forsætte med at tage Telmisartan Actavis hver dag, så længe lægen ikke har givet besked på andet.
English: In some cases you may have to stop taking one of the medicines.
Danish: Muligvis vil der være nødvendigt at stoppe brugen af anden medicin, specielt hvis det er noget af følgende:
English: Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Danish: Symptomer: De mest udtalte symptomer ved telmisartanoverdosering er hypotension og takykardi.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Danish: Sepsis* (ofte kaldet "blodforgiftning", en alvorlig infektion med betændelsesreaktion i hele kroppen), hurtig hævelse af hud og slimhinder (angioødem).