FrancophonIA/ELRC3.0 huggingface dataset:
English: INSTRUCTIONS ON USE
Danish: Oral anvendelse.
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Danish: NSAID (f.eks. acetylsalicylsyre i doser beregnet til anti-inflammatorisk behandling, COX-2-hæmmere og ikke-selektive NSAID) kan muligvis nedsætte den antihypertensive virkning af angiotensin IIreceptorantagonister.
English: Symptomatic hypotension, especially after the first dose of Telmisartan Teva, 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 Teva 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: Influenza-like illness
Danish: Influenzalignende symptomer
English: Skin and subcutaneous tissue disorders Uncommon:
Danish: Hud og subkutane væv Ikke almindelig:
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensin aldosteronesystem and/or potassium supplements.
Danish: De væsentlige 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: If you get any side effects,talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: How to take Telmisartan Teva
Danish: Sådan skal du tage Telmisartan Teva
English: Concomitant use requiring caution
Danish: Nedenstående kombinationer kræver forsigtighed.
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 virkningsmekanisme, som andel af den blodtrykssænkende effekt, er endnu ikke klarlagt.
English: As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, 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 negroide end hos ikke-negroide personer.
English: To be taken into account with concomitant use
Danish: Vær opmærksom ved samtidig brug med nedenstående.
English: Meglumine
Danish: Meglumin
English: Hepatic function abnormal/liver disorder 3
Danish: Abnorm leverfunktion/leversygdom3
English: Alternatively, Telmisartan Teva may 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 Teva.
Danish: Alternativt kan Telmisartan Teva også bruges sammen med vanddrivende medicin, såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Telmisartan Teva.
English: Povidone (PVP K-30) Sorbitol (E420)
Danish: Povidon (PVP K-30)
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 diabetesrelated kidney problems.
Danish: Kontakt lægen, før du tager Telmisartan Teva: - hvis du tager digoxin - 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 nyreproblemer i forbindelse med sukkersyge - aliskiren.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the benefit risk ratio should be evaluated.
Danish: Før start af behandling med flere typer medicin, der påvirker renin-angiotensin-aldosteronsystemet bør man nøje afveje fordele og ulemper mod hinanden..
English: The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been established.
Danish: Telmisartan Tevas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Telmisartan Teva may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Danish: Telmisartan Teva kan øge den blodtryksnedsættende virkning af andre blodtryksnedsættende lægemidler.
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 statistisk forskel i det primære sammensatte endepunkt (kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal 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: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere og angiotensin II-receptorantagonister eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: No posology adjustment is required for patients with mild to moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Udsættelse for behandling i andet og tredje trimester med angiotensin II-receptorantagonister kan medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinkelse af knogledannelsen i kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi).
English: Tabulated summary of adverse reactions
Danish: Tabuleret sammendrag af bivirkninger
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 nedsat nyreinsufficiens, for diabetespatienter, for patienter i behandling med andre lægemidler, der kan øge kaliumniveauet og/eller for patienter med tilstødende komplikationer.
English: Nervous system disorders Uncommon:
Danish: Nervesystemet Ikke almindelig:
English: Telmisartan Teva should be used only with caution in patients with mild to moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når Telmisartan Teva bruges til patienter med let til moderat nedsat leverfunktion.
English: In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults.
Danish: Hos nogle patienter blev anvendt en daglig dosis svarende til 160 mg, hvilket har været testet hos voksne, men er højere end normalt anbefalet til voksne hypertensionspatienter.
English: - Elevated potassium levels in your blood - Diabetes
Danish: Højt kaliumindhold i blodet
English: Telmisartan is not removed by haemodialysis.
Danish: Telmisartan kan ikke fjernes ved hæmodialyse.
English: EU/1/09/610/030 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Danish: EU/1/09/610/062 Æske med 30 tabletter i aluminium-aluminiumblistere
English: Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Telmisartan Teva er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Aluminium-Aluminium peelable perforated unit dose blisters and aluminium-aluminium perforated unit-dose blisters.
Danish: Perforerede aluminium-aluminium-enhedsdosisblistere med aftrækkeligt folie og perforerede aluminiumaluminium enhedsdosisblistere.
English: In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.
Danish: Ved utilstrækkelig virkning, kan telmisartandosis øges op til højst 80 mg én gang daglig.
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 klinisk terapeutiske område, fandt man en reduktion af røde blodcelleparametre (erytrocyter, hæmoglobin, hæmatokrit), såvel som forhøjet serumkalium.
English: The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Danish: Farmakokinetikken for to dosisregimer af telmisartan - telmisartan 1 mg/kg og 2 mg/kg - blev vurderet i en fire-ugers behandlingsperiode hos hypertensive patienter (n = 57) i alderen 6 til <18 år.
English: The elimination half-life is not changed in patients with renal impairment.
Danish: Elimineringshalveringstiden er uændret hos patienter med nedsat leverfunktion.
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)].
Danish: Der var evidens for en fordel ved telmisartan i forhold til placebo i det præspecificerede sekundære sammensatte endepunkt (kardiovaskulær død, ikke letalt myokardieinfarkt og ikke-letal apopleksi) [0,87 (95% CI 0,76-1,00; p = 0,048)].
English: Hepatic function abnormal / liver disorder
Danish: Unormal leverfunktion/leversygdom
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Hypotension, ortostatisk hypotension Luftveje, thorax og mediastinum Ikke almindelig:
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: Data fra kliniske studier har vist, at dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) gennem kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren, er forbundet med en højere hyppighed af bivirkninger som hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: Tel: +(44) 1977 628 500
Danish: Teva UK Limited Tel: +(44) 1977 628 500
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 de epidemiologiske data, kan man ikke konkludere, at behandling med ACE-hæmmere i første trimester medfører en risiko for teratogenicitet.
English: Renal and urinary disorders Uncommon:
Danish: Nyrer og urinveje Ikke almindelig:
English: LIST OF EXCIPIENTS Contains sorbitol (E420).
Danish: Indeholder sorbitol (E420).
English: When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Danish: Efter generelt 4-8 ugers behandling, vil den maksimale blodtrykssænkende virkning være opnået, hvilket skal tages i betragtning ved overvejelser om dosisforøgelse (se pkt.
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4% vs 43.9 %) in controlled trials in patients treated for hypertension.
Danish: I kontrollerede forsøg med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan sædvanligvis sammenlignelig med placebo (41,4 % vs. 43,9 %).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of blisters
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske med blistere
English: If you feel dizzy or tired, do not drive or operate machinery.
Danish: Kør ikke bil eller motorcykel eller cykel, hvis du føler dig svimmel eller træt.
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 4.6).
Danish: I tilfælde af konstateret graviditet skal behandling med angiotensin II-receptorantagonister straks seponeres, og alternativ behandling påbegyndes (se pkt.
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Danish: Der var ikke evidens for reduktion af kardiovaskulær mortalitet i forhold til placebo (hazard ratio 1,03, CI 0,85-1,24).
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets
Danish: 14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet 30 tabletter
English: Telmisartan Teva 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 Teva må ikke gives til patienter med kolestase, obstruktive galdelidelser eller svært nedsat leverfunktion (se pkt.
English: A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate
Danish: Øvrige indholdsstoffer: microkrystallinsk cellulose (Avicel PH 102), natriumstivelsesglycolat (Type A), poloxamerer, meglumin, povidon (PVP K-30), sorbitol (E420), magnesiumstearat
English: Read all of this leaflet carefully before you start taking this medicine because it contains inportant information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage medicinen.
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 IIreceptorantagonister har været anvendt efter start af andet trimester, bør nyrefunktionen og kraniet kontrolleres ved hjælp af ultralyd.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of peelable blisters
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske med blistere med aftrækkeligt folie
English: Psychiatric disorders Uncommon:
Danish: Psykiske forstyrrelser Ikke almindelig:
English: The elimination half-life is not changed in patients with hepatic impairment.
Danish: Elimineringshalveringstiden er uændret hos patienter med nedsat nyrefunktion.
English: Suomi/Finland ratiopharm Oy Puh/Tel: +358 20 180 5900
Danish: Puh/Tel: +358 20 180 5900
English: - This medicine has been prescribed for you only.
Danish: Lægemidlet må kun udleveres efter recept.
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets
Danish: 14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet
English: Teva Pharmaceuticals Ireland L-Irlanda
Danish: Teva Pharma - Produtos Farmacêuticos Lda
English: In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).
Danish: Patienter med nedsat leverfunktion Dosis bør ikke overskride 40 mg hos patienter med let til moderat nedsat leverfunktion (se pkt.
English: This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
Danish: Hos patienter med velkontrolleret blodtryk, der var i behandling med telmisatan for reduktion af kardiovaskulær morbiditet i tillæg til standardbehandling, blev hypotension rapporteret som almindeligt forekommende.
English: Chest pain, asthenia (weakness)
Danish: Brystsmerter, asteni (træthed)
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Danish: Dobbelthæmning af RAAS ved kombination af ACE-hæmmere med angiotensin II-receptorantagonister eller aliskiren frarådes derfor (se pkt.
English: Telmisartan Teva 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 Teva bruges også til at nedsætte risikoen for hjerte-kar-hændelser og blodprop i hjernen hos voksne, som har en forøget risiko.
English: This applies especially to the medicines listed below taken at the same time with Telmisartan Teva.
Danish: Muligvis vil det være nødvendigt at stoppe brugen af anden medicin specielt, hvis det er noget af følgende, der tages samtidig med Telmisartan Teva.
English: Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response usually accompanied by high fevers, hot, flushed skin, elevated heart rate, rapid breathing, altered mental status, swelling, and low blood pressure), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 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) normalt ledsaget af høj feber, rødme og varme i huden, hurtigere hjerterytme, hurtig vejrtrækning, ændring i mental tilstand, hævelser og lavt blodtryk), hurtig hævelse af hud og slimhinder (angioødem).
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 forudgående har modtaget behandling med høje doser af diuretika såsom furosemid (loop-diuretika) og hydrochlorthiazid (thiazid-diuretika).
English: Do not take Telmisartan Teva - if you are allergic to telmisartan or any other ingredients of medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage Telmisartan Teva Tag ikke Telmisartan Teva hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Telmisartan Teva (angivet i pkt.
English: Teл: +359 2 489 95 82
Danish: Тева Фармасютикълс България ЕООД Teл: +359 2 489 95 82
English: Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Danish: Urinvejsinfektion, infektion i de øvre luftveje (som ondt i halsen, bihulebetændelse, almindelig forkølelse), blodmangel (anæmi), forhøjet kaliumindhold i blodet, besvær med at falde i søvn, tristhed (depression), besvimelse, svimmelhed, langsom puls (bradykardi), lavt blodtryk (hypotension) hos patienter i behandling mod forhøjet blodtryk, svimmelhed når man rejser sig op (ortostatisk hypotension), stakåndethed, hoste, mavesmerter, diarré, maveubehag, oppustethed, opkastning, kløe, øget svedtendens, hududslæt udløst af medicinen, rygsmerter, muskelkramper, muskelsmerter, nedsat nyrefunktion herunder akut nyresvigt, brystsmerter, følelse af træthed og forhøjet kreatininniveau i blodet.
English: The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period.
Danish: Den blodtrykssænkende virkning af henholdsvis telmisartan 1 mg/kg (n = 29) og 2 mg/kg (n = 31) blev undersøgt hos 76 hypertensive, stærkt overvægtige patienter i alderen 6 til <18 år over en fire-ugers behandlingsperiode.
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: Lithium Der er rapporteret reversible stigninger i serum-lithiumkoncentrationerne samt toksicitet ved samtidig behandling med lithium og ACE-hæmmere.
English: Back pain (e.g. sciatica), muscle spasms, myalgia
Danish: Rygsmerter (f.eks. iskias), muskelkramper, myalgi
English: Because no information is available regarding the use of Telmisartan Teva during breast-feeding, Telmisartan Teva 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.