FrancophonIA/ELRC3.0 huggingface dataset:
English: Pritor 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 Pritor tidligt i graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Danish: ** Tilfælde af tiltagende arvævsdannelse i lungerne er blevet rapporteret ved indtagelse af telmisartan.
English: 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 spironolacton, eplerenon, triamteren eller amilorid, kaliumtilskud eller kaliumholdige saltsubstitutter kan medføre en signifikant stigning i serumkalium.
English: Pritor 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: Pritor kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: Anaemia Eosinophilia, thrombocytopenia
Danish: Eosinofili, trombocytopeni
English: If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
Danish: Hvis du har nedsat leverfunktion, bør dosis normalt ikke overskride 40 mg én gang om dagen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bayer (Logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bayer (Logo)
English: The concomitant use of Pritor with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5, and 5.1).
Danish: Samtidig brug af Pritor og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with 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: After adjustment for age group effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group.
Danish: Efter justering for aldersgruppeeffekt var den gennemsnitlige SBP-ændring fra baseline (primære mål)14,4 (1,7) mmHg i telmisartan 2 mg/kg gruppen; -9,7 (1,7) mmHg i telmisartan 1 mg/kg gruppen og -6,0 (2,4) mmHg i placebogruppen.
English: Renal impairment including acute renal failure General disorders and administration site conditions Uncommon: Rare:
Danish: Nedsat nyrefunktion herunder akut nyresvigt Almene symptomer og reaktioner på administrationsstedet Ikke almindelig:
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 1.002.06)]; 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 letale sepsistilfælde var øget hos patienter, som fik telmisartan (0,33 %) vs. patienter, som fik placebo (0,16 %) [RR 2,07 (95 % sikkerhedsinterval 1,143,76)].
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pritor 20 mg tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pritor 20 mg tabletter
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea,
Danish: • For lavt blodtryk (hypotension), som kan forekomme, hvis du er dehydreret (overdrevent tab af kropsvæske) eller er i saltunderskud efter anvendelse af vanddrivende medicin, er på saltfattig kost, har diarré eller ved opkastning.
English: However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Pritor 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 Pritor.
Danish: Nogle patienter får anbefalet en lavere dosis på 20 mg eller en højere dosis på 80 mg. Pritor kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Pritor.
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Danish: 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 IIreceptorantagonister.
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis, Sepsis including fatal outcome
Danish: Urinvejsinfektion herunder cystitis, infektion i øvre luftveje herunder faryngitis og sinuitis
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Danish: Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af renin-angiotensinaldosteronsystemets aktivitet (f.eks. patienter med svær højresidig hjerteinsufficiens eller tilgrundliggende nyresygdom, herunder nyrearteriestenose), har behandling med lægemidler, som påvirker dette system, såsom telmisartan, været forbundet med akut hypotension, hyperazotæmi, oliguri eller i sjældne tilfælde akut nyresvigt (se pkt.
English: The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.
Danish: Øvrige indholdsstoffer: povidon, meglumin, natriumhydroxid, sorbitol (E420), magnesiumstearat
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Pritor.
Danish: Hvis du skal opereres eller have anden form for bedøvelse, så fortæl lægen, at du tager Pritor.
English: • Heart trouble.
Danish: • Hjerteproblemer
English: To be taken into account with concomitant use.
Danish: Vær opmærksom ved samtidig brug med nedenstående.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: For reduction of cardiovascular events, the usual dose of Pritor is one 80 mg tablet once a day.
Danish: Til nedsættelse af risikoen for hjerte-kar-hændelser er den sædvanlige dosis Pritor 80 mg én gang daglig.
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Danish: Disse farmakologisk betingede bivirkninger, som er kendt fra prækliniske forsøg med både ACE-hæmmere og angiotensin II-receptorantagonister, kunne forhindres/afhjælpes ved oral salttilførsel.
English: The risk is particularly high in combination with potassium sparing-diuretics, and when combined with salt substitutes containing potassium.
Danish: Risikoen er i særdeleshed høj ved samtidig behandling med kaliumbesparende diuretika, og med kaliumholdige saltsubstitutter.
English: Other medicines and Pritor
Danish: Brug af anden medicin sammen med Pritor
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-angiotensinaldosterone system 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: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl altid lægen, hvis du ammer eller vil starte på at amme.
English: Pritor is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Pritor er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Fortæl din læge, hvis du tror, du er gravid.
English: What Pritor is and what it is used for What you need to know before you take Pritor How to take Pritor
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Pritor Sådan skal du tage Pritor Bivirkninger
English: Pritor 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 Pritor.
Danish: Pritor kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Pritor.
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 28 x 1 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter 280 tabletter 28 x 1 tablet
English: Pritor 20 mg tablets Pack sizes: Blister with 14, 28, 30, 56, 90 or 98 tablets.
Danish: Pritor 20 mg tabletter Pakningsstørrelser: Blister med 14, 28, 30, 56, 90 eller 98 tabletter.
English: You should store your medicine in the original package in order to protect the tablets from moisture.
Danish: Du skal opbevare Pritor i den originale yderpakning for at beskytte tabletterne mod fugt.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone 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: • If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Pritor” and “Warnings and precautions”).
Danish: • Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskriften
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Pritor.
Danish: Du skal derfor tale med din læge om eventuelt at få ændret doseringen af din medicin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister (28 x 1 tablets pack) or any non 7 count blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister (28 x 1 tablet) og andre blisters bortset fra 7 styk
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: Children and adolescents The use of Pritor in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og unge Børn og unge under 18 år bør ikke behandles med Pritor.
English: Symptomatic hypotension, especially after the first dose of Pritor, 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 Pritor 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: Manufacturer Bayer AG
Danish: Fremstiller Bayer AG
English: • Diuretics ('water tablets'), especially if taken in high doses together with Pritor, may lead to excessive loss of body water and low blood pressure (hypotension).
Danish: • Vanddrivende medicin i høje doser kan føre til overdrevent tab af kropsvæske og for lavt blodtryk (hypotension).
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i original emballage for at beskytte mod fugt.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Danish: Abdominalsmerter, diare, dyspepsi, flatulens, opkastning
English: For treatment of high blood pressure, the usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Danish: Til behandling af forhøjet blodtryk er den normale dosering af Pritor til kontrol af blodtrykket i 24 timer én tablet á 40 mg én gang daglig.
English: • Kidney disease or kidney transplant.
Danish: • Nyresygdom eller du har fået en nyretransplantation
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), og ændringer i den renale hæmodynamik (forhøjet BUN og kreatinin) såvel som forhøjet serumkalium.
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: Pritor 20 mg tablets 3 years
Danish: Pritor 20 mg tabletter 3 år.
English: Pritor 40 mg and 80 mg tablets 4 years
Danish: Pritor 40 mg og 80 mg tabletter 4 år.
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 studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs. 43,9%).
English: Pritor should be used only with caution in patients with mild to moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når Pritor bruges til patienter med let til moderat nedsat leverfunktion.
English: If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Danish: Hvis du har taget for meget Pritor Hvis du har taget for mange tabletter, så kontakt lægen, skadestuen eller apoteket.
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: Behandling i andet og tredje trimester med angiotensin II-receptorantagonister kan medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinkelse af knogledannelsen i kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi).
English: Each 80 mg tablet contains 338 mg sorbitol (E420).
Danish: En tablet med 80 mg indeholder 338 mg sorbitol (E420).
English: Each 40 mg tablet contains 169 mg sorbitol (E420).
Danish: En tablet med 40 mg indeholder 169 mg sorbitol (E420).
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 Din læge vil eventuelt måle din nyrefunktion, dit blodtryk og elektrolytter (f.eks. kalium) i dit blod med jævne mellemrum.
English: Povidone (K25) Meglumine Sodium hydroxide Sorbitol (E420) Magnesium stearate.
Danish: Povidon (K25), meglumin, natriumhydroxid, sorbitol (E420), magnesiumstearat.
English: Pritor is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets.
Danish: Pritor er pakket i blisterpakninger med 14, 28, 30, 56, 90 eller 98 tabletter.
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 letal 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: White round tablets of 2.5 mm engraved with the code number '50H' on one side and the company logo on the other side.
Danish: Hvide runde 2,5 mm tabletter, hvori firmaets logo og koden 50H er præget.
English: Pack sizes: Blister with 14, 28, 30, 56, 90, 98 or 280 tablets or perforated unit dose blisters with 28 x 1 tablets.
Danish: Pakningsstørrelser: Blister med 14, 28, 30, 56, 90, 98 eller 280 tabletter eller perforeret enkeltdosisblister med 28 x 1 tabletter.
English: This medicinal product contains sorbitol (E420).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sorbitol (E420).
English: INFORMATION IN BRAILLE Pritor 40 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pritor 40 mg
English: What Pritor contains
Danish: Pritor indeholder:
English: Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98 or 280 tablets, or unit dose blister packs containing 28 x 1 tablets.
Danish: Pritor er pakket i blisterpakninger med 14, 28, 30, 56, 90, 98 eller 280 tabletter eller enkeltdosisblisterpakning indeholdende 28 x 1 tabletter.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bayer AG
English: If you feel dizzy or tired, do not drive or operate machinery.
Danish: Før ikke motorkøretøj, hvis du føler dig svimmel eller træt.
English: The effect of Pritor may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Danish: Den blodtrykssænkende virkning med Pritor kan blive mindre, hvis du samtidig tager medicin mod gigt og lette smerter (non-steroid antiinflammatorisk medicin (NSAID) såsom acetylsalicylsyre eller ibuprofen) eller kortikosteroider.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Any non 7 count blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Alle ikke 7 styks blisterkort
English: INFORMATION IN BRAILLE Pritor 20 mg
Danish: INFORMATION I BRAILLESKRIFT Pritor 20 mg
English: Pritor 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 Pritor tages mere end 3 måneder henne i graviditeten, kan det forårsage alvorlige fosterskader (se afsnit Graviditet).
English: Bradycardia Tachycardia
Danish: Bradykardi
English: Pritor 40 mg and 80 mg tablets
Danish: Pritor 40 mg og 80 mg tabletter
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased,
Danish: Nedsat hæmoglobin, forhøjet urinsyre, forhøjede leverenzymer,
English: INFORMATION IN BRAILLE Pritor 80 mg
Danish: INFORMATION I BRAILLESKRIFT Pritor 80 mg
English: Because no information is available regarding the use of Pritor during breast-feeding, Pritor 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: Pritor 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: Pritor må ikke gives til patienter med kolestase, obstruktive galdelidelser eller svært nedsat leverfunktion (se pkt.
English: • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Danish: • Nedsat blodtilstrømning til en eller begge nyrer (nyrearteriestenose)
English: Each tablet contains 40 mg telmisartan.
Danish: En tablet indeholder 40 mg telmisartan.
English: How to take Pritor
Danish: Sådan skal du tage Pritor
English: Pritor 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: Pritor bruges også til at nedsætte risikoen for hjerte-kar-hændelser og blodprop i hjernen hos voksne, som har en forøget risiko.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP 7 styk blisterkort
English: What Pritor looks like and contents of the pack Pritor 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Danish: Udseende og pakningsstørrelser Pritor 20 mg tabletter er hvide runde tabletter, hvorpå firmaets logo og koden 50H er præget.
English: • Liver disease.
Danish: • Leversygdom