FrancophonIA/ELRC3.0 huggingface dataset:
English: The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines).
Danish: I den første undersøgelse blev kombinationen af emtricitabin og tenofovirdisoproxil sammenlignet med en kombination af lamivudin og zidovudin (andre antivirale lægemidler).
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving Truvada for pre-exposure prophylaxis.
Danish: Sundhedspersonalet vil også modtage en brochure og et huskekort, som skal udleveres til personer, der tager Truvada som forebyggende behandling før eksponering.
English: What benefits of Truvada have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Truvada?
English: Truvada is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Danish: Truvada anvendes også til forebyggelse af seksuelt overført hiv-1-infektion hos voksne og unge, som har høj risiko for at blive smittet (forebyggende behandling før eksponering).
English: Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Danish: Truvada indeholder to aktive stoffer: emtricitabin, der er en nukleosid revers transkriptasehæmmer, og tenofovirdisoproxil, der er et "prodrug" (forstadium) til tenofovir.
English: How is Truvada used?
Danish: Hvordan anvendes Truvada?
English: Of the patients taking the active substances of Truvada, 80% (194 out of 244) achieved and maintained viral load below 50 HIV1 copies/ml by 48 weeks, compared with 70% of the patients taking the comparator medicines (171 out of 243).
Danish: Af de patienter, der fik de aktive stoffer i Truvada, opnåede 80 % (194 af 244) en virusbelastning på under 50 hiv-1-kopier/ml og fastholdt den efter 48 ugers behandling sammenholdt med 70 % af de patienter, der fik sammenligningspræparaterne (171 ud af 243).
English: Two main studies have examined the effects of Truvada's active substances, emtricitabine and tenofovir disoproxil, in adults infected with HIV-1 who had not been treated before.
Danish: Der blev gennemført to hovedundersøgelser af virkningerne af de aktive stoffer i Truvada, emtricitabin og tenofovirdisoproxil, hos voksne hiv-1-patienter, som ikke tidligere var blevet behandlet.
English: The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients with HIV-1 infection.
Danish: I den anden undersøgelse bedømtes virkningerne af emtricitabin og tenofovirdisoproxil taget sammen med lopinavir og ritonavir (andre antivirale lægemidler) hos 196 patienter med hiv-1-infektion.
English: In both studies Truvada was compared with placebo (a dummy treatment) in adults at high risk of sexually transmitted HIV-1 infection.
Danish: I begge undersøgelser blev Truvada sammenlignet med placebo (ikke-aktivt stof) hos voksne med høj risiko for seksuelt overført hiv-1infektion.
English: For the full list of all side effects reported with Truvada, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Truvada fremgår af indlægssedlen.
English: Both active substances have been authorised in the European Union (EU) since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in
Danish: Begge aktive stoffer har været godkendt i Den Europæiske Union (EU) siden begyndelsen af 2000'erne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truvada have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Truvada.
English: For the treatment of HIV-1 infection, Truvada, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved behandling af hiv-1-infektion nedsætter Truvada hiv-mængden i blodet og holder den nede, når det anvendes i kombination med mindst ét andet hiv-lægemiddel.
English: Truvada can be used for pre-exposure prophylaxis only in individuals who have been tested to be free of HIV infection.
Danish: Truvada kan anvendes til forebyggende behandling før eksponering hos personer, hvis testresultater har vist, at de ikke har hiv-infektion.
English: For more information, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: Date of first authorisation: 4 June 2010 Date of latest renewal: 19 March 2015
Danish: Dato for første markedsføringstilladelse: 04 juni 2010 Dato for seneste fornyelse: 19 marts 2015
English: You may notice this as dizziness when standing up.
Danish: Du kan opleve det som svimmelhed, når du rejser dig.
English: In some cases you may have to stop taking one of the medicines.
Danish: I nogle tilfælde skal du stoppe med at bruge et af lægemidlerne.
English: However, it is not known whether telmisartan was the cause.
Danish: Det er imidlertid ikke kendt, hvorvidt telmisartan var årsagen.
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Danish: Den lille reduktion i AUC forventes ikke at forårsage en reduktion i den terapeutiske virkning.
English: See also information under the heading “Do not take Tolura”.
Danish: Se også information under overskriften ”Tag ikke Tolura”.
English: Cumulative urinary excretion is <1 % of dose.
Danish: Den kumulative udskillelse i urinen er <1% af dosis.
English: 1, 2, 3, 4: for further descriptions, please see sub-section “Description of selected adverse reactions”
Danish: 1,2,3,4: For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger”
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Danish: Derfor er det vigtigt, at få målt blodtrykket regelmæssigt for at finde ud af, om det ligger i normalområdet.
English: Some people feel dizzy or tired when taking Tolura.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Tolura.
English: - Lithium containing medicines to treat some types of depression.
Danish: - medicin, som indeholder lithium til behandling af nogle typer depression.
English: Each blister contains 7 or 10 tablets.
Danish: Hver blisterpakning indeholder 7 eller 10 tabletter.
English: Reduction of the antihypertensive effect.
Danish: Reducerer den antihypertensive virkning.
English: You can take Tolura with or without food.
Danish: Tolura kan både tages med mad og uden.
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Danish: Det kan være nødvendigt for din læge at ændre dosis af disse andre lægemidler eller tage andre forholdsregler.
English: There are usually no symptoms of high blood pressure before damage occurs.
Danish: Der er normalt ingen symptomer på forhøjet blodtryk, før en skade sker.
English: There are no adequate data from the use of Tolura in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Tolura hos gravide kvinder.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Danish: Den gennemsnitlige, absolutte biotilgængelighed af telmisartan er ca. 50%.
English: Diabetic patients treated with insulin or antidiabetics
Danish: Diabetespatienter, som behandles med insulin eller antidiabetika
English: OPA/Al/PVC Al blister.
Danish: OPA/Al/PVC Al blisterpakning.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på fremstilleren, som er ansvarlig for frigivelsen af den pågældende batch.
English: After adjustment for age group effects mean SBP changes from baseline (primary objective)
Danish: Efter justering for aldersgruppeeffekt var den gennemsnitlige SBP-ændring fra baseline (primære mål)
English: It is important that you take Tolura every day until your doctor tells you otherwise.
Danish: Det er vigtigt at du tager Tolura hver dag, så længe lægen ikke har givet dig besked på andet.
English: 02-235 Warszawa Poland
Danish: 02-235 Warszawa Polen
English: Your doctor will normally advise you to stop taking Tolura before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tolura.
Danish: Din læge vil normalt råde dig til at stoppe behandling med Tolura, inden du bliver gravid, eller lige så snart du opdager, at du er gravid, og råde dig til at tage en anden medicin i stedet for Tolura.
English: Precautions to be taken before handling or administering the medicinal product
Danish: Sikkerhedsforanstaltninger før håndtering og administration af lægemidlet
English: Sepsis including fatal outcome
Danish: sepsis herunder med dødsfald
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: 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.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er 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.
English: Only on blisters containing 7 tablets MON
Danish: Kun på blistre, der indeholder 7 tabletter MA
English: Read the package leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: Równoległa 5, 02-235 Warszawa, Poland
Danish: Równoległa 5, 02-235 Warszawa, Polen
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolura” and “Warnings and precautions”).
Danish: - Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Tolura” og ”Advarsler og forsigtighedsregler”).
English: Oral use Read the package leaflet before use.
Danish: Oral brug Læs indlægssedlen inden brug.
English: By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Danish: Tre timer efter administration er plasmakoncentrationerne ens, hvad enten telmisartan tages fastende eller med føde.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan bindes i høj grad til plasmaprotein (>99,5%), hovedsagelig til albumin og alfa 1syreglycoprotein.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisteren efter ”EXP”.
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Tag ikke en dobbeltdosis som erstatning for den glemte tablet.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Danish: Den totale plasmaclearance, (Cltot), er høj (ca. 1000 ml/min) sammenlignet med den hepatiske blodgennemstrømning (ca. 1500 ml/min).
English: After oral (and intravenous) administration telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Danish: Efter oral (og intravenøs) administration blev telmisartan udskilt næsten udelukkende i fæces og hovedsagelig som uændret stof.
English: Do not take Tolura - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Tolura - hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Tolura (angivet i punkt 6).
English: If you forget to take Tolura
Danish: Hvis du har glemt at tage Tolura
English: The recommended dose of Tolura is one tablet a day.
Danish: Den anbefalede dosis af Tolura er 1 tablet daglig.
English: Volume and/or sodium depletion should be corrected prior to administration of Tolura.
Danish: Volumen- og/eller natriummangel bør korrigeres før behandling med Tolura.
English: What Tolura contains - The active substance is telmisartan.
Danish: Tolura indeholder: - Det aktive stof er telmisartan.
English: Possible side effects of Tolura:
Danish: Bivirkninger ved Tolura:
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Danish: I farmakokinetiske studier af patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100 %.
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Bivirkningerne er opdelt efter hyppighed ud fra følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til <1/1.000); meget sjælden (< 1/10.000).
English: Talk to your doctor before taking Tolura: - if you are taking digoxin.
Danish: Kontakt lægen, før du tager Tolura: - hvis du tager digoxin.
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Der var ingen tegn på mutagenicitet eller relevant clastegen aktivitet ved in vitro-forsøg og ingen tegn på karcinogenicitet i rotter og mus.
English: If you have the impression that the effect of Tolura is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du synes, at virkningen af Tolura er for stærk eller svag, så sig det til lægen eller på apoteket.
English: The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Danish: Telmisartans farmakokinetikske egenskaber er ikke anderledes hos ældre patienter i forhold til de, der er under 65 år.
English: Tolura tablets contain lactose.
Danish: Tolura indeholder lactose.
English: (It is also better to avoid Tolura in early pregnancy see pregnancy section.)
Danish: (Det er også bedst at undgå Tolura i de første 3 måneder af graviditeten - se afsnittet om graviditet).
English: Corticosteroids (systemic route)
Danish: Kortikosteroider (systemisk administration)
English: Always take Tolura exactly as your doctor has told you.
Danish: Tag altid Tolura nøjagtigt efter lægens anvisning.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelige, ATC kode: C09CA07.
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Danish: Der er en tilsyneladende trend mod en dosisafhængighed i forhold til tid til tilbagevenden til baseline for det systoliske blodtryk (SBT).
English: Insomnia, depression Anxiety
Danish: Søvnløshed, depression
English: Such conditions should be corrected before the administration of Tolura.
Danish: Sådanne tilstande bør korrigeres før behandling med Tolura.
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Danish: Denne hæmmende virkning vedvarer i mere end 24 timer og kan måles i op til 48 timer.
English: This applies especially to the medicines listed below taken at the same time with Tolura:
Danish: Det gælder især, hvis du tager medicin fra listen nedenfor sammen med Tolura:
English: <2D barcode carrying the unique identifier included.>
Danish: <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Fortæl det til lægen, hvis du tror, at du er (eller kan blive) gravid.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Danish: Derfor bør samtidig behandling ske med forsigtighed, især hos ældre patienter.
English: Non-steroidal anti-inflammatory medicinal products
Danish: Nonsteroide antiinflammatoriske lægemidler
English: Tolura is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Tolura frarådes til mødre, der ammer, og lægen kan vælge en anden behandling til dig, hvis du ønsker at amme, især hvis barnet er nyfødt eller for tidlig født.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Danish: Endvidere kan ortostatisk hypotension blive forværret af alkohol, barbiturater, narkotika eller antidepressiva.
English: Take it as soon as you remember then carry on as before.
Danish: Tag tabletten så snart du kommer i tanke om det og fortsæt derefter som normalt.
English: The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Danish: Den antihypertensive virkning holder sig konstant i 24 timer efter dosering, hvilket også gælder de sidste 4 timer forud for næste dosis, som påvist ved ambulatorie blodtryksmålinger.
English: Hypotension 2, orthostatic hypotension
Danish: hypotension 2, ortostatisk hypotension
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Danish: Efter administration af den første dosis telmisartan indtræder den antihypertensive virkning gradvist indenfor 3 timer.
English: - Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Danish: - forhøjede aldosteronværdier (vand- eller saltophobning i kroppen sammen med ubalance i mineralsammensætningen).
English: Telmisartan does not show affinity for other receptors, including AT2and other less characterised AT receptors.
Danish: Telmisartan udviser ikke affinitet til andre receptorer, herunder AT2 og andre mindre karakteriserede AT-receptorer.
English: Plasma aldosterone levels are decreased by telmisartan.
Danish: Plasma-aldosteronniveauet sænkes af telmisartan.
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Danish: Funktionen af disse receptorer er ikke kendt, dette gælder også virkningen af deres mulige overstimulering af angiotensin II, hvis niveau øges af telmisartan.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Danish: I ét studie medførte samtidig administration af telmisartan og ramipril en op til 2,5 gange øgning af AUC0-24 og Cmax af ramipril og ramiprilat.
English: When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Danish: Ved opstart af telmisartan til reduktion af kardiovaskulær morbiditet anbefales tæt monitorering af blodtryk og muligvis er det nødvendigt med en justering af de lægemidler, der nedsætter blodtrykket.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Danish: Selvom der ikke findes kontrollerede epidemiologiske data for angiotensin IIreceptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke angiotensin-convertingenzyme (kininase-II enzymet), som også nedbryder bradykinin.
English: No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offsprings such as lower body weight and delayed eye opening was observed.
Danish: Der var ingen klare tegn på teratogenicitet, men ved toksiske doser sås en påvirkning af den postnatale udvikling af afkommet såsom lavere legemsvægt og forsinket åbning af øjnene.
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets 100 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter 100 tabletter
English: - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Danish: - samtidig anvendelse af et eller flere lægemidler, der påvirker renin-angiotensinaldosteronsystemet og/eller kaliumtilskud.
English: 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).
Danish: 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).
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system
Danish: Andre tilstande med stimulering af renin-angiotensin-aldosteronsystemet
English: For treatment of high blood pressure, the usual dose of Tolura 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 sædvanlige dosis af Tolura til de fleste patienter én tablet à 40 mg dagligt til kontrol af blodtrykket i 24 timer.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Danish: Patienterne skal indtage tilstrækkeligt med væske, og det bør overvejes at monitorere nyrefunktionen efter initiering af samtidig behandling og regelmæssigt derefter.
English: 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.
Danish: 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.
English: Tolura is used to treat essential hypertension (high blood pressure) in adults.
Danish: Tolura bruges til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne.
English: Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Danish: Køn Der er observeret forskelle i plasmakoncentrationen med Cmaks og AUC hhv. 3 og 2 gange højere hos kvinder sammenlignet med mænd.
English: When Tolura is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Tolura anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniveauerne for kalium og kreatinin.