FrancophonIA/ELRC3.0 huggingface dataset:
English: Biktarvy must not be used together with rifampicin (an antibiotic) or with St. John's wort (a herbal medicine used for treating depression).
Danish: Biktarvy må ikke anvendes sammen med rifampicin (et antibiotikum) eller med prikbladet perikum (et naturlægemiddel, der bruges mod depression).
English: Overall, 92% of patients taking Biktarvy (290 out of 314) achieved viral load reduction, compared with 93% (293 out of 315) of patients who achieved it with the comparator.
Danish: Samlet set opnåede 92 % (290 ud af 314) af de patienter, der fik Biktarvy, en reduktion af virusbelastningen sammenholdt med 93 % (293 ud af 315) af de patienter, der opnåede det med sammenligningspræparatet.
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: • Tenofoviralafenamid er et forstadium (et "prodrug"), der i kroppen omdannes til det aktive stof tenofovir.
English: Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide.
Danish: Biktarvy indeholder de aktive stoffer bictegravir, emtricitabin og tenofoviralafenamid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Biktarvy have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Biktarvy.
English: For the full list of side effects of Biktarvy, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Biktarvy fremgår af indlægssedlen.
English: In one study, the percentage of patients with viral load greater than or equal to 50 copies/ml was 1% (3 out of 282) of patients who switched to Biktarvy, compared with 0.5% (1 out of 281) of patients who stayed on their previous treatment (dolutegravir, abacavir, lamivudine).
Danish: I det ene studie var andelen af patienter med en virusbelastning højere end eller lig med 50 kopier/ml 1 % (3 ud af 282) af de patienter, der skiftede til Biktarvy, sammenholdt med 0,5 % (1 ud af 281) af de patienter, der fortsatte med deres tidligere behandling (dolutegravir, abacavir, lamivudin).
English: In the second study, the viral load went above the threshold in 2% (5 out of 290) of patients switched to Biktarvy, and in 2% (5 out of 287) of patients who stayed on their previous treatment (‘boosted' atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine).
Danish: I det andet studie oversteg virusbelastningen grænseværdien hos 2 % (5 ud af 290) af de patienter, der skiftede til Biktarvy, og hos 2 % (5 ud af 287) af de patienter, der fortsatte med deres tidligere behandling (boostet atazanavir eller darunavir plus enten emtricitabin/tenofovir eller abacavir/lamivudin).
English: The second study compared Biktarvy with dolutegravir plus emtricitabine/tenofovir alafenamide in 645 patients: 89% (286 out of 320) of patients taking Biktarvy achieved satisfactory viral load reduction, compared with 93% (302 out of 325) of patients on the comparator.
Danish: Det andet studie sammenlignede Biktarvy med dolutegravir plus emtricitabin/tenofoviralafenamid hos 645 patienter: 89 % (286 ud af 320) af de patienter, der fik Biktarvy, opnåede en tilfredsstillende reduktion af virusbelastning sammenholdt med 93 % (302 ud af 325) af de patienter, der fik sammenligningspræparatet.
English: How does Biktarvy work?
Danish: Hvordan virker Biktarvy?
English: How is Biktarvy used?
Danish: Hvordan anvendes Biktarvy?
English: • Bictegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Danish: • Det antivirale stof bictegravir er en såkaldt integrasehæmmer.
English: Two studies involved adults infected with HIV-1 who had not been treated previously, and looked at the numbers whose viral load (the amount of HIV-1 in the blood) was reduced to less than 50 copies per ml after 48 weeks of treatment.
Danish: Studierne så nærmere på, hvor mange patienters virusbelastning (mængden af hiv-1 i blodet) der blev reduceret til under 50 kopier pr. ml efter 48 ugers behandling.
English: What benefits of Biktarvy have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Biktarvy?
English: When should emergency contraception be used?
Danish: Hvornår skal der anvendes prævention?
English: [The information below should be added in this section together with the two tables which follow]
Danish: [Følgende oplysninger skal indsættes i dette punkt sammen med de to nedenstående tabeller]
English: Pregnancy rate 0.9% 1.3% 1.4% 6.4% 5.7%
Danish: Graviditetshyppighed 0,9 % 1,3 % 1,4 % 6m4 % 5,7 %
English: Ask your doctor or pharmacist for advice on alternative methods of emergency contraception.
Danish: Spørg lægen eller apotekspersonalet til råds angående alternative metoder for nødprævention.
English: Therefore, <invented name> is still recommended for all women regardless of their weight or BMI.
Danish: Derfor anbefales <særnavn> fortsat til alle kvinder, uanset vægt eller BMI.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III ÆNDRINGER TIL RELEVANTE PUNKTER I PRODUKTRESUME OG INDLÆGSSEDDEL
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [De eksisterende produktoplysninger skal rettes (indsæt, erstat eller slet tekst, hvor det er nødvendigt) så den afspejler den godkendte tekst nedenfor]
English: For Levonorgestrel-containing emergency contraceptive medicinal products A. Summary of product characteristics
Danish: For Levonorgestrelholdige lægemidler til nødprævention A. Produktresume
English: You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Danish: Du rådes til at tale med din læge eller sundhedspersonalet, hvis du er bekymret over problemer i forbindelse med brug af nødprævention.
English: B. Package leaflet
Danish: B. Indlægsseddel
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of levonorgestrel) and women who had further acts of unprotected intercourse.
Danish: Begge metaanalyser udelukkede indtagelse senere end 72 timer efter et ubeskyttet samleje (dvs. off-label-anvendelse af levonorgestrel) og kvinder, som havde yderligere ubeskyttede samlejer.
English: There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy.
Danish: Der er begrænsede og inkonklusive data vedrørende virkningen af høj kropsvægt/højt BMI på den kontraceptive effekt.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)
Danish: Tabel 1: Metaanalyse af tre WHO-studier (von Hertzen et al., 1998 og 2002; Dada et al., 2010)
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Danish: Tabel 2: Metaanalyse af studier af Creinin et al., 2006 og Glasier et al., 2010
English: Pregnancy rate (95% CI) according to weight categories Weight (kg) N total N pregnancies
Danish: Graviditetshyppighed (95 % KI) fordelt på vægtkategorier Vægt (kg)
English: In three WHO studies no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2).
Danish: I tre WHO-studier blev der ikke observeret tendens til reduceret effekt i forbindelse med øget kropsvægt/BMI (tabel 1), hvorimod to andre studier (Creinin et al., 2006 og Glasier et al., 2010) viste en reduceret effekt ved stigende kropsvægt eller BMI (tabel 2).
English: There is some evidence that <invented name> may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Danish: Der foreligger nogen dokumentation for, at levonorgestrel kan have en nedsat virkning ved stigende legemsvægt eller body mass index (BMI), men disse data er begrænsede og utilstrækkelige.
English: Section 4.2 Posology and method of administration
Danish: 4.2 Dosering og indgivelsesmåde
English: BEFORE YOU USE <invented name> <strength> TABLET
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE <SÆRNAVN> <styrke>
English: Limited and inconclusive data suggest that there may be reduced efficacy of <invented name> with increasing body weight or body mass index (BMI) (see section 5.1).
Danish: Begrænsede og inkonklusive data tyder på, at levonorgestrels virkning kan være nedsat ved stigende kropsvægt eller body mass indeks (BMI) (se pkt.
English: - if you weigh 75 kg or more (see “What <invented name> <strength> tablet is and what it is used for” for further details)
Danish: Advarsler og forsigtighedsregler hvis du vejer 75 kg eller mere (se “virkning og anvendelse” for at få yderligere oplysninger)
English: [The information below should be deleted together with the table] In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.2 and 4.4).
Danish: [Følgende oplysninger skal slettes sammen med tabellen] I kliniske forsøg var den præventive effekt reduceret hos kvinder, som vejede 75 kg eller mere og levonorgestrel var ikke effektiv til kvinder, der vejede mere end 80 kg (se pkt.
English: Studies suggest that <invented name> is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg.
Danish: I kliniske forsøg var den præventive effekt reduceret hos kvinder, som vejede 75 kg eller mere og levonorgestrel var ikke effektiv til kvinder, der vejede mere end 80 kg.
English: [the phrase below should be deleted from this section] Special population: body weight 75 kg or more
Danish: [Følgende oplysninger skal fjernes fra dette punkt] Særlig population: kropsvægt på 75 kg eller mere I kliniske forsøg var den præventive effekt reduceret hos kvinder, som vejede 75 kg eller mere og levonorgestrel var ikke effektiv til kvinder, der vejede mere end 80 kg (se pkt.
English: Your doctor can tell you if you are at high risk for such events.
Danish: Din læge kan fortælle dig om du er i høj risiko for sådanne hændelser.
English: - If you are more than 3 months pregnant.
Danish: - hvis du er mere end 3 måneder henne i graviditeten.
English: Al/Al blisters:
Danish: Al/AL blister:
English: - if you are taking digoxin.
Danish: - hvis du tager digoxin.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Danish: Patienten bør monitorerres nøje, og behandlingen bør være symptomatisk og understøttende.
English: Cumulative urinary excretion is < 1% of dose.
Danish: Den kumulative udskillelse i urinen er <1% af dosis.
English: 250 tablets
Danish: 250 tabletter
English: Try to take the tablet at the same time each day.
Danish: Det er mest hensigtsmæssigt at tage tabletten på samme tid hver dag.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag ikke en dobbelt dosis som erstatning for den glemte tablet.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden, du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: If you forget to take your medicine you should take the dose as soon as you remember on the same day.
Danish: Hvis du glemmer at tage din medicin, skal du tage den så snart du husker det samme dag.
English: Some side effects can be serious and need immediate medical attention: You should see your doctor immediately if you experience any of the following symptoms:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægehjælp: Du skal straks kontakte din læge, hvis du får nogle af følgende symptomer:
English: 1,2,3,4: for further descriptions, please see sub-section 4 ”Description of selected adverse reactions”.
Danish: 1,2,3,4: For yderligere beskrivelse, se venligst under punktet ”Beskrivelse af udvalgte bivirkninger”.
English: The mean absolute bioavailability for telmisartan is about 50%.
Danish: Den gennemsnitlige, absolutte biotilgængelighed af telmisartan er ca. 50%.
English: Some people feel dizzy or tired when taking Telmisartan Actavis.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Telmisartan Actavis.
English: (It is also better to avoid Telmisartan Actavis in early pregnancy - see pregnancy section.)
Danish: (Du skal desuden helst undgå at bruge Telmisartan Actavis tidligt i graviditeten - se afsnittet om Graviditet).
English: See also information under the heading “Do not take Telmisartan Actavis”.
Danish: Se også information under overskriften ”Tag ikke Telmisartan Actavis”
English: Telmisartan is largely bound to plasma protein (> 99.5%), mainly albumin and alpha-1 acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaprotein (>99,5%), hovedsagelig til albumin og Alfa I-syreglycoprotein.
English: Corticosteroids (systemic route) Reduction of the antihypertensive effect.
Danish: Corticosteroid (systemisk administration) Reducerer den antihypertensive virkning.
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Danish: Det tilsyneladende fordelingsvolumen, (Vdss), ved ”steady state” er ca. 500 l.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Danish: Tabletten bør synkes med vand eller anden væske uden alkohol.
English: There are no adequate data from the use of Telmisartan Actavis in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Telmisartan Actavis hos gravide kvinder.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC) increase disproportionately with dose.
Danish: Den maksimale plasmakoncentration (Cmaks) og, i mindre grad, arealet under plasmakoncentrationtidskurven (AUC) stiger disproportionalt med dosis.
English: Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Danish: Telmisartan udviser ikke affinitet til andre receptorer, herunder AT2 og andre mindre karakteriserede AT receptorer.
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 plasmaclearenace, (Cltot), er høj (ca. 1000 ml/min) sammenlignet med den hepatiske blodgennemstrømning (ca. 1500 ml/min).
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 klasteogen aktivitet ved et in-vitro forsøg og ingen tegn på karcinogenicitet i rotter og mus.
English: 220 Hafnarfjörður
Danish: 220 Hafnarfjordur
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Danish: I farmakokinetiske studier med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100%.
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: opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Treatment of essential hypertension
Danish: Behandling af essential hypertension
English: Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Actavis .
Danish: Volumen- og/eller natriumdepletering bør korrigeres før behandling med Telmisartan Actavis.
English: Hypertension Treatment of essential hypertension in adults.
Danish: Hypertension Behandling af essential hypertension hos voksne.
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Danish: Denne hæmmende effekt vedvarer i mere en 24 timer og kan måles i op til 48 timer.
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 ikker findes kontrollerede epidemiologiske data for angiotensin II-receptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse.
English: By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Danish: Tre timer efter indgiften er plasmakoncentrationerne ens, hvad enten telmisartan tages fastende eller med føde.
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 antidepressiv.
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of > 20 hours.
Danish: Telmisartan er karatkeriseret ved en farmakokinetisk bieksponentiel udskillelse med en terminal eliminationshalveringstid på >20 timer.
English: The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
Danish: Den maksimale reduktion i blodtrykket opnås generelt 4-8 uger efter behandlingen er påbegyndt og fastholdes gennem langtidsbehandling.
English: ‘Essential' means that the high blood pressure is not caused by any other condition.
Danish: 'Essentiel' betyder, at det ikke er nogen sygdom, der er årsag til, at blodtrykket er forhøjet.
English: Japanese patients are more likely to experience these adverse reactions.
Danish: Japanske patienter er mere udsatte for at få disse bivirkninger.
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Danish: Hos begge dyrearter fandt man forøget plasma-reninakvtivitet og hypertrofi/hyperplasi af de renale juxtaglomerulære celler.
English: The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Danish: Den observerede øgede forekomst af sepsis forbundet med brugen af telmisartan kan enten være en tilfældighed eller relateret til en mekanisme, som på nuværenede tidspunkt ikke er kendt.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7%) and ramipril (16.5%) groups.
Danish: Forekomsten af hændelser svarende til det primære endepunkt var ens for telmisartan (16,7%) og ramipril (16,5%).
English: It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Danish: Det vises ikke, om lavere doser end 80 mg telmisartan reducerer kardiovaskulær morbiditet.
English: Gender differences in plasma concentrations were observed, Cmax and AUC being approximately 3-and 2-fold higher, respectively, in females compared to males.
Danish: Der er observeret kønsforskelle i plasmakoncentrationen med Cmaks og AUC hhv. 3 og 2 gange højere hos kvinder end hos mænd.
English: If you have the impression that the effect of Telmisartan Actavis is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror virkningen af Telmisartan Actavis er for stærk eller svag, så sig det til din læge eller på apoteket.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke ”angiotensin-converting-enzyme”(kininase-II enzymet), som også nedbryder bradykinin.
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: Al/Al blisters: Store in the original package in order to protect from light.
Danish: Al/Al blister: Opbevares i den originale yderpakning for at beskytte mod lys.
English: Reykjavíkurvegi 76-78
Danish: Reykjavikurvegi 76-78
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30.09.2010
Danish: Dato for første markedsføringstilladelse: 30.09.2010 Dato for fornyelse af tilladelsen:
English: Talk to your doctor before taking Telmisartan Actavis: - if you are taking digoxin.
Danish: Kontakt lægen, før du tager Telmisartan Actavis: - hvis du tager digoxin.
English: Such conditions should be corrected before the administration of Telmisartan Actavis .
Danish: Sådanne tilstande bør korrigeres før behandling med Telmisartan Actavis.
English: A. MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
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: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Danish: Død af alle årsager var 11,6% henholdsvis 11,8% for telmisartan og ramiprilbehandlede patienter.
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Danish: Diabetespatienter, som behandles med insulin eller andiabetika Hos disse patienter kan hypoglykæmi forekomme i forbindelse med telmisartan-terapi.
English: Tablet container: 30 and 250 tablets.
Danish: Tabletbeholder: 30 og 250 tabletter.
English: Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients.
Danish: De fleste tilfælde af insufficient leverfunktion/-lidelse fra post-marketing erfaring forekom hos japanske patienter.
English: When Telmisartan Actavis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Telmisartan Actavis anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniverauerne for kalium og kreatinin.
English: Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Administration Telmisartan tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: Treatment: Telmisartan is not removed by haemodialysis.
Danish: Behandling: Telmisartan kan ikke fjernes ved hæmodialyse.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelige, ATC kode: C09CA07
English: - The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone,
Danish: - De øvrige indholdsstoffer er magnestiumstearat, croscarmellosenatrium, mannitol, povidon,
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Danish: Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5% CI 0,93-1,10, p (non-inferiorietet) = 0,0019 ved en margin på 1,13).