FrancophonIA/ELRC3.0 huggingface dataset:
English: ITT (Ext) Population TLOVR analysis
Danish: ITT(Ext) population TLOVR analyse
English: Patients with renal impairment have not been specifically studied.
Danish: Patienter med nedsat nyrefunktion er ikke undersøgt specifikt.
English: Haemophiliac patients should therefore be informed of the possibility of increased bleeding.
Danish: Hæmofilipatienter bør derfor gøres opmærksom på muligheden for øget blødningstendens.
English: People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections).
Danish: Personer med fremskreden hiv-infektion (aids) har et svækket immunforsvar og har større risiko for at udvikle alvorlige infektioner (opportunistiske infektioner).
English: Yet, Telzir should be used with caution in patients with a known sulphonamide allergy.
Danish: Alligevel bør Telzir foreløbig anvendes med forsigtighed til patienter med kendt sulfonamidallergi.
English: • Flare up of old infections
Danish: • opblussen af tidligere infektioner
English: As shown in the above table, there were only 16 patients harbouring baseline virus with resistance to FPV/RTV according to the ANRS score.
Danish: Som vist i tabellen ovenfor var der kun 16 patienter med baseline-virus med resistens over for FPV/RTV ifølge ANRS-score.
English: Concomitant administration of Telzir and quetiapine is contra-indicated as it may increase quetiapine-related toxicity.
Danish: Samtidig administration af Telzir og quetiapin er kontraindiceret, da det kan medføre øget quetiapinrelateret toksicitet.
English: What Telzir contains
Danish: Telzir indeholder
English: Don't take a double dose to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Danish: Sammenhængen mellem amprenavirs in vitro-anti-hiv-1-aktivitet og hæmningen af hiv-1-replikationen i mennesker kendes ikke.
English: All Patients, RD=F Analysis2
Danish: Alle patienter, RD = F analyse n (%)
English: • clarithromycin, erythromycin (an antibiotic)
Danish: • clarithromycin, erythromycin (antibiotika)
English: No dose recommendations can be given.
Danish: Der kan ikke gives doseringsvejledning.
English: It is not known whether the ingredients in Telzir can also pass into your breast milk.
Danish: Det vides ikke, om nogle af indholdsstofferne i Telzir også kan udskilles i mælken.
English: These include:
Danish: Disse tilstande er:
English: Shake the bottle for 5 seconds before subsequent uses.
Danish: Ryst flasken 5 sekunder før efterfølgende brug.
English: The population enrolled mainly consisted of moderately antiretroviral experienced patients.
Danish: Den indrullerede patientgruppe bestod for hovedparten af moderat antiretroviral-erfarne patienter.
English: Slowly push the plunger in, allowing time to swallow.
Danish: Tryk langsomt på stemplet, så der er tid til at synke.
English: Midazolam: ↑ expected (3-4 fold for parenteral midazolam)
Danish: Midazolam:  forventet (3-4 fold ved parenteral midazolam)
English: It is taken with low doses of another medicine, ritonavir, which boosts the level of Telzir in the blood.
Danish: Det tages sammen med lave doser af en anden medicin, ritonavir, som forøger mængden af Telzir i blodet.
English: It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate.
Danish: Det anbefales at måle phenytoins plasmakoncentration og om nødvendigt øge dosis af phenytoin.
English: In some patients taking antiretroviral medicines including protease inhibitors, there have been reports of increased sugar in the blood and diabetes getting worse.
Danish: Hos nogle patienter, der tager antiretroviral medicin, herunder proteasehæmmere, er der set forhøjet sukker i blodet og forværring af sukkersyge.
English: The absolute bioavailability of fosamprenavir in humans has not been established.
Danish: Den absolutte biotilgængelighed af fosamprenavir i mennesker kendes ikke.
English: Cyclosporin Rapamycin Tacrolimus
Danish: Ciclosporin Rapamycin Tacrolimus
English: Frequency categories for the reactions below have been based on clinical trials and postmarketing data.
Danish: Frekvenskategorierne for nedennævnte bivirkninger er baseret på kliniske studier og data efter markedsføringen.
English: The thyroid tumorigenic potential is regarded to be species-specific.
Danish: Risikoen for tumorer i thyreoidea anses for at være artsspecifik.
English: Only 22% of the original population of the KLEAN study was enrolled in the study extension.
Danish: Kun 22 % af den oprindelige population af KLEAN-studiet blev medtaget i forlængelsesstudiet.
English: Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised (see section
Danish: Hyppig monitorering af terapeutiske koncentrationer af immunsuppressiva anbefales, indtil niveauerne er stabiliseret (se pkt.
English: These data were further substantiated by the supportive study APV20003; however, a different dosage regimen than that of study APV29005 was used.
Danish: Disse data er yderligere dokumenteret i det underbyggende studie APV20003; dog blev der i dette studie anvendt en anden dosering end den anvendt i studie APV29005.
English: A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir.
Danish: En nedsættelse af rifabutindosis på mindst 75 % anbefales, når rifabutin administreres samtidig med Telzir og ritonavir.
English: This value is decreased by approximately 40 % when Telzir is co-administered with ritonavir, most likely due to an increase in amprenavir bioavailability.
Danish: Denne værdi nedsættes med ca. 40 %, når Telzir administreres sammen med ritonavir, muligvis pga. amprenavirs øgede biotilgængelighed.
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Danish: Risiko for øgede koncentrationer af alfuzosin, hvilket kan medføre hypotension.
English: Take the syringe and the adapter off and wash them thoroughly in clean water.
Danish: Sprøjte og adapter tages af flasken og vaskes grundigt i rent vand.
English: Capsule or Solution
Danish: Kapsler eller opløsning
English: • methadone (a heroin substitute)
Danish: • methadon (erstatning for heroin)
English: 2RD=F: Rebound or discontinuation equal failure analysis which is equivalent to TLOVR.
Danish: RD = F: ”Rebound or discontinuation” er lig med “failure”-analyse, som er ækvivalent med TLOVR.
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations)
Danish: Glaxo Operations UK Ltd (registreret som GlaxoWellcome Operations)
English: Vomiting occurred more frequently amongst paediatric patients.
Danish: Opkastning forekom oftere blandt pædiatriske patienter.
English: After single dose administration of fosamprenavir, amprenavir peak plasma concentrations are observed approximately 2 hours after administration.
Danish: Efter en enkelt dosis af fosamprenavir ses den maksimale plasmakoncentrationen for amprenavir ca. 2 timer efter administrationen.
English: Don't take other medicines for the infection without your doctor's advice.
Danish: Tag ikke anden medicin mod infektionen, medmindre lægen anbefaler det.
English: → Use an alternative non-hormonal type of contraception such as a condom.
Danish:  Brug derfor anden ikke-hormonel prævention, f.eks. kondom.
English: Anticonvulsants (carbamazepine, phenobarbital) should be used with caution.
Danish: Krampestillende lægemidler (carbamazepin, phenobarbital) bør anvendes med forsigtighed.
English: Desipramine Nortriptyline
Danish: Desipramin Nortriptylin
English: You will be monitored while you are taking Telzir.
Danish: Du vil blive fulgt tættere, mens du tager Telzir.
English: • Tingling or numbness around the lips and mouth.
Danish: • følelsesløshed eller prikkende fornemmelse omkring munden og læberne.
English: Alternative non-hormonal methods of contraception are recommended for women of childbearing potential (see section 4.4).
Danish: Alternative ikke-hormonale kontraceptionsmetoder anbefales til kvinder i den fødedygtige alder (se pkt.
English: Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Danish: Ritonavir inducerer CYP3A4, CYP1A2, CYP2C9 og glucuronosyltransferase.
English: The pharmacokinetics of fosamprenavir in combination with ritonavir has not been studied in patients over 65 years of age.
Danish: Farmakokinetikken af fosamprenavir i kombination med ritonavir er ikke blevet undersøgt hos patienter over 65 år.
English: • lidocaine given by injection
Danish: • lidocain som injektion
English: In addition, decreased number of implantation sites per litter and a prolongation of gestation were seen when pups were mated after reaching maturity.
Danish: Ydermere var antallet af implantationssteder per kuld nedsat og gestationsperioden var forlænget hos ungerne, når disse efter at være blevet kønsmodne blev parret.
English: Telzir helps to control your condition, but it is not a cure for HIV infection.
Danish: Telzir hjælper med at holde din sygdom under kontrol, men det helbreder ikke hiv-infektion.
English: The increase of 25-Odesacetylrifabutin (active metabolite) could potentially lead to an increase of rifabutin related adverse events, notably uveitis.
Danish: Stigningen af 25-Odesacetylrifabutin (aktiv metabolit) kan potentielt medføre en stigning af rifabutinrelaterede bivirkninger, især uveitis.
English: Telzir may require dose reduction (using oral suspension).
Danish: Reduktion af Telzirdosis kan være nødvendig (anvend oral suspension).
English: Paediatric patients from 6 years of age
Danish: Pædiatriske patienter fra 6 år
English: If you get any symptoms of infection or signs of inflammation while you're taking Telzir: →Tell your doctor immediately.
Danish: Hvis du får symptomer på en infektion eller tegn på inflammation (en betændelseslignende reaktion), mens du tager Telzir:  Tal med lægen med det samme.
English: • Increase in cholesterol (a type of blood fat).
Danish: • forhøjet kolesterol (en type fedt i blodet).
English: In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
Danish: I de pivotale studier af Telzir, med patienter behandlet med fosamprenavir og ritonavir, fandt man ingen tegn på forøget risiko for udslæt hos patienter med kendt sulfonamidallergi, sammenlignet med patienter som ikke havde sulfonamidallergi.
English: (Ritonavir 100 mg capsules twice daily for 7 days)
Danish: (Ritonavir 100 mg kapsler 2 gange daglig i 7 dage)
English: • Increases in triglycerides (a type of blood fat).
Danish: • forhøjede triglycerider (en type fedt i blodet).
English: AAUCMB Observed Analysis
Danish: AAUCMB observeret analyse
English: Possible ↓ or ↑ of antithrombotic effect.
Danish: Mulig  eller  af antitrombotisk virkning.
English: High doses (> 200 mg/day) of ketoconazole or itraconazole are not recommended.
Danish: Høje doser (> 200 mg/dag) af ketoconazol eller itraconazol frarådes.
English: Less than 1 % of the therapeutic dose of amprenavir is excreted unchanged in the urine.
Danish: Mindre end 1 % af den terapeutiske dosis af amprenavir udskilles uændret i urinen.
English: Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
Danish: Det er vist, at koncentrationen af AAG falder under antiretrovirale behandlingsforløb.
English: • warfarin and other medicines that stop blood clotting
Danish: • warfarin og anden medicin mod blodpropper
English: Date of renewal of authorisation: 15 May 2009.
Danish: Dato for første markedsføringstilladelse: 12. juli 2004 Dato for seneste fornyelse: 15. maj 2009
English: Turn the bottle the right way up and remove the syringe from the adapter.
Danish: Vend flasken og fjern sprøjten fra adaptoren.
English: • if their immune systems are very weak
Danish: • hvis immunforsvaret er stærkt nedsat
English: The efficacy and safety of these therapies with fosamprenavir and ritonavir has not been established.
Danish: Effekten og sikkerheden af disse terapier sammen med fosamprenavir og ritonavir er ikke klarlagt.
English: Increased plasma concentrations of quetiapine may lead to coma.
Danish: Stigning i plasmakoncentrationen af quetiapin kan medføre koma.
English: Co-administration of amprenavir with grapefruit juice was not associated with clinically significant changes in plasma amprenavir pharmacokinetics.
Danish: Samtidig administration af amprenavir med grapefrugtjuice var ikke associeret med nogen klinisk signifikant ændring i plasma amprenavir farmakokinetikken.
English: Paediatric patients (from 6 years of age)
Danish: Pædiatriske patienter (fra 6 år)
English: Adults with liver disease
Danish: Voksne med leversygdom
English: Both of these studies compared fosamprenavir/ritonavir with lopinavir / ritonavir.
Danish: Begge studier sammenlignede fosamprenavir/ritonavir med lopinavir/ritonavir.
English: Telzir tablet is administered orally.
Danish: Telzir tabletter administreres oralt.
English: In this case close monitoring is required.
Danish: I så fald skal personen følges tæt
English: No drug interaction studies.
Danish: Ingen interaktionsstudier.
English: Your dose of Telzir may need to be changed if you are taking • etravirine (used to treat HIV infection)
Danish: Det kan være, at din dosis af Telzir skal ændres, hvis du tager • etravirin (mod hiv-infektion).
English: ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A
Danish: ANTINEOPLASTISKE MIDLER METABOLISERET AF CYP3A
English: Telzir is supplied in plastic bottles containing 225 ml oral suspension.
Danish: Telzir findes i plastflasker med 225 ml oral suspension.
English: Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Danish: Risiko for alvorlige og/eller livstruende reaktioner såsom akut ergotamintoksicitet karakteriseret ved perifere vasospasmer og iskæmi i ekstremiteterne og andre væv.
English: TRICYCLIC ANTIDEPRESSANTS
Danish: TRICYKLISKE ANTIDEPRESSIVA
English: • dasatinib, nilotinib, ibrutinib, vinblastine and everolimus (used to treat several types of cancer)
Danish: • dasatinib, nilotinib, ibrutinib, vinblastin og everolimus (til behandling af flere typer af kræft).
English: Insert the syringe firmly into the adapter.
Danish: Sæt sprøjten fast i adaptoren.
English: Antiretroviral Naïve Adult Patients
Danish: Antiretroviral naive voksne patienter
English: When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself.
Danish: Ved behandling af hiv-infektion er det ikke altid muligt at afgøre, om nogen af de bivirkninger, der opstår, skyldes Telzir, andre lægemidler taget samtidigt eller hiv-sygdommen.
English: Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.
Danish: Det anbefales at dosistitrere paroxetin ud fra en klinisk vurdering af det antidepressive respons.
English: • desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression)
Danish: • desipramin, nortriptylin, paroxetin og lignende medicin (mod depression)
English: Your doctor will work out the right dose based on your weight.
Danish: Lægen beregner den rigtige dosis ud fra kropsvægt.
English: Due to CYP3A inhibition by Telzir, concentrations of quetiapine are expected to increase.
Danish: På grund af Telzirs hæmning af CYP3A forventes det, at koncentrationen af quetiapin vil stige.
English: Efficacy outcomes are described in the table below.
Danish: Effektresultatet er beskrevet i tabellen nedenfor.
English: Pravastatin or fluvastatin are recommended because their metabolism is not dependent on CYP 3A4 and interactions are not expected with protease inhibitors.
Danish: Pravastatin eller fluvastatin anbefales, fordi deres metabolisme er uafhængig af CYP3A4, og der forventes ikke interaktioner med proteasehæmmere.
English: Patients on stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response.
Danish: Patienter, der er på en stabil dosis af paroxetin, og som påbegynder behandling med Telzir og ritonavir, bør overvåges for antidepressivt respons.
English: The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Danish: Amprenavirs antivirale in vitro-aktivitet blev evalueret over for hiv-1-IIIB i både akut og kronisk inficerede lymfoblastiske cellelinjer (MT-4, CEM-CCRF, H9) og perifere blodlymfocytter.
English: People with hepatitis B or C taking combination therapy are at increased risk of getting severe liver problems.
Danish: Personer med hepatitis B eller C, der får kombinationsbehandling, har større risiko for at få alvorlige leverproblemer
English: Shake the bottle for 20 seconds before the first use.
Danish: Ryst flasken 20 sekunder før første anvendelse.
English: Non-nucleoside reverse transcriptase inhibitors:
Danish: Non-nukleoside revers transkriptasehæmmere:
English: Shake the bottle vigorously before use.
Danish: Ryst flasken kraftigt før brug.
English: 6-17 years >39 kg Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Danish: 6-17 år ≥ 39 kg Tabletter eller oral suspension 700 mg (1 tablet eller 14 ml suspension)
English: It is not known whether amprenavir can be removed by peritoneal dialysis or haemodialysis.
Danish: Det vides ikke, om amprenavir kan fjernes ved peritonealdialyse eller hæmodialyse.
English: You must take Telzir oral suspension.
Danish: Du skal derfor tage Telzir oral suspension.
English: In females, at the high dose, there was a reduction in the weight of gravid uterus (0 to 16%) probably due to a reduction of the number of ovarian corporea lutea and implantations.
Danish: Hos hunrotterne, der fik den høje doseis, var vægten af den drægtige livmoder nedsat (0-16 %), formentlig på grund af, at antallet af ovarie corpora lutea og livmoderimplantationssteder var reduceret.
English: Telzir tablets may be taken without regard to food intake.
Danish: Telzir-tabletter kan tages uden hensyn til fødeindtagelse.
English: There are some medicines that must not be taken with Telzir.
Danish: Der er nogle typer af medicin, som du ikke må tage sammen med Telzir.
English: If Telzir/ritonavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Telzir/ritonavir gives i kombination med parenteral midazolam, skal det gøres på en intensivafdeling eller under tilsvarende forhold, som sikrer tæt klinisk monitorering og hensigtsmæssig behandling i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Hertfordshire SG12 0DJ United Kingdom
Danish: Hertfordshire SG12 ODJ Storbritannien
English: Table 5 Baseline Characteristics and Efficacy Outcomes at Week 48 in APV29005 ITT(E) Population
Danish: Tabel 5 Baseline karakteristika og effektresultat ved uge 48 i APV29005 ITT(E) population
English: Telzir is used to treat HIV (human immunodeficiency virus) infection.
Danish: Telzir anvendes til behandling af hiv (humant immundefekt)-infektion.
English: Anti-hepatitis C virus medicinal products
Danish: Lægemidler mod hepatitis C-virus Simeprevir
English: Amprenavir (APV) pharmacokinetics were studied in pregnant women receiving FPV/RTV 700/100 mg twice daily during the second trimester (n=6) or third trimester (n=9) and postpartum.
Danish: Amprenavirs (APV) farmakokinetik blev undersøgt hos gravide kvinder, der fik FPV/RTV 700/100 mg to gange dagligt i andet trimester (n=6) eller tredje trimester (n=9) og post partum.
English: Efficacy outcomes by subgroups are described in the table below.
Danish: Effektresultat opdelt i undergrupper er beskrevet i tabellen nedenfor.
English: The primary route of metabolism is via the cytochrome P450 3A4 enzyme.
Danish: Den primære metaboliseringsvej er via cytokrom P450 3A4-enzymet.
English: Clarithromycin: moderate ↑ expected
Danish: Clarithromycin: moderat  forventet
English: • Skin rashes (red, raised or itchy) - if the skin rash is severe, you may have to stop taking this medicine
Danish: • udslæt (rødt, hævet eller kløende) - hvis udslættet er alvorligt, kan det være, at du skal stoppe med at tage Telzir.
English: Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4.
Danish: Ritonavir hæmmer også CYP2D6, men i mindre udstrækning end CYP3A4.
English: ANTIRETROVIRAL MEDICINAL PRODUCTS
Danish: ANTIRETROVIRALE LÆGEMIDLER
English: This dose adjustment cannot be made with Telzir tablets.
Danish: Dosis kan ikke justeres med Telzir-tabletter.
English: In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Danish: Hos voksne, der tidligere er blevet behandlet med antiretrovirale midler, har Telzir i kombination med en lav dosis ritonavir ikke vist sig så effektivt som lopinavir/ritonavir.
English: If you forget to take Telzir
Danish: Hvis du har glemt at tage Telzir
English: Please refer to the table below for the dosing recommendations in paediatric patients.
Danish: Se nedenstående tabel for doseringsanbefalinger til pædiatriske patienter.
English: Severe or life-threatening cases of rash, including Stevens-Johnson syndrome are rare.
Danish: Alvorlige og livstruende hudreaktioner, herunder Stevens-Johnsons syndrom, er sjældne.
English: The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Danish: Den 50 % hæmmende koncentration (IC50) for amprenavir varierede fra 0,012 til 0,08 M i akut inficerede celler og var 0,41 M i kronisk inficerede celler (1 M = 0,50 g/ml).
English: After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation.
Danish: Efter oral administration bliver fosamprenavir hurtigt og næsten fuldstændigt hydrolyseret til amprenavir og uorganisk phosphat før det når kredsløbet.
English: (R-) methadone: Cmax ↓
Danish: (R-) methadon: Cmax 
English: No dose separation or dosage adjustment necessary (see Antacids).
Danish: Dosisadskillelse og dosisjustering er ikke nødvendig (se ”Antacida”).
English: The mean AAUCMBs (log10 c/ml) in the ITT (E) population (Observed analysis) at 48 weeks (primary end-point) and other efficacy outcomes by subgroup are described in the tables below:
Danish: Den gennemsnitlige ændring i AAUCMB (Log10 kopier/ml) i ITT(E) populationen (observeret analyse) ved uge 48 (det primære endepunkt) og andre effektresultater opdelt i undergrupper er beskrevet i tabellen nedenfor:
English: Pup survival was decreased.
Danish: Ungernes overlevelse var nedsat.
English: The relevance of the uterine endometrial adenocarcinomas for humans is uncertain; however there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance.
Danish: Relevansen af de uterin endometriale adenocarcinomaer for mennesker er ukendt, men der er ingen kliniske studier eller postmarketingsdata, der tyder på, at disse fund har klinisk betydning.
English: Ranitidine 300 mg single dose
Danish: Ranitidin 300 mg enkelt dosis
English: Telzir is also available as an oral suspension for those patients unable to swallow the tablets.
Danish: Telzir findes også som en oral suspension til patienter, der ikke kan synke tabletter.
English: Very common side effects These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):