FrancophonIA/ELRC3.0 huggingface dataset:
English: However, without new enfuvirtide some patients began to lose antiviral activity between weeks 4 and 8.
Danish: Det viste sig dog, at patienter, der ikke havde startet enfuvirtid ved studiestart, begyndte at tabe antiviral aktivitet mellem uge 4 og 8.
English: Clinical pharmacodynamic data
Danish: Kliniske farmakodynamiske data
English: Recombinant viruses showing ≥ 3fold resistance to tipranavir grow at less than 1% of the rate detected for wild type HIV-1 in the same conditions.
Danish: Rekombinante vira, der udviser 3 gange resistens over for tipranavir vokser med mindre end 1% af den hastighed, der er påvist for vildtype hiv-1 under de samme betingelser.
English: The 1483 patients included in the primary analysis had a median age of 43 years (range 17-80), were 86% male, 75% white, 13% black and 1% Asian.
Danish: De 1483 patienter, som indgik i den primære analyse, havde en gennemsnitsalder på 43 år (interval 1780 år), 86% var mænd, 75% var hvide, 13% var sorte og 1% var asiatiske.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the infection.
Danish: Når enzymet er blokeret, reproduceres virusset ikke normalt, hvilket hæmmer infektionen.
English: Steady-state is attained in most subjects after 7 days of dosing.
Danish: Steady state opnås hos de fleste personer efter 7 dages administration.
English: Multivariate analyses showed that baseline ALAT or ASAT above DAIDS Grade 1 and co-infection with hepatitis B or C were risk factors for these elevations.
Danish: Multivariate analyser viste, at ALAT eller ASAT ved baseline over DAIDS Grad 1, og smittede med hepatitis B eller C var risikofaktorer for disse forhøjelser.
English: The clinical significance of these observations has not been fully explored.
Danish: Den kliniske signifikans af disse observationer er endnu ikke belyst fuldt ud.
English: Number of patients Primary efficacy endpoint: % with VL < 400
Danish: Primært endpoint: % med VL < 400
English: For this reason it is very important that you tell your child's doctor about any changes in their health.
Danish: Det er derfor meget vigtigt, at du fortæller dit barns læge om enhver ændring i dit barns helbred.
English: However, some PK interaction studies were not performed with this recommended dosage.
Danish: Nogle farmakokinetiske (PK) interaktionsstudier var dog ikke udført med anbefalet dosis.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Danish: Det blokerer et enzym kaldet protease, der er involveret i reproduktionen af hiv.
English: In cases where co-administration is necessary, the dose of 10 mg atorvastatin daily should not be exceeded.
Danish: Hvis samtidig administration er nødvendig, bør dosis højst være 10 mg atorvastatin dagligt.
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Danish: Hæmofilipatienter skal derfor gøres opmærksom på risikoen for øget blødning.
English: For example they had other medical conditions or were receiving other medicine that may have caused the bleeding.
Danish: De havde f.eks. andre sygdomme eller fik anden medicin samtidig, der kunne være årsagen til blødningen.
English: Agents that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse reactions are detailed in this section, and listed in section 4.3.
Danish: Midler, som er særligt kontraindiceret pga. det forventede omfang af en interaktion og med potentiale for alvorlige bivirkninger nævnes i dette afsnit, og er anført i pkt.
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials (n=6300).
Danish: Denne bivirkning blev identificeret under post-marketing overvågning, men blev ikke observeret i randomiserede, kontrollerede kliniske studier (n=6.300).
English: Aptivus is specifically used for the treatment of HIV which is resistant to most other protease inhibitors.
Danish: Aptivus bruges specifikt til behandling af hiv, som er resistent overfor de fleste andre proteasehæmmere.
English: Liver impairment could therefore result in an increase of tipranavir exposure and a worsening of its safety profile.
Danish: Leverinsufficiens kan derfor medføre en stigning i eksponeringen for tipranavir og en forværret sikkerhedsprofil.
English: Before taking Aptivus it should be checked that the oral solution is clear and whether there are crystals or other particles at the bottom of the bottle.
Danish: Før indtagelse af Aptivus skal det sikres, at den orale opløsning er klar, og der ikke er krystaller eller andre partikler i bunden af flasken.
English: Mechanism unknown.
Danish: Ukendt virkningsmekanisme.
English: Your child's doctor will test for these changes.
Danish: Dit barns læge vil holde øje med disse ændringer.
English: ALAT increased
Danish: Forhøjet ALAT
English: If the co-administration with bupropion is judged unavoidable, this should be done under close clinical monitoring for bupropion efficacy, without exceeding the recommended dosage, despite the observed induction.
Danish: Hvis samtidig brug af bupropion vurderes at være nødvendig, bør dette ske under tæt klinisk monitorering af bupropions virkning, uden at overskride den anbefalede dosering, til trods for den observerede induktion.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE09
Danish: Farmakoterapeutisk klassifikation: Antiviralt til systemisk brug, proteasehæmmere, ATC-kode: J05A E09
English: It is not known whether Aptivus may be used safely during pregnancy.
Danish: Det er uvist, om det er sikkert at tage Aptivus under graviditet.
English: Aptivus is not a cure for HIV infection:
Danish: Aptivus kan ikke helbrede en hiv-infektion:
English: Tipranavir showed no evidence of genetic toxicity in a battery of in vitro and in vivo tests.
Danish: Tipranavir viste imidlertid ingen tegn på genetisk toksicitet i en række in vitro og in vivo test.
English: It is advisable that the patient writes the date of opening the bottle on the label and/or carton.
Danish: Det anbefales, at patienten skriver anbrudsdatoen på etiketten og/eller kartonen.
English: It is recommended to start with the lowest dose and careful clinical monitoring is necessary (see section 4.4).
Danish: Det anbefales at starte med den lavest mulige dosis, og nøje klinisk monitorering er nødvendig (se pkt.
English: Dizziness, somnolence, and fatigue have been reported in some patients; therefore, caution should be recommended when driving a car or operating machinery.
Danish: Svimmelhed, døsighed og træthed blevet rapporteret for nogle patiener; derfor anbefales det at udvise forsigtighed ved bilkørsel og betjening af maskiner.
English: Patients receiving Aptivus or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Danish: Patienter, der får Aptivus eller enhver anden antiretroviral-behandling kan fortsat få opportunistiske infektioner og andre komplikationer til hiv-1infektion.
English: The dose for children should not exceed 5 ml (500 mg) twice a day.
Danish: Dosis for dit barn bør ikke overskride 5 ml (500 mg) to gange daglig.
English: Insert the oral syringe into the adapter located in the neck of the bottle.
Danish: Anbring den orale sprøjte i adaptoren, som er anbragt i flaskehalsen.
English: Food improves the tolerability of tipranavir with ritonavir.
Danish: Mad forbedrer tolerabiliteten af tipranavir med ritonavir.
English: Do not store below 15°C.
Danish: Må ikke opbevares under 15ºC.
English: More frequent concentration monitoring of these medicinal products is recommended until blood levels have been stabilised.
Danish: Hyppig monitorering af koncentrationen af disse lægemidler anbefales, indtil plasmakoncentrationerne er stabiliseret.
English: The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with Aptivus (especially as regards the contraindications, warnings and undesirable effects sections).
Danish: Produktresuméet for ritonavir skal derfor gennemlæses, inden behandling med Aptivus påbegyndes (især afsnittene om kontraindikationer, advarsler og bivirkninger).
English: Patients using clarithromycin at doses higher than 500 mg twice daily should be carefully monitored for signs of toxicity of clarithromycin and tipranavir.
Danish: Patienter, der tager clarithromycin i doser, der er højere end 500 mg to gange daglig, bør monitoreres omhyggeligt for tegn på toksicitet for clarithromycin og tipranavir.
English: The majority of the effects in repeat-dose toxicity studies appeared at systemic exposure levels which are equivalent to or even below the human exposure levels at the recommended clinical dose.
Danish: Størstedelen af påvirkningerne i toksicitetsstudier med gentagen dosis forekom ved systemiske eksponeringsniveauer, som svarede til eller var lavere end de humane eksponeringsniveauer ved anbefalet klinisk dosis.
English: Vomiting, rash and fever were observed more frequently in children than in adults.
Danish: Opkastning, udslæt og feber blev set hyppigere hos børn end hos voksne.
English: A small amount of crystals does not affect the strength or safety of your child's medicine.
Danish: Dette har ingen betydning for styrken eller sikkerheden af dit barns medicin.
English: Sustained HIV-1 RNA decreases up to week 48 were mainly observed in patients who received tipranavir with ritonavir and new enfuvirtide.
Danish: Vedvarende fald i hiv-1 RNA frem til uge 48 blev hovedsageligt observeret hos patienter, som modtog tipranavir med ritonavir og ny enfuvirtid.
English: Patients had prior exposure to a median of 6 NRTIs, 1 NNRTI, and 4 PIs.
Danish: Patienterne havde forudgående været behandlet med en median af 6 NRTI'er, 1 NNRTI og 4 PI'er.
English: Until you exchange the bottle, please continue to give your child their usual doses of Aptivus oral solution.
Danish: Indtil du har fået flasken ombyttet bør du fortsætte med at give dit barn den sædvanlige dosis Aptivus oral opløsning.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Danish: En dosisreduktion af glukokortikoidet bør overvejes med nøje monitorering af lokale og systemiske påvirkninger eller et skift til et glukokortikoid, som ikke er et substrat for CYP3A4 (f.eks. beclomethason).
English: Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Der kan forventes større påvirkning, hvis fluticasonpropionat inhaleres.
English: In preclinical studies of tipranavir in dogs, an effect on coagulation parameters was not seen.
Danish: I prækliniske studier med tipranavir til hunde, blev der ikke set nogen virkning på koagulationsparametre.
English: RESIST study
Danish: RESIST-studie
English: A causal relationship has been evoked, although the mechanism of action had not been elucidated.
Danish: Formodning om en kausal sammenhæng foreligger, selvom virkningsmekanismen ikke er blevet afdækket.
English: No studies have been conducted to determine the distribution of tipranavir into human cerebrospinal fluid or semen.
Danish: Der er ikke gennemført studier for at fastlægge fordelingen af tipranavir i rygmarvsvæske eller sæd hos mennesker.
English: Once the bottle is opened the contents must be used within 60 days (stored below 25°C).
Danish: Når beholderen er åbnet, skal indholdet anvendes i løbet af 60 dage (og opbevares ved højst 25ºC).
English: Aptivus is not a cure for HIV-1 infection or AIDS.
Danish: Aptivus helbreder ikke hiv-1-infektion eller aids.
English: Patients should be instructed accordingly.
Danish: Patienterne skal vejledes om dette.
English: Clinical isolates that exhibited a  10-fold decrease in tipranavir susceptibility harboured 8 or more tipranavir-associated mutations.
Danish: Kliniske isolater, som viste et  10-gange fald i følsomheden overfor tipranavir, havde 8 eller flere tipranavir-associerede mutationer.
English: As demonstrated in a doseranging evaluation in 113 HIV-negative healthy male and female volunteers, ritonavir increases AUC012h, Cmax and Cmin and decreases the clearance of tipranavir.
Danish: Som påvist i et dosisvariende studie med 113 hiv-negative, raske mandlige og kvindelige frivillige øger ritonavir AUC0-12t, Cmax og Cmin og nedsætter clearance af tipranavir.
English: Do not give a double dose to make up for a forgotten dose.
Danish: Du må ikke give en dobbeltdosis som erstatning for en glemt dosis.
English: After Week 8, patients in the comparator arm who met the protocol defined criteria of initial lack of virologic response had the option of discontinuing treatment and switching over to tipranavir with ritonavir in a separate roll-over study.
Danish: Efter uge 8 havde patienterne i komparatorgruppen, som opfyldte protokollens kriterier om initialt manglende virologisk respons, mulighed for at ophøre med behandlingen og skifte over til tipranavir med ritonavir i et særskilt studie.
English: Median change from baseline in log10 HIV-1 RNA (copies/ml) Median change from baseline in CD4+ cell count (cells/mm3) Median change from baseline in % CD4+ cells
Danish: Medianændring fra baseline i log10 hiv-1 RNA (kopier/ml) Medianændring fra baseline i CD4+ celletal (celler/mm3) Medianændring fra baseline i % CD4+ celler
English: With respect to mutations on codons 33, 82, 84 and 90 approximately 4% had no mutations, 24% had mutations at codons 82 (less than 1% of patients had the mutation V82L) and 90, 18% had mutations at codons 84 and 90 and 53% had at least one key mutation at codon 90.
Danish: Hvad angår mutationer på kodon 33, 82, 84 og 90, havde ca. 4% ingen mutationer, 24% havde mutationer på kodon 82 (mindre end 1% af patienterne havde mutationen V82L) og 90, 18% havde mutationer på kodon 84 og 90, og 53% havde mindst en nøglemutation på kodon 90.
English: Close clinical and biological (INR measurement) monitoring is recommended when warfarin and tipranavir are combined.
Danish: Det anbefales at udføre en tæt klinisk og biologisk monitorering (INR-målinger), når warfarin og tipranavir gives samtidigt.
English: At present there are no results from controlled trials evaluating the effect of tipranavir on clinical progression of HIV.
Danish: Der er ingen resultater fra kontrollerede studier, der vurderer effekten af tipranavir på den kliniske udvikling af hiv.
English: Baseline CD4+ (cells/mm
Danish: Baseline CD4+ (celler/mm
English: Aptivus oral solution is supplied in amber glass bottles containing 95 ml of oral solution.
Danish: Aptivus oral opløsning bliver leveret i brune flasker indeholdende 95 ml oral opløsning.
English: p-value n (%)
Danish: p-værdi n (%)
English: Pharmacokinetic enhancer Cobicistat and cobicistatcontaining products
Danish: Farmakokinetisk forstærker Cobicistat og præparater indeholdende cobicistat
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Bør tages i betragtning ved graviditet eller amning, hos børn eller højrisiko-grupper, såsom patienter med leversygdomme eller epilepsi.
English: At 48-weeks the relative risk decreased to 1.27 (95% CI=0.76, 2.12).
Danish: Ved 48 uger var den relative risiko faldet til 1,27 (95% CI=0,76; 2,12).
English: Due to limitations in the study design (e.g. nonrandomized switch allowed according to patient/clinician decision), any comparisons between patients taking capsules and oral solution are not meaningful.
Danish: Pga. begrænsningerne i studiesdesignet (en tilladt nonrandomiseret ændring jf. patient/kliniske overvejelser), vil enhver sammenligning mellem patienterne, der fik kapsler og de, der fik oral opløsning, ikke være af betydning.
English: Laboratory abnormalities
Danish: Laboratoriemæssige abnormiteter
English: By contrast, evaluation of the steady-state plasma tipranavir trough concentrations at 10-14 h after dosing from the RESIST-1 and RESIST-2 studies demonstrate that females generally had higher tipranavir concentrations than males.
Danish: I modsætning hertil viser evaluering af steady state-dalværdien for plasmakoncentrationer af tipranavir 10-14 timer efter dosering i studierne RESIST-1 og RESIST-2, at kvinder generelt havde højere koncentrationer af tipranavir end mænd.
English: With repeated dosing, tipranavir plasma concentrations are lower than predicted from single dose data, presumably due to hepatic enzyme induction.
Danish: Ved gentagne doser er plasmakoncentrationerne af tipranavir lavere end forventet fra enkeltdosis-data, sandsynligvis pga. hepatisk enzym-induktion.
English: You should return the bottle to your child's pharmacist or doctor for a replacement as soon as possible if: - there is more than a thin layer of crystals at the bottom of the bottle, or - you are uncertain about the amount of crystals you see or - any other particles are visible.
Danish: Du skal returnere din flaske til apoteket for at få den ombyttet snarest hvis: - der er mere end et tyndt lag af krystaller på bunden af flasken eller - du er usikker på, om mængden af krystaller eller - der er andre partikler i flasken
English: Animal toxicology studies have been conducted with tipranavir alone, in mice, rats and dogs, and coadministered with ritonavir (3.75:1 w/w ratio) in rats and dogs.
Danish: Toksikologiske dyrestudier er gennemført med tipranavir alene på mus, rotter og hunde og plus ritonavir (3,75:1 w/w-forhold) til rotter og hunde.
English: The mean half-life was 5.5 (females) or 6.0 hours (males).
Danish: Halveringstiden er gennemsnitligt mellem 5,5 t. (for kvinder) og 6,0 t. (for mænd).
English: The human immunodeficiency virus (HIV-1) encodes an aspartyl protease that is essential for the cleavage and maturation of viral protein precursors.
Danish: Human Immunodeficency Virus (hiv-1) omkoder en aspartylprotease, som er essentiel for spaltning og modning af forstadier for virusprotein.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination therapy and should be monitored according to standard practice.
Danish: Patienter med leverdysfunktion, herunder kronisk aktiv hepatitis har en øget forekomst af leverfunktionsabnormiteter ved kombinationsbehandling og bør monitoreres i henhold til almindelig praksis.
English: In vitro metabolism studies with human liver microsomes indicated that CYP3A4 is the predominant CYP isoform involved in tipranavir metabolism.
Danish: In vitro-studier af metabolismen med humane levermikrosomer indikerede, at CYP3A4 er den dominerende CYP-isoform, der indgår i tipranavir-metabolismen.
English: Interactions between Aptivus and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”,once daily as “QD”, twice daily as “BID”).
Danish: Interaktioner mellem Aptivus og samtidigt administrerede lægemidler er anført i nedenstående tabel (øgning er angivet som ”↑”, reduktion som ”↓”, ingen ændring som ””, en gang daglig som ” x 1”, 2 gange daglig som ” x 2”).
English: Total plasma tipranavir concentrations for these samples ranged from 9 to 82 M.
Danish: De totale plasmakoncentrationer af tipranavir varierede fra 9 til 82 µM.
English: No pattern of abnormal haematological or coagulation parameters has been observed in patients in general, or preceding the development of ICH.
Danish: Der er ikke set noget mønster af abnorme hæmatologiske parametre eller koagulationsparametre hos patienter i almindelighed, eller forud for udvikling af ICH.
English: Remove the syringe cap covering the tip of the oral syringe (the cap will not be attached if this is the first time the oral syringe has been used) and insert the oral syringe into the adapter located in the neck of the bottle.
Danish: Fjern hætten fra enden af den orale sprøjte (hætten vil ikke blive berørt, hvis det er første gang den oral sprøjte bruges) og anbring den i adaptoren, som er anbragt i flaskehalsen.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2-8ºC).
English: Serious side effects associated with Aptivus:
Danish: Alvorlige bivirkninger forbundet med Aptivus-behandlingen:
English: There was no pattern for the bleeding events and no difference between treatment groups in coagulation parameters.
Danish: Der var intet mønster for blødningerne og ingen forskel mellem behandlingsgrupper med hensyn til koagulationsparametre.
English: In urine, unchanged tipranavir was found in trace amounts (0.5% of urine radioactivity).
Danish: I urinen blev der fundet uændret tipranavir i spormængder (0,5% af urinens radioaktivitet).
English: This indication is based on the results of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus oral solution in mostly treatment-experienced children aged 2 to 12 years.
Danish: Denne indikation er baseret på resultaterne fra et fase-II studie, der undersøgte farmakokinetik, sikkerhed og virkning af Aptivus oral opløsning hovedsagligt hos behandlingserfarne børn fra 2 til 12 år.
English: Discuss with your child's doctor the precautions needed to avoid infecting other people.
Danish: Tal med dit barns læge om, hvilke forholdsregler der er nødvendige for at undgå at smitte andre personer.
English: Ritonavir is a potent inhibitor of CYP3A4 and therefore affect drugs metabolised by this enzyme.
Danish: Ritonavir er en potent hæmmer af CYP3A4 og påvirker derfor lægemidler, der metaboliseres via dette enzym.
English: There are no data available indicating that omeprazole or esomeprazole dose adjustments will overcome the observed pharmacokinetic interaction.
Danish: Der findes ingen data, der indikerer, at dosisregulering af omeprazol eller esomeprazol kan kompensere for den observerede farmakokinetiske interaktion.
English: The available clinical data do not support the use of Aptivus oral solution in adolescents or adults.
Danish: Der findes ingen kliniske data for brug af Aptivus oral opløsning til unge og voksne.
English: This can lead to permanent disability or death, and has occurred in some patients treated with Aptivus in clinical trials.
Danish: Sådanne blødninger kan føre til varig invaliditet eller dødsfald, og er set hos enkelte patienter, som fik Aptivus i kliniske studier.
English: Tipranavir is a non-peptidic inhibitor of the HIV-1 protease that inhibits viral replication by preventing the maturation of viral particles.
Danish: Tipranavir er en non-peptid-inhibitor af det hiv-1-protease, som hæmmer viral replikation ved at forhindre modning af virale partikler.
English: The decrease in tipranavir concentrations may result in decreased effectiveness.
Danish: Koncentrationsfaldet af tipranavir kan resultere i nedsat virkning.
English: Once the bottle is opened your child should use the medicine within 60 days.
Danish: Når flasken er åbnet, skal indholdet anvendes i løbet af 60 dage.
English: Dosage reductions of rifabutin by at least 75% of the usual 300 mg/day are recommended (ie 150 mg on alternate days, or three times per week).
Danish: Dosisreduktioner af rifabutin med mindst 75% af de sædvanlige 300 mg/dag anbefales (dvs. 150 mg hver anden dag, eller tre gange om ugen).
English: In the paediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was higher than in adult patients.
Danish: I de pædiatriske kliniske studier var frekvensen af udslæt (alle former, alle årsagssammenhæng) højere, end hos de voksne patienter, der blev behandlet i 48 uger.
English: BSA Range (m
Danish: BSA område (m
English: Tipranavir is a P-gp substrate, a weak P-gp inhibitor and appears to be a potent P-gp inducer as well.
Danish: Tipranavir er et P-gp-substrat, en svag P-gp-hæmmer og synes også at være en kraftig P-gp-inducer.
English: The clinical impact of the observed data, especially regarding the tipranavir with ritonavir safety profile, remains unknown.
Danish: Den kliniske betydning af de observerede data, specielt sikkerhedsprofilen for tipranavir med ritonavir, forbliver ukendt.