FrancophonIA/ELRC3.0 huggingface dataset:
English: At maternal doses producing systemic exposure levels similar to or below those at the recommended clinical dose, tipranavir did not produce teratogenic effects.
Danish: Ved maternelle doser, der frembringer systemiske eksponeringsniveauer identisk med eller lavere end dem ved anbefalet klinisk dosis, viste tipranavir ingen teratogene virkninger.
English: From clinical samples of healthy volunteers and HIV-1 positive subjects who received tipranavir without ritonavir the mean fraction of tipranavir unbound in plasma was similar in both populations (healthy volunteers 0.015%  0.006%; HIV-positive subjects 0.019%  0.076%).
Danish: Fra raske frivillige og hiv-1-positive patienter, som fik tipranavir uden ritonavir, var gennemsnitsfraktionen for ubundet tipranavir i plasma det samme i begge populationer (raske frivillige 0,015%  0,006%; hiv-positive patienter 0,019% +/+0,076%).
English: - Abnormal liver function - Hepatitis and fatty liver - Liver failure.
Danish: - Unormal leverfunktion - leverbetændelse og fedtlever - leversvigt.
English: If observed, crystals are typically seen as a paper-thin layer on the bottom when the bottle is stored upright.
Danish: Hvis der er krystaller, ses det typisk som et papirtyndt lag på bunden af flasken, når flasken står oprejst.
English: Baseline characteristics for patients 12 - 18 years of age who took capsule
Danish: Baseline karakteristik for patienter 12 - 18 år, som fik kapsler Variabel
English: In vitro studies show that tipranavir is a substrate and also an inhibitor of P-gp.
Danish: In vitro-studier viser, at tipranavir er et substrat for og også en hæmmer af P-gp.
English: Genotypically Resistant LPV/rtv
Danish: Genotypisk resistens LPV/rtv
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are as yet unknown.
Danish: Virkningen på ritonavirniveauet i plasma ved høj systemisk fluticasoneksponering er endnu ukendt.
English: Your child's doctor, together with you, will decide which other medicines your child should take.
Danish: Dit barns læge vil afgøre sammen med dig, hvilken medicin der skal indgå i dit barns behandling.
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: Hvis der samtidig gives antiviralbehandling pga. hepatitis B eller C, henvises der til de pågældende produktresuméer for disse lægemidler.
English: Intracranial haemorrhage (ICH) was only observed in post marketing experience (see section 4.4).
Danish: Intrakraniel blødning (ICH) blev kun observeret post-marketing (se pkt.
English: Purified water ‘Sorbitol special-glycerin blend' (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) Titanium dioxide (E171)
Danish: Renset vand ”Sorbitol-specialglycerin-blanding” (d-sorbitol, 1,4-sorbitan, mannitol og glycerin) Titandioxid (E171)
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner, kan autoimmune lidelser (en tilstand, der opstår, når immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv infektion.
English: Therefore, it is recommended that patients switching from Aptivus oral solution to capsules at the age of 12 years are closely monitored for the virologic response of their antiretroviral regimen (see sections 5.1 and 5.2).
Danish: Det anbefales derfor, at monitorere 12-årige patienter, som har skiftet fra Aptivus oral opløsning til kapsler, tæt for det virologiske respons på deres antiretrovirale behandlingsregime (se pkt.
English: Mild to moderate rash, including: - hives - rash with flat or raised small red spots - sensitivity to the sun have been reported in approximately 1 in 10 patients receiving Aptivus.
Danish: Mildt til moderat udslæt, herunder: - nældefeber - fladt eller hævet udslæt, røde prikker - følsomhed overfor solen er set hos ca. 10 % af de patienter, der har fået Aptivus.
English: If patients did not receive tipranavir with ritonavir with new enfuvirtide, diminished treatment responses at week 48 were observed, relative to new enfuvirtide use (see Table below).
Danish: Hos patienter, som ikke modtog tipranavir med ritonavir med ny enfuvirtid, blev der observeret nedsat behandlingsrespons ved uge 48 set i forhold til brug af ny enfuvirtid (se tabel nedenfor).
English: Group O and HIV-2 isolates have reduced susceptibility in vitro to tipranavir with EC50 values ranging from 0.164-1 µM and 0.233-0.522 µM, respectively.
Danish: Gruppe O og hiv-2 isolater viser nedsat modtagelighed in vitro over for tipranavir med EC50 værdier i intervaller på henholdsvis 0,164-1 µM og 0,233-0,522 µM.
English: PHARMACEUTICAL FORM AND CONTENTS 120 soft capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 120 bløde kapsler
English: C-tipranavir human study (500 mg
Danish: tipranavir-studie (500 mg
English: The following clinical safety features (hepatotoxicity, hyperlipidaemia, bleeding events, rash) were seen at higher frequency among tipranavir with ritonavir treated patients when compared with the comparator arm treated patients in the RESIST trials, or have been observed with tipranavir with ritonavir administration.
Danish: De følgende kliniske sikkerhedsforhold (hepatotosicitet, hyperlipidæmi, blødninger, udslæt) forekom hyppigere blandt patienter behandlet med tipranavir med ritonavir sammenlignet med patienterne i komparatorgruppen i RESIST-studierne, eller er observeret ved administration af tipranavir med ritonavir.
English: Concomitant use of Aptivus/ritonavir caused a decrease of etravirine exposure that could significantly impair the virologic response to etravirine.
Danish: Samtidig administration af Aptivus/ritonavir medførte et fald i eksponeringen af etravirin, der i betydelig grad kan nedsætte det virologiske respons på etravirin.
English: The predominant effects of repeated administration of tipranavir across all species toxicologically tested were on the gastrointestinal tract (emesis, soft stool, diarrhoea) and the liver (hypertrophy).
Danish: De dominerende virkninger ved gentagne doser tipranavir på tværs af alle arter, der er testet toksikologisk, var på mave/tarm-kanalen (emesis, løs afføring, diarre) og leveren (hypertrofi).
English: No dosage adjustment necessary in patients with normal renal function.
Danish: Dosisjustering er ikke nødvendig for patienter med normal nyrefunktion.
English: Your doctor, together with you, will decide which other medicines you should take.
Danish: Din læge vil afgøre sammen med dig, hvilken medicin der skal indgå i din behandling.
English: There is increased potential for PDE5 inhibitorassociated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).
Danish: Der er en øget risiko for bivirkninger relateret til PDE5-hæmmeren (såsom synsforstyrrelser, hypotension, forlænget erektion og synkope).
English: Your child can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Dit barn kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Interaction study performed only with ritonavir
Danish: Interaktionsstudier er kun udført med ritonavir
English: Tipranavir inhibits the replication of laboratory strains of HIV-1 and clinical isolates in acute models of T-cell infection, with 50% and 90% effective concentrations (EC50 and EC90) ranging from 0.03 to 0.07 µM (18-42 ng/ml) and 0.07 to 0.18 µM (42-108 ng/ml), respectively.
Danish: Tipranavir hæmmer replikationen af hiv-1-laboratoriestammer og kliniske isolater i akutte modeller af T-celle-infektion ved 50% og 90% effektive koncentrationer (EC50 og EC90) varierende fra hhv. 0,03-0,07 µM (18-42 ng/ml) og hhv. 0,07-0,18 µM (42-108 ng/ml).
English: All patients had received at least two PI-based antiretroviral regimens and were failing a PI-based regimen at the time of study entry.
Danish: Alle patienter havde tidligere fået mindst to proteasehæmmerbaserede, antiretrovirale behandlingsregimer, og på inklusionstidspunktet svigtede en proteasehæmmerbaseret behandlingsregime.
English: In such cases no dosage adjustment of abacavir can be recommended (see section
Danish: I sådanne tilfælde anbefales ingen dosisjustering af abacavir (se pkt.
English: Tipranavir, co-administered with low dose ritonavir, exhibits linear pharmacokinetics at steady state.
Danish: Tipranavir administreret samtidig med lavdosis ritonavir, viser lineær farmakokinetik ved steady state.
English: However, if atorvastatin is specifically required for patient management, it should be started with the lowest dose and careful monitoring is necessary.
Danish: Hvis atorvastatin er specifikt påkrævet, bør initialdosis være lavest mulig, og tæt monitorering er nødvendig.
English: Fluticasone propionate Interaction study performed only with ritonavir
Danish: Fluticasonpropionat Interaktionsstudier er kun udført med ritonavir
English: In a study comparing 9 patients with mild (Child-Pugh A) hepatic impairment to 9 controls, the single and multiple dose exposure of tipranavir and ritonavir were increased in patients with hepatic impairment but still within the range observed in clinical studies.
Danish: I et studie, der sammenlignede 9 patienter med mild (Child-Pugh A) lever insufficiens med 9 kontrolpersoner, øgedes farmakokinetikken for enkeltdoser og multiple doser af tipranavir og ritonavir hos patienter med lever insufficiens, men stadig inden for intervallet som observeret i de kliniske studier.
English: 3); median baseline plasma HIV-1 RNA was 4.79 and 4.80 log10 copies/ml, respectively (ranges 2.34-6.52 and 2.01-6.76 log10 copies/ml).
Danish: 3); median baseline-plasma hiv-1 RNA var hhv. 4,79 og 4,80 log10 partikler/ml (interval 2,34 - 6,52 og 2,01 - 6,76 log10 partikler/ml).
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child. - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt, inden dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Remove the syringe cap covering the tip of the oral syringe (the cap will not be attached if this is the first time you are using the syringe).
Danish: Fjern hætten fra enden af den orale sprøjte (hætten vil ikke blive berørt, hvis det er første gang sprøjten bruges)
English: In case of concomitant administration of emtricitabine and Aptivus/ritonavir, renal function should be evaluated before initiating the co-administration.
Danish: Ved samtidig administration af emtricitabin og Aptivus/ritonavir bør nyrefunktionen vurderes før behandlingen påbegyndes.
English: Relationships between baseline phenotypic susceptibility to tipranavir, primary PI mutations, protease mutations at codons 33, 82, 84 and 90, tipranavir resistance-associated mutations, and response to tipranavir with ritonavir therapy were assessed.
Danish: Forholdene mellem baseline fænotypisk modtagelighed over for tipranavir, primære proteasehæmmermutationer, proteasemutationer ved kodon 33, 82, 84 og 90, mutationer i forbindelse med tipranavirresistens og respons på behandling med tipranavir med ritonavir blev vurderet.
English: Particular caution should be used when prescribing the phosphodiesterase (PDE5) inhibitors sildenafil or vardenafil in patients receiving Aptivus, coadministered with low dose ritonavir.
Danish: Der skal udvises særlig forsigtighed ved ordinering af phosphodiesterase (PDE5)-hæmmerne sildenafil eller vardenafil til patienter, der får Aptivus sammen med lavdosis ritonavir.
English: Additional side effects in children and adolescents The most common side effects were generally similar to those described in adults.
Danish: Generelt er de mest almindelige bivirkninger hos børn de samme, som hos voksne.
English: Tadalafil should not be prescribed until Aptivus has been taken for 7 days or more.
Danish: Tadalafil må ikke tages, indtil Aptivus-behandlingen har været i gang i mindst 7 dage.
English: Includes abdominal pain (N=1), dysphagia (N=1) and epigastric discomfort (N=1).
Danish: Omfatter abdominalsmerte (N=1), synkebesvær (N=1) og epigastriske gener (N=1).
English: Do NOT stop taking Aptivus unless your doctor instructs you to do so.
Danish: Du MÅ IKKE standse behandlingen med Aptivus, medmindre din læge siger, at du skal.
English: This will depend on, for example: which other medicines you have already taken for HIV which medicines your HIV is resistant to.
Danish: Dette vil være afhængigt af f.eks.: - Hvilken anden medicin du tidligere har fået mod hiv.
English: After 48 weeks of follow-up, the frequency of Grade 3 or 4 ALAT and/or ASAT abnormalities was higher in tipranavir with ritonavir patients compared with comparator arm patients (10% and 3.4%, respectively).
Danish: Efter 48 ugers opfølgning var frekvensen af ALAT og/eller ASAT abnormaliteter på niveau 3 eller 4 højere hos tipranavir med ritonavir-patienter i forhold til komparatorgruppens patienter (henholdsvis 10% og 3,4%).
English: Aptivus with ritonavir should be discontinued once signs of worsening liver function occur in patients with pre-existing liver disease.
Danish: Behandlingen med Aptivus og ritonavir bør afbrydes, hvis der ses tegn på forværring af leverfunktionen hos patienter, der tidligere har fået diagnosticeret en leversygdom.
English: It has been shown that taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV becoming resistant to your antiretroviral medicines
Danish: Det er påvist, at ved at tage alle doser på det rigtige tidspunkt: - så øger det i høj grad effekten af kombinationsbehandlingen - mindsker det risikoen for, at dit barns hiv udvikler resistens overfor den antiretrovirale behandling.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for the treatment of your child's HIV infection.
Danish: Ud over de opportunistiske infektioner, kan autoimmune lidelser (en tilstand, der opstår, når immunsystemet angriber sundt kropsvæv) også opstå, efter dit barn er begyndt at tage medicin til behandling af hiv infektionen.
English: Interactions with other HIV medicines: - etravirine belongs to a class of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: Interaktioner med anden medicin mod hiv: - etravirin tilhører typen af hiv-medicin, der kaldes non-nukleosid revers-transkriptase-hæmmere
English: UNIQUE IDENTIFIER --- 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: The exact dose should be measured using the supplied measuring syringe and adapter, as follows:
Danish: Den korrekte dosis afmåles med den vedlagte doseringssprøjte og adapter på følgende vis:
English: The influence of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment on the multiple dose pharmacokinetics of either tipranavir or ritonavir has so far not been investigated.
Danish: Indflydelsen af moderat (Child-Pugh B) eller alvorlig (Child-Pugh C) lever insufficiens på flerdosisfarmakokinetikken for enten tipranavir eller ritonavir er endnu ikke klarlagt.
English: You should know that your child may continue to develop infections and other illnesses associated with HIV disease.
Danish: Dit barn vil fortsat kunne få infektioner og andre sygdomme i relation til hiv-sygdommen.
English: INFORMATION IN BRAILLE Aptivus 250 mg
Danish: INFORMATION I BRAILLESKRIFT Aptivus 250 mg
English: Co-administration of tipranavir and vitamin E has not been studied in dogs.
Danish: Samtidig administration af tipranavir og vitamin E til hunde er ikke blevet undersøgt.
English: Immune system disorders uncommon hypersensitivity
Danish: Immunsystemet Ikke almindelig overfølsomhed
English: Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products.
Danish: Aptivus skal altid gives med lavdosis ritonavir som farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler.
English: However a decrease of colchicine concentrations cannot be excluded since both tipranavir and ritonavir exhibit inducing potential towards CYP3A and P-gp.
Danish: Dog kan et fald i colchicinkoncentrationen ikke udelukkes, da både tipranavir og ritonavir udviser inducerende potentiale af CYP3A og P-gp.
English: Key efficacy results at 48 weeks for patients 2 - <12 years treated with Aptivus oral solution Endpoint
Danish: De vigtigste resultater ved uge 48 for patienter på 2 - < 12 år, som blev behandlet med Aptivus oral opløsning
English: Based on the known interaction of voriconazole with low dose ritonavir (see voriconazole SmPC) the co-administration of tipranavir/r and voriconazole should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Danish: På baggrund af interaktionen mellem voriconazol og lavdosis ritonavir (jævnfør produktresumé for voriconazol) bør samtidig behandling med tipranavir/r og voriconazol undgås, medmindre fordelene ved anvendelsen af voriconazol opvejer ulemperne for patienten.
English: In a clinical study where ritonavir 100 mg capsules bid were coadministered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82-89%).
Danish: I et klinisk studie, hvor ritonavir 100 mg kapsler to gange dagligt blev plus 50 µg intranasal fluticasonpropionat (4 gange daglig) i 7 dage til raske frivillige, øgedes niveauet af fluticasonpropionat i plasma signifikant, hvorimod de reelle kortisolniveauer faldt med ca. 86% (90% konfidensinterval 82-89%).
English: No dosing adjustment is required in patients with mild hepatic impairment but patients should be closely monitored (see sections 4.2 and
Danish: Der kræves ingen dosisjustering til patienter med mild lever insufficiens, men patienten bør følges nøje (se pkt.
English: If you notice any symptoms of infection (for example fever, enlarged lymph nodes), please inform your doctor immediately.
Danish: Hvis du får symptomer på en infektion (for eksempel feber eller hævede lymfeknuder), skal du kontakte din læge med det samme.
English: Coadministration of Aptivus and medicinal products that inhibit P-gp may increase tipranavir plasma concentrations.
Danish: Samtidig administration af Aptivus og lægemidler, som hæmmer P-gp, kan øge plasmakoncentrationerne af tipranavir.
English: Mono/diglycerides of caprylic/capric acid Sucralose
Danish: Mono/diglycerider af caprylsyre/caprinsyre Sukralose
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set, og tiden til udbrud er mere variabel og kan være mange måneder efter initiering af behandling (se pkt.
English: Phenobarbital and phenytoin induce CYP3A4.
Danish: Phenobarbital og phenytoin inducerer CYP3A4.
English: The mean steady-state trough concentration prior to the morning dose was 41.6 ± 24.3 µM for female patients and 35.6 ± 16.7 µM for male patients.
Danish: Gennemsnittet af steady state-dal-koncentrationen før morgendosis var 41,6 +/- 24,3 µM for kvindelige patienter og 35,6 +/- 16,7 µM for mandlige patienter.
English: Co-administration of Aptivus with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Danish: Samtidig behandling med Aptivus plus lavdosis ritonavir og aktive substanser, hvis clearance er stærkt afhængig af CYP3A, og hvor forhøjede plasmakoncentrationer medfører alvorlige og/eller livstruende hændelser.
English: If affected, you should not drive or operate machinery.
Danish: Hvis du får disse bivirkninger, må du ikke køre bil eller betjene maskiner.
English: RESIST data also demonstrate that tipranavir co-administered with low dose ritonavir exhibits a better treatment response at 48 weeks when the OBR contains genotypically available antiretroviral agents (e.g. enfuvirtide).
Danish: RESIST-data viser også, at tipranavir indplus lavdosis ritonavir viser et bedre behandlingsrespons efter 48 uger, når den optimerede baggrundsbehandling indeholder genotypisk tilgængelige antiretrovirale midler (f.eks. enfuvirtid).
English: Greater than 10-fold resistance to tipranavir is uncommon (< 2.5% of tested isolates) in viruses obtained from highly treatment experienced patients who have received multiple peptidic protease inhibitors.
Danish: En nedsat følsomhed på > 10 gange over for tipranavir er usædvanlig (<2,5% af de testede isolater) i vira fra patienter, der er behandlet med flere regimer, indeholdende adskillige peptid-proteasehæmmere.
English: Increased monitoring (i.e. prior to initiation of therapy, every two weeks during the first three months of treatment, then monthly until 48 weeks, and then every eight to twelve weeks thereafter) is warranted when Aptivus and low dose ritonavir are administered to patients with elevated ASAT and ALAT levels, mild hepatic impairment, chronic hepatitis B or C, or other underlying liver disease.
Danish: Øget monitorering (dvs. inden behandlingen påbegyndes, hveranden uge i de første tre måneder med behandling og derefter hver måned intil 48 uger og derefter hver ottende til tolvte uge) er indiceret, når Aptivus og lavdosis ritonavir gives til patienter med forhøjede værdier af ASAT og ALAT, mild leverinsufficiens, kronisk hepatitis B eller C eller anden tilgrundliggende leversygdom.
English: Combined 48-week treatment response (composite endpoint defined as patients with a confirmed 1 log RNA drop from baseline and without evidence of treatment failure) for both studies was 34% in the tipranavir with ritonavir arm and 15% in the comparator arm.
Danish: Kombineret 48 ugers behandlingsrespons (sammensat endpoint defineret som patienter med et bekræftet log RNA fald 1 i forhold til baseline og uden påvisning af behandlingsfejl) for begge studier var 34% i tipranavir med ritonavir-gruppen og 15% i komparatorgruppen.
English: Tipranavir resistant viruses which emerge in vitro from wild-type HIV-1 show decreased susceptibility to the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir and ritonavir but remain sensitive to saquinavir.
Danish: Tipranavir-resistente vira, som frembringes in vitro ud fra vildtype hiv-1, viser nedsat følsomhed over for proteasehæmmerne amprenavir, atazanavir, indinavir, lopinavir, nelfinavir og ritonavir, men forbliver følsomme over for saquinavir.
English: Make sure the oral syringe is tightly inserted.
Danish: Sæt den orale sprøjte godt fast.
English: Aptivus, co-administered with low dose ritonavir, when combined with warfarin may be associated with changes in INR (International Normalised Ratio) values, and may affect anticoagulation (thrombogenic effect) or increase the risk of bleeding.
Danish: Samtidig brug af Aptivus plus lavdosis ritonavir og warfarin kan være forbundet med forandringer af INR-værdier (International Normalised Ratio) og kan påvirke antikoagulationen (den trombotiske effekt) eller øge risikoen for blødning.