FrancophonIA/ELRC3.0 huggingface dataset:
English: Adding additional ritonavir to an amprenavir plus Kaletra regimen increase lopinavir Cmin values, but not amprenavir Cmin values.
Danish: Ved at give yderligere ritonavir til amprenavir plus Kaletra regimet øges lopinavir Cmin værdierne, men ikke amprenavir Cmin værdierne.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
English: Therefore, although food affects the extent and rate of absorption, the steady-state trough concentration (Cmin,ss) was not affected by food intake.
Danish: Så selv om mad påvirker både absorptionsgraden og -hastigheden, påvirkes den minimale steady state koncentration (Cmin,ss) ikke af fødeindtagelse.
English: Agenerase may interact with certain other medicines.
Danish: Agenerase kan reagere med visse andre lægemidler.
English: What Agenerase contains
Danish: Agenerase indeholder
English: It is therefore recommended that women of child-bearing potential taking Agenerase should practice effective contraception (e.g. barrier methods).
Danish: Det anbefales derfor, at kvinder i den fertile alder, som får Agenerase, anvender effektiv svangerskabsforebyggelse (f.eks. barrieremetoder).
English: Early discontinuation of failing therapies is recommended in order to limit the accumulation of multiple mutations, which may be detrimental to a subsequent rescue regimen.
Danish: Tidlig seponering af svigtende behandling anbefales for at begrænse akkumulering af multiple mutationer, som kan være ugunstig for en efterfølgende supplerende behandling.
English: - Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Danish: - Omfordeling, ophobning eller tab af kropsfedt kan forekomme hos patienter, som er i antiretroviral kombinationsbehandling.
English: Coadministration with Agenerase with or without ritonavir may cause a large increase in the concentration of this benzodiazepine.
Danish: Samtidig administration af Agenerase, med eller uden ritonavir, kan medføre en stor stigning i koncentrationen af dette benzodiazepin.
English: Lactation: amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Danish: Amning: Der er fundet amprenavirbeslægtet materiale i rottemælk, men det vides ikke, om amprenavir udskilles i modermælk.
English: Frequency categories for the events below have been based on clinical trials and postmarketing data.
Danish: Placeringen af nedenfor nævnte bivirkninger med hensyn til frekvens er baseret på data fra kliniske undersøgelser og postmarketing data.
English: Treatment difference
Danish: Forskel mellem behandlingerne
English: There is also insufficient information to recommend the use of Agenerase capsules boosted with ritonavir in children of 4 to 12 years of age or any patients weighing less than fifty kilograms.
Danish: Der er ligeledes ikke tilstrækkelig information til at anbefale brugen af Agenerase kapsler sammen med ritonavir til børn mellem 4 og 12 år eller til patienter under 50 kilo.
English: When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Agenerase, by other medicines taken at the same time or by the HIV disease.
Danish: Ved behandling af HIV-infektion er det ikke altid muligt at afgøre, om nogen af de bivirkninger, der opstår, skyldes Agenerase, andre lægemidler taget samtidigt eller HIV-sygdommen.
English: A 20 ml measuring cup is provided in the pack.
Danish: Der findes et 20 ml målebæger i pakningen.
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause an 82% decrease in amprenavir AUC, which can result in virological failure and resistance development.
Danish: Rifampicin er en potent CYP3A4 inducer og har vist sig at forårsage en reduktion i amprenavir AUC med 82 %, hvilket kan føre til manglende virologisk effekt og resistensudvikling.
English: Always take Agenerase exactly as your doctor has told you.
Danish: Tag altid Agenerase nøjagtigt efter lægens anvisning.
English: Agenerase is prescribed for use in combination with other antiretroviral medicinal products.
Danish: Agenerase er foreskrevet til brug i kombination med andre antiretrovirale lægemidler.
English: You may need additional factor VIII to control bleeding.
Danish: Du kan få brug for ekstra faktor VIII for at stoppe blødningen.
English: Steroids: oestrogens and progestogens may interact with amprenavir.
Danish: Steroider: Østrogener og progesteroner kan interagere med amprenavir.
English: Amprenavir is primarily bound to the alpha-1-acid glycoprotein (AAG), but also to albumin.
Danish: Amprenavir er primært bundet til alfa-1-syreglycoprotein (AAG), men også til albumin.
English: • Glaxo Wellcome GmbH & Co. KG Industrie straße 32-36, 23843 Bad Oldesloe, Germany
Danish: • Glaxo Wellcome GmbH & Co. KG. Industrie straße 32-36, 23843 Bad Oldesloe, Tyskland.
English: Median CD4 (cells/ml) (range)
Danish: Median CD4 (celler/ml) (interval)
English: Contact your doctor if you notice changes in body fat.
Danish: Kontakt lægen, hvis du bemærker ændringer der vedrører kropsfedtet.
English: Each of these four genetic patterns associated with reduced susceptibility to amprenavir produces some cross-resistance to ritonavir but susceptibility to indinavir, nelfinavir and saquinavir is generally retained.
Danish: Hvert af disse fire genetiske mønstre, som er forbundet med nedsat følsomhed over for amprenavir, medfører krydsresistens over for ritonavir, mens følsomheden over for indinavir, nelfinavir og saquinavir generelt er bevaret.
English: Symptoms of abnormal fat redistribution were infrequent in PROAB3001 with amprenavir.
Danish: Symptomer på unormal omfordeling af fedt var sjældne med amprenavir i PROAB3001.
English: These combinations should be used with caution and therapeutic concentration monitoring is recommended (see section 4.4).
Danish: Disse kombinationer skal bruges med forsigtighed og terapeutisk monitorering af koncentrationer er anbefalet (se afsnit 4.4).
English: Therefore, interactions with amprenavir due to protein binding displacement are highly unlikely.
Danish: Derfor er interaktioner med amprenavir som følge af fortrængning på proteinbindingsstedet yderst usandsynlige.
English: Agenerase is not recommended for use as monotherapy, due to the rapid emergence of resistant virus.
Danish: Agenerase anbefales ikke som monoterapi på grund af hurtig forekomst af resistente virus.
English: Middlesex UB6 ONN United Kingdom
Danish: Middlesex UB6 ONN Storbritannien
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: A second peak is observed after 10 to 12 hours and may represent either delayed absorption or enterohepatic recirculation.
Danish: Et andet toppunkt ses efter 10 til 12 timer og kan skyldes enten forsinket absorption eller enterohepatisk recirkulation.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations of amprenavir is between 1-2 hours for the capsule and 0.5 to 1 hour for the oral solution.
Danish: Efter peroral administration er den gennemsnitlige tid (tmax) til maksimale serumkoncentrationer af amprenavir mellem 1-2 timer for kapslerne og ca. 0,5 til 1 time for den orale opløsning.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: I dyreforsøg er der observeret reproduktiv toksicitet (se afsnit 5.3).
English: If your liver disease is severe you must not use this combination.
Danish: Hvis du har svært nedsat leverfunktion, må du ikke bruge denne kombination.
English: Because of the potential for metabolic interactions with amprenavir, the efficacy of hormonal contraceptives may be modified, but there is insufficient information to predict the nature of the interactions.
Danish: På grund af muligheden for metaboliske interaktioner med amprenavir, kan effekten af hormonal antikonception ændres, men der foreligger ikke tilstrækkelig information til at forudsige hvorledes de to stoffer vil interagere.
English: Therefore, medicinal products that either share this metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir.
Danish: Derfor kan lægemidler, som enten deler denne metaboliseringsvej eller modificerer aktiviteten af CYP3A4, eventuelt ændre farmakokinetikken af amprenavir.
English: You should not take more than 2800 mg per
Danish: Du bør ikke tage mere end 2800 mg pr. døgn.
English: Many of the patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Danish: Hos mange af patienterne var der flere medicinske tilstande tilstede, heraf nogle som krævede behandling med midler, der er forbundet med udvikling af diabetes mellitus eller hyperglykæmi.
English: Approximately 90 % of an orally administered radiolabelled amprenavir dose was recovered in the urine and the faeces, primarily as amprenavir metabolites.
Danish: Cirka 90 % af en oral administreret strålemærket amprenavir dosis blev udskilt i urinen og fæces, primært som amprenavir metabolitter.
English: Analyses based on genotypic resistance testing.
Danish: Analyser baseret på genotype-resistens-test
English: Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Danish: Behandling med Agenerase har ikke vist sig at formindske risikoen for at overføre HIV-infektion til andre ved seksuel kontakt eller ved overførsel af blod.
English: The subsequent development of the offspring, including fertility and reproductive performance, was not affected by the maternal administration of amprenavir.
Danish: Den videre udvikling af afkommet, inklusive fertilitet og reproduktiv formåen, var ikke påvirket af indgift af amprenavir til moderen.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Danish: Data for samtidig brug af parenteral midazolam og andre proteasehæmmere indikerer en mulig 3-4 fold stigning i plasmaniveauet af midazolam.
English: There is no data on the efficacy of boosted Agenerase in children.
Danish: Der er ingen data om effekten af boostet Agenerase hos børn.
English: The Summary of Product Characteristics of Agenerase oral solution should be consulted for full prescribing information.
Danish: Produktresuméet for Agenerase oral opløsning bør ses igennem for fyldige oplysninger.
English: Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
Danish: Det er vist, at koncentrationerne af AAG falder under det antiretrovirale behandlingsforløb.
English: Resistance testing diagnostic companies have developed clinical phenotypic cut-offs for FPV/RTV that can be used to interpret resistance test results.
Danish: Firmaer, der resistenstester og diagnostiserer, har udviklet klinisk fænotypiske ”cutoffs” for FPV/RTV, som kan bruges til at fortolke resultater fra resistenstest.
English: Other substances: plasma concentrations of other substances may be increased by amprenavir.
Danish: Andre stoffer: Amprenavir kan øge plasmakoncentrationerne af andre stoffer.
English: Ritonavir also inhibits CYP2D6 and induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Danish: Ritonavir hæmmer også CYP2D6 og inducerer CYP3A4, CYP1A2, CYP2C9 og glucuronolsyl transferase.
English: Paediatrics: the pharmacokinetics of amprenavir in children (4 years of age and above) are similar to those in adults.
Danish: Pædiatriske: Farmakokinetikken af amprenavir hos børn (fra 4 år) svarer til den hos voksne.
English: The bioavailability of the oral solution at equivalent doses is lower than that of the capsules, with an AUC and Cmax approximately 14 % and 19 % lower, respectively (see section 4.2).
Danish: Biotilgængeligheden af den orale opløsning ved ækvivalente doser er mindre end for kapslerne med AUC og Cmax henholdsvis ca. 14 % og 19 % lavere (se afsnit 4.2).
English: - Patients of 4 years of age and older unable to swallow capsules: The dose will be calculated according to your weight by your doctor.
Danish: - Patienter fra 4 år og derover som ikke er i stand til at synke kapsler: Dosis beregnes af lægen i forhold til din vægt.
English: Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.
Danish: Fortæl din læge hvis du lider af nogle af de nævnte tilstande eller tager nogle af de nævnte lægemidler.
English: The concomitant use of Agenerase and contraceptive pill may result in a decrease of the therapeutic effect of Agenerase.
Danish: Samtidig brug af Agenerase og p-piller kan medføre en nedsættelse af den terapeutiske effekt af Agenerase.
English: Alternative methods of contraception are recommended for women of childbearing potential.
Danish: Alternative svangerskabsforebyggende metoder anbefales til kvinder i den frugtbare alder.
English: The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace amounts of amprenavir.
Danish: Den antivirale in vitro-aktivitet, der er observeret for fosamprenavir, skyldes tilstedeværelsen af spormængder af amprenavir.
English: Anticonvulsants (carbamazepine, phenobarbital, phenytoin) should be used with caution.
Danish: Krampestillende lægemidler (carbamazepin, phenobarbital, phenytoin) skal bruges med forsigtighed.
English: Increased CPK, myalgia, myositis, and rarely rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Danish: Øget CPK, myalgi, myositis og sjældent rhabdomyolyse er rapporteret med proteasehæmmere, særligt i kombination med nukleosidanaloger.
English: When it is clinically necessary to co-administer rifabutin with Agenerase, a dosage reduction of at least half the recommended dose of rifabutin is advised, although no clinical data are available.
Danish: Når det er klinisk nødvendigt at administrere rifabutin samtidig med Agenerase, er en dosisreduktion for rifabutin på mindst halvdelen af den anbefalede dosis tilrådelig, men der er ingen tilgængelige kliniske data.
English: Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
Danish: Amprenavir binder til det aktive site på HIV-1-proteasen og forebygger dermed spaltningen af viral gag og gag-pol polyprotein forstadier, og der dannes umodne, ikke-infektiøse viruspartikler.
English: The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
Danish: Valget af amprenavir bør baseres på individuel testning af virusresistens og patientens tidligere behandling (se afsnit 5.1).
English: Do not store above 30o C. Keep the container tightly closed, in order to protect from moisture.
Danish: Må ikke opbevares ved temperaturer over 30 oC. Hold beholderen tæt tillukket for at beskytte mod fugt.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Danish: I tilfælde af behandlingsophør med glukokortikoider skal nedtrapningen ske gradvist over en længere periode.
English: Rifabutin: co-administration of amprenavir with rifabutin resulted in a 193 % increase in rifabutin AUC and an increase of rifabutin-related adverse events.
Danish: Rifabutin: Samtidig administration af amprenavir og rifabutin resulterede i en øgning på 193 % for rifabutin AUC og en øgning i rifabutin-relaterede bivirkninger.
English: The mean AUC over a dosing interval of 12 hours is 18.46 μg.h/ml (3.0232.95).
Danish: AUC over et doseringsinterval på 12 timer er i gennemsnit 18,46 μg.·h/ml (3,02-32,95).
English: These include substances such as: clozapine, cimetidine, dapsone and loratadine.
Danish: Dette inkluderer stoffer som: clozapin, cimetidin, dapson og loratadin.
English: Clinical experience:
Danish: Klinisk erfaring
English: A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Danish: En højere risiko for at få lipodystrofi er blevet sat i forbindelse med individuelle faktorer som højere alder og lægemiddelrelaterede faktorer som længere antiretroviral behandlingstid og ledsagende metaboliske forstyrrelser.
English: Children less than 4 years of age: Agenerase is not recommended in children below 4 years due to lack of data on safety and efficacy (see section 5.2).
Danish: Børn under 4 år: Agenerase bør ikke anvendes til børn under 4 år p.g.a. manglende dokumentation for sikkerhed og virkning (se afsnit 5.2).
English: In children, the nature of the safety profile is similar to that seen in adults.
Danish: Sikkerhedsprofilen, som den tegner sig hos børn, er af samme karakter som hos voksne.
English: At Week 48, approximately 25 % of those enrolled had plasma HIV-1 RNA < 10,000 copies/ml and 9 % < 400 copies/ml with a median change from baseline in CD4+ cells of 26 cells/mm3 (n=74).
Danish: Ved uge 48 havde cirka 25 % af patienterne plasma HIV-1-RNA < 10,000 kopier/ml og 9 % < 400 kopier/ml med en medianændring fra baseline i CD4+-celletal på 26 celler/mm3 (n = 74).
English: If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e.g. didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.
Danish: Hvis du har brug for at tage et syreneutraliserende middel mod fordøjelsesbesvær, eller hvis du tager et lægemiddel, som indeholder et syreneutraliserende stof (f.eks. didanosin), rådes du til at tage det mere end en time før eller efter Agenerase, ellers kan virkningen af Agenerase nedsættes.
English: Itraconazole concentrations are expected to increase in the same manner as ketoconazole.
Danish: Koncentrationen af itraconazol forventes at at stige på samme vis som koncentrationen af ketonazol.
English: Other medicinal products, listed below, including examples of substrates, inhibitors or inducers of CYP3A4, may lead to interactions when administered with Agenerase.
Danish: Andre lægemidler som anført nedenfor, herunder eksempler på substrater, hæmmere eller induktorer for CYP3A4, kan føre til interaktioner, når de gives med Agenerase.
English: Antibiotics/antifungals
Danish: Antibiotika/svampemidler
English: Antacids: on the basis of the data for other protease inhibitors, it is advisable not to take antacids at the same time as Agenerase, since its absorption may be impaired.
Danish: Antacida: På baggrund af data fra andre proteasehæmmere, tilrådes det, at antacida ikke tages på samme tid som Agenerase, da absorptionen kan forringes.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig behandling af hepatitis B eller C med antivirale midler, henvises til oplysninger om disse produkter.
English: In addition, patients on stable dose of paroxetine who start treatment with Agenerase and ritonavir should be monitored for antidepressant response.
Danish: Patienter, der allerede er i behandling med en stabil dosis paroxetin, og som påbegynder behandling med Agenerase og ritonavir, bør overvåges for antidepressivt respons.
English: Heavily pre-treated children, unboosted Agenerase
Danish: Børn tidligere stærkt medicinerede, behandlet med ikke-boostet Agenerase
English: This will result in a fluctuation in the apparent volume of distribution of total active substance but the volume of distribution of free active substance does not change.
Danish: Dette vil resultere i svingning af det tilsyneladende fordelingsvolumen for totalt aktivt stof, men fordelingsvolumen for frit aktivt stof ændres ikke.
English: Alcohol and inhibitors of alcohol metabolism: Agenerase oral solution contains propylene glycol (550 mg/ml), which is primarily metabolised via alcohol dehydrogenase.
Danish: Alkohol og inhibitorer af alkoholmetabolisme: Agenerase oral opløsning indeholder propylenglycol (550 mg/ml), som primært metaboliseres af alkoholdehydrogenase.
English: When ritonavir is co-administered, the effect on hormonal contraceptive concentrations cannot be predicted, therefore, alternative methods of contraception are also recommended.
Danish: Når ritonavir administreres samtidig kan effekten på koncentrationen af de kontraceptive hormoner ikke forudsiges, og derfor anbefales andre svangerskabsforebyggende metoder.
English: Soft capsules
Danish: Bløde kapsler
English: A higher incidence of rash was reported in patients treated with amprenavir in combination with efavirenz.
Danish: En højere incidens af udslæt blev rapporteret hos patienter behandlet med amprenavir i kombination med efavirenz.
English: If you stop taking Agenerase You must not stop taking Agenerase without consulting your doctor.
Danish: Hvis du holder op med at tage Agenerase Du må ikke stoppe med at tage Agenerase uden først at have talt med lægen om det.
English: The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Agenerase and ritonavir.
Danish: Den fulde information for ritonavir skal derfor konsulteres, før påbegyndelse af kombinationsterapi med Agenerase og ritonavir.
English: Very common Common Uncommon Rare
Danish: Meget almindelig Almindelig Ikke almindelig Sjælden
English: 1.0 (range 0-2)
Danish: 1,0 (interval 0 - 2)
English: Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Danish: Bivirkninger er nævnt nedenfor fordelt efter MedDRA organklasser og frekvens.
English: Elevated triglycerides, elevated amylase, abnormal fat redistribution, anorexia
Danish: Forhøjede triglycerider, forhøjet amylase, abnorm fedtomfordeling, anorexi
English: Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
Danish: Nedsat leverfunktion: Den primære metaboliseringsvej for amprenavir er via leveren.
English: - In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: - Hos nogle patienter med fremskreden HIV infektion (AIDS) som tidligere har haft opportunistisk infektion, kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-HIV-behandlingen er startet.
English: St John's wort (Hypericum perforatum)
Danish: PerikonPerikon (Hypericum perforatum)
English: If you forget to take Agenerase
Danish: Hvis du har glemt at tage Agenerase
English: Middlesex UB6 0NN United Kingdom
Danish: Middlesex UB6 0NN Storbritannien
English: If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til lægen eller apoteket.
English: Agenerase belongs to a group of antiviral medicines called protease inhibitors.
Danish: Agenerase tilhører en gruppe af antivirale lægemidler (midler mod virus), som kaldes proteasehæmmere.
English: Due to the potential risk of toxicity from the high propylene glycol content of Agenerase oral solution, this formulation is contraindicated in children below the age of four years and should be used with caution in certain other patient populations.
Danish: På grund af muligheden for toksicitet af det høje indhold af propylenglycol i Agenerase oral opløsning er denne formulering kontraindiceret til børn under 4 år og bør bruges med forsigtighed til visse andre patientkategorier.