FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose recommendation can be given for the coadministration of amprenavir and Kaletra, but close monitoring is advised because the safety and efficacy of this combination is unknown.
Danish: Der kan ikke gives anbefalinger vedrørende dosering ved samtidig administration af amprenavir og Kaletra, men hyppig monitorering anbefales, da sikkerhed og effekt af denne kombination er uafklaret.
English: Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered 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: Fluticasonpropionat (interaktion med ritonavir): I et klinisk studie, hvor ritonavir 100 mg kapsler blev givet 2 gange daglig samtidig med 50 µg intranasal fluticasonpropionat (4 gange daglig) i 7 dage til raske personer, steg fluticasonpropionatplasmaniveauet signifikant, mens det interne kortisolniveau faldt med cirka 86 % (90 % konfidensinterval 82-89 %).
English: Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Agenerase (see sections 4.3, 4.4 and 4.5).
Danish: Lægemidler, som inducerer, hæmmer eller er substrater for CYP3A4, skal derfor bruges med forsigtighed, hvis de gives sammen med Agenerase (se afsnit 4.3, 4.4 og 4.5).
English: Three of 14 isolates had protease resistance mutations.
Danish: 14 af disse isolater blev genotypeanalyseret, hvoraf tre isolater havde mutationer med proteaseresistens.
English: The Cmin of ethinyl estradiol was increased by 32%, whilst the AUC and Cmin of norethindrone were increased by 18% and 45% respectively.
Danish: Cmin for ethinylestradiol steg med 32 %, mens AUC og Cmin for norethidrom forøgedes med henholdsvis 18 % og 45 %.
English: Lamivudine: the AUC and Cmax of lamivudine and amprenavir, respectively, were both unaltered when these two medicinal products were given concomitantly.
Danish: Lamivudin: AUC og Cmax for henholdsvis lamivudin og amprenavir var begge uændrede, når disse lægemidler blev givet samtidigt.
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, bør du fortælle det til din læge.
English: Agenerase oral solution should not be used in patients with hepatic impairment or failure (see section 4.3).
Danish: Agenerase oral opløsning bør ikke anvendes til patienter med nedsat leverfunktion eller leversvigt (se afsnit 4.3).
English: • Increases in triglycerides (a type of blood fat), changes in body shape because of fat
Danish: - Stigning i triglycerider (en type fedt i blodet), ændringer i kropsform på grund af
English: The plasma amprenavir half-life is increased when Agenerase capsules are co-administered with ritonavir.
Danish: Denne halveringstid øges når Agenerase kapsler administreres sammen med ritonavir.
English: Coadministration with Agenerase may substantially increase PDE5 inhibitor plasma concentrations and associated adverse events, including hypotension, visual changes and priapism (see section 4.4).
Danish: Samtidig administration med Agenerase kan føre til en betydelig stigning i plasmakoncentrationen af PDE5 hæmmerne og antallet af associerede bivirkninger, herunder hypotension, synsforstyrrelser og priapismus (se afsnit 4.4).
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Danish: Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsterapi har øget risiko for alvorlige og potentielt fatale leverpåvirkninger.
English: CYP2D6 substrates with narrow therapeutic index Agenerase with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
Danish: Kombinationsbehandling med Agenerase og ritonavir må ikke administreres samtidig med lægemidler indeholdende aktive substanser, der i høj grad er afhængige af CYP2D6 metabolismen, og for hvilke en forøget plasmakoncentration er forbundet med alvorlige og/eller livstruende bivirkninger.
English: Erectile dysfunction agents: based on data for other protease inhibitors caution should be used when prescribing PDE5 inhibitors (e.g. sildenafil and vardenafil) to patients receiving Agenerase.
Danish: Midler mod erektil dysfunktion: På baggrund af data fra andre proteasehæmmere, bør der udvises forsigtighed, hvis PDE5 hæmmere (f.eks.sildenafil og vardenafil) ordineres til patienter, der får Agenerase.
English: For subjects with hepatic impairment, pharmacokinetic data are available for the use of Agenerase capsules without the boosting effect of ritonavir.
Danish: For patienter med nedsat leverfunktion findes farmakokinetiske data for brugen af Agenerase kapsler uden samtidig administration af ritonavir.
English: Hepatic impairment: Agenerase oral solution is contraindicated in patients with hepatic impairment or failure (see section 4.3) (see Summary of Product Characteristics of Agenerase Capsules for prescribing information)
Danish: Nedsat leverfunktion: Agenerase oral opløsning er kontraindiceret til patienter med nedsat leverfunktion eller leversvigt (se afsnit 4.3) (se produktresuméet for Agenerase kapsler for yderligere oplysninger).
English: Pharmacotherapeutic group; protease inhibitor; ATC Code: J05A E05
Danish: Farmakoterapeutisk klassifikation: proteasehæmmer, ATC-kode: J05A E05
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
English: A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Danish: Det er blevet antaget, at der er en forbindelse mellem visceral lipomatose og proteasehæmmere samt lipoatrofi og nucleosid revers transkriptase inhibitorer.
English: These dosing regimens will provide plasma amprenavir levels comparable to those achieved in healthy subjects given a 1200 mg dose twice daily without concomitant administration of ritonavir.
Danish: Sådanne dosisjusteringer vil medføre amprenavirkoncentrationer tilsvarende koncentrationer opnået hos raske personer, som har fået 1200 mg amprenavir 2 gange daglig uden samtidig administration af ritonavir.
English: Agenerase is administered orally and can be taken with or without food.
Danish: Agenerase administreres oralt og kan tages med eller uden mad.
English: Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Danish: Antiretroviral kombinationsbehandling er hos HIV patienter blevet forbundet med en omfordeling af legemsfedt (lipodystrofi).
English: The AUC increased nearly three-fold in patients with moderate impairment and four fold in patients with severe hepatic impairment.
Danish: AUC var næsten tredoblet hos patienter med moderat insufficiens og firedoblet hos patienter med svært nedsat leverfunktion.
English: Renal impairment: no dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion: Dosisjustering vurderes ikke at være nødvendig hos patienter med nedsat nyrefunktion (se afsnit 5.2).
English: The primary route of elimination of amprenavir is via hepatic metabolism with less than 3 % excreted unchanged in the urine.
Danish: Den primære eliminationsvej af amprenavir er hepatisk metabolisme med under 3 % udskilt uomdannet i urinen.
English: Agenerase 150 mg soft capsules are supplied in a pack with two plastic bottles each containing 240 soft capsules.
Danish: Agenerase 150 mg bløde kapsler findes i en pakning med to plastbeholdere hver med 240 bløde kapsler.
English: MARKETING AUTHORISATION HOLDER Glaxo Group Ltd
Danish: Glaxo Group Ltd.
English: If you are taking certain medicines that can cause serious side effects, such as carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants and warfarin, at the same time as you are taking Agenerase, your doctor may carry out additional blood tests to minimise any potential safety problems.
Danish: Hvis du tager lægemidler, som kan give alvorlige bivirkninger, såsom carbazepin, phenobarbital, phenytoin, lidocain, cyclosporin, tacrolimus, rapamycin, tricycliske antidepressiva og warfarin samtidig med, at du tager Agenerase, kan din læge eventuelt tage nogle ekstra blodprøver for at minimere de mulige sikkerhedsproblemer.
English: Renal impairment: although no dose adjustment is considered necessary for amprenavir, Agenerase oral solution is contraindicated in patients with renal failure (see section 4.3).
Danish: Nedsat nyrefunktion: Selvom dosisjustering ikke vurderes at være nødvendig for amprenavir, er Agenerase oral opløsning kontraindiceret i patienter med nedsat nyrefunktion (se afsnit 4.3).
English: No drug interaction study has been performed for the co-administration of Agenerase with benzodiazepines.
Danish: Der er ikke udført interaktionsanalyser af Agenerase i kombination med benzodiazepiner.
English: In the same study, the AUC, Cmax, and Cmin of amprenavir were increased 72%, 12%, and 483%, respectively, when compared to values after standard doses of amprenavir (1200 mg twice daily).
Danish: I den samme undersøgelse øgedes AUC, Cmax og Cmin for amprenavir med henholdsvis 72 %, 12 % og 483 % sammenlignet med værdier efter standard doser af amprenavir (1200 mg 2 gange daglig).
English: • Increases in triglycerides (a type of blood fat), changes in body shape because of fat redistribution,
Danish: - Stigning i triglycerider (en type fedt i blodet), ændringer i kropsform på grund af fedtomfordeling.
English: Concomitant use of Agenerase with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig brug af Agenerase med ritonavir og fluticason eller andre glukokortikoider, som metaboliseres af CYP3A4, anbefales ikke, med mindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se afsnit 4.5).
English: Since amprenavir is highly protein bound, dialysis is unlikely to be helpful in reducing blood levels of amprenavir.
Danish: Da amprenavir i udstrakt grad er proteinbundet, vil dialyse sandsynligvis ikke hjælpe til nedsættelse af koncentrationen af amprenavir i blodet.
English: Propylene glycol can be removed by hemodialysis.
Danish: Propylenglycol kan fjernes ved hæmodialyse.
English: Patients should be advised that Agenerase, or any other current antiretroviral therapy does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Danish: Patienter bør orienteres om, at Agenerase eller enhver anden nuværende antiretroviral behandling ikke kurerer HIV.
English: If these medicinal products are used concomitantly care is advised, and close clinical and virological monitoring should be performed since it is difficult to predict the effect of the combination of amprenavir and ritonavir on delavirdine.
Danish: Klinisk og virologisk monitorering bør foretages og følges nøje, idet det er svært at forudsige effekten af den samtidige administration af amprenavir og ritonavir på delavirdine.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors.
Danish: Der er rapporteret om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthroner hos hæmofilipatienter type A og B, som blev behandlet med proteasehæmmere.
English: Important information about ingredients of Agenerase oral solution The oral solution contains propylene glycol, which can cause adverse effects in high doses.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Agenerase Den orale opløsning indeholder propylenglycol, der i store doser kan give bivirkninger.
English: Agenerase oral solution is administered orally and can be taken with or without food.
Danish: Agenerase oral opløsning administreres oralt og kan tages med eller uden mad.
English: Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Danish: Da Agenerase kapsler indeholder vitamin E, bør du ikke tage ekstra vitamin E tilskud.
English: Agenerase capsules contain vitamin E (109 IU/150 mg capsule), therefore additional vitamin E supplementation is not recommended.
Danish: Agenerase kapsler indeholder vitamin E (109 IU/150 mg kapsel), derfor anbefales ekstra vitamin Etilskud ikke.
English: Various regimens have been assessed in the amprenavir/fosamprenavir development programs with and without co-administration of ritonavir.
Danish: Adskillige behandlingsregimer både med og uden samtidig administration af ritonavir er undersøgt i forbindelse med udviklingsprogrammet for amprenavir/fosamprenavir.
English: It is a clear, pale yellow to yellow solution with grape, bubblegum and peppermint flavouring.
Danish: Det er en klar, svagt gullig til gul opløsning med drue-, tyggegummi- og pebermyntesmag.
English: Capsule shell: gelatin, glycerol, d-sorbitol (E420) and sorbitans solution, titanium dioxide, red printing ink.
Danish: Kapselskal: gelatine, glycerol, opløsning af d-sorbitol (E420) og sorbitaner, titandioxid, rødt prægeblæk.
English: However, since amprenavir is highly protein bound, dialysis is unlikely to be helpful in reducing blood levels of amprenavir.
Danish: Da amprenavir i udstrakt grad er proteinbundet, vil dialyse dog sandsynligvis ikke hjælpe til nedsættelse af koncentrationen af amprenavir i blodet.
English: The metabolites and unchanged amprenavir account for approximately 14 % of the administered amprenavir dose in the urine, and approximately 75 % in the faeces.
Danish: Ca. 14 % af den indgivne dosis amprenavir findes som metabolitter og uomdannet amprenavir i urinen og ca. 75 % i fæces.
English: If these medicinal products are used concomitantly care is advised, as delavirdine may be less effective due to decreased and potentially sub-therapeutic plasma concentrations.
Danish: Det anbefales at udvise forsigtighed ved samtidig administration af disse lægemidler, da effekten af delavirdin kan være nedsat på grund af subtrapeutiske plasmakoncentrationer.
English: Metabolism: amprenavir is primarily metabolised by the liver with less than 3 % excreted unchanged in the urine.
Danish: Metabolisme: Amprenavir metaboliseres hovedsageligt i leveren, og mindre end 3 % udskilles uomdannet i urinen.
English: When amprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Danish: Når amprenavir og ritonavir co-administreres vil ritonavirs metaboliske interaktion tilsyneladende dominere, idet ritonavir er en mere potent CYP3A4 hæmmer.
English: No dose adjustment is necessary for either medicinal product when nelfinavir is administered in combination with amprenavir (see also efavirenz below).
Danish: Dosisjustering er ikke nødvendig for nogen af lægemidlerne, når nelfinavir administreres sammen med amprenavir (se også efavirenz nedenfor).
English: Because Agenerase oral solution contains vitamin E, you should not take additional vitamin E supplements.
Danish: Da Agenerase oral opløsning indeholder vitamin E, bør du ikke tage ekstra vitamin E tilskud.
English: - Please speak with your doctor if you have a history of liver disease.
Danish: - Tal med din læge hvis du tidligere har haft en leversygdom.
English: This medicinal product contains 4 mg sodium per ml.
Danish: Dette lægemiddel indeholder 4 mg natrium pr. ml.
English: Mood disorders, depressive disorders Nervous system disorders
Danish: Humørsvingninger, depressive sygdomme
English: Agenerase capsules should normally be given in combination with low dose ritonavir and in combination with other antiretroviral agents (see section 4.2).
Danish: Agenerase kapsler bør normalt administreres sammen med en lav dosis af ritonavir og i kombination med andre antiretrovirale midler (se afsnit 4.2).
English: The increase in rifabutin plasma concentration is likely to result from inhibition of rifabutin CYP3A4 mediated metabolism by amprenavir.
Danish: Øgningen i plasmakoncentrationen af rifabutin stammer sandsynligvis fra amprenavirs hæmning af CYP3A4-medieret metabolisme af rifabutin.
English: HMG-CoA reductase inhibitors: HMG-CoA reductase inhibitors which are highly dependent on CYP3A4 for metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with Agenerase.
Danish: HMG-CoA reduktase hæmmere: HMG-CoA reduktase hæmmere, der primært metaboliseres af CYP3A4 (f.eks. lovastation og simvastation), forventes at få en markant stigning af plasmakoncentrationen ved samtidig administration med Agenerase.
English: Liver toxicity consisted of increases in liver enzymes, liver weights and microscopic findings including hepatocyte necrosis.
Danish: Levertoksiciteten bestod af stigning i leverenzymer, levervægt og mikroskopiske fund inklusive nekrose af hepatocytter.
English: HIV-1 isolates with a decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments.
Danish: HIV-1-isolater med en nedsat følsomhed over for amprenavir er selekteret efter en række in vitropassager.
English: The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.
Danish: Kapselskallen indeholder gelatine, glycerol, opløsning af d-sorbitol og sorbitaner, titandioxid og rødt prægeblæk.
English: When ritonavir is co-administered a larger increase in rifabutin concentration may occur.
Danish: Samtidig administration af ritonavir kan resultere i en endnu større stigning i koncentrationen af rifabutin.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apoteket.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Danish: Den induktive effekt kan vedblive i op til 2 uger efter ophør af behandlingen med perikon.
English: This product contains propylene glycol, potassium and sodium See leaflet for further information
Danish: Dette produkt indeholder propylenglycerol, kalium og natrium Se indlægsseddel for yderligere oplysninger
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Danish: Forsøg på at modvirke denne reduktion i amprenavir AUC, ved at øge dosis af andre proteasehæmmere sammen med ritonavir, resulterede i en højere forekomst af leverpåvirkninger.
English: Soft capsule.
Danish: Kapsler, bløde.
English: Liver Disease: The safety and efficacy of amprenavir has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og effekten af amprenavir er ikke klarlagt hos patienter med underliggende leversygdomme.
English: Agenerase with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone (see section 4.5).
Danish: Samtidig administration af Agenerase og ritonavir må ikke kombineres med lægemidler med smalt terapeutisk vindue, som er afhængige af CYP2D6 metabolisme, f.eks. flecainid og propafenon (se afsnit 4.5).
English: However, this increase was not statistically significantly different from male control mice by appropriate tests.
Danish: Denne forøgelse var dog ikke statistisk signifikant ved passende tests og blev ikke betragtet som relateret til administrationen af amprenavir.
English: Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Danish: Hos nogle patienter har antiretroviral kombinationsbehandling medført ændringer i kropsbygningen på grund af omfordeling af fedt.
English: Caution is advised when Agenerase is used concomitantly with delavirdine (see section 4.5).
Danish: Forsigtighed er tilrådet ved samtidig brug af Agenerase og delavirdin (se afsnit 4.5).
English: Baseline characteristics Median HIV-1 RNA (log10 copies/ml) (range)
Danish: Baselinekarakteristika Median HIV-1-RNA (log10 kopier/ml) (interval)
English: Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase oral solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic impairment or failure, patients with renal failure, and patients treated with disulfiram or metronidazole or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol (see also Take special care with Agenerase).
Danish: På grund af den mulige risiko for forgiftning af den store mængde af indholdsstoffet propylenglycol er Agenerase oral opløsning kontraindiceret til spædbørn og børn under 4 år, gravide kvinder, patienter med nedsat leverfunktion eller leversvigt, patienter med nyresvigt og patienter i behandling med disulfiram eller metronidazol eller præparater der indeholder alkohol (f.eks. ritonavir oral opløsning) eller yderligere propylenglycol (se også Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Analyses based on phenotypic resistance testing.
Danish: Analyser baseret på fænotype-resistens-test
English: Very Common:
Danish: Meget almindelig:
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Danish: Hos patienter, der fik ritonavir og inhaleret eller intranasalt fluticasonpropionat, er der rapporteret om systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression, hvilke også kan forekomme med andre kortikosteroider, som metaboliseres via P450 3A, for eksempel budesonid.
English: Agenerase in combination with ritonavir is contraindicated in patients with severe hepatic impairment.
Danish: Agenerase i kombination med ritonavir er kontraindiceret hos patienter med svært nedsat leverfunktion.
English: Caution is advised when Agenerase is used concomitantly with PDE5 inhibitors (e.g. sildenafil and vardenafil) (see section 4.5).
Danish: Forsigtighed er tilrådet ved samtidig brug af Agenerase og PDE5 hæmmere (f.eks. sildenafil og vardenafil) (se afsnit 4.5).
English: What Agenerase looks like and contents of the pack
Danish: Agenerases udseende og pakningstørrelse
English: Sixteen of 434 ART-naïve patients who received fosamprenavir 700mg/ritonavir 100mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Danish: I studiet ESS100732 fik 16 ud af 434 ART-naive patienter, der blev behandlet med 700 mg fosamprenavir/100 mg ritonavir to gange daglig, virologisk svigt efter 48 ugers behandling.
English: Agenerase oral solution and ritonavir oral solution should not be co-administered (see section 4.3).
Danish: Agenerase oral opløsning og ritonavir oral opløsning bør ikke gives samtidigt (se afsnit 4.3)
English: If you suffer from liver disease and your doctor decides to use unboosted Agenerase capsules (that is without ritonavir), the dose of Agenerase may need to be adjusted.
Danish: Hvis du lider af en leversygdom, og din læge beslutter, at du skal have Agenerase kapsler uden samtidig brug af ritonavir, skal dosis justeres.