natgillin/translations-raw huggingface dataset:
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. 
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.
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). 
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).
Der er ikke udført interaktionsanalyser af Agenerase i kombination med benzodiazepiner. 
No drug interaction study has been performed for the co-administration of Agenerase with benzodiazepines.
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). 
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).
- Stigning i triglycerider (en type fedt i blodet), ændringer i kropsform på grund af fedtomfordeling. 
• Increases in triglycerides (a type of blood fat), changes in body shape because of fat redistribution,
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). 
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).
Da amprenavir i udstrakt grad er proteinbundet, vil dialyse sandsynligvis ikke hjælpe til nedsættelse af koncentrationen af amprenavir i blodet. 
Since amprenavir is highly protein bound, dialysis is unlikely to be helpful in reducing blood levels of amprenavir.
Propylenglycol kan fjernes ved hæmodialyse. 
Propylene glycol can be removed by hemodialysis.
Patienter bør orienteres om, at Agenerase eller enhver anden nuværende antiretroviral behandling ikke kurerer HIV. 
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.
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. 
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.
Der er rapporteret om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthroner hos hæmofilipatienter type A og B, som blev behandlet med proteasehæmmere. 
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors.
Vigtig information om nogle af de øvrige indholdsstoffer i Agenerase Den orale opløsning indeholder propylenglycol, der i store doser kan give bivirkninger. 
Important information about ingredients of Agenerase oral solution The oral solution contains propylene glycol, which can cause adverse effects in high doses.
Agenerase oral opløsning administreres oralt og kan tages med eller uden mad. 
Agenerase oral solution is administered orally and can be taken with or without food.
Da Agenerase kapsler indeholder vitamin E, bør du ikke tage ekstra vitamin E tilskud. 
Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Agenerase kapsler indeholder vitamin E (109 IU/150 mg kapsel), derfor anbefales ekstra vitamin Etilskud ikke. 
Agenerase capsules contain vitamin E (109 IU/150 mg capsule), therefore additional vitamin E supplementation is not recommended.
Adskillige behandlingsregimer både med og uden samtidig administration af ritonavir er undersøgt i forbindelse med udviklingsprogrammet for amprenavir/fosamprenavir. 
Various regimens have been assessed in the amprenavir/fosamprenavir development programs with and without co-administration of ritonavir.
Det er en klar, svagt gullig til gul opløsning med drue-, tyggegummi- og pebermyntesmag. 
It is a clear, pale yellow to yellow solution with grape, bubblegum and peppermint flavouring.
Kapselskal: gelatine, glycerol, opløsning af d-sorbitol (E420) og sorbitaner, titandioxid, rødt prægeblæk. 
Capsule shell: gelatin, glycerol, d-sorbitol (E420) and sorbitans solution, titanium dioxide, red printing ink.
Da amprenavir i udstrakt grad er proteinbundet, vil dialyse dog sandsynligvis ikke hjælpe til nedsættelse af koncentrationen af amprenavir i blodet. 
However, since amprenavir is highly protein bound, dialysis is unlikely to be helpful in reducing blood levels of amprenavir.
Ca. 14 % af den indgivne dosis amprenavir findes som metabolitter og uomdannet amprenavir i urinen og ca. 75 % i fæces. 
The metabolites and unchanged amprenavir account for approximately 14 % of the administered amprenavir dose in the urine, and approximately 75 % in the faeces.
Det anbefales at udvise forsigtighed ved samtidig administration af disse lægemidler, da effekten af delavirdin kan være nedsat på grund af subtrapeutiske plasmakoncentrationer. 
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.
Metabolisme: Amprenavir metaboliseres hovedsageligt i leveren, og mindre end 3 % udskilles uomdannet i urinen. 
Metabolism: amprenavir is primarily metabolised by the liver with less than 3 % excreted unchanged in the urine.
Når amprenavir og ritonavir co-administreres vil ritonavirs metaboliske interaktion tilsyneladende dominere, idet ritonavir er en mere potent CYP3A4 hæmmer. 
When amprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Dosisjustering er ikke nødvendig for nogen af lægemidlerne, når nelfinavir administreres sammen med amprenavir (se også efavirenz nedenfor). 
No dose adjustment is necessary for either medicinal product when nelfinavir is administered in combination with amprenavir (see also efavirenz below).
Da Agenerase oral opløsning indeholder vitamin E, bør du ikke tage ekstra vitamin E tilskud. 
Because Agenerase oral solution contains vitamin E, you should not take additional vitamin E supplements.
- Tal med din læge hvis du tidligere har haft en leversygdom. 
- Please speak with your doctor if you have a history of liver disease.
Dette lægemiddel indeholder 4 mg natrium pr. ml. 
This medicinal product contains 4 mg sodium per ml.
Humørsvingninger, depressive sygdomme 
Mood disorders, depressive disorders Nervous system disorders
Agenerase kapsler bør normalt administreres sammen med en lav dosis af ritonavir og i kombination med andre antiretrovirale midler (se afsnit 4.2). 
Agenerase capsules should normally be given in combination with low dose ritonavir and in combination with other antiretroviral agents (see section 4.2).
Øgningen i plasmakoncentrationen af rifabutin stammer sandsynligvis fra amprenavirs hæmning af CYP3A4-medieret metabolisme af rifabutin. 
The increase in rifabutin plasma concentration is likely to result from inhibition of rifabutin CYP3A4 mediated metabolism by amprenavir.
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. 
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.
Levertoksiciteten bestod af stigning i leverenzymer, levervægt og mikroskopiske fund inklusive nekrose af hepatocytter. 
Liver toxicity consisted of increases in liver enzymes, liver weights and microscopic findings including hepatocyte necrosis.
HIV-1-isolater med en nedsat følsomhed over for amprenavir er selekteret efter en række in vitropassager. 
HIV-1 isolates with a decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments.
Kapselskallen indeholder gelatine, glycerol, opløsning af d-sorbitol og sorbitaner, titandioxid og rødt prægeblæk. 
The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.
Samtidig administration af ritonavir kan resultere i en endnu større stigning i koncentrationen af rifabutin. 
When ritonavir is co-administered a larger increase in rifabutin concentration may occur.
Er du i tvivl, så spørg lægen eller apoteket. 
• If you have any further questions, ask your doctor or pharmacist.
Den induktive effekt kan vedblive i op til 2 uger efter ophør af behandlingen med perikon. 
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Dette produkt indeholder propylenglycerol, kalium og natrium Se indlægsseddel for yderligere oplysninger 
This product contains propylene glycol, potassium and sodium See leaflet for further information
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. 
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.
Kapsler, bløde. 
Soft capsule.
Sikkerheden og effekten af amprenavir er ikke klarlagt hos patienter med underliggende leversygdomme. 
Liver Disease: The safety and efficacy of amprenavir has not been established in patients with significant underlying liver disorders.
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). 
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).
Denne forøgelse var dog ikke statistisk signifikant ved passende tests og blev ikke betragtet som relateret til administrationen af amprenavir. 
However, this increase was not statistically significantly different from male control mice by appropriate tests.
Hos nogle patienter har antiretroviral kombinationsbehandling medført ændringer i kropsbygningen på grund af omfordeling af fedt. 
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Forsigtighed er tilrådet ved samtidig brug af Agenerase og delavirdin (se afsnit 4.5). 
Caution is advised when Agenerase is used concomitantly with delavirdine (see section 4.5).
Baselinekarakteristika Median HIV-1-RNA (log10 kopier/ml) (interval) 
Baseline characteristics Median HIV-1 RNA (log10 copies/ml) (range)
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). 
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).
Analyser baseret på fænotype-resistens-test 
Analyses based on phenotypic resistance testing.
Meget almindelig: 
Very Common:
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. 
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.
Agenerase i kombination med ritonavir er kontraindiceret hos patienter med svært nedsat leverfunktion. 
Agenerase in combination with ritonavir is contraindicated in patients with severe hepatic impairment.
Forsigtighed er tilrådet ved samtidig brug af Agenerase og PDE5 hæmmere (f.eks. sildenafil og vardenafil) (se afsnit 4.5). 
Caution is advised when Agenerase is used concomitantly with PDE5 inhibitors (e.g. sildenafil and vardenafil) (see section 4.5).
Agenerases udseende og pakningstørrelse 
What Agenerase looks like and contents of the pack
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. 
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.
Agenerase oral opløsning og ritonavir oral opløsning bør ikke gives samtidigt (se afsnit 4.3) 
Agenerase oral solution and ritonavir oral solution should not be co-administered (see section 4.3).
Hvis du lider af en leversygdom, og din læge beslutter, at du skal have Agenerase kapsler uden samtidig brug af ritonavir, skal dosis justeres. 
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.
Hvis Agenerase kapsler anvendes uden samtidig indgift af ritonavir, bør højere doser af Agenerase indgives (1200 mg 2 gange daglig). 
If Agenerase capsules are used without the boosting effect of ritonavir higher doses of Agenerase (1200 mg twice daily) should be used.
Doseringer med Agenerase kapsler 20 mg/kg 2 gange daglig og 15 mg/kg 3 gange daglig medførte lignende daglige plasmakoncentrationer af amprenavir som dem, der blev opnået ved dosering af 1200 mg 2 gange daglig til voksne. 
Dosages of 20 mg/kg twice a day and 15 mg/kg three times a day with Agenerase capsules provided similar daily amprenavir exposure to 1200 mg twice a day in adults.
Agenerase oral opløsning indeholder vitamin E (46 IU/ml), derfor anbefales ekstra vitamin E-tilskud ikke. 
Agenerase oral solution contains vitamin E (46 IU/ml), therefore additional vitamin E supplementation is not recommended.
Brug af Agenerase sammen med mad og drikke Agenerase kapsler skal synkes hele med vand eller anden drikke. 
Agenerase capsules should be swallowed whole with water or another drink.
Det anbefales derfor altid at konsultere de nyeste fortolkningssystemer ved analyse af resultater fra resistenstest. 
Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Samtidig administration af 0,035 mg ethinylestradiol og 1,0 mg norethidrom resulterede i et fald i AUC og Cmin for Agenerase på henholdsvis 22 % og 20 %, Cmax var uændret. 
Co-administration of 0.035 mg ethinyl estradiol plus 1.0 mg norethindrone resulted in a decrease of the amprenavir AUC and Cmin of 22% and 20% respectively, Cmax being unchanged.
De øvrige indholdsstoffer i kapslen er d-alpha tocopherylpolyethylenglycol 1000 succinat (TPGS), macrogol 400 (polyethylenglycol 400) og propylenglycol. 
The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol.
Sikkerheden og effekten af Agenerase til børn under 4 år er endnu ikke slået fast i kliniske undersøgelser. 
In clinical studies, the safety and efficacy of amprenavir have not yet been established in children below four years of age.
Baseret på data fra 25 antiviral-naive patienter, der er blevet behandlet med et svigtende fosamprenavirregime (hvoraf én udviste resistens over for lopinavir og saquinavir ved baseline og en anden over for tipranavir), frembringer resistensmønstret, som er forbundet med amprenavir, begrænset krydsresistens over for atazanavir/ritonavir (tre ud af 25 isolater), darunavir/ritonavir (fire ud af 25 isolater), indinavir/ritonavir (en ud af 25 isolater), lopinavir/ritonavir (tre ud af 24 isolater), saquinavir (tre ud af 24 isolater) og tipranavir/ritonavir (fire ud af 24 isolater). 
Based on data from twenty-five antiretroviral naïve patients failing a fosamprenavir containing regimen (one of whom showed Baseline resistance to lopinavir and saquinavir and another to tipranavir) the resistance pathways associated with amprenavir produce limited cross-resistance to atazanavir/ritonavir (three of 25 isolates), darunavir/ritonavir (four of 25 isolates), indinavir/ritonavir (one of 25 isolates), lopinavir/ritonavir (three of 24 isolates), saquinavir (three of 24 isolates) and tipranavir/ritonavir (four of 24 isolates).. Conversely amprenavir retains activity against some isolates with resistance to other PIs and this retained activity would depend on the number and type of protease resistance mutations present in the isolates.
Cmax, AUC og Cmin for amprenavir var uforandret. 
The Cmax, AUC and Cmin of amprenavir were unchanged.
Tricykliske antidepressiva: Effekten og bivirkninger af tricykliske antidepressiva bør overvåges omhyggeligt, når disse (f.eks. desipramin og nortriptylin) anvendes samtidig med Agenerase (se afsnit 
Tricyclic antidepressants: careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they (for example desipramine and nortriptyline) are concomitantly administered with Agenerase (see section 4.4).
Agenerase kapsler indeholder vitamin E (36 IU/50 mg kapsel), derfor anbefales ekstra vitamin Etilskud ikke. 
Agenerase capsules contain vitamin E (36 IU/50 mg capsule), therefore additional vitamin E supplementation is not recommended.
Erythromycin: Der er ikke udført farmakokinetiske undersøgelser med Agenerase i kombination med erythromycin. 
Erythromycin: no pharmacokinetic study has been performed with Agenerase in combination with erythromycin, however, plasma levels of both medicinal products may be increased when co-administered.
Reduceret følsomhed over for amprenavir var associeret med virus, som havde udviklet I50V, I84V, V32I+I47V eller I54M mutationer. 
Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47V or I54M mutations.
Tidligere samtidige administrationer viste ingen ændring i de farmakokinetiske parametre for amprenavir. 
Based on historical comparison, amprenavir pharmacokinetic parameters were not altered by paroxetine.
- Agenerase kapsler (uden samtidig brug af ritonavir) er studeret hos patienter med nedsat leverfunktion. 
- Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with liver impairment.
Amprenavir og ritonavir metaboliseres primært i leveren af CYP3A4. 
Amprenavir and ritonavir are primarily metabolised in the liver by CYP3A4.
- Hovedpine, træthed - Diarré, opkastningsfornemmelser, opkastning, luft i maven - Hududslæt (rødt, hævet eller kløende) - af og til kan hududslættet blive alvorligt, og du kan blive nødt til at holde op med at tage dette lægemiddel. 
• Diarrhoea, feeling sick, vomiting, flatulence • Skin Rashes (red, raised or itchy) - Occasionally, the skin rash may be svere and you may
Virksomhedsgodkendelse udstedt den 30. juni 1995 af Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, UK. 
• Glaxo Operations UK Limited, trading as Glaxo Wellcome Operations Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom Manufacturing authorisation issued on 30 June 1995 by the Medicine Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, United Kingdom.
Rifampicin i kombination med Agenerase og lavdosis ritonavir er kontraindiceret (se afsnit 4.3). 
The combination of rifampicin and Agenerase with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Orale antikoagulanter: Når warfarin eller andre orale antikoagulanter administreres samtidig med Agenerase, anbefales en øget monitorering af INR (International Normaliseret Ratio) på grund af et muligt fald eller en mulig stigning i deres anti-thrombotiske virkning (se afsnit 4.4). 
Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Agenerase with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect (see section 4.4).
Meget almindelige bivirkninger (disse kan påvirke mere end 10 ud af 100 patienter) 
Very common side effects (these can affect more than 10 in 100 patients treated)
Abacavir: AUC, Cmin og Cmax for abacavir var uændrede, når det blev givet med amprenavir. 
Abacavir: the AUC, Cmin and Cmax of abacavir were unaltered when given with amprenavir.
Kapselindhold: d-alfatocopherylpolyethylenglycol 1000 succinat (TPGS), macrogol 400 (PEG 400), propylenglycol. 
Capsule contents: d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (PEG 400), propylene glycol.
- Forhøjet kolesterol i blodet (en type fedt i blodet). 
• Increases in blood sugar or cholesterol (a type of blood fat)
MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Når methadon gives samtidig med amprenavir, bør patienter overvåges for opioid abstinenssyndrom, særligt hvis der også gives lav dosis ritonavir. 
When methadone is co-administered with amprenavir, patients should be monitored for opiate abstinence syndrome, in particular if low-dose ritonavir is also given.
Følgende mutationer, som også kan bidrage til resistens, blev ligeledes observeret: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V og I93L. 
Additional mutations observed which may contribute to resistance were: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V, and I93L.
Meget almindelig: Almindelig: 
Very Common: Common:
Samtidig administration af ritonavir kan resultere i en endnu større stigning i koncentrationen af clarithromycin. 
When ritonavir is co-administered an increase in clarithromycin concentrations may occur.