FrancophonIA/ELRC3.0 huggingface dataset:
English: However, at systemic plasma exposures significantly below (rabbits) or not significantly higher (rat) than the expected human exposures during therapeutic dosing, a number of minor changes, including thymic elongation and minor skeletal variations were seen, indicating developmental delay.
Danish: Ved systemiske plasmaeksponeringer, der lå væsentlig under (kaniner) eller ikke meget over (rotter) den forventede humane eksponering ved terapeutisk dosering, sås imidlertid en række mindre ændringer, herunder forlænget thymus og mindre skeletafvigelser, hvilket antyder forsinket udvikling.
English: Local toxicity and sensitising potential was absent in animal studies, but slight irritating properties to the rabbit eye were identified.
Danish: Der fandtes ingen lokal toksicitet eller noget sensibiliseringspotentiale i dyreundersøgelser, men der er set let øjenirritation hos kaniner.
English: Agenerase capsules also contain sorbitol (E420).
Danish: Agenerase kapsler indeholder også sorbitol (E420).
English: Co-administration of amprenavir with methadone leads to a decrease of methadone concentrations.
Danish: Samtidig administration af amprenavir og methadon medfører en nedsættelse af koncentrationen af methadon.
English: The metabolism of pravastatin and fluvastatin is not dependent on CYP3A4, and interactions are not expected with protease inhibitors.
Danish: Pravastatin og fluvastatin metaboliseres ikke af CYP3A4, og der forventes ikke interaktioner med proteasehæmmere.
English: The evidence of efficacy of unboosted Agenerase was based on two uncontrolled clinical studies involving 288 HIV infected children aged between 2 and 18 years, 152 of whom were PI experienced.
Danish: Beviset for effekten af ikke-boostet Agenerase blev baseret på to ukontrollerede kliniske studier med 288 HIV-inficerede børn mellem 2 og 18 år.
English: Your doctor may monitor you for adverse reactions potentially related to the propylene glycol content of the Agenerase oral solution, especially when you have renal or hepatic disease.
Danish: Din læge kan eventuelt kontrollere dig for bivirkninger, som muligvis har forbindelse med indholdet af propylenglycol i Agenerase oral opløsning, særligt hvis du har en nyre- eller leversygdom.
English: Distribution: the apparent volume of distribution is approximately 430 litres (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
Danish: Distribution: Det tilsyneladende fordelingsvolumen er ca. 430 liter (6 l/kg ved estimeret legemsvægt på 70 kg), hvilket indikerer et stort fordelingsvolumen ved at amprenavir nemt trænger ud i væv uden for den systemiske cirkulation.
English: Based on these data, careful consideration should be given to the expected benefit of unboosted Agenerase when optimising therapy for PI experienced children.
Danish: På baggrund af disse data bør fordelen ved behandling med ikke-boostet Agenerase nøje overvejes, når behandlingen af PI-tilvænnede børn skal optimeres.
English: Discard the oral solution 15 days after first opening the bottle.
Danish: Kassér den orale opløsning 15 dage efter første åbning af flasken.
English: In toxicological studies with mature animals, the clinically relevant findings were mostly confined to the liver and gastrointestinal disturbances.
Danish: I toksikologiske undersøgelser hos voksne dyr begrænsede klinisk relevante fund sig til leveren og til gastrointestinale forstyrrelser.
English: Paroxetine: plasma concentrations of paroxetine may be significantly decreased when co-administered with amprenavir and ritonavir.
Danish: Paroxetin: Plasmakoncetrationen af paroxetin kan blive signifikant reduceret, når paroxetin administreres samtidig med amprenavir og ritonavir.
English: Do not take Agenerase if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in
Danish: Tag ikke Agenerase - hvis du er overfølsom (allergisk) over for amprenavir eller et af de øvrige indholdsstoffer i Agenerase.
English: Almost all subjects with abnormal liver function tests were co-infected with Hepatitis B or C virus.
Danish: Næsten alle patienter med unormale leverfunktionsprøver var samtidig inficeret med hepatitis B eller C virus.
English: Adverse events considered associated with the use of Agenerase are gastro-intestinal symptoms, rash and oral/peri-oral paraesthesia.
Danish: Bivirkninger, som betragtes forbundet med anvendelsen af Agenerase, er gastrointestinale symptomer, udslæt og oral/perioral paræstesi.
English: The usual dose of Agenerase oral solution is 17 mg (1.1 ml) for each kg of body weight three times a day.
Danish: Dosis for Agenerase oral opløsning er normalt 17 mg (1,1 ml) for hvert kg legemsvægt tre gange daglig.
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: These results imply that young animals lack fully developed metabolic pathways enabling them to excrete amprenavir or some critical components of the formulation (e.g. propylene glycol, PEG 400).
Danish: Disse resultater antyder, at unge dyr mangler fuldt udviklede metaboliseringsveje, der gør dem i stand til at udskille amprenavir eller nogle kritiske bestanddele af formuleringen (f.eks. propylenglycol, PEG 400).
English: Plasma HIV-1 RNA below 400 copies/ml
Danish: Plasma HIV-1 RNA under 400 kopier/ml
English: Antiretroviral agents
Danish: Antiretrovirale midler
English: Agenerase is also available as an oral solution for use in children or adults unable to swallow capsules.
Danish: Agenerase findes også som en oral opløsning til børn eller voksne, som ikke kan synke kapsler.
English: The number of key PI-resistance mutations increases markedly the longer a failing PI-containing regimen is continued.
Danish: Antallet af mutationer, der har betydning for PI-resistens øges væsentligt, jo længere et regime med svigtende proteasehæmmere fortsættes.
English: M46I/L, G48V, I50V, V82A/F/T/S, I84V, L90M.
Danish: D30N, M46I/L, G48V, I50V, V82A/F/T/S, I84V, L90M.
English: Agenerase capsules should be used with caution in patients with hepatic impairment.
Danish: Agenerase kapsler bør anvendes med forsigtighed hos patienter med nedsat leverfunktion.
English: Your doctor will normally direct that Agenerase capsules should be taken with low doses of ritonavir to boost its efficacy.
Danish: Din læge vil normalt vejlede om, at Agenerase kapsler bør tages med en lav dosis af ritonavir for at forøge effekten af Agenerase.
English: Only one case (a buffalo hump) was reported in 113 (< 1 %) antiretroviral naive subjects treated with amprenavir in combination with lamivudine/zidovudine for a median duration of 36 weeks.
Danish: Kun ét tilfælde (Buffalo hump) blev rapporteret blandt 113 (<1 %) patienter, som ikke før havde fået antiretroviral behandling, og som fik amprenavir i kombination med lamivudin/zidovudin af en middelvarighed på 36 uger.
English: The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Danish: Den 50 % hæmmende koncentration (IC50) for amprenavir varierede fra 0,012 til 0,08 μM i akut inficerede celler og var 0,41 μM i kronisk inficerede celler (1 μM = 0,50 μg/ml).
English: If Agenerase with or without ritonavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Agenerase, med eller uden ritonavir, gives i kombination med parenteral midazolam, skal det gøres på en intensivafdeling eller under tilsvarende forhold, som sikrer tæt klinisk monitorering og tilgængelig medicinsk behandling i tilfælde af, at der skulle opstå respiratorisk depression og/eller forlænget sedation.
English: You should stop taking Agenerase oral solution as soon as you are able to swallow the Agenerase capsules.
Danish: Du bør stoppe med at tage Agenerase oral opløsning ligeså snart, du er i stand til at synke Agenerase kapsler.
English: Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Danish: Antiretroviral kombinationsbehandling kan også give øget mælkesyre og sukker i blodet, hyperlipidæmi (øget fedtindhold i blodet) og resistens over for insulin.
English: Bone problems
Danish: Knogleproblemer
English: The studies evaluated Agenerase oral solution and capsules at doses of 15 mg/kg three times daily, 20 mg/kg three times daily, 20 mg/kg twice daily and 22.5 mg/kg twice daily although the majority received 20 mg/kg twice daily.
Danish: Studiet undersøgte Agenerase oral opløsning og kapsler ved doser på 15 mg/kg tre gange daglig, 20 mg/kg tre gange daglig, 20 mg/kg to gange daglig og 22,5 mg/kg to gange daglig, selv om flertallet fik 20 mg/kg to gange daglig.
English: Current antiretroviral therapies, including Agenerase, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Danish: Det er ikke påvist, at nuværende antiretroviral behandling, herunder Agenerase, forebygger risikoen for at overføre HIV til andre gennem seksuel kontakt eller gennem smittet blod.
English: In study PROAB3006, seven cases (3 %) were reported in 245 NRTI-experienced subjects treated with amprenavir and in 27 (11 %) of 241 subjects treated with indinavir, in combination with various NRTIs for a median duration of 56 weeks (p< 0.001).
Danish: I undersøgelsen PROAB3006 blev der rapporteret 7 (3 %) tilfælde blandt 245 patienter, der tidligere havde fået NRTI, og som fik amprenavir, samt 27 tilfælde (11 %) ud af 241 patienter, som fik indinavir, i kombination med forskellige NRTI af en middelvarighed på 56 uger (p<0,001).
English: A dosedependent increase in placental weight was found in the rabbit and rat which may indicate effects on placental function.
Danish: En dosisafhængig stigning i vægten af placenta sås hos både kaniner og rotter, hvilket antyder en påvirkning af placentas funktion.
English: The systemic exposure to the dams associated with this finding was similar to exposure in humans, following administration of the recommended dose.
Danish: Den systemiske eksposition hos moderdyrene i forbindelse med dette fund svarede til ekspositionen hos mennesker efter administration af den anbefalede dosis.
English: Patients should discontinue Agenerase oral solution as soon as they are able to swallow the capsule formulation (see section 4.4).
Danish: Patienter bør ophøre med Agenerase oral opløsning ligeså snart de er i stand til at synke kapslerne (se afsnit 4.4).
English: Important information about ingredients of Agenerase capsules These capsules contain glycerol, which can cause adverse effects in high doses.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Agenerase Disse kapsler indeholder glycerol, der i store doser kan give bivirkninger.
English: Nevirapine : The effect of nevirapine on other protease inhibitors and the limited evidence available suggest that nevirapine may decrease the serum concentrations of amprenavir.
Danish: Nevirapin: Påvirkningen af nevirapin på andre proteasehæmmere og de få data, som er tilgængelige, tyder på at nevirapin kan nedsætte serumkoncentrationerne af amprenavir.
English: At therapeutic dosages (1200 mg twice daily), the mean maximum steady state concentration (Cmax,ss) of amprenavir capsules is 5.36 μg/ml (0.92-9.81) and the minimum steady state concentration (Cmin,ss) is 0.28 μg/ml (0.12-0.51).
Danish: Ved terapeutiske doser (1200 mg 2 gange daglig) er den maksimale gennemsnitlige steady state koncentration (Cmax,ss) for amprenavir kapsler 5,36 μg/ml (0,92-9,81), og den minimale steady state koncentration (Cmin,ss) er 0,28 μg/ml (0,12-0,51).
English: Those of at least 13 years of age and weighing at least 50 kg received 1200 mg Agenerase twice daily.
Danish: De børn, som var mindst 13 år og som vejede mindst 50 kg, fik 1200 mg Agenerase to gange daglig.
English: The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Danish: Amprenavirs antivirale in vitro-aktivitet blev evalueret over for HIV-1-IIIB i både akut og kronisk inficerede lymfoblastiske cellelinier (MT-4, CEM-CCRF, H9) og perifere blodlymfocytter.
English: If you are taking the contraceptive pill, it is recommended that you use an alternative method (e.g. a condom) to prevent pregnancy while you are taking Agenerase.
Danish: Hvis du tager p-piller, anbefales det, at du bruger en alternativ svangerskabsforebyggende barrieremetode (f.eks. kondom) for at undgå graviditet, mens du tager Agenerase.
English: These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump').
Danish: Dette kan omfatte tab af fedt fra ben, arme eller ansigtet, øget fedt på maven (vommen) og andre indre organer, forstørrede bryster og fedtpukkel i nakken ('buffalo hump').
English: A reduction of rifabutin dosage of at least 50 % is recommended when administered with Agenerase.
Danish: En nedsættelse af rifabutin dosis med mindst 50 % er anbefalet ved samtidig brug af Agenerase.
English: Hepatic impairment: the pharmacokinetics of amprenavir are significantly altered in patients with moderate to severe hepatic impairment.
Danish: Nedsat leverfunktion: Farmakokinetikken af amprenavir er signifikant ændret hos patienter med moderat til svært nedsat leverfunktion.
English: An oral solution of Agenerase is available for children or adults unable to swallow capsules.
Danish: Der findes en Agenerase oral opløsning til børn eller voksne, som ikke kan synke kapsler.
English: Some substances (e.g. lidocaine (by systemic route) and halofantrine) given with Agenerase may cause serious adverse reactions.
Danish: Visse stoffer (f.eks. lidocain (systemisk) og halofantrin) administreret samtidig med Agenerase kan give alvorlige bivirkninger.
English: A reproduction study in pregnant rats dosed from the time of uterine implantation through lactation showed reduced body weight gains in the offspring during the nursing period.
Danish: En reproduktionsundersøgelse hos drægtige rotter, som blev doseret fra tidspunktet for uterin implantation og til og med diegivningen, viste nedsatte øgninger i legemsvægten hos afkommet i diegivningsperioden.
English: A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Danish: Det bør overvejes at reducere dosis af glukokortikoidet samtidig med tæt monitorering af lokale og systemiske bivirkninger eller at skifte til et glukokortikoid, som ikke er substrat for CYP3A4 (for eksempel beclometason).
English: Excipients: d-sorbitol (E420)
Danish: Hjælpestoffer: d-sorbitol (E420)
English: If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment provided as necessary.
Danish: Hvis der forekommer overdosering, bør patienten overvåges for tegn på toksicitet (se afsnit 4.8), og standard symptomatisk behandling iværksættes om nødvendigt.
English: Cross-Resistance
Danish: Krydsresistens
English: Any unused product should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel bør bortskaffes i overensstemmelse med lokale krav.
English: Metronidazole: Agenerase oral solution is contraindicated in patients treated with metronidazole (see section 4.3).
Danish: Metronidazol: Agenerase oral opløsning er kontraindiceret hos patienter i behandling med metronidazol (se afsnit 4.3).
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Danish: Data for andre CYP3A4-hæmmere indikerer, at midazolamkoncentrationen bliver signifikant højere, når midazolam gives oralt.
English: Clinically significant binding displacement interactions involving medicinal products primarily bound to AAG are generally not observed.
Danish: Der ses generelt ingen klinisk signifikante interaktioner med fortrængning på bindingsstedet for lægemidler, som primært er bundet til AAG.
English: For patients with renal failure, hepatic impairment or failure, children and pregnant women, see section 4.3.
Danish: Vedrørende patienter med nyresvigt, nedsat leverfunktion eller leversvigt, børn og gravide kvinder (se afsnit 4.3).
English: Agenerase oral solution should not be used during pregnancy due to the potential risk of toxicity to the foetus from the propylene glycol content (see section 4.3).
Danish: Agenerase oral opløsning bør ikke anvendes under graviditet på grund af den mulige risiko for fosteret for toksicitet af indholdet af propylenglycol (se afsnit 4.3).
English: Therefore, if efavirenz is given in combination with amprenavir (600 mg twice daily) and ritonavir (100 mg twice daily), no dose adjustment is necessary.
Danish: Hvis efavirenz derfor gives i kombination med amprenavir (600 mg 2 gange daglig) og ritonavir (100 mg 2 gange daglig) er dosisjustering ikke nødvendig.
English: Calcium-channel blockers: amprenavir may lead to increased serum concentrations of calcium channel blockers such as amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil, possibly resulting in enhanced activity and toxicity of these medicinal products.
Danish: Kalciumkanalblokkere: Amprenavir kan medføre øgede serumkoncentrationer af calciumkanalblokkere som amlodipin, diltiazem, felodipin, isradipin, nicardipin, nifedipin, nimodipin, nisoldipin og verapamil, hvilket muligvis vil medføre øget aktivitet og toksicitet af disse lægemidler.
English: This liver toxicity can be monitored for and detected in clinical use, with measurements of AST, ALT and alkaline phosphatase activity.
Danish: Denne levertoksicitet kan monitoreres og detekteres under klinisk brug ved måling af ASAT, ALAT og alkalisk fosfataseaktivitet.
English: Further, if efavirenz is given in combination with amprenavir and nelfinavir, no dosage adjustment is necessary for any of the medicinal products.
Danish: Hvis efavirenz gives sammen med amprenavir og nelfinavir, er dosisjustering ikke nødvendig for nogen af lægemidlerne.
English: Therefore, alternative reliable methods of contraception are recommended for women of childbearing potential (see section 4.5).
Danish: Derfor anbefales alternativ sikker svangerskabsforebyggelse til kvinder i den fertile alder (se afsnit 4.5).
English: Elderly: the pharmacokinetics of amprenavir have not been studied in patients over 65 years of age.
Danish: Ældre: Farmakokinetikken af amprenavir er ikke undersøgt hos patienter over 65 år.
English: Such combinations should be avoided in patients with hepatic impairment.
Danish: Sådanne kombinationer bør undgås til patienter med nedsat leverfunktion.
English: Renal impairment: patients with renal impairment have not been specifically studied.
Danish: Nedsat nyrefunktion: Patienter med nedsat nyrefunktion er ikke undersøgt specifikt.
English: Therefore Agenerase should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Agenerase and parenteral midazolam.
Danish: Derfor må Agenerase ikke anvendes i kombination med oral midazolam (se afsnit 4.3), og der bør udvises forsigtighed, når Agenerase anvendes i kombination med parenteral midazolam.
English: A higher incidence of hepatocellular carcinoma was seen in all amprenavir male mouse treatment groups.
Danish: En højere incidens af hepatocellulær carcinom sås hos alle hanmus i amprenavir behandlingsgrupperne.
English: White High Density Polyethylene (HDPE) bottles containing 240 ml of oral solution.
Danish: Hvid High Density Polyethylene (HDPE)-flaske med 240 ml oral opløsning.
English: Genotypic interpretation systems may be used to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in subjects with PI-resistant isolates.
Danish: Genotypiske fortolkningssystemer kan bruges til at bestemme aktiviteten af amprenavir/ritonavir eller fosamprenavir/ritonavir hos personer med PI-resistente isolater.
English: For many of these events, it is unclear whether they are related to Agenerase, to concomitant treatment used in the management of HIV disease or to the disease process.
Danish: For mange af disse bivirkninger er det uklart, om de er relateret til Agenerase, til den øvrige behandling i kontrollen af HIV sygdommen eller til selve sygdomsprocessen.
English: In clinical trials, doses of amprenavir 600 mg twice daily and ritonavir 100 mg twice daily have been used; confirming the safety and efficacy of this regimen.
Danish: I kliniske undersøgelser er der blevet anvendt doser på 600 mg amprenavir 2 gange daglig og 100 mg ritonavir 2 gange daglig, hvilket bekræfter sikkerheden og effekten af dette regime.
English: When amprenavir is combined with ritonavir, the effect of efavirenz is compensated by the pharmacokinetic booster effect of ritonavir.
Danish: Når amprenavir gives i kombination med ritonavir, kompenseres effekten af efavirenz af ritonavirs farmakokinetiske boostereffekt.
English: - Children (4 to 12 years) and patients less than 50 kg body weight: the dose will be calculated according to your weight by your doctor.
Danish: - Børn (4 til 12 år) og patienter med legemsvægt under 50 kg: Dosis beregnes af lægen i forhold til din vægt.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Danish: Hvis behandling med HMG-CoA reduktase hæmmere er indiceret, anbefales behandling med pravastatin eller fluvastatin.
English: No studies on the effects of Agenerase on the ability to drive and use machines have been done.
Danish: Det er ikke undersøgt, om Agenerase påvirker evnen til at køre bil eller betjene maskiner.
English: The safe use of Agenerase in pregnancy has not been established.
Danish: Det er ikke slået fast, om det er sikkert at anvende Agenerase under graviditet.
English: Based on pharmacokinetic data, the dose of Agenerase capsules should be reduced to 450 mg twice a day for adult patients with moderate hepatic impairment and to 300 mg twice a day for adult patients with severe hepatic impairment.
Danish: Ud fra farmakokinetiske data bør dosis reduceres til 450 mg 2 gange daglig til voksne patienter med moderat nedsat leverfunktion og til 300 mg 2 gange daglig til voksne patienter med svært nedsat leverfunktion.
English: Most of the adverse events below come from two clinical trials (PROAB3001, PROAB3006) involving PI naïve subjects receiving Agenerase 1200mg twice daily.
Danish: Hovedvægten af nedenfor nævnte bivirkninger er set i 2 kliniske undersøgelser (PROAB3001, PROAB3006) med PI-naive patienter, som modtog Agenerase 1200 mg 2 gange daglig.
English: In some cases, your doctor may adapt the dose of Agenerase when other drugs are administered concomitantly with Agenerase.
Danish: I nogle tilfælde kan lægen tilpasse doseringen af Agenerase, hvis der gives andre lægemidler sammen med Agenerase.
English: Interaction studies have been performed with amprenavir as the sole protease inhibitor.
Danish: Interaktionsstudier er udført med amprenavir som eneste proteasehæmmer.
English: The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day.
Danish: Dosis for Agenerase kapsler er normalt 20 mg for hvert kg legemsvægt 2 gange daglig.
English: The 50 mg and 150 mg capsules have been shown to be bioequivalent.
Danish: De bløde kapsler på 50 mg og 150 mg er vist at være bioækvivalente.
English: Similarly, amprenavir might also modify the pharmacokinetics of other medicinal products that share this metabolic pathway.
Danish: Tilsvarende kan amprenavir eventuelt modificere farmakokinetikken af andre lægemidler, som deler denne metaboliseringsvej.