FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients taking the oral solution of Agenerase, particularly those with renal impairment or those with decreased ability to metabolise propylene glycol (e.g. those of Asian origin), should be monitored for adverse reactions potentially related to the high propylene glycol content (550 mg/ml), such as seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis.
Danish: Patienter, som tager Agenerase oral opløsning, særligt dem med nedsat nyrefunktion eller dem med nedsat evne til at metabolisere propylenglycol (f.eks. patienter af asiatisk oprindelse), bør monitoreres for bivirkninger der muligvis kan være knyttet til det høje indhold af propylenglycol (550 mg/ml), såsom kramper, stupor, takykardi, hyperosmolaritet, laktatacidose, nyretoksicitet, hæmolyse.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin are recommended (see section 4.5).
Danish: Hvis behandling med en HMG-CoA reduktasehæmmer er indiceret, anbefales pravastatin eller fluvastatin (se afsnit 4.5).
English: Absorption: after oral administration, amprenavir is rapidly and well absorbed.
Danish: Absorption: Amprenavir absorberes hurtigt og godt efter peroral administration.
English: Less than 3 % of the therapeutic dose of amprenavir is excreted unchanged in the urine.
Danish: Mindre end 3 % af den terapeutiske dosis af amprenavir udskilles uomdannet i urinen.
English: New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Danish: Der er rapporteret om nyudviklet diabetes mellitus, hyperglykæmi eller forværring af eksisterende diabetes mellitus hos patienter, der fik antiretroviral behandling inklusive proteasehæmmere.
English: The pharmacokinetic interactions between amprenavir and low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
Danish: De farmakokinetiske interaktioner mellem amprenavir og lave doser af ritonavir eller andre proteasehæmmere er endnu ikke vurderet hos børn.
English: The primary route of metabolism is via the cytochrome P450 CYP3A4 enzyme.
Danish: Den primære metaboliseringsvej er via cytokrom P450 CYP3A4 enzymet.
English: Additionally, as no dosing recommendations can be made regarding the concomitant use of Agenerase oral solution and low dose ritonavir, the use of this combination must be avoided in these patient populations.
Danish: Da der derfor ikke kan gives doseringsanbefalinger for kombinationen af Agenerase oral opløsning og lave doser af retronavir skal kombinationen undgås til denne patientgruppe.
English: Appropriate antihistamines (e.g. cetirizine dihydrochloride) may reduce pruritus and hasten the resolution of rash.
Danish: Egnede antihistaminer (f.eks. cetirizindihydrochlorid) kan reducere kløe og fremskynde heling af udslættet.
English: No dosing recommendations can be made regarding the use of low dose ritonavir (normally used as an activity booster with Agenerase capsules) together with Agenerase oral solution.
Danish: Der kan ikke gives doseringsanbefalinger for samtidig administration af en lav dosis ritonavir (normalt anvendt for at forøge effekten af Agenerase kapsler) og Agenerase oral opløsning.
English: Treatment with efavirenz in combination with amprenavir and saquinavir is not recommended, as the exposure to both protease inhibitors would be decreased.
Danish: Behandling med efavirenz i kombination med amprenavir og saquinavir kan ikke anbefales, da ekspositionen af begge proteasehæmmere ville være nedsat.
English: Midazolam: midazolam is extensively metabolized by CYP3A4.
Danish: Midazolam: Midazolam metaboliseres i stor udstrækning af CYP3A4.
English: Diarrhoea, nausea, flatulence, vomiting
Danish: Diarré, kvalme, flatulens, opkastning
English: Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Agenerase is not recommended.
Danish: Da en øget koncentration af HMG-CoA reduktase hæmmere kan forårsage myopati, herunder rhabdomyolyse, kan samtidig administration med Agenerase ikke anbefales.
English: The choice of Agenerase will be based on any resistance testing your doctor may have carried out and your treatment history.
Danish: Valget af Agenerase vil blive baseret på resistenstest og dit behandlingsforløb.
English: Elderly: the pharmacokinetics, efficacy and safety of amprenavir have not been studied in patients over 65 years of age (see section 5.2).
Danish: Ældre: Farmakokinetikken, effekten og sikkerheden af amprenavir er ikke undersøgt hos patienter over 65 år (se afsnit 5.2).
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25°C
English: Do not use Agenerase after the expiry date which is stated on the carton.
Danish: Brug ikke Agenerase efter den udløbsdato, der står på pakningen.
English: Prior number of NRTIs taken [n (%)]
Danish: Antal af tidligere anvendte PI'er [n (%)]
English: Severe or life-threatening skin reactions have also occurred in patients treated with amprenavir (see section 4.4).
Danish: Alvorlige eller livstruende hudreaktioner er forekommet hos patienter i behandling med amprenavir (se afsnit 4.4).
English: The use of Agenerase concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Danish: Samtidig brug af Agenerase og halofantrin eller lidocain (systemisk) er ikke anbefalet (se afsnit 4.5).
English: Anticonvulsant active substances: concomitant administration of anticonvulsant active substances known as enzymatic inductors (phenytoin, phenobarbital, carbamazepine) with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Danish: Krampestillende aktive substanser: Samtidig administration af krampestillende aktive substanser, kendt som enzymatiske induktorer (phenytoin, carbamazepin, phenobarbital), og amprenavir kan føre til nedsat plasmakoncentration af amprenavir.
English: Renal clearance of ritonavir is also negligible; therefore the impact of renal impairment on amprenavir and ritonavir elimination should be minimal.
Danish: Nyrernes udskillelse af ritonavir er ligeledes forsvindende lille, og derfor vurderes betydningen af nedsat nyrefunktion på eliminationen af amprenavir og ritonavir til at være minimal.
English: Cross resistance between amprenavir and reverse transcriptase inhibitors is unlikely to occur because the enzyme targets are different.
Danish: Krydsresistens mellem amprenavir og revers transkriptasehæmmere er usandsynlig, da angrebspunktet på enzymet er forskellig.
English: There are currently data on cross-resistance between amprenavir and other protease inhibitors for all 4 fosamprenavir resistance pathways, either alone or in combination with other mutations.
Danish: På nuværende tidspunkt er der data om krydsresistens mellem amprenavir og andre proteasehæmmere for alle fire resistensmønstre med fosamprenavir.
English: Abdominal pain, abdominal discomfort, dyspeptic symptoms, loose stools
Danish: Mavesmerter, abdominalt ubehag, dyspeptiske symptomer, løs afføring
English: Events (grade 2-4) reported by study investigators as attributable to study medication and occurring in >1% of patients, are included as well as grade 3-4 treatment emergent laboratory abnormalities.
Danish: Virkninger (grad 2-4), som er rapporteret af investigator som henførende til undersøgelsesmedicinen er inkluderet, såvel som grad 3-4 behandlings relaterede abnormiteter set ved undersøgelser i laboratoriet.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels is yet unknown.
Danish: Påvirkningen af ritonavirplasmaniveauet ved systemisk høje fluticasonkoncentrationer er endnu ukendt.
English: Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with amprenavir (see section 4.4).
Danish: Immunosuppressive stoffer: Hyppig terapeutisk koncentrationsmåling af immunosuppressantniveauerne anbefales indtil niveauerne er stabiliserede, idet plasmakoncentrationen af cyklosporin, rapamycin og tacrolimus kan være forhøjet, når stofferne administreres sammen med amprenavir (se afsnit 4.4).
English: Efavirenz: efavirenz has been seen to decrease the Cmax, AUC and Cmin,ss of amprenavir by approximately 40 % in adults.
Danish: Efavirenz: Det er set, at efavirenz har nedsat Cmax, AUC og Cmin,ss for amprenavir med ca. 40 % hos voksne.
English: Additionally, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV.
Danish: Desuden anbefales det, at HIV-inficerede kvinder ikke ammer deres spædbørn for at undgå at overføre HIV.
English: General disorders and administration site conditions Very Common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Agenerase oral solution should be used with caution if you have limited liver enzyme activity, kidney impairment or a genetically lower ability to metabolise alcohol (e.g. Asian origin) due to adverse reactions that may be related to the propylene glycol in the solution.
Danish: Agenerase oral opløsning bør bruges med forsigtighed, hvis du har begrænset aktivitet af leverenzymer, nedsat nyrefunktion eller har en arvelig nedsat evne til at nedbryde alkohol (f.eks. asiatisk afstamning) på grund af bivirkninger, som kan være knyttet til propylenglycol i opløsningen.
English: Clinically validated phenotypic interpretation systems may be used in association with the genotypic data to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in patients with PIresistant isolates.
Danish: Klinisk validerede fænotypiske fortolkningssystemer kan bruges i tilknytning til genotypiske data til at bestemme aktiviteten af amprenavir/ritonavir eller fosamprenavir/ritonavir hos patienter med PIresistente isolater.
English: Agenerase oral solution is supplied in plastic bottles containing 240 ml of oral solution.
Danish: Agenerase oral opløsning findes i plastflasker med 240 ml oral opløsning.
English: The safety of Agenerase has been studied in adults and children of at least 4 years of age in controlled clinical trials, in combination with various other antiretroviral agents.
Danish: Sikkerheden ved Agenerase er undersøgt hos voksne og børn på mindst 4 år i kontrollerede kliniske afprøvninger i kombination med forskellige andre antiretrovirale midler.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Most undesirable effects associated with Agenerase therapy were mild to moderate in severity, early in onset, and rarely treatment limiting.
Danish: De fleste bivirkninger under behandling med Agenerase var af mild til moderat sværhedsgrad, startede tidligt i forløbet og var sjældent begrænsende for behandlingen.
English: PI-experienced adults, boosted Agenerase capsules
Danish: PI-tilvænnede voksne behandlet med boostede Agenerase kapsler
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Danish: Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner (se afsnit 4.4).
English: Taking Agenerase with food and drink Agenerase oral solution can be taken with or without food.
Danish: Brug af Agenerase sammen med mad og drikke Agenerase oral opløsning kan tages med eller uden mad.
English: Before starting treatment with Agenerase, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Før du begynder behandling med Agenerase, bør du fortælle din læge eller dit apotek om alle de lægemidler, du tager eller har taget for nyligt, inklusiv ikke-receptpligtige lægemidler.
English: Other possible effects
Danish: Andre mulige bivirkninger
English: Agenerase should be permanently discontinued when rash is accompanied with systemic symptoms or allergic symptoms or mucosal involvement (see section 4.8).
Danish: Agenerase skal seponeres permanent, hvis udslættet er ledsaget af systemiske eller allergiske symptomer, eller hvis slimhinderne er involveret (se afsnit 4.8).
English: The pharmacokinetics, efficacy and safety of Agenerase in combination with low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
Danish: Farmakokinetikken, effekten og sikkerheden af Agenerase i kombination med lave doser af ritonavir eller andre proteasehæmmere er endnu ikke vurderet hos børn.
English: Genotypic analysis of isolates from 13 of 14 paediatric patients exhibiting virological failure among the 59 PI-naïve patients enrolled, demonstrated resistance patterns similar to those observed in adults.
Danish: Blandt de 59 involverede PI-naive patienter viste genotypeanalyser af isolater fra 13 ud af 14 pædiatriske patienter med virologisk svigt resistensmønstre, som var magen til dem observeret hos voksne.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle af de patienter, der får flere antiretrovirale lægemidler på samme tid, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: If your doctor has recommended that you take Agenerase capsules together with low doses of ritonavir, used to boost its activity, then please make sure that you carefully read the ritonavir Package Leaflet before starting therapy.
Danish: Hvis din læge har angivet, at du skal tage Agenerase kapsler sammen med en lav dosis ritonavir for at øge Agenerases effekt, bør du omhyggeligt læse produktinformationen for ritonavir inden du starter med behandlingen.
English: Elevated triglycerides, elevated amylase and hyperglycaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
Danish: Forhøjede triglycerider, forhøjet amylase og hyperglykæmi (grad 3-4) blev primært rapporteret hos patienter med unormale udgangsværdier.
English: Agenerase oral solution contains a large amount of propylene glycol (see section 4.4).
Danish: Agenerase oral opløsning indeholder en stor mængde propylenglycol (se afsnit 4.4).
English: The Cmax of amprenavir was decreased by 14 % whilst the AUC and Cmin were increased by 9 % and 189 %, respectively.
Danish: Cmax for amprenavir var nedsat med 14 %, mens AUC og Cmin var øget med henholdsvis 9 % og 189 %.
English: Mean plasma HIV-1 RNA AAUCMB (log10 copies/ml)
Danish: Middel plasma HIV-1RNA AAUCMB (log10 kopier/ml)
English: • Non-nucleoside reverse transcriptase inhibitors (NNRTIs):
Danish: • Non-nukleosid revers transkriptasehæmmere (NNRTI)
English: This must be taken into consideration when prescribing to patients on a controlled sodium diet.
Danish: Dette bør tages med i overvejelserne ved ordinering til patienter på kontrolleret kaliumdiæt.
English: Consequently, concomitant administration of Agenerase with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Samtidig administration af Agenerase med ritonavir og disse glukokortikoider anbefales derfor ikke, med mindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider (se afsnit 4.4).
English: When ritonavir is co-administered further dose reduction may be necessary (see section 4.5).
Danish: Gives ritonavir samtidig er yderligere dosisnedsættelse muligvis nødvendigt (se afsnit 4.5).
English: Very Common: Uncommon: Rare:
Danish: Meget almindelig: Ikke almindelig: Sjælden:
English: On the basis of current pharmacodynamic data, amprenavir should be used in combination with at least two other antiretrovirals.
Danish: Ud fra foreliggende farmakodynamiske data, bør amprenavir bruges i kombination med mindst 2 andre antiretrovirale midler.
English: Similarly, amprenavir and ritonavir might also modify the pharmacokinetics of other medicinal products that share this metabolic pathway.
Danish: Tilsvarende kan amprenavir og ritonavir eventuelt modificere farmakokinetikken af andre lægemidler, som deler denne metaboliseringsvej.
English: Concomitant use is not recommended (see section 4.4).
Danish: Samtidig administration er ikke anbefalet (se afsnit 4.4).
English: One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively.
Danish: En resistensmutation forekom i alle 3 isolater: henholdsvis K20K/R, I54I/L og I93I/L.
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Danish: Der er rapporteret om muskelsmerter, ømhed eller svaghed, særligt ved antiretroviral behandling med proteasehæmmere og nukleosidanaloger.
English: BATCH NUMBER LOT
Danish: FREMSTILLERENS BATCHNUMMER LOT
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Hos patienter med leverinsufficiens, herunder kronisk aktiv hepatitis, ses oftere abnorm leverfunktion i forbindelse med den antiretrovirale behandling, og disse patienter bør kontrolleres i henhold til standardpraksis.
English: Taking/using other medicines
Danish: Brug af anden medicin
English: When used with Agenerase, the lowest possible dose of atorvastatin should be administered.
Danish: Såfremt avestorvastatin anvendes sammen med Agenerase, bør atorvastatin anvendes i så lav dosering som muligt.
English: Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Danish: Antiretroviral kombinationsbehandling er forbundet med en omfordeling af legemsfedt (lipodystrofi) hos HIV patienter, herunder tab af subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, bryst hypertrofi og dorso-cervikal fedtophobning (buffalo hump).
English: Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Agenerase (see section 4.5).
Danish: Terapeutiske koncentrationsmålinger anbefales for immunosuppresive lægemidler (cyclosporin, tacrolimus, rapamycin), når disse administreres samtidig med Agenerase (se afsnit 4.5).
English: Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Danish: Antiretroviral kombinationsbehandling er forbundet med metaboliske abnormiteter såsom hypertriglyceridæmi, hyperkolesterolæmi, insulinresistens og hyperglykæmi og hyperlaktæmi (se afsnit 4.4).
English: Discard Agenerase oral solution 15 days after first opening the bottle.
Danish: Kassér Agenerase oral opløsning 15 dage efter første åbning af flasken.
English: Amprenavir was not mutagenic or genotoxic in a battery of in vivo and in vitro genetic toxicity assays, including bacterial reverse mutation (Ames Test), mouse lymphoma, rat micronucleus, and chromosome aberration in human peripheral lymphocytes.
Danish: Amprenavir var ikke mutagent eller genotoksisk i en række genetiske toxicitets assays foretaget in vivo og in vitro herunder bakterielle tilbagemutations (Ames) test, muselymfomcelletest, mikronukleusundersøgelse hos rotter og kromosomafvigelsesprøve med perifere, humane lymfocytter.
English: This must be considered when prescribing to patients with reduced kidney function or patients on a controlled potassium diet.
Danish: Dette bør tages med i overvejelserne ved ordinering til patienter med nedsat nyrefunktion eller patienter på kontrolleret kaliumdiæt.
English: 6.5 Nature and contents of container White High Density Polyethylene (HDPE) bottles containing 480 capsules.
Danish: 6.5 Emballagetype og pakningsstørrelser Hvide High Density Polyethylene (HDPE)-beholdere med 480 kapsler.
English: Concomitant administration should be used with caution in patients with mild and moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Samtidig administration af ovennævnte bør anvendes med forsigtighed til patienter med mild og moderat nedsat leverfunktion og er kontraindiceret til patienter med svært nedsat leverfunktion (se afsnit 4.3).
English: Take special care with Agenerase
Danish: Vær ekstra forsigtig med at tage Agenerase
English: Clarithromycin: the AUC and Cmin of clarithromycin were unaltered and the Cmax decreased by 10 % when given with amprenavir.
Danish: Clarithromycin: AUC og Cmin for clarithromycin var uændrede og Cmax nedsat med 10 %, når det blev givet med amprenavir.
English: Agenerase may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Danish: Effekten af Agenerase kan være nedsat på grund af fald i plasmakoncentrationer af amprenavir hos patienter, der samtidig bruger disse lægemidler (se afsnit 4.5).
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 and patients with renal failure.
Danish: På grund af den mulige risiko for toksicitet fra 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 og patienter med nyresvigt.
English: Propylene glycol can cause a range of adverse effects including seizures, stupor, rapid heart beat and the breakdown of red blood cells (see also Do not take Agenerase, Take special care with Agenerase).
Danish: Propylenglycol kan give en række bivirkninger, herunder kramper, feberdøs, øget hjertefrekvens og nedbrydning af røde blodlegemer (se også Du bør ikke tage Agenerase, Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: - Swallow Agenerase capsules whole with water or another drink.
Danish: - Synk Agenerase kapsler hele med vand eller anden væske.
English: No recommendations can currently be made regarding adjustment of amprenavir dose when amprenavir is co-administered with methadone due to the inherent low reliability of nonmatched historical controls.
Danish: Der kan på nuværende tidspunkt ikke gives anbefalinger vedrørende justering af amprenavirdoseringen, når amprenavir gives samtidig med methadon på grund af den naturlige lave reliabilitet af den ikke-matched historiske kontrol.