FrancophonIA/ELRC3.0 huggingface dataset:
English: Median Change from baseline in CD4 cells (cells/µl)
Danish: Median ændring fra baseline i CD4-celler (celler/µl)
English: • doses of rifabutin greater than 150 mg every other day (an antibiotic)
Danish: • rifabutin doser på mere end 150 mg hver anden dag (et antibiotikum)
English: The adverse reaction profile of Telzir should be borne in mind when considering the patient's ability to drive or operate machinery (see section 4.8).
Danish: Bivirkningsprofilen for Telzir skal tages i betragtning, når patientens evne til at føre motorkøretøj eller betjene maskiner vurderes (se pkt.
English: 18 mg/kg (0.36 ml/kg ); maximum 700 mg or 14 ml
Danish: 18 mg/kg (0,36 ml/kg); max. 700 mg eller 14 ml
English: Co-administration of Telzir with low dose ritonavir and these medicinal products is expected to substantially increase their concentrations and may result in PDE5 inhibitor-associated adverse events such as hypotension, visual changes and priapism (see section 4.5).
Danish: Samtidig administration af Telzir med lavdosis ritonavir og disse lægemidler formodes at øge koncentrationerne af disse markant og kan resultere i PDE5-hæmmerassocierede bivirkninger, såsom hypotension, synsændringer og priapisme (se pkt.
English: Hormonal contraception
Danish: Hormonel prævention
English: Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Danish: Hold sprøjtens spids mod indersiden af kinden og sprøjt dosis ind i munden.
English: Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common).
Danish: Abnorme laboratorieværdier: Abnorme laboratorieværdier (grad 3 eller 4) potentielt relateret til behandling med fosamprenavir og ritonavir, og rapporteret hos 1 % eller mere end 1 % af de voksne patienter, inkluderede: Forhøjet ALAT (almindelig), ASAT (almindelig), serumlipase (almindelig) og triglycerider (almindelig).
English: Among the 81 PI-naïve paediatric patients treated with fosamprenavir / ritonavir, 15 patients met protocol-defined virological failure through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Danish: Blandt de 81 PI-naive pædiatriske patienter behandlet med fosamprenavir/ritonavir, oplevede 15 patienter protokoldefineret virologisk svigt gennem 48 uger i APV29005 og op til 108 uger i APV20003.
English: Phenobarbital Carbamazepine
Danish: Phenobarbital Carbamazepin
English: Similarily, administration of fosamprenavir with ritonavir may modify the pharmacokinetics of other active substances that share this metabolic pathway.
Danish: Tilsvarende kan administration af fosamprenavir og ritonavir modificere farmakokinetikken af andre aktive substanser med denne metaboliseringsvej.
English: (Telzir 1400 mg single dose)
Danish: (Telzir 1.400 mg enkelt dosis)
English: Children from 6 years of age and weighing less than 39 kg Use Telzir oral suspension.
Danish: Børn fra 6 år, som vejer mindre end 39 kg Tag Telzir som oral suspension.
English: Co-administration of fosamprenavir/ritonavir with other antineoplastics metabolised by CYP3A (for example dasatinib, nilotinib, ibrutinib, vinblastine and everolimus) may increase concentrations of these medicinal products, potentially increasing the risk of adverse events usually associated with these agents.
Danish: Samtidig administration af fosamprenavir/ritonavir med andre antineoplastiske midler metaboliseret af CYP3A (f.eks. dasatinib, nilotinib, ibrutinib, vinblastin og everolimus) kan øge koncentrationerne af disse lægemidler, hvilket potentielt øger risikoen for bivirkninger, der normalt er forbundet med disse midler.
English: Immune Reactivation Syndrome: 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.
Danish: Immunreaktiveringssyndrom: 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.
English: Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron oxide red (E172)
Danish: Titandioxid (E171) Glyceroltriacetat Rød jernoxid (E172)
English: Change from baseline in CD4 cells (cells/µl)
Danish: Ændring fra baseline i CD4celler (celler/µl)
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Danish: Autoimmune sygdomme (som f.eks. Graves´ sygdom og autoimmun hepatitis) er også blevet rapporteret i forbindelse med immunreaktivering; dog er den rapporterede tid til frembrud mere variabel, og frembrud kan forekomme mange måneder efter behandlingsstart.
English: Results were in favour of the lopinavir / ritonavir arm as detailed below.
Danish: Resultatet var til fordel for lopinavir/ritonavir armen som vist nedenfor.
English: Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5).
Danish: Samtidig administration af det antipsykotiske lægemiddel lurasidon og fosamprenavir/ritonavir (FPV / RTV) er kontraindiceret (se pkt.
English: If you have any questions about this information or the advice given: →Talk to your doctor.
Danish: Hvis du har spørgsmål til disse oplysninger:  Tal med lægen.
English: Nucleoside / Nucleotide reverse transcriptase inhibitors:
Danish: Nukleosid/Nukleotid revers transkriptasehæmmere:
English: Telzir does not require any special storage conditions.
Danish: Telzir kræver ingen særlige forholdsregler vedrørende opbevaringen.
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: The Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Danish: Telzir oral suspension indeholder propyl- og methylparahydroxybenzoat.
English: In view of the low exposure in reproductive toxicity studies, the potential developmental toxicity of Telzir has not been fully determined.
Danish: Idet doserne anvendt i reproduktionsstudierne var lave, er den potentielle udviklingstoksicitet af Telzir ikke fuldstændigt klarlagt.
English: Most of the adverse reactions below were reported from three large clinical studies in adults, where the adverse events were of at least moderate intensity (Grade 2 or more) occurring in at least 1% of patients and reported by investigators as being attributable to the medicinal products used in the studies.
Danish: Bivirkningerne havde som minimum moderat intensitet (grad 2 eller derover) hos mindst 1 % af patienterne og blev rapporteret af investigator som relateret til lægemidlet anvendt i studiet.
English: Fosamprenavir was not mutagenic or genotoxic in a standard battery of in vitro and in vivo assays.
Danish: Fosamprenavir var ikke mutagent eller genotoksisk i en række genetiske toksicitetsprøver foretaget in vivo og in vitro.
English: Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data
Danish: Ritonavir: Cmax  63 %* Ritonavir: AUC  45 %* * sammenlignet med historiske data
English: Concomitant use of Telzir 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
Danish: Samtidig brug af Telzir med ritonavir og fluticason eller andre glukokortikoider, som metaboliseres af CYP3A4, frarådes, med mindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
English: • If you have liver disease.
Danish: • hvis du har en leversygdom.
English: What you need to know before you take Telzir
Danish: Det skal du vide, før du begynder at tage Telzir
English: Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients)
Danish: Tabel 1 Effektresultat ved uge 48 i studiet ESS100732 (ART-naive patienter)
English: Concomitant use is not recommended.
Danish: Samtidig anvendelse frarådes.
English: Patients with plasma HIV-1 RNA <400 copies/ml, Snapshot analysis Median change from baseline in CD4 cells
Danish: Patienter med plasma hiv-1 RNA < 400 kopier/ml, snapshot analyse Median ændring fra baseline i CD4-celler (celler/μl), observeret analyse
English: Telzir will not stop you passing on HIV.
Danish: Telzir kan ikke forhindre dig i at smitte.
English: Clinically significant hepatic transaminase elevations occurred in some subjects.
Danish: En klinisk signifikant stigning af levertransaminase forekom hos nogle personer.
English: No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).
Danish: Der er ikke udført studier, hvor Telzir/ritonavir tages sammen med anden hormonbehandling såsom hormonerstatning.
English: The most frequently (> 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Danish: De hyppigst (> 5 % af behandlede voksne patienter) rapporterede bivirkninger med kombination af fosamprenavir/ritonavir var gastrointestinale reaktioner (kvalme, diarré, mavesmerter og opkastning) og hovedpine.
English: Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies, one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003).
Danish: Den kliniske erfaring med fosamprenavir boosted med ritonavir er hovedsageligt baseret på to åbne studier, et studie udført hos antiretroviral-naive patienter (studie ESS100732), samt et studie hos antiretroviral-erfarne patienter (studie APV30003).
English: Antiviral activity according to genotypic/phenotypic resistance
Danish: Antiviral aktivitet baseret på genotype/fænotype-resistens
English: The incidence of endometrial findings was slightly increased over concurrent controls, but within background range for female rats.
Danish: Forekomsten af de endometriale fund var en smule højere sammenlignet med kontrolgruppen, men inden for normalen (background range) for hunrotter.
English: No dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Danish: Dosisjustering vurderes unødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: No dosing recommendations can be made for the very young (children < 2 years of age) and Telzir with ritonavir is not recommended for this patient population (see section 4.2).
Danish: Der kan ikke gives doseringsanbefalinger for meget unge børn (børn < 2 år), og Telzir i kombination med ritonavir bør ikke anvendes til denne patientgruppe (se pkt.
English: In paediatric patients, the oral suspension should be taken with food in order to aid palatability and assist compliance (see section 5.2).
Danish: Pædiatriske patienter bør tage den orale suspension med mad for at forbedre smag og komplians (se pkt.
English: The decrease of (R-) methadone (active enantiomer) is not expected to be clinically significant.
Danish: Reduktionen af (R-) methadon (aktiv enantiomer) forventes ikke at være klinisk signifikant, men for en sikkerheds skyld skal patienterne overvåges for abstinenser.
English: In protease inhibitor (PI) experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1).
Danish: Hos patienter, der tidligere er behandlet med proteasehæmmere (PI'er), bør valget af Telzir baseres på individuel testning af virusresistens og patientens tidligere behandling (se pkt.
English: ANTACIDS, HISTAMINE H2 RECEPTOR ANTAGONIST AND PROTON-PUMP INHIBITORS
Danish: ANTACIDA, HISTAMINH2-RECEPTORANTAGONISTER OG PROTONPUMPEHÆMMERE
English: No clinically significant interaction is observed.
Danish: Der er ikke observeret klinisk signifikant interaktion.
English: Toxicity was similar to that of amprenavir and occurred at amprenavir plasma exposure levels below human exposure after treatment with fosamprenavir in combination with ritonavir at the recommended dose.
Danish: Toksiciteten forekom ved plasmakoncentrationer, som var lavere end plasmakoncentrationen hos mennesker ved behandling med fosamprenavir i kombination med ritonavir ved den anbefalede dosis.
English: Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy') to treat adults, adolescents and children aged over 6 years infected with HIV.
Danish: Telzir i kombination med en lav dosis ritonavir anvendes sammen med anden antiretroviral medicin (”kombinationsbehandling”) til behandling af voksne, unge og børn fra 6 år, der har hiv.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SUSPENSION
Danish: ETIKET TIL FLASKE TIL ORAL SUSPENSION
English: Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines.
Danish: Telzir skal anvendes i kombination med lave doser ritonavir og anden antiretroviral medicin.
English: Dihydroergotamine Ergotamine Ergonovine Methylergonovine
Danish: Dihydroergotamin Ergotamin Ergometrin Methylergometrin
English: Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe.
Danish: Telzir må ikke blandes med andre lægemidler, hverken i sprøjten eller i flasken.
English: Children and adolescents should take the Telzir oral suspension with food.
Danish: Børn og unge bør tage Telzir oral suspension sammen med mad.
English: Treatment-emergent major protease or APV-associated mutations were observed in virus isolated from 1 patient in APV29005 and 6 patients from APV20003.
Danish: Alvorlige proteasemutationer opstået under behandling eller APV-forbundede mutationer blev set i virus isoleret fra 1 patient i APV29005 og 6 patienter fra APV20003.
English: Tenofovir disoproxil 245 mg once daily
Danish: Tenofovirdisoproxil 245 mg én gang daglig
English: Telzir belongs to a group of anti-retroviral medicines called protease inhibitors.
Danish: Telzir hører til i en gruppe af antiretroviral medicin, der kaldes proteasehæmmere.
English: Let them dry completely before you use them again.
Danish: Lad sprøjte og adapter ligge, således at disse er helt tørre før de skal anvendes igen.
English: Please refer to the table below for the dosing recommendations in adults.
Danish: Se nedenstående tabel for doseringsanbefalinger til voksne.
English: No FPV/RTV drug interaction studies.
Danish: Ingen FPV/RTV interaktionsstudier.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinier.
English: As an alternative to taking Telzir oral suspension:
Danish: I stedet for Telzir oral suspension:
English: Telzir is also available as 700 mg film-coated tablets.
Danish: Telzir findes også som 700 mg filmovertrukne tabletter.
English: Amprenavir exposure unchanged when compared to historical data.
Danish: Sammenlignet med historiske data er eksponeringen af amprenavir uændret.
English: → Keep in touch with your doctor, and don't stop taking Telzir without your doctor's advice.
Danish:  Hold kontakt med lægen og stop ikke med at tage Telzir, før lægen anbefaler det.
English: SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
Danish: SELEKTIVE SEROTONINREUPTAKE-HÆMMERE (SSRI'er)
English: Amprenavir in addition is also an inhibitor of the CYP3A4 enzyme, although to a lesser extent than ritonavir.
Danish: Amprenavir hæmmer endvidere CYP3A4-enzymet, dog i mindre omfang end ritonavir.
English: • lopinavir/ritonavir combination (used to treat HIV infection)
Danish: • en kombination af lopinavir/ritonavir (mod hiv-infektion)
English: Magnesium stearate Colloidal anhydrous silica
Danish: Magnesiumstearat Kolloid vandfri silica
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The mean steady state plasma amprenavir trough concentration (Cmin) was 2.12 (1.77-2.54) µg/ml and AUC0-tau was 39.6 (34.5-45.3) h*µg/ml.
Danish: Den gennemsnitlige laveste steady state amprenavir-plasmakoncentration (Cmin) var 2,12 (1,772,54) g/ml, og AUC0-tau var 39,6 (34,5-45,3)h·g/ml.
English: Table 3 Efficacy at Week 48 Outcomes in APV30003 ITT(E) Population (ART-experienced Patients)
Danish: Tabel 3 Effektresultat ved uge 48 i APV30003 ITT(E)-populationen (patienter, der tidligere har fået antiviral behandling)
English: Contraindicated (see section
Danish: Kontraindiceret (se pkt.
English: Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Danish: Effekten af Telzir kan være nedsat på grund af fald i plasmakoncentrationen af amprenavir hos patienter, som tager disse lægemidler (se pkt.
English: Dosing recommendations for Telzir with ritonavir Age
Danish: Doseringsanbefalinger for Telzir i kombination med ritonavir
English: Unless otherwise stated, studies detailed below have been performed with the recommended dosage of fosamprenavir/ritonavir (i.e. 700/100 mg twice daily), and the interaction was assessed under steadystate conditions where drugs were administered for 10 to 21 days.
Danish: Medmindre andet er angivet, er studierne nedenfor udført med den anbefalede dosis af fosamprenavir (FPV)/ritonavir (RTV) (dvs. 700/100 mg 2 gange daglig), og interaktionen blev vurderet under steadystate-forhold, efter lægemidlerne var administreret i 10 til 21 dage.
English: Fosamprenavir contains a sulphonamide moiety.
Danish: Fosamprenavir indeholder en sulfonamid.
English: Ritonavir AUC12 ↓ 0.66 Ritonavir Cmax ↓ 0.61 Ritonavir C12 ↔ 0.86
Danish: Ritonavir AUC12  0,66 Ritonavir Cmax  0,61
English: Placental transfer of amprenavir has been shown to occur in humans.
Danish: Overførelse af amprenavir via placenta har vist sig at forekomme hos mennesker.
English: (Telzir 1400 mg twice daily)
Danish: (Telzir 1.400 mg 2 gange daglig)
English: Baseline Characteristics ART/PI status, n (%) ART-naïve ART-experienced, PI-naïve PI-experienced Median duration of prior ART exposure, weeks NRTI PI Median plasma HIV-1 RNA log10 copies/mL
Danish: Baseline karakteristika ART/PI status, n (%) ART-naive Patienter der tidligere har fået antiretroviral behandling, PI-naive Patienter der tidligere har fået proteasehæmmere, PI-erfarne Median varighed af tidligere ART-eksponering, uger NRTI PI Median plasma hiv-1 RNA log10 kopier/ml
English: In children and adolescents the fosamprenavir oral suspension should be taken with food.
Danish: Børn og unge bør tage fosamprenavir oral suspension sammen med mad.
English: Co-administration of Telzir 700 mg twice daily with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated.
Danish: Samtidig administration af Telzir 700 mg 2 gange daglig og ritonavir i doser større end 100 mg 2 gange daglig er ikke blevet klinisk undersøgt.
English: Overall, even with these dose adjustments for adults with hepatic impairment, some patients may have higher or lower than anticipated amprenavir and/or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore close monitoring of safety and virologic response is warranted.
Danish: Overordnet kan, selv med ovennævnte dosisjusteringer til voksne med nedsat leverfunktion, nogle patienter have en højere eller lavere amprenavir- og/eller ritonavirkoncentration i plasma end forventet i forhold til patienter med normal leverfunktion pga. øget inter-individuel variation (se pkt.
English: Geometric mean change
Danish: Geometrisk middelændring
English: Fosamprenavir tablets and oral suspension with ritonavir in combination with NRTIs have been evaluated in protease inhibitor naïve and experienced children and adolescent patients.
Danish: Fosamprenavir tabletter og oral suspension administreret med ritonavir og kombineret med NRTI'er er blevet evalueret hos proteasehæmmernaive børn og unge, samt hos børn og unge, der tidligere er behandlet med proteasehæmmere.
English: Oral use Read the package leaflet before use
Danish: Læs indlægssedlen inden brug
English: Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Telzir with ritonavir (see sections 4.3 and 4.5).
Danish: Lægemidler, som inducerer, hæmmer eller er substrater for CYP3A4, skal derfor bruges med forsigtighed, hvis de skal gives sammen med Telzir og ritonavir (se pkt.
English: These medicines are not recommended with Telzir/ritonavir:
Danish: Det frarådes at tage følgende medicin sammen med Telzir/ritonavir:
English: APV geometric mean (95% CI) and Ctau values were 1.31 (0.97, 1.77), 1.34 (0.95, 1.89), and 2.03 (1.46, 2.83) µg/mL for the second trimester, third trimester, and postpartum, respectively and within the range of values in non-pregnant patients on the same FPV/RTV containing regimens.
Danish: APVs geometriske middelværdi (95 % konfidensinterval) og Ctau-værdier var 1,31 (0,97; 1,77), 1,34 (0,95; 1,89) og 2,03 (1,46; 2,83) μg/ml for henholdsvis andet trimester, tredje trimester og post partum og inden for intervallet af værdier hos ikke-gravide patienter på de samme behandlingsregimer med FPV/RTV.
English: Therefore, any medicinal products that either share this metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir.
Danish: Derfor kan lægemidler, som har samme metaboliseringsvej eller modificerer aktiviteten af CYP3A4, muligvis ændre farmakokinetikken af amprenavir og ritonavir.
English: 25-O-desacetylrifabutin: AUC(0-48) ↑ 11-fold* *compared to rifabutin 300 mg once daily
Danish: 25-O-desacetylrifabutin: AUC(0-48)  11-fold* *sammenlignet med rifabutin 300 mg én gang daglig
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are unknown.
Danish: Påvirkningen af p-ritonavir ved høje systemiske fluticasonkoncentrationer kendes ikke.
English: Administration of the fosamprenavir tablet formulation in the fed state (standardised high fat meal: 967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) did not alter plasma amprenavir pharmacokinetics (Cmax, tmax or AUC0-∞) compared to the administration of this formulation in the fasted state.
Danish: Administration af fosamprenavir tabletter efter fødeindtagelse (standardiseret meget fedtholdigt måltid: 967 kcal, 67 gram fedt, 33 gram protein, 58 gram kulhydrat) ændrede ikke på plasma amprenavir farmakokinetikken (Cmax, Tmax eller AUC0-) sammenlignet med administration under faste.
English: Amprenavir is primarily metabolised by the liver with less than 1 % excreted unchanged in the urine.
Danish: Amprenavir metaboliseres hovedsageligt i leveren, og mindre end 1 % udskilles uomdannet i urinen.
English: Administration of the fosamprenavir oral suspension formulation with a high fat meal (967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) reduced plasma amprenavir AUC(0-∞) by 28% and Cmax by 46% and delayed Tmax by 0.72 hours.
Danish: Administration af fosamprenavir oral suspension sammen med et meget fedtholdigt måltid (967 kcal, 67 gram fedt, 33 gram protein, 58 gram kulhydrat) reducerede plasma amprenavir AUC(0-) med 28 % og Cmax med 46 % og forsinkede Tmax med 0,72 timer.