FrancophonIA/ELRC3.0 huggingface dataset:
English: • decompensated liver disease (see section 4.4)
Danish: • dekompenseret leversygdom (se pkt.
English: If you are taking an oral contraceptive to prevent pregnancy, you should use an additional or different type of contraception since ritonavir may reduce the effectiveness of oral contraceptives.
Danish: Hvis du tager p-piller for at undgå graviditet skal du yderligere anvende et præventionsmiddel eller en anden type prævention da ritonavir kan nedsætte effekten af p-pillerne.
English: Additionally, in vitro studies have shown that saquinavir is a substrate and an inhibitor for P-glycoprotein (P-gp).
Danish: Derudover er det i in vitro studier vist at saquinavir er et substrat og en inhibitor for P-glycoprotein (P-gp).
English: • certain medicines commonly used for allergy symptoms such as terfenadine and astemizole
Danish: • visse lægemidler sædvanligvis anvendt til behandling af allergiske symptomer - såsom terfenadin og astemizol
English: On Day 3, mean Cmax values were approximately 3-fold and 4-fold higher with the therapeutic and supra-therapeutic doses, respectively, relative to the mean Cmax observed at steady state with the therapeutic dose administered to HIV patients.
Danish: På dag 3 var de gennemsnitlige Cmax-værdier for de terapeutiske og supraterapeutiske doser henholdsvis ca. 3 gange og 4 gange højere end den gennemsnitlige Cmax, der blev observeret ved steady state med den terapeutiske dosis administreret til hiv-patienter.
English: Liver function should be monitored (see section 4.4).
Danish: Leverfunktionen skal monitoreres (se pkt.
English: • simvastatin and lovastatin - for lowering blood cholesterol
Danish: • simvastatin og lovastatin - til at sænke kolesterolindholdet i blodet.
English: • any heart problems that show on an electrocardiogram (ECG, electrical recording of the heart)
Danish: • hvis du har problemer med hjertet, som kan ses på et elektrokardiogram (ekg, optagelse af hjertets elektriske aktivitet) - det kan være medfødt
English: Contraindicated in combination with Invirase/ritonavir due to potential increase in alfuzosin concentration which can result in hypotension and potentially life-threatening cardiac arrhythmia.
Danish: Kontraindiceret i kombination med Invirase/ritonavir på grund af potentiel stigning i koncentrationen af alfuzosin, hvilket kan føre til hypotension og potentielt livstruende hjertearytmi.
English: Close monitoring of safety (including signs of cardiac arrhythmia) and of virologic response is recommended due to increased variability of the exposure in this population.
Danish: Tæt monitorering af sikkerhed (herunder tegn på hjertearytmi) og virologisk respons anbefales på grund af øget variabilitet i eksponeringen hos denne population.
English: Similarly, saquinavir might also modify the pharmacokinetics of other medicinal products that are substrates for CYP3A4 or P-gp.
Danish: På tilsvarende måde kan saquinavir måske også modificere farmakokinetikken af andre lægemidler som er substrater for CYP3A4 eller P-gp.
English: MaxCmin2: any rise > 0.5 log at a specific visit; < 0.5 log reduction if VL > 200 copies/ml at week 4; < 1.0 log reduction from base line if VL > 200 copies/ml at week 12; and a VL > 200 copies/ml at week 24.
Danish: MaxCmin2: enhver stigning > 0,5 log ved et enkelt besøg ; < 0,5 log reduktion hvis VL > 200 kopier/ml ved uge 4; < 1,0 log reduktion fra baseline hvis VL > 200 kopier/ml ved uge 12; og VL > 200 kopier/ml ved uge 24.
English: The mean (% coefficient of variation in parentheses) values for saquinavir AUC0-12 and Cmax were 24.3 (102%) µg·hr/ml and 3.6 (83%) µg/ml, respectively, for HIV-infected patients with moderate hepatic impairment.
Danish: Gennemsnitsværdierne (% variationskoefficient i parenteser) for saquinavir AUC0-12 og Cmax var henholdsvis 24,3 (102 %) µg·timer/ml og 3,6 (83 %) µg/ml for hiv-inficerede patienter med moderat nedsat leverfunktion.
English: Invirase 500 mg film-coated tablets are light orange to greyish or brownish orange tablets of oval shape with the marking "SQV 500" on one side and "ROCHE" on the other side.
Danish: Invirase 500 mg filmovertrukne tabletter er lyse orange til grå- eller brunligt orange ovale tabletter mærket med “SQV 500” på den ene side og “ROCHE” på den anden side.
English: τ = dosing interval, i.e. 8 hour for tid and 12 h for bid dosing.
Danish: τ = doseringsinterval, dvs. 8 timer for dosering 3 gange daglig og 12 timer for dosering 2 gange daglig.
English: Streptogramin antibiotics such as quinupristin/dalfopristin inhibit CYP3A4.
Danish: - Streptogramin-antibiotika som f.eks. quinupristin/dalfopristin hæmmer CYP3A4.
English: Anaemia, decreased haemoglobin, decreased lymphocyte count, decreased white blood cell count
Danish: Anæmi, nedsat hæmoglobin, nedsat lymfocyttal, nedsat antal hvide blodlegemer
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TEXT FOR THE BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TEKST PÅ FLASKEETIKETTEN
English: Interaction with tipranavir: Concomitant use of boosted saquinavir and tipranavir, co-administered with low dose ritonavir in a dual-boosted regimen, results in a significant decrease in saquinavir plasma concentrations (see section 4.5).
Danish: Interaktion med tipranavir: Samtidig anvendelse af boostet saquinavir og boostet tipranavir, begge i kombination med lavdosis ritonavir i et således dobbeltboostet regime, resulterer i et betydeligt fald i saquinavirplasmakoncentrationen (se pkt.
English: No dose recommendations for paediatric patients ≥2 years of age could be established that are both effective and below thresholds of concern for QT and PR interval prolongation.
Danish: Det har ikke været muligt at fastsætte dosisanbefalinger for pædiatriske patienter ≥ 2 år, som både er vist at være effektive og som er under de fastsatte grænser for, hvornår forlængelse af QT- og PR-intervallet er uden betydning.
English: Discontinued assigned treatment, n (%)
Danish: Afbrudt tildelt behandling, n (%)
English: Ritonavir can affect the pharmacokinetics of other medicinal products because it is a potent inhibitor of CYP3A4 and P-gp.
Danish: Ritonavir kan påvirke farmakokinetikken af andre lægemidler fordi det er en potent hæmmer af CYP3A4 og P-pg.
English: Only 2/21 (9%) patients across all study days had maximum QTcF change from dense predose baseline ≥ 30 ms following administration of the modified Invirase/ritonavir regimen in the treatment-naïve HIV-1 infected patient population; and the maximum mean change from dense predose baseline in QTcF was < 10 ms across all study days.
Danish: Kun 2/21 (9 %) patienter hen over alle forsøgsdage havde en maksimal ændring fra gennemsnitlig præ-dosis baseline i QTcF intervallet ≥ 30 ms efter administration af det modificerede Invirase/ritonavir-regime i populationen med behandlingsnaive hiv1-inficerede patienter; og den maksimale ændring fra gennemsnitlig præ-dosis baseline i QTcF intervallet var < 10 ms hen over alle forsøgsdagene.
English: In vitro studies have shown that saquinavir is a substrate for P-glycoprotein (P-gp).
Danish: In vitro studier har vist, at saquinavir er et substrat for P-glycoprotein (P-gp).
English: Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Danish: Vægt og metaboliske parameter: Vægtstigning og forhøjede lipider og glucose i blodet kan forekomme under antiretroviral behandling.
English: • hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Danish: • overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Increased alanine aminotransferase, increased aspartate aminotransferase, increased low density lipoprotein
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet LDL
English: • quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Danish: • quetiapin - bruges til at behandle skizofreni, bipolar (manio-depressiv) lidelse og svær depression
English: There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Danish: Der er rapporteret smerter eller ømhed i musklerne samt muskelsvækkelse, især efter antiretroviral kombinationsbehandling med proteasehæmmere og nukleosidanaloger.
English: The metabolism of saquinavir is mediated by cytochrome P450, with the specific isoenzyme CYP3A4 responsible for 90 % of the hepatic metabolism.
Danish: Saquinavirs metabolisme medieres af cytokrom P450, med det specifikke isoenzym, CYP3A4, som ansvarlig for 90 % af den hepatiske metabolisme.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Danish: Patienter med kronisk hepatitis B eller C, og som bliver behandlet med antiretroviral kombinationsterapi, har en øget risiko for alvorlige og potentielt fatale leverskader.
English: In the “High Age Group”, the number of patients with a viral load <400 copies/mL at week 48 was 11 of 13.
Danish: I den ”Ældre aldersgruppe” var antallet af patienter, der ved uge 48 havde en virusbelastning under 400 kopier/ml, 11 ud af 13.
English: Ritonavir ↓ (effectiveness as boosting agent not modified).
Danish: Ritonavir ↓ (effekten som booster var uændret).
English: mesoridazine, phenothiazines, sertindole, sultopride, thioridazine, ziprasidone
Danish: mesoridazin, phenothiaziner, sertindol, sultoprid, thioridazin, ziprasidon
English: Alternative or additional contraceptive measures should be used when oestrogen-based oral contraceptives are co-administered (see section 4.4).
Danish: Der bør anvendes andre eller ekstra præventionsmidler når østrogenbaserede orale kontraceptiva coadministreres (se pkt.
English: Marcelin et al (2007) identified nine protease codons (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M) that were associated with decreased virological response to saquinavir/ritonavir (1000/100 mg twice daily) in 138 saquinavir naive patients.
Danish: Marcelin et al (2007) identificerede ni proteasekodoner (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M), som var forbundet med nedsat virologisk respons af saquinavir/ritonavir (1.000/100 mg 2 gange daglig) hos 138 saquinavir naive patienter.
English: Number of Saquinavir Associated Resistance Mutations at Baseline*
Danish: Antal baseline saquinavirforbundne resistensmutationer*
English: Calcium channel blockers Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Danish: Calciumantagonister Felodipin, nifedipin, nicardipin, diltiazem, nimodipin, verapamil, amlodipin, nisoldipin, isradipin (saquinavir/ritonavir)
English: MaxCmin1: For those entering with VL > 200 copies/ml, VF defined as any increase > 0.5 logs and/or VL > 50,000 copies/ml at week 4, > 5,000 copies/ml at week 12, or > 200 copies/ml at week 24 or thereafter.
Danish: MaxCmin1: For patienter der indgik i studiet med VL > 200 kopier/ml, er VF defineret som enhver stigning > 0,5 logs og/eller VL > 50.000 kopies/ml ved uge 4, > 5.000 kopier/ml ved uge 12, eller > 200 kopier/ml ved uge 24 eller derefter.
English: In an additional four subjects administered 10.5 mg 14C-saquinavir intravenously, 81 % and 3 % of the intravenously administered radioactivity was recovered in faeces and urine, respectively, within 4 days of dosing.
Danish: Hos yderligere 4 personer der fik indgivet 10,5 mg 14C-saquinavir intravenøst, genfandtes henholdsvis 81 % og 3 % af den intravenøst indgivne radioaktivitet i fæces og i urin indenfor 4 døgn efter indgift.
English: - Grapefruit juice (single dose) (unboosted saquinavir)
Danish: - Grapefrugtjuice (enkeltdosis) (ikke-boostet saquinavir)
English: Mean Invirase Cmax with the modified Invirase/ritonavir regimen was approximately 53-83% lower across study days in the HIV-1 infected patients relative to the mean Cmax achieved in healthy volunteers in the TQT study on Day 3.
Danish: Gennemsnitlig Cmax af Invirase ved det modificerede Invirase/ritonavir-regime var ca. 53-83 % lavere hen over forsøgsdagene hos hiv-1inficerede patienter i forhold til de gennemsnitlige Cmax-værdier, der blev opnået hos raske frivillige i TQT-studiet på dag 3.
English: Biotransformation and elimination in adults: In vitro studies using human liver microsomes have shown that the metabolism of saquinavir is cytochrome P450 mediated with the specific isoenzyme, CYP3A4, responsible for more than 90 % of the hepatic metabolism.
Danish: Biotransformation og udskillelse hos voksne: In vitro eksperimenter har vist at saquinavir's metabolisme er P450 medieret med det specifikke isoenzym, CYP3A4, som ansvarlig for over 90 % af den hepatiske metabolisme.
English: Enfuvirtide ↔
Danish: Enfuvirtid ↔
English: Metabolism of pravastatin and fluvastatin is not dependent on CYP3A4.
Danish: Metabolisering af pravastatin og fluvastatin er ikke afhængig af CYP3A4.
English: Invirase film-coated tablets should be swallowed whole and taken at the same time as ritonavir with or after food (see section 5.2).
Danish: De filmovertrukne Inviraset-tabletter skal synkes hele og tages samtidig med ritonavir og sammen med eller efter fødeindtagelse (se pkt.
English: Asthenia, fatigue, increased fat tissue, malaise
Danish: Asteni, træthed, øget fedtvæv, utilpashed
English: No data are available on concomitant use of ritonavir boosted saquinavir with intravenous midazolam.
Danish: Der er ingen tilgængelige data om samtidig anvendelse af ritonavir boostet saquinavir og intravenøs admininistration af midazolam.
English: Mean ddQTcS
Danish: Gennemsnitlig ddQTcS
English: Autoimmune disorders (such as Graves'disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også set; tiden til udbrud er mere variabel og kan være mange måneder efter initiering af behandling (se pkt.
English: Invirase/ritonavir may increase ergot alkaloids exposure, and consequently, increase the potential for acute ergot toxicity.
Danish: Invirase/ritonavir kan øge eksponering af sekalealkaloider og som en konsekvens af dette øge risikoen for akut ergotamintoksicitet.
English: Adverse events of nausea, dizziness, hypotension and syncope have been observed following coadministration of trazodone and ritonavir.
Danish: Bivirkninger som kvalme, svimmelhed, hypotension og besvimelse er observeret efter co-administration af trazodon og ritonavir.
English: Table 8: Mean (% CV) AUC, Cmax and Cmin of saquinavir in patients following multiple dosing of Invirase, saquinavir soft capsules, Invirase/ritonavir, and saquinavir soft capsules/ritonavir
Danish: Tabel 8: Middel (% CV)-AUC, Cmax og Cmin af saquinavir hos patienter efter behandling med Invirase, saquinavir bløde kapsler, Invirase/ritonavir og saquinavir bløde kapsler/ritonavir i multiple doser
English: Women and elderly patients may be more susceptible to drug-associated effects on the QT and/or PR interval.
Danish: Kvinder og ældre patienter kan være mere følsomme for lægemiddelrelaterede virkninger på QTog/eller PR-intervallet.
English: HMG-CoA reductase inhibitors Pravastatin
Danish: HMG-CoA-reduktasehæmmere Pravastatin
English: • certain medicines for severe mental health problems such as pimozide
Danish: • visse lægemidler som bruges til behandling af alvorlige mentale forstyrrelser - såsom pimozid
English: Cardiac conduction and repolarisation abnormalities:
Danish: Kardiale lednings- og repolariseringsabnormiteter:
English: In a mass balance study using 600 mg 14C-saquinavir (n = 8), 88 % and 1 % of the orally administered radioactivity, was recovered in faeces and urine, respectively, within 4 days of dosing.
Danish: I en massebalanceundersøgelse med anvendelse af 600 mg 14C-saquinavir (n = 8), genfandtes henholdsvis 88 % og 1 % af den oralt indgivne radioaktivitet i fæces og i urin indenfor 4 døgn efter indgift.
English: Liver disease: Please speak with your doctor if you have a history of liver disease.
Danish: Leversygdom: Tal med din læge, hvis du har haft en leversygdom.
English: Post-Dose Time Point
Danish: Post-dosis tidspunkt
English: CYP3A4 Interactions: Saquinavir could interact and modify the pharmacokinetics of other drugs that are substrates for CYP3A4 and/or P-gp and should be used with caution.
Danish: Interaktioner med CYP3A4: Saquinavir kan interagere og ændre farmakokinetikken af andre lægemidler, der er substrater for CYP3A4 og/eller P-gp, og der skal udvises forsigtighed ved samtidig anvendelse.
English: • certain medicines for infection - such as clarithromycin, dapsone, erythromycin, halofantrine,
Danish: • visse lægemidler mod infektioner - såsom clarithromycin, dapson, erythromycin, halofantrin,
English: • certain medicines (so called tyrosine kinase inhibitors) used to treat different types of cancer such as dasatinib and sunitinib.
Danish: • visse lægemidler (tyrosinkinasehæmmere) som bruges til behandling af visse former for kræft såsom dasatinib og sunitinib
English: Table 4: Summary of Electrocardiogram Parameters following administration of the Modified Invirase/ritonavir Regimen in Treatment Naïve HIV-1 infected Patients initiating treatment with Invirase/ritonavir
Danish: Tabel 4: Sammendrag af elektrokardiogramparametre efter administration af det modificerede Invirase/ritonavir-regime i behandlingsnaive hiv-1-inficerede patienter, der indledte behandling med Invirase/ritonavir.
English: • antifungals - ketoconazole, itraconazole, fluconazole, miconazole
Danish: • svampemidler - ketoconazol, itraconazol, fluconazol og miconazol,
English: Hepatitis, jaundice
Danish: Hepatitis, gulsot
English: • certain medicines used to treat the symptoms of Benign Prostatic Hyperplasia (an increase in size of the prostate) such as alfuzosin
Danish: • visse lægemidler til behandling af symptomerne ved godartet prostatahyperplasi (forstørret prostata) - såsom alfuzosin
English: Antiretroviral agents
Danish: Antiretrovirale stoffer
English: Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
Danish: Forhøjet kreatinkinase, myalgi, myositis og i sjældne tilfælde rabdomyolyse er blevet rapporteret for proteasehæmmere, specielt ved kombination med nukleosidanaloger.
English: Patients with chronic diarrhoea or malabsorption: No information on boosted saquinavir and only limited information on the safety and efficacy of unboosted saquinavir is available for patients suffering from chronic diarrhoea or malabsorption.
Danish: Patienter med kronisk diarré eller malabsorption: Der findes ingen henholdsvis kun begrænset information om sikkerhed og effekt hos patienter med kronisk diarré eller malabsorption, der behandles med boostet saquinavir henholdsvis ikke-boostet saquinavir.
English: Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Danish: Patienter med kronisk hepatitis B eller C, og som samtidig bliver behandlet med antiretrovirale lægemidler, kan have øget risiko for alvorlige og potentielt dødelige leverskader og kan være nødt til at afgive blodprøver til kontrol af leverfunktionen.
English: The safety and activity of saquinavir boosted with ritonavir in HIV-infected patients less than 2 years have not been established.
Danish: Sikkerheden og virkningen af ritonavirboostet saquinavir hos hiv-inficerede børn under 2 år er ikke klarlagt.
English: General disorders and administration site conditions Common
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Patients stable on ritonavir-boosted Invirase and requiring concomitant medication with potential to increase the exposure of saquinavir or patients on medication with potential to increase the exposure of saquinavir and requiring concomitant ritonavir-boosted Invirase where no alternative therapy is available and the benefits outweigh the risks: - An ECG should be performed prior to initiation of the concomitant therapy: patients with a QT interval > 450 msec should not initiate the concomitant therapy (see section 4.5).
Danish: Patienter, som er stabile i behandling med ritonavirboostet Invirase, og samtidigt behøver behandling med lægemidler, som potentielt øger eksponeringen af saquinavir, eller patienter, der får medicin, som potentielt øger eksponeringen af saquinavir, og samtidig behøver behandling med ritonavir-boostet Invirase, hvor ingen alternativ behandling er tilgængelig, og fordelene opvejer risiciene: - Et ekg skal tages før start af samtidig behandling: Patienter med et QT- interval > 450 ms bør ikke starte den samtidige behandling (se pkt.
English: Effects of high fluticasone systemic exposure on ritonavir plasma levels yet unknown.
Danish: Påvirkningen af ritonavirs plasmakoncentration ved høj systemisk fluticasonkoncentration er endnu ukendt.
English: There are limited safety and no efficacy data available from the use of this combination.
Danish: For anvendelsen af denne kombination er der begrænsede sikkerhedsdata og ingen effektdata tilgængelige.
English: No dose adjustment is recommended.
Danish: Der anbefales ingen dosisjustering.
English: Elderly patients may be more susceptible to drug-associated effects on the QT and/or PR interval.
Danish: Ældre patienter kan være mere følsomme for lægemiddelinducerede påvirkninger af QT- og/eller PR-intervallet.
English: 6.6 Special precautions for disposal No special requirements for disposal.
Danish: Ingen særlige forholdsregler ved bortskaffelse.
English: You should not breast-feed your baby if you are taking Invirase/ritonavir.
Danish: Du må ikke amme, hvis du tager Invirase/ritonavir.
English: The modified Invirase/ritonavir regimen reduced mean maximum ΔQTcFdense in the first week of treatment compared with the same value in healthy volunteers receiving the standard Invirase/ritonavir dosing regimen in the TQT study on Day 3, (Table 4) based on cross-study comparison in a different population.
Danish: Det modificerede Invirase/ritonavir-regime reducerede gennemsnittet af maksimal ΔQTcFgennemsnit i den første uge af behandlingen sammenlignet med den samme værdi i raske frivillige, der fik Invirase/ritonavir-standarddosisregimet i TQT studiet på dag 3 (tabel 4), baseret på en sammenligning på tværs af studier i en anden population.
English: On Day 3, the upper 1-sided 95% confidence interval of the maximum mean difference in pre-dose baseline-corrected QTcS (study specific heart rate corrected QT) between the active drug and placebo arms was > 10 msec for the two ritonavir-boosted Invirase treatment groups (see results in Table 3).
Danish: På dag 3 var det øvre ensidede 95 % konfidensinterval for den maksimale ændring fra gennemsnitlig præ-dosis baseline-korrigeret QTcS (studiespecifik hjertefrekvens-korrigeret QT) mellem den aktive lægemiddelarm og placeboarmen > 10 ms for de to ritonavirboostede Invirase-behandlingsgrupper (se resultater i tabel 3).
English: Tyrosine kinase inhibitors All tyrosine kinase inhibitors with a risk of QT prolongation e.g. dasatinib, sunitinib
Danish: Tyrosinkinasehæmmere Alle tyrosinkinasehæmmere med en risiko for QTforlængelse, f.eks. dasatinib, sunitinib
English: • certain medicines for HIV - such as atazanavir, lopinavir, rilpivirine
Danish: • visse lægemidler mod hiv - såsom atazanavir, lopinavir, rilpivirin
English: • previous history of symptomatic arrhythmias
Danish: • symptomatiske arytmier i anamnesen