FrancophonIA/ELRC3.0 huggingface dataset:
English: Invirase/ritonavir may be taken with a number of other medications that are commonly used in HIV infection.
Danish: Invirase/ritonavir kan tages sammen med en del andre lægemidler som er almindeligt anvendt ved hivinfektioner.
English: Methadone AUC ↓ 19 % (90 % CI 9 % to 29 %) None of the 12 patients experienced withdrawal symptoms.
Danish: Methadon AUC ↓ 19 % (90 % konfidensinterval 9 % to 29 %) Ingen af de 12 patienter oplevede abstinenssymptomer.
English: Outcomes
Danish: Resultat
English: Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig
English: Diarrhoea, nausea
Danish: Diarré, kvalme
English: Table 7: Outcomes at Week 48 MaxCmin1 and MaxCmin2†
Danish: Tabel 7: Resultater ved uge 48 MaxCmin1 og MaxCmin2†
English: Lopinavir ↔ (based on historical comparison with unboosted lopinavir)
Danish: Lopinavir ↔ (baseret på historisk sammenligning med ikke-boostet lopinavir)
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Danish: Patienter med hæmofili bør derfor gøres opmærksom på muligheden for øget blødningstendens.
English: Antiarrhythmics Bepridil
Danish: Antiarytmika Bepridil
English: Tacrolimus may be associated with torsades de pointes.
Danish: Tacrolimus kan være associeret med torsades de pointes.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/026/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/026/002
English: Each film-coated tablet contains lactose (monohydrate) 38.5 mg.
Danish: Hver filmovertrukken tablet indeholder lactose (monohydrat) 38,5 mg.
English: Large increments of digoxin may be expected when saquinavir/ritonavir is introduced in patients already treated with digoxin.
Danish: En stor stigning i digoxinkoncentrationen kan forventes, når saquinavir/ritonavir administreres til patienter, der allerede er i behandling med digoxin.
English: Rifabutin active moiety*
Danish: Rifabutin aktiv del*
English: Patients should be informed that saquinavir is not a cure for HIV infection and that they may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections.
Danish: Patienterne bør informeres om, at saquinavir ikke kurerer hiv-infektion og at de fortsat kan pådrage sig sygdomme, som kan forekomme i forbindelse med fremskreden hiv-infektion, inklusiv opportunistiske infektioner.
English: The corresponding values in the control group were 28.5 (71%) µg·hr/ml and 4.3 (68%) µg/ml.
Danish: De tilsvarende værdier for kontrolgruppen var 28,5 (71 %) µg·timer/ml og 4,3 (68 %) µg/ml.
English: You should know that Invirase/ritonavir is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease.
Danish: Du bør vide at Invirase/ritonavir ikke helbreder hiv-infektion og at du fortsat kan få infektioner eller andre sygdomme associeret med hiv-lidelse.
English: Considerations when initiating Invirase therapy: Invirase should not be given as the sole protease inhibitor.
Danish: Overvejelser i forbindelse med initiering af Invirasebehandling: Invirase bør ikke gives som eneste proteasehæmmer.
English: Mutagenesis: Mutagenicity and genotoxicity studies, with and without metabolic activation where appropriate, have shown that saquinavir has no mutagenic activity in vitro in either bacterial (Ames test) or mammalian cells (Chinese hamster lung V79/HPRT test).
Danish: Mutagenicitet: Mutagene og genotoksiske studier, med og uden relevant metabolisk aktivering, har vist, at saquinavir ikke har mutagen aktivitet in vitro i hverken bakterielle celler (Ames test) eller pattedyrsceller (kinesisk hamsterlunge V79/HPRT-test).
English: Therefore you should not take Invirase/ritonavir with other medicines without your doctor's consent.
Danish: Du må derfor ikke indtage Invirase/ritonavir sammen med andre lægemidler med mindre din læge er indforstået dermed.
English: What you need to know before you take Invirase
Danish: Det skal du vide før du begynder at tage Invirase
English: • The active substance is saquinavir.
Danish: • Aktivt stof: saquinavir.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede laktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: In vitro experiments have shown that the hepatic metabolism of saquinavir becomes saturable at concentrations above 2 µg/ml.
Danish: In vitro eksperimenter har vist at den hepatiske metabolisme af saquinavir mættes ved koncentrationer over 2µg/ml.
English: 13 % of circulating saquinavir in plasma was present as unchanged compound after oral administration and the remainder as metabolites.
Danish: 13 % af cirkulerende saquinavir i plasma fandtes som uomdannet stof efter oral indgift og resten som metabolitter.
English: Genotypic and phenotypic clinical cut-offs predicting the clinical efficacy of ritonavir boosted saquinavir have been derived from retrospective analyses of the RESIST 1 and 2 clinical studies and analysis of a large hospital cohort (Marcelin et al 2007).
Danish: Genotypiske og fænotypiske, kliniske skæringspunkter, som forudsiger den kliniske effekt af ritanovir boostet saquinavir, er blevet fastlagt på baggrund af retrospektive analyser af RESIST 1- og 2studierne samt analyse af en stor hospital kohorte (Marcelin et al 2007).
English: The association between the number of these saquinavir-associated resistance mutations and virological response was confirmed in an independent clinical study (RESIST 1 and 2) involving a more heavily treatment experienced patient population, including 54% who had received prior saquinavir (p=0.0133, see Table 5).
Danish: Sammenhængen mellem antallet af disse saquinavir-associerede resistensmutationer og det virologiske respons blev bekræftet i et uafhængigt klinisk studie (RESIST 1 og 2), som involverede en erfaringsmæssig stærkere behandlet patientpopulation, hvoraf 54 % tidligere havde været behandlet med saquinavir (p=0,0133, se tabel 5).
English: The number of patients with viral load <50 copies/mL was 9 of 13 for the same period.
Danish: Antallet af patienter, som havde en virusbelastning under 50 kopier/ml, var 9 ud af 13 i den samme periode.
English: Lidocaine (systemic) Quinidine
Danish: Lidocain (systemisk) Kinidin
English: Distribution in adults: Saquinavir partitions extensively into the tissues.
Danish: Fordeling hos voksne: Saquinavir penetrerer udtalt ind i vævene.
English: Based on in vitro studies, saquinavir is rapidly metabolised to a range of mono- and di-hydroxylated inactive compounds.
Danish: Baseret på in vitro studier, metaboliseres saquinavir hurtigt til en række mono- og dihydroxylerede inaktive stoffer.
English: Gastric pH has been shown to be only a minor component in the large increase in bioavailability seen when given with food.
Danish: Ventrikel pH er vist kun at være af mindre betydning ved den store øgning i biotilgængelighed der ses ved samtidig fødeindtagelse.
English: - lurasidone (potential for serious and/or life-threatening reactions, see section 4.5)
Danish: 4.5) - lurasidon (risiko for alvorlige og/eller livstruende reaktioner, se pkt.
English: Furthermore, results seen with saquinavir soft capsules may not predict the magnitude of these interactions with Invirase/ritonavir.
Danish: Desuden er de resultater som ses med saquinavir bløde kapsler ikke prædiktive for størrelsesordenen af disse interaktioner med Invirase/ritonavir.
English: • recently taken the HIV medicine rilpivirine.
Danish: • hvis du for nyligt har taget hiv lægemidlet rilpivirin
English: If you stop taking Invirase
Danish: Hvis du holder op med at tage Invirase
English: Cobicistat is not recommended in combination with regimens containing ritonavir due to similar effects of cobicistat and ritonavir on CYP3A.
Danish: Cobicistat er ikke anbefalet i kombination med behandlinger indeholdende ritonavir på grund af lignende virkninger af cobicistat og ritonavir på CYP3A.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis du har fået at vide af din læge at du ikke kan tåle visse sukkerarter, skal du kontakte lægen før du begynder at tage dette lægemiddel.
English: Mucosal ulceration c. Description of selected adverse reactions
Danish: Slimhindeulceration c. Beskrivelse af udvalgte bivirkninger
English: Median Baseline HIV-1 RNA, log10 copies/ml (IQR) Median Baseline CD4+ Cell Count, cells/mm3 (IQR) † data from clinical study report
Danish: Median baseline hiv-1 RNA, log10 kopier/ml (IQR) Median baseline CD4+ celletal, celler/mm3 (IQR) † data fra den kliniske studierapport
English: It is unknown whether medicinal products which reduce the gastrointestinal transit time could lead to lower saquinavir plasma concentrations.
Danish: Det vides ikke om lægemidler, der nedsætter den gastrointestinale transittid, kan medføre lavere plasmakoncentrationer af saquinavir.
English: Midazolam AUC ↑ 12.4 fold Midazolam Cmax ↑ 4.3 fold Midazolam t1/2 ↑ from 4.7 h to 14.9 h
Danish: Midazolam AUC ↑ 12,4 gange Midazolam Cmax ↑ 4,3 gange Midazolam t1/2 ↑ fra 4,7 til 14,9 timer
English: pentamidine, sparfloxacin
Danish: pentamidin, sparfloxacin
English: Corticosteroids - Dexamethasone
Danish: Kortikosteroider - Dexamethason
English: • If you are taking any medicine that decreases your blood potassium levels talk to your doctor before taking Invirase.
Danish: • Hvis du tager medicin, som nedsætter kaliumindholdet i dit blod, så tal med din læge, før du tager Invirase
English: Studies of other CYP3A modulators and i.v.
Danish: Studier med andre CYP3Amodulatorer og i.v.
English: Stevens Johnson syndrome, dermatitis bullous
Danish: Stevens-Johnsons syndrom, bulløs dermatitis
English: Clinical experience in pregnant women is limited: Congenital malformations, birth defects and other disorders (without a congenital malformation) have been reported rarely in pregnant women who had received saquinavir in combination with other antiretroviral agents.
Danish: Der findes kun begrænsede kliniske erfaringer på gravide kvinder: Kongenitte misdannelser, fødselsskader og andre lidelser (uden kongenitte misdannelser) er blevet rapporteret sjældent hos gravide kvinder der har fået saquinavir i kombination med andre antiretrovirale stoffer.
English: Plasma concentrations of trazodone may increase.
Danish: Plasmakoncentrationen af trazodon kan stige.
English: On rare occasions these muscle disorders have been serious (rhabdomyolysis).
Danish: Muskellidelserne har i sjældne tilfælde været alvorlige (rabdomyolyse).
English: You should, therefore, remain under the care of your doctor while taking Invirase/ritonavir.
Danish: Du bør derfor forblive under tilsyn af din læge medens du behandles med Invirase/ritonavir.
English: It is a member of a class of medicines called protease inhibitors.
Danish: Det tilhører den lægemiddelgruppe, som kaldes proteasehæmmere.
English: Cobicistat containing medicinal products Cobicistat
Danish: Lægemidler indeholdende cobicistat Cobicistat
English: The mean steady-state volume of distribution following intravenous administration of a 12 mg dose of saquinavir was 700 l (CV 39 %).
Danish: Middel steady state fordelingsvolumen efter intravenøs indgift af en 12 mg dosis af saquinavir var 700 l (CV 39 %).
English: Medicinal products that are substrates of P-glycoprotein Digitalis glycosides
Danish: Lægemidler der er substrater for P-glycoprotein Digitalis glykosider
English: • a very slow heart rate (bradycardia)
Danish: • hvis du har en meget langsom hjerterytme (bradykardi)
English: Saquinavir concentrations may be increased.
Danish: Koncentrationen af saquinavir kan øges.
English: Ritonavir-boosted Invirase should be discontinued if arrhythmias are demonstrated, or if prolongation occurs in the QT or PR interval.
Danish: Ritonavirboostet Invirase bør seponeres, hvis der påvises arytmier, eller hvis der forekommer forlængelse i QT- eller PR-intervallet.
English: Therefore, medicinal products that either share this metabolic pathway or modify CYP3A4 and/or P-gp activity (see "Other potential interactions") may modify the pharmacokinetics of saquinavir.
Danish: Derfor kan lægemidler, som enten benytter den samme metaboliseringsvej eller som modificerer aktiviteten af CYP3A4 og/eller af P-gp (se ”Andre potentielle interaktioner”), måske modificere saquinavirs farmakokinetik.
English: Antiviral activity in vitro: Saquinavir demonstrates antiviral activity against a panel of laboratory strains and clinical isolates of HIV-1 with typical EC50 and EC90 values in the range 1-10 nM and 5-50 nM, respectively, with no apparent difference between subtype B and non-B clades.
Danish: Antiviral aktivitet in vitro: Saquinavir udviser antiviral aktivitet mod et panel af laboratoriestammer og kliniske isolater af hiv-1 med typiske EC50- og EC90-værdier i intervaller på henholdsvis 1-10 nM og 5-50 nM. Der er ingen tydelig forskel mellem subtype B og non-clade B-isolater.
English: Continue to take this medicine until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage medicinen indtil din læge beslutter at du skal ophøre dermed.
English: The study included a control group consisting of 7 HIV-infected patients with normal hepatic function matched with the hepatically impaired patients for age, gender, weight and tobacco use.
Danish: Studiet omfattede en kontrolgruppe bestående af 7 hiv-inficerede patienter med normal leverfunktion parret i forhold til alder, køn, vægt og tobaksforbrug med patienterne med nedsat leverfunktion.
English: In two patients receiving Invirase 600 mg three times daily, cerebrospinal fluid concentrations of saquinavir were negligible when compared to concentrations from matching plasma samples.
Danish: Hos to patienter, der fik Invirase 600 mg 3 gange daglig, fandtes koncentrationer af saquinavir i cerebrospinalvæsken ubetydelig sammenlignet med koncentrationeni tilsvarende plasmaprøver.
English: Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities in clinical studies and post-marketing experience in adult patients.
Danish: Tabel 2: Hyppigheder af bivirkninger og ændrede laboratorieværdier i kliniske studier og fra erfaring efter markedsføring hos voksne patienter.
English: Mean ± SD Saquinavir (%CV) Pharmacokinetic Parameters*
Danish: Gennemsnit ± SD (% CV) saquinavir famakokinetiske parametre*
English: In a small, preliminary study, hepatocellular enzyme elevations occurred in 13 % of subjects during the first several weeks of the delavirdine and saquinavir combination (6 % Grade 3 or 4).
Danish: I et lille, præliminært studie forekom der stigninger i hepatocellulært enzym hos 13 % af patienterne i de første mange uger af kombinationsbehandlingen med delavirdin og saquinavir (6 % grad 3 eller 4).
English: Table 10: Pharmacokinetic parameters of saquinavir at steady-state in HIV-infected pediatric patients
Danish: Tabel 10: Saquinavirs farmakokinetiske parametre ved steady state hos hiv-inficerede pædiatriske patienter
English: Glycerol triacetate, Iron oxide yellow and red (E172).
Danish: Glyceroltriacetat Gult og rødt jernoxid (E172)
English: None of the subjects in the lopinavir/ritonavir arm had been exposed to lopinavir prior to randomisation whereas 16 of the subjects in the saquinavir/ritonavir arm had previously been exposed to saquinavir.
Danish: Ingen af patienterne i armen med lopinavir/ritonavir havde været udsat for lopinavir før randomiseringen, mens 16 af patienterne i armen med saquinavir/ritonavir havde tidligere været udsat for saquinavir.
English: • Essential Patient Information: Prescribers must ensure that patients are fully informed regarding the following information on cardiac conduction and repolarisation abnormalities: - Patients initiating therapy with ritonavir boosted Invirase should be warned of the arrhythmogenic risk associated with QT and PR prolongation and told to report any sign or symptom suspicious of cardiac arrhythmia (e.g., chest palpitations, syncope, presyncope) to their physician.
Danish: • Vigtig patientinformation: Den ordinerende læge skal sikre sig, at patienten er fuldt informeret om følgende information omkring kardiale lednings- og repolariseringsabnormiteter: - Patienter, som begynder behandling med ritonavirboostet Invirase, skal advares om den arytmogene risiko forbundet med QT- og PR-forlængelse og skal informeres om at rapportere ethvert tegn eller symptom på mistænkt hjertearytmi (f.eks. palpitationer, synkope, præsynkope) til deres læge.
English: Do not drive or operate machines if you experience these symptoms.
Danish: Du må derfor ikke køre bil eller motorcykel eller cykle eller arbejde med værktøj eller maskiner, hvis du oplever disse symptomer.
English: For comprehensive dose adjustment recommendations and drug-associated adverse reactions for ritonavir and other medicinal products used in combination with saquinavir, physicians should refer to the Summary of Product Characteristics for each of these medicinal products.
Danish: For detaljeret information om anbefalede dosisjusteringer og lægemiddelassocierede bivirkninger for ritonavir og andre lægemidler, der anvendes i kombination med saquinavir, henvises de behandlende læger til produktresuméerne for hvert af disse lægemidler.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended with careful monitoring (see section
Danish: Hvis behandling med HMG-CoAreduktasehæmmere er indiceret, anbefales pravastatin eller fluvastatin under nøje observation (se pkt.
English: Median increase in CD4 cell count at week 48 (cells/mm3) * For both studies: For patients entering study with VL < 200 copies/ml, VF defined as > 200 copies/ml.
Danish: Median stigning i CD4 celletal ved uge 48 (celler/mm3) * For begge studier: For patienter, der ved indgang i studiet havde VL < 200 kopier/ml, er VF defineret som > 200 kopier/ml.
English: Gastroenterological medicinal products Metoclopramide
Danish: Gastroenterologiske lægemidler Metoclopramid
English: Key: ↓ reduced, ↑ increased, ↔ unchanged, ↑↑ markedly increased
Danish: ↓ indikerer fald, ↑ indikerer stigning, ↔ indikerer ingen ændring, ↑↑ indikerer markant stigning
English: Concomitant administration of Invirase and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Danish: Samtidig administration af Invirase og quetiapin er kontraindiceret, da det kan øge quetiapin-relateret toksicitet.
English: Invirase is indicated for the treatment of HIV-1 infected adult patients.
Danish: Invirase er indiceret til behandling af hiv-1-inficerede voksne patienter.
English: • a weak heart (heart failure)
Danish: • hvis du har et svagt hjerte (hjertesvigt)
English: Fluticasone propionate ↑ Intrinsic cortisol ↓ 86% (90% CI 82%-89%) Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Intern kortisol ↓ 86 % (90 % konfidensinterval 82 %-89 %) Større påvirkning kan forventes når fluticasonpropionat inhaleres.
English: Increased blood cholesterol, increased blood triglycerides
Danish: Forhøjet kolesterol, forhøjede triglycerider
English: Invirase may have a minor influence on the ability to drive and use machines.
Danish: Invirase kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Reproductive toxicity: Fertility, peri- and postnatal development were not affected, and embryotoxic / teratogenic effects were not observed in rats or rabbits at plasma exposures lower than those achieved in humans at the recommended clinical dose of ritonavir boosted Invirase.
Danish: Forplantningstoksicitet: Fertilitet, peri- og postnatal udvikling blev ikke påvirket og embryotoksiske/teratogene virkninger blev ikke observeret hos rotter eller kaniner ved plasmakoncentrationer, der var lavere end de, der blev opnået hos mennesker ved den anbefalede kliniske dosis af Invirase boostet med ritonavir.
English: * Saquinavir Mutation Score Mutations: L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M
Danish: * Saquinavir mutationsscore mutationer: L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M
English: Breast-feeding: There are no laboratory animal or human data available on secretion of saquinavir in breast milk.
Danish: Amning: Der findes ingen data fra laboratoriedyr eller humane data om udskillelse af saquinavir i modermælk.
English: Following intravenous administration 66 % of circulating saquinavir was present as unchanged compound and the remainder as metabolites, suggesting that saquinavir undergoes extensive first pass metabolism.
Danish: Efter intravenøs indgift fandtes 66 % af cirkulerende saquinavir som uomdannet stof og resten som metabolitter, hvilket tyder på at saquinavir undergår udtalt first pass metabolisme.
English: • Take one 100 mg capsule of ritonavir (Norvir) twice a day.
Danish: • Tag én 100 mg ritonavir (Norvir) kapsel to gange daglig
English: Upper 95%-CI of ddQTcS
Danish: Øvre 95 % konfidensinterval for ddQTcS
English: If you are not sure, talk to your doctor or pharmacist before taking Invirase.
Danish: Hvis du er i tvivl, så kontakt din læge eller apoteket, før du tager Invirase.
English: The potential for adverse reactions to saquinavir in nursing infants cannot be assessed, and therefore, breast-feeding should be discontinued prior to receiving saquinavir.
Danish: Potentielle bivirkninger af saquinavir hos brystbørn kan ikke vurderes, derfor bør amning ophøre forud for indgift af saquinavir.
English: No safety and efficacy data available for this combination.
Danish: Der foreligger ingen sikkerheds- og effektdata om anvendelsen af denne kombination.
English: There have been reports of exacerbation of chronic liver dysfunction, including portal hypertension, in patients with underlying hepatitis B or C, cirrhosis and other underlying liver abnormalities.
Danish: Der er rapporteret om forværring af kronisk leverdysfunktion herunder portal hypertension hos patienter med underliggende hepatitis B eller C, cirrose og andre underliggende leverabnormaliteter.
English: The corresponding serum (50% human serum) adjusted EC50 ranged from 25-250 nM. Clinical isolates of HIV-2 demonstrated EC50 values in the range of 0.3-2.4 nM.
Danish: De korresponderende serum-justerede (50 % human serum) EC50-værdier var i intervallet 25-250 nM. Kliniske isolater af hiv-2 gav EC50-værdier i intervallet fra 0,3-2,4 nM.
English: Consideration should be given for performing baseline and follow-up electrocardiograms after initiation of treatment, e.g. in patients taking concomitant medication known to increase the exposure of saquinavir (see section 4.5).
Danish: Det bør overvejes at udføre baseline- og opfølgnings-elektrokardiogram efter initiering af behandling, f.eks. hos patienter, som samtidigt er i behandling med lægemidler kendt for at øge eksponeringen af saquinavir (se pkt.
English: If you have taken more than the prescribed dose of Invirase/ritonavir you must contact your doctor or pharmacist.
Danish: Hvis du har indtaget flere tabletter Invirase/ritonavir end foreskrevet, skal du kontakte din læge eller apoteket.
English: There are also some medicines that require dosage reduction of that medicine or Invirase or ritonavir (see section “Medicines that can interact with saquinavir or ritonavir include:” below).
Danish: Der er også nogle lægemidler, hvor dosisreduktion af lægemidlet eller af Invirase eller ritonavir er nødvendig (se afsnit ”Lægemidler som kan interagere med saquinavir og/eller ritonavir omfatter” nedenfor ).
English: Ritonavirboosted Invirase at a dose of 2000 mg once daily with ritonavir 100 mg once daily has not been studied with regard to the risk of QT prolongation and is not recommended.
Danish: Ritonavirboostet Invirase i en dosis på 2000 mg 1 gang daglig med 100 mg ritonavir 1 gang daglig er ikke blevet undersøgt med henblik på risikoen for QT-forlængelse og anbefales ikke.