FrancophonIA/ELRC3.0 huggingface dataset:
English: PREZISTA cannot work properly without food.
Danish: PREZISTA virker ikke korrekt uden mad.
English: PREZISTA contains the active substance darunavir.
Danish: PREZISTA indeholder det aktive stof darunavir.
English: Do not take PREZISTA - if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke PREZISTA - hvis du er allergisk over for darunavir eller et af de øvrige indholdsstoffer i dette lægemiddel
English: For the treatment of pulmonary arterial hypertension Sildenafil
Danish: Til behandling af pulmonal arteriel hypertension Sildenafil Tadalafil
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of PREZISTA/ritonavir.
Danish: På baggrund af observationer kan der være behov for, at carbamazepindoseringen skal reduceres med 25-50 % ved samtidig behandling med PREZISTA/ritonavir.
English: Co-administration with boosted PREZISTA may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Danish: Co-administration af boostet PREZISTA kan medføre en markant stigning i eksponeringen for dabigatran eller ticagrelor.
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Danish: Det uomdannede darunavir udgjorde ca. 41,2 % og 7,7 % af den administrerede dosis i henholdsvis fæces og urin.
English: During the Phase III clinical trial GS-US-216-130 with darunavir/cobicistat (N=313 treatment-naïve and treatment-experienced subjects), 66.5% of subjects experienced at least one adverse reaction.
Danish: Under det kliniske fase III-studie GS-US-216-130 med darunavir/cobicistat (N=313 behandlingsnaive og behandlingserfarne forsøgspersoner) oplevede 66,5 % af forsøgspersonerne mindst én bivirkning.
English: The exposure to cobicistat was lower during pregnancy, potentially leading to suboptimal boosting of darunavir.
Danish: Eksponeringen for cobicistat var lavere under graviditeten, hvilket muligvis kan føre til suboptimal boostning af darunavir.
English: Glecaprevir/pibrentasvir Based on theoretical considerations boosted PREZISTA may increase the exposure to glecaprevir and pibrentasvir.
Danish: Glecaprevir/pibrentasvir Baseret på teoretiske overvejelser kan boostet PREZISTA øge eksponeringen for glecaprevir og pibrentasvir.
English: These patients received PREZISTA/ritonavir 800/100 mg once daily in combination with other antiretroviral agents.
Danish: Disse patienter fik PREZISTA/ritonavir 800/100 mg en gang dagligt i kombination med andre antiretrovirale lægemidler.
English: Investigations common increased blood creatinine * these adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Danish: Undersøgelser almindelig forhøjet kreatinin i blodet * disse bivirkninger har ikke været indberettet i forbindelse med de kliniske studier med darunavir/cobicistat, men har været bemærket under behandling med darunavir/ritonavir, og kan også forventes med darunavir/cobicistat.
English: Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV infected females compared to males.
Danish: En populationsfarmakokinetisk analyse viste en lidt højere eksponering for darunavir (16,8 %) hos hiv-inficerede kvinder i forhold til mænd.
English: Based upon the safety profile of PREZISTA/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for PREZISTA/ritonavir.
Danish: På baggrund af sikkerhedsprofilen for PREZISTA/ritonavir giver denne øgede eksponering af darunavir ved samtidig administration af rifabutin ikke anledning til en justering af dosis for PREZISTA/ritonavir.
English: Baseline genotype or phenotype and virologic outcome Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Danish: Genotype / fænotype ved baseline og virologisk udfald Baseline-genotype og darunavir FC (skift i følsomhed i forhold til reference) blev vist at være en forudsigende faktor for virologisk udfald.
English: In GS-US216-130 baseline phenotype was not available
Danish: I GS-US216-130 forelå baseline-fænotype ikke
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking PREZISTA co-administered with cobicistat.
Danish: Omhyggelig monitorering af patienten og justering af metformindosis anbefales til patienter, som tager PREZISTA coadministreret med cobicistat.
English: People taking PREZISTA may develop a skin rash.
Danish: Personer, der tager PREZISTA, kan udvikle hududslæt.
English: This protein binding is concentration-dependent indicative for saturation of binding.
Danish: Denne proteinbinding er koncentrationsafhængig, hvilket indicerer, at bindingskapaciteten mættes.
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Danish: Desuden blev AUC for totalt aktivt rifabutin (moderstof + 25-Odesacetyl metabolit) forøget 1,6 gange, mens Cmax forblev sammenlignelig.
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after boosted PREZISTA given with food.
Danish: Didanosin skal administreres på tom mave, således at det bliver administreret 1 time før eller 2 timer efter boostet PREZISTA, taget sammen med føde.
English: 200 ml bottle
Danish: 200 ml flaske
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Danish: Retningen af pilen ud for hver farmakokinetisk parameter er baseret på 90 % konfidensintervallet for den geometriske middelværdi værende inden for (), under () eller over () 80-125 % intervallet (ikke fastsat (not determined) som ”ND”).
English: Voriconazole should not be combined with boosted PREZISTA unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Danish: Voriconazol bør ikke kombineres med boostet PREZISTA, medmindre en risk/benefitvurdering retfærdiggør brug af voriconazol.
English: The PREZISTA 800 milligram tablets are available in packs containing one bottle or three bottles per carton.
Danish: PREZISTA 800 mg tabletter fås i pakninger med 1 beholder eller 3 beholdere pr. æske.
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Danish: DRESS (hududslæt med eosinofili og systemiske symptomer) og Stevens-Johnsons syndrom er rapporteret i sjældne tilfælde (< 0,1 %), og efter markedsføringen er toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose blevet rapporteret.
English: PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Danish: PREZISTA 400 mg og 800 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer til behandling af hiv-1-infektion hos voksne og pædiatriske patienter fra en alder af 3 år og en legemsvægt på mindst 40 kg:
English: Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients receive rifabutin at doses other than 300 mg/day.
Danish: På baggrund af en farmakokinetisk model er det også relevant at reducere dosis med 75 % hos patienter, der får rifabutin i andre doser end 300 mg/dag.
English: Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen.
Danish: Der er forskellige tabletstyrker tilgængelige, din læge kan derfor have ordineret en bestemt kombination af tabletter for at opnå den korrekte dosis.
English: Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment.
Danish: Relevante laboratorieundersøgelser bør udføres før indledning af behandling med PREZISTA/ritonavir, og patienterne bør monitoreres under behandlingen.
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA.
Danish: Lægemiddelinduceret hepatitis (f.eks. akut hepatitis, cytolytisk hepatitis) er blevet rapporteret efter anvendelse af PREZISTA.
English: Poly(vinyl alcohol) - partially hydrolysed Macrogol 3350
Danish: Polyvinylalkohol - delvist hydrolyseret Macrogol 3350
English: - Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Danish: - atorvastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Interaction table Interaction studies have only been performed in adults.
Danish: Interaktionstabel Interaktionsstudier er kun udført hos voksne.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with PREZISTA/ritonavir.
Danish: Under det kliniske udviklingsprogram med darunavir/ritonavir (N=3.063) rapporteredes hepatitis hos 0,5 % af patienterne, der fik antiretroviral kombinationsbehandling med PREZISTA/ritonavir.
English: • In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA
Danish: ● Hos ART-erfarne patienter uden DRV-RAMs*, som har plasma-hiv-1-RNA
English: PREZISTA/cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Danish: PREZISTA/cobicistat kan i modsætning hertil øge plasmakoncentrationen af methadon (se produktresuméet for cobicistat).
English: Hydroxypropylcellulose Microcrystalline cellulose Carmellose sodium
Danish: Hydroxypropylcellulose Mikrokrystallinsk cellulose Carmellosenatrium
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Danish: Derfor kan fortrængning af lægemidler, der i udstrakt grad bindes til surt 1-glykoprotein, ikke udelukkes (se pkt.
English: based on published data with darunavir/ritonavir
Danish: baseret på offentliggjorte data med darunavir/ritonavir
English: As limited information is available on the use of PREZISTA in patients aged 65 and over, caution should be exercised in the administration of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Danish: Da der kun foreligger begrænsede oplysninger om brug af PREZISTA til patienter over 65 år, skal der udvises forsigtighed ved administration af PREZISTA til ældre patienter, for hvilke der skal tages højde for den højere forekomst af nedsat leverfunktion, samtidige sygdomme og andre behandlinger (se pkt.
English: darunavir Cmax ↓ 15%
Danish: darunavir Cmin ↓ 31 %
English: The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Danish: PREZISTAs sikkerhed og virkning sammen med 100 mg ritonavir og andre HIV-PI (f.eks. (fos)amprenavir, nelfinavir og tipranavir) er ikke klarlagt hos hiv-patienter.
English: Manufacturer Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Danish: Fremstiller Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgien
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with PREZISTA should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Danish: Derfor skal mærkningen af hvert lægemiddel, som administreres sammen med PREZISTA, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration.
English: Didanosine is to be administered on an empty stomach, thus it should be administered 1 hour before or 2 hours after PREZISTA/ritonavir given with food.
Danish: Didanosin skal administreres på tom mave, således at det bliver administreret 1 time før eller 2 timer efter PREZISTA/ritonavir, taget sammen med føde.
English: The dose of cobicistat to be used with PREZISTA has not been established in this patient population.
Danish: Dosen af cobicistat til administration sammen med PREZISTA er ikke blevet fastlagt hos denne patientpopulation.
English: sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Danish: totalt aktivt rifabutin (moderstof + 25-O-desacetylmetabolit)
English: White to off-white opaque suspension
Danish: Hvid til offwhite opaliserende suspension.
English: What you need to know before you take PREZISTA
Danish: Det skal du vide, før du begynder at tage PREZISTA
English: A
Danish: Et
English: based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Danish: baseret på offentliggjorte data med darunavir/ritonavir rosuvastatin AUC ↑ 93 % rosuvastatin Cmax ↑ 277 % rosuvastatin Cmin ND
English: Twice daily dosing Weight
Danish: Dosering to gange dagligt Legemsvægt
English: Interactions between PREZISTA/ritonavir and antiretroviral and non-antiretroviral medicinal products are listed in the table below.
Danish: Interaktioner mellem PREZISTA/ritonavir og antiretrovirale og non-antiretrovirale lægemidler er opført i tabellen nedenfor.
English: Ethinylestradiol Norethindrone 35 g/1 mg once daily
Danish: Ethinylestradiol Norethindron 35 g/1 mg x 1
English: PREZISTA/ritonavir should not be used in children with a body weight of less than 15 kg as the dose for this population has not been established in a sufficient number of patients (see section 5.1).
Danish: PREZISTA/ritonavir bør ikke anvendes til børn med en legemsvægt under 15 kg, da dosis til denne population ikke er påvist hos tilstrækkeligt mange patienter (se pkt.
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with PREZISTA/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Danish: I løbet af det kliniske udviklingsprogram (N=2.613 behandlingserfarne forsøgspersoner, som indledte behandling med PREZISTA/ritonavir 600/100 mg to gange dagligt), fik 51,3 % af deltagerne mindst en bivirkning.
English: These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the PREZISTA/ritonavir arm having HIV-1 RNA < 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Danish: Disse resultater blev bekræftet ved analysen af data efter 96 ugers behandling i TITAN-studiet, idet 60,4 % af patienterne i PREZISTA/ritonavir-armen havde hiv1-RNA < 50 kopier/ml sammenlignet med 55,2 % i lopinavir/ritonavir-armen ved uge 96 [forskel: 5,2 %; 95 % CI (-2,8; 13,1)]
English: Pregnant or breast-feeding mothers should not take PREZISTA with ritonavir unless specifically directed by the doctor.
Danish: Gravide eller ammende mødre bør ikke tage PREZISTA sammen med ritonavir, medmindre lægen specifikt har foreskrevet det.
English: In addition, patients on a stable dose of these antidepressants who start treatment with boosted PREZISTA should be monitored for antidepressant response.
Danish: Ydermere skal patienter, der får en stabil dosis af disse antidepressiva, og som starter behandling med boostet PREZISTA, monitoreres for antidepressivt respons.
English: - Take your other HIV medicines used in combination with PREZISTA and ritonavir as recommended by your doctor.
Danish: - Tag din anden hiv-medicin, der skal bruges sammen med PREZISTA og ritonavir, som din læge anbefaler det.
English: PREZISTA oral suspension contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).
Danish: PREZISTA oral suspension indeholder natriummethylparahydroxybenzoat (E219), som kan give allergiske reaktioner (kan være forsinkede).
English: PREZISTA tablets Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Danish: PREZISTA tabletter Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italien
English: The child must eat a meal or a snack within 30 minutes prior to taking PREZISTA and ritonavir.
Danish: Barnet skal indtage et måltid eller et mellemmåltid inden for 30 minutter, før det tager PREZISTA og ritonavir.
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Tilregning af LOCF (sidste udførte observation) 95 % konfidensintervaller.
English: The use of 75 mg and 150 mg tablets to achieve the recommended dose is appropriate when there is a possibility of hypersensitivity to specific colouring agents, or difficulty in swallowing the 300 mg or 600 mg tablets.
Danish: Anvendelse af 75 mg og 150 mg tabletter til at opnå den anbefalede dosis er hensigtsmæssig, når der foreligger risiko for overfølsomhed over for specifikke farvestoffer eller ved besvær med at synke tabletterne på 300 mg eller 600 mg.
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of PREZISTA/ritonavir 800/100 mg once daily was 162.5 weeks.
Danish: Ingen nye sikkerhedsfund blev identifieret i 192ugers-analysen af behandlingsnaive forsøgspersoner, hvor den gennemsnitlige behandlingstid med PREZISTA/ritonavir 800/100 mg en gang dagligt var 162,5 uger.
English: Concentrations of voriconazole may increase or decrease when co-administered with PREZISTA co-administered with cobicistat.
Danish: Koncentrationen af voriconazol kan øges eller nedsættes ved co-administration med PREZISTA co-administreret med cobicistat.
English: Instructions for children - The child must take PREZISTA always together with ritonavir.
Danish: Anvisninger for børn - Barnet skal altid tage PREZISTA sammen med ritonavir.
English: Lidocaine (systemic) Mexiletine
Danish: Lidocain (systemisk)
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when PREZISTA co-administered with low dose ritonavir is given in combination with efavirenz.
Danish: Klinisk monitorering for centralnervesystemstoksicitet i forbindelse med øget eksponering for efavirenz kan være indiceret, når PREZISTA administreret sammen med lavdosis ritonavir gives i kombination med efavirenz.
English: When administered without food, the relative bioavailability of darunavir in the presence of low dose ritonavir is 30% lower as compared to intake with food.
Danish: Ved administration uden indtagelse af mad er den relative biotilgængelighed af darunavir ved tilstedeværelse af lavdosis ritonavir 30 % lavere sammenlignet med administration med mad.
English: PREZISTA might increase sugar levels in the blood.
Danish: PREZISTA kan forhøje blodsukkerniveauet.
English: In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Danish: I de fleste tilfælde kan PREZISTA tages sammen med hiv-medicin, der tilhører en anden gruppe (f.eks. NRTI (nukleosid revers-transkriptase-hæmmere), NNRTI (non-nukleosid revers-transkriptasehæmmere), CCR5-antagonister og FI (fusionshæmmere)).
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with boosted PREZISTA.
Danish: Det anbefales at monitorere INR (International normaliseret ratio), når warfarin kombineres med boostet PREZISTA.
English: C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Danish: C-darunavir med ritonavir-dosis på 400/100 mg kunne 79,5 % og 13,9 % af den administrerede dosis af
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Danish: I et enkeltarmet studie, som undersøgte darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt og andre antiretrovirale midler, afbrød 2,2 % af patienterne behandlingen på grund af udslæt.
English: When PREZISTA is coadministered with a drospirenonecontaining product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Danish: Når PREZISTA gives sammen med et præparat, der indeholder drospirenon, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 g intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 82-89%).
Danish: Fluticason: I et klinisk studie hvor ritonavir 100 mg kapsler to gange dagligt blev administreret samtidig med 50 µg intranasalt fluticasonpropionat (4 gange dagligt) i 7 dage hos raske forsøgspersoner, steg plasmaniveauerne af fluticasonpropionat signifikant, hvorimod de naturlige kortisolniveauer faldt med ca. 86 % (90 % konfidensinterval 82-89 %).
English: Even if you feel better, do not stop taking PREZISTA and ritonavir without talking to your doctor.
Danish: Selvom du får det bedre, må du ikke stoppe med at tage PREZISTA og ritonavir uden først at tale med din læge.
English: PREZISTA in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Danish: PREZISTA i kombination med ritonavir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Danish: I begge arme anvendtes et fast baggrundsregime, der bestod af tenofovirdisoproxilfumarat 300 mg en gang dagligt og emtricitabin 200 mg en gang dagligt.
English: The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Danish: Den absolutte, orale biotilgængelighed af en enkeltdosis darunavir på 600 mg var ca. 37 %, og den steg til ca. 82 % ved tilstedeværelse af 100 mg ritonavir to gange dagligt.
English: C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Danish: C-darunavir med ritonavir viste, at ca. 7,7 % af den administrerede dosis darunavir udskilles uomdannet i urinen.
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Danish: KORTIKOSTEROIDER Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison, triamcinolon)