FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with REZOLSTA will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection.
Danish: Behandling med REZOLSTA forbedrer dit immunforsvar (kroppens naturlige forsvarssystem) og nedsætter risikoen for at udvikle sygdomme, der er forbundet med hiv-infektion.
English: Caution should be exercised when clarithromycin is combined with REZOLSTA.
Danish: Der skal udvises forsigtighed, når clarithromycin kombineres med REZOLSTA.
English: It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.
Danish: Du må ikke amme, hvis du har hiv, både fordi der er en risiko for, at dit spædbarn kan blive smittet med hiv via mælken, og fordi medicinens virkning på dit barn ikke kendes.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Danish: Darunavir metaboliseres i udstrakt grad via det hepatiske CYP-system og næsten udelukkende af isozymet CYP3A4.
English: The rash is usually mild to moderate.
Danish: Udslættet er sædvanligvis let til moderat.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of REZOLSTA treatment.
Danish: Monitorering for forhøjet ASAT/ALAT bør overvejes hos patienter med underliggende kronisk hepatitis eller cirrose og hos patienter med forhøjede aminotransferaser før behandlingen - specielt i de første mange måneder af REZOLSTA-behandling.
English: Therefore, protein displacement of medicinal products highly bound to 1-acid glycoprotein cannot be ruled out (see section 4.5).
Danish: Derfor kan displacering af lægemidler, der i udstrakt grad bindes til surt 1-glykoprotein, ikke udelukkes (se pkt.
English: During the clinical development program (N = 3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Danish: Under det kliniske udviklingsprogram (N=3.063) rapporteredes hepatitis hos 0,5 % af de patienter, der fik antiretroviral kombinationsbehandling med darunavir/ritonavir.
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Danish: Gentagen administration af darunavir til rotter forårsagede induktion af mikrosomale enzymer i leveren og øgede eliminationen af tyroide hormoner, som prædisponerer rotter, men ikke mennesker, for tyroide neoplasmer.
English: Based on the different elimination pathways of the other NRTIs (i.e. emtricitabine, lamivudine, stavudine and zidovudine) that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP, no interactions are expected for these medicinal compounds and REZOLSTA.
Danish: På grund af forskellig eliminationsvej for de andre NRTI-midler (dvs. emtricitabin, lamivudin, stavudin og zidovudin), der primært udskilles via nyrerne, og abacavir, hvis metabolisering ikke medieres af CYP, forventes der ikke nogen lægemiddelinteraktioner mellem disse lægemidler og REZOLSTA.
English: Darunavir Results from a mass balance study with
Danish: Darunavir Resultater af et massebalancestudie med
English: Based on animal studies, no effect on mating or fertility is expected with REZOLSTA.
Danish: Baseret på dyrestudier forventes der ingen effekt på parring eller fertilitet i forbindelse med REZOLSTA.
English: This protein binding is concentration dependent indicative for saturation of binding.
Danish: Denne proteinbinding er koncentrationsafhængig, hvilket indikerer, at bindingskapaciteten mættes.
English: Other medicines and REZOLSTA Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med REZOLSTA Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: The plastic bottle comes with a child resistant cap and must be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Danish: Plastbeholderen er forsynet med et børnesikret låg og skal åbnes således: Tryk plastskruelåget nedad, samtidig med at det drejes mod uret.
English: Darunavir given with low dose ritonavir may be considered as an alternative.
Danish: Darunavir i kombination med en lav dosis ritonavir kan overvejes som et alternativ.
English: Side effects with unknown frequency: a rash may become severe or potentially life-threatening: - rash with blisters and peeling skin over much of the body - red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever.
Danish: Bivirkninger med ukendt hyppighed: et udslæt kan blive alvorligt eller muligvis livstruende: - udslæt med blærer og afskalning af huden over en stor del af kroppen - rødt udslæt med små, pusfyldte knopper, der kan sprede sig over hele kroppen; nogle gange med feber.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking REZOLSTA.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager REZOLSTA.
English: All of these serious ADRs occurred in one (0.1%) subject except for rash in 4 (0.6%) subjects.
Danish: Disse alvorlige bivirkninger forekom alle hos én patient (0,1 %) med undtagelse af udslæt, som forekom hos 4 patienter (0,6 %).
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 darunavirdosis udskilles uomdannet i urinen.
English: Severe hepatic impairment could result in an increase of darunavir and/or cobicistat exposure and a worsening of its safety profile.
Danish: Alvorlig leverfunktionsnedsættelse kan medføre øget eksponering for darunavir og/eller cobicistat og forværring af deres sikkerhedsprofil.
English: (CYP3A inhibition) Concentrations of clarithromycin may be increased upon co-administration with REZOLSTA.
Danish: (CYP3A-hæmning) Koncentrationen af clarithromycin øges muligvis ved coadministration med REZOLSTA.
English: Pharmacokinetics of cobicistat have not been fully evaluated in older people (65 years of age and older).
Danish: Cobicistat Cobicistats farmakokinetik er ikke fuldt evalueret hos ældre patienter (over 65 år).
English: The safety and efficacy of REZOLSTA, darunavir, or cobicistat have not been established in patients with severe underlying liver disorders.
Danish: Sikkerheden og virkningen af REZOLSTA, darunavir eller cobicistat er ikke blevet fastslået hos patienter med alvorlige, underliggende leversygdomme.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis B eller C, har en øget risiko for leverfunktionsanomalier, herunder alvorlige og potentielt dødelige leverbivirkninger.
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir when co-administered with ritonavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Danish: Ved de højeste af de testede doser var den systemiske eksponering (baseret på AUC) for darunavir ved co-administration med ritonavir mellem 0,4 og 0,7 gange (mus) og 0,7 og 1 gang (rotter) sammenlignet med den, der blev observeret hos mennesker ved de anbefalede terapeutiske doser.
English: reactivation of herpes simplex and herpes zoster has been observed in clinical trials with darunavir co-administered with low dose ritonavir.
Danish: Derudover er der observeret reaktivering af herpes simplex og herpes zoster i kliniske studier med darunavir co-administreret med lavdosis ritonavir.
English: What you need to know before you take REZOLSTA
Danish: Det skal du vide, før du begynder at tage REZOLSTA
English: The resistance profile of REZOLSTA is driven by darunavir.
Danish: Resistensprofilen for REZOLSTA skyldes darunavir.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with REZOLSTA has not been established.
Danish: En sikker og effektiv dosis af sildenafil til behandling af pulmonal arteriel hypertension co-administreret med REZOLSTA er ikke fastlagt.
English: Description of clinical studies of darunavir/ritonavir in adults
Danish: Beskrivelse af kliniske studier med darunavir/ritonavir hos voksne
English: Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
Danish: Enkeltdoser op til 3.200 mg darunavir som oral opløsning alene og op til 1.600 mg som tabletformulering i kombination med ritonavir er blevet givet til raske, frivillige forsøgspersoner uden nogen utilsigtede, symptomatiske virkninger.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with REZOLSTA is required.
Danish: Dosisreduktion eller afbrydelse af colchicin anbefales hos patienter med normal nyre- og leverfunktion, hvis behandling med REZOLSTA er nødvendig.
English: Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs.
Danish: Der er blevet udført toksikologiske dyrestudier ved eksponeringer op til kliniske eksponeringsniveauer med darunavir administreret alene hos mus, rotter og hunde og i kombination med ritonavir hos rotter og hunde.
English: Darunavir was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation (Ames), chromosomal aberration in human lymphocytes and in vivo micronucleus test in mice.
Danish: Darunavir var ikke mutagent eller genotoksisk i en række in vitro- og in vivo-analyser, herunder bakteriel revers mutation (Ames), kromosomafvigelse i humane lymfocytter og in vivo mikronukleustest hos mus.
English: - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Danish: - ciclosporin, everolimus, tacrolimus, sirolimus (til dæmpning af immunforsvaret), da virkningen eller bivirkningerne af disse lægemidler kan blive forstærket.
English: Please see section ‘Other medicines and REZOLSTA'.
Danish: Se afsnittet 'Brug af anden medicin sammen med REZOLSTA'.
English: When REZOLSTA is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Danish: Når REZOLSTA coadministreres med et lægemiddel, som indeholder drospirenon, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
English: REZOLSTA must not be used with another antiviral medicine that contains a booster or another antiviral that requires boosting.
Danish: REZOLSTA må ikke tages sammen med et andet antiviralt lægemiddel, der allerede indeholder en forstærker, eller et andet antiviralt lægemiddel, der kræver forstærkning.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking REZOLSTA.
Danish: Omhyggelig monitorering af patienten og justering af metformindosis anbefales, hvis patienten får REZOLSTA.
English: Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Danish: Patienter med hæmofili skal derfor være opmærksomme på risikoen for øget blødningstendens.
English: It is, therefore, important to talk to your doctor if you develop a rash.
Danish: Derfor er det vigtigt, at du taler med lægen, hvis du får udslæt.
English: When administered with food, the relative exposure of darunavir is 1.7-fold higher as compared to intake without food.
Danish: Den relative eksponering for darunavir er 1,7 gang højere ved administration i forbindelse med et måltid i forhold til indtagelse uden mad.
English: REZOLSTA can be co-administered with H2-receptor antagonists without dose adjustments.
Danish: REZOLSTA kan coadministreres med H2receptorantagonister uden dosisjusteringer.
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to HIV PIs in virologic failures at endpoint in the GS-US-216-130, ARTEMIS and ODIN trials.
Danish: Tabellen nedenfor viser udvikling af hiv-1-protease-mutationer og tab af følsomhed for hiv-PI'er i forbindelse med virologisk svigt ved endepunktet i studierne GS-US-216-130, ARTEMIS og ODIN.
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily)
Danish: ØSTROGENBASERET PRÆVENTION Drospirenon (3 mg en gang dagligt)
English: Since darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substances.
Danish: Da darunavir og cobicistat i høj grad er proteinbundet, vil dialyse sandsynligvis ikke være effektiv til fjernelse af de aktive stoffer i tilstrækkelig grad.
English: Interaction not studied with any of the components of REZOLSTA.
Danish: Interaktion er ikke undersøgt, hvad angår indholdsstofferne i REZOLSTA.
English: In repeated-dose toxicology studies in mice, rats and dogs, there were only limited effects of treatment with darunavir.
Danish: I toksikologistudier med gentagne doser hos mus, rotter og hunde var der kun begrænsede virkninger af darunavirbehandling.
English: As limited information is available on the use of REZOLSTA in patients aged 65 and over, caution should be exercised, 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 REZOLSTA til patienter over 65 år, skal der udvises forsigtighed, og der skal tages højde for den hyppigere forekomst af nedsat leverfunktion, samtidige sygdomme og andre behandlinger (se pkt.
English: Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Danish: Cobicistat er en mekanismebaseret hæmmer af cytochrom P450 i CYP3A subfamilien.
English: Number of subjects with virologic failure and phenotype data that show a loss of susceptibility to PIs at endpoint compared to baseline d, n/N
Danish: Antal patienter med virologisk svigt og fænotypedata, der viser tab af følsomhed for PI'er ved endepunktet sammenlignet med baseline d, n/N
English: Immune system disorders Common
Danish: Immunsystemet almindelig
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Danish: Cobicistats hæmning af CYP3A-medieret metabolisme øger den systemiske eksponering for CYP3A-substrater, såsom darunavir, hvor biotilgængeligheden er begrænset og halveringstiden forkortet på grund af den CYP3A-afhængige metabolisme.
English: Number of subjects with virologic failure and genotype data that develop mutations c at endpoint, n/N
Danish: Antal patienter med virologisk svigt og genotypedata, der udviklede mutationer c ved endepunktet, n/N
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Danish: Cobicistat hæmmer transportørerne P-glykoprotein (P-gp), BCRP, MATE1, OATP1B1 og OATP1B3.
English: Limited information is available in this population, and therefore, REZOLSTA should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Danish: Der foreligger kun begrænsede oplysninger for denne population, og REZOLSTA skal derfor anvendes med forsigtighed til patienter over 65 år (se pkt.
English: Darunavir and cobicistat are metabolised by CYP3A.
Danish: Darunavir og cobicistat metaboliseres via CYP3A.
English: Clinical monitoring is recommended when co-administering REZOLSTA with these sedatives/hypnotics and a lower dose of the sedatives/hypnotics should be considered.
Danish: Klinisk monitorering anbefales ved co-administration af REZOLSTA og disse sedativa/hypnotika, og det bør overvejes at give en lavere dosis af disse sedativa/hypnotika.
English: Lovastatin, simvastatin, and lomitapide to lower cholesterol levels
Danish: Lovastatin, simvastatin og lomitapid til nedsættelse af kolesterol i blodet
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Danish: Virkningen af svært nedsat leverfunktion (ChildPugh klasse C) på cobicistats farmakokinetik er ikke undersøgt.
English: The combination may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombination kan medføre øget risiko for kardiovaskulære bivirkninger af salmeterol inklusive QT-forlængelse, palpitationer og sinustakykardi.
English: The film-coating contains polyvinyl alcoholpartially hydrolyzed, titanium dioxide, polyethylene glycol (macrogol), talc, iron oxide red, and iron oxide black.
Danish: Filmovertrækket indeholder polyvinylalkohol (delvist hydrolyseret), titandioxid, polyethylenglycol (macrogol), talcum, rød jernoxid og sort jernoxid.
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Danish: Indehaver af markedsføringstilladelsen Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgien
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with REZOLSTA.
Danish: Den anbefalede dosis af emtricitabin/tenofoviralafenamid er 200/10 mg en gang dagligt ved brug sammen med REZOLSTA.
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 REZOLSTA 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 REZOLSTA, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration.
English: Based on theoretical considerations dolutegravir is not expected to affect the pharmacokinetics of REZOLSTA.
Danish: Baseret på teoretiske overvejelser forventes det ikke, at dolutegravir påvirker farmakokinetikken af REZOLSTA.
English: The table below shows the 48-week efficacy data of the darunavir/cobicistat arm of the TMC114FD2HTX3001 trial:
Danish: Tabellen nedenfor viser effektdata for darunavir/cobicistat-armen ved uge 48 fra TMC114FD2HTX3001-studiet:
English: In some patients with advanced HIV infection and a history of unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion, som tidligere har haft usædvanlige infektioner på grund af et svækket immunforsvar (opportunistiske infektioner), kan tegn og symptomer på betændelse fra tidligere infektioner vise sig kort efter påbegyndelse af hiv-behandling.
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 l (Mean ± SD) and increased to 131 ± 49.9 l (Mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Danish: Efter intravenøs administration var distributionsvolumen for darunavir administreret alene 88,1 ± 59,0 l (gennemsnit ± SD) og steg til 131 ± 49,9 l (gennemsnit ± SD) ved kombination med 100 mg ritonavir to gange dagligt.
English: REZOLSTA is, therefore, contraindicated in patients with severe hepatic impairment.
Danish: REZOLSTA er derfor kontraindiceret til patienter med svært nedsat leverfunktion.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, men risikoen er nedsat ved effektiv antiretroviral terapi (medicin mod retrovirus, f.eks. hiv).
English: Co-administration of darunavir/cobicistat and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Danish: Co-administration af darunavir/cobicistat med lægemidler, der primært metaboliseres af CYP3A, kan forårsage øget systemisk eksponering for sådanne lægemidler, hvilket kan øge eller forlænge både den terapeutiske virkning og bivirkninger.
English: Based on the very limited renal elimination of cobicistat and darunavir, no special precautions or dose adjustments of REZOLSTA are required for patients with renal impairment.
Danish: På grund af cobicistats og darunavirs meget begrænsede renale elimination, kræves der ingen særlige forholdsregler eller dosisjusteringer af REZOLSTA hos patienter med nedsat nyrefunktion.
English: Treatment with REZOLSTA during pregnancy results in low darunavir exposure.
Danish: Behandling med REZOLSTA under graviditet fører til lav eksponering for darunavir.
English: The overall safety profile of REZOLSTA is based on available clinical trial data from darunavir boosted with either cobicistat or ritonavir, from cobicistat and from post-marketing data from darunavir/ritonavir.
Danish: Den samlede sikkerhedsprofil for REZOLSTA er baseret på tilgængelige kliniske studiedata fra darunavir boosted med enten cobicistat eller ritonavir, fra cobicistat og fra data for darunavir/ritonavir efter markedsføringen.
English: The activity of cobicistat as a pharmacokinetic enhancer to darunavir has been demonstrated in pharmacokinetic trials.
Danish: Cobicistats aktivitet som farmakokinetisk forstærker af darunavir er blevet påvist i farmakokinetiske studier.
English: Patients should be instructed to take REZOLSTA within 30 minutes after completion of a meal (see sections 4.4, 4.5 and 5.2).
Danish: Patienterne bør informeres om at tage REZOLSTA inden for 30 minutter efter indtagelse af et måltid (se pkt.
English: If concomitant use of REZOLSTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Danish: Hvis samtidig brug af REZOLSTA og sildenafil, vardenafil eller tadalafil er indiceret, anbefales det at give en enkeltdosis sildenafil på højst 25 mg i løbet af 48 timer, en enkeltdosis vardenafil på højst 2,5 mg i løbet af 72 timer eller en enkeltdosis tadalafil på højst 10 mg i løbet af 72 timer.
English: In rodents the target organs identified were the haematopoietic system, the blood coagulation system, liver and thyroid.
Danish: Hos gnavere var de identificerede målorganer det hæmatopoietiske system, blodkoagulationssystemet, leveren og skjoldbruskkirtlen.
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.