FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical relevance of this increase is unknown, therefore, darunavir/ritonavir should be used with caution.
Danish: Den kliniske relevans af denne stigning kendes ikke, og darunavir/ritonavir bør derfor anvendes med forsigtighed.
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Danish: * DRV-RAM: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
English: Following oral administration of
Danish: Efter oral administration af
English: Do not combine REZOLSTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Danish: Du må ikke tage REZOLSTA sammen med følgende lægemidler Hvis du tager et af disse lægemidler, skal du tale med din læge om at skifte til anden medicin.
English: - Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
Danish: - Fortæl straks din læge, hvis du bemærker nogen symptomer på infektion (f.eks. forstørrede lymfeknuder eller feber).
English: Darunavir belongs to a group of HIV medicines called ‘protease inhibitors' which work by reducing the amount of HIV in your body to a very low level.
Danish: Darunavir tilhører en gruppe hiv-lægemidler, der kaldes proteasehæmmere, som virker ved at reducere mængden af hiv i kroppen til et meget lavt niveau.
English: Studies in animals have demonstrated that cobicistat is excreted in milk.
Danish: Dyrestudier har vist, at cobicistat udskilles i mælk.
English: Your doctor should do blood tests before you start REZOLSTA.
Danish: Din læge vil tage nogle blodprøver, før du starter behandling med REZOLSTA.
English: An increase in serum creatinine due to the inhibitory effect of cobicistat generally does not exceed 0.4 mg/dl.
Danish: En stigning i serumkreatinin på grund af cobicistats hæmmende virkning overstiger normalt ikke 0,4 mg/dl.
English: The median terminal plasma half-life of cobicistat following administration of REZOLSTA is approximately 3-4 hours.
Danish: Cobicistats mediane terminale plasmahalveringstid efter administration af REZOLSTA er ca. 3-4 timer.
English: REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older.
Danish: REZOLSTA er indiceret, i kombination med andre antiretrovirale lægemidler, til behandling af humant immundefektvirus 1 (hiv-1)-infektion hos voksne over 18 år.
English: If REZOLSTA is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis REZOLSTA coadministreres med parenteral midazolam, skal det foregå på en intensivafdeling eller i lignende rammer, der sikrer en tæt klinisk monitorering og passende medicinsk håndtering i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Second trimester of pregnancy N=7
Danish: Andet trimester af graviditeten (n = 7)
English: Do not use this medicine after 6 weeks of first opening the bottle.
Danish: Brug ikke dette lægemiddel senere end 6 uger efter første åbning af beholderen.
English: If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems.
Danish: Hvis du har kronisk hepatitis B eller C, skal du oftere til blodprøvekontrol hos lægen, fordi du har en øget risiko for at få leverproblemer.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take REZOLSTA.
Danish: Din læge kan vurdere, hvor alvorlig din leversygdom er, inden han eller hun beslutter, om du kan tage REZOLSTA.
English: Nervous system disorders Very common headache
Danish: Nervesystemet meget almindelig hovedpine
English: There are some medicines that you must not combine with REZOLSTA.
Danish: Nogle typer medicin må du ikke tage sammen med REZOLSTA.
English: Psychiatric disorders Common abnormal dreams
Danish: Psykiske forstyrrelser almindelig unormale drømme
English: REZOLSTA is used to treat adults 18 years or older who are infected by HIV (see How to take REZOLSTA).
Danish: REZOLSTA anvendes til at behandle voksne over 18 år, som er smittet med hiv (se afsnittet Sådan skal du tage REZOLSTA).
English: Very common side effects (may affect more than 1 in 10 people) - headache - diarrhoea, nausea.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - hovedpine - diarré, kvalme.
English: Investigations Common increased blood creatinine
Danish: Undersøgelser almindelig forhøjet kreatinin i blodet
English: Cobicistat does not select any HIV resistance mutations, due to its lack of antiviral activity.
Danish: Cobicistat selekterer ingen hiv-resistente mutationer på grund af dets manglende antivirale aktivitet.
English: The dosage of other medicines might need to be changed since either their own or REZOLSTA's therapeutic effect or side effects may be influenced when combined.
Danish: Doseringen af anden medicin skal muligvis ændres, da virkningen eller bivirkningerne af enten denne eller REZOLSTA kan blive påvirket, når de kombineres.
English: In the dog, no major toxicity findings or target organs were identified up to exposures equivalent to clinical exposure at the recommended dose.
Danish: Hos hunde blev der ikke identificeret nogen vigtige toksicitetsfund eller målorganer ved eksponeringer op til klinisk eksponering ved den anbefalede dosis.
English: - In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: - Ud over de opportunistiske infektioner kan autoimmune lidelser (lidelser, der skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
English: - Take your other HIV medicines used in combination with REZOLSTA as recommended by your doctor.
Danish: - Tag din anden hiv-medicin, der skal tages i kombination med REZOLSTA, efter din læges anvisninger.
English: At present the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically relevant;
Danish: Aktuelt synes raltegravirs påvirkning af darunavirs plasmakoncentration ikke at være klinisk relevant.
English: In GS-US-216-130 baseline phenotype was not available
Danish: I GS-US-216-130 var baseline-fænotype ikke tilgængelig
English: Your doctor will advise you how to deal with your symptoms or whether REZOLSTA must be stopped.
Danish: Din læge vil rådgive dig om, hvad du skal gøre ved symptomerne, eller om du skal holde op med at tage REZOLSTA.
English: C-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
Danish: C-cobicistat blev 86 % og 8,2 % af dosis genfundet i henholdsvis fæces og urin.
English: Systemic dexamethasone should be used with caution when combined with REZOLSTA.
Danish: Systemisk dexamethason skal anvendes med forsigtighed ved kombination med REZOLSTA.
English: Increased monitoring for rifabutin associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Danish: Øget overvågning for rifabutinassocierede bivirkninger herunder neutropeni og uveitis er nødvendig på grund af en forventet øget eksponering for rifabutin.
English: There is no specific antidote for overdose with REZOLSTA.
Danish: Der findes ingen specifik antidot mod REZOLSTA.
English: Ethinylestradiol (0.02 mg once daily)
Danish: Ethinylestradiol (0,02 mg en gang dagligt)
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes REZOLSTA should not be used in paediatric patients below 3 years of age.
Danish: På grund af usikkerheden omkring udviklingshastigheden af blod-hjerne-barrieren og leverenzymer hos mennesket bør REZOLSTA ikke bruges til pædiatriske patienter under 3 år.
English: Third trimester of pregnancy N=6
Danish: Tredje trimester af graviditeten (n = 6)
English: Therefore, REZOLSTA tablets should be taken with food.
Danish: REZOLSTA bør derfor indtages med mad.
English: Studies in rats have demonstrated that darunavir is excreted in milk and at high levels (1,000 mg/kg/day) resulted in toxicity.
Danish: Rottestudier har vist, at darunavir udskilles i mælk, og høje niveauer (1.000 mg/kg/dag) medførte toksicitet.
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Danish: Der er identificeret mindst 3 oxidative metabolitter af darunavir hos mennesker, som alle viste en aktivitet over for vildtype hiv, der var mindst 10 gange mindre end darunavirs aktivitet.
English: Cobicistat is 97 to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Danish: Cobicistat er 97-98 % bundet til humane plasmaproteiner, og forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blod var 2.
English: Co-administration of REZOLSTA and rilpivirine can be used without dose adjustments, as the expected increase in rilpivirine concentrations is not considered clinically relevant.
Danish: REZOLSTA og rilpivirin kan co-administreres uden dosisjusteringer, da den forventede stigning i rilpivirinkoncentrationen ikke betragtes som klinisk relevant.
English: C-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Danish: C cobicistat stammede 99 % af den cirkulerende radioaktivitet i plasma fra uomdannet cobicistat.
English: REZOLSTA might increase the risk of bleeding.
Danish: REZOLSTA kan øge risikoen for blødning.
English: In the Phase III single-arm trial (GS-US-216-130), a decrease in eGFRCG was noted at week 2, which remained stable through week 48.
Danish: I et enkelt-armet fase III-studie (GS-US-216-130) blev der i uge 2 rapporteret et fald i eGFRCG, som forblev stabil indtil uge 48.
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Danish: Der foreligger i øjeblikket ikke tilstrækkelige data til at afgøre, om co-administration af tenofovirdisoproxil og cobicistat er forbundet med en større risiko for renale bivirkninger sammenlignet med regimer, der omfatter tenofovirdisoproxil uden cobicistat.
English: Dose adjustment for buprenorphine may not be necessary when co-administered with REZOLSTA but a careful clinical monitoring for signs of opiate toxicity is recommended.
Danish: Dosisjustering af buprenorphin er muligvis ikke nødvendig ved co-administration med REZOLSTA, men omhyggelig klinisk monitorering for tegn på opioidtoksicitet anbefales.
English: The effects of REZOLSTA might be reduced if you take any of the following products.
Danish: Virkningen af REZOLSTA kan blive nedsat, hvis du tager et eller flere af følgende lægemidler.
English: Monitoring of renal function may be indicated when REZOLSTA is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Danish: Monitorering af nyrefunktionen kan være indiceret, når REZOLSTA gives i kombination med tenofovirdisoproxil, især hos patienter med underliggende systemisk eller renal sygdom og hos patienter, der tager nefrotoksiske midler.
English: If you have renal and/or hepatic impairment see section ‘Do not combine REZOLSTA with any of the following medicines'.
Danish: Hvis du har nedsat nyre- og/eller leverfunktion, se afsnittet 'Du må ikke tage REZOLSTA sammen med følgende lægemidler'.)
English: Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg once daily and emtricitabine 200 mg once daily.
Danish: Begge behandlingsarme brugte et fast baggrundsregime bestående af tenofovirdisoproxilfumarat 300 mg en gang dagligt og emtricitabin 200 mg en gang dagligt.
English: Therapy should be initiated by a healthcare provider experienced in the management of HIV infection.
Danish: Behandlingen skal påbegyndes af en læge, der har erfaring med håndtering af hiv-infektion.
English: Imputations according to the Snapshot algorithm.
Danish: I henhold til Snapshot-algoritmen.
English: In a study conducted in rats, the number of corpora lutea and implantations were decreased in the presence of maternal toxicity.
Danish: I et studie med rotter faldt antallet af corpora lutea og implantationssteder ved maternel toksicitet.
English: Studies in animals do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier har ikke vist nogen direkte skadelige virkninger med hensyn til drægtighed, embryo-/fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Tenofovir disoproxil *
Danish: Tenofovirdisoproxil*
English: A long term carcinogenicity study of cobicistat in rats revealed tumourigenic potential specific for this species, that is regarded as of no relevance for humans.
Danish: Et langvarigt karcinogenicitetstudie med cobicistat til rotter viste tumorigent potentiale specifikt for denne art, hvilket ikke betragtes som relevant for mennesker.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Der er rapporteret tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
English: REZOLSTA should not be used in combination with the individual components of REZOLSTA (darunavir or cobicistat).
Danish: REZOLSTA bør ikke anvendes i kombination med de enkelte indholdsstoffer i REZOLSTA (darunavir eller cobicistat).
English: REZOLSTA must therefore not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
Danish: REZOLSTA må derfor ikke kombineres med lægemidler, der er meget afhængige af CYP3A i forbindelse med clearance, og for hvilke øget systemisk eksponering er forbundet med alvorlige og/eller livstruende bivirkninger (snævert terapeutisk indeks) (se pkt.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Danish: Ex vivo-studier hos kaniner og in vivo-studier hos hunde tyder på, at cobicistat har et lavt potentiale for QT-forlængelse, kan forlænge PR-intervallet let og reducere venstre ventrikelfunktion ved gennemsnitskoncentrationer, der er mindst 10 gange højere end den humane eksponering ved den anbefalede daglige dosis på 150 mg.
English: REZOLSTA should not be used in combination with another antiretroviral that requires pharmacoenhancement since dosing recommendations for such combination have not been established.
Danish: REZOLSTA bør ikke anvendes i kombination med et andet antiretroviralt lægemiddel, der kræver farmakokinetisk forstærkning, da der ikke er fastsat doseringsanbefalinger for en sådan kombination.
English: The concomitant use with REZOLSTA may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Danish: Samtidig brug med REZOLSTA kan nødvendiggøre nedsættelse af alfentanildosis og kræver overvågning for risici i forbindelse med forlænget eller forsinket respirationsdepression.
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effect of darunavir.
Danish: Cobicistat har ingen påviselig antiviral aktivitet over for hiv-1 og antagoniserer ikke darunavirs antivirale virkning.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jirovecii (formerly known as Pneumocystis carinii).
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jirovecii (tidligere Pneumocystis carinii).
English: These decreases in eGFRCG were reversible after cobicistat was discontinued and did not affect the actual glomerular filtration rate, as determined by the clearance of probe drug iohexol.
Danish: Disse fald i eGFRCGværdien var reversible efter seponering af cobicistat og påvirkede ikke den faktiske glomerulære filtrationshastighed, bestemt ved clearance af teststoffet iohexol.
English: REZOLSTA has only been used in limited numbers of patients 65 years or older.
Danish: REZOLSTA har kun været anvendt til et begrænset antal patienter over 65 år.
English: These are: - muscle pain, tenderness or weakness.
Danish: Disse omfatter: - muskelsmerter, muskelømhed eller muskelsvaghed.
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving REZOLSTA.
Danish: På grund af risiko for både hiv-transmission og bivirkninger hos ammede spædbørn, skal mødre informeres om, at de under ingen omstændigheder må amme, hvis de behandles med REZOLSTA.
English: Both arms used an optimised background regimen (OBR) of ≥ 2 NRTIs.
Danish: I begge behandlingsarme anvendes et optimeret baggrundsregime (OBR) med ≥ 2 NRTI'er.
English: Concentrations of voriconazole may increase or decrease when co-administered with REZOLSTA.
Danish: Koncentrationen af voriconazol kan øges eller nedsættes ved coadministration med REZOLSTA.
English: Darunavir, cobicistat, or the combination of both have not been studied in patients receiving dialysis, and therefore no recommendation can be made for these patients (see section 5.2).
Danish: Hverken darunavir, cobicistat eller kombinationen af disse er blevet undersøgt hos patienter i dialyse, og der kan derfor ikke gives nogen anbefalinger for disse patienter (se pkt.
English: There are no adequate and well controlled trials with darunavir, or cobicistat, in pregnant women.
Danish: Der er ikke udført tilstrækkelige og velkontrollerede studier med darunavir eller cobicistat hos gravide kvinder.
English: In the table below it is specified when recommendations for REZOLSTA differ from those for darunavir boosted with low dose ritonavir.
Danish: Det er angivet i tabellen nedenfor, hvis anbefalingerne for REZOLSTA er forskellige fra dem for darunavir boostet med lavdosis ritonavir.
English: Caution should be used with co-administration of REZOLSTA and parenteral midazolam.
Danish: Der skal udvises forsigtighed ved co-administration af REZOLSTA og parenteral midazolam.
English: This effect on serum creatinine, leading to a decrease in the estimated creatinine clearance, should be taken into consideration when REZOLSTA is administered to patients, in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
Danish: Denne påvirkning af serumkreatinin, som fører til et fald i den estimerede kreatininclearance, skal tages i betragtning, når REZOLSTA administreres til patienter, hvor den estimerede kreatininclearance anvendes som vejledning for den kliniske behandling, herunder dosisjustering af samtidigt administrerede lægemidler.
English: It is not known whether darunavir or cobicistat are excreted in human milk.
Danish: Det vides ikke, om darunavir eller cobicistat udskilles i human mælk.
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Danish: De observerede hepatocellulære og tyroide tumorer hos gnavere anses for at være af begrænset relevans for mennesker.
English: If switching from ritonavir as a pharmacoenhancer to cobicistat, caution is required during the first two weeks of treatment with REZOLSTA, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer.
Danish: Hvis der skiftes fra ritonavir til cobicistat som farmakokinetisk forstærker, skal der udvises forsigtighed de første to uger af REZOLSTA-behandlingen, især hvis dosis af eventuelle samtidigt administrerede lægemidler er blevet titreret eller justeret, mens ritonavir blev anvendt som farmakokinetisk forstærker.
English: Imputations according to the TLOVR algorithm Based on a normal approximation of the difference in % response Clades A1, D, F1, G, K, CRF02_AG, CRF12_BF, and CRF06_CPX Difference in means
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation til forskellen i % respons Subtype A1, D, F1, G, K, CRF02_AG, CRF12_BF og CRF06_CPX Forskelle i gennemsnit
English: Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side.
Danish: Lyserød, oval tablet på 23 mm x 11,5 mm med ”800” præget på den ene side og ”TG” på den anden side.
English: The recommended dose of maraviroc is 150 mg twice daily when co-administered with REZOLSTA.
Danish: Den anbefalede dosis af maraviroc er 150 mg to gange dagligt ved co-administration med REZOLSTA.
English: When administration of HMG CoA reductase inhibitors and REZOLSTA is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.
Danish: Hvis der er behov for coadministration af en HMG-CoAreduktasehæmmer og REZOLSTA, anbefales det at starte med den lavest mulige dosis og titrere op til den ønskede kliniske virkning samtidig med at sikkerheden overvåges.
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Danish: Darunavirs terminale halveringstid var ca. 15 timer, når det blev givet med ritonavir.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Danish: PHOSPHODIESTERASE-TYPE 5 (PDE-5)-HÆMMERE Til behandling af erektil dysfunktion Sildenafil Tadalafil Vardenafil
English: After 2 years administration of darunavir at exposures at or below the human exposure, kidney changes were observed in mice (nephrosis) and rats (chronic progressive nephropathy).
Danish: Efter 2 års administration af darunavir ved en eksponering på niveau med eller under den humane eksponering blev der observeret renale ændringer hos mus (nefrose) og rotter (kronisk progressiv nefropati).
English: White, high density polyethylene (HDPE) bottle containing 30 tablets, fitted with polypropylene (PP) child resistant closure with induction seal.
Danish: Hvid beholder af polyethylen med høj densitet (HDPE), der indeholder 30 tabletter og er forsynet med børnesikret låg af polypropylen (PP) med induktionsforsegling.
English: It is given with cobicistat, which increases the amount of darunavir in your blood.
Danish: Det gives sammen med cobicistat, som kaldes en forstærker, idet det øger mængden af darunavir i blodet.
English: Darunavir in combination with ritonavir caused a reduction in the number of pups that exhibited the startle response on day 15 of lactation and a reduced pup survival during lactation.
Danish: Darunavir i kombination med ritonavir medførte et fald i antallet af unger, der udviste forskrækkelsesrespons på dag 15 af diegivningen og en reduceret overlevelse for ungerne i diegivningsperioden.