FrancophonIA/ELRC3.0 huggingface dataset:
English: After day 23 of life, the exposure was comparable to that in adult rats.
Danish: I en alder på over 23 dage var eksponeringen sammenlignelig med eksponeringen hos voksne rotter.
English: Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Danish: Administration af darunavir forårsagede ikke en statistisk signifikant stigning i incidensen af andre benigne eller maligne neoplasmer hos mus eller rotter.
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 så har en øget risiko for at få leverproblemer.
English: People taking Darunavir Krka may still develop infections or other illnesses associated with HIV infection.
Danish: Personer, der tager Darunavir Krka, kan stadig udvikle infektioner eller andre sygdomme forbundet med hiv-infektion.
English: Maximum plasma concentration of darunavir in the presence of low dose ritonavir is generally achieved within 2.5-4.0 hours.
Danish: Den maksimale plasmakoncentration for darunavir ved tilstedeværelse af lavdosis ritonavir opnås generelt inden for 2,5-4,0 timer.
English: Total number of virologic failures a, n (%)
Danish: Samlet antal virologiske svigt a, n (%)
English: Darunavir was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Danish: Darunavir er blevet vurderet for karcinogent potentiale ved oral tvangsfodring af mus og rotter i op til 104 uger.
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 graviditet, embryo-/fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Darunavir Krka.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Darunavir Krka.
English: Limited efficacy data are available in paediatric patients below 15 kg and no recommendation on a posology can be made.
Danish: Der er kun begrænsede effektdata tilgængelige fra pædiatriske patienter under 15 kg, og der kan ikke gives nogen anbefalinger vedrørende dosering.
English: There are no adequate and well controlled studies on pregnancy outcome with darunavir in pregnant women.
Danish: Der er ikke udført tilstrækkelige og velkontrollerede studier af graviditetsudfald efter behandling af gravide kvinder med darunavir.
English: The effects of Darunavir Krka might be reduced if you take any of the following products.
Danish: Virkningen af Darunavir Krka kan blive nedsat, hvis du tager et eller flere af følgende produkter.
English: In the study, patients who were at risk of discontinuing therapy due to intolerance of ritonavir oral solution (e.g. taste aversion) were allowed to switch to the capsule formulation.
Danish: De patienter i studiet, der var i risiko for at afbryde behandlingen på grund af intolerans over for ritonavir oral opløsning (f.eks. aversion for smagen), blev det tilladt at skifte til kapselformuleringen.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført iAppendix V.
English: In juvenile rats receiving darunavir up to days 23-26, increased mortality was observed with convulsions in some animals.
Danish: Hos unge rotter, der fik darunavir indtil dag 23-26, blev der observeret øget mortalitet med krampeanfald hos nogle dyr.
English: It belongs to a group of medicines called protease inhibitors.
Danish: Det tilhører den lægemiddelgruppe, der kaldes proteasehæmmere.
English: Combinations with optimised background regimen (OBRs) other than ≥ 2 NRTIs have not been studied in this population.
Danish: Kombinationer med andre optimerede baggrundsregimer (OBR'er) end ≥2 NRTI'er er ikke undersøgt hos denne population.
English: Astemizole or terfenadine to treat allergy symptoms
Danish: Astemizol eller terfenadin til behandling af symptomer på allergi
English: Talk to your doctor about the signs and symptoms of liver problems.
Danish: Tal med din læge om symptomerne på leverproblemer.
English: You must eat a meal or a snack within 30 minutes prior to taking your Darunavir Krka and ritonavir.
Danish: Du skal spise et måltid eller mellemmåltid inden for 30 minutter før indtagelse af Darunavir Krka og ritonavir.
English: Isolates with baseline FC ≤ 10 are susceptible; isolates with FC > 10 to 40 have decreased susceptibility; isolates with FC > 40 are resistant (see Clinical results).
Danish: Isolater med baseline FC ≤ 10 (mindre end 10fold øgning i EC50) er følsomme; isolater med FC > 10 til 40 har nedsat følsomhed; isolater med FC > 40 er resistente (se ”Kliniske resultater”).
English: A lower and upper clinical cut-off of 10 and 40 were identified.
Danish: Der blev identificeret en nedre- og øvre klinisk grænse (cut-off) på 10 og 40.
English: No mother to child transmission occurred in the infants born to the 31 subjects who stayed on the antiretroviral treatment through delivery.
Danish: Der forekom ingen overførsel fra moder til barn for de spædbørn, der blev født af de 31 forsøgspersoner, som opretholdt den antiretrovirale behandling indtil fødslen.
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 suboptimalboostning af darunavir.
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Danish: TAD Pharma GmbH Heinz-Lohmann-Straβe 5 27472 Cuxhaven TYSKLAND
English: Nervous system disorders very common headache
Danish: Nervesystemet meget almindelig hovedpine
English: The risk of muscle damage might be increased.
Danish: Risikoen for en muskelskade kan være forhøjet.
English: Interactions between darunavir/ritonavir and antiretroviral and non-antiretroviral medicinal products are listed in the table below.
Danish: Interaktioner mellem darunavir/ritonavir og antiretrovirale og non-antiretrovirale lægemidler er opført i tabellen nedenfor.
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 (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
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: This cannot be administered with these 600 milligram tablets.
Danish: Denne dosis kan ikke administreres med disse 600 mg tabletter.
English: The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject.
Danish: Dosis af digoxin skal titreres forsigtigt for at opnå den ønskede kliniske effekt samtidig med, at patientens generelle kliniske tilstand vurderes.
English: Type AE Type C
Danish: Type AE
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 15% R(-) methadone Cmax ↓ 24%
Danish: R(-) metadon AUC ↓ 16% R(-) metadon Cmin ↓ 15% R(-) metadon Cmax ↓ 24%
English: Please discuss with your doctor which dose is right for you.
Danish: Tal med din læge om, hvilken dosis der er den rette til dig.
English: Caution is warranted and clinical monitoring is recommended.
Danish: Der skal udvises forsigtighed, og klinisk monitorering anbefales.
English: In cases of severe skin reaction see the warning in section 4.4.
Danish: I tilfælde af alvorlige hudreaktioner, se advarslen i pkt.
English: It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Danish: Det er en selektiv hæmmer af spaltningen af hivkodede Gag-Pol polyproteiner i virusinficerede celler, hvorved dannelsen af modne, infektiøse viruspartikler forhindres.
English: A lower dose of the β-blocker should be considered.
Danish: En lavere dosis af betablokkeren bør overvejes.
English: If prescribed Darunavir Krka twice daily the child must take one dose in the morning, and one dose in the evening.
Danish: Hvis Darunavir Krka er ordineret to gange dagligt, skal barnet tage en dosis om morgenen og en dosis om aftenen.
English: In the setting of lack or loss of virological response, resistance testing should be performed.
Danish: Ved manglende eller tab af virologisk respons bør patienten testes for resistens.
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 kendt som Pneumocystis carinii).
English: The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Danish: Sikkerhedsvurderingen for pædiatriske patienter er baseret på analysen af sikkerhedsdata efter 48 uger fra tre fase II-studier.
English: The type of food does not affect exposure to darunavir.
Danish: Typen af mad påvirker ikke eksponeringen for darunavir.
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: Increased concentrations of quetiapine may lead to coma (see section 4.3).
Danish: En øget koncentration af quetiapin kan føre til koma (se pkt.
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: Hiv-inficerede kvinder må ikke amme, både fordi der er en risiko for, at dit spædbarn kan blive inficeret med hiv via brystmælken, og fordi medicinens virkning på dit barn ikke kendes.
English: Patients should be instructed to take darunavir with low dose ritonavir within 30 minutes after completion of a meal.
Danish: Patienterne bør vejledes i at tage darunavir sammen med lavdosis ritonavir inden for 30 minutter efter indtagelse af et måltid.
English: The table below shows the development of HIV-1 protease mutations and loss of susceptibility to PIs in virologic failures at endpoint in the ARTEMIS, ODIN and TITAN trials.
Danish: Tabellen nedenfor viser udvikling af hiv-1 protease-mutationer og tab af følsomhed for PI'er i forbindelse med virologiske svigt ved endepunktet i studierne ARTEMIS, ODIN og TITAN.
English: Psychiatric disorders common abnormal dreams
Danish: Psykiske forstyrrelser almindelig unormale drømme
English: Therapy should be initiated by a health care provider experienced in the management of HIV infection.
Danish: Behandlingen skal påbegyndes af en læge, der har erfaring med håndtering af hivinfektion.
English: The rash is usually mild to moderate.
Danish: Udslættet er sædvanligvis mildt til moderat.
English: Darunavir Krka has only been used in limited numbers of patients 65 years or older.
Danish: Darunavir Krka har kun været anvendt til et begrænset antal patienter over 65 år.
English: With HIV-1 clade Type B
Danish: Med hiv-1-subtype Type B
English: (not applicable for darunavir coadministered with ritonavir)
Danish: (Gælder ikke for darunavir coadministreret med ritonavir)
English: No human data on the effect of darunavir on fertility are available.
Danish: Der foreligger ingen data om virkningen af darunavir på fertilitet hos mennesker.
English: No pharmacokinetic data are available in patients with severe hepatic impairment.
Danish: Der foreligger ingen farmakokinetiske data for patienter med svært nedsat leverfunktion.
English: Shelf life after first opening: 3 months.
Danish: Holdbarhed efter første åbning: 3 måneder.
English: Treatment of overdose with darunavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling ved overdosering af darunavir består af generelle supportive foranstaltninger, herunder monitorering af vitaltegn og observation af patientens kliniske tilstand.
English: Fentanyl Oxycodone Tramadol
Danish: Fentanyl Oxycodon Tramadol
English: ANTIPSYCHOTICS/NEUROLEPTICS Quetiapine
Danish: ANTIPSYKOTIKA/NEUROLEPTIKA Quetiapin
English: Cobicistat has not been studied in patients receiving dialysis, therefore, no recommendation can be made for the use of darunavir/cobicistat in these patients (see section 4.2).
Danish: Cobicistat er ikke blevet undersøgt hos patienter i dialyse, og der kan derfor ikke gives nogen anbefaling vedrørende brugen af darunavir/cobicistat til disse patienter (se pkt.
English: Your child's doctor will determine the appropriate dosing regimen for your child.
Danish: Barnets læge fastlægger den korrekte dosis til dit barn.
English: Your doctor should do blood tests before you start Darunavir Krka.
Danish: Din læge bør udføre nogle blodprøver, før du starter på Darunavir Krka.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE10.
Danish: Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, proteasehæmmere, ATC-kode: J05AE10.
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir 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 mellem 0,4- og 0,7-fold (mus) og 0,7- og 1-fold (rotter), sammenlignet med den, der blev observeret hos mennesker ved de anbefalede terapeutiske doser.
English: No interaction studies presented in the table have been performed with darunavir boosted with cobicistat.
Danish: Ingen af de interaktionsstudier, som præsenteres i tabellen, er blevet udført med darunavir boostet med cobicistat.
English: For full information on interactions with other medicinal products see section 4.5.
Danish: For fuldstændig information om interaktioner med anden medicin, se pkt.
English: Purpose of the medicine
Danish: Formålet med medicinen
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 erkendte risikofaktorer, fremskreden hiv-sygdom eller langtidseksponering for antiretroviral kombinationsbehandling (CART).
English: Your doctor will discuss with you which combination of medicines is best for you.
Danish: Din læge vil fortælle dig, hvilken medicinkombination, der er bedst for dig.
English: 4.4Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: A variable but limited decrease in red blood cell-related parameters was observed, together with increases in activated partial thromboplastin time.
Danish: Der blev observeret et variabelt men begrænset fald i parametre for røde blodlegemer samt stigninger i aktiveret, partiel tromboplastintid.
English: For use in these patients, more suitable formulations containing darunavir should be checked for their availability.
Danish: Tilgængeligheden af bedre egnede formuleringer indeholdende darunavir skal undersøges til brug hos disse patienter.
English: Tell your doctor if you have diabetes.
Danish: - Fortæl din læge, hvis du har sukkersyge (diabetes).
English: In case of safety issues, a further increase of the dosing interval for rifabutin and/or monitoring of rifabutin levels should be considered.
Danish: I tilfælde af sikkerhedsmæssige risici skal det overvejes at forlænge doseringsintervallet yderligere og/eller monitorere rifabutinniveauerne.
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 nyreændringer hos mus (nefrose) og rotter (kronisk progressiv nefropati).
English: common angioedema, pruritus, urticaria rare drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Danish: almindelig angioødem, pruritus, urticaria sjælden lægemiddelreaktion med eosinofili og systemiske symptomer*, Stevens-Johnson syndrom*
English: The lowest rates of developing resistant HIV virus are observed in ART-naïve patients who are treated for the first time with darunavir in combination with other ART.
Danish: Den laveste forekomst af udvikling af resistent hiv-virus ses hos ART-naive patienter, som behandles for første gang med darunavir i kombination med et andet antiretroviralt middel.
English: The safety and efficacy of darunavir have not been established in patients with severe underlying liver disorders and darunavir is therefore contraindicated in patients with severe hepatic impairment.
Danish: Sikkerheden og virkningen af darunavir er ikke blevet fastslået hos patienter med alvorlige, underliggende leversygdomme, og darunavir er derfor kontraindiceret til patienter med svært nedsat leverfunktion.
English: In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Danish: In vitro-studier med humane levermikrosomer (HLM'er) tyder på, at darunavir primært gennemgår oxidativ metabolisme.
English: The child must swallow the tablets with a drink such as water or milk.
Danish: - Barnet skal synke tabletterne med noget væske som f.eks. vand eller mælk.
English: Dasatinib Nilotinib Vinblastine Vincristine
Danish: Dasatinib Nilotinib Vinblastin Vincristin
English: Unlike ritonavir, cobicistat does not induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Danish: Til forskel fra ritonavir inducerer cobicistat ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller UGT1A1.
English: Fluconazole Isavuconazole Itraconazole Posaconazole
Danish: Fluconazol Isavuconazol Itraconazol Posaconazol
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors
Danish: DIREKTE VIRKENDE ANTIVIRALE MIDLER MOD HEPATITIS C-VIRUS (HCV) NS3-4A-proteasehæmmere
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler.
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: 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 utilstrækkelige data til at afgøre, om samtidig administration af tenofovirdisoproxil og cobicistat er forbundet med en større risiko for nyre-relaterede bivirkninger sammenlignet med regimer, som inkluderer tenofovirdisoproxil uden cobicistat.
English: Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10
Danish: Darunavir er en hæmmer af dimer-dannelsen og den katalytiske aktivitet af hiv-1 proteasen (KD på 4,5 x 10
English: Elbasvir/grazoprevir to treat hepatitis C infection
Danish: Elbasvir/grazoprevir til behandling af hepatitis C-infektion
English: This protein binding is concentrationdependent indicative for saturation of binding.
Danish: Denne proteinbinding er koncentrations-afhængig, hvilket indicerer, at bindingskapaciteten mættes.
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 Darunavir Krka.
Danish: Både på grund af risiko for overførsel af hiv og risiko for bivirkninger hos de ammede spædbørn, skal mødre instrueres i, at de under ingen omstændigheder må amme, hvis de behandles med Darunavir Krka
English: Pharmacokinetics of total darunavir (mean ± SD)
Danish: Farmakokinetik for total darunavir (middel ± SD)
English: However, for unbound (i.e. active) darunavir, the pharmacokinetic parameters were less reduced during pregnancy compared to postpartum, due to an increase in the unbound fraction of darunavir during pregnancy compared to postpartum.
Danish: For ubunden (dvs. aktiv) darunavir var de farmakokinetiske parametre dog i mindre grad reduceret på grund af en stigning i den ubundne fraktion af darunavir under graviditet i forhold til post partum.
English: For the treatment of pulmonary arterial hypertension Sildenafil
Danish: Til behandling af pulmonal arteriel hypertension Sildenafil
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: Studier med rotter har vist, at darunavir udskilles i mælk og medførte toksicitet ved høje niveauer (1.000 mg/kg/dag).
English: b fold change in EC50 “Patients with no/non-naïve use of ENF” are patients who did not use ENF or who used ENF but not for the first time “Patients with naïve use of ENF” are patients who used ENF for the first time
Danish: “Patienter som ikke bruger eller som er non-naive over for brug af ENF” er patienter som ikke brugte ENF eller som brugte ENF men ikke for første gang “Patienter som er naive over for brug af ENF” er patienter som brugte ENF for første gang
English: During attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with low dose ritonavir, a high frequency of liver reactions was seen with rifampicin.
Danish: Ved forsøg på at løse problemet med den nedsatte eksponering, ved at øge dosis af andre proteasehæmmere med lavdosis ritonavir, blev der set en høj frekvens af leverreaktioner med rifampicin.
English: Data based on analyses at week 48
Danish: Data baseret på analyser ved uge 48
English: The substantial reduction in darunavir exposure may result in virological failure and an increased risk of mother to child transmission of HIV infection.
Danish: Den betydelige reduktion i eksponeringen for darunavir kan medføre virologisk svigt og en øget risiko for overførsel af hivinfektion fra mor til barn.
English: Pregnant or breast feeding mothers should not take darunavir with cobicistat.
Danish: Gravide eller ammende mødre bør ikke tage darunavir sammen med cobicistat.
English: IMMUNOSUPPRESSANTS Ciclosporin
Danish: IMMUNSUPPRIMERENDE MIDLER Ciclosporin
English: Co-administration is contraindicated (see section 4.3)
Danish: Co-administration er kontraindiceret (se pkt.
English: Patients with no/nonnaïve use of ENF Patients with naïve use of ENF
Danish: Patienter som ikke bruger eller som er non-naive over for brug af ENF Patienter som er naive over for brug af ENF