FrancophonIA/ELRC3.0 huggingface dataset:
English: REZOLSTA should not be initiated in patients with creatinine clearance less than 70 mL/min, if any co-administered medicinal product (e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate), or adefovir dipivoxil) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Danish: Behandling med REZOLSTA bør ikke initieres hos patienter med kreatininclearance under 70 ml/min, hvis dosisjustering på basis af kreatininclearance for et samtidigt administreret lægemiddel (f.eks. emtricitabin, lamivudin, tenofovirdisoproxilfumarat (som furamat, fosfat eller succinat) eller adefovirdipivoxil) er nødvendig (se pkt.
English: In women receiving REZOLSTA during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Danish: Hos kvinder, der fik REZOLSTA i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24t og Cmin for total-darunavir hhv. 49 %, 56 % og 92 % lavere i forhold til post partum.
English: Efficacy of darunavir 800 mg once daily co-administered with 150 mg cobicistat once daily in ART-naïve and ART-experienced patients
Danish: Virkningen af darunavir 800 mg en gang dagligt co-administreret med 150 mg cobicistat en gang dagligt hos ART-naive og ART-erfarne patienter
English: Co-administration of REZOLSTA with alfuzosin is contraindicated (see section 4.3).
Danish: Samtidig administration af REZOLSTA og alfuzosin er kontraindiceret (se pkt.
English: darunvir/ritonavir 600/100 mg twice daily + OBR N = 296
Danish: darunavir/ritonavir 600/100 mg to gange dagligt + OBR N=296
English: Efficacy of darunavir 800 mg once daily co-administered with 100 mg ritonavir once daily in ART-naïve patients
Danish: Virkning af darunavir 800 mg en gang dagligt co-administreret med 100 mg ritonavir en gang dagligt hos ART-naive patienter
English: Uncommon side effects (may affect up to 1 in 100 people) - symptoms of infection or of autoimmune disorders (immune reconstitution inflammatory syndrome) - osteonecrosis (death of bone tissue caused by loss of blood supply to the bone) - enlargement of breasts - abnormal blood test results such as some tests for your pancreas, high level of sugar, abnormal levels of ‘lipids' (fats).
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - symptomer på infektion eller på autoimmune lidelser (immunrekonstitutionsinflammatorisk syndrom (IRIS)) - osteonekrose (hvor knoglevævet dør på grund af manglende blodforsyning til knoglen) - udvikling af bryster hos mænd (gynækomasti) - unormale resultater af blodprøver som for eksempel undersøgelser af bugspytkirtel, højt sukkerniveau, unormale niveauer af "lipider" (fedtstoffer); din læge vil forklare dig om dette - allergiske reaktioner som for eksempel nældefeber (urticaria), svær hævelse af huden og andre væv (oftest læberne eller øjnene) - alvorligt udslæt med blærer og og afskallende hud, især omkring munden, næsen, øjnene og kønsorganerne.
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir
Danish: ANTIRETROVIRALE MIDLER MOD HIV Integrasehæmmere
English: Treatment-experienced darunavir/ritonavir 600/100 mg twice daily N = 296
Danish: Behandlingserfarne darunavir/ritonavir 600/100 mg to gange dagligt N=296
English: Co-administration of REZOLSTA and etravirine is not recommended.
Danish: Co-administration af REZOLSTA og etravirin frarådes.
English: REZOLSTA should not be used in paediatric patients below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Danish: REZOLSTA bør af sikkerhedsmæssige grunde ikke anvendes til pædiatriske patienter under 3 år (se pkt.
English: Based on theoretical considerations REZOLSTA may increase methadone plasma concentrations.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA muligvis øge plasmakoncentrationen af methadon.
English: If you notice within 12 hours, you must take the tablet immediately.
Danish: Hvis du kommer i tanke om den glemte dosis inden for 12 timer, skal du straks tage den. Skal altid tages sammen med mad.
English: Not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Danish: urticaria sjælden eosinofili og systemiske symptomer* som reaktion over for lægemidlet ikke kendt toksisk epidermal nekrolyse*, akut generaliseret eksantematøs pustulose*
English: The combination of avanafil and REZOLSTA is contraindicated (see section 4.3).
Danish: Samtidig administration af avanafil og REZOLSTA er kontraindiceret (se pkt.
English: REZOLSTA and dolutegravir can be used without dose adjustments.
Danish: REZOLSTA og dolutegravir kan anvendes uden dosisjustering.
English: Based on theoretical considerations REZOLSTA may alter warfarin plasma concentrations.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA muligvis ændre plasmakoncentrationen af warfarin.
English: CD4+ cell count mean change from baseline
Danish: CD4+ celletal gennemsnitlig ændring fra baseline
English: Uncommon hepatitis*, cytolytic hepatitis*
Danish: Lever og galdeveje almindelig forhøjede leverenzymer ikke almindelig hepatitis*, cytolytisk hepatitis*
English: - Clonazepam (to prevent seizures).
Danish: - clonazepam (til at hindre krampeanfald) - østrogenholdig prævention og hormonerstatningsbehandling.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
Danish: Behandling med 800/150 mg darunavir/cobicistat under graviditet fører til lav eksponering for darunavir (se pkt.
English: (CYP3A inhibition and/or P-gp inhibition)
Danish: (CYP3A-hæmning og/eller P-gp-hæmning)
English: HIV-1 RNA < 50 copies/mL mean HIV-1 RNA log change from baseline (log10 copies/mL) CD4+ cell count mean change from baseline
Danish: Hiv-1 RNA < 50 kopier/ml Hiv-1 RNA gennemsnitlig ændring fra baseline (log10kopier/ml)
English: General disorders and administration site conditions Common fatigue, asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet almindelig
English: Based on theoretical considerations REZOLSTA is expected to increase digoxin plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af digoxin.
English: Outcomes darunvir/ritonavir 800/100 mg once daily + OBR N = 294
Danish: Resultater darunavir/ritonavir 800/100 mg en gang dagligt + OBR N=294
English: Based on theoretical considerations REZOLSTA is expected to increase maraviroc plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af maraviroc.
English: urticaria
Danish: Udslæt
English: Darunavir exposure was shown to be comparable in a bioavailability trial between REZOLSTA and darunavir/ritonavir 800/100 mg q.d.
Danish: Et biotilgængelighedsstudie viste, at eksponeringen for darunavir er sammenlignelig mellem REZOLSTA og darunavir/ritonavir 800/100 mg en gang dagligt ved steady state hos ikke-fastende raske forsøgspersoner.
English: Treatment-experienced darunavir/ritonavir 800/100 mg once daily N = 294
Danish: Behandlingserfarne darunavir/ritonavir 800/100 mg en gang dagligt N=294
English: Co-administration of REZOLSTA and bosentan is not recommended.
Danish: Det frarådes at co-administrere REZOLSTA med bosentan.
English: Voriconazole should only be taken after medical evaluation.
Danish: voriconazol må kun tages, når en læge har bedømt brugen af det. - rifabutin (mod bakterieinfektioner).
English: Co-administration with the following medicinal products due to the potential for loss of therapeutic effect (see section 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St John's wort, (Hypericum perforatum).
Danish: 4.5): - carbamazepin, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - perikon (Hypericum perforatum).
English: Based on theoretical considerations REZOLSTA may alter norethindrone plasma concentrations.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA muligvis ændre plasmakoncentrationen af norethisteron.
English: Carbamazepine, phenobarbital and phenytoin to prevent seizures Astemizole or terfenadine to treat allergy symptoms
Danish: Amiodaron, bepridil, dronedaron, ivabradin, kinidin, ranolazin til behandling af visse hjertelidelser som f.eks. unormal hjerterytme Carbamazepin, phenobarbital og phenytoin til forebyggelse af krampeanfald Astemizol eller terfenadin til behandling af symptomer på allergi
English: All subjects darunavir/cobicistat 800/150 mg once daily + OBR N = 313
Danish: Alle patienter darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=313
English: (CYP3A and/or P-glycoprotein inhibition)
Danish: (CYP3A- og/eller P-glykoproteinhæmning)
English: - Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Colchicine (to treat gout or familial Mediterranean fever).
Danish: - amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst).
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N = 295
Danish: Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=295
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily N = 295
Danish: Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt N=295
English: Based on theoretical considerations REZOLSTA is expected to increase salmeterol plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af salmeterol.
English: REZOLSTA should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Danish: Ved symptomer på alvorlige hudreaktioner skal REZOLSTA straks seponeres.
English: Based on theoretical considerations REZOLSTA is expected to increase colchicine plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af colchicin.
English: Please contact your doctor whenever you develop a rash.
Danish: Kontakt lægen, hvis du får udslæt.
English: Based on theoretical considerations these antimycobacterials are expected to decrease darunavir and/or cobicistat plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes disse antimykobakterielle midler at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat.
English: Based on theoretical considerations REZOLSTA is expected to increase tenofovir plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af tenofovir.
English: Based on theoretical considerations REZOLSTA is expected to increase these PDE-5 inhibitor plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse PDE-5-hæmmere.
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily N = 18
Danish: Behandlingserfarne darunavir/cobicistat 800/150 mg en gang dagligt N=18
English: Based on theoretical considerations REZOLSTA is expected to increase these immunosuppressant plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse immunsuppressiva.
English: What REZOLSTA is and what it is used for What you need to know before you take REZOLSTA How to take REZOLSTA
Danish: Det skal du vide, før du begynder at tage REZOLSTA Sådan skal du tage REZOLSTA Bivirkninger
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Den rapporterede tid til udbrud er variabel og kan være mange måneder efter behandlingsstart (se pkt.
English: Based on theoretical considerations REZOLSTA is expected to increase alfentanil plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af alfentanil.
English: Treatment-naïve darunavir/ritonavir 800/100 mg once daily N = 343
Danish: Behandlingsnaive darunavir/ritonavir 800/100 mg en gang dagligt N=343
English: Based on theoretical considerations REZOLSTA is expected to increase alfuzosin plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af alfuzosin.
English: Based on theoretical considerations rifampin is expected to decrease darunavir and/or cobicistat plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes rifampicin at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat.
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily + OBR N = 18
Danish: Behandlingserfarne darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=18
English: Based on theoretical considerations REZOLSTA is expected to increase metformin plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af metformin.
English: Outcomes darunavir/ ritonavir 800/100 mg once daily N = 343
Danish: Resultater darunavir/ ritonavir 800/100 mg en gang dagligt N=343
English: Based on theoretical considerations REZOLSTA is expected to increase these anti-depressant plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antidepressiva.
English: For further details, consult the maraviroc Summary of Product Characteristics.
Danish: Der henvises til produktresuméet for maraviroc for yderligere oplysninger.
English: Iron oxide black
Danish: Jernoxid, sort
English: Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine, when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - elbasvir/grazoprevir - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Danish: 4.5) - rifampicin - sekalealkaloider (f.eks. dihydroergotamin, ergometrin, ergotamin, methylergometrin) - cisaprid - dapoxetin - domperidon - naloxegol - lurasidon, pimozid, quetiapin, sertindol (se pkt.
English: Based on theoretical considerations REZOLSTA is expected to increase these antiarrhythmic plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antiarytmika.
English: Based on theoretical considerations these anticonvulsants are expected to decrease darunavir and/or cobicistat plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes disse antiepileptika at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat.
English: Based on theoretical considerations REZOLSTA is expected to increase lumefantrine plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af lumefantrin.
English: The evidence of efficacy of darunavir/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing darunavir/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Danish: Dokumentationen for virkning af darunavir/ritonavir 800/100 mg en gang dagligt er baseret på 192 ugers-analysen af data hos ART-naive hiv-1-patienter i det randomiserede, kontrollerede, åbne fase III-studie ARTEMIS.
English: Based on theoretical considerations efavirenz is expected to decrease darunavir and/or cobicistat plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes efavirenz at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat.
English: During the second trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin were 50%,
Danish: I andet trimester af graviditeten var værdierne for Cmax, AUC24t og Cmin for cobicistat hhv. 50 %, 63 % og 83 % lavere i forhold til post partum.
English: Based on theoretical considerations etravirine is expected to decrease darunavir and/or cobicistat plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes etravirin at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat.
English: Your doctor might want to do some additional tests.
Danish: Din læge skal muligvis kontrollere dit blod.
English: darunavir/ ritonavir 800/100 mg once daily N = 343
Danish: darunavir / ritonavir 800/100 m g en gang dagligt N=343
English: Based on theoretical considerations REZOLSTA is expected to increase these calcium channel blocker plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse calciumantagonister.
English: Co-administration of St John's wort and REZOLSTA is contraindicated (see section 4.3).
Danish: Co-administration af perikon og REZOLSTA er kontraindiceret (se pkt.
English: Based on theoretical considerations REZOLSTA is expected to increase rilpivirine plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af rilpivirin.
English: Uncommon immune reconstitution inflammatory syndrome
Danish: (lægemiddel)overfølsomhed ikke almindelig immunrekonstitutionsinflammatorisk syndrom (IRIS)
English: Based on theoretical considerations REZOLSTA is expected to increase these anti-neoplastic plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antipsykotika.
English: REZOLSTA and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Danish: REZOLSTA og artemether/lumefantrin kan anvendes uden dosisjusteringer.
English: Rifampicin to treat some infections such as tuberculosis Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Danish: Sekalealkaloider (f.eks. ergotamin, dihydroergotamin, ergometrin og methylergometrin)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering.
English: Xultophy received a marketing authorisation valid throughout the EU on 18 September 2014.
Danish: Xultophy fik markedsføringstilladelse med gyldighed i hele EU den 18. september 2014.
English: Xultophy is given once a day, preferably at the same time each day.
Danish: Xultophy gives én gang dagligt, fortrinsvis på samme tidspunkt hver dag.
English: Further information on Xultophy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Xultophy findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports..
English: As for all medicines, data on the use of Xultophy are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Xultophy løbende overvåget.
English: In the group that kept on receiving the GLP-1 agonist, it fell from 7.7% to 7.4%.
Danish: I den gruppe, der fortsatte med at få GLP-1agonisten, faldt det fra 7,7 % til 7,4 %.
English: Other information about Xultophy
Danish: Andre oplysninger om Xultophy
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the medicine work less well than expected.
Danish: Der bør skiftes injektionssted for hver injektion for at undgå hudforandringer (såsom fortykkelse), der kan få lægemidlet til at virke dårligere end forventet.
English: What measures are being taken to ensure the safe and effective use of Xultophy?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xultophy?
English: Patients in the study either continued with their current treatment or received Xultophy instead of the GLP-1 agonist.
Danish: Patienterne i undersøgelsen fortsatte enten med deres igangværende behandling eller fik Xultophy i stedet for GLP-1agonisten.
English: Side effects on the digestive system occurred in up to 1 in 10 patients and included nausea (feeling sick), diarrhoea, vomiting, constipation, dyspepsia (indigestion), gastritis (inflammation of the stomach), abdominal pain (stomach ache), flatulence (wind), gastroesophageal reflux disease (passage of stomach acid back up towards the mouth), and distension (swelling) of the belly.
Danish: Bivirkninger for fordøjelsessystemet forekom hos op til 1 ud af 10 patienter og omfattede kvalme, diarré, opkastning, forstoppelse, fordøjelsesbesvær (dyspepsi), mavekatar (gastritis), mavesmerter, luft i maven (flatulens), tilbageløb af maveindholdet op mod munden (gastroøsofagealt reflukssygdom) og oppustet mave.
English: The European Medicines Agency decided that Xultophy's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Xultophy opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In the group using insulin degludec it fell from 8.8% to 8.0%.
Danish: I den gruppe, som fik insulin degludec, faldt det fra 8,8 % til 8,0 %.
English: An overview of Xultophy and why it is authorised in the EU
Danish: Oversigt over Xultophy, og hvorfor det er godkendt i EU
English: Insulin degludec is slightly different from human insulin as it is absorbed more slowly and regularly by the body after an injection and it works for a long time.
Danish: Insulin degludec er kun en anelse forskelligt fra det menneskelige insulin, idet det optages langsommere og jævnt af kroppen efter en indsprøjtning og virker i lang tid.
English: Xultophy is a medicine that is used for the treatment of type 2 diabetes.
Danish: Xultophy er et lægemiddel, der anvendes til behandling af type 2-sukkersyge.
English: Side effects reported with Xultophy are carefully evaluated and any necessary action taken to protect patients.
Danish: De bivirkninger, der blev indberettet for Xultophy, vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Xultophy, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Xultophy, kan du læse indlægssedlen eller kontakte lægen eller apoteket.
English: Once-daily injection of Xultophy has been shown to be of benefit in controlling blood glucose in three main studies involving 2,514 patients with type 2 diabetes.
Danish: Én daglig indsprøjtning af Xultophy er påvist at have gavnlig virkning på reguleringen af blodsukkeret i tre hovedundersøgelser med 2 514 patienter med type 2-sukkersyge.
English: Xultophy (insulin degludec / liraglutide)
Danish: Xultophy (insulin degludec / liraglutid)