natgillin/translations-raw huggingface dataset:
Ydermere skal patienter, der får en stabil dosis af disse antidepressiva, og som starter behandling med darunavir og lavdosis ritonavir, monitoreres for antidepressivt respons.
In addition, patients on a stable dose of these antidepressants who start treatment with darunavir with low dose ritonavir should be monitored for antidepressant response.
Rosuvastatin 10 mg en gang daglig rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48% rosuvastatin Cmax ↑ 144%
Ritonavir hæmmer transportørerne P-glykoprotein, OATP1B1 og OATP1B3, og coadministration med substrater for disse transportører kan medføre øgede plasmakoncentrationer af disse stoffer (f.eks. dabigatranetexilat, digoxin, statiner og bosentan - se interaktionstabellen nedenfor).
Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Hvis du har glemt at tage Darunavir Krka Hvis du kommer i tanke om den glemte dosis inden for 6 timer, skal du straks tage en dosis.
If you forget to take Darunavir Krka If you notice within 6 hours, you must take your missed dose immediately.
En alvorlig leverfunktionsnedsættelse kan medføre et øget niveau af darunavir og en forværring af stoffets sikkerhedsprofil.
Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile.
Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt.
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
BEHANDLING AF PRÆMATUR EJAKULATION Dapoxetin
TREATMENT FOR PREMATURE EJACULATION Dapoxetine
I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation af forskellen i % respons Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter der afbrød behandlingen i utide medregnes med en ændring, der tillægges størrelsen 0.
Imputations according to the TLOVR algorithm d Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
- Hos alle andre ART-erfarne patienter, eller i tilfælde af, at der ikke foreligger en hiv-1- genotypebestemmelse, er det anbefalede behandlingsregime beskrevet i produktresumeet for Darunavir Krka 600 mg tabletter.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is described in the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.
På baggrund af en farmakokinetisk model er det også relevant at reducere dosis med 75% hos patienter, der får rifabutin i andre doser end 300 mg/dag.
Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients receive rifabutin at doses other than 300 mg/day.
30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 180 filmovertrukne tabletter
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 180 film-coated tablets
Som hovedregel skal såvel dyredata som kliniske erfaringer hos gravide kvinder tages i betragtning, når det besluttes at anvende antiretrovirale lægemidler til behandling af hiv-infektion hos gravide kvinder og dermed til at reducere risikoen for vertikal transmission af hiv til den nyfødte.
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
Potente CYP3A-induktorer omfatter f.eks. carbamazepin, phenobarbital og phenytoin (se pkt.
Strong CYP3A inducers include e.g. carbamazepine, phenobarbital and phenytoin (see sections 4.4 and 4.5).
ANTIMYKOBAKTERIELLE MIDLER Rifampicin
ANTIMYCOBACTERIALS Rifampicin
Lægemidler, som kan blive påvirket af darunavir boostet med cobicistat
Medicinal products that may be affected by darunavir boosted with cobicistat
Resultater ved uge 48
Outcomes at week 48
Hos rotter medførte kombinationen af darunavir med ritonavir en lille stigning i virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtlen og øget incidens af pankreasfibrose (kun hos hanrotter) sammenlignet med behandling med darunavir alene.
In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
De kan omfatte gulfarvning af huden og det hvide i øjnene, mørk (tefarvet) urin, bleg afføring, kvalme, opkastning, appetittab eller smerter, jag eller smerter og ubehag i højre side under ribbenene.
These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at farmakokinetikken for darunavir ikke var signifikant påvirket hos hiv-inficerede patienter med moderat nedsat nyrefunktion (CrCl mellem 30 og 60 ml/min, n=20) (se pkt.
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinations behandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
I løbet af det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) rapporteredes alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4 % af patienterne.
During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Sekalealkaloider f.eks. ergotamin, dihydroergotamin, ergometrin og methylergonovin til behandling af migræne hovedpine
Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Din læge vil vurdere, hvilken kolesterolsænkende behandling, der egner sig bedst til dig.
Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
ENDOTELINRECEPTOR-ANTAGONISTER Bosentan
ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
INHALEREDE  -AGONISTER Salmeterol
INHALED BETA AGONISTS Salmeterol
Co-administration med darunavir/ritonavir kan give anledning til en kraftig forøgelse af koncentrationen af disse lægemidler.
Coadministration with darunavir/ritonavir may cause a large increase in the concentration of these medicines.
Hvis hivgenotypebestemmelse ikke er gennemførlig, anbefales dosisregimet med darunavir/ritonavir en gang dagligt til hiv-proteasehæmmer-naive pædiatriske patienter, og doseringen to gange dagligt til hivproteasehæmmer-erfarne patienter.
However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
Der sås ingen virkning på parring eller fertilitet hos rotter i forbindelse med behandling med darunavir (se pkt.
There was no effect on mating or fertility with darunavir treatment in rats (see section 5.3).
Det er påvist, at behandling med darunavir/cobicistat 800/150 mg en gang dagligt i det andet og tredje trimester fører til lav eksponering for darunavir med en reduktion i værdierne for Cmin på ca. 90 % (se pkt.
Treatment with darunavir/cobicistat 800/150 mg once daily during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Lægemidler, som kan blive påvirket af darunavir boostet med ritonavir
Medicinal products that may be affected by darunavir boosted with ritonavir
Co-administration af darunavir/cobicistat med svage til moderate CYP3A-induktorer (f.eks. efavirenz, etravirin, nevirapin, boceprevir, fluticason og bosentan) frarådes (se interaktionstabel nedenfor).
Coadministration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
I henhold til TLOVR-algoritmen (time to loss of viral response) I henhold til LOCF (last obervation carried forward) 95% konfidensintervaller.
Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
I de fleste tilfælde kan Darunavir Krka tages sammen med hiv-medicin, der tilhører en anden gruppe (f.eks. NRTI (nukleosid revers-transkriptase-hæmmere), NNRTI (nonnukleosid revers-transkriptasehæmmere), CCR5-antagonister og FI (fusionshæmmere)).
In most cases, Darunavir Krka can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Brug af anden medicin sammen med Darunavir Krka Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
Other medicines and Darunavir Krka Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
I det kliniske udviklingsprogram med raltegravir hos behandlingserfarne patienter forekom udslæt uanset årsagssammenhæng hyppigere, når regimet indeholdt darunavir/ritonavir + raltegravir, end når det indeholdt darunavir/ritonavir uden raltegravir eller raltegravir uden darunavir/ritonavir.
During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing darunavir/ritonavir + raltegravir compared to those containing darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
Gælder for darunavir boostet med cobicistat, men ikke hvis darunavir er boostet med ritonavir: - Darunavir boostet med cobicistat er mere følsomt for CYP3A-induktion end darunavir boostet med ritonavir.
Applicable to darunavir boosted with cobicistat, not when boosted with ritonavir: Darunavir boosted with cobicistat is more sensitive for CYP3A induction than darunavir boosted with ritonavir.
Patienterne fik et vægtbaseret behandlingsregime to gange dagligt; patienter med en legemsvægt på 10 kg til < 15 kg fik darunavir/ritonavir 25/3 mg/kg to gange dagligt og patienter med en legemsvægt på 15 kg til < 20 kg fik darunavir/ritonavir 375/50 mg to gange dagligt.
Patients received a weight-based twice daily treatment regimen, patients weighing 10 kg to < 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
POWER 1 og POWER 2 er randomiserede, kontrollerede studier, der sammenligner darunavir, når det gives sammen med ritonavir (600/100 mg to gange dagligt) med en kontrolgruppe, der får et eller flere PI-regimer valgt af investigator, hos hiv-1inficerede patienter, som tidligere har oplevet svigt i mere end et PI-regime.
POWER 1 and POWER 2 are randomised, controlled trials comparing darunavir co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Behandling med darunavir/cobicistat 800/150 mg en gang dagligt under graviditet fører til lav eksponering for darunavir.
Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure.
Ritonavir kan nedsætte plasmakoncentrationen af voriconazol.
Ritonavir may decrease plasma concentrations of voriconazole.
Disse reaktioner kan omfatte, men er ikke begrænset til, alvorligt udslæt eller udslæt ledsaget af feber, almen utilpashed, træthed, muskel- eller ledsmerter, blæredannelse, mundsår, konjunktivitis, hepatitis og/eller eosinofili.
These can include, but are not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Cobicistat 150 mg givet sammen med darunavir 800 mg en gang dagligt forstærker darunavirs farmakokinetiske parametre på en måde, som er sammenlignelig med ritonavir (se pkt.
Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Darunavir skal derfor tages med cobicistat eller ritonavir og med mad.
Therefore, darunavir tablets should be taken with cobicistat or ritonavir and with food.
Samtidig behandling med et eller flere af følgende lægemidler på grund af den forventede reduktion af plasmakoncentration af darunavir, ritonavir og cobicistat og potentialet for tab af terapeutisk effekt (se pkt.
Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and cobicistat and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).
(↑ clarithromycin fra CYP3Ahæmning og mulig P-gphæmning)
(↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition)
- Apixaban, edoxaban, rivaroxaban, warfarin (til at hindre blodpropper), da behandlingsvirkningen eller bivirkninger af denne medicin kan blive ændret.
Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
Pravastatin 40 mg som enkeltdosis pravastatin AUC ↑ 81%¶ pravastatin Cmin ND pravastatin Cmax ↑ 63% ¶ en op til femdobling blev set hos en begrænset undergruppe af forsøgspersoner
Pravastatin 40 mg single dose pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63% an up to five-fold increase was seen in a limited subset of subjects
Antal deltagere med virologisk svigt og parrede genotyper ved baseline og endepunkt, der udviklede mutationer b ved endepunktet, n/N
Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Det vægtbaserede dosisregime for darunavir og ritonavir til pædiatriske patienter fremgår af tabellerne ovenfor.
The weight-based dose regimen for darunavir and ritonavir is provided in the tables above.
Til oral anvendelse.
Oral use
- Ciclosporin, everolimus, tacrolimus, sirolimus (til dæmpning af immunforsvaret), da behandlingsvirkningen eller bivirkninger af denne medicin kan blive forstærket.
Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Tabletdimension: 17 × 8.5 mm.
Tablet dimension: 17 x 8.5 mm.
Under det kliniske udviklingsprogram med darunavir/ritonavir (N=3.063) rapporteredes hepatitis hos 0,5 % af patienterne, der fik antiretroviral kombinationsbehandling med darunavir/ritonavir.
During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
De viste alle aktivitet, der var mindst 10 gange mindre end aktiviteten af darunavir over for vildtype hiv.
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.
Darunavir og cobicistat metaboliseres via CYP3A, og co-administration med CYP3Ainduktorer kan derfor medføre subterapeutisk plasmaeksponering for darunavir.
Darunavir and cobicistat are metabolised by CYP3A, and co-administration with CYP3A inducers may therefore result in subtherapeutic plasma exposure to darunavir.
I et flerdosisstudie med darunavir co-administreret med ritonavir (600/100 mg) to gange daglig, blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med mild (ChildPugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
In a multiple dose study with darunavir co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Ved administration uden indtagelse af mad er den relative biotilgængelighed af darunavir ved tilstedeværelse af cobicistat eller lavdosis ritonavir lavere sammenlignet med administration med mad.
When administered without food, the relative bioavailability of darunavir in the presence of cobicistat or low dose ritonavir is lower as compared to intake with food.
Filmovertrukken tablet
film-coated tablet
Darunavir administreret sammen med lavdosis ritonavir bør ikke anvendes i kombination med disse lægemidler.
Darunavir co-administered with low dose ritonavir should not be used in combination with these medicines.
Det frarådes at ændre dosis af cobicistat eller ritonavir.
It is not recommended to alter the dose of cobicistat or ritonavir.
Der har været rapporter om øget spontan blødningstendens hos patienter med hæmofili, der fik antiretrovirale proteasehæmmere (se pkt.
There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Ikke undersøgt med darunavir/ritonavir.
Not studied with darunavir/ritonavir.
Der gælder ingen særlige sikkerhedsregler eller dosisjusteringer for darunavir/ritonavir for patienter med nedsat nyrefunktion.
No special precautions or dose adjustments for darunavir/ritonavir are required in patients with renal impairment.
KORTIKOSTEROIDER Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison, triamcinolon)
Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Der er øget risiko for sildenafilrelaterede bivirkninger (inklusive synsforstyrrelser, hypotension, forlænget erektion og synkope).
There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
150 mg to gange daglig maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavirkoncentrationer er i overensstemmelse med de historiske data.
150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
20 mg en gang daglig darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
20 mg once daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Darunavir indeholder en sulfonamid-del. Darunavir skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi.
Darunavir should be used with caution in patients with a known sulphonamide allergy.
De hyppigste alvorlige bivirkninger er akut nyresvigt, myokardieinfarkt, immunrekonstitutionsinflammatorisk syndrom (IRIS), trombocytopeni, osteonekrose, diarre, hepatitis og pyreksi.
The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.
Den øgede eksponering for darunavir hos hiv-1-inficerede patienter sammenlignet med raske forsøgspersoner kan muligvis forklares ved de højere koncentrationer af surt α1-glykoprotein (AAG) hos hiv-1inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma-AAG og derfor i højere plasmakoncentrationer.
The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Dosisjustering af darunavir/ritonavir er ikke nødvendig under graviditet og post partum.
No dose adjustment is required for darunavir/ritonavir during pregnancy and postpartum.
Det anbefales at monitorere INR (International normaliseret ratio), når warfarin kombineres med boostet darunavir.
It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with boosted darunavir.
Der var ingen nye klinisk relevante sikkerhedsfund i forhold til den kendte sikkerhedsprofil for darunavir/ritonavir hos hiv 1-inficerede voksne (se pkt.
There were no new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
- Hos alle andre ART-erfarne patienter eller i tilfælde af, at der ikke foreligger en hiv-1-genotypebestemmelse er det anbefalede behandlingsregime 600 mg to gange dagligt sammen med ritonavir 100 mg to gange dagligt i forbindelse med et måltid.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Darunavir Krka 400 mg og 800 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer til behandling af hiv-1-infektion hos voksne og pædiatriske patienter fra en alder af 3 år og en legemsvægt på mindst 40 kg hos: - ART-naive (som ikke tidligere har fået antiretroviral behandling) (se pkt.
Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2).
Det frarådes at ændre dosis af ritonavir.
It is not recommended to alter the dose of ritonavir.
Hvis en daglig dosis af darunavir og/eller ritonavir glemmes i op til 12 timer efter det tidspunkt, hvor den sædvanligvis tages, skal patienterne informeres om snarest muligt at tage den ordinerede dosis darunavir og ritonavir sammen med et måltid.
If a once daily dose of darunavir and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible.
Darunavir Krka kan ikke helbrede hiv-infektion.
Darunavir Krka is not a cure for HIV infection.
Darunavir i kombination med cobicistat eller ritonavir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines.
Det er vigtigt at tale med lægen, hvis du får udslæt.
It is important to talk to your doctor if you develop a rash.
Vaskulære forstyrrelser ikke almindelig hypertension, rødmen
Vascular disorders uncommon hypertension, flushing