natgillin/translations-raw huggingface dataset:
Den anbefalede dosis REZOLSTA er en filmovertrukken tablet en gang dagligt i forbindelse med et måltid.
ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Klinisk monitorering af terapeutisk virkning og bivirkninger anbefales, når disse lægemidler co-administreres med REZOLSTA.
Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with REZOLSTA.
Der er indberettet livstruende og dødelige lægemiddelinteraktioner hos patienter, der blev behandlet med colchicin og potente CYP3A- og P-glykoprotein (P-gp)-hæmmere (se pkt.
Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (see section 4.5).
GS-US-216-130 er et åbent, enkeltarmet fase III-studie, som evaluerede farmakokinetik, sikkerhed, tolerabilitet og virkning af darunavir sammen med cobicistat hos 313 hiv-1-inficerede voksne patienter (295 behandlingsnaive og 18 behandlingserfarne).
GS-US-216-130 is a single-arm, open-label, Phase III trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with cobicistat in 313 HIV-1 infected adult patients (295 treatment-naïve and 18 treatment-experienced).
Samtidig brug af everolimus eller irinotecan og REZOLSTA frarådes.
Concomitant use of everolimus or irinotecan and REZOLSTA is not recommended.
Justering af REZOLSTA-dosis er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
No dosage adjustment of REZOLSTA is necessary for patients with mild to moderate hepatic impairment.
Sådan skal du tage REZOLSTA
How to take REZOLSTA
Disse resultater blev bekræftet af analysedata efter 96 ugers behandling i ARTEMISstudiet og blev opretholdt i op til 192 ugers behandling i ARTEMIS-studiet.
These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial.
I kliniske studier med darunavir/ritonavir og darunavir/cobicistat var udslættet for det meste let til moderat og debuterede ofte i løbet af de første fire behandlingsuger, hvorefter det fortog sig under den fortsatte behandling (se pkt.
In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see section 4.4).
Samtidig brug af salmeterol og REZOLSTA frarådes.
Concomitant use of salmeterol and REZOLSTA is not recommended.
Tag ikke REZOLSTA - hvis du er allergisk over for darunavir, cobicistat eller et af de øvrige indholdsstoffer i
Do not take REZOLSTA - if you are allergic to darunavir, cobicistat or any of the other ingredients of this medicine (listed in section 6).
Se produktresuméet for PREZISTA for yderligere oplysninger.
Refer to the Summary of Product Characteristics for PREZISTA for further information.
Koncentrationen af disse lægemidler øges muligvis ved co-administration med REZOLSTA og kan således muligvis resultere i en øget forekomst af de bivirkninger, som normalt er forbundet med disse lægemidler.
Concentrations of these medicinal products may be increased when co-administered with REZOLSTA resulting in the potential for increased adverse events usually associated with these medicinal products.
- atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
- Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Tabellen nedenfor viser effektdata fra 48 ugers-analysen fra GS-US-216-130-studiet:
The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
- Øvrige indholdsstoffer: hypromellose, silicificeret mikrokrystallinsk cellulose, kolloid silica, crospovidon og magnesiumstearat.
- The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone and magnesium stearate.
C-darunavir med ritonavir i en dosis på 400/100 mg kunne ca. 79,5 % og 13,9 % af det administrerede
C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Se produktresuméerne for andre antiretrovirale lægemidler for yderligere oplysninger om dosering.
Refer to the Summary of Product Characteristics of other antiretroviral medicinal products for dosing information.
(CYP3A-induktion) REZOLSTA forventes at øge plasmakoncentrationen af bosentan.
(CYP3A induction) REZOLSTA is expected to increase bosentan plasma concentrations.
Disse patienter fik darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt sammen med et optimeret baggrundsregime (OBR) valgt af investigator bestående af 2 aktive NRTI'er.
These patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily with an investigator selected optimised background regimen (OBR) consisting of 2 active NRTIs.
Co-administration af REZOLSTA og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og cobicistat og medføre øgede plasmakoncentrationer af darunavir og cobicistat (f.eks. antimykotiske azoler som clotrimazol).
Co-administration of REZOLSTA and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals such as clotrimazole).
Justering af methadondosis forventes ikke at være nødvendig, når behandling med REZOLSTA påbegyndes.
No adjustment of methadone dosage is expected when initiating co-administration with REZOLSTA.
Hos alle andre ART-erfarne patienter eller i tilfælde, hvor der ikke foreligger hiv-1genotypebestemmelse, er REZOLSTA ikke egnet.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used.
Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale 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.
Nogle patienter, der tager flere forskellige lægemidler mod hiv, kan udvikle en knoglesygdom, hvor knoglevævet dør på grund af manglende blodforsyning til knoglen (osteonekrose).
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv 1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Da REZOLSTA indeholder darunavir og cobicistat, kan interaktioner, som er identificeret med darunavir (i kombination med cobicistat eller med lavdosis ritonavir) eller med cobicistat, muligvis forekommer med REZOLSTA.
As REZOLSTA contains darunavir and cobicistat, interactions that have been identified with darunavir (in combination with cobicistat or with low dose ritonavir) or with cobicistat determine the interactions that may occur with REZOLSTA.
Du skal fortælle det til din læge, hvis du tager: - Bosentan (til behandling af hjertesygdomme) - Dexamethason (til injektion) (kortikosteroid) - Efavirenz, etravirin, nevirapin (til behandling af hiv-infektion) - Rifapentin, rifabutin (til behandling af bakterieinfektioner)
Tell your doctor if you take: - Bosentan (to treat heart disease) - Dexamethasone (injectable) (corticosteroid) - Efavirenz, etravirine, nevirapine (to treat HIV infection) - Rifapentine, rifabutin (to treat bacterial infections).
Der gælder ingen særlige forholdsregler eller dosisjusteringer hos patienter med nedsat nyrefunktion.
No special precautions or dose adjustments are required in patients with renal impairment.
Behandling med REZOLSTA bør derfor ikke påbegyndes under graviditet, og kvinder, som bliver gravide under behandling med REZOLSTA, bør skiftes til et alternativt regime (se pkt.
Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen (see sections 4.4 and 4.6).
Du skal fortælle det til din læge, hvis du tager: - amlodipin, carvedilol, diltiazem, disopyramid, felodipin, flecainid, lidocain, metoprolol, mexiletin, nicardipin, nifedipin, propafenon, timolol, verapamil (til hjertesygdomme), da virkningen eller bivirkningerne af disse lægemidler kan blive forstærket.
Tell your doctor if you take: - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
ODIN er et randomiseret, åbent fase III-studie, der sammenligner darunavir/ritonavir 800/100 mg en gang dagligt med darunavir/ritonavir 600/100 mg to gange dagligt hos ART-erfarne hiv-1-inficerede patienter, hvor screening for genotype-resistens ikke har vist darunavir-RAM (dvs. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), og screening for hiv-1 RNA viste > 1.000 kopier/ml.
ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/mL.
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 with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Kortikosteroider, som er mindre afhængige af CYP3Ametabolisering, f.eks. nasal eller inhaleret beclomethason, bør overvejes, navnlig ved langvarig brug.
Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) - en reaktion kaldet DRESS [et alvorligt udslæt, der kan være ledsaget af feber, træthed, hævelser i ansigt eller lymfekirtler, øgning i antallet af eosinofile celler (en type hvide blodlegemer) samt påvirkning af lever, nyrer eller lunger].
Rare side effects (may affect up to 1 in 1,000 people) - a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung].
Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison og triamcinolon).
CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Cobicistats virkning på serumkreatinin blev undersøgt i et fase I-studie med patienter med normal nyrefunktion (eGFR ≥ 80 ml/min, n=12) og let til moderat nedsat nyrefunktion (eGFR 50-79 ml/min, n=18).
The effect of cobicistat on serum creatinine was investigated in a Phase I trial in subjects with normal renal function (eGFR ≥ 80 mL/min, n = 12) and mild to moderate renal impairment (eGFR:50-79 mL/min, n = 18).
* Disse bivirkninger er ikke blevet rapporteret i kliniske studier med darunavir/cobicistat, men er blevet observeret ved behandling med darunavir/ritonavir og kan også forventes med darunavir/cobicistat.
* These adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
I et flerdosisstudie med darunavir/ritonavir (600/100 mg) to gange dagligt blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med let (Child-Pugh 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 trial with darunavir/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 (Child-Pugh Class B, n = 8) hepatic impairment were comparable with those in healthy subjects.
ANTIMYKOTIKA Clotrimazol Fluconazol Itraconazol Isavuconazol Posaconazol
ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
REZOLSTA indeholder de aktive stoffer darunavir og cobicistat.
REZOLSTA contains the active substances darunavir and cobicistat.
Resistensprofilen for REZOLSTA understøttes af to fase III-studier udført med darunavir/ritonavir hos behandlingsnaive (ARTEMIS) og behandlingserfarne (ODIN) patienter og af analysen af 48-ugers data i studiet GS-US-216-130 med behandlingsnaive og behandlingserfarne patienter.
The resistance profile of REZOLSTA is supported by two Phase III trials conducted with darunavir/ritonavir in treatment-naïve (ARTEMIS) and treatment-experienced (ODIN) patients and the analysis of 48 week data from trial GS-US-216-130 in treatment-naïve and treatment-experienced patients.
Samtidig brug af REZOLSTA og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroid-bivirkninger, herunder Cushings syndrom og binyrebarksuppression.
Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Hos rotter medførte kombinationen af darunavir og ritonavir en let øget virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtel og øget incidens af fibrose i de langerhanske øer i pancreas (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.
Ved nyopstået eller forværret leverdysfunktion (med klinisk signifikant forhøjede leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørk urin, ømhed over leveren, hepatomegali) hos patienter, der tager REZOLSTA, skal det omgående overvejes midlertigt at afbryde eller helt seponere behandlingen.
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using REZOLSTA, interruption or discontinuation of treatment should be considered promptly.
Risikoen for dette øges i forbindelse med langvarig behandling, alvorlig svækkelse af immunforsvaret, overvægt eller brug af alkohol eller lægemidler, der kaldes binyrebarkhormoner (kortikosteroider).
This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids.
Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle for cobicistat på grund af køn.
Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Der foreligger ingen data om virkningen af darunavir eller cobicistat på fertiliteten hos mennesker.
No human data on the effect of darunavir or cobicistat on fertility are available.
Forsigtighed tilrådes, og monitorering af den terapeutiske koncentration anbefales om muligt, når disse antiarytmika co-administreres med REZOLSTA.
Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with REZOLSTA.
Co-administration af oral midazolam eller triazolam og REZOLSTA er kontraindiceret (se pkt.
Co-administration of oral midazolam or triazolam and REZOLSTA is contraindicated (see section 4.3).
Lægemidler, der kan påvirkes af darunavir/cobicistat
Medicinal products that may be affected by darunavir/cobicistat
Interaktionsstudier med darunavir/cobicistat, darunavir/ritonavir og cobicistat er kun udført hos voksne.
Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Co-administration af REZOLSTA og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt.
Therefore, co-administration of REZOLSTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Pædiatrisk population REZOLSTAs farmakokinetik er ikke blevet undersøgt hos pædiatriske patienter.
Paediatric population The pharmacokinetics of REZOLSTA in paediatric patients have not been investigated.
Filmovertrukken, lyserød, oval tablet med TG trykt på den ene side og 800 på den anden side.
What REZOLSTA looks like and contents of the pack Film-coated, pink, oval shaped tablet, mentioning TG on one side, 800 on the other side.
Baseret på teoretiske overvejelser kan administration af REZOLSTA og dabigatran eller ticagrelor øge koncentrationen af antikoagulansen.
Based on theoretical considerations co-administration of REZOLSTA with dabigatran or ticagrelor may increase concentrations of the anticoagulant.
Alternativ eller yderligere prævention anbefales ved coadministration af østrogenbaseret prævention med REZOLSTA.
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Der foreligger ingen farmakokinetiske data vedrørende anvendelse af REZOLSTA til patienter med nedsat leverfunktion.
There are no pharmacokinetic data regarding the use of REZOLSTA in patients with hepatic impairment.
Hvis du kommer i tanke om den glemte dosis efter mere end 12 timer, skal du springe den over og tage de næste doser som sædvanligt.
If you notice after 12 hours, then skip the intake and take the next doses as usual.
REZOLSTA bør ikke anvendes sammen med præparater, der indeholder ritonavir, eller regimer, der indeholder ritonavir eller cobicistat.
REZOLSTA should not be used concurrently with products containing ritonavir or regimens containing ritonavir or cobicistat.
(CYP2D6- og/eller CYP3A-hæmning) Tidligere data med ritonavir-boostet darunavir har dog vist en nedsat plasmakoncentration af disse antidepressiva (ukendt mekanisme); sidstnævnte kan være specifikt for ritonavir.
Prior data with ritonavir-boosted darunavir however showed a decrease in these anti-depressant plasma concentrations (unknown mechanism); the latter may be specific to ritonavir.
Klinisk monitorering anbefales ved co-administration af REZOLSTA med disse analgetika.
Clinical monitoring is recommended when co-administering REZOLSTA with these analgesics.
- apixaban, edoxaban, rivaroxaban, warfarin (til at hindre blodpropper), da virkningen eller bivirkningerne af disse lægemidler 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.
Samtidig administration af amiodaron, bepridil, dronedaron, ivabradin, quinidin eller ranolazin og REZOLSTA er kontraindiceret (se pkt.
Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Hiv 1-inficerede patienter, som var egnede til deltagelse i dette studie, havde en plasma hiv 1-RNA ≥ 1.000 kopier/ml.
HIV-1 infected patients who were eligible for this trial had a plasma HIV-1 RNA ≥ 1,000 copies/mL.
Da REZOLSTA indeholder darunavir og cobicistat, kan der forventes de samme bivirkninger, der er forbundet med de enkelte stoffer.
As REZOLSTA contains darunavir and cobicistat, the adverse reactions associated with each of the individual compounds may be expected.
Klinisk monitorering anbefales ved co-administration af REZOLSTA og perphenazin, risperidon eller thioridazin.
Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Dosisreduktion af disse neuroleptika bør overvejes ved co-administration med REZOLSTA.
For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with REZOLSTA.
Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at darunavirs farmakokinetik 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).
Udslæt forekom hyppigere hos behandlingserfarne patienter, der blev behandlet med darunavir/ritonavir + raltegravir, end hos patienter, der fik darunavir/ritonavir uden raltegravir eller raltegravir uden darunavir/ritonavir (se pkt.
Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/ritonavir + raltegravir compared to patients receiving darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir (see section 4.8).
De poolede data i et enkelt-armet studie, hvor darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt og andre antiretrovirale lægemidler blev undersøgt, samt i en arm i et studie, hvor REZOLSTA 800/150 mg en gang dagligt og andre antiretrovirale lægemidler blev administreret, viste, at 1,9 % af patienterne måtte afbryde behandlingen på grund af udslæt.
The pooled data of a single-arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals and one arm of a trial in which REZOLSTA 800/150 mg once daily and other antiretrovirals were administered, showed that 1.9% of patients discontinued treatment due to rash.
De selekterede vira kunne ikke vokse ved tilstedeværelse af darunavir-koncentrationer over 400 nM. Vira, der blev selekteret under disse betingelser, og som viste reduceret følsomhed for darunavir (område: 23-50 fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet.
Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv 1-inficerede patienter med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min).
A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Alvorlige bivirkninger var diabetes mellitus, (lægemiddel-) overfølsomhed, immunrekonstitutionsinflammatorisk syndrom (IRIS), udslæt, Stevens-Johnsons syndrom og opkastning.
Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.