FrancophonIA/ELRC3.0 huggingface dataset:
English: In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV.
Danish: I AC-052-352 studiet blev 92% af de 213 patienter klassificeret ud fra initialværdier som WHO funktionsklasse III og 8% som funktionsklasse IV.
English: Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Danish: Hvis De anvender et hormonelt præventionsmiddel, skal De derfor også anvende en barrieremetode (f.eks. femidom, pessar eller svangerskabsforebyggende svamp, eller Deres partner skal også anvende kondom).
English: At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Danish: Ved baseline havde patienterne idiopatisk (31 patienter [86%]) eller familiær (5 patienter [14%]) PAH og var i WHO-funktionsklasse II (n=23, 64%) eller III (n=13, 36%).
English: In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.
Danish: Hos drengebørn kan det ikke udelukkes, at der på langt sigt er en indvirkning på fertiliteten efter behandling med bosentan.
English: Gastrooesophageal reflux disease Diarrhoea
Danish: Gastroøsofageal reflukssygdom Diarré
English: The mean increase from baseline in cardiac index was 0.5 L/min/m2, the mean decrease in mean pulmonary arterial pressure was 8 mmHg, and the mean decrease in PVR was 389 dyn·sec·cm-5.
Danish: Middelstigningen fra basalniveau ved hjerteindeks var 0,5 l/min/m2, gennemsnitligt fald i gennemsnitligt pulmonalt arterielt tryk var 8 mmHg, og gennemsnitligt fald i PVR var 389 dyn·sec·cm-5.
English: Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1).
Danish: Nogen bedring er ligeledes vist hos patienter med pulmonal arteriel hypertension WHO funktionsklasse II (se pkt.
English: Elevations in aminotransferases were associated with elevated bilirubin (≥ 2 × ULN) without evidence of biliary obstruction in 0.2% (5 patients) on bosentan and 0.3% (6 patients) on placebo.
Danish: Stigninger i aminotransferaser blev associeret med forhøjet bilirubin (> 2 x ULN) uden tegn på biliær obstruktion hos 0,2% (5) af patienterne på bosentan og hos 0,3% (6) af patienterne på placebo.
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Danish: Bosentan filmovertrukne tabletter blev evalueret i et åbent ikke-kontrolleret studie med 19 pædiatriske patienter i alderen 3 til15 år med PAH.
English: In the FUTURE-4 study, 6 out of 13 bosentan-treated neonates with PPHN experienced a decrease in haemoglobin from within the reference range at baseline to below the lower limit of normal during the treatment.
Danish: I FUTURE-4-studiet oplevede 6 ud af 13 bosentanbehandlede nyfødte med PPHN et fald i hæmoglobin fra en værdi inden for referenceområdet ved baseline til et niveau under den nedre normalgrænse under behandlingen.
English: Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Danish: Studie udført hos nyfødte med persisterende pulmonal hypertension hos nyfødte (PPHN)
English: STAYVEER contains sodium
Danish: STAYVEER indeholder natrium
English: Concomitant use with other medicinal products
Danish: Samtidig anvendelse af andre lægemidler:
English: STAYVEER has no or negligible influence on the ability to drive and use machines.
Danish: STAYVEER påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Danish: Vitalstatus over længere tid for alle 235 patienter, som blev behandlet med bosentan, blev imidlertid noteret, i de to pivotale placebo-kontrollerede studier (AC-052-351 og AC-052-352) og/eller deres to ukontrollerede, open-label forlængelser.
English: The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Danish: Den gennemsnitlige varighed for eksponering for bosentan var 1,9 år ± 0,7 år; (min: 0,1 år; max: 3,3 år) og patienterne blev observeret i gennemsnitligt 2,0 ± 0,6 år.
English: However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.
Danish: Ved kombination med en CYP3A4 inhibitor risikerer patienter med dårlig omsætning af CYP2C9 dog forøgede plasmakoncentrationer af bosentan, som kan være endnu højere og dermed føre til potentielt skadelige bivirkninger.
English: Other medicines and STAYVEER
Danish: Brug af anden medicin sammen med STAYVEER
English: At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Danish: I FUTURE 1 fik 9 patienter epoprostenol ved baseline.
English: Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.
Danish: Kvinder i den fertile alder må derfor ikke anvende hormonale præventionsmetoder (inklusive orale, injicerbare, transkutane eller implantable former) som den eneste form for prævention, men skal anvende en supplerende eller en alternativ pålidelig form for prævention.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Danish: Titandioxid (E171) Jernoxid, gult (E172) Jernoxid, rødt (E172) Ethylcellulose
English: For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C.
Danish: For PVC/PE/PVDC/aluminium-blisterpakninger: Må ikke opbevares ved temperaturer over 30 °C.
English: Concomitant use of STAYVEER with glibenclamide, fluconazole and rifampicin is not recommended.
Danish: Samtidig anvendelse af STAYVEER og glibenclamid, fluconazol og rifampicin anbefales ikke.
English: In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Danish: I BREATHE-3 var de hyppigste bivirkninger ansigtsrødme (21%), hovedpine og unormal leverfunktionstest (begge 16%).
English: Liver enzyme changes typically occur within the first 26 weeks of treatment but may also occur late in treatment (see section 4.8).
Danish: Leverenzymændringer forekommer typisk inden for de første 26 uger af behandlingen, men kan også forekomme senere under behandlingen (se pkt.
English: Treatment with bosentan led to a significant increase in cardiac index associated with a significant reduction in pulmonary artery pressure, pulmonary vascular resistance and mean right atrial pressure.
Danish: Behandling med bosentan førte til en signifikant forøgelse af hjerteindeks som var forbundet med en signifikant nedsættelse af det pulmonale arterielle tryk, pulmonal vaskulær modstand og gennemsnitligt tryk i højre atrium.
English: In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Danish: I studie AC-052-365 (FUTURE 1) blev der administreret dispergible tabletter til 36 PAH-børn i alderen fra 2 til 11 år.
English: At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.
Danish: Ved voksenalderen (dag 69 post partum) blev der ikke set nogen virkninger af bosentan ved en eksponering, der var 1,3 (hanner) og 2,6 (hunner) gange højere end den terapeutiske eksponering hos børn med PAH.
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Danish: I 20 placebo-kontrollerede undersøgelser ved forskellige terapeutiske indikationer blev i alt 2.486 patienter behandlet med bosentan i daglige doser fra 100 mg til 2.000 mg, og 1.838 patienter blev behandlet med placebo.
English: Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Danish: Forøgelser af leveraminotransferaser, dvs. aspartat- og alaninaminotransferaser (ASAT og/eller ALAT) i forbindelse med bosentan er dosisafhængige.
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with STAYVEER.
Danish: Leveraminotransferaseniveauer skal måles inden behandlingens start og derefter med månedlige intervaller under hele behandlingsforløbet med STAYVEER.
English: Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Danish: Deres læge og/eller gynækolog vil sørge for en passende præventionsmetode til Dem.
English: The tablets can be taken with or without food.
Danish: Tabletterne kan tages i forbindelse med eller uden for måltider.
English: After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
Danish: Efter 16 ugers behandling var der signifikante forbedringer fra udgangsværdier for arbejdskapacitet: Den gennemsnitlige øgning i 6 minutters gangdistance +91,4 m fra 332,6 m i gennemsnit ved udgangsværdier (p<0,001).
English: In an animal model of pulmonary fibrosis, bosentan reduced collagen deposition in the lungs.
Danish: I et dyreforsøg med lungefibrose nedsatte bosentan collagenaflejringen i lungerne.
English: - The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate.
Danish: - Øvrige indholdsstoffer, tabletkerne: majsstivelse, prægelatineret stivelse, natriumstivelsesglycolat (type A), povidon, glyceroldibehenat og magnesiumstearat.
English: An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Danish: Et åbent, non-komparativt studie (AC-052-362 [BREATHE-4]) blev udført med 16 patienter med WHO funktionsklasse III PAH associeret med hiv-infektion.
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Danish: Der blev ikke set dosisproportionalitet, idet steady-state-plasmakoncentrationerne af bosentan og AUC'erne var ens ved orale doser på 2 og 4 mg/kg (AUCτ: 3,577 ng·t/ml og 3,371 ng·t/ml for hhv. 2 mg/kg to gange dagligt og 4 mg/kg to gange dagligt).
English: No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Danish: Der er ikke udført specifikke undersøgelser hos patienter med pulmonal hypertension og samtidig dysfunktion af venstre ventrikel.
English: Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days.
Danish: Patienter med suboptimalt respons på inhaleret nitrogenmonoxid (iNO) til trods for mindst 4 timers kontinuerlig behandling blev behandlet med bosentan dispergible tabletter i en dosis på 2 mg/kg to gange dagligt (n=13) eller placebo (n=8) via nasogastrisk sonde som tillægsbehandling til iNO, indtil de var fuldstændigt afvænnet fra iNO, eller indtil behandlingssvigt (defineret som behov for ekstrakorporal membranoxygenering [EMCO] eller opstart af anden pulmonal vasodilatator), og i højst 14 dage.
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease.
Danish: I post marketing perioden har der været sjældne rapporter om pulmonært ødem hos patienter i behandling med STAYVEER, og som havde pulmonær veno-okklusiv sygdom som formodet diagnose.
English: Patients were divided into three body-weight groups and dosed with bosentan at approximately 2 mg/kg twice daily for 12 weeks.
Danish: Patienterne blev delt i tre grupper afhængigt af legemsvægt og fik administreret bosentan i en dosis på cirka 2 mg/kg to gange dagligt i 12 uger.
English: In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
Danish: I denne undersøgelse manifesterede væskeretention sig som tidlig vægtøgning, nedsat hæmoglobinkoncentration og øget forekomst af ødemer i ben.
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Danish: • Levercirrhose (skrumpelever), leversvigt (alvorlig forstyrrelse af leverfunktionen)
English: The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Danish: Plasmakoncentrationen af ciclosporin (et CYP3A4-substrat) faldt med cirka 50%.
English: • Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Danish: • Forhøjede leverfunktionsprøver med hepatitis (leverbetændelse), herunder mulig forværring af underliggende hepatitis, og/eller gulsot (gulfarvning af huden eller det hvide i øjnene)
English: Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended.
Danish: Som følge af nevirapins udtalte hepatotoksicitet, som vil kunne forstærkes af bosentans hepatotoksicitet, frarådes denne kombination.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
Danish: Kaplan-Meier-estimatet (hændelsesfri) for forværring af PAH (død, lungetransplantation eller hospitalsindlæggelse på grund af PAH-forværring) efter 24 uger var hhv. 96,9% og 96,7% i grupperne med dosering to gange dagligt og tre gange dagligt.
English: The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Danish: Virkningen af moderat nedsat leverfunktion (Child-Pugh klasse B) på farmakokinetikken af bosentan og dets primære metabolit Ro 48-5033 er blevet undersøgt i et studie, der omfattede 5 patienter med pulmonal hypertension forbundet med portal hypertension og leverinsufficiens i Child-Pugh klasse B og 3 patienter med PAH af andre årsager og med normal leverfunktion.
English: • a blood test to check for anaemia (low haemoglobin)
Danish: • en blodprøve for at kontrollere for blodmangel (lavt hæmoglobin)
English: Syncope1, 4
Danish: Synkope1,4
English: The overall goal of the Patient Alert Card is to educate patients on important safety information that they need to be aware of before and during treatment with STAYVEER.
Danish: Det overordnede mål med patientadvarselskortet er at oplyse patienterne om at være opmærksomme på vigtig sikkerhedsinformation før og under behandlingen med STAYVEER.
English: Studies performed in children with pulmonary arterial hypertension
Danish: Studier med børn med pulmonal arteriel hypertension
English: 33 of these patients were provided with continued treatment with bosentan dispersible tablets at a dose of 4 mg/kg twice daily in the FUTURE 2 uncontrolled extension phase for a median overall treatment duration of 2.3 years (range: 0.2 to 5.0 years).
Danish: 33 af disse patienter fik fortsat behandling med bosentan dispergible tabletter i en dosis på 4 mg/kg to gange dagligt i den ikke-kontrollerede forlængelsesfase FUTURE 2 med en gennemsnitlig samlet behandlingsvarighed på 2,3 år (interval 0,2 til 5,0 år).
English: In a retrospective responder analysis based on change in walking distance, WHO functional class and dyspnoea of the 95 patients randomised to bosentan 125 mg twice daily in the placebo-controlled studies, it was found that at week 8, 66 patients had improved, 22 were stable and 7 had deteriorated.
Danish: I en retrospektiv respondensanalyse baseret på ændringen i 6-minutters gangdistance, WHO funktionsklasse og dyspnø hos de 95 patienter, som var randomiseret til bosentan 125 mg to gange daglig i de placebokontrollerede studier, blev det observeret, at i uge 8 havde 66 patienter forbedrede resultater, 22 var stabiliseret, og 7 havde forringede resultater.
English: In both studies, patients on bosentan were less likely to develop multiple new digital ulcers during the study and took longer to develop each successive new digital ulcer than did those on placebo.
Danish: I begge studier var det mindre sandsynligt at patienter, som blev behandlet med bosentan, udviklede flere nye fingersår i løbet af studiet, og det tog længere tid at udvikle hvert af disse nye fingersår hos disse end hos patienter behandlet med placebo.
English: years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Danish: 43 (67,2%) var ≥ 2 år til 11 år, 15 (23,4%) var mellem 1 og 2 år, og 6 (9,4%) var mellem 3 måneder og 1 år.
English: Fluconazole and other inhibitors of both CYP2C9 and CYP3A4: Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
Danish: Fluconazol og andre hæmmere af både CYP2C9 og CYP3A4: Samtidig administration af fluconazol, som hovedsagligt hæmmer CYP2C9, men også i en vis udstrækning CYP3A4, kan medføre store forøgelser af plasmakoncentrationerne af bosentan.
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Danish: Ved steady-state var AUCτ i helblod 6.165 ng·t/ml (CV 133%, n=7), hvilket svarer til den eksponering, der blev set hos voksne PAH-patienter, der fik 125 mg to gange dagligt, under hensyntagen til en blod/plasmafordelingsratio på 0,6.
English: ((Back cover))
Danish: ((Bagside))
English: No specific studies have been conducted to assess the direct effect of STAYVEER on the ability to drive and use machines.
Danish: Der er ikke udført specifikke studier af STAYVEERS direkte virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Pharmacokinetic data are not available for STAYVEER in young children with this disease.
Danish: Farmakokinetiske data fra yngre børn med denne sygdom er ikke tilgængelige for STAYVEER.
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Danish: Derfor vil plasmakoncentrationer af stoffer, som omsættes af disse isoenzymer, nedsættes ved samtidig indgift af STAYVEER.
English: Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
Danish: Patienterne havde primær pulmonal hypertension (10 patienter) eller PAH relateret til kongenit hjertesygdom (9 patienter) og var i WHO-funktionsklasse II (n=15, 79%) eller III (n=4, 21%) ved baseline.
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER.
Danish: Behandling med diuretika bør overvejes hos patienter med konstateret væskeretention før initiering af behandling med STAYVEER.
English: The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
Danish: Farmakokinetikken af bosentan er hovedsagelig vist hos raske individer.
English: For PVC/PE/PVDC/aluminium-blisters:
Danish: For PVC/PE/PVDC/aluminium-blisterpakninger:
English: The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Danish: Filmovertræk: hypromellose, glyceroltriacetat, talcum, titandioxid (E171), gult jernoxid (E172), rødt jernoxid (E172) samt ethylcellulose.
English: For white high-density polyethylene bottles:
Danish: For hvide polyethylenflasker af høj densitet:
English: Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Danish: Der blev set en let øget forekomst af testikulær tubulær atrofi hos rotter, der fik oralt administreret bosentan i doser på helt ned til 125 mg/kg/dag (cirka 4 gange højere end den maksimalt anbefalede dosis til mennesker [MRHD] og de laveste afprøvede doser) i to år, men ikke ved doser på helt op til 1.500 mg/kg/dag (cirka 50 gange højere end MRHD) i 6 måneder.
English: Oct _____
Danish: Okt _____
English: STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
Danish: STAYVEER 62,5 mg filmovertrukne tabletter EU/1/13/832/001
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Danish: Ud af de 7 patienter, som havde dårligere resultater i uge 8, havde 3 forbedrede resultater i uge 12/16, og 4 dårligere resultater sammenlignet med basalniveau.
English: In study AC-052-331, patients had to have at least one digital ulcer of recent onset, and across the two studies 85% of patients had ongoing digital ulcer disease at baseline.
Danish: I studie AC-052-331 skulle patienter have haft mindst et fingersår i nyligt udbrud, og i begge studier havde 85% af patienterne akutte fingersår ved basalniveau.
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Danish: Tacrolimus, sirolimus: Samtidig administration af tacrolimus eller sirolimus og STAYVEER har ikke været undersøgt hos mennesker, men samtidig administration af tacrolimus eller sirolimus og STAYVEER kan medføre forhøjede plasmakoncentrationer af bosentan ligesom ved samtidig administration af ciclosporin.
English: In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics.
Danish: Hos raske individer udviser bosentan dosis- og tidsafhængig farmakokinetik.
English: The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5-10.0 days) and 4.0 days (range 2.5-6.5 days).
Danish: Den gennemsnitlige varighed af bosentan- og placebobehandlingen var henholdsvis 4,5 dage (interval 0,5-10,0 dage) og 4,0 dage (interval 2,5-6,5 dage).
English: Palpitations1, 4
Danish: Palpitationer1,4
English: Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4).
Danish: Lignende virkning vil kunne forventes med andre ritonavir-boostede proteaseinhibitorer (se pkt.