FrancophonIA/ELRC3.0 huggingface dataset:
English: Zykadia 150 mg film-coated tablets
Danish: Zykadia 150 mg filmovertrukne tabletter
English: In healthy subjects, co-administration of a single 450 mg fasted ceritinib dose with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A/P-gp inhibitor, resulted in 2.9-fold and 1.2-fold increase in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis ceritinib på 450 mg fastende og den potente CYP3A/P-gp-hæmmer ketoconazol (200 mg to gange dagligt i 14 dage), at ceritinibs AUCinf og Cmax steg henholdsvis 2,9 og 1,2 gange sammenlignet med administration af ceritinib alene.
English: Renal impairment (azotaemia, renal impairment)
Danish: Nedsat nyrefunktion (azotæmi, nedsat nyrefunktion)
English: Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Sodium starch glycolate (type A) Magnesium stearate
Danish: Cellulose, mikrokrystallinsk Hydroxypropylcellulose, lavsubstitueret Natriumstivelseglycolat (type A) Magnesiumstearat
English: No patients had diarrhoea, nausea, or vomiting that required dose reduction or discontinuation of study drug.
Danish: Ingen patienter havde behov for dosisreduktion eller behandlingsstop af studiemedicinen på grund af diarré, kvalme eller opkastning.
English: Agents that may decrease ceritinib plasma concentrations
Danish: Lægemidler, der kan nedsætte plasmakoncentrationen af ceritinib
English: Table 1 Zykadia dose adjustment and management recommendations for ADRs
Danish: Tabel 1 Anbefalinger vedrørende dosisjustering af Zykadia og behandling af bivirkninger
English: Elevations of lipase and/or amylase have occurred in patients treated with ceritinib in clinical studies.
Danish: I kliniske studier er der set forhøjet lipase og/eller amylase hos patienter, der blev behandlet med ceritinib.
English: Previously untreated ALK-positive advanced NSCLC - randomised phase 3 Study A2301 (ASCEND-4) The efficacy and safety of Zykadia for the treatment of advanced ALK-positive NSCLC patients who have not received previous systemic treatment anti-cancer therapy (including ALK inhibitor) with the exception of neo-adjuvant or adjuvant therapy, was demonstrated in a global multicentre, randomised, open-label phase 3 Study A2301.
Danish: Virkningen og sikkerheden af Zykadia til behandling af patienter med fremskreden ALK-positive NSCLC, som ikke tidligere har fået systemisk anti-cancerbehandling (inklusive ALK-hæmmer) med undtagelse af neo-adjuverende eller adjuverende behandling, blev påvist i et globalt, multicenter-, randomiseret, open-label fase 3-studie; A2301.
English: The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Danish: Median-alderen var 54,0 år (interval: 28 til 84 år).
English: Figure 4 ASCEND-5 (Study A2303) - Kaplan-Meier plot of overall survival by treatment arm
Danish: Figure 4 ASCEND-5 (Studie A2303) - Kaplan-Meier plot af samlet overlevelse efter behandlingsarm
English: Rash (rash, dermatitis acneiform, rash maculopapular)
Danish: Udslæt (udslæt, acneiform dermatitis, maculopapulært udslæt)
English: In healthy subjects, co-administration of a single 750 mg fasted ceritinib dose with rifampicin (600 mg daily for 14 days), a strong CYP3A/P-gp inducer, resulted in 70% and 44% decreases in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Danish: Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis på 750 mg ceritinib fastende og den potente CYP3A/P-gp-induktor rifampicin (600 mg dagligt i 14 dage) at ceritinibs AUCinf og Cmax faldt henholdsvis 70 % og 44 % sammenlignet med administration af ceritinib alene.
English: Each tablet contains 150 mg ceritinib.
Danish: Hver tablet indeholder 150 mg ceritinib.
English: The other ingredients are: Tablet core: cellulose, microcrystalline; hydroxypropylcellulose, low-substituted; povidone; croscarmellose sodium; magnesium stearate; silica, colloidal anhydrous.
Danish: Øvrige indholdsstoffer: Tabletkerne: cellulose, mikrokrystalinsk; hydroxypropylcellulose, lavsubstitueret; povidon; croscarmellosenatrium; magnesiumstearat; silica, kolloid vandfri; Filmovertræk: hypromellose; titandioxid (E171); macrogol; talcum; indigotin (E132).
English: Each hard capsule contains 150 mg ceritinib.
Danish: Hver hård kapsel indeholder 150 mg ceritinib.
English: Figure 2 ASCEND-4 (Study A2301)- Kaplan-Meier plot of overall survival by treatment arm
Danish: Figur 2 ASCEND-4 (Studie A2301) - Kaplan-Meier plot af samlet overlevelse efter behandlingsarm
English: Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin,
Danish: Samtidig administration af ceritinib med substrater, som primært metaboliseres via CYP3A eller CYP3A-substrater, der vides at have et snævert terapeutisk indeks (fx alfuzosin, amiodaron, cisaprid, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quetiapin, quinidin, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil og sirolimus), bør undgås.
English: Table 2 Zykadia dose adjustment and management recommendations for ADRs
Danish: Tabel 2 Anbefalinger vedrørende dosisjustering af Zykadia og behandling af bivirkninger
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (se pkt.
English: These may be symptoms of lung problems.
Danish: Dette kan være symptomer på fordøjelsesproblemer.
English: Across the seven clinical studies, 9.7% of patients treated with ceritinib had events of QT prolongation (any grade), including grade 3 or 4 events in 2.1% of patients.
Danish: På tværs af de syv kliniske studier havde 9,7 % af patienterne, der blev behandlet med ceritinib QT-forlængelse (alle grader), inkl.
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, reinitiate Zykadia with dose reduced by 150 mg upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Danish: Hvis der ikke identificeres noget medvirkende lægemiddel, der tages samtidig, eller hvis medvirkende lægemidler, der tages samtidig, ikke seponeres eller dosisreduceres, skal Zykadia genoptages med en dosisreduktion på 150 mg efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover.
English: (72.7%, 95% CI: 49.8, 89.3) as compared to the chemotherapy arm (27.3%, 95% CI: 10.7, 50.2).
Danish: Den samlede intrakranielle responsrate (OIRR) var højere med ceritinib (72,7 %, 95 % CI: 49,8; 89,3) sammenlignet med kemoterapi-armen (27,3%, 95 % CI: 10,7; 50,2).
English: Renal impairment l
Danish: Nedsat nyrefunktion l
English: Excessive thirst, increased frequency of urination (symptoms of high level of glucose in the blood)
Danish: Overdreven tørst, hyppigere vandladning (symptomer på for højt blodsukker) Kraftige smerter i den øvre del af maven (tegn på betændelse i bugspytkirtlen, også kaldet pankreatitis)
English: ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Chemotherapy 187 172 161 150 146 141 134 124 97 69 49 35 19 10 5 1 0 0
Danish: Tid (Måneder) ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Kemoterapi
English: Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil and sirolimus) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Danish: Samtidig administration af ceritinib og substrater, der hovedsageligt metaboliseres via CYP3A eller CYP3Asubstrater, der vides at have et snævert terapeutisk indeks (fx alfuzosin, amiodaron, cisaprid, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quetiapin, quinidin, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil og sirolimus), bør undgås.
English: If you cannot eat food while taking Zykadia, talk to your doctor.
Danish: Tal med din læge, hvis du ikke kan spise mad, når du tager Zykadia.
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia at the previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Danish: Hvis et medvirkende lægemiddel, der tages samtidig, identificeres og seponeres, eller dets dosis justeres, skal Zykadia genoptages med den tidligere dosis efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover.
English: The PFS benefit of ceritinib was consistent by investigator assessment and across various subgroups including age, gender, race, smoking class, ECOG performance status and disease burden.
Danish: alder, køn, race, rygerklasser, ECOG performance status og sygdomsbyrde.
English: Ceritinib significantly prolonged time to deterioration for the lung cancer specific symptoms of interest of cough, pain and dyspnoea (composite endpoint LCSS: HR=0.40; 95% CI: 0.25, 0.65, median Time to Deterioration [TTD] 18.0 months [95% CI: 13.4, NE] in the ceritinib arm versus 4.4 months [95% CI: 1.6, 8.6] in the chemotherapy arm; LC13: HR=0.34; 95% CI: 0.22, 0.
Danish: Ceritinib forlængede tiden til forværring af de lungecancerspecifikke symptomer hoste, smerter og dyspnø signifikant (sammensat endepunkt LCSS: HR=0,40; 95 % CI: 0,25; 0,65, median tid til forværring [TTD] 18 måneder [95 % CI: 13,4; NE] i ceritinib-armen versus 4,4 måneder [95 % CI: 1,6; 8,6] i kemoterapi-armen; LC13: HR=0,34; 95 % CI: 0,22; 0,52, median TTD 11,1 måneder [95 % CI: 7,1; 14,2] i ceritinib-armen versus 2,1 måneder [95 % CI: 1,0; 5,6] i kemoterapi-armen.
English: Electrocardiogram QT prolonged
Danish: QT-forlængelse i EKG
English: QTc prolongation has been observed in clinical studies in patients treated with ceritinib (see sections 4.8 and 5.2), which may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Danish: 4.8 og 5.2), hvilket kan medføre øget risiko for ventrikulære takyarytmier (fx torsade de pointes) eller pludselig død.
English: Withhold Zykadia until recovery to baseline ALT/AST levels or to ≤3 times ULN, then reinitiate with dose reduced by 150 mg.
Danish: Pausér Zykadia indtil bedring til baseline ALT/AST niveau eller til ≤3 gange ULN.
English: Each film-coated tablet contains 150 mg ceritinib.
Danish: Hver filmovertrukket tablet indeholder 150 mg ceritinib.
English: Renal and urinary disorders Renal failure k
Danish: Nyrer og urinveje Nyresvigt k
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia with dose reduced by 150 mg upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring b.
Danish: Hvis et medvirkende lægemiddel, der tages samtidig, identificeres og seponeres, eller dets dosis justeres, skal Zykadia genoptages med en dosisreduktion på 150 mg efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover og med hyppig monitorering b.
English: If unavoidable, dose reduction for co-administered medicinal products that are CYP3A substrates with narrow therapeutic indices should be considered.
Danish: Hvis samtidig administration af lægemidler, der er CYP3A-substrater med et snævert terapeutisk indeks, ikke kan undgås, bør der overvejes dosisreduktion af disse.
English: The median age was 51 years (range: 29-80 years); 87.1% of patients were younger than 65 years and 50.0% were female.
Danish: 87,1 % af patienterne var yngre end 65 år og 50,0 % af patienterne var kvinder.
English: Pericarditis (pericardial effusion, pericarditis)
Danish: Perikarditis (perikardieeffusion, perikarditis)
English: Cases of pancreatitis have been reported in patients treated with ceritinib (see section 4.8).
Danish: Der er rapporteret tilfælde af pankreatitis hos patienter, som blev behandlet med Zykadia (se pkt.
English: In the majority of NSCLC cases, EML4 is the translocation partner for ALK; this generates an EML4-ALK fusion protein containing the protein kinase domain of ALK fused to the
Danish: I de fleste NSCLC-tilfælde er EML4 translokationspartner for ALK.
English: Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia (see section 4.5).
Danish: Undgå samtidig behandling med Zykadia og potente CYP3A-hæmmere (se pkt.
English: These events required dose reduction or interruption in 1.1% of patients and led to discontinuation in 0.9% of patients.
Danish: Disse bivirkninger krævede dosisreduktion eller -afbrydelse hos 1,1 % af patienterne og seponering hos 0,9 % af patienterne.
English: If the concomitant medicinal product can be adjusted or discontinued, Zykadia should be reinitiated with dose reduced by 150 mg on recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring (see sections 4.2 and 4.8).
Danish: Hvis det lægemiddel, der tages samtidig, kan justeres eller seponeres, skal behandling med Zykadia genoptages med en dosisreduktion på 150 mg efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover og med hyppig monitorering (se pkt.
English: Censoring Times Ceritinib 750 mg (n/N = 48/115) Chemotherapy (n/N = 50/116)
Danish: Censoreringstider Ceritinib 750 mg (n/N = 48/115) Kemoterapi (n/N = 50/116)
English: What Zykadia is and what it is used for What you need to know before you take Zykadia How to take Zykadia
Danish: Det skal du vide, før du begynder at tage Zykadia Sådan skal du tage Zykadia Bivirkninger
English: ceritinib 750 mg 189 155 139 125 116 105 98 76 59 43 32 23 16 11 1 1 1 0 Chemotherapy 187 136 114 82 71 60 53 35 24 16 11 5 3 1 1 0 0 0
Danish: Tid (Måneder) ceritinib 750 mg 189 155 139 125 116 105 98 76 59 43 32 23 16 11 1 1 1 0 Kemoterapi
English: Censoring Times ceritinib 750 mg (n/N = 89/189) Chemotherapy (n/N = 113/187)
Danish: Censoreringstider ceritinib 750 mg (n/N = 89/189) Kemoterapi (n/N = 113/187)
English: Abdominal pain (abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort)
Danish: Mavesmerter (mavesmerter, øvre mavesmerter, maveubehag, epigastrisk ubehag)
English: What Zykadia contains
Danish: Zykadia indeholder:
English: Previously treated ALK-positive advanced NSCLC - randomised phase 3 Study A2303 (ASCEND-5) The efficacy and safety of Zykadia for the treatment of ALK-positive advanced NSCLC patients who have received previous treatment with crizotinib, was demonstrated in a global multicentre, randomised, open-label phase 3 Study A2303.
Danish: Effekten og sikkerheden af Zykadia til behandling af ALK-positive, fremskredne NSCLC-patienter, som tidligere havde fået behandling med crizotinib, blev påvist i et globalt, multicenter-, randomiseret, open-label fase 3-studie; A2303.
English: Zykadia 150 mg film-coated tablets ceritinib
Danish: Zykadia 150 mg filmovertrukne tabletter ceritinib
English: Censoring Times ceritinib 750 mg (n/N = 48/189) Chemotherapy (n/N = 59/187)
Danish: Censoreringstider ceritinib 750 mg (n/N = 48/189) Kemoterapi (n/N = 59/187)
English: These events required dose reduction or interruption in 1.4% of patients and led to discontinuation in 0.1% of patients.
Danish: Disse bivirkninger krævede dosisreduktion eller -afbrydelse hos 1,4 % af patienterne og seponering hos 0,1 % af patienterne.
English: Patients should be managed as recommended in sections 4.2 and 4.4.
Danish: Patienter skal behandles som anbefalet i pkt.
English: St. John's Wort, a herbal medicine used to treat depression.
Danish: Perikum, naturmedicin til behandling af depression.
English: How to take Zykadia
Danish: Sådan skal du tage Zykadia
English: Cases of hyperglycaemia (all grades) have been reported in less than 10% of patients treated with ceritinib in clinical studies; grade 3-4 hyperglycaemia was reported in 5.4% of patients.
Danish: Tilfælde af hyperglykæmi (alle grader) er blevet indberettet hos færre end 10 % af de patienter, der blev behandlet med ceritinib i kliniske studier.
English: Time (Months) Ceritinib 750 mg 115 107 92 83 71 61 52 37 28 23 13 8 2 2 0 0 Chemotherapy 116 109 91 78 66 53 43 39 29 22 17 7 5 2 1 0
Danish: Tid (måneder) Ceritinib 750 mg 115 107 92 83 71 61 52 37 28 23 13 8 2 2 Kemoterapi
English: The median PFS in patients with brain metastases was 10.7 months (95% CI: 8.1, 16.4) versus 6.7 months (95% CI: 4.1, 10.6) in the ceritinib and chemotherapy arms, respectively, with HR=0.70 (95% CI: 0.44, 1.12).
Danish: Den mediane PFS hos patienter med hjernemetastaser var 10,7 måneder (95 % CI: 8,1; 16,4) versus 6,7 måneder (95 % CI: 4,1; 10,6) i henholdsvis ceritinib- og kemoterapi-armene med HR=0,70 (95 % CI: 0,44; 1,12).
English: Censoring Times Ceritinib 750 mg (n/N = 83/115) Chemotherapy (n/N = 89/116)
Danish: Censoreringstider Ceritinib 750 mg (n/N = 83/115) Kemoterapi (n/N = 89/116)
English: Zykadia should be withheld in patients who develop QTc >500 msec on at least two separate ECGs until recovery to baseline or a QTc ≤480 msec, then reinitiated with dose reduced by 150 mg (see sections 4.2, 4.8 and 5.2).
Danish: i mindst to separate EKG'er indtil bedring til baseline eller QTc ≤480 msek.
English: The median PFS in patients without brain metastases was 8.3 months (95% CI: 4.1, 14.0) versus 2.8 months (95% CI: 1.4, 4.1) in the ceritinib and chemotherapy arms, respectively with HR=0.41 (95% CI: 0.24, 0.69).
Danish: Den mediane PFS hos patienter uden hjernemetastaser var 8,3 måneder (95 % CI: 4,1; 14,0) versus 2,8 måneder (95 % CI: 1,4; 4,1) i henholdsvis ceritinib- og kemoterapi-armen med HR=0,41 (95 % CI: 0,24; 0,69).
English: The median PFS in patients with brain metastases was 4.4 months (95% CI: 3.4, 6.2) versus 1.5 months (95% CI: 1.3, 1.8) in the ceritinib and chemotherapy arms, respectively with HR=0.54 (95% CI: 0.36, 0.80).
Danish: Den mediane PFS hos patienter med hjernemetastaser var 4,4 måneder (95 % CI: 3,4; 6,2) versus 1,5 måneder (95 % CI: 1,3; 1,8) i henholdsvis ceritinib- og kemoterapi-armen med HR=0,54 (95 % CI: 0,36; 0,80).
English: Dose adjustment due to adverse reactions
Danish: Dosisjustering som følge af bivirkninger
English: Withhold Zykadia until recovery to baseline or to a QTc ≤480 msec, check and if necessary correct electrolytes, then reinitiate with dose reduced by 150 mg.
Danish: Pausér Zykadia indtil bedring til baseline eller til QTc ≤480 msek.
English: The median PFS in patients without brain metastases was 26.3 months (95% CI: 15.4, 27.7) versus 8.3 months (95% CI: 6.0, 13.7) in the ceritinib and chemotherapy arms, respectively, with HR=0.48 (95% CI: 0.33, 0.69).
Danish: Den mediane PFS hos patienter uden hjernemetastaser var 26,3 måneder (95 % CI: 15,4; 27,7) versus 8,3 måneder (95 % CI: 6,0; 13,7) i henholdsvis ceritinibog kemoterapi-armene med HR=0,48 (95 % CI: 0,33; 0,69).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription such as vitamins or herbal supplements, because they might interact with Zykadia.
Danish: Det gælder også medicin, som ikke er købt på recept, som fx vitaminer eller naturlægemidler, da de kan påvirke virkningen af Zykadia.
English: Withhold Zykadia until hyperglycaemia is adequately controlled, then reinitiate Zykadia with dose reduced by 150 mg.
Danish: Pausér Zykadia, indtil hyperglykæmien er under tilstrækkelig kontrol.
English: These events required dose reduction or interruption in 2.1% of patients and led to discontinuation in 0.2% of patients.
Danish: Disse bivirkninger krævede dosisreduktion ellerafbrydelse hos 2,1 % af patienterne og seponering hos 0,2 % af patienterne.
English: 53.7% of the study population was Caucasian, 42.0% Asian, 1.6% Black and 2.6% other races The majority of patients had adenocarcinoma (96.5%) and had either never smoked or were former smokers (92.0%).
Danish: 53,7 % af studiepopulationen var kaukasiske, 42,0 % asiatiske, 1,6 % sorte og 2,6 % andre racer.
English: Zykadia should be permanently discontinued in patients who develop QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia.
Danish: fra baseline og torsade de pointes eller polymorf ventrikulær takykardi eller tegn/symptomer på alvorlig arytmi.
English: Patients should be carefully monitored for safety.
Danish: Der skal udvises særlig forsigtighed, når patienter med svært nedsat leverfunktion behandles.
English: If you take more Zykadia than you should
Danish: Hvis du har taget for meget Zykadia
English: How much to take The recommended dose is 450 mg (three tablets) taken once daily with food, although your doctor could modify this recommendation if needed.
Danish: Den anbefalede dosis er 450 mg (tre tabletter) én gang daglig sammen med mad.
English: In the event of life-threatening bradycardia Zykadia should be permanently discontinued if no contributing concomitant medicinal product is identified; however, if associated with a concomitant medicinal product known to cause bradycardia or hypotension, Zykadia should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Danish: Hvis bradykardien er forbundet med et lægemiddel, der tages samtidig og som vides at forårsage bradykardi eller hypotension, skal Zykadia pauseres indtil bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover.
English: For subsequent dose adjustment and management recommendations for ADRs, please follow table 1 (see section 4.2).
Danish: 4.2) vedrørende efterfølgende dosisjustering og håndtering som følge af bivirkninger.
English: Strong CYP3A inhibitors
Danish: Potente CYP3A-hæmmere
English: How much to take The recommended dose is 450 mg (three capsules) taken once daily with food, although your doctor could modify this recommendation if needed.
Danish: Den anbefalede dosis er 450 mg (tre kapsler) én gang daglig sammen med mad.
English: sildenafil, midazolam, triazolam, tacrolimus, alfentanil and sirolimus) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Danish: Hvis muligt, bør der anvendes alternative lægemidler, der er mindre følsomme overfor CYP3A4-hæmmere.
English: Capsule shell
Danish: Kapslen
English: Similar products with 8 or 10 days treatment durations are also available within the EU.
Danish: Tilsvarende produkter med 8 eller 10 dages behandlingsvarighed er ligeledes tilgængelige inden for EU.
English: The CVMP Opinion was adopted on 14 February 2007 and the subsequent Commission Decision on 22 May 2007.
Danish: CVMP's udtalelse blev vedtaget den 14. februar 2007, og Kommissionens efterfølgende beslutning blev vedtaget den 22. maj 2007.
English: Therefore, the recommendation is to remove this pathogen from the indications.
Danish: Derfor anbefales det at fjerne dette patogen fra indikationerne.
English: In December 2005, a Mutual Recognition Procedure (MRP) started with Spain acting as Reference Member State and ten Concerned Member States.
Danish: I december 2005 blev der indledt en gensidig godkendelsesprocedure (MRP) med Spanien som referencemedlemsstat og ti berørte medlemsstater.