FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.
Danish: Samtidig administration af atazanavir/ritonavir og boceprevir resulterede i lavere eksponering af atazanavir, hvilket kan være forbundet med en lavere effekt og manglende hiv-kontrol.
English: If you are not sure, talk to your doctor or pharmacist before taking Victrelis.
Danish: Hvis du ikke er sikker, så tal med din læge eller apoteket, før du tager Victrelis.
English: A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4).
Danish: Et studie med peginterferon alfa-2a hos behandlingserfarne patienter gav konsistente resultater sammenlignet med P05101-studiet (se pkt.
English: Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons' and ‘pegylated interferons'.
Danish: Victrelis kan bruges hos voksne, der ikke tidligere er behandlet for hcv-infektion eller som tidligere har fået medicin, der kaldes ‘interferoner' og ‘pegylerede interferoner'.
English: Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro.
Danish: Boceprevir er vist at være substrat for p-glykoprotein (P-gp) og brystcancer-resistent protein (BCRP) in vitro.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjælden arvelig galactoseintolerance, Lapp lactase-mangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Danish: Hvis det skønnes nødvendigt, kan samtidig administration overvejes på individuel basis hos patienter med supprimeret hivvirusniveau og med hivvirusstammer uden mistænkt resistens over for hiv-regimet.
English: It is unknown what effect therapy with Victrelis will have on the activity of subsequently administered HCV protease inhibitors, including re-treatment with Victrelis.
Danish: Det er uvist hvilken virkning behandling med Victrelis vil have på aktiviteten af efterfølgende administreret hcv-proteasehæmmere, herunder gen-behandling med Victrelis.
English: Data obtained in juvenile rats suggest that the pharmacokinetic profile of boceprevir may be different than in adult rats, possibly due to immaturity of some metabolic pathways.
Danish: Data fra unge rotter indikerer, at boceprevirs farmakokinetiske profil kan være forskellig fra den hos voksne rotter, muligvis på grund af umodenhed i visse metaboliske veje.
English: At Treatment Week 24
Danish: Behandlingsuge 24
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Danish: Patienter, der tager østrogener som hormonsubstitutionsbehandling , skal monitoreres klinisk for tegn på østrogenmangel.
English: Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Danish: Boceprevir har en gennemsnitlig fuldstændig krops-clearance (CL/F) på cirka 161 l/t.
English: However, the combination therapy of Victrelis, peginterferon alfa and ribavirin may make you feel tired, faint, a sensation of your head spinning, changes in blood pressure, confused or difficulty seeing clearly.
Danish: Dog kan kombinationen af Victrelis, peginterferon alfa og ribavirin få dig til at føle dig træt, besvime, få en fornemmelse af, at dit hoved kører rundt, eller forårsage ændringer i blodtrykket, gøre dig forvirret eller give dig problemer med at se tydeligt.
English: • Store in a refrigerator until expiry.
Danish: • Opbevares i køleskab indtil udløbsdatoen.
English: Due to the combined treatment with peginterferon alfa and ribavirin, extreme care must be taken to avoid pregnancy in female patients or in female partners of male patients.
Danish: På grund af kombinationsbehandling med peginterferon alfa og ribavirin skal der udvises den yderste forsigtighed, for at undgå graviditet hos kvindelige patienter eller hos kvindelige partnere til mandlige patienter.
English: - if you are a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Danish: - hvis du er en kvinde i den fødedygtige alder og tager ribavirin: du skal have en negativ graviditetstest før behandlingsstart, hver måned under behandlingen og i 4 måneder efter ophørt behandling.
English: The V55I and D168N single substitutions did not reduce sensitivity to boceprevir.
Danish: Enkelt-substitutionerne V55I og D168N reducerede ikke følsomheden over for boceprevir.
English: No clinically significant differences in pharmacokinetic parameters were observed between patients with end-stage renal disease (ESRD) and healthy subjects.
Danish: Der blev ikke observeret klinisk signifikante forskelle i farmakokinetiske parametre mellem patienter med slutstadie nyresygdom (ESRD) og raske forsøgspersoner.
English: Store in the original blister in order to protect from moisture.
Danish: Opbevares i den originale blisterpakning, for at beskytte mod fugt.
English: • immunosuppressants - tacrolimus, sirolimus, cyclosporine
Danish: • immunsuppressiva - tacrolimus, sirolimus, ciclosporin
English: For data regarding drug-drug interactions with antiretroviral agents, see section 4.5.
Danish: For data vedrørende lægemiddel-interaktioner med antiretrovirale midler, se pkt.
English: Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being
Danish: Psykisk sygdom: humørændringer; følelse af at dit liv er ved at falde fra hinanden; ser, føler eller hører ting, der ikke er virkelige (hallucinationer); selvmordstanker, selvmordsforsøg; følelse af stor glæde (mani) og dernæst en følelse af dyb tristhed eller af ikke at være noget
English: Eleven subjects were missing TW 4 assessment (HCV-RNA) and were not included in the Lead-In
Danish: 11 forsøgspersoner manglede behandlingsuge 4 evaluering (hcv-RNA) og blev ikke inkluderet i
English: Each blister cavity is heat sealed closed with the peelable lidding in a configuration of 3 blister cavities per blister card and packaged.
Danish: Hvert blisterrum er lukket med varmeforseglet, aftrækningsklart folie, der er opdelt i 3 blisterrum per blisterkort og pakket.
English: No human data on the effect of Victrelis on fertility are available.
Danish: Der foreligger ingen humane data vedrørende Vicrelis' virkning på fertilitet.
English: • select statins - atorvastatin or pravastatin
Danish: • visse statiner - atorvastatin eller pravastatin
English: The majority of the anaemia subjects received erythropoietin when haemoglobin levels were ≤ 10 g/dL (or 6.2 mmol/L).
Danish: Størstedelen af de anæmiske forsøgspersoner modtog erythropoeitin når hæmoglobinniveauerne var ≤ 6,2 mmol/l (10 g/dl).
English: If there were no such values at and after FW 24, the FW 12 value was used.
Danish: Hvis der ikke forelå sådanne værdier i og efter FW 24, blev FW 12-værdien anvendt.
English: Subjects randomized to receive erythropoietin (N=251)
Danish: Forsøgspersoner randomiseret til erythropoietin (N=251)
English: Food enhanced the exposure of boceprevir by up to 60% at the 800 mg three times daily dose when administered with a meal relative to the fasting state.
Danish: Mad forøgede eksponeringen til boceprevir med op til 60 % ved dosering på 800 mg tre gange daglig, når det blev taget sammen med et måltid i forhold til i fastende tilstand.
English: At Treatment Week 8
Danish: Behandlingsuge 8
English: It is possible that boceprevir is excreted in human milk.
Danish: Boceprevir udskilles muligvis i human mælk.
English: Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (Ser139) through a (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells.
Danish: Boceprevir binder sig kovalent, men reversibelt, til det NS3-protease-aktive serin-center (Ser139) gennem en (alfa)-ketoamid funktionsgruppe og hæmmer virusreplikationen i hcv-inficerede værtsceller.
English: No effects on foetal development have been observed in rats and rabbits (see section 5.3).
Danish: Der er ikke observeret effekt på fosterudviklingen hos rotter og kaniner (se pkt.
English: The IC50 and IC90 values for boceprevir against different genotype 1b replicons ranged from 200 to 600 nM and 400 to 900 nM, respectively, in a 72-hour cell culture assay.
Danish: IC50- og IC90-værdierne for boceprevir mod forskellige genotype 1b-replikoner, varierede fra henholdsvis 200 til 600 nM og 400 til 900 nM i en 72 timers cellekulturtest.
English: Alternative contraceptives should be considered (see section 4.5).
Danish: Alternative præventionsmidler bør overvejes (se pkt.
English: Victrelis 200 mg hard capsules
Danish: Victrelis 200 mg hårde kapsler
English: • antimicrobial medicine - pentamidine
Danish: • antimikrobiel medicin - pentamidin
English: Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Danish: Der bør udvises forsigtighed med lægemidler, der er kendt for at forlænge QT-intervallet såsom amiodaron, quinidin, methadon, pentamidin og visse antipsykotika.
English: Table 2 provides dosing recommendations as a result of drug interactions with Victrelis.
Danish: Tabel 2 giver dosisanbefalinger på baggrund af lægemiddelinteraktioner med Victrelis.
English: No data are available; therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Danish: Der foreligger ingen data, og derfor anbefales kombinationen af boceprevir med disse lægemidler ikke (se pkt.
English: Decreased fertility was also observed in male rats, most likely as a consequence of testicular degeneration (no testicular degeneration has been observed in mice or monkeys).
Danish: Nedsat fertilitet sås også hos hanrotter, højst sandsynligt som en konsekvens af testikeldegeneration (der sås ikke testikeldegeneration hos mus eller aber).
English: The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines.
Danish: Samtidig brug af Victrelis og doxazosin eller tamsulosin kan øge plasmakoncentrationen af disse lægemidler.
English: Prolonged exposure resulted in a 2-log decrease in RNA levels by Day 15.
Danish: Eksponering over længere tid resulterede i 2 log-fald i RNA-koncentrationen på dag 15.
English: C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
Danish: C-boceprevir var majoriteten af cirkulerende metabolitter en diasteriomerisk blanding af keton-reducerede metabolitter med en gennemsnitlig eksponering, der var cirka 4-gange større end den for boceprevir.
English: Studies in vitro indicate that boceprevir primarily undergoes metabolism through the aldoketoreductase (AKR)-mediated pathway to ketone-reduced metabolites that are inactive against HCV.
Danish: In vitro-studier indikerer, at boceprevir primært gennemgår metabolisme gennem den aldo-ketoreduktase (AKR)-medierede vej til keton-reducerede metabolitter, der er inaktive over for hcv.
English: Each hard capsule contains 200 mg boceprevir.
Danish: Hver hård kapsel indeholder 200 mg boceprevir.
English: The TW 4 response was a stronger predictor of SVR compared to response to previous treatment and allowed the determination of the subject's on-treatment interferon
Danish: Behandlingsuge 4-responset var en bedre prediktor for SVR sammenlignet med responset på tidligere behandling og muliggjorde bestemmelse af forsøgspersonens on-treatment interferonfølsomhed.
English: Do not use this medicine after the expiry date which is stated on the carton and blisterfoil after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterfolien efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: A clinical drug interaction study with digoxin demonstrated that boceprevir is a mild P-gp inhibitor in vivo, increasing digoxin exposure by 19%.
Danish: Et klinisk lægemiddelinteraktionsstudie med digoxin viste, at boceprevir er en svag P-gp-hæmmer in vivo, som øger digoxineksponeringen med 19 %.
English: Boceprevir was shown to be devoid of embryonic or teratogenic potential in both rats and rabbits at maternotoxic dose levels.
Danish: Boceprevir har ikke embryonisk eller teratogent potentiale hos både rotter og kaniner ved maternotoksiske doseringsniveauer.
English: The antiviral activity of boceprevir was evaluated in a biochemical assay for slow binding inhibitors of NS3 protease and in the genotype 1a and 1b HCV replicon system.
Danish: Boceprevirs antivirale aktivitet er evalueret i en biokemisk analyse af langsomt bindende hæmmere af NS3-protease og i genotype 1a og 1b-hcv-replikonsystemer.
English: • have hepatitis C other than genotype 1
Danish: • har en form for hepatitis C, der ikke er genotype 1
English: Do not take Victrelis if you are taking any of the medicines above.
Danish: Tag ikke Victrelis, hvis du tager noget af ovenstående medicin.
English: A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon alfa-2b/ribavirin.
Danish: En genetisk variant tæt ved genet som koder for interferon-lambda-3 (IL28B rs12979860, en C til T ændring) er en stærk indikator for peginterferon alfa-2b/ribavirin-respons.
English: Also, tell your doctor or pharmacist if you are taking any of the following:
Danish: Fortæl det også til din læge eller på apoteket, hvis du tager noget af følgende:
English: Decreases in neutrophil counts may require dose reduction of peginterferon alfa or discontinuation of therapy.
Danish: Fald i neutrofiltal kan påkræve dosisreduktion af peginterferon alfa eller seponering af behandling.
English: Victrelis is partly metabolized by CYP3A4/5.
Danish: Victrelis bliver delvist metaboliseret af CYP3A4/5.
English: .hr/mL, Cmax of 1,913 ng/mL, and Cmin of 90 ng/mL.
Danish: på 1.913 ng/ml, og Cmin på 90 ng/ml.
English: Pack sizes: carton of 84 hard capsules and multipack containing 336 (4 packs of 84) hard capsules.
Danish: Pakningsstørrelser: karton med 84 hårde kapsler og multipakning med 336 (4 pakninger af 84) hårde kapsler.
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Danish: Øget klinisk og laboratoriemæssig monitorering for hiv-suppression er påkrævet.
English: No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis af Victrelis hos patienter med let, moderat eller alvorlig nedsat leverfunktion.
English: The majority of subjects (87%; 85/98) were taking a ritonavir-boosted HIV protease inhibitor (PI) combined with HIV nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Hovedparten af forsøgspersonerne (87 %; 85/98) tog en ritonavir-boosted hiv-proteasehæmmer i kombination med hiv nukleosid revers transkriptasehæmmere (NRTIer).
English: Laboratory testing
Danish: Andre laboratorieresultater
English: The concomitant use of Victrelis with rifampicin or anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) may significantly reduce the plasma exposure of boceprevir.
Danish: Samtidig brug af Victrelis med rifampicin eller antikonvulsiva (såsom phenytoin, phenobarbital eller carbamazepin) kan reducere boceprevirs plasma-eksponering signifikant.
English: • HIV protease inhibitors - atazanavir, darunavir, lopinavir, ritonavir
Danish: • hiv proteasehæmmere - atazanavir, darunavir, lopinavir, ritonavir
English: • Store in a refrigerator (2C - 8C) until expiry.
Danish: • Opbevares i køleskab (2 C - 8 C) indtil udløbsdato.
English: Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin.
Danish: Samtidig administration af pravastatin og Victrelis øgede eksponeringen af pravastatin.
English: diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
Danish: nicardipin, nifedipin, nisoldipin, verapamil)
English: In comparison, 79% (66/84) of genotype 1b subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Danish: Til sammenligning blev der hos 79 % (66/84) af genotype 1b-forsøgspersonerne ikke længere detekteret RAVer ved boceprevir-resistens-associerede loci ved populationssekventering.
English: Bronchitis*, cellulitis*, herpes simplex, influenza, oral fungal infection, sinusitis
Danish: Bronkitis*, cellulitis*, herpes simplex, influenza, oral svampeinfektion, sinusitis
English: Subjects were randomized in a 1:2:2 ratio and stratified based on response to their previous qualifying regimen (relapsers vs. partial responders) and by HCV subtype (1a vs. 1b) to one of the following treatment arms:
Danish: Forsøgspersonerne blev randomiseret i et 1:2:2 forhold og stratificeret på basis af respons på tidligere kvalificerende regimen (patienter med tilbagefald vs. delvis respons) og i henhold til hcv-subtype (1a vs. 1b) til en af følgende behandlingsarme:
English: Patients should be informed that fatigue, dizziness, syncope, blood pressure fluctuations and blurred vision have been reported (see section 4.8).
Danish: Patienter skal informeres om, at der er rapporteret om træthed, svimmelhed, synkope, blodtrykssvingninger og sløret syn (se pkt.
English: ACTION
Danish: HANDLING
English: Boceprevir is an inhibitor of the HCV NS3 protease.
Danish: Boceprevir er en hcv NS3-protease-hæmmer.
English: No dose adjustment of escitalopram is anticipated, but doses may need to be adjusted based on clinical effect.
Danish: Dosisjustering af escitalopram forventes ikke at være nødvendig, men afhængigt af den kliniske effekt kan der være behov for dosisjustering.
English: Victrelis should be administered with food.
Danish: Victrelis skal tages sammen med mad.
English: Sustained Virologic Response (SVR) to treatment was defined as undetectable
Danish: Vedvarende virologisk respons (SVR) over for behandlingen blev defineret som ikkedetekterbart
English: The safety profile of Victrelis in HCV/HIV-1 co-infected patients (n=64) was overall similar to the safety profile in mono-infected HCV patients.
Danish: Victrelis' sikkerhedsprofil hos hcv/hiv-1 co-inficerede patienter var generelt den samme som sikkerhedsprofilen hos mono-inficerede patienter.
English: This regimen has only been tested in subjects who have failed previous therapy who were late responders (see section 5.1).
Danish: Dette regime er kun blevet undersøgt hos forsøgspersoner, hvor tidligere behandling havde svigtet og som havde sent respons (se pkt.
English: † Rates for patients who are previously untreated
Danish: † hos patienter, der ikke tidligere har været i behandling
English: If you are breast-feeding, your doctor will advise you to discontinue breast-feeding or to discontinue Victrelis while breast-feeding.
Danish: Hvis du ammer, vil din læge råde dig til enten at stoppe amningen eller stoppe med at tage Victrelis, mens du ammer.
English: Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.
Danish: Samtidig administration af Victrelis og et oralt præventionsmiddel med ethinylestradiol og mindst 1 mg norethisteron vil sandsynligvis ikke ændre den præventive virkning.
English: If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Danish: Hvis hæmoglobin er < 6,2 mmol/l (eller < 10 g/dl), kan anæmibehandling være berettiget (se pkt.
English: If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis, og der er 2 timer eller mere til næste dosis skal tages, skal patienten tage den glemte dosis sammen med mad og fortsætte med det normale doseringsskema.
English: Based on results of clinical studies, Victrelis must not be used alone due to the high probability of increased resistance without combination anti-HCV therapies (see section 5.1).
Danish: Baseret på resultater fra kliniske studier, må Victrelis ikke anvendes som monoterapi på grund af den høje sandsynlighed for øget resistens ved ikke-kombineret anti-hcv-behandling (se pkt.
English: In a study comparing the use of ribavirin dose reduction and erythropoesis stimulating agents in the management of treatment-emergent anaemia, the use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events (see section 5.1).
Danish: I et studie, hvor reduktion af ribavirindosis og erythropoiese-stimulerende lægemidler blev sammenlignet til håndtering af behandlingsrelateret anæmi, var anvendelse af erythropoiesestimulerende lægemidler forbundet med en øget risiko for tromboemboliske hændelser (se pkt.
English: Steady state AUC, Cmax and Cmin increased in a less-than dose-proportional manner and individual exposures overlapped substantially at 800 mg and 1,200 mg, suggesting diminished absorption at higher doses.
Danish: og Cmin steg mindre end dosis-proportionelt og de enkelte eksponeringer overlappede i betydelig grad hinanden ved 800 mg og 1.200 mg, hvilket tyder på reduceret absorption ved højere doser.
English: Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during coadministration of norethindrone 1 mg/ethinyl estradiol 0.035 mg with Victrelis (see section 4.6).
Danish: Faktisk indikerede koncentrationerne af progesteron, luteiniserende hormon (LH) og follikelstimulerende hormon (FSH), at ovulationen supprimeres ved samtidig administration af norethisteron 1 mg/ethinylestradiol 0,035 mg og Victrelis (se pkt.
English: Following a single 800 mg oral
Danish: Efter en 800 mg oral enkeltdosis af
English: The SVR rates for those who received at least one dose of Victrelis (i.e. excluding patients who discontinued during PR lead-in) are 41% for null responders, 67% for partial responders and 96% for relapsers.
Danish: SVR-rater for de forsøgspersoner, som fik mindst en dosis Victrelis (dvs. fraregnet de patienter, der udgik under PR lead-in-perioden), er 41 % for null-responders, 67 % for forsøgspersoner med delvis respons og 96 % for forsøgspersoner med tilbagefald.
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines (alprazolam, midazolam, triazolam).
Danish: Der bør foretages tæt klinisk monitorering for respiratorisk depression og/eller længerevarende sedation under samtidig administration af Victrelis med intravenøse benzodiazepiner (alprazolam, midazolam, triazolam).