natgillin/translations-raw huggingface dataset:
På grund af den øgede risiko for bivirkninger med Victrelis (især anæmi); Såfremt patienten ikke kan tåle behandlingen, bør det overvejes at fortsætte med 12 ugers tostofbehandling i de sidste 12 ugers behandling i stedet for tre-stofbehandling (se pkt.
Given the incremental risk of adverse events with Victrelis (anaemia notably); in case the patient cannot tolerate the treatment, consideration could be given to pursue with 12 weeks of bitherapy for the final 12 weeks of treatment instead of tritherapy (see sections 4.8 and 5.1).
Hos raske forsøgspersoner, der fik 800 mg tre gange dagligt alene, blev boceprevirmedicineksponeringen karakteriseret ved AUC(т) på 6.147 ng.t/ml, Cmaks.
In healthy subjects who received 800 mg three times daily alone, boceprevir medicine exposure was characterized by AUC(т) of 6,147 ng
Patienter uden cirrose, der ikke tidligere er blevet behandlet eller med tidligere svigt af behandling De følgende doseringsanbefalinger afviger for enkelte subgrupper fra de doser, som blev anvendt i registrerings fase 3-undersøgelserne (se pkt.
Patients without cirrhosis who are previously untreated or who have failed previous therapy The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1).
Samtidig administration af Victrelis med lægemidler, der inducerer eller hæmmer CYP3A4/5 kan øge eller mindske eksponering af Victrelis (se pkt.
Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).
Af de 314 behandlingsnaive og tidligere behandlede forsøgspersoner fra fase 2/3-studierne (P03523, P03659, P05216 og P05101), som ikke opnåede SVR, og hvor boceprevir-resistente varianter opstod under behandlingen, blev der hos 73 % (228/314) ikke længere målt RAVer ved boceprevir-resistens-associerede loci ved populationssekventering inden for 3 år efter behandling.
Of 314 treatment-naïve and previously treated subjects who did not achieve SVR from Phase 2/3 studies (P03523, P03659, P05216, and P05101) in whom boceprevir-resistant variants had emerged during treatment, 73% (228/314) of subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing within 3 years post-therapy.
• Øvrige indholdsstoffer: natriumlaurilsulfat, mikokrystallinsk cellulose, lactosemonohydrat, croscarmellosenatrium, pregelatineret stivelse, magnesiumstearat, gul jernoxid (E 172), rød jernoxid (E 172), titandioxid (E171), gelatin og shellac.
• The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, and shellac.
Hos rotter inducerede boceprevir en reversibel effekt på fertilitet og tidlig embryonisk udvikling hos hunrotter ved eksponeringer, der var 1,2 gange eksponeringen hos mennesker ved den anbefalede terapeutiske dosis.
In rats, boceprevir induced reversible effects on fertility and early embryonic development in female rats at exposures 1.2-fold the human exposure at the recommended therapeutic dose.
• typen af ‘sekale'lægemidler såsom dihydroergotamin, ergonovin, ergotamin eller methylergonovin - bruges ved migræneanfald og klyngehovedpine
• ‘ergot' type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine - used for migraine and cluster headaches
Der bør udvises forsigtighed hos patienter, der tager drospirenon-indeholdende lægemidler med tilstande, der prædisponerer for hyperkaliæmi eller patienter, der tager kalium-besparende vanddrivende midler.
Caution should be exercised in patients taking drospirenone-containing medicines with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics.
Der foreligger ingen kliniske data for pædiatrisk eksponering (se pkt.
No clinical paediatric exposure data is available (see section 4.2).
Kombineret brug af peginterferon alfa-2a sammenlignet med alfa-2b:
Combined use with peginterferon alfa-2a as compared to alfa-2b:
Gennemsnitsalderen for de randomiserede forsøgspersoner var 52,7 år.
Mean age of subjects randomized was 52.7 years.
Punktestimat for forskellen (Victrelis-RGT minus Victrelis-PR48) [95 % KONFIDENSINTERVAL]
Point estimate of the difference (Victrelis-RGT minus VictrelisPR48) [95% CI]
I begge behandlingsarme havde cirrosepatienter højere risiko for at opleve grad 3-4 trombocytopeni sammenlignet med patienter, som ikke havde cirrose.
In both treatment arms, patients with cirrhosis were at a higher risk to experience Grade 3-4 thrombocytopenia compared with non
Victrelis hæmmer eller inducerer ikke andre
Victrelis does not inhibit or induce the other enzymes
Vedvarende virologisk respons (SVR) rater efter IL28B rs12979860 genotype
Table 10 Sustained Virologic Response (SVR) rates by IL28B rs12979860 genotype
SVR-raten var 62,5 % (40/64) hos forsøgspersoner, der var blevet behandlet med Victrelis i kombination med PR, og 29,4 % hos forsøgspersoner, der var blevet behandlet med PR alene (se tabel
The SVR rate was 62.5% (40/64) in subjects treated with Victrelis in combination with PR and 29.4% (10/34) in subjects treated with PR alone (see Table 6).
Nedsættelse af ribavirindosis er den foretrukne strategi ved behandlingsrelateret anæmi (se pkt.
Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia (see section 5.1).
Hvis du kan svare ja til noget af ovenstående (eller du ikke er sikker), så tal med din læge eller
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Boceprevir var ikke genotoksisk i en række in vitro- og in vivo-tests, herunder tests for bakteriel mutagenicitet, perifere humane blodlymfocytter og mikronukleærtest hos mus.
Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays.
Øget klinisk og laboratoriemæssig monitorering for hiv- og hcv-suppression anbefales.
Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Victrelis indeholder lactose
Victrelis contains lactose
I toksicitetsstudier med gentagen dosering viste boceprevir testikeldegeneration hos rotter ved systemisk eksponering, der var lavere end hos mennesker ved den anbefalede humane terapeutiske dosis.
In repeat-dose toxicity studies boceprevir showed testicular degeneration in rats at systemic exposures lower than those in humans at the recommended human therapeutic dose.
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i
• Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Mandlige patienter og deres kvindelige partnere skal anvende effektiv antikonception under behandlingen og i syv måneder efter ophørt behandling.
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Hvis du holder op med at tage Victrelis Hold kun op med at tage Victrelis, hvis din læge siger, du skal.
Do not stop taking Victrelis unless your doctor tells you to.
Hvis serumhæmoglobin fortsatte med at falde til ≤5,3 mmol/l (≤8,5 g/dl), kunne forsøgspersonerne få behandling med ekstra anæmi-interventioner, herunder anvendelse af erythropoietin eller reduktion af
If serum haemoglobin concentrations continued to decrease to ≤ 8.5 g/dL, subjects could be treated with additional anaemia interventions, including the use of erythropoietin or ribavirin dose reduction.
Anæmi*, neutropeni* Leukopeni*, trombocytopeni*, pancytopeni,
Anaemia*, neutropenia* Leukopenia*, thrombocytopenia*, pancytopenia,
Den anbefalede dosering af Victrelis er 800 mg, som skal tages oralt tre gange dagligt sammen med et måltid eller en snack.
The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack).
• har hiv (humant immundefekt virus) eller har haft andre problemer med dit immunsystem
• have another liver problem in addition to hepatitis C infection • have HIV (human immunodeficiency virus) or have ever had any other problems with your
Pleural fibrose*, ortopnø, respiratorisk svigt
Pleural fibrosis*, orthopnoea, respiratory failure
Eksponeringen til lægemidler, der primært metaboliseres af CYP3A4/5 kan forøges, når de tages med Victrelis, hvilket kan forøge eller forlænge deres terapeutiske virkninger- eller bivirkninger (se tabel 2).
Medicines metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse reactions (see Table 2).
3 og/eller serumalbumin <35 g/l og/eller tegn på koagulopati (INR
3 and/or serum albumin < 35 g/L and/or signs of coagulopathy (International Normalized Ratio (INR) > 1.7) at baseline.
Ved evaluering af forskellige kombinationer af boceprevir og interferon alfa-2b, som forårsagede 90 % hæmning af replikon-RNA, blev der påvist additiv effekt; der blev ikke påvist tegn på synergi
Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was
Sikkerhedsprofilen, repræsenteret af omkring 1.500 patienter for kombinationen af Victrelis med peginterferon alfa-2b og ribavirin, er baseret på poolede sikkerhedsdata i to kliniske forsøg: et med patienter, der ikke tidligere var behandlet og et med patienter, hvor tidligere behandling havde svigtet
The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see
Dosisreduktion af Victrelis anbefales ikke.
Dose reduction of Victrelis is not recommended.
Populations-farmakokinetisk analyse af Victrelis indikerede, at race ikke havde nogen effekt på
Population pharmacokinetic analysis of Victrelis indicated that race had no apparent effect on exposure.
Det undersøges i øjeblikket, hvorvidt tidlig virus-respons i behandlingen og/eller IL28B genotype med sikkerhed vil kunne identificere de patienter, der sandsynligvis ikke vil få signifikant fordel af tilføjelse af boceprevir (højere SVR-rater eller kortsigtet behandlingsvarighed) til tostofbehandlingen.
Whether on treatment early viral response and/or IL28B genotype could reliably identify those patients who are unlikely to retrieve significant benefit of boceprevir (higher SVR rates or short course treatment duration) on top of the bitherapy is currently under investigation.
Nullresponders (historisk defineret som fald i hcv-RNA-viral-load < 2 log10 i uge 12 ved tidligere behandling) blev udelukket.
Null responders (as defined historically by a decrease in HCV-RNA viral load < 2 log10 by Week 12 to prior therapy) were excluded.
Hvis du tager for meget Victrelis, skal du tale med din læge eller tage til nærmeste skadestue med det
If you take more Victrelis than you should If you take more Victrelis than you should, talk to a doctor or go to the nearest hospital emergency
• hiv non-nukleosid revers transkriptase-hæmmere - efavirenz, etravirin
• HIV non-nucleoside reverse transcriptase inhibitor - efavirenz, etravirine
Hos patienter med ringe interferonrespons (defineret som et fald i hcv-RNA på < 1-log10 i behandlingsuge 4) bør brug af tre-stofbehandling overvejes på individuel basis, da sandsynligheden for at opnå vedvarende virologisk respons (SVR) med tre-stofbehandling er lavere hos disse patienter
In poorly interferon responsive patients (defined as < 1-log10 decline in HCV-RNA at TW 4) the use of triple therapy should be considered on a case by case basis, as the likelihood of achieving sustained virologic response (SVR) with triple therapy is lower in these patients (see section 5.1).
Populations-farmakokinetisk analyse af Victrelis indikerede, at alder ikke havde nogen effekt på
Population pharmacokinetic analysis of Victrelis indicated that age had no apparent effect on exposure.
Reaktioner på injektionsstedet er ikke medtaget, da Victrelis administreres oralt.
Injection-site reactions have not been included since Victrelis is administered orally.
Læs indlægssedlen for mere information.
See package leaflet for further information.
Sådan skal du tage Victrelis
How to take Victrelis
Hvorvidt amningen skal fortsættes eller om behandling med Victrelis skal seponeres/afholdes skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with Victrelis taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Forsøgspersonerne blev randomiseret i et 2:1 forhold og stratificeret på baggrund af cirrose/fibrose og hcv-RNA (< 800.000 IE/ml versus ≥ 800.000 IE/ml) ved baseline.
Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Victrelis indeholder det aktive stof boceprevir, som ved at stoppe virusformeringen, hjælper med at bekæmpe hepatitis C-infektion.
Victrelis contains the active ingredient boceprevir which helps to fight against hepatitis C infection by stopping the virus multiplying.
Hos 77 forsøgspersoner blev ribavirindosis reduceret (≥5 trin) for at behandle anæmi.
There were 77 subjects who received ≥ 5 steps ribavirin dose reduction for the management of anaemia.
IL28B rs12979860 blev genotypebestemt hos 653 af 1.048 (62 %) forsøgspersoner i SPRINT-2 (ikke tidligere behandlede) og 259 ud af 394 (66 %) forsøgspersoner i RESPOND-2 (tidligere behandlingssvigt) [se pkt.
IL28B rs12979860 was genotyped in 653 of 1,048 (62%) subjects in SPRINT-2 (previously untreated) and 259 of 394 (66%) subjects in RESPOND-2 (previous treatment failure) [see section 5.1 for the clinical trial descriptions].
En stigning i plasmakoncentrationen af substrater for P-gp-efflukstransporteren, såsom digoxin eller dabigatran, må
An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).
Tag ikke Victrelis i kombination med peginterferon alfa og ribavirin, hvis du: • er allergisk over for boceprevir eller et af de øvrige indholdsstoffer i Victrelis (angivet i punkt
Do not take Victrelis in combination with peginterferon alfa and ribavirin if you: • are allergic to boceprevir or any of the other ingredients of this medicine (listed in section 6)
Bryst: være stakåndet, når du ligger ned; alvorlig lungeinfektion, som lungebetændelse; stærke brystsmerter, der er værre, når man trækker vejret; smerter bag brystbenet, der kan sprede sig til nakke og skuldre
Chest: being short of breath when lying flat; serious lung infection like pneumonia; sharp chest pains which are worse when breathing; pain behind breast bone which can spread to neck and
Et begrænset antal forsøgspersoner (n=12) fik ≤200 mg/dag ribavirin i mindst 14 dage.
A limited number of subjects (n=12) received ≤ 200mg/day of ribavirin for at least
Den ovulationssupprimerende virkning af orale præventionsmidler med lavere doser af norethisteron/ethinylestradiol eller af andre former for hormonel kontraception er ikke klarlagt ved administration sammen med Victrelis.
The ovulation suppression activity of oral contraceptives containing lower doses of norethindrone/ethinyl estradiol and of other forms of hormonal contraception during coadministration with Victrelis has not been established.
Patienter, der får prednison og Victrelis, skal monitoreres efter behov.
Patients receiving prednisone and Victrelis should be monitored appropriately.
Samtidig brug af Victrelis og potente CYP3A4-inducere (rifampicin, carbamazepin, phenobarbital, phenytoin) anbefales ikke (se pkt.
The concomitant use of Victrelis with potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin) is not recommended (see section 4.5).
Kombinationsbehandling med Victrelis, peginterferon alfa og ribavirin kan påvirke enkelte patienters evne til at føre motorkøretøj og betjene maskiner.
Combination therapy of Victrelis, peginterferon alfa and ribavirin may influence some patients' ability to drive and use machines.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs
Detailed information on this medicinal product is available on the website of the European Medicines
Tilgængelige farmakodynamiske/toksikologiske data hos rotter har vist effekt af boceprevir/metabolitter på fertilitet, som hos hunrotter har vist sig at være reversibel (se pkt.
Available pharmacodynamic/toxicological data in rats have shown effects of boceprevir/metabolites on fertility, which in females have been shown to
Alle cirrosepatienter og null-responders - Anbefalet behandlingsvarighed er 48 uger: 4 ugers to-stofbehandling med peginterferon alfa + ribavirin + 44 ugers tre-stofbehandling med peginterferon alfa + ribavirin + Victrelis.
All cirrhotic patients and null responders - Recommended treatment duration is 48 weeks: 4 weeks of bitherapy with peginterferon alfa+ ribavirin + 44 weeks of tritherapy with peginterferon alfa + ribavirin + Victrelis.
Se produktresumeet for peginterferon alfa vedrørende kontraindikationer hos patienter med dekompenseret leversygdom.
Please refer to the Summary of Product Characteristics for peginterferon alfa for the contraindication in patients with decompensated liver disease.
• quetiapin - bruges til behandling af skizofreni, maniodepressiv sygdom (bipolar sygdom) og moderat til svær depression
• quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Nogle tilfælde er også rapporteret hos patienter, der er co-inficerede med hepatitis B- og hepatitis C-virus, som blev behandlet med interferon (se produktresuméet for peginterferon alfa for yderligere oplysninger om reaktivering af hbv hos patienter, der er co-inficerede med hbv og hcv, som blev behandlet med interferon).
Some cases have also been reported in patients coinfected with hepatitis B and C viruses treated with interferon (refer to the Summary of Product Characteristics for peginterferon alfa for more information on HBV reactivation in patients coinfected with HBV and HCV treated with interferon).
Victrelis er en stærk hæmmer af CYP3A4/5.
Victrelis is a strong inhibitor of CYP3A4/5.
Forsøgspersoner, der ikke kunne indrulleres i dette studie inden for 2 uger, fik PR i 4 uger efterfulgt af Victrelis 800 mg tre gange dagligt + PR i 44 uger.
Subjects who were not able to enrol in this study within 2 weeks received PR for 4 weeks followed by Victrelis 800 mg three times daily + PR for 44 weeks.
Som en konservativ forholdsregel set i lyset af de begrænsede data hos behandlingsnaive patientersene respondenter - anbefales det som en sikkerhedsforanstaltning at forlænge behandlingsvarigheden af tre-stofbehandlingen til 32 uger sammenlignet med den undersøgte varighed på 24 uger af trestofbehandlingen til en samlet behandlingsvarighed på 48 uger.
As a conservative measure in view of the limitations of the data, in treatment naïve patients-late responders, the treatment duration of the tritherapy is recommended to be prolonged to 32 weeks as compared to the tested 24 weeks duration of the tritherapy, for a total treatment duration of 48 weeks.
Hver kapsel har en gulbrun, uigennemsigtig del med "MSD" logo trykt med rød farve og en råhvid, uigennemsigtig del med koden "314" trykt med rød farve.
Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Behandling med pravastatin kan initieres med den anbefalede dosis ved administration sammen med Victrelis.
Treatment with pravastatin can be initiated at the recommended dose when co-administered with Victrelis.
Patienter, der får digoxin, skal monitoreres efter behov.
Patients receiving digoxin should be monitored appropriately.
Hjerte eller kredsløb: hjerteanfald; vejrtrækningsstop; blodprop i benet eller armen; mindsket blodtilførsel til dele af hjernen (f.eks. svimmelhed, dobbeltsyn eller svækkelse i begge sider af kroppen)
Heart or circulation: heart attack; stopping breathing; blood clot in the leg or arm; decreased blood flow to parts of the brain (e.g., dizziness, double vision, or weakness on both sides of the
Du eller din partner skal bruge sikker prævention i den periode, hvor du tager ribavirin og i 7 måneder efter ophørt behandling.
You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment.
Hos C/C-patienter der fik trestofbehandling havde 89 % behandlingsnaive ikke-detekterbart hcv-RNA ved behandlingsuge 8 og var dermed egnede til kortere behandlingsvarighed sammenlignet med 52 % af behandlingsnaive, der ikke
In C/C patients receiving tritherapy 89% in treatment naive were HCV-RNA undetectable by TW 8 and eligible for shorter duration of therapy as compared to 52% in treatment naïve non C/C.
Cerebral iskæmi*, encefalopati
Cerebral ischaemia*, encephalopathy
Opnåelse af SVR blev associeret med forsøgspersonens respons på behandlingen med peginterferon alfa-2b og ribavirin, hvad enten dette blev defineret ved klassificering af respons på tidligere behandling eller ved et fald i hcv-RNA i behandlingsuge 4 (se tabel 7).
Achievement of SVR was associated with the subject's response to peginterferon alfa-2b and ribavirin therapy, whether defined by classification of response to previous treatment, or by a decrease in HCVRNA at TW 4 (see Table 7).
Du skal bruge effektiv prævention i den periode, hvor du tager ribavirin og i 4 måneder efter ophørt behandling.
You must use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment.
Blandt varianterne var 91 % af V36M, 98 % af T54A, 71 % af T54S, 78 % af V55A, 76 % af R155K, 92 % af A156S, 96 % af I/V170A, 77 % af R155K+T54S og 95 % af R155K+V36M ikke-detekterbare ved populationssekventering.
Among the variants, 91% of V36M, 98% of T54A, 71% of T54S, 78% of V55A, 76% of R155K, 92% of A156S, 96% of I/V170A, 77% of R155K+T54S and 95% of R155K+V36M were undetectable by population sequencing.
Hos forsøgspersoner behandlet med boceprevir, der ikke opnåede SVR og med analyserede postbaseline-prøver for RAVer, blev interferonfølsomhed associeret med påvisning af færre RAVer, hvor 31 % af disse forsøgspersoner havde post-baseline RAV sammenlignet med 69 % af forsøgspersonerne med < 1 log10 fald i viral-load i behandlingsuge 4.
In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Victrelis 200 mg hårde kapsler boceprevir
Victrelis 200 mg hard capsules boceprevir
Den gavnlige effekt af tilføjelsen af Victrelis til to-stofbehandlingen hos C/C patienter vil afhænge af sandsynligheden for, at der opnås SVR med to-stofbehandlingen alene.
The degree of added value of Victrelis on top of the bitherapy in C/C patients will depend on the likelihood of achieving SVR with the bitherapy only.
Anvendelse hos organtransplantatmodtagere
Use in patients with an organ transplant
Mere end 10 gange reduceret følsomhed over for boceprevir opstod ved aminosyresubstitutionerne R155T og A156S.
A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions R155T and A156S.
• Produktresumé (fuld tekst)
• The Summary of Product Characteristics (in full)