natgillin/translations-raw huggingface dataset:
Stop med at tage Victrelis og gå straks til lægen, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan få brug for akut medicinsk behandling:
Stop taking Victrelis and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Efter denne periode bør lægemidlet destrueres.
After this period, the medicinal product should be disposed.
• har en tilstand, der hedder "autoimmun hepatitis"
• have a condition called ‘autoimmune hepatitis'
Neutropeni påvirker kroppens evne til at holde infektioner væk
Neutropenia affects the body's ability to fight off infections
Yderkarton med blue box
Outer carton with Blue Box
Victrelis må ikke bruges alene.
Victrelis must not be used by itself.
Victrelis' sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
The safety and efficacy of Victrelis in children aged below 18 years have not yet been established.
VURDERING * (hcv-RNA-resultater
ASSESSMENT* (HCV-RNA Results
• Aktivt stof: boceprevir.
• The active substance is boceprevir.
• statiner - simvastatin eller lovastatin
• statins - simvastatin or lovastatin
Dosisjustering af benzodiazepinet bør overvejes.
Dose adjustment of the benzodiazepine should be considered.
Se afsnittet ”Bivirkninger” for mere information.
Please see "Possible side effects" for more information.
Behandlingsvarighed = 28 uger
Treatment duration = 28 weeks
Tab af replikon-RNA ser ud til at være af første orden med hensyn til behandlingstidspunktet.
Loss of replicon RNA appears to be first-order with respect to time of treatment.
Disse anbefalinger er baseret på enten lægemiddelinteraktionsstudier (angivet med *) eller på forventede interaktioner ud fra det forventede omfang af interaktionen og risikoen for alvorlige bivirkninger eller
These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
De hepatocellulære tumorer anses for at være forårsaget af enzyminduktion og er derfor ikke relevant for mennesker.
The hepatocellular tumours are considered due to enzyme induction and therefore not relevant for humans.
Forsigtighed er påkrævet, og klinisk monitorering af patienterne anbefales.
Caution is warranted and clinical monitoring of patients is recommended.
Behandling ved IC90 i 72 timer resulterede i et 1 log10-fald i replikon-RNA.
Treatment at IC90 for 72 hours resulted in a 1-log10 drop in replicon RNA.
Blod: lave kalium-niveauer i blodet; høje calciumniveauer i blodet
Blood: low potassium levels in your blood; high calcium levels in the blood
Eksponering over for boceprevir hos diende spædbørn estimeres til at være mindre end 1 % af dosis.
Exposure to boceprevir in nursing human infants is estimated to be less than 1% of the dose.
o Varigheden af tre-stofbehandlingen efter de første 4 ugers to-stofbehandling bør ikke være mindre end 32 uger.
o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks.
Data indikerer, at boceprevir primært bliver elimineret af leveren.
The data indicate that boceprevir is eliminated primarily by the liver.
Victrelis påvirker ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
Victrelis does not affect your ability to drive or use tools or machines.
- hvis du er mand og tager ribavirin: du må ikke have samleje med en gravid kvinde, medmindre du bruger kondom.
- if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Din læge kan være nødt til hyppigere at kontrollere, hvor godt dit blod størkner.
Your doctor may need to increase the frequency of your blood tests to check how well your blood can
• har haft et blodproblem såsom neutropeni (mangel på visse typer af hvide blodlegemer).
• have ever had a blood problem such as neutropenia (lack of a certain type of white blood cells).
RAVer blev målt hos 8 % af patienterne ved baseline efter populations-sekventering.
RAVs were detected in 8% of patients at baseline by population sequencing.
Bivirkninger er angivet efter systemorganklasse (se tabel 3).
Adverse reactions are listed by System Organ Class (see Table 3).
Tæt klinisk monitorering er påkrævet.
Close clinical monitoring is warranted.
Boceprevir blev absorberet efter oral administration med en median Tmaks.
Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Hyppigheden af alvorlige eller livstruende infektioner har vist tendens til at være højere i boceprevirindeholdende arme end i kontrolarmen.
The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Eksplorativ farmakogenomisk analyse af IL28B i fase 3-studier af Victrelis
Exploratory pharmacogenomic analysis of IL28B in phase 3 studies of Victrelis
Når boceprevir administreres med ritonavir alene, nedsættes boceprevir-koncentrationerne.
When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased.
(postuleret aktionsmekanisme,
(postulated mechanism of
I hver systemorganklasse er bivirkningerne opdelt efter hyppighed i kategorierne: meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Within each system organ class, adverse reactions are listed under headings of frequency using the categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Der er ingen data fra anvendelse af Victrelis til gravide kvinder.
There are no data on the use of Victrelis in pregnant women.
Akkumulering er minimal og farmakokinetisk steady state opnås efter cirka 1 dag med dosering
Accumulation is minimal and pharmacokinetic steady state is achieved after approximately 1 day of three times daily dosing.
Hvis behandling initieres, er meget tæt monitorering for tegn på infektioner og forværring af leverfunktionen påkrævet.
If therapy is initiated, a very close monitoring for signs of infections and worsening liver function is warranted.
• Træk slippen tilbage for at komme ind til kapslen - kapslen må ikke presses gennem blisteren, da kapslen kan gå i stykker, hvis den presses gennem pakken.
• Peel back the tab to get to the capsule - do not push the capsule through the blister since pushing the capsule through the package may break the capsule.
Boceprevir har en gennemsnitlig distributionsvolumen (Vd/F) på circa 772 l i steady state.
Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state.
Raske frivillige har taget daglige doser på op til 3.600 mg i 5 dage uden ubehagelige symptomatiske
Daily doses of 3,600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
For yderligere information om brugen af Victrelis hos patienter med fremskreden
For additional information on use of Victrelis in patients with advanced
Der sås ingen karcinomer eller adenomer hos rotter.
No carcinomas or adenomas were observed in rats.
• warfarin og lignende lægemidler, såkaldte vitamin K-antagonister, der anvendes til fortynding af blodet.
• warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Multipakning: 336 (4 pakker af 84) hårde kapsler
Multipack: 336 (4 packs of 84) hard capsules
Virkning på fertilitet og Sertoliceller er blevet observeret hos rotter, men ikke hos mus og aber.
Effects on fertility and Sertoli cells have been observed in rats but not in mice and monkeys.
Sjælden (kan berøre op til 1 ud af 1.000)
Rare (may affect up to 1 in 1,000 people)
Resultatet af denne retrospektive sub-gruppeanalyse bør fortolkes med forsigtighed på grund af det lille udsnit og potentielle forskelle af populationen i substudiepopulationen i forhold til den samlede forsøgspopulation.
The results of this retrospective subgroup analysis should be viewed with caution because of the small sample size and potential differences of the sub-study population relative to the overall trial
Boceprevir elimineres ikke ved dialyse.
Boceprevir is not eliminated by dialysis.
Anden klinisk erfaring har ikke identificeret forskelle i respons mellem ældre og yngre patienter (se pkt.
Other clinical experience has not identified differences in responses between the older and younger patients (see section 5.2).
5.1 for beskrivelser af kliniske forsøg for hver behandlings-arm.
*Please see section 5.1 clinical trial descriptions for each treatment arm.
Hypoalbuminæmi og lavt trombocyttal samt svære infektioner er blevet identificeret som prædiktive faktorer for svære komplikationer ved leversygdom.
Hypoalbuminemia and low platelet count, as well as severe infections, have been identified as predictive factors of severe complications of liver disease.
Kliniske studier med boceprevir omfattede ikke et tilstrækkeligt antal af forsøgspersoner i alderen 65 og derover til at fastslå, om disse patienter responderer anderledes end yngre forsøgspersoner.
Clinical studies of boceprevir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Lægemidler fordelt på terapeutiske områder
Medicinal products by therapeutic areas
• har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere
• have a current or previous infection with the hepatitis B virus, since your doctor may want to
Den anbefalede dosis Victrelis er 4 kapsler tre gange dagligt (i alt 12 kapsler om dagen).
The recommended dose of Victrelis is 4 capsules three times a day (a total of 12 capsules a day).
Tabel 6
Table 4
Klare polychlortrifluoronethylen/PVC/aluminiumblisterkort, der indeholder 4 hårde kapsler per blisterrum.
Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity.
SVR-rater for de forsøgspersoner, som fik mindst en dosis studiemedicin (Intent-to-Treat population), er vist i tabel 9.
The SVR rates for subjects who received at least one dose of any study medication (Intent-to-Treat population) are shown in Table 9.
• har haft et blodproblem såsom anæmi (hvis du mangler tilstrækkeligt antal raske røde blodlegemer, som transporterer ilten rundt i din krop)
• have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body)
Koncentrationen af boceprevir vil sandsynligvis ikke blive påvirket af samtidig administration af maraviroc (baseret på eliminationsvejen for boceprevir).
Boceprevir concentrations are not likely to be affected by maraviroc co-administration (based on elimination pathway of boceprevir).
Boceprevir bliver elimineret med en gennemsnitlig plasma-halveringstid (t½) på cirka 3,4 timer.
Boceprevir is eliminated with a mean plasma half-life (t½) of approximately 3.4 hours.
Ændring i procent og pile (↑ = stigning, ↓ = fald, ↔ = ingen ændring) er brugt til at vise omfang og ændringsretning i estimeret gennemsnitsratio for hver farmakokinetisk parameter.
The percent change and arrows (↑ = increase, ↓ = decrease, ↔ = no change) are used to show the magnitude and direction of change in mean ratio estimate for each pharmacokinetic parameter.
Ved steady-state var eksponeringsforholdet for de to diastereomere ca. 2:1, hvor den dominerende diastereomer var farmakologisk aktiv.
At steady-state, the exposure ratio for the two diastereomers is approximately 2:1, with the predominant diastereomer being pharmacologically active.
Victrelis indeholder lactose (en slags sukker).
Victrelis contains lactose (a type of sugar).
Det skal bemærkes, at retrospektive analyser af data fra de to pivotale undersøgelser har ført til dosisrekommandationer, der adskiller sig fra det undersøgte regime hos enkelte patient-sub-grupper.
It should be noted that retrospective analyses bridging the data between the two pivotal studies have led to a recommended posology that differs from the regimen studied in some patient subgroups.
Hæmmere af disse transportere kan potentielt øge koncentrationen af boceprevir; den kliniske relevans af disse interaktioner er ukendt.
There is potential for inhibitors of these transporters to increase concentrations of boceprevir; the clinical implications of these interactions are not known.
Behandling med Victrelis skal initieres og monitoreres af en læge med erfaring i behandling af
Treatment with Victrelis should be initiated and monitored by a physician experienced in the
I et studie med patienter med forskellige grader af stabil, kronisk nedsat leverfunktion (let, moderat og alvorlig) blev der ikke fundet klinisk signifikante forskelle i farmakokinetiske parametre, og der kræves ingen dosisjustering.
In a study of patients with varying degrees of stable chronic liver impairment (mild, moderate and severe), no clinically significant differences in pharmacokinetic parameters were found, and no dose adjustment is recommended.
Behandling af overdosering med Victrelis bør bestå af generel understøttende behandling, herunder monitorering af livstegn og observation af patientens kliniske status.
Treatment of overdose with Victrelis should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Victrelis' absolutte biotilgængelighed er ikke undersøgt.
The absolute bioavailability of Victrelis has not been studied.
Der findes ingen specifik antidot mod overdosering af Victrelis.
There is no specific antidote for overdose with Victrelis.
Det Europæiske Lægemiddelagentur har fremsat kravet om fremlæggelse af resultaterne af studier med Victrelis hos en eller flere undergrupper af den pædiatriske population ved kronisk viral hepatitis C (se pkt 4.2 for information om pædiatrisk anvendelse).
The European Medicines Agency has deferred the obligation to submit the results of studies with Victrelis in one or more subsets of the paediatric population in chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Kliniske data (sædanalyser og inhibin-B-niveauer - [et glykoprotein produceret af Sertoliceller - anvendt som surrogatmarkør for testikelfunktionen]) viste ikke tegn på ændret testikelfunktion.
Clinical data (semen analyses and inhibin B levels - [a glycoprotein produced by Sertoli cells - used as a surrogate marker of testicular function]) showed no evidence of altered testicular function.
C-boceprevir blev cirka 79 % og 9 % af dosis udskilt i henholdsvis fæces og urin, og cirka 8 % og 3 % af det doserede radioaktive-kulstof blev elimineret som boceprevir i fæces og urin.
C-boceprevir, approximately 79% and 9% of the dose was excreted in faeces and urine, respectively, with approximately 8% and 3% of the dosed radiocarbon eliminated as boceprevir in faeces and urine.
Almindelig (kan berøre op til 1 ud af 10)
Common (may affect up to 1 in 10 people)
Vedvarende virologisk respons (SVR)
Sustained Virologic Response (SVR)
Biotilgængeligheden af boceprevir er uafhængig af typen af måltid (f.eks. højt fedtindhold vs. lavt fedtindhold) eller om det bliver indtaget 5 minutter før et måltid, under et måltid
The bioavailability of boceprevir is regardless of meal type (e.g., high-fat vs. low-fat) or whether taken 5 minutes prior to eating, during a meal, or immediately following completion of the meal.
Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive eller anvende Victrelis, ved lanceringen får en uddannelsespakke til sundhedspersonale, som indeholder
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Victrelis are provided with a healthcare professional educational pack containing the following at
Da leverfunktionen kan ændre sig under behandling med Victrelis, anbefales tæt monitorering af INR (international normaliseret ratio) hos patienter i behandling med vitamin K-antagonister.
As liver function may change during treatment with Victrelis, a close monitoring of International Normalised Ratio (INR) values is recommended in patients treated with vitamin K antagonists.
Det gennemsnitlige fald i hæmoglobinværdierne i forhold til baseline var større hos tidligere behandlede patienter end hos patienter, der ikke tidligere havde været i behandling.
The mean decreases in haemoglobin values from baseline were larger in previously treated patients compared to patients who had never received prior therapy.
Boceprevir bliver primært metaboliseret af aldoketo-reduktase (AKR).
Boceprevir is primarily metabolized by aldoketo reductase (AKR).
Boceprevir/lægemiddelderiveret materiale blev overført til mælken hos lakterende rotter.
Boceprevir/medicine derived material was shown to be transferred into the milk of lactating rats.
Hvis sådanne reaktioner opstår, skal kombinationsbehandlingen seponeres og passende behandling påbegyndes omgående (se
If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
Hvis du har fået at vide af din læge, at du ikke kan tåle eller fordøje visse sukkerarter (du er intolerant over for nogle sukkerarter) såsom en særlig form for arvelig lactasemangel (Lapp lactase-mangel) eller forstyrrelser i glucose-galactose-optagelsen, skal du tale med din læge, før du tager denne medicin.
If you have been told by your doctor that you cannot tolerate or digest some sugars (you have an intolerance to some sugars), such as Lapp lactase deficiency, or glucose-galactose malabsorption, talk to your doctor before taking this medicine.
(virkning på P-gp-transport i
(effect on P-gp transport in the
I et in vitro-studie med hunde-Purkinje-fibre forlængede boceprevir varigheden af aktionspotentialet med invers frekvensafhængighed; den kliniske relevans er fortsat uvis.
In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain.
Hbv/hcv co-inficerede patienter har risiko for reaktivering af hbv og bør derfor monitoreres og behandles i henhold til gældende kliniske vejledninger.
HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current
Uddannelsesmateriale til lægen skal indeholde følgende hovedelementer:
The PEM should contain the following key elements:
• pimozid eller lurasidon - bruges til behandling af psykiske problemer
• pimozide or lurasidone - used for mental health problems
Sarcoidose*, ikke-akut porfyri
Sarcoidosis*, porphyria non-acute
Den sidst tilgængelige værdi i perioden op til og efter FW 24.
The last available value in the period at and after FW 24.
Behandlingsvarighed = 48 uger 1.
Treatment duration = 48 weeks
I 2-årige karcinogenicitetsstudier sås ingen karcinogenicitet, men der var øget incidens af hepatocellulære adenomer hos mus, hvilket ikke var statistisk signifikant, ved systemiske eksponeringer, der var 5,7 gange højere end hos mennesker ved den anbefalede terapeutiske dosis.
In 2-year carcinogenicity studies, no carcinogenicity was observed, but there was an increased incidence of hepatocellular adenomas in mice, which was not statistically significant, at systemic exposures 5.7-fold higher than those in humans at the recommended therapeutic dose.
Et 3-års opfølgningsstudie med forsøgspersoner, som opnåede SVR med et Victrelis-baseret regime, viste, at >99% (693/696) af patienterne opretholdt deres SVR (intet tilbagefald) i hele den tilgængelige opfølgningsperiode (gennemsnitsvarighed 3,4 år).
A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period
† hos tidligere ubehandlede forsøgspersoner med hiv co-infektion
† in previously untreated subjects with HIV co-infection
Den kliniske konsekvens af denne reduktion er ikke blevet vurderet direkte.
The clinical outcome of this observed reduction of Victrelis trough concentrations has not been directly assessed.
Hvis din kvindelige partner ikke er gravid, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen og i 7 måneder efter ophørt behandling.
If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
• oral midazolam eller oral triazolam - beroligende medicin, der gives via munden
• oral midazolam or oral triazolam - a sedative, given by mouth
Anvendelse hos patienter med hcv-genotyper ud over genotype 1
Use in patients having HCV genotypes other than genotype 1
Der kræves ingen dosisjustering hos disse patienter eller hos patienter med nogen grad af nedsat
No dose adjustment is required in these patients and in patients with any degree of renal impairment.
Patienterne skal monitoreres for tegn på opiattoksicitet i forbindelse med buprenorphin.
Patients should be monitored for signs of opiate toxicity associated with buprenorphine.
• har haft et blodproblem såsom pancytopeni (en kombination af lavt antal blodplader, hvide og
• have ever had a blood problem such as pancytopenia (a combination of low platelet, red and
Enkeltsubstitutionen D168V reducerede ikke følsomheden over for boceprevir.
The D168V single substitution did not reduce sensitivity to boceprevir.
• selv har eller har et familiemedlem med uregelmæssig hjerterytme, især en tilstand, der hedder
• have or anyone in your family has an irregular heartbeat, especially a condition called “QT
I et genotype 1a-replikon var IC50- og IC90-værdierne for boceprevir henholdsvis 900 nM og 1.400 nM.
In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
For enkelte patienter kan ekstra titrering af methadondosis være nødvendig, når Victrelis startes op eller seponeres for at sikre klinisk virkning af methadon.
Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.
Derfor skal du og din partner tage særlige forholdsregler i forbindelse med seksuel
Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Det skal du vide, før du begynder at tage Victrelis
What you need to know before you take Victrelis
Der er ikke observeret kønsrelaterede farmakokinetiske forskelle hos voksne patienter i fase III
No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
En opfølgningsanalyse af boceprevir-behandlede forsøgspersoner, som ikke opnåede SVR, viste at populationen af vildtype virus steg, og størstedelen af de boceprevir-resistente varianter blev ikkedetekterbare over tid efter afsluttet boceprevir-behandling.
Follow-up analysis of boceprevir-treated subjects who did not achieve SVR showed that the population of wild-type virus increased and the majority of boceprevir-resistant variants became undetectable over time after the end of boceprevir treatment.
Dette skyldes, at leverfunktionen kan ændre sig under behandling med Victrelis.
This is due to liver function changes during treatment with Victrelis.
For de fleste af forsøgspersonerne (n=54) var den laveste ribavirin-dosis i mindst 14 dage ≥600 mg/dag.
For most of these subjects (n=54), the lowest dose of ribavirin received for at least 14 days was ≥ 600mg/day.
Samtidig administration af Victrelis og quetiapin kan øge plasmakoncentrationen af quetiapin og medføre quetiapin-relateret toksicitet, herunder koma.
Concomitant administration of Victrelis and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Maraviroc 150 mg to gange dagligt ved samtidig anvendelse af boceprevir.
Maraviroc 150 mg twice daily when co-administered with boceprevir.