natgillin/translations-raw huggingface dataset:
a Patienter, som opnåede viral suppression (ikke-detekterbar HCV-RNA, <50 IE/ml) ved uge 12, blev anset for at have virologisk respon ved uge 12.
a Patients who achieved viral suppression (undetectable HCV RNA, < 50 IU/ml) at week 12 were considered to have a virological response at week 12.
Rens området med spritservietten og læg spritservietten til side, så du kan tørre området igen efter injektionen, hvis det er nødvendigt.
Clean the area using the alcohol pad and put the pad aside to wipe the site again after injection, if necessary.
●Du må ikke røre spidsen på den fyldte pen, idet stikuheld kan forekomme.
● Do not touch the tip of the pre-filled pen, since needlestick injuries may occur.
Hvis du bemærker luftbobler, skal du langsomt trække stemplet tilbage.
If you see any bubbles, pull the plunger slightly back.
Hvis de psykiatriske symptomer varer ved eller forværres eller sucidale tanker er konstateret anbefales det, at behandlingen med Pegasys stoppes, og patienten kontrolleres med psykiatrisk behandling som nødvendigt.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Pegasys be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Tilfælde af Vogt-Koyanagi-Harada (VKH)-syndrom har været rapporteret hos patienter med kronisk hepatitis C, som har været behandlet med interferon.
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with CHC treated with interferon.
Behandlingsvarighed, når Pegasys gives i kombination med andre lægemidler
Duration of therapy when Pegasys is used in combination with other medicinal products
HBV-DNA blev målt med COBAS AMPLICOR
HBV-DNA was measured by the COBAS AMPLICOR HBV
Tabel 11: Ydeevne for individuelle biomarkører i behandlingsuge 12 hos CHB HBeAg-positive og HBeAg-negative patienter ud fra genotype
Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Den ribavirindosis, som skal anvendes i kombination med Pegasys fremgår af tabel 1.
The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Der er blevet rapporteret alvorlige infektioner (bakterielle, virale og fungale) og sepsis under behandlingen med interferon alfa herunder Pegasys.
Serious infections (bacterial, viral, fungal) and sepsis have been reported during treatment with alfa interferons including Pegasys.
Metabolisme: Appetitløshed
Metabolic disorders: Loss of appetite
Eksplorative analyser baseret på begrænsede data viser, at pædiatriske patienter med større fald i HBV-DNA i uge 12 af behandlingen var mere tilbøjelige til at opnå HBeAg sero-konversion ved 24 ugers opfølgning (tabel 24).
Exploratory analyses based on limited data show paediatric patients with greater decline in HBV-DNA at week 12 of therapy were more likely to achieve HBeAg seroconversion at 24 weeks of follow-up (Table 24).
● bruge den fyldte pen, hvis den ser ud til være beskadiget.
● use if pre-filled pen appears to be damaged.
HBeAg Sero-konversion HBV DNA < 20,000 IE/ml* HBV DNA < 2,000 IE/ml ALAT Normalisering HBsAg Sero-konversion Tab af HBsAg
HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Daglig dosis af ribavirin (Ca. 15 mg/kg/dag)
Ribavirin daily dose (Approx. 15 mg/kg/day)
8) Bortskaf den fyldte pen
8) Dispose of pre-filled pen
Hvis abnormiteten reverterer, kan behandlingen med ribavirin genoptages med en dosis på 600 mg daglig, og dosis kan yderligere øges til 800 mg daglig iht.
If the abnormality is reversed, ribavirin may be restarted at 600 milligrams daily, and further increased to 800 milligrams daily at the discretion of the treating physician.
Total Lav viral belastning Høj viral belastning Genotype 1/4 Lav viral belastning Høj viral belastning Genotype 2/3 Lav viral belastning Høj viral belastning Cirrose status Cirrose Ikke cirrose Bedste respons ved tidligere behandling ≥2log10 fald i HCV-RNA <2log10 fald i HCV-RNA Mangler bedste tidligere respons
Overall Low viral load High viral load Genotype 1/4 Low viral load High viral load Genotype 2/3 Low viral load High viral load Cirrhosis Status Cirrhosis Noncirrhosis Best Response during Previous Treatment ≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
Det anbefales at nedsætte dosis hos voksne, hvis det absolutte neutrofilocyttal (ANC) er 500 til <750 celler/mm3.
For adults, dose reduction is recommended if the absolute neutrophil count (ANC) is 500 to < 750 cells/mm3.
Faldet i CD4+ celletal var reversibelt efter reduktion af dosis eller efter behandlingsophør.
The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Hos pædiatriske patienter vil toksicitet forbundet med ribavirinbehandling, såsom anæmi, som viser sig under behandlingen, blive hånderet med reduktion af den fulde dosis.
In paediatric patients, ribavirin treatment-associated toxicities, such as treatment-emergent anaemia, will be managed by reduction of the full dose.
Fisher's Exact testResponshastigheden for HBeAg sero-konversion var lavere hos patienter med HBV genotype D, også hos patienter med ingen til minimal stigning i ALAT-niveau ved baseline (se tabel 23).
The response rate of HBeAg seroconversion was lower in patients with HBV genotype D, also in patients with no to minimal increase in ALT level at baseline (see Table 23).
Et klinisk studie, som undersøgte kombinationen af 600 mg telbivudin dagligt og 180 mikrogram pegyleret interferon alfa-2a subkutant én gang ugentligt for behandling af HBV, indikerede, at kombinationen er forbundet med en øget risiko for udvikling af perifer neuropati.
A clinical trial investigating the combination of telbivudine 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration for the treatment of HBV, indicates that the combination is associated with an increased risk for developing peripheral neuropathy.
Efter 8 ugers behandling var yderligere fald sjældent.
Progressive decreases after 8 weeks of therapy were infrequent.
Selvmord, psykiatrisk lidelse
Suicide, psychotic disorder
Pegasys indeholder benzylalkohol
Pegasys contains benzyl alcohol
Gennemsnitseksponering (AUC) under doseringsinterval forventes at være 25 % til 70 % højere end det observeret hos voksne, som fik 180 mikrogram som fast dosering.
The mean exposure (AUC) during the dosing interval is predicted to be 25% to 70% higher than that observed in adults receiving 180 mcg fixed dosing.
Vær opmærksom på også at læse indlægssedlen for ribavirin.
Please be sure to read the ribavirin package leaflet also.
Der skal derfor iagttages forsigtighed, når Pegasys og ribavirin gives som adjuvans til HAART-behandling (se produktresuméet for ribavirin).
Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SmPC).
Bank let på sprøjten for at få boblerne op til toppen.
Tap the syringe gently to bring the bubbles to the top.
I studie WV16240 var primære endepunkter for effekt HBeAg-serokonversion og HBV-DNA under 105 kopier/ml.
In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
• Nyfødte og børn op til 3 år, på grund af hjælpestoffet benzylalkohol (se pkt.
• Neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.4 for benzyl alcohol)
I individuelle tilfælde, hvor fordelen ved administrationen af ribavirin sammen med azathioprin opvejer den potentielle risiko, anbefales tæt hæmatologisk monitorering ved samtidig brug af azathioprin for at identificere tegn på myelotoksicitet.
In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close haematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicinal products should be stopped (see section 4.4).
● hvis du får symptomer på forkølelse eller andre luftvejsinfektioner (som f.eks. hoste, feber eller åndenød).
● if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
I ca. halvdelen af de tilfælde, hvor stigningen oversteg 10 gange øvre referencegrænse, blev Pegasys-dosis reduceret eller seponeret, indtil aminotransferasestigningerne var forsvundet, hvorimod behandlingen fortsatte uændret i de resterende tilfælde.
In approximately half the cases of flares exceeding 10x ULN, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
Både ved Pegasys-monoterapi og ved kombineret behandling med ribavirin fik op til 2 % af patienterne ALAT-stigninger, som medførte dosisjustering eller afbrydelse af behandlingen.
With both Pegasys monotherapy, and also the combined treatment with ribavirin, up to 2% of patients experienced increased ALT levels that led to dose modification or discontinuation of the treatment.
Patienter inficeret med viral genotype 2 eller 3 skal behandles i 24 uger, mens patienter inficeret med andre genotyper skal behandles i 48 uger.
Patients infected with viral genotypes 2 or 3 should receive 24 weeks of treatment, while patients infected with any other genotype should receive 48 weeks of therapy.
En meta-analyse på patient-niveau af 9 Pegasys kliniske studier (N=1.423) med CHB HBeAg-positive og HBeAg-negative patienter viste, at HBsAg og HBV-DNA niveauer ved behandlingsuge 12 er prædiktive, for behandlingsresultatet i uge 24 efter behandling, hos visse genotyper.
A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes.
AUC var let forøget (1.663 versus 1.295 ng*t/ml), men peakkoncentrationerne (9,1 versus 10,3 ng/ml) var de samme hos forsøgspersoner over 62 år.
The AUC was slightly increased (1663 vs. 1295 ng·h/ml) but peak concentrations (9.1 vs. 10.3 ng/ml) were similar in subjects older than 62 years.
Respons ved afslutning af behandling
Response at End of Treatment
Det betyder, at Pegasys injiceres med en kort kanyle i fedtvævet under huden på maven eller låret.
This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh.
● et hætteglas med Pegasysopløsning til injektion Ikke indlagt i pakningen:
● a vial of Pegasys solution for injection Not included in the pack:
Hvis det overvejes at behandle patienter, som er inficeret med virusgenotype 1, og som ikke har reageret på tidligere behandling med peginterferon og ribavirin, er den anbefalede totale behandlingsvarighed 72 uger (se pkt.
If patients infected with virus genotype 1, not responding to prior treatment with peginterferon and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).
Kronisk hepatitis C og hiv-co-infektion
Chronic hepatitis C and HIV co-infection
Bivirkninger rapporteret i kliniske studier er grupperet i følgende frekvenser: 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), meget sjælden (< 1/10.000).
Undesirable effects reported in clinical studies are grouped according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Foreløbige og begrænsede sikkerhedsdata viste ingen tydelig afvigelse fra den kendte sikkerhedsprofil for kombinationen hos voksne med kronisk HCV-infektion.
Preliminary and limited safety data demonstrated no obvious departure from the known safety profile of the combination in adults with chronic HCV infection, but, importantly, the potential impact on growth has not been reported.
Tidligt virologisk respons ved uge 12, defineret som et 2 log viralt fald eller ikke-detekterbare koncentrationer af HCV-RNA har vist sig at være prædiktivt for vedvarende respons (se tabel 2 og
Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Tables 2 and 13).
● hvis du har infektioner med både hepatitis C og hiv og din lever ikke fungerer, som den skal (f.eks. hvis din hud bliver gul).
● if you are infected with both the hepatitis C virus and the human immunodeficiency virus, and your liver does not work properly (e.g. your skin has become yellow).
Hjælpestof, som behandleren skal være opmærksom på: Benzylalkohol (10 mg/1 ml)
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
• Træk kanylen ud af huden.
● Pull the needle straight out of the skin.
Der foreligger begrænsede sikkerhedsdata hos co-inficerede patienter med CD4+ celletal < 200/μl.
Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Hvis du opdager, at du har glemt injektionen 6 dage efter, den var planlagt, skal du vente med at tage den indtil næste dag, som er din normalt planlagte dag.
If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
Sæt aldrig hætten på igen efter, at den er blevet fjernet.
Never re-attach protective cap after removal.
Absorptionen af Pegasys vedvarer, og serum-peakkoncentrationen nås efter 72 til 96 timers behandling.
The absorption of Pegasys is sustained with peak serum concentrations reached 72 to 96 hours after dosing.
Væksthæmning blev observeret hos pædiatriske patienter (se pkt.
Growth inhibition was observed in paediatric patients (see section 4.4).
Kombinationen af Pegasys og telbivudin er derfor kontraindiceret.
Therefore, the combination of Pegasys with telbivudine is contraindicated.
Eksponeringen for Pegasys var nedsat i studier, som anvendte administration af Pegasys i armen, sammenlignet med administration i abdomen eller lår.
Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm compared to administration in the abdomen and thigh.
Dosis-respons under monoterapi
Dose-response in monotherapy
Tabel 20:Vedvarende virologisk respons i HALT-C ved tidligere behandling hos ikkeresponderende population
Table 20: Sustained virological response in HALT-C by previous treatment regimen in nonresponder population
Voksne og pædiatriske patienter, som allerede har øjensygdomme (f.eks. diabetisk eller hypertensiv retinopati), skal have foretaget periodiske øjenundersøgelser under behandlingen med Pegasys.
Adult and paediatric patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
● en lang kanyle til at trække Pegasys op af hætteglasset
● a long needle to withdraw Pegasys from the vial
Interstitiel pneumonitis inklusiv dødelig udgang, lungeemboli
Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
Pulmonal arteriel hypertension§
Pulmonary arterial hypertension§
Pegasys's farmakokinetik var ens hos raske forsøgspersoner og hos patienter med hepatitis B eller C. Der blev set sammenlignelige eksponeringer og farmakokinetiske profiler hos patienter med cirrose (Child-Pugh grad A) og patienter uden cirrose.
The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Hos patienter med kardiovaskulær sygdom, kan anæmi nødvendiggøre dosisreduktion eller afbrydelse af behandling med ribavirin (se pkt.
In patients with cardiovascular disease, anaemia may necessitate dose reduction or discontinuation of ribavirin (see section 4.2).
Pædiatriske patienter behandlet med Pegasys plus ribavirin kombinationsbehandling udviste en forsinket vægt- og højdestigning efter 48 ugers behandling sammenlignet med baseline.
Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Tabel 24: HBeAg sero-konversionshastighed (%) for HBV-DNA fald fra baseline til uge 12 af Pegasys behandlingen hos pædiatriske patienter
Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
I det kliniske studie NV15495 blev der specielt rekrutteret patienter med histologisk diagnosticeret cirrose (omkring 80 %) eller begyndende cirrose (omkring 20 %).
Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Baseline-variabler hos co-inficerede cirrotiske patienter, som kan være relateret til hepatisk dekompensation, omfatter: Forhøjet serum-bilirubin, nedsat hæmoglobin, forhøjet basisk phosphatase eller nedsat trombocyttal samt behandling med didanosin (ddI).
Baseline variables in co-infected cirrhotic patients that may be associated with hepatic decompensation include: increased serum bilirubin, decreased haemoglobin, increased alkaline phosphatase or decreased platelet count, and treatment with didanosine (ddI).
Interferon alfa-2a er konjugeret med bis-[monomethoxy polyethylenglycol] med en substitutionsgrad på ét mol af polymer/mol protein.
Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/mole of protein.
I et andet klinisk studie blev ikke-responderende patienter med fremskreden fibrose eller cirrose (Ishak score mellem 3 og 6) og baseline blodpladetal så lavt som 50.000 celler/mm3 behandlet i 48 uger.
In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
• Rens gummiet på toppen af hætteglasset med et stykke rensevat.
● Clean the rubber top of the vial with a cleansing swab.
Hos patienter, der fik Pegasys-monoterapi i studie WV16241, var raten af HBV-DNA respons og ALAT-normalisering 12 måneder efter afslutning af behandling henholdsvis 42 % (41/97) og 59 % (58/99).
In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/97) and 59% (58/99), respectively.
• Overfølsomhed overfor det aktive stof, overfor interferon alfa eller overfor et eller flere af hjælpestofferne anført i punkt 6.1
• Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1
Patienter med eksisterende eller svære psykiatriske sygdomme i anamnesen: Hvis behandling med Pegasys er vurderet at være nødvendig hos patienter, som har eller tidligere har haft svære psykiatriske lidelser, bør behandlingen kun påbegyndes, når den psykiatriske lidelse er individuelt diagnosticeret og behandlet på passende måde.
Patients with existence of, or history of severe psychiatric conditions: If treatment with Pegasys is judged necessary in patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Patienter, som også er smittet med hiv, og som får højaktiv, antiretroviral behandling (HAART), kan have en øget risiko for at udvikle lactacidosis.
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
HBsAg-serokonversion
HBsAg Seroconversion
Absolut neutrofilocyttal
Absolute Neutrophil Count
Efter intravenøs administration er den terminale halveringstid for peginterferon alfa-2a hos raske forsøgspersoner ca. 60 til 80 timer, sammenlignet med 3-4 timer for standard-interferon.
After intravenous administration, the terminal half-life of peginterferon alfa2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
I en direkte sammenligning med 90 mikrogram var en dosis på 180 mikrogram forbundet med et større vedvarende virologisk respons hos patienter med cirrose, men hos non-cirrotiske patienter var resultaterne meget ens efter hhv. 135 mikrogram og 180 mikrogram.
In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Du skal nu tage injektionen om fredagen så hurtigt som muligt og tage den næste injektion om onsdagen
You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday
3 år, fordi det indeholder benzylalkohol og kan forårsage giftige reaktioner og allergiske reaktioner hos disse børn.
Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.
I de kliniske studier med Pegasys ved HBV har markante aminotransferasestigninger været ledsaget af lette ændringer i andre mål for leverfunktionen og uden evidens for hepatisk dekompensation.
In clinical trials with Pegasys in HBV, marked transaminase flares have been accompanied by mild changes in other measures of hepatic function and without evidence of hepatic decompensation.
Patienter, som opnåede ikke-detekterbare niveauer af HCV-RNA efter 20 ugers behandling, fortsatte i Pegasys plus ribavirin kombinationsbehandling i sammenlagt 48 uger og blev siden fulgt i 24 uger efter afsluttet behandling.
Patients who achieved undetectable levels of HCV RNA after 20 weeks of treatment remained on Pegasys plus ribavirin combination therapy for a total of 48 weeks and were then followed for 24 weeks after the end of treatment.
Du må ikke køre bil eller motorcykel og lad være med at cykle eller arbejde med værktøj eller maskiner, hvis du føler dig omtåget, træt eller konfus, mens du tager Pegasys.
Driving and using machines Do not drive or use machines if you feel drowsy, tired, or confused while taking Pegasys.
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 18).
The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 18).
HCV-monoinficerede patienter og HBV-monoinficerede patienter
HCV monoinfected patients and HBV monoinfected patients
Alle behandlingsarme havde en 24 ugers behandlingsfri opfølgningsperiode.
All treatment arms had 24 week treatment-free follow-up.
Behandlingen skal seponeres hos patienter, som stadig har detekterbare niveauer af HCV-RNA på trods af en initial 24 ugers behandling, idet det ikke er sandsynligt, at disse patienter vil opnå et vedvarende virologisk respons med fortsat behandling.
Patients who still have detectable levels of HCV-RNA despite an initial 24 weeks of therapy, should discontinue therapy, as it is unlikely they will be able to achieve a sustained virological response with continued therapy.
Alopeci, dermatitis, kløe, tør hud
Alopecia, dermatitis, pruritis, dry skin
Blandt patienter fra studie WV16240, som fik Pegasys-monoterapi og indgik i langtidsfollow-up-studiet, var raten af vedvarende HbeAg-serokonversion 12 måneder efter afslutningen af behandlingen 48 % (73/153).
Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
● Dit barn kan have langsommere vækst og udvikling, mens barnet får Pegasys (se punkt 4).
• When receiving Pegasys, your child may have slower growth and development (see section 4).