FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Danish: Resultater fra farmakokinetiske substudier fra pivotale fase III-studier viste ingen farmakokinetisk interaktion mellem lamivudin og Pegasys hos HBV-patienter eller mellem Pegasys og ribavirin hos HCV-patienter.
English: Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
Danish: Ribavirin havde ingen signifikant effekt på den initiale virale kinetik i de første 4 til 6 uger hos patienter, som behandledes med kombinationen af ribavirin og pegyleret interferon alfa-2a eller med interferon alfa.
English: In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration.
Danish: Hos disse patienter bør der tages hensyn til tolerancen over for kombinationsbehandlingen og tilstedeværelsen af øvrige kliniske eller prognostiske faktorer såsom graden af fibrose, hvis der overvejes afvigelser fra standard 24 ugers behandlingsvarighed.
English: ● try to re-use the pre-filled pen.
Danish: ● forsøge at genbruge den fyldte pen.
English: With up to one year of treatment with Pegasys in combination with ribavirin, some children and adolescents with chronic hepatitis C did not grow or gain weight as much as expected.
Danish: Efter op til et års behandling med Pegasys i kombination med ribavirin er det set, at nogle børn og unge med kronisk hepatitis C ikke er vokset eller har taget på i vægt som forventet.
English: It is recommended that patients who have pre-existing cardiac abnormalities have an electrocardiogram prior to initiation of Pegasys therapy.
Danish: Det anbefales, at patienter med hjerteabnormiteter får taget elektrokardiogram før behandlingen med Pegasys påbegyndes.
English: The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 14 and 15).
Danish: Resultaterne fra studie NV15942 udgør rationalet for at anbefale behandling baseret på genotype, viral belastning ved baseline og virologisk respons ved uge 4 (se tabel 1, 14 og 15).
English: When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Danish: Når Pegasys anvendtes i kombination med ribavirin, forårsagede det ingen virkninger på aber, som ikke var set efter de aktive stoffer alene.
English: HCV patients with normal ALT
Danish: HCV-patienter med normal ALAT
English: StevensJohnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme
Danish: StevensJohnsons syndrom, toksisk epidermal necrolyse, angioødem, erythem multiforme
English: Comprehensive instructions for the preparation and administration of Pegasys in pre-filled pen are given in the package leaflet.
Danish: Udførlige anvisninger om forberedelse og administraton af Pegasys i fyldt pen findes i indlægssedlen.
English: Infections: Fungal, viral and bacterial infections.
Danish: Infektioner: Svampeinfektioner, virale og bakterielle infektioner.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug Anvendes subkutant
English: A similar negative predictive value has been observed in HIV-HCV co-infected patients treated with Pegasys monotherapy or in combination with ribavirin (100% (130/130) or 98% (83/85), respectively).
Danish: Der er set en tilsvarende negativ prædiktiv værdi hos hiv-HCV-co-inficerede patienter i behandling med henholdsvis Pegasys monoterapi eller i kombination med ribavirin (100 % (130/130) eller 98 % (83/85).
English: The pharmacokinetics of Pegasys after single subcutaneous injections was comparable between male and female healthy subjects.
Danish: Pegasys's farmakokinetik efter subkutane enkeltinjektioner var sammenlignelig hos raske mænd og kvinder.
English: Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
Danish: Der er givet ugentlige doser op til 540 og 630 mikrogram i studier om renalcellekarcinom og kronisk myeloid leukæmi.
English: In these patients, tolerability to combination therapy and additional prognostic factors such as degree of fibrosis should be taken into account when deciding on treatment duration.
Danish: Hos disse patienter bør tolerancen over for kombinationsbehandlingen samt prognostiske faktorer såsom graden af fibrose tages med i overvejelserne, når der tages beslutning om behandlingsvarighed.
English: No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12-week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
Danish: Der kunne ikke påvises nogen lægemiddelinteraktion hos 47 hiv-HCV-co-inficerede patienter, som fuldførte et 12 ugers farmakokinetisk delstudie med henblik på at undersøge ribavirins effekt på den intracellulære phosphorylering af visse reverse nukleotid transkriptasehæmmere (lamivudin og zidovudin eller stavudin).
English: SI unit = µmol/l)
Danish: SI- enheder = µmol /l
English: ● if the patient is a child who has ever had serious psychiatric conditions such as severe depression or thoughts of committing suicide.
Danish: ● hvis patienten er et barn, som på et tidspunkt har haft en alvorlig psykiatrisk lidelse såsom svær depression eller selvmordstanker.
English: Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor.
Danish: Anvend Pegasys nøjagtigt og i så lang tid, som lægen har foreskrevet det.
English: Pinch and hold a fold of skin at the injection site with your free hand, such that the needle-shield can rest on the skin-fold firmly and safely.
Danish: Klem og hold en hudfold på injektionsstedet sammen med den frie hånd, så kanylebeskyttelsen kan hvile fast og sikkert på hudfolden.
English: 6) Place pre-filled pen on injection site 7) Give injection
Danish: 6) Placér den fyldte pen på injektionsstedet 7) Giv injektionen
English:  The needle-shield will automatically move out and lock to prevent needle injuries.
Danish:  Kanylebeskyttelsen vil automatisk bevæge sig tilbage og låse for at forhindre stikuheld.
English: * Subgroup of patients with genotype D had a higher proportion with baseline ALT < 1.5x ULN (13/31) compared to other genotype groups ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Danish: * Subgruppen med patienter med genotype D havde en større andel med baseline ALAT <1,5x øvre referencegrænse (13/31) sammenlignet med andre grupper af genotyper (16/70) ** Patienter, som skiftede til Pegasys behandling efter den primære observationsperiode og før 24 ugers opfølgningsperiode blev regnet som ikke-responderende.
English: In patients co-infected with HIV-HCV, limited efficacy and safety data are available in patients with CD4 counts less than 200 cells/µl.
Danish: Hos patienter, der er co-inficeret med hiv-HCV, er begrænsede effekt- og sikkerhedsdata tilgængelige hos patienter med CD4-tal mindre end 200 celler/µl.
English: It is also used to treat chronic hepatitis B in children and adolescents aged 3 years and older and chronic hepatitis C in children and adolescents aged 5 years and older, who have not been treated before.
Danish: Det anvendes også til behandling af kronisk hepatitis B hos børn og unge, som er 3 år og ældre, samt kronisk hepatitis C hos børn og unge, som er 5 år og ældre, og som ikke er blevet behandlet før.
English: Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ribavirin because of haematological toxicity were excluded from enrolling in this trial.
Danish: Patienter, som blev seponeret fra tidligere behandling med pegyleret interferon alfa-2b/ribavirin på grund af hæmatologisk toksicitet, blev udelukket fra deltagelse i dette studie.
English: Efficacy response in group C to Pegasys treatment was in line with that seen in group A. For paediatric patients, efficacy has not been established in HBV genotypes other than genotypes A-D.
Danish: Effektrespons i gruppe C på Pegasys behandling var i overensstemmelse med den, der blev set i gruppe A. Virkningen for pædiatriske patienter er ikke blevet klarlagt hos HBV genotyper, undtagen genotype A-D.
English: Seven patients receiving combination Pegasys and ribavirin treatment for 48 weeks discontinued therapy for safety reasons (depression, psychiatric evaluation abnormal, transient blindness, retinal exudates, hyperglycaemia, type 1 diabetes mellitus, and anaemia).
Danish: Syv patienter, som fik Pegasys og ribavirin kombinationsbehandling i 48 uger, fik seponeret behandlingen af sikkerhedsmæssige årsager (depression, abnorm psykiatrisk vurdering, forbigående blindhed, retinale ekssudater, hyperglykæmi, type 1 diabetes mellitus og anæmi).
English: The PK model developed from this study shows a linear influence of BSA on the apparent clearance of the drug over the age range studied.
Danish: Den farmakokinetiske model, som blev udviklet i dette studie, viser en lineær indflydelse af legemsoverfladeareal på lægemidlets tilsyneladende clearance i det undersøgte aldersinterval.
English: The Pegasys prefilled pens do not allow for appropriate adjustment of dosing in these patients.
Danish: Pegasys forfyldte penne tillader ikke en passende justering af dosering for disse patienter.
English: Based on the population pharmacokinetic model, the mean exposure (AUC) during the dosing interval for each BSA category was comparable with that observed in adults receiving 180 mcg fixed dosing.
Danish: Baseret på den populationsfarmakokinetiske model, var gennemsnitseksponeringen (AUC) under doseringsintervallet for hver legemsoverfladeareal (BSA) kategori sammenlignelig med, hvad der blev observeret hos voksne, der fik 180 mikrogram som dosering.
English: Needle-shield (only visible once cap is removed in Step 5)
Danish: Kanylebeskyttelse (kun synlig, når hætten bliver fjernet i trin 5)
English: 1) Visually check the pre-filled pen
Danish: 1) Undersøg den fyldte pen visuelt
English: Hold the pre-filled pen comfortably in your hand.
Danish: Hold den fyldte pen i hånden.
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Danish: Hvis du samtidig får ribavirin, vær da særlig opmærksom på de respektive indlægssedler for lægemidler, der indeholder ribavirin.
English: Pegasys injection is normally taken at bedtime.
Danish: Pegasys injektion gives normalt ved sengetid.
English: Response Parameter
Danish: Responsparameter
English: 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.
Danish: 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.
English: Clean the area using the alcohol pad and put the pad aside to wipe the site again after injection, if necessary.
Danish: Rens området med spritservietten og læg spritservietten til side, så du kan tørre området igen efter injektionen, hvis det er nødvendigt.
English: ● Do not touch the tip of the pre-filled pen, since needlestick injuries may occur.
Danish: ●Du må ikke røre spidsen på den fyldte pen, idet stikuheld kan forekomme.
English: If you see any bubbles, pull the plunger slightly back.
Danish: Hvis du bemærker luftbobler, skal du langsomt trække stemplet tilbage.
English: 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.
Danish: 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.
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with CHC treated with interferon.
Danish: Tilfælde af Vogt-Koyanagi-Harada (VKH)-syndrom har været rapporteret hos patienter med kronisk hepatitis C, som har været behandlet med interferon.
English: Duration of therapy when Pegasys is used in combination with other medicinal products
Danish: Behandlingsvarighed, når Pegasys gives i kombination med andre lægemidler
English: HBV-DNA was measured by the COBAS AMPLICOR HBV
Danish: HBV-DNA blev målt med COBAS AMPLICOR
English: Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Danish: Tabel 11: Ydeevne for individuelle biomarkører i behandlingsuge 12 hos CHB HBeAg-positive og HBeAg-negative patienter ud fra genotype
English: The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Danish: Den ribavirindosis, som skal anvendes i kombination med Pegasys fremgår af tabel 1.
English: Serious infections (bacterial, viral, fungal) and sepsis have been reported during treatment with alfa interferons including Pegasys.
Danish: Der er blevet rapporteret alvorlige infektioner (bakterielle, virale og fungale) og sepsis under behandlingen med interferon alfa herunder Pegasys.
English: Metabolic disorders: Loss of appetite
Danish: Metabolisme: Appetitløshed
English: 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).
Danish: 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).
English: ● use if pre-filled pen appears to be damaged.
Danish: ● bruge den fyldte pen, hvis den ser ud til være beskadiget.
English: HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Danish: HBeAg Sero-konversion HBV DNA < 20,000 IE/ml* HBV DNA < 2,000 IE/ml ALAT Normalisering HBsAg Sero-konversion Tab af HBsAg
English: Ribavirin daily dose (Approx. 15 mg/kg/day)
Danish: Daglig dosis af ribavirin (Ca. 15 mg/kg/dag)
English: 8) Dispose of pre-filled pen
Danish: 8) Bortskaf den fyldte pen
English: 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.
Danish: 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.
English: 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
Danish: 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
English: For adults, dose reduction is recommended if the absolute neutrophil count (ANC) is 500 to < 750 cells/mm3.
Danish: Det anbefales at nedsætte dosis hos voksne, hvis det absolutte neutrofilocyttal (ANC) er 500 til <750 celler/mm3.
English: Study NV17317
Danish: Studie NV17317
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Danish: Faldet i CD4+ celletal var reversibelt efter reduktion af dosis eller efter behandlingsophør.
English: In paediatric patients, ribavirin treatment-associated toxicities, such as treatment-emergent anaemia, will be managed by reduction of the full dose.
Danish: Hos pædiatriske patienter vil toksicitet forbundet med ribavirinbehandling, såsom anæmi, som viser sig under behandlingen, blive hånderet med reduktion af den fulde dosis.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Progressive decreases after 8 weeks of therapy were infrequent.
Danish: Efter 8 ugers behandling var yderligere fald sjældent.
English: Suicide, psychotic disorder
Danish: Selvmord, psykiatrisk lidelse
English: Pegasys contains benzyl alcohol
Danish: Pegasys indeholder benzylalkohol
English: 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.
Danish: Gennemsnitseksponering (AUC) under doseringsinterval forventes at være 25 % til 70 % højere end det observeret hos voksne, som fik 180 mikrogram som fast dosering.
English: Please be sure to read the ribavirin package leaflet also.
Danish: Vær opmærksom på også at læse indlægssedlen for ribavirin.
English: Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SmPC).
Danish: Der skal derfor iagttages forsigtighed, når Pegasys og ribavirin gives som adjuvans til HAART-behandling (se produktresuméet for ribavirin).
English: Tap the syringe gently to bring the bubbles to the top.
Danish: Bank let på sprøjten for at få boblerne op til toppen.
English: In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
Danish: I studie WV16240 var primære endepunkter for effekt HBeAg-serokonversion og HBV-DNA under 105 kopier/ml.
English: • Neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.4 for benzyl alcohol)
Danish: • Nyfødte og børn op til 3 år, på grund af hjælpestoffet benzylalkohol (se pkt.
English: 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).
Danish: 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.
English: ● if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
Danish: ● hvis du får symptomer på forkølelse eller andre luftvejsinfektioner (som f.eks. hoste, feber eller åndenød).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Patienter inficeret med viral genotype 2 eller 3 skal behandles i 24 uger, mens patienter inficeret med andre genotyper skal behandles i 48 uger.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Response at End of Treatment
Danish: Respons ved afslutning af behandling
English: This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh.
Danish: Det betyder, at Pegasys injiceres med en kort kanyle i fedtvævet under huden på maven eller låret.
English: ● a vial of Pegasys solution for injection Not included in the pack:
Danish: ● et hætteglas med Pegasysopløsning til injektion Ikke indlagt i pakningen:
English: 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).
Danish: 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.
English: Chronic hepatitis C and HIV co-infection
Danish: Kronisk hepatitis C og hiv-co-infektion
English: 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).
Danish: 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).
English: 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.
Danish: Foreløbige og begrænsede sikkerhedsdata viste ingen tydelig afvigelse fra den kendte sikkerhedsprofil for kombinationen hos voksne med kronisk HCV-infektion.