natgillin/translations-raw huggingface dataset:
Ved kombinationsbehandling i op til 48 uger med PegIntron og ribavirin blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt. 
During combination therapy for up to 48 weeks with PegIntron and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Tag ikke PegIntron 
Do not use PegIntron
• Læg den fyldte pen på en plan, ren overflade og vent, til den får stuetemperatur (men ikke over 
• Lay the pre-filled pen on a flat clean surface and wait until it reaches room temperature (but not more than 25
NR: Ikke-responderende defineres som serum/plasma-hcv-RNA-positive ved afslutning af mindst 12 ugers behandling. 
NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Flerdosis farmakokinetiske egenskaber for PegIntron og ribavirin (kapsler og oral opløsning) hos børn og unge patienter med kronisk hepatitis C er blevet evalueret i et klinisk forsøg. 
Multiple-dose pharmacokinetic properties for PegIntron and ribavirin (capsules and oral solution) in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
PegIntron 1,5 mikrogram/kg/uge i kombination med ribavirin kapsler. 
PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Tabel 8 Vedvarende virologisk respons (% patienter hcv-negative) PegIntron monoterapi 
Table 8 Sustained virological response (% patients HCV negative) PegIntron monotherapy
Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med PegIntron i monoterapi var 98 %. 
The negative predictive value for sustained response in patients treated with PegIntron in monotherapy was 98 %.
På grund af meddelelser om at interferon alfa kan forværre tilstedeværende psoriasissygdom og sarkoidose, kan brug af PegIntron til patienter med psoriasis eller sarkoidose kun anbefales, hvis den potentielle gavnlige effekt retfærdiggør den mulige risiko. 
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
PegIntron monoterapi blev ikke undersøgt i hcv/hiv co-inficerede patienter. 
PegIntron monotherapy was not studied in HCV/HIV co-infected patients.
Resultater fra ældre patienter behandlet med en enkelt dosis PegIntron tyder på, at ingen ændring i PegIntron dosis er nødvendig på basis af alder (se pkt. 
Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Når patienterne får PegIntron sammen med medicin, der metaboliseres af CYP1A2 eller CYP2D6, er det ikke sandsynligt, at faldet i CYP-aktivitet har klinisk indvirkning, undtagen med medicin, der har en snæver terapeutisk margin (Tabel 5). 
When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin (Table 5).
Retningslinjer for dosisjustering hos voksne patienter, som anvender PegIntron monoterapi, fremgår af Tabel 3a. 
Dose modification guidelines for adult patients who use PegIntron monotherapy are shown in Table 3a.
• Indfør kanylen i ampullen med solvens og træk hele mængden af solvens op. 
- Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
• Bank let på toppen af ampullen med solvens for at sikre, at al væsken er i bunden af ampullen. 
- Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Efter enkeltdoser af PegIntron mellem 0,25 og 2,0 mikrogram/kg/uge, blev serum neopterin-koncentrationen øget på en dosisafhængig måde. 
Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
a: p værdi baseret på Cochran-Mantel Haenszel Chi square test. b: P-værdi baseret på chi-square test. c: forsøgspersoner < 75 kg fik 100 µg/uge PegIntron og forsøgspersoner ≥ 75 kg fik 150 µg/uge PegIntron. 
a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week PegIntron and subjects ≥ 75 kg received 150 µg/week PegIntron.
Der sås ingen klinisk signifikant farmakokinetisk interaktion mellem peginterferon alfa-2b (PegIntron) og tolbutamid, midazolam eller dapson; dosisjustering er derfor ikke nødvendig, når peginterferon alfa-2b (PegIntron) administreres sammen med lægemidler, der metaboliseres af CYP2C9, CYP3A4 og N-acetyltransferase. 
A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (PegIntron) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Der er ingen påviselige aldersrelaterede virkninger på farmakokinetikken for PegIntron. 
There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Forsigtighed bør udvises, når PegIntron og ribavirin adderes til HAART terapi (se ribavirin SPC). 
Caution should be used when adding PegIntron and ribavirin to HAART therapy (see ribavirin SmPC).
PegIntron bør anvendes med forsigtighed hos patienter med moderat til kraftig nedsættelse af nyrefunktionen. 
PegIntron should be used with caution in patients with moderate to severe renal impairment.
Hvis psykiatriske symptomer vedvarer eller forværres, eller hvis selvmords- eller drabstanker identificeres, anbefales det, at PegIntron seponeres, og at patienten følges med passende psykiatrisk intervention. 
If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Ved PegIntron 1,5 μg/kg plus ribavirin-dosen, var den vedvarende virologiske responsrate lavere hos patienter med cirrose, end patienter med normal ALAT-værdi, hos patienter med en baseline virusbelastning > 600.000 IE/ml, og hos patienter > 40 år. 
At the PegIntron 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Træthed, alopeci, kløe, kvalme, anoreksi, vægttab, irritabilitet og søvnløshed forekommer i en bemærkelsesværdig lavere frekvens hos patienter behandlet med PegIntron monoterapi sammenlignet med dem, der behandledes med kombinationsbehandling (se Tabel 6). 
Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron monotherapy compared to those treated with combination therapy (see Table 6).
PegIntron bør indgives som en ugentlig subkutan injektion. 
PegIntron should be administered as a once weekly subcutaneous injection.
Der er udført to forsøg hos patienter med samtidig infektion af hcv og hiv. 
Two trials have been conducted in patients co-infected with HIV and HCV.
PegIntron-monoterapi - Voksne 
PegIntron monotherapy - Adults
Inden initiering af PegIntron-behandling skal TSH-niveauet evalueres, og mulige thyroideaabnormaliteter detekteret på dette tidspunkt skal behandles med konventionel behandling. 
Prior to initiation of PegIntron therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Den 6 måneders behandlingsvarighed i dette forsøg blev tolereret bedre end et års behandling i det grundlæggende kombinationsforsøg; seponering hos 5 % versus 14 %, dosisjustering hos 18 % versus 
The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
5.1) blev der set et fald i absolut neutrofil-tal til under 500 celler/mm 
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm 3 was observed in 4 %
I dette forsøg var kombinationen af PegIntron (1,5 mikrogram/kg/uge) og ribavirin signifikant mere effektivt end kombinationen af interferon alfa-2b og ribavirin (Tabel 8), især hos patienter inficeret med genotype 1 (Tabel 9). 
In this trial, the combination of PegIntron (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
In vitro og in vivo forsøg tyder på, at den biologiske aktivitet af PegIntron stammer fra dets interferon alfa2b-del. 
In vitro and in vivo studies suggest that the biological activity of PegIntron is derived from its interferon alfa-2b moiety.
I et klinisk forsøg med 107 børn og unge patienter (3 til 17 år), behandlet med PegIntron og ribavirin som kombinationbehandling, var dosisændring nødvendig hos 25 % af patienterne, hyppigst på grund af anæmi, neutropeni og vægttab. 
In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of PegIntron and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
- Hvis du også behandles for hiv (se afsnittet ”Brug af anden medicin sammen med PegIntron”). 
- If you are also being treated for HIV (see section “Other medicines and PegIntron”).
Enhver patient, der får feber, hoste, dyspnø eller andre luftvejssymptomer, skal have taget thorax-røntgen. 
Any patient developing pyrexia, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Kontusion klasseeffekt for lægemidler som indeholder interferon-alfa - rapporteret ved standard interferon-behandling af voksne og pædiatriske patienter; med PegIntron er det rapporteret for voksne patienter. 
Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with PegIntron reported in adult patients.
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af PegIntron og ribavirin. 
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of PegIntron and ribavirin.
PegIntron hætteglas er kun til engangsbrug. 
PegIntron vials are for single use only.
Populationen, der var tilmeldt, bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data for børn med svær progression af sygdommen, og potentialet for uønskede virkninger, skal fordel/risiko for kombinationen af PegIntron og ribavirin nøje overvejes i denne population (se pkt. 
The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of PegIntron with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Vigtige behandlingsrelaterede bivirkninger, som opstod hos denne patientpopulation, var nervøsitet (8 %), aggression (3 %), vrede (2%), depression / trykket stemning (4 %) og hypotyroidisme (3 %); 5 forsøgspersoner fik levothyroxin-behandling for hypotyroidisme / forhøjet TSH. 
Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Patienter inficeret med genotype 4 betragtes generelt som sværere at behandle, og begrænsede undersøgelsesresultater (n=66) tyder på, at de er forenelige med en behandlingsvarighed med 2stofsbehandling som for genotype 1. 
In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment with bitherapy as for genotype 1.
Som ved alle parenterale lægemidler skal den tilberedte opløsning inspiceres visuelt før indgift. 
As for all parenteral medicinal products, the reconstituted solution is to be inspected visually prior to administration.
Den anbefalede dosis for PegIntron er 60 µg/m2/uge subkutant i kombination med 15 mg/kg/dag ribavirin oralt fordelt på to doser sammen med et måltid (morgen og aften). 
The recommended dose of PegIntron is 60 g/m2/week subcutaneously in combination with ribavirin 15 mg/kg/day orally in two divided doses with food (morning and evening).
Der sås ingen farmakokinetiske interaktioner mellem PegIntron og ribavirin i en flerdosis farmakokinetisk undersøgelse. 
No pharmacokinetic interactions were noted between PegIntron and ribavirin in a multiple-dose pharmacokinetic study.
Omtrent 21 % af børn behandlet med kombinationsbehandling med PegIntron/ribavirin fik øget thyroideastimulerende hormon (TSH). 
Approximately 21 % of children treated with PegIntron/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
I PegIntron monoterapiforsøget var livskvaliteten generelt mindre påvirket ved 0,5 mikrogram/kg PegIntron end ved enten 1,0 mikrogram/kg PegIntron en gang om ugen eller 3 MIE interferon alfa-2b tre gange om ugen. 
In the PegIntron monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of PegIntron than by either 1.0 microgram/kg of PegIntron once weekly or 3 MIU of interferon alfa-2b three times a week.
Dosisreduktion af PegIntron hos voksne kan ske ved at reducere det ordinerede volumen eller ved at bruge en lavere styrke, som anført i Tabel 2b. 
Dose reduction of PegIntron in adults may be accomplished by reducing the prescribed volume or by utilizing a lower dose strength as shown in Table 2b.
Den rekonstituerede opløsning bør være klar og farveløs. 
The reconstituted solution should be clear and colourless.
Analyser af interferonneutraliserende faktor blev udført på serum-prøver fra patienter, som fik PegIntron i det kliniske forsøg. 
Interferon neutralising factor assays were performed on serum samples of patients who received PegIntron in the clinical trial.
Seponer PegIntron, hvis: 
Discontinue PegIntron if:
Hos patienter med afroamerikansk oprindelse (som er kendt for at være en dårlig prognostisk faktor for hcv-udryddelse), medførte en behandling med PegIntron (1,5 μg/kg)/ribavirin kombinationsbehandling højere vedvarende virologisk responsrate sammenlignet med PegIntron 1 μg/kg dosis. 
In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with PegIntron (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to PegIntron 1 µg/kg dose.
For patienter i PegIntron monoterapi: Der henvises til afsnittet om retningslinjer for dosisreduktion ved monoterapi. 
For patients on PegIntron monotherapy: refer to monotherapy dose reduction guidelines section for dose reduction.
Psykiatriske sygdomme og sygdomme i centralnervesystemet (CNS) Alvorlig CNS-påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under PegIntron-behandling, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden. 
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
• Tilsæt LANGSOMT solvens, ved at rette væskestrømmen mod glasvæggen i hætteglasset. 
- Inject the solvent SLOWLY, aiming the stream of liquid at the glass wall of the vial.
Reduktionen i antallet af neutrofiler og leukocytter ved slutningen af uge 4 korrelerede til dosis af PegIntron. 
Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of PegIntron.
Kun 5 børn og unge med Genotype 4 blev behandlet i kliniske forsøg med PegIntron/ribavirin. 
Only 5 children and adolescents with Genotype 4 were treated in the PegIntron/ribavirin clinical trial.
I en enkeltdosisforsøg (1,0 mikrogram/kg) hos patienter med nedsat nyrefunktion, steg Cmax, AUC og halveringstiden i forhold til graden af nyrefunktionsforringelsen. 
In a single dose study (1.0 microgram/kg) in patients with impaired renal function, Cmax, AUC, and half-life increased in relation to the degree of renal impairment.
Ved udgangen af 24 ugers opfølgningen efter behandling var den gennemsnitlige reduktion fra baseline i vægt og højde percentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene fortsatte med at have hæmmet vækst (væksthastighed < 3. percentil). 
At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still of 3 percentiles and 7 percentiles respectively, and 20 % of the children continued to have inhibited growth (growth velocity < 3
Kombination af PegIntron og telbivudin er derfor kontraindiceret (se pkt. 
Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Renal elimination kan imidlertid forklare en mindre del (cirka 30 %) af den tilsyneladende clearance af PegIntron. 
However, renal elimination may account for a minority (approximately 30 %) of PegIntron apparent clearance.
Begrænsede sikkerhedsdata er tilgængelige (N = 25) hos coinficerede patienter med CD4+-celletællinger < 200/μl (se pkt. 
Limited safety data (N= 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
• er smittet med både humant immundefekt-virus (hiv-positiv) og hepatitis C-virus (hcv), og bliver behandlet med et anti-hiv lægemiddel - [nukleosid revers transkriptasehæmmer (NRTI) og/eller høj-aktiv anti-retroviral terapi (HAART)]. 
- are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C Virus (HCV) and are being treated with an anti-HIV medicine(s) - [nucleoside reverse transcriptase inhibitor (NRTI), and/or highly active anti-retroviral therapy (HAART)].
Detaljerede vejledninger for subkutan anvendelse er angivet i slutningen af denne indlægsseddel (se pkt ”Hvordan du selv indsprøjter PegIntron”). 
Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject PegIntron”).
I et klinisk forsøg rapporterede cirka 1,2 % af patienter behandlet med PegIntron eller interferon alfa2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling. 
In a clinical trial, approximately 1.2 % of patients treated with PegIntron or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Forsøg med andre interferoner har vist artsspecificitet. 
Studies with other interferons have demonstrated species specificity.
3-stofsbehandling (PegIntron med ribavirin og boceprevir): Kan anvendes til voksne patienter med genotype 1-CHC. 
Tritherapy (PegIntron with ribavirin and boceprevir): applies to adult patients with genotype 1 CHC.
Sikkerheden og effekten af PegIntron alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever- eller andre organtransplanterede er ikke blevet undersøgt. 
The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Responsraterne i dette forsøg blev imidlertid vist også at være afhængige af dosis af ribavirin indgivet i kombination med PegIntron eller interferon alfa-2b. 
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with PegIntron or interferon alfa-2b.
Hæmatologiske anomalier blev rapporteret mere hyppigt hos patienter, der modtog PegIntron i kombination med ribavirin end hos patienter, der modtog interferon alfa-2b i kombination med ribavirin. 
Haematological abnormalities were more frequently reported in patients receiving PegIntron in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Vigtige oplysninger om visse af indholdsstofferne i PegIntron Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galaktose malabsorption eller sucrase-isomaltasemangel. 
Important information about some of the ingredients of PegIntron Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Der er ikke foretaget reproduktionsforsøg med PegIntron. 
Reproduction studies of PegIntron have not been performed.
I PegIntron kombinationsforsøget blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimer: - PegIntron (1,5 mikrogram/kg/uge) + ribavirin (800 mg/dag), (n = 511). 
In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: - PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511).
PegIntron har et potentiale for at depegylere til frit interferon alfa-2b. 
PegIntron has a potential to depegylate to free interferon alfa-2b.
På grund af betydelig variabilitet i interferons farmakokinetik fra person til person anbefales det, at patienter med stærkt nedsat nyrefunktion monitoreres omhyggeligt under behandling med PegIntron (se pkt. 
Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with PegIntron (see section 4.2)
Anden dosisreduktion til PegIntron 0,5 µg/kg 
Second dose reduction to PegIntron 0.5 µg/kg
Dosisjustering for alle patienter (monoterapi og kombinationsbehandling) Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med PegIntron monoterapi eller kombinationsbehandling, skal doserne af PegIntron og/eller ribavirin justeres efter behov, indtil bivirkningerne aftager. 
Dose modification for all patients (monotherapy and combination therapy) If severe adverse reactions or laboratory abnormalities develop during treatment with PegIntron monotherapy or combination therapy, the dosages of PegIntron and/or ribavirin must be modified as appropriate, until the adverse reactions abate.
Patienter med kreatininclearance < 50 ml/minut må ikke behandles med PegIntron i kombination med ribavirin (se ribavirin SPC). 
Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SmPC).
De hyppigste behandlingsrelaterede bivirkninger, der er rapporteret under kliniske undersøgelser med PegIntron i kombination med ribavirin hos voksne, og som er set hos mere end halvdelen af forsøgspersonerne, var træthed, hovedpine og reaktion på injektionsstedet. 
The most common treatment-related adverse reactions reported during clinical trials with PegIntron in combination with ribavirin in adults, seen in more than half of the study subjects, were fatigue, headache, and injection site reaction.
- I undergruppen af patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml), som bliver hcv-RNA-negative ved behandlingsuge 4, og som stadig er hcv-RNA-negative ved uge 24, kan behandlingen enten stoppes efter denne 24 ugers behandlingsperiode eller fortsættes i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode). 
- In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).