natgillin/translations-raw huggingface dataset:
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).
Medens feber kan være del af det influenzalignede syndrom, som ofte rapporteres under behandling med interferon, skal andre årsager til vedvarende feber udelukkes, specielt alvorlige infektioner (bakterielle, virale og fungale), især hos patienter med neutropeni. 
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever, particularly serious infections (bacterial, viral, fungal) must be ruled out, especially in patients with neutropenia.
• Vælg et injektionssted på maven eller låret (bortset fra navlen eller taljen). 
● Select the injection site in the abdomen or thigh (except your navel or waistline).
Pegasys anvendes til behandling af kronisk hepatitis B eller kronisk hepatitis C hos voksne. 
Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
HCV-inficerede patienter, der samtidigt har et stofmisbrug (alkohol, cannabis, osv.), har en øget risiko for at udvikle psykiatriske sygdomme eller forværring af allerede eksisterende psykiatriske sygdomme under behandling med interferon alfa. 
Patients with substance use/abuse: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alfa interferon.
TSH-niveauet skal kontrolleres under behandlingen, hvis en patient får kliniske symptomer på en mulig dysfunktion af thyroidea (se pkt. 
TSH levels should be determined during the course of therapy if a patient develops clinical symptoms consistent with possible thyroid dysfunction (see section 4.8).
Der skal udvises forsigtighed, hvis Pegasys kombineres med andre potentielt myelosuppresive stoffer. 
Caution should be exercised when administering Pegasys in combination with other potentially myelosuppressive agents.
• Fjern beskyttelseshætten fra kanylen uden at røre ved kanylen og behold sprøjten med kanylen i hånden. 
● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Der er rapporteret om fatal leversvigt samt perifer neuropati, pancreatitis og symptomatisk hyperlaktæmi/mælkesyreacidose under anvendelse af ribavirin. 
Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
• Hold hætteglas og sprøjte i den ene hånd og vend hætteglasset opad og sprøjten nedad (4). 
● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
Anafylaksi, systemisk lupus erytematosus, rheumatoid arthritis 
Anaphylaxis, systemic lupus erythematosu s rheumatoid arthritis
Hos mennesker er den systemiske clearance af peginterferon alfa-2a ca. 100 gange lavere end clearance for nativ interferon alfa-2a. 
In humans, the systemic clearance of peginterferon alfa-2a is about 100-fold lower than that of the native interferon alfa-2a.
Der er ingen eller utilstrækkelige data om brugen af peginterferon alfa-2a til gravide kvinder. 
There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women.
Tabel 10: Bivirkninger rapporteret blandt pædiatriske patienter inficeret med HCV, som fik Pegasys plus ribavirin i studie NV17424 
Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Hypoglykæmi, hyperglykæmi og diabetes mellitus er observeret med Pegasys (se pkt. 
Hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Patienter, som ikke havde HCV-RNA-resultater ved uge 12, blev eksluderet fra analysen. 
Patients missing HCV RNA results at week 12 have been excluded from the analysis.
Der henvises til produktresuméerne for de retrovirale lægemidler, som skal gives samtidig med HCVbehandling vedrørende opmærksomhed på og håndtering af toksicitet specifikt for hvert produkt samt for potentielt overlap af toksicitet med Pegasys med eller uden ribavirin. 
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
Patienter med tegn og symptomer som svarer til autoimmune lidelser skal undersøges omhyggeligt, og fordele og ulemper ved fortsat behandling skal genvurderes (se også Det endokrine system i pkt. 
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be re-assessed (see also Endocrine system in sections 4.4 and 4.8).
Influenza-lignende sygdom, reaktion på injektionsstedet, irritabilitet, træthed 
Influenza-like illness, injection site reaction, irritability, fatigue
Bronkitis, øvre luftvejsinfektioner, oral candidiasis, herpes simplex, svampeinfektioner, virale og bakterielle infektioner 
Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Pegasys indeholder 
What Pegasys contains
Hvis du har taget for meget Pegasys Kontakt din læge eller apotekspersonalet så hurtigt som muligt. 
If you use more Pegasys than you should Contact your doctor or pharmacist as soon as possible.
På grund af risikoen for bivirkninger hos børn, som ammes, skal amning afbrydes før behandlingen påbegyndes. 
Because of the potential for adverse reactions in breastfed infants, breastfeeding should be discontinued prior to initiation of treatment.
Pegasys' farmakokinetik er karakteriseret hos pædiatriske patienter med kronisk hepatitis B (YV25718), så vel hos pædiatriske patienter med kronisk hepatitis C (NR16141), ud fra populations farmakokinetik. 
Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.
Den forventede behandlingsfordel bør i hvert enkelt tilfælde opvejes nøje imod de sikkerhedsmæssige fund, der er observeret hos børn og unge i de kliniske studier (se pkt. 
The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1).
Den anbefalede dosis og behandlingsvarighed af Pegasys til såvel HBeAg-positiv og HBeAg-negativ kronisk hepatitis B er 180 mikrogram én gang ugentlig i 48 uger. 
The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative CHB is 180 micrograms once weekly for 48 weeks.
Denne myelotoksicitet var reversibel inden for 4 til 6 uger efter ophør af HCV-antiviral-behandling sammen med azathioprin og opstod ikke igen ved genoptagelse af behandlingerne hver for sig (se pkt. 
This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon re-introduction of either treatment alone (see section
2) Lad den fyldte pen tilpasse sig til stuetemperatur 
2) Allow the pre-filled pen to adjust to room temperature
Ribavirin skal gives sammen med mad. 
The ribavirin dose should be administered with food.
Sværhedsgraden af de hyppigst rapporterede bivirkninger efter 180 mikrogram Pegasys var for det meste mild til moderat, og bivirkningerne kunne behandles uden behov for justering af dosis eller seponering af behandlingen. 
The most frequently reported adverse reactions with Pegasys 180 micrograms were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Interferon alfa-2b 3 MIE Ribavirin mg (N=444) 48 uger 
Interferon alfa-2b 3 MIU Ribavirin mg (N=444) 48 weeks
Pegasys 360/180 eller 180 mikrogram 
Pegasys 360/180 or 180 mcg
Hiv-HCV-co-infektion 
HIV-HCV co-infection
Fald i hæmoglobin, neutrofilocytter, blodplader eller øget ALAT-niveauer kan kræve dosisreduktion eller permanent seponering af behandling (se pkt. 
Decreases in haemoglobin, neutrophils, platelets or increased ALT may require dose reduction or permanent discontinuation from treatment (see section 4.2).
For vedvarende ALAT-værdier ≥10 x øvre referencegrænse: seponer behandling. 
For persistent ALT values ≥10 x ULN discontinue treatment.
Der er begrænset erfaring med Pegasys til behandling af pædiatriske patienter med kronisk hepatitis C i alderen 3 til 5 år, eller som har en tidligere fejlslagen behandling. 
There is limited experience with Pegasys in treating paediatric patients with CHC aged 3 to 5 years, or who have failed to be adequately treated previously.
Behandling med Pegasys blev ledsaget af klinisk signifikante abnormiteter i thyreoidealaboratorieværdier, som krævede klinisk intervention (se pkt. 
Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
I henhold til studier på rotter om massebalance, vævsdistribution og helkropsautoradioluminografi fordeles peginterferon alfa-2a, udover at opkoncentreres i blodet, til lever, nyrer og knoglemarv. 
From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, peginterferon alfa-2a is distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Brug af Pegasys hos børn og unge, som har eller tidligere har haft en svær psykiatrisk tilstand er kontraindiceret (se pkt. 
The use of Pegasys in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Findes i en pakning med 1, 4 eller en multipakning med 12 (2 pakker med 6) fyldte injektionssprøjter. 
Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Blod: Aplastisk anæmi (svigt i knoglemarvens produktion af røde blodceller, hvide blodceller og blodplader). 
Blood disorders: Aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets)
Det anbefales, at Pegasys forfyldte injektionssprøjter anvendes til pædiatriske patienter. 
It is recommended that Pegasys pre-filled syringes be used for paediatric patients.
Forbered sprøjten og kanylen til injektion 
Preparing the syringe and needle for injection
Patienternes vægt sammenlignet med alder og højde sammenlignet med alder-percentiler i forhold til den normative population faldt under behandlingen. 
Patient ‘weight for age' and ‘height for age' percentiles of the normative population decreased during treatment.
Det skal du vide, før du begynder at tage Pegasys 
What you need to know before you use Pegasys
Efter en enkelt subkutan injektion af 180 mikrogram hos forsøgspersoner over 62 år var absorptionen af Pegasys forsinket, men stadig forlænget, sammenlignet med unge raske forsøgspersoner (Tmax på 115 timer versus 82 timer hos ældre over 62 år versus yngre). 
In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs. 82 hours, older than 62 years vs. younger, respectively).
Patienter, der udvikler disse tilstande under behandlingen, og som ikke kan kontrolleres med medicinering, bør afbryde behandlingen med Pegasys eller Pegasys/ribavirin. 
Patients who develop these conditions during treatment and cannot be controlled with medication should discontinue Pegasys or Pegasys/ribavirin therapy.
Den absolutte biotilgængelighed af Pegasys er 84 %, og den svarer til biotilgængeligheden hos interferon alfa-2a. 
The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Voksne patienter med kronisk hepatitis C, som ikke har responderet på tidligere behandling I studie MV17150 blev patienter, som ikke havde responderet på tidligere behandling med pegyleret interferon alfa-2b plus ribavirin, randomiseret til 4 forskellige behandlinger: 
Adult chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
Overordnet svarede sikkerhedsprofilen for Pegasys i kombination med ribavirin hos tidligere ikkeresponderende patienter til den hos naive patienter. 
Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
Deraf var 51 % piger, 82 % var kaukasiske og 82 % var inficeret med HCV-genotype 1. 
A total of 55 patients received initial combination treatment of Pegasys plus ribavirin, of whom 51% were female, 82% were Caucasian, and 82% were infected with HCV genotype 1.
Vask hænderne grundigt, før du foretager dig yderligere. 
Wash your hands carefully before handling any of the items.
Tal med sundhedspersonalet, hvis du har spørgsmål. 
Ask your healthcare provider any questions you may have.
Hvis Pegasys anvendes som eneste præparat hos patienter med hepatitis B eller C forekommer nogle af disse bivirkninger sjældnere. 
When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur.
Cochran-Mantel-Haenszel test, stratificeret af genotype (A versus ikke-A) og baseline ALAT (<5x øvre referencegrænse og ≥5x øvre referencegrænse) 
1 Cochran-Mantel-Haenszel test, stratified by genotype (A vs. non-A) and baseline ALT (< 5 × ULN and >= 5 × ULN) 2 Fisher's Exact Test
Pegasys er ikke undersøgt hos patienter med dekompenseret cirrose (f.eks. Child Pugh B/C eller blødende øsofagusvaricer (se pkt. 
Pegasys has not been evaluated in patients with decompensated cirrhosis (e.g., Child-Pugh B or C or bleeding oesophageal varices) (see section 4.3).
Aktiveringsknap 
Activation button
Behandling med Pegasys blev ledsaget af abnorme laboratorieværdier: ALAT-stigninger, stigning i bilirubin, elektrolytforstyrrelser (hypokaliæmi, hypocalcæmi, hypofosfatæmi), hyperglykæmi, hypoglykæmi og forhøjede triglycerider (se pkt. 
Pegasys treatment was associated with abnormal laboratory values: ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Justering af dosis på grund af bivirkninger hos voksne patienter 
Dose adjustment for adverse reactions in adult patients
Andre symptomer fra centralnervesystemet omfattende aggressiv adfærd (nogle gange rettet mod andre såsom drabstanker), bipolære affektive sindslidelser, mani, konfusion og psykiske ændringer er observeret ved interferon alfa. 
Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alfa interferons.
Det anbefales at nedsætte dosis til 90 mikrogram, hvis trombocyttallet er 25.000 til <50.000 celler/mm3. 
Dose reduction to 90 micrograms is recommended if the platelet count is 25,000 to < 50,000 cells/mm3.
Tag ikke Pegasys 
Do not use Pegasys
● hvis du udvikler symptomer på Vogt-Koyanagi-Haradas syndrom: kombination af symptomer i form af stivhed i nakken, hovedpine, tab af farve i hud eller hår, øjenforstyrrelse (såsom uklart syn) og/eller problemer med hørelsen (såsom ringen for ørerne). 
● if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).
Et trins dosisjustering (Ca. 7,5 mg/kg/dag) 
One step dose modification (Approx. 7.5 mg/kg/day)
På nuværende tidspunkt vides det ikke, om en højere dosis af ribavirin (f.eks. 1.000/1.200 mg/dag baseret på kropsvægt) resulterer i højere vedvarende virologiske responsrater (SVR) end 800 mg/dag, når behandlingen er afkortet til 16 uger. 
It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Hos hiv-HCV-co-inficerede patienter var profilen af indberettede kliniske bivirkninger for Pegasys, alene eller i kombination med ribavirin, tilsvarende profilen hos HCV-monoinficerede patienter. 
In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients.
Når din behandling med Pegasys er påbegyndt, skal du kontakte lægen, sundhedspersonalet eller apotekspersonalet: 
Once you have started Pegasys treatment, talk to your doctor, nurse or pharmacist:
Laboratorieværdier hos hiv-HCV-co-inficerede patienter Selvom hæmatologisk toksicitet som neutropeni, trombocytopeni og anæmi indtraf hyppigere hos hivHCV-patienter, kunne størstedelen af tilfældene af hæmatologisk toksicitet håndteres ved hjælp af dosismodifikation og anvendelse af vækstfaktorer. 
Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Pegasys fyldt pen 
Pegasys pre-filled pen
Pegasys er i kombination med ribavirin indiceret til behandling af kronisk hepatitis C hos behandlingsnaive børn og unge 5 år og ældre, som er positive for serum-HCV-RNA. 
Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
Den anbefalede behandlingsvarighed er 48 uger for patienter med kronisk hepatitis B. Inden behandling af kronisk hepatitis B påbegyndes, skal vedvarende forhøjede serum ALATniveauer være dokumenteret. 
The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented.
Tabel 12: Serologisk, virologisk og biokemisk respons ved kronisk hepatitis B HBeAg-positiv Studie WV16240 
Table 12: Serological, virological and biochemical responses in chronic hepatitis B HBeAg positive Study WV16240
Svære bivirkninger blev rapporteret hos 2 patienter i gruppen, som fik Pegasys plus ribavirin kombinationsbehandling (hyperglykæmi og kolecystektomi). 
Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
Hypertension Hjerneblødning, vasculitis 
Flushing Hypertension Cerebral haemorrhage, vasculitis
Risikoen for væksthæmning skal vejes op imod barnets sygdomskarakteristika, såsom evidens for sygdomsprogression (især fibrose), co-morbiditeter, som kan påvirke sygdomsprogression negativt (såsom hiv-co-infektion), såvel som prognostiske faktorer på responset(for HBVinfektion primært HBV genotype og ALAT-niveauer; for HCV-infektion primært HCV genotype og HCV-RNA-niveauer ) (se pkt. 
The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Genotype 2 eller 3 RVR 
Genotype 2 or 3 RVR
Efter en enkelt subkutan injektion med Pegasys 180 mikrogram til raske forsøgspersoner opnås der målelige serumkoncentrationer af peginterferon alfa-2a i løbet af 3 til 6 timer. 
Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours.
Patienter, som får azathioprin i kombination med ribavirin og peginterferon, har øget risiko for at udvikle alvorlige blodsygdomme. 
Patients receiving azathioprin in combination with ribavirin and peginterferon are at increased risk of developing severe blood disorders.
Følgende værdier kan anses som baselineværdier ved påbegyndelsen af behandlingen: - Trombocyttal ≥90.000 celler/mm3 - Absolut neutrofilocyttal (ANC) ≥1.500 celler/mm3 
The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3
Dosisjustering hos pædiatriske patienter - kombinationsbehandling med Pegasys og ribavirin 
Dose adjustement in paediatric patients - dual therapy with Pegasys and ribavirin