FrancophonIA/ELRC3.0 huggingface dataset:
English: When the increase in ALT levels is progressive and clinically significant, despite dose reduction, or is accompanied by increased direct bilirubin, therapy should be discontinued (see sections 4.2 and 4.8).
Danish: Hvis stigningerne af ALAT fortsat øges og er klinisk signifikante, trods reduktion af dosis, eller ledsages af stigninger i bilirubin, skal behandlingen stoppes (se pkt.
English: The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV coinfected patients are summarised below in Table 21.
Danish: Det virologiske respons for patienter behandlet med Pegasys monoterapi og med Pegasys og ribavirin kombinationsbehandling i relation til genotype og viral belastning ved baseline for hiv-HCV-coinficerede patienter er angivet i tabel 21.
English: Do not shake.
Danish: Ikke cirrose
English: The clinical significance of this finding is unknown; nonetheless, patients should be monitored for the signs and symptoms of methadone toxicity.
Danish: Patienterne bør alligevel kontrolleres for tegn og symptomer på methadontoksicitet.
English: Peptic ulcer, pancreatitis
Danish: Mavesår, pancreatitis
English: The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Danish: Den anbefalede dosis af Pegasys i kombination med ribavirin er 180 mikrogram én gang om ugen ved subkutan administration.
English: Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment.
Danish: Blodplader 25.000 til <50.000 celler/mm3: 2. niveau justering.
English: In CHC clinical trials with adult patients, isolated increases in ALT (≥ 10x upper limit of normal [ULN], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy.
Danish: I de kliniske studier med kronisk hepatitis C hos voksne patienter blev der hos 8 af 451 patienter, som fik kombinationsbehandling, set enkeltstående stigninger i ALAT (≥10 x øvre referencegrænse eller ≥2 x baseline hos patienter med baseline-ALAT ≥10 x øvre referencegrænse), som normaliseredes uden justering af dosis.
English: Chronic hepatitis C
Danish: Kronisk Hepatitis C
English: Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalization at 6 months posttreatment.
Danish: NPV= negativ prædiktiv værdi; Sensitivitet = % af alle responderende, der ikke opfyldte seponeringsanvisningen; Specificitet = % af alle ikke-responderende, der opfyldte seponeringsanvisningen (a) Behandlingsrespons hos HBeAg-positive patienter er defineret som HBeAg serokonversion (defineret som tab af HBeAg og tilstedeværelse af anti-HBe) + HBV-DNA < 2.000 IE/ml ved 6 måneder efter behandling, og behandlingsrespons hos HBeAg-negative patienter er defineret som HBV-DNA < 2.000 IE/ml + ALAT normalisering ved 6 måneder efter behandling.
English: The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 14 and Table 15, respectively.
Danish: Det virologiske respons hos HCV-monoinficerede patienter, som behandledes med Pegasys og ribavirin kombinationsterapi, baseret på genotype og viral belastning ved baseline samt i relation til genotype, viral belastning ved baseline og hurtig virologisk respons ved uge 4, er opsummeret i hhv. tabel 14 og 15.
English: Chronic hepatitis B - adult patients
Danish: Kronisk hepatitis B - voksne patienter
English: 180 micrograms/0.5 ml
Danish: 180 mikrogram/0,5 ml
English: Ribavirin 800 mg 16 weeks
Danish: Ribavirin 800 mg 16 uger
English: For children and adolescents 23 kg or greater, a dosing schedule using 200 mg ribavirin tablets is provided in Table 7.
Danish: Tabel 7 viser et doseringsskema til børn og unge, der vejer mindst 23 kg, hvor 200 mg ribavirin tabletter anvendes.
English: Coma, convulsions, facial palsy
Danish: konvulsioner, facialisparese
English: Neoplasms benign and malignant
Danish: Benigne og maligne tumorer
English: Vision blurred, eye pain, eye inflammation, xerophthalmia
Danish: Sløret syn, øjensmerter, øjenbetændelse, xerophthalmi
English: Treatment for only 16 weeks may be considered in selected patients infected with genotype 2 or 3 with LVL (≤ 800,000 IU/ml) at baseline who become HCV negative by week 4 of treatment and remains HCV negative by week 16.
Danish: Behandling i kun 16 uger kan overvejes hos udvalgte patienter, som er smittet med genotype 2 eller 3 med lav viral belastning (≤800.000 IE/ml) ved baseline, og som bliver HCV-negative ved uge 4 af behandling og forbliver HCV-negative ved uge 16.
English: Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Danish: Hver fyldte injektionssprøjte med 0,5 ml opløsning indeholder 90, 135 eller 180 mikrogram peginterferon alfa-2a.
English: Patients receiving zidovudine in combination with ribavirin and alfa interferons are at increased risk of developing anaemia.
Danish: Patienter, som får zidovudin i kombination med ribavirin og interferon alfa, har øget risiko for at udvikle blodmangel (anæmi).
English: HIV-HCV co-infected patients
Danish: Hiv-HCV-co-inficerede patienter
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Danish: Kombinationsbehandling med ribavirin og zidovudin anbefales ikke, idet der er en forhøjet risiko for udvikling af anæmi (se pkt.
English: Digestive system disorders: Gastrointestinal bleeding Liver disorders: Poor functioning of the liver
Danish: Fordøjelsessystemet: Blødning i mave-tarmkanalen Lever: Dårlig leverfunktion
English: INFORMATION IN BRAILLE pegasys 180 mcg
Danish: INFORMATION I BRAILLESKRIFT pegasys 180 mcg
English: Table 25: Sustained virological response in the NV17424 study Pegasys 180 mcg x BSA/1.73 m² + Ribavirin 15 mg/kg (N=55)*
Danish: Pegasys 180 mikrogram x legemsoverfladeareal/1,73 m² + ribavirin 15 mg/kg (N=55)*
English: Pegasys 180 mcg Ribavirin mg (N=436) 48 weeks
Danish: Pegasys mikrogram Ribavirin mg (N=436) 48 uger
English: Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Danish: Læs også indlægssedlerne for de lægemidler, som anvendes i kombination med Pegasys.
English: Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Danish: I dyreforsøg med interferon alfa-2a er der set reproduktionstoksicitet (se pkt.
English: Ribavirin 800 mg 48 weeks
Danish: Ribavirin 800 mg 48 uger
English: Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
Danish: Opkastning, dyspepsi, dysfagi, sår i munden, gingival blødning, glossitis, stomatitis, flatulens, mundtørhed
English: In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
Danish: I et farmakokinetisk studie fik 24 HCV-patienter methadon-vedligeholdelsesbehandling (mediandosis 95 mg; interval 30 mg til 150 mg) samtidig med Pegasys 180 mikrogram subkutant én gang om ugen i 4 uger.
English: Pegasys 180 mcg Ribavirin mg (N=453) 48 weeks
Danish: Pegasys mikrogram Ribavirin mg (N=453) 48 uger
English: Study YV25718 was conducted in previously untreated paediatric patients aged 3 to 17 years (51% < 12 years old) with HBeAg positive CHB and ALT > ULN but < 10 x ULN in two blood samples taken
Danish: YV25718 studiet blev gennemført i tidligere ubehandlede pædiatriske patienter i alderen 3 til 17 år (51% <12 år) med HBeAg-positiv kronisk hepatitis B og ALAT-værdier > øvre referencegrænse, men
English: Table 17: Sustained virological response overall and based on rapid viral response by week 4 for genotype 2 or 3 after Pegasys combination therapy with ribavirin in CHC patients
Danish: Tabel 17: Vedvarende virologisk respons totalt og baseret på hurtigt virologisk response ved uge 4 for genotype 2 eller 3 efter Pegasys kombinationsterapi med ribavirin hos kronisk hepatitis C patienter
English: HBeAg Seroconversion
Danish: HBeAg-serokonversion
English: Shortening the treatment duration in patients infected with genotype 2 or 3 with HVL (> 800,000 IU/ml) at baseline who become HCV negative by week 4 should be considered with more caution as this may significantly negatively impact the sustained virological response (see Table 1).
Danish: Afkortning af behandlingsvarigheden bør overvejes med yderligere forsigtighed hos patienter, som er smittet med genotype 2 eller 3 med høj viral belastning (>800.000 IE/ml) ved baseline, og som bliver HCV-negative ved uge 4, da dette kan have signifikant negativ indflydelse på det forhøjede virologiske respons (se tabel 1).
English: Ribavirin 1000/1200 mg 72 Weeks (N = 473) SVR in Pts with VR at Wk 12 b
Danish: Ribavirin 1.000/1.200 mg 72 uger (N=473) SVR hos patienter med VR ved uge 12 b
English: Genotype 2 or 3 without RVR**
Danish: Genotype 2 eller 3 uden RVR**
English: For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalization at Week 24 post treatment.
Danish: HBeAg-negative patienter med HBV-genotype D infektion, HBsAg > 20.000 IE/ml eller HBV-DNA > 6,5 log10 IE/ml i behandlingsuge 12 er forbundet med en høj sandsynlighed for ikke at opnå HBV
English: Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or - genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
Danish: Behandling i 24 uger bør overvejes hos patienter inficeret med - genotype 1 med lav viral belastning (≤800.000 IE/ml) ved baseline eller - genotype 4 som bliver HCV-RNA-negative ved uge 4 og forbliver negative ved uge 24.
English: In a clinical trial with 114 paediatric patients (5 to 17 years of age) treated with Pegasys alone or in combination with ribavirin (see section 5.1), dose modifications were required in approximately onethird of patients, most commonly for neutropenia and anaemia.
Danish: I et klinisk studie med 114 pædiatriske patienter (5 til 17 år), som blev behandlet med Pegasys alene eller i kombination med ribavirin (se pkt.
English: From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
Danish: I studie NR16141 fik 14 børn i alderen 2 til 8 år med kronisk hepatitis C Pegasys-monoterapi med en dosis på180 mikrogram x barnets legemsoverfladeareal/1,73 m2.
English: Patients with moderate renal impairment receiving Pegasys 180 mcg once weekly exhibited similar peginterferon alfa-2a plasma exposures compared to patients with normal renal function.
Danish: Patienter med moderat nedsat nyrefunktion, der fik Pegasys 180 mikrogram én gang ugenlig havde sammenlignelig plasmakoncentrationer af peginterferon alfa-2a sammenlignet med patienter med normal nyrefunktion.
English: Headache, dizziness*, concentration impaired
Danish: Nervesystemet Hovedpine, svimmelhed*, koncentrationsbesvær
English: Table 15: Sustained virological response based on rapid viral response at week 4 for genotype 1 and 4 after Pegasys combination therapy with ribavirin in CHC patients
Danish: Tabel 15: Vedvarende virologisk respons baseret på hurtig virologisk respons ved uge 4 for genotype 1 og 4 efter Pegasys kombinationsbehandling med ribavirin hos kronisk hepatitis C patienter
English: Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
Danish: Ribavirin 1.000/1.200 mg 72 eller 48 uger (N=942) Patienter med VR ved uge 12 a
English: Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Danish: Lægen har fastsat den nøjagtige dosis Pegasys efter dine individuelle behov og lægen vil fortælle dig, hvor ofte du skal anvende det. Om nødvendigt, kan dosis blive ændret under behandlingen.
English: MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003
Danish: MARKEDSFØRINGSTILLADELSESNUMRE Pegasys 180 mikrogram injektionsvæske, opløsning EU/1/02/221/003
English: Ribavirin 1000/1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b
Danish: Ribavirin 1.000/1.200 mg 48 uger (N=469) SVR hos patienter med VR ved uge 12 b
English: Interferon alfa-2a 6 MIU/3 MIU
Danish: Interferon alfa-2a 6 MIE/3 MIE
English: Tachycardia, oedema peripheral, palpitations
Danish: Takykardi, perifere ødemer, hjertebanken
English: Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Danish: Pegasys 90 mikrogram injektionsvæske, opløsning i en fyldt injektionssprøjte Injektionssprøjten er mærket med gradueringer svarende til en dosis på 90 mikrogram, 65 mikrogram, 45 mikrogram, 30 mikrogram, 20 mikrogram og 10 mikrogram.
English: Grade 3-4*
Danish: Ingen, grad 1-2, grad 3-4*
English: Body Surface Area (BSA) range (m2)
Danish: Interval for legemsoverfladeareal (m2)
English: In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys 100 mcg/m2 sc once weekly and ribavirin 15 mg/kg/day for 24 weeks (genotypes 2 and 3) or 48 weeks
Danish: I det investigator-sponsorerede CHIPS-studie (Chronic Hepatitis C International Paediatric Study) blev 65 børn og unge (6-18 år) med kronisk HCV-infektion behandlet med Pegasys 100 mikrogram/m2
English: Thrombocyto penia, anaemia, lymphadenop athy
Danish: Trombocytopeni, anæmi, lymfadenopati
English: A subsequent study (NV18209) in patients co-infected with HCV genotype 1 and HIV compared treatment using Pegasys 180 mcg/week and either ribavirin 800 mg or 1000 mg (<75 kg)/1200 mg (≥75 kg) daily for 48 weeks.
Danish: Patienter, som var co-inficeret med HCV-genotype 1 og hiv, blev i et efterfølgende studie (NV18209) behandlet med Pegasys 180 mikrogram/uge sammen med enten ribavirin 800 mg eller 1.000 mg (<75 kg)/1.200 mg (≥75 kg) dagligt i 48 uger.
English: For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Danish: Hos hiv-HCV-patienter, som får kombinationsbehandling med Pegasys og ribavirin, er der rapporteret om andre bivirkninger hos mellem 1 % og 2 % af patienterne: hyperlaktacidæmi/mælkesyreacidose, influenza, pneumoni, affektlabilitet, apati, tinnitus, pharyngolaryngeale smerter, cheilitis, erhvervet lipodystrofi og chromaturi.
English: Hypothyroidis m, hyperthyroidi sm
Danish: Hypothyroidisme, hyperthyroidisme
English: Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentexperienced patients
Danish: Forudsigelighed af respons og non-respons ved Pegasys og ribavirin to-stofsbehandling - behandlingserfarne patienter
English: High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Danish: Høj viral belastning= >800.000 IE/ml, lav viral belastning= ≤800.000 IE/ml.
English: Ribavirin 800 mg 24 weeks
Danish: Ribavirin 800 mg 24 uger
English: Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).
Danish: Pegasys er i kombination med andre lægemidler indiceret til behandling af kronisk hepatitis C (CHC) hos patienter med kompenseret leversygdom (se pkt.
English: ● an adhesive bandage
Danish: ● hæfteplaster
English: Ribavirin 1000/1200 mg 48 weeks
Danish: Ribavirin 1.000/1.200 mg 48 uger
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Pegasys findes på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
Danish: Dosisbegrænsende toksicitet omfattede træthed, forhøjede leverenzymer, neutropeni og trombocytopeni, som også kan forventes med interferonbehandling.
English: ● Remove the needle guard from the syringe needle (5).
Danish: • Fjern beskyttelseshætten fra kanylen (5).
English: Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with Pegasys.
Danish: I sjældne tilfælde er der efter behandling med Pegasys rapporteret om retinopati, inklusive retinal hæmoragi, ekssudater, papilødem, optisk neuropati og obstruktion af arterier og vener i retina, som kan medføre synstab.
English: • Pegasys 180 mcg/week for 48 weeks
Danish: • Pegasys 180 mikrogram/uge i 48 uger.
English: Ribavirin 1000/1200 mg 24 weeks
Danish: Ribavirin 1.000/1.200 mg 24 uger
English: 1000 mg/day
Danish: 1.000 mg/dag
English: Each pre-filled pen of 0.5 ml solution contains
Danish: Hver fyldte pen med 0,5 ml opløsning indeholder 135 eller
English: In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Danish: Det er vist, at Pegasys er effektivt og sikkert hos patienter med kompenseret cirrose (f.eks. Child-Pugh A).
English: Common Uncommon Rare
Danish: Sjælden Meget sjælden
English: Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentnaïve patients
Danish: Forudsigelighed af respons og non-respons ved Pegasys og ribavirin to-stofsbehandling - behandlingsnaive patienter
English: Liver function
Danish: Leverdysfunktion
English: Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Danish: 88 % af de patienter, der blev behandlet med Pegasys oplevede uønskede hændelser sammenlignet med 53 % af patienterne i sammenligningsgruppen behandlet med lamivudin.
English: *These adverse reactions were common (≥1/100 to < 1/10) in CHB patients treated with Pegasys monotherapy § Class label for interferon products, see below Pulmonary arterial hypertension.
Danish: * Disse bivirkninger var almindelige (≥1/100 til <1/10) hos patienter med kronisk hepatitis B, der blev behandlet med
English: (N=444) 48 weeks
Danish: (N=444) 48 uger
English: For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%).
Danish: HBeAg-positive patienter med HBV-genotype B og C infektion, HBsAg > 20.000 IE/ml eller HBVDNA > 8 log10 IE/ml i behandlingsuge 12 er forbundet med en høj sandsynlighed for ikke at opnå
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection
Danish: LÆGEMIDLETS NAVN Pegasys 180 mikrogram injektionsvæske, opløsning
English: Table 5: Pegasys dose modification recommendations in paediatric patients with chronic hepatitis B or chronic hepatitis C Starting dose (mcg)
Danish: Tabel 5: Anbefalinger for dosisændringer af Pegasys til pædiatriske patienter med kronisk hepatitis B eller kronisk hepatitis C Startdosis (mikrogram)
English: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Danish: Der er blevet rapporteret dentale og parodontale lidelser, som kan føre til tab af tænder, hos patienter, der får kombinationsbehandling med Pegasys og ribavirin.
English: Dose increases to or towards the original dose may be considered when the adverse reaction abates (see sections 4.4 and 4.8).
Danish: Det kan overvejes at sætte dosis op til den oprindelige dosis, når bivirkningerne forsvinder (se pkt.
English: 4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml
Danish: 4 fyldte injektionssprøjter + 4 kanyler 135 mikrogram/0,5 ml
English: A reduced dose of 135 mcg once weekly is recommended in adult patients with severe renal impairment or end stage renal disease (see section 5.2).
Danish: Til patienter med svært nedsat nyrefunktion eller terminal nyresygdom anbefales nedsat dosis på 135 mikrogram én gang ugentlig (se pkt.
English: For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Danish: For patienter <75 kg og ≥75 kg bør der uanset genotype administreres henholdsvis 1.000 mg og 1.200 mg af ribavirin daglig.
English: Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR HCV Test, version 2.0 (limit of detection 100 copies/ml equivalent to 50 International Units/ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Danish: (detektionsgrænse 100 kopier/ml, lig med 50 internationale enheder/ml) og vedvarende respons blev defineret som én negativ prøve omkring 6 måneder efter behandlingens ophør.
English: Mania, bipolar disorders, homicidal ideation
Danish: Mani, bipolære affektive sindslidelser, drabstanker
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 48 weeks
Danish: Pegasys 180 mikrogram Ribavirin 1.000/1.200 mg 48 uger
English: By HBV-DNA (IU/mL) decline from baseline to week 12
Danish: Ved HBV-DNA (IE/ml) fald fra baseline til uge <1 log10 fald 1 - <2 log10 fald
English: ALT <1xULN >=1xULN<1.5xULN >=1.5xULN<2xULN >=2xULN<5xULN >=5xULN<10xULN >=10xULN
Danish: ALAT <1x øvre referencegrænse ≥1x øvre referencegrænse<1,5x øvre referencegrænse ≥1,5x øvre referencegrænse<2x øvre referencegrænse ≥2x øvre referencegrænse<5x øvre referencegrænse ≥5x øvre referencegrænse<10x øvre referencegrænse ≥10x øvre referencegrænse
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mcg/1 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 180 mikrog/1 ml
English: 4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml
Danish: 4 fyldte injektionssprøjter + 4 kanyler 180 mikrogram/0,5 ml
English: Neoplasms benign and malignant disorders: Liver tumour Immune system disorders: Sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid
Danish: Immunsystemet: Sarcoidose (områder med betændt væv over hele kroppen) og betændelse i skjoldbruskkirtlen
English: As with other interferons, a higher incidence of neutralising antibodies was seen in CHB.
Danish: Ligesom for andre interferoner blev der set en højere incidens af neutraliserende antistoffer ved kronisk hepatitis B. Ved ingen af sygdommene var dette dog korreleret med fravær af terapeutisk respons.