natgillin/translations-raw huggingface dataset:
I 6% af patienterne blev et fald i højden observeret og i 11% af patienterne et fald i vægt, mens der i den ubehandlede gruppe var 2% af patienterne i højden og 9% i vægt.
At Week 48 of Pegasys treatment, a height or weight percentile decrease of more than 15 percentiles on the normative growth curves was observed in 6% of patients for height and 11% of patient for weight, whereas in the untreated group it was 2% of patients for height and 9% for weight.
• Injicer opløsningen ved blidt at skubbe stemplet helt i bund.
● Inject the solution by gently pushing the plunger all the way down.
• Sæt kanylen fast på sprøjtens spids (4).
● Place the needle firmly on the tip of the syringe (4).
Vertigo, øresmerter
Vertigo, earache
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
• Injicer opløsningen ved blidt at skubbe stemplet ned til den passende mængde (ses udfra gradueringen).
● Inject the solution by gently pushing the plunger all the way down to the appropriate graduation.
• Pegasys 360 mikrogram/uge i 12 uger efterfulgt af 180 mikrogram/uge i yderligere 36 uger
• Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 36 weeks
Under behandling med Pegasys er der rapporteret om lungesymptomer, inklusive dyspnø, lungeinfiltrater, pneumoni og pneumonitis.
Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Under Pegasys- +/- ribavirin-behandling i op til 48 uger var vægttab og væksthæmning almindeligt hos patienter mellem 3 og 17 år (se pkt.
During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
* For HBeAg-positive patienter: HBV-DNA <105 kopier/ml
* For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
Hos 13 patienter med terminal nyresygdom som kræver kronisk hæmolyse, der fik 135 mikrogram Pegasys én gang ugenligt havde 34% lavere peginterferon alfa-2a eksponering sammenlignet med patienter med normal nyrefunktion.
In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
● hvis du får symptomer forbundet med depression (f.eks. er ked af det, føler dig nedtrykt osv.)
● if you develop symptoms associated with depression (e.g. feelings of sadness, dejection, etc.) (see section 4).
Leverinsufficiens, cholangitis, fedtlever
Hepatic failure, cholangitis, fatty liver
Der blev observeret fald i det absolutte neutrofilocyttal til under 500 celler/mm3 hos henholdsvis 13 % og 11 % af patienterne, som fik Pegasys-monoterapi eller kombinationsbehandling.
Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Optisk neuropati, papilødem, retinal vaskulær lidelse, retinopati, sår på cornea
Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Det findes i pakninger, der indeholder 1, 4 eller 12 fyldte penne.
It is available in packs containing 1, 4 or 12 pre-filled pens.
Pegasys findes som injektionsvæske, opløsning i et hætteglas (1 ml).
Pegasys is presented as a solution for injection in a vial (1 ml).
HCV-genotype 2 og 3
HCV genotype 2 and 3
Hos patienter, som samtidigt tager theophyllin og Pegasys, skal serumkoncentrationerne af theophyllin kontrolleres, og theophyllindosis skal justeres.
Serum concentrations of theophylline should be monitored and appropriate dose adjustments of theophylline made for patients taking theophylline and Pegasys concomitantly.
Findes i pakninger, som indeholder 1, 4 eller 12 fyldte penne.
Available in packs containing 1, 4 or 12 pre-filled pens.
Behandlingsvarighed - to-stofsbehandling med Pegasys og ribavirin Behandlingsvarigheden af kombinationsbehandlingen med ribavirin ved kronisk hepatitis C afhænger af viral genotype.
Duration of treatment - dual therapy with Pegasys and ribavirin The duration of combination therapy with ribavirin for CHC depends on viral genotype.
Kvindelige patienter i den fertile alder skal anvende sikker prævention under behandlingen og i 4 måneder efter, behandlingen er ophørt.
Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
• Pegasys 360 mikrogram/uge i 12 uger efterfulgt af 180 mikrogram/uge i yderligere 60 uger
• Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 weeks
180 mikrogram peginterferon alfa-2a.
135 or 180 micrograms peginterferon alfa-2a.
Sygdomme i tænder og gummer, som kan medføre tab af tænder, er blevet rapporteret hos patienter, der får behandling med Pegasys, samtidigt med ribavirin.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
INFORMATION I BRAILLESKRIFT pegasys 90 mcg
INFORMATION IN BRAILLE pegasys 90 mcg
Foreligger i pakninger med 1 eller 4 hætteglas.
Available in packs of 1 or 4 vials.
Det findes i pakninger, der indeholder 1 eller 4 enkeltdosis hætteglas.
It is available in packs containing 1 or 4 single dose vials.
Dette kan muligvis føre til en akkumulering af 6-methylthio inosin-monofosfat (6-MTIMP), som har været forbundet med myelotoksicitet hos patienter behandletmed azathioprin.
Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Administration af 180 mikrogram Pegasys én gang ugentlig i 4 uger til raske mænd havde ingen effekt på farmakokinetikken af mephenytoin, dapson, debrisoquin og tolbutamid.
Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
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.
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).
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.
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.
Ikke cirrose
Do not shake.
Patienterne bør alligevel kontrolleres for tegn og symptomer på methadontoksicitet.
The clinical significance of this finding is unknown; nonetheless, patients should be monitored for the signs and symptoms of methadone toxicity.
Mavesår, pancreatitis
Peptic ulcer, pancreatitis
Den anbefalede dosis af Pegasys i kombination med ribavirin er 180 mikrogram én gang om ugen ved subkutan administration.
The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Blodplader 25.000 til <50.000 celler/mm3: 2. niveau justering.
Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment.
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.
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.
Kronisk Hepatitis C
Chronic hepatitis C
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.
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.
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.
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.
Kronisk hepatitis B - voksne patienter
Chronic hepatitis B - adult patients
180 mikrogram/0,5 ml
180 micrograms/0.5 ml
Ribavirin 800 mg 16 uger
Ribavirin 800 mg 16 weeks
Tabel 7 viser et doseringsskema til børn og unge, der vejer mindst 23 kg, hvor 200 mg ribavirin tabletter anvendes.
For children and adolescents 23 kg or greater, a dosing schedule using 200 mg ribavirin tablets is provided in Table 7.
konvulsioner, facialisparese
Coma, convulsions, facial palsy
Benigne og maligne tumorer
Neoplasms benign and malignant
Sløret syn, øjensmerter, øjenbetændelse, xerophthalmi
Vision blurred, eye pain, eye inflammation, xerophthalmia
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.
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.
Hver fyldte injektionssprøjte med 0,5 ml opløsning indeholder 90, 135 eller 180 mikrogram peginterferon alfa-2a.
Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Patienter, som får zidovudin i kombination med ribavirin og interferon alfa, har øget risiko for at udvikle blodmangel (anæmi).
Patients receiving zidovudine in combination with ribavirin and alfa interferons are at increased risk of developing anaemia.
Hiv-HCV-co-inficerede patienter
HIV-HCV co-infected patients
Kombinationsbehandling med ribavirin og zidovudin anbefales ikke, idet der er en forhøjet risiko for udvikling af anæmi (se pkt.
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Fordøjelsessystemet: Blødning i mave-tarmkanalen Lever: Dårlig leverfunktion
Digestive system disorders: Gastrointestinal bleeding Liver disorders: Poor functioning of the liver
INFORMATION I BRAILLESKRIFT pegasys 180 mcg
INFORMATION IN BRAILLE pegasys 180 mcg
Pegasys 180 mikrogram x legemsoverfladeareal/1,73 m² + ribavirin 15 mg/kg (N=55)*
Table 25: Sustained virological response in the NV17424 study Pegasys 180 mcg x BSA/1.73 m² + Ribavirin 15 mg/kg (N=55)*
Pegasys mikrogram Ribavirin mg (N=436) 48 uger
Pegasys 180 mcg Ribavirin mg (N=436) 48 weeks
Læs også indlægssedlerne for de lægemidler, som anvendes i kombination med Pegasys.
Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
I dyreforsøg med interferon alfa-2a er der set reproduktionstoksicitet (se pkt.
Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Ribavirin 800 mg 48 uger
Ribavirin 800 mg 48 weeks
Opkastning, dyspepsi, dysfagi, sår i munden, gingival blødning, glossitis, stomatitis, flatulens, mundtørhed
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
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.
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.
Pegasys mikrogram Ribavirin mg (N=453) 48 uger
Pegasys 180 mcg Ribavirin mg (N=453) 48 weeks
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
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
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
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
HBeAg-serokonversion
HBeAg Seroconversion
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).
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).
Ribavirin 1.000/1.200 mg 72 uger (N=473) SVR hos patienter med VR ved uge 12 b
Ribavirin 1000/1200 mg 72 Weeks (N = 473) SVR in Pts with VR at Wk 12 b
Genotype 2 eller 3 uden RVR**
Genotype 2 or 3 without RVR**
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Nervesystemet Hovedpine, svimmelhed*, koncentrationsbesvær
Headache, dizziness*, concentration impaired
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
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
Ribavirin 1.000/1.200 mg 72 eller 48 uger (N=942) Patienter med VR ved uge 12 a
Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
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.
Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
MARKEDSFØRINGSTILLADELSESNUMRE Pegasys 180 mikrogram injektionsvæske, opløsning EU/1/02/221/003
MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003
Ribavirin 1.000/1.200 mg 48 uger (N=469) SVR hos patienter med VR ved uge 12 b
Ribavirin 1000/1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b
Interferon alfa-2a 6 MIE/3 MIE
Interferon alfa-2a 6 MIU/3 MIU
Takykardi, perifere ødemer, hjertebanken
Tachycardia, oedema peripheral, palpitations
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.
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.
Ingen, grad 1-2, grad 3-4*
Grade 3-4*
Interval for legemsoverfladeareal (m2)
Body Surface Area (BSA) range (m2)
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
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
Trombocytopeni, anæmi, lymfadenopati
Thrombocyto penia, anaemia, lymphadenop athy
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.
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.
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.
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,
Hypothyroidisme, hyperthyroidisme
Hypothyroidis m, hyperthyroidi sm
Forudsigelighed af respons og non-respons ved Pegasys og ribavirin to-stofsbehandling - behandlingserfarne patienter
Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentexperienced patients
Høj viral belastning= >800.000 IE/ml, lav viral belastning= ≤800.000 IE/ml.
High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Ribavirin 800 mg 24 uger
Ribavirin 800 mg 24 weeks
Pegasys er i kombination med andre lægemidler indiceret til behandling af kronisk hepatitis C (CHC) hos patienter med kompenseret leversygdom (se pkt.
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).
● hæfteplaster
● an adhesive bandage
Ribavirin 1.000/1.200 mg 48 uger
Ribavirin 1000/1200 mg 48 weeks
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Pegasys findes på det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Dosisbegrænsende toksicitet omfattede træthed, forhøjede leverenzymer, neutropeni og trombocytopeni, som også kan forventes med interferonbehandling.
Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
• Fjern beskyttelseshætten fra kanylen (5).
● Remove the needle guard from the syringe needle (5).
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.
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.
• Pegasys 180 mikrogram/uge i 48 uger.
• Pegasys 180 mcg/week for 48 weeks
Ribavirin 1.000/1.200 mg 24 uger
Ribavirin 1000/1200 mg 24 weeks
1.000 mg/dag
1000 mg/day
Hver fyldte pen med 0,5 ml opløsning indeholder 135 eller
Each pre-filled pen of 0.5 ml solution contains
Det er vist, at Pegasys er effektivt og sikkert hos patienter med kompenseret cirrose (f.eks. Child-Pugh A).
In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Sjælden Meget sjælden
Common Uncommon Rare
Forudsigelighed af respons og non-respons ved Pegasys og ribavirin to-stofsbehandling - behandlingsnaive patienter
Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentnaïve patients
Leverdysfunktion
Liver function
88 % af de patienter, der blev behandlet med Pegasys oplevede uønskede hændelser sammenlignet med 53 % af patienterne i sammenligningsgruppen behandlet med lamivudin.
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.
* Disse bivirkninger var almindelige (≥1/100 til <1/10) hos patienter med kronisk hepatitis B, der blev behandlet med
*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.