natgillin/translations-raw huggingface dataset:
RVR = hurtigt virologisk respons (ikke- målelig HCV- RNA) ved uge 4 og HCV- RNA ikke- målelig ved uge 24 ** RVR = hurtigt virologisk respons (HCV- RNA- negativ) ved uge 4 Lav viral belastning = ≤800. 000 IE/ ml; høj viral belastning = > 800. 000 IE/ ml
*RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4 LVL= ≤ 800,000 IU/ mL; HVL= > 800,000 IU/ mL
29 Tabel 2:
Table 2:
Den negativ prædiktive værdi for vedvarende respons hos patienter behandlet med Pegasys monoterapi var 98%.
30 The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
30 Tabel 3:
31 Table 3:
Hvis ALAT- forhøjelserne progredierer eller persisterer, skal dosis initialt nedsættes til 135 mikrogram.
If ALT increase is progressive or persistent, the dose should be reduced initially to135 micrograms.
4. 3 og 4. 4).
Pegasys is contraindicated in neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.3 and 4.4).
31 skal foretages passende reduktion af Pegasys- dosis under behandlingen, hvis der kommer bivirkninger.
Regardless of the starting dose or degree of renal impairment, patients should be monitored and appropriate dose reductions of Pegasys during the course of therapy should be made in the event of adverse reactions.
Child- Pugh A).
32 Patients with hepatic impairment In patients with compensated cirrhosis (eg, Child-Pugh A), Pegasys has been shown to be effective and safe.
32 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
33 4.4 Special warnings and precautions for use
Psykiatri og centralnervesystemet (CNS):
Psychiatric and Central Nervous System (CNS):
Hvis disse symptomer forekommer, skal den potentielle alvorlighed af disse bivirkninger vurderes af lægen og behovet for tilstrækkelig medicinsk behandling skal overvejes.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
- Adækvat kontrolleret thyreoideafunktion (TSH og T4)
- Adequately controlled thyroid function (TSH and T4).
I de kliniske studier med Pegasys var faldet i ANC reversibelt efter dosisreduktion eller ophør af behandlingen (se 4. 2), opnåede normale værdier efter 8 uger hos hovedparten af patienterne og vendte tilbage til baseline hos alle patienter efter 16 uger.
The decrease in ANC was reversible upon dose reduction or cessation of therapy (see section 4.2), reached normal values by 8 weeks in the majority of patients and returned to baseline in all patients after about 16 weeks.
33 I de kliniske studier om kombineret behandling af Pegasys med ribavirin er der set anæmi (hæmoglobin < 10 g/ dl) hos op til 15% af patienterne med kronisk hepatitis C.
34 The occurrence of anaemia (haemoglobin < 10 g/ dl) has been observed in up to 15% of chronic hepatitis C patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Brugen af Pegasys og ribavirin i kombinationsbehandling hos kroniske hepatitis C- patienter, hvor tidligere behandling har svigtet, er ikke blevet undersøgt tilstrækkelig hos patienter, som har afbrudt tidligere behandling på grund af hæmatologiske uønskede hændelser.
The use of Pegasys and ribavirin combination therapy in chronic hepatitis C patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for hematological adverse events.
34 Autoimmune sygdomme Der er rapporteret om udvikling af autoantistoffer og autoimmunsygdomme under behandling med alfa- interferoner.
Autoimmune disease The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Patienter med disposition for udvikling af autoimmune sygdomme kan være særligt udsat.
Patients predisposed to the development of autoimmune disorders may be at
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 4. 4 og 4. 8).
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also Endocrine System in sections 4.4 and 4.8).
Øjenforandringer Som tilfældet er for andre interferoner, er der efter behandling med Pegasys i sjældne tilfælde rapporteret om retinopati, inklusive retinal hæmoragi, ekssudater, papilødem, optisk neuropati og obstruktion af arterier og vener i retina, som kan medføre synstab.
Ocular changes As with other interferons 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.
Patienter, som allerede har øjensygdomme (feks. diabetisk eller hypertensiv retinopati), skal have foretaget periodiske øjenundersøgelser under behandlingen med Pegasys.
Patients with preexisting ophthalmologic disorders (eg, diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
Hos patienter, der er co- inficeret med hiv- HCV, er begrænsede effekt - og sikkerhedsdata (N = 51) tilgængelige hos personer med CD4- tal mindre end 200 celler/ µl.
36 In patients co-infected with HIV-HCV, limited efficacy and safety data (N = 51) are available in subjects with CD4 counts less than 200 cells/ uL.
I det samme studie blev der set en 25% stigning i AUC for theophyllin (markør for cytokrom P450 1A2 aktivitet), hvilket viser, at Pegasys er en moderat hæmmer af cytokrom P450 1A2 aktivitet.
In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
Specielt hos patienter, der får en høj methadon- dosis, bør risikoen for forlængelse af QTc- intervallet tages i betragtning.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
36 Samtidig administration af ribavirin og didanosin anbefales ikke.
Co-administration of ribavirin and didanosine is not recommended.
Forværring af anæmi pga. ribavirin er rapporteret, når zidovudin anvendes som del af hiv- behandling, dog er den eksakte mekanisme stadig ikke belyst.
37 Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Med undtagelse af pyreksi var frekvensen for størstedelen af de rapporterede bivirkninger markant mindre for patienter med kronisk hepatitis B, der blev behandlet med Pegasys- monoterapi sammenlignet med HCV - patienter, der blev behandlet med Pegasys- monoterapi (se tabel 4).
With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 4). 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.
88% af de patienter, der blev behandlet med Pegasys oplevede uønskede hændelser sammenlignet med 53% af patienterne i
The percentage of patients with
Seponeringsraterne for patienter med cirrose svarede til raterne i hele populationen i hver behandlingsgruppe.
38 cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
Hyppigheden for seponering på grund af uønskede hændelser eller laboratorieabnormiteter fra Pegasys- behandling og ribavirin- behandling var henholdsvis 6% og 7% i 48 ugers armene og henholdsvis 12% og 13% i 72 ugers armene.
In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13%, respectively, in the 72 week arms.
38 Tabel 4:
Table 4:
Hepatisk neoplasma
Very Common ≥ 1/ 10
Blod og lymfesystem
Very rare < 1/ 10,000
Trombocytopeni, anæmi, lymfadenopati
Blood and lymphatic system disorders
Idiopatisk eller trombotisk trombocyto - penisk purpura
idiopathic or thrombotic thrombocytopenic purpura
Hypothyroidisme, hyperthyroidisme
Diabetic ketoacidosis
Diabetes Dehydrering
Metabolism and Nutrition Disorders
Diabetisk ketoacidose
Dehydration
Selvmordstanker, Hallucinationer
Suicidal ideation, hallucinations
Optisk neuropati, Synstab papilødem, retinal vaskulær lidelse, retinopati, sår på cornea
Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Diarré *, kvalme *, abdominalsmerter *
Diarrhoea*, nausea*, abdominal pain*
39 System - organklasse
Hepato-biliary disorders
Meget almindelig ≥1/ 10
Hepatic dysfunction
Ikke almindelig ≥1/ 1. 000 til < 1/ 100
Hepatic failure, cholangitis, fatty liver
Meget sjælden < 1/ 10. 000
Skin and subcutaneous
Lever og galdeveje
Alopecia, dermatitis,
Leverdysfunktion
Rash, sweating increased,
Leverinsuffi - ciens, cholangitis, fedtlever
Toxic epidermal necrolysis,
Alopeci, dermatitis, kløe, tør hud
pruritis, dry skin
Udslæt, øget svedtendens psoriasis, urticaria, eksem, hudsygdomme, lysoverfølsomhedsreak - tioner, nattesved
psoriasis, urticaria, eczema, skin disorder, photosensitivity reaction, night sweats
Toksisk epidermal necrolyse, Stevens - Johnsons syndrom, angioødem, erythem multiforme
Stevens-Johnson syndrome, angioedema, erythema multiforme
Uønskede hændelser efter markedsføring
41 Post marketing adverse events
Laboratorieværdier Behandling med Pegasys ledsagedes af abnorme laboratorieværdier:
Laboratory values Pegasys treatment was associated with abnormal laboratory values:
40 Moderat (absolut neutrofillocyttal:
Moderate (ANC:
1260 mikrogram/ uge).
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (ie, 1260 micrograms/ week) have been reported.
Interferon alfa- 2a er konjugeret med bis - [monomethoxy polyethylenglycol] med en substitutionsgrad på ét mol af polymer/ mol protein.
Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/ mole of protein.
20. 000.
The average molecular mass is approximately 60 000 of which the protein moiety constitutes approximately 20 000.
41 Kronisk hepatitis B:
Chronic hepatitis B:
Resultater fra kliniske studier Alle kliniske studier rekrutterede patienter med kronisk hepatitis B med aktiv viral replikation bedømt ved HBV- DNA, forhøjede ALAT - niveauer og en leverbiopsi, som var konsistent med kronisk hepatitis.
Clinical trial results All clinical trials recruited patients with chronic hepatitis B who had active viral replication measured by HBV DNA, elevated levels of ALT and a liver biopsy consistent with chronic hepatitis.
Tabel 5:
43 Table 5:
HBeAg- positiv
HBeAg positive Study WV16240
HBeAg- negativ / anti- HBe- positiv
HBeAg negative / anti-HBe positive Study WV16241
Studie WV16241
Response Parameter
HbeAg- sero - konversion
HBeAg Sero- conversion
HbsAg- sero - konversion
HBsAg Sero- conversion
42 Kronisk Hepatitis C:
Chronic hepatitis C
Virologisk respons blev defineret som ikke detekterbare niveauer af HCV- RNA, når det blev målt med COBAS AMPLICORTM HCV - test version 2. 0.
Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR™ HCV Test, version 2.0
(detektionsgrænse 100 kopier/ ml, lig med 50 internationale enheder/ ml) og vedvarende respons blev defineret som een negativ prøve omkring 6 måneder efter behandlingens ophør.
44 (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.
Studie NV15495 St
Study NV15495 Study
Interferon Pegasys Interferon alfa- 2a 180 µg alfa- 2a 6 MIE/ 3 3 MIE
Pegasys 180 mcg
Pegasys Pegasys 180 µg 180 µg
Interferon alfa-2b
Interferon alfa- 2b 3 MIE
3 MIU 3 MIU & & &
MIE & 3 MIE
3 MIU &
& & Ribavirin Ribavirin 1000/ 1200 1000/ 1200 mg mg
Ribavirin Ribavirin 1000/ 1200 1000/ 1200 mg mg
& Ribavirin 1000/ 1200 mg
Ribavirin 1000/ 1200 mg
(N=478) (N=87) (N=88) 48 uger 48 uger 48 uger
(N=88)
43 ved baseline samt i relation til genotype, viral belastning ved baseline og hurtig virologisk respons ved uge 4, er opsummeret i hhv. tabel 7 og 8.
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and 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 7 and Table 8, respectively.
Resultaterne fra studie NV15942 udgør rationalet for at anbefale behandling baseret på genotype, viral belastning ved baseline og virologisk respons ved uge 4 (se tabel 1, 7 og 8).
The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 7and 8).
Tabel 7:
45 Table 7:
Høj viral bel.
Pegasys 180 mcg ribavirin 1000/ 1200 mg, 24 w:
44 Tabel 8:
Table 8:
Lav viral belastning= ≤800. 000 IE/ ml; Høj viral belastning = > 800. 000 IE/ ml Hurtig viral respons (HCV- RNA ikke- målelig) ved uge 4 og HCV- RNA ikke- målelig ved uge 24
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
En begrænset mængde data viser, at en forkortelse af behandlingen til 24 uger kan være forbundet med højere risiko for recidiv (se tabel 9).
46 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
Pegasys Pegasys 180 µg 180 µg & &
Pegasys 180 mcg &
Det vedvarende virologiske respons opnået efter 16 uger og 24 ugers behandling blev også undersøgt i en retrospektiv undergruppe- undersøgelse af patienter, som var HCV- RNA- negative ved uge 4, og som havde en lav virologisk belastning ved baseline (se tabel 10).
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 10)
45 Tabel 10:
Table 10:
Vedvarende virologisk respons totalt og baseret på hurtigt virologisk response ved uge 4 for genotype 2 eller 3 efter Pegasys kombinationsterapi med ribavirin hos HCV- patienter Studie NV17317
Sustained Virological Response Overall and Based on Rapid Viral Response by Week4 for Genotype 2 or 3 after Pegasys Combination Therapy with Ribavirin in HCV Patients Study NV17317
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 11).
47 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
95% Komfidensinterval
difference 95%CI
46 Tabel 12:
48 Table 12:
47 Tabel 13 Vedvarende virologisk respons i HALT- C ved tidligere behandling hos ikke - responderende population Pegasys 180 µg & Ribavirin 1000/ 1200 mg Tidligere behandling
Table 13 Sustained Virological Response in HALT-C by Previous Treatment Regimen in Non-responder Population Previous Treatment
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- co - inficerede patienter er angivet i tabel 14.
49 HIV-HCV co-infected patients 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 co- infected patients are summarised below in Table 14
Ribavirin 800 mg 48 uger
Ribavirin 800 mg
Placebo 48 uger
Placebo
Alle patienter
48 weeks 48 weeks
Lav viral belastning = ≤800. 000 IE/ ml; Høj viral belastning = > 800. 000 IE/ ml * Pegasys 180 μg ribavirin 800 mg vs.
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL * Pegasys 180 mcg ribavirin 800 mg vs.
Interferon alfa- 2a 3MIE ribavirin 800 mg:
Interferon alfa-2a 3MIU ribavirin 800 mg:
HCV- patienter med normal ALAT I studie NR16071 blev HCV- patienter med normale ALAT- værdier randomiseret til at få Pegasys 180 mikrogram/ uge og ribavirin 800 milligram/ dag i enten 24 eller 48 uger efterfulgt af 24- ugers behandlingsfri follow- up periode eller ingen behandling i 72 uger.
HCV patients with normal ALT In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/ week and ribavirin 800 milligrams/ day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
Peginterferon alfa- 2a findes fortrinsvis i blodet og ekstracellulærvæsken, som det fremgår af distributionsvolumenet i steady- state (Vd) på 6 til 14 liter hos mennesker efter intravenøs
Peginterferon alfa-2a is found predominantly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6 to 14 litres in humans after intravenous administration.
Hos raske forsøgspersoner og hos patienter med kronisk hepatitis B eller C er der set dosisproportional stigning i ekspositionen for Pegasys efter behandling én gang ugentlig.
50 Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
Baseret på lægemiddelbelastning, farmakodynamisk respons og tolerabilitet er det ikke nødvendigt med en lavere Pegasys- dosis til ældre patienter (se 4. 2).
Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see 4.2).
natriumchlorid polysorbat 80 benzylalkohol (10 mg/ 1ml) natriumacetat eddikesyre vand til injektionsvæsker
sodium chloride polysorbate 80 benzyl alcohol (10 mg/ 1 ml) sodium acetate acetic acid water for injections
1 ml af opløsning til injection i hætteglas (silikoniseret type I glas) med hætte (butylgummi).
1 ml of solution for injection in vial (siliconised Type I glass) with stopper (rubber butyl).
51 1.
53 1.
En fyldt sprøjte indeholder Hvert hætteglas på 0, 5 ml opløsning indeholder 135 mikrogram peginterferon alfa- 2a *.
One pre-filled syringe contains peginterferon alfa-2a*..................................................................... 135 micrograms Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Styrken indikerer størrelsen af interferon alfa- 2a delen af peginterferon alfa- 2a uden hensyntagen til pegyleringen.
The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
52 4. 2 Dosering og indgivelsesmåde
54 4.2 Posology and method of administration
Den ribavirindosis, som skal anvendes i kombination med Pegasys fremgår af tabel 1.
The dose of ribavirin to be used in combination with Pegasys s given in Table 1.
En samlet behandlingsperiode på 24 uger kan dog være forbundet med større risiko for recidiv end en behandlingsperiode på 48 uger (se pkt. pkt.
However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
53 Tabel 1:
55 Table 1:
Anbefalet dosering for kombinationsbehandling til HCV- patienter Genotype
Dosing Recommendations for Combination therapy for HCV Patients Genotype
En behandlingsvarighed under 48 uger er ikke tilstrækkeligt undersøgt.
A duration of therapy less than 48 weeks has not been adquately studied.
54 Tabel 2:
56 Table 2:
4. 4 og 4. 8).
Dose increases to or towards the original dose may be considered when the adverse reaction abates (see section 4.4 for use and section 4.8).
Hæmatologiske bivirkninger (se også tabel 3) Det anbefales at nedsætte dosis, hvis neutrofillocyttallet er < 750/ mm3.
Haematological (see also Table3) Dose reduction is recommended if the neutrophil count is < 750/ mm3.
55 Tabel 3:
57 Table 3:
ribavirin
Discontinue
behandlingen
ribavirin ribavirin
Pegasys til behandl
Pegasys Pegasys
kombinations -
Combination
til 600 mg
to 600 mg
Absolut neutrofillocyttal
Absolute Neutrophil Count
< 50, 000/ mm3 > 25, 000/ mm3
< 50,000/mm3 > 25,000/ mm3
Child- Pugh A).
58 Patients with hepatic impairment In patients with compensated cirrhosis (eg, Child-Pugh A), Pegasys has been shown to be effective and safe.
57 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
59 4.4 Special warnings and precautions for use
58 I de kliniske studier om kombineret behandling af Pegasys med ribavirin er der set anæmi (hæmoglobin < 10 g/ dl) hos op til 15% af patienterne med kronisk hepatitis C.
60 The occurrence of anaemia (haemoglobin < 10 g/ dl) has been observed in up to 15% of chronic hepatitis C patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Hyppigheden afhænger af behandlingsvarigheden og ribavirindosis. (Se 4. 8).
The frequency depends on the treatment duration and the dose of ribavirin (see section 4.8,).
59 Autoimmune sygdomme Der er rapporteret om udvikling af autoantistoffer og autoimmunsygdomme under behandling med alfa- interferoner.
Autoimmune disease The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Patienter, som er prædisponeret til udvikling af autoimmune forstyrrelser kan have forøget risiko.
Patients predisposed to the development of autoimmune disorders may be at
Feber/ infektioner Medens feber kan være en 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.
Fever/ infections 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.
Alle patienter skal have foretaget en øjenundersøgelse inden start af behandling. Alle patienter, som klager over nedsat syn eller tab af syn, skal straks have foretaget en fuldstændig øjenundersøgelse.
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Hos patienter, der er co- inficeret med hiv- HCV, er begrænsede effekt - og sikkerhedsdata (N = 51) tilgængelige hos personer med CD4- tal mindre end 200 celler/ µl.
62 In patients co-infected with HIV-HCV, limited efficacy and safety data (N = 51) are available in subjects with CD4 counts less than 200 cells/ uL.
61 Samtidig administration af ribavirin og didanosin anbefales ikke.
Co-administration of ribavirin and didanosine is not recommended.
Forværring af anæmi pga. ribavirin er rapporteret, når zidovudin anvendes som del af hiv- behandling, dog er den eksakte mekanisme stadig ikke belyst.
63 Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Sværhedsgraden af de hyppigst rapporterede bivirkninger efter 180 mikrogram Pegasys var for det meste let til moderat, og bivirkningerne kunne behandles uden behov for justering af dosis eller afbrydelse af behandlingen.
The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 4). 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.