natgillin/translations-raw huggingface dataset:
En begrænset mængde data viser, at en forkortelse af behandlingen til 24 uger kan være forbundet med højere risiko for recidiv (se tabel 9).
20 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
Recidiv for virologisk respons efter endt behandling hos patienter med hurtig virologisk respons
Relapse of Virological Response at the End of Treatment for Rapid Virological Response Population
1000/ 1200 mg 1000/ 1200 mg 24 uger 48 uger
1000/ 1200 mg 1000/ 1200 mg 24 weeks 48 weeks
1000/ 1200 mg 48 uger
1000/ 1200 mg 48 weeks
Genotype 1 hurtig viral respons
Genotype 1 RVR
Muligheden for afkortelse af behandlingsvarigheden til 16 uger hos patienter med genotype 2 eller 3 blev undersøgt, baseret på et vedvarende virologisk respons hos patienter, som havde et hurtigt virologisk respons ved uge 4 i studie NV17317 (se tabel 10).
The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 10).
I studie NV17317 med patienter smittet med virologisk genotype 2 eller 3, modtog alle patienter Pegasys 180 μg s. c. én gang ugentlig og 800 mg ribavirin, og patienterne blev randomiceret til 16 eller 24 ugers behandling.
In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 μ g sc qw and a ribavirin dose of 800 mg and were randomized to treatment for either 16 or 24 weeks.
Behandling i 16 uger resulterede i lavere vedvarende virologisk respons (65%) end behandling i 24 uger (76%) (p < 0, 0001).
Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
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).
20 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 Week 4 for Genotype 2 or 3 after Pegasys Combination Therapy with Ribavirin in HCV Patients Study NV17317
180 µg 180 µg & &
Pegasys Pegasys 180 mcg 180 mcg & &
95% Konfidensinterval
Treatment difference 95%CI
p < 0, 0001
[-15.5%; - P < 0.0001 0.06%]
p=0, 0006
P=0.002
Lav viral belastning Høj viral belastning
High viral load
Lav viral belastning = ≤ 800, 000 IE/ ml; Høj viral belastning = > 800, 000 IE/ ml RVR = hurtigt virologisk respons (HCV- RNA ikke- detekterbar) ved uge 4
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 11).
21 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
Relaps af virologisk respons efter endt behandling hos patienter med genotype 2 eller 3 med hurtigt virologisk respons Studie NV17317
Relapse of Virological Response after the End of Treatment in Genotype 2 or 3 Patients with a Rapid Viral Response Study NV17317
Behandlingsforskel
Treatment
180 µg 180 µg & &
mcg 180 mcg & &
95% Konfidensinterval
difference 95%CI
Genotype 2 or 3 RVR Lav viral belastning
Genotype 2 or 3
15 6
15%
% (67/ 439)% (10/ 155)
6% (23/ 386)
6 1
RVR
% (23/ 386)% (2/ 141)
1% (2/ 141)
9, 3% [5, 2%; 13, 6%] 5% [0, 6%; 10, 3%]
13.6%]
p < 0, 0001 p=0, 04
Low viral load
11, 5% [5, 6%; 17, 4%]
17.4%]
Dette gjaldt også patienter med cirrose og/ eller hiv- HCV- co- infektion.
Superior efficacy of Pegasys compared to interferon alfa-2a was demonstrated also in terms of histological response, including patients with cirrhosis and/ or HIV-HCV co-infection.
Alle patienterne fik ribavirin (1000 eller 1200 mg/ dag) i kombination med Pegasys.
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 randomized to four different treatments: • Pegasys 360 mcg/ week for 12 weeks, followed by 180 mcg/ week for a further 60 weeks • Pegasys 360 mcg/ week for 12 weeks, followed by 180 mcg/ week for a further 36 weeks • Pegasys 180 mcg/ week for 72 weeks • Pegasys 180 mcg/ week for 48 weeks All patients received ribavirin (1000 or 1200 mg/ day) in combination with Pegasys.
Flere regression - og samlede gruppeanalyser, som evaluerede påvirkningen af behandlingsvarighed og brug af induktionsdosis, identificerede klart behandlingsvarighed på 72 uger som den primære drivkraft for at opnå et vedvarende virologisk respons.
Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Forskelle i vedvarende virologisk respons (SVR) baseret på behandlingsvarighed, demografiske karakteristika og bedste respons ved tidligere behandling er vist i tabel 12.
Differences in sustained virological response (SVR) based on treatment duration, demographics and best responses to previous treatment are displayed in Table 12.
21 Tabel 12:
22 Table 12:
Virologiske respons (VR) ved uge 12 og vedvarende virologisk respons (SVR) hos patienter med virologisk respons ved uge 12 efter kombinationsbehandling med Pegasys og ribavirin, som ikke har responderet på tidligere behandling med peginterferon alfa- 2b plus ribavirin.
Week 12 Virological Response (VR) and Sustained Virological Response (SVR) in Patients with Virological Response at Week 12 after Treatment with Pegasys and Ribavirin Combination Therapy in Nonresponders to Peginterferon alfa-2b plus Ribavirin.
Pegasys 360/ 180 Pegasys 360/ 180 eller 180 μg eller 180 μg & &
Pegasys 360/ 180 or Pegasys 360/ 180 or 180 μ g 180 μ g & & Ribavirin 1000/ 1200 Ribavirin mg 1000/ 1200 mg 72 or 48 Weeks 72 Weeks (N = 942) (N = 473) Pts with SVR in Pts with VR at Wk 12 a VR at Wk 12 b (N = 876) (N = 100)
hos patienter med VR ved uge 12 b (N = 57)
Pegasys 360/ 180 or 180 μ g & Ribavirin 1000/ 1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b (N = 57)
Total Lav viral belastning Høj viral belastning Genotype 1/ 4 Lav viral belastning Høj viral belastning Genotype 2/ 3 Lav viral belastning
Overall Low viral load High viral load Genotype 1/ 4 Low viral load High viral load Genotype 2/ 3 Low viral load High viral load Cirrhosis Status
(157/ 876) (56/ 159) (97/ 686) (140/ 846) (54/ 154) (84/ 663) (15/ 26) (2/ 5)
18% (157/ 876) 57% (57/ 100) 35% (56/ 159) 63% (22/ 35) 14% (97/ 686) 54% (34/ 63) 17% (140/ 846) 55% (52/ 94) 35% (54/ 154) 63% (22/ 35) 13% (84/ 663) 52% (30/ 58) 58% (15/ 26) (4/ 5) (2/ 5) — (11/ 19) (3/ 4)
35% (20/ 57) 38% (8/ 21) 32% (11/ 34) 35% (16/ 46) 37% (7/ 19) 35% (9/ 26) (3/ 10) (1/ 2)
35% (20/ 57) 38% (8/ 21) 32% (11/ 34) 35% (16/ 46) 37% (7/ 19) 35% (9/ 26) (3/ 10) (1/ 2) (1/ 7)
Ikke cirrose Bedste respons ved tidligere behandling
Cirrhosis Noncirrhosis Best Response during Previous Treatment
(137/ 633)
8% (19/ 239) (6/ 13) 22% (137/ 633) 59% (51/ 87)
34% (17/ 50)
(3/ 6) 34% (17/ 50)
≥2log10 fald i HCV- RNA < 2log10 fald i HCV- RNA Mangler bedste tidligere
≥ 2log10 decline in HCV RNA < 2log10 decline in HCV RNA Missing best previous response
68% (15/ 22) 64% (16/ 25)
28% (34/ 121) 68% (15/ 22) 12% (39/ 323) 64% (16/ 25) 19% (84/ 432) 49% (26/ 53)
29% (9/ 31)
(6/ 12) (5/ 14) 29% (9/ 31)
Høj viral belastning = > 800, 000 IE/ ml, lav viral belastning = ≤ 800, 000 IE/ ml. a Patienter, som opnåede viral suppression (ikke- detekterbar HCV- RNA, < 50 IE/ ml) ved uge 12, blev anset for at have virologisk respon ved uge 12.
High viral load = > 800,000 IU/ mL, low viral load = ≤ 800,000 IU/ mL. a Patients who achieved viral suppression (undetectable HCV RNA, < 50 IU/ mL) at week 12 were considered to have a virological response at week 12.
Patienter, som ikke havde HCV- RNA- resultater ved uge 12, blev eksluderet fra analysen. b Patienter, som opnåede viral suppression ved uge 12 men manglede HCV- RNA- resultater ved slutningen af opfølgningsperioden, blev anset for at være ikke- responderende.
Patients missing HCV RNA results at week 12 have been excluded from the analysis. b Patients who achieved viral suppression at week 12 but were missing HCV RNA results at the end of follow-up were considered to be nonresponders
Patienter med kronisk hepatitis C og fremskreden fibrose eller cirrose, som ikke havde responderet på tidligere behandling med interferon alfa eller pegyleret interferon alfa- monobehandling eller kombinationsbehandling med ribavirin, blev i HALT- C studiet behandlet med Pegasys 180 µg/ uge og ribavirin 1000/ 1200 mg daglig.
In the HALT-C study, patients with chronic hepatitis C and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/ week and ribavirin 1000/ 1200 mg daily.
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.
Sandsynligheden for et vedvarende virologisk respons varierede som følge af den tidligere behandling; se tabel 13.
The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 13.
22 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
48 uger
180 mcg &
Interferon Pegyleret interferon Interferon plus ribavirin Pegyleret interferon plus ribavirin
Ribavirin 1000/ 1200 mg 48 weeks Interferon Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
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.
23 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.
Vedvarende virologisk respons baseret på genotype og viral belastning ved baseline efter behandling med Pegasys i kombination med ribavirin hos hiv- HCV- co- inficerede patienter Studie NR15961
Sustained Virological Response based on Genotype and Pre-treatment Viral Load after Pegasys Combination Therapy with Ribavirin in HIV-HCV Co-infected Patients Study NR15961
Interferon alfa- 2a 3 MIE &
Pegasys 180 mcg &
Pegasys 180 μg &
Pegasys 180 mcg &
20
20% (58/ 286)*
Genotype 1 Lav viral belastning Høj viral belastning
Genotype 1 Low viral load High viral load
Genotype 2- 3 Lav viral belastning Høj viral belastning
Genotype 2-3 Low viral load High viral load
Interferon alfa- 2a 3MIE ribavirin 800mg:
Interferon alfa-2a 3MIU ribavirin 800 mg:
Odds Ratio (95% konfidensinterval) = 5, 40 (3, 42 til 8, 54), …. p- værdi (stratificeret Cochran- Mantel- Haenszel test) = < 0, 0001 * Pegasys 180 μg ribavirin 800 mg vs.
Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), …. P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg ribavirin 800 mg vs.
Pegasys 180 μg:
Pegasys 180μ g:
Odds Ratio (95% konfidensinterval) = 2, 89 (1, 93 til 4, 32), …. p - værdi (stratificeret Cochran- Mantel- Haenszel test) = < 0, 0001 * Interferon alfa- 2a 3MIE ribavirin 800 mg vs.
Odds Ratio (95% CI) = 2.89 (1.93 to 4.32), …. P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Interferon alfa-2a 3MIU ribavirin 800 mg vs.
Pegasys 180 μg:
Pegasys 180 mcg:
Odds Ratio (95% konfidensinterval) = 0, 53 (0, 33 til 0, 85), … p- værdi (stratificeret Cochran- Mantel- Haenszel test) = < 0, 0084
Odds Ratio (95% CI) = 0.53 (0.33 to 0.85), … P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0084
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.
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.
Inden 24 timer nås 80% af serum- peakkoncentrationen.
Within 24 hours, about 80% of the peak serum concentration is reached.
Absorptionen af Pegasys vedvarer, og serum- peakkoncentrationen nås efter 72 til 96 timers behandling.
The absorption of Pegasys is sustained with peak serum concentrations reached 72 to 96 hours after dosing.
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.
23 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 administration.
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.
Efter indgift af en enkelt intravenøs dosis blev der ikke fundet radioaktivt mærket peginterferon alfa- 2a i hjernen.
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.
Metabolismen af Pegasys er ikke fuldt karakteriseret, men studier på rotter tyder på, at nyren er et hovedorgan for udskillelse af radioaktivt markeret materiale.
The metabolism of Pegasys is not fully characterised; however studies in rats indicate that the kidney is a major organ for excretion of radiolabelled material.
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.
60 til 80 timer, sammenlignet med 3- 4 timer for standard- interferon.
After intravenous administration, the terminal half-life of peginterferon alfa-2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
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.
24 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.
Hos patienter med kronisk hepatitis B eller C akkumulerer serumkoncentrationen af peginterferon alfa- 2a 2 til 3 gange efter 6 til 8 ugers behandling én gang ugentlig, sammenlignet med enkeltdoser.
In chronic hepatitis B or C patients, peginterferon alfa-2a serum concentrations accumulate 2 to 3 fold after 6 to 8 weeks of once weekly dosing compared to single dose values.
1, 5 til 2.
The peak to trough ratio after 48 weeks of treatment is about 1.5 to 2.
Serumkoncentrationerne af peginterferon alfa- 2a vedvarer en hel uge (168 timer).
Peginterferon alfa-2a serum concentrations are sustained throughout one full week (168 hours).
Patienter med nyreinsufficiens Nyreinsufficiens er forbundet med let nedsat CL/ F og forlænget halveringstid.
Patients with renal impairment Renal impairment is associated with slightly decreased CL/ F and prolonged half-life.
Hos patienter (n=3) med CLcrea mellem 20 og 40 ml/ min er middel- CL/ F nedsat med 25%, sammenlignet med patienter med normal nyrefunktion.
In patients (n=3) with CLcrea between 20 and 40 ml/ min, the average CL/ F is reduced by 25% compared with patients with normal renal function.
4. 2).
In patients with end stage renal disease undergoing haemodialysis, there is a 25% to 45% reduction in the clearance, and doses of 135 micrograms result in similar exposure as 180 micrograms doses in patients with normal renal function (see section 4.2).
Køn Pegasys’ s farmakokinetik efter subkutane enkeltinjektioner var sammenlignelig hos raske mænd og kvinder.
Gender The pharmacokinetics of Pegasys after single subcutaneous injections were comparable between male and female healthy subjects.
Ældre 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).
The AUC was slightly increased (1663 vs.
AUC var let forøget (1663 versus 1295 ng⋅h/ ml), men peakkoncentrationerne (9, 1 versus 10, 3 ng/ ml) var de samme hos forsøgspersoner over 62 år.
10.3 ng/ ml) were similar in subjects older than 62 years.
4. 2).
Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see section 4.2).
Leverinsufficiens Pegasys’ s farmakokinetik var ens hos raske forsøgspersoner og hos patienter med hepatitis B eller C.
Hepatic impairment The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C.
Der blev set sammenlignelige eksponeringer og farmakokinetiske profiler hos patienter med cirrose (Child- Pugh grad A) og patienter uden cirrose.
Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Administrationssted Subkutan administration af Pegasys skal begrænses til abdomen og lår, idet omfanget af absorptionen baseret på AUC var omkring 20- 30% højere ved injektion i abdomen og lår.
Site of administration Subcutaneous administration of Pegasys should be limited to the abdomen and thigh, as the extent of absorption based on AUC was about 20% to 30% higher upon injection in the abdomen and thigh.
24 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Prækliniske toksicitetsstudier med Pegasys var begrænsede af artsspecificitet for interferoner.
The Non-clinical toxicity studies conducted with Pegasys were limited due to species specificity of interferons.
Resultaterne hos dyr, der fik peginterferon alfa- 2a svarede til resultaterne efter interferon alfa- 2a.
Acute and chronic toxicity studies have been carried out in cynomolgus monkeys, and the findings observed in peginterferon dosed animals were similar in nature to those produced by interferon alfa-2a.
Som for andre alfa- interferoner blev der hos hunaber observeret en forlængelse af menstruationscyklus efter administration af peginterferon alfa - 2a.
As with other alpha interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Behandling med interferon alfa- 2a medførte en statistisk signifikant stigning i abortfremkaldende aktivitet hos rhesusaber.
Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys.
Pegasys plus ribavirin Når Pegasys anvendtes i kombination med ribavirin, forårsagede det ingen virkninger på aber, som ikke var set efter de aktive stoffer alene.
Pegasys plus ribavirin When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Den vigtigste behandlingsrelaterede ændring var reversibel let til moderat anæmi, hvis sværhedsgrad var større end efter de enkelte aktive stoffer alene.
The major treatment-related change was reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
natriumchlorid polysorbat 80 benzylalkohol (10 mg/ 1 ml) natriumacetat eddikesyre vand til injektionsvæsker
sodium chloride polysorbate 80 benzyl alcohol (10 mg/ 1 ml) sodium acetate acetic acid water for injections
Da der ikke foreligger undersøgelser vedrørende eventueller uforligeligheder, bør dette præparat ikke blandes med andre præparater.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Opbevares i køleskab (2 °C– 8 °C).
Store in a refrigerator (2°C-8°C).
1 ml af opløsning for injektion 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).
Foreligger i pakninger med 1 eller 4 hætteglas.
Available in packs of 1 or 4.
20. juni 2002 / 20. juni 2007
20 June 2002/ 20 June 2007
26 1.
27 1.
peginterferon alfa- 2a *..................................................................................... 180 mikrogram Hvert hætteglas på 1 ml opløsning indeholder 180 mikrogram peginterferon alfa- 2a *.
peginterferon alfa-2a*.................................................................................... .180 micrograms Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*.
* Det aktive indholdsstof, peginterferon alfa- 2a, er et kovalent konjugat af proteinet interferon alfa- 2a produceret ved rekombinant DNA- teknologi ud fra Escherichia coli og konjugeret med bis - [monomethoxy polyethylenglycol].
*The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
Kombinationen af Pegasys og ribavirin er indiceret hos naive patienter og hos patienter hvor tidligere behandling med interferon alfa (pegyleret eller ikke- pegyleret) alene eller i kombinationsbehandling med ribavirin har svigtet.
The combination of Pegasys and ribavirin is indicated in naive patients and patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.
27 4. 2 Dosering og indgivelsesmåde
28 4.2 Posology and method of administration
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.
28 Tabel 1:
29 Table 1: