natgillin/translations-raw huggingface dataset:
Om nødvendigt kan injektionsmængden justeres med enten en opløsning af 9 mg/ ml (0, 9%) natriumklorid til injektion eller en opløsning af 50 mg/ ml (5%) glukose til injektion.
If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection.
Dette kan så progressivt blive øget i de følgende 1- 2 uger (omkring 20 ml/ kg fødselsvægt/ dag) op til en maksimal mængde på 180 ml/ kg fødselsvægt/ dag.
A maximal volume of 80 ml/ kg/ day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/ kg birthweight/ day) up to a maximal volume of 180 ml/ kg birthweight/ day.
Dette lægemiddel må ikke blandes med andre lægemidler med undtagelse af 9 mg/ ml (0, 9%) natriumkloridopløsning til injektion eller 50 mg/ ml (5%) glukoseopløsning.
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
For at kunne undgå enhver væsentlig variation i pH på grund af tilstedeværelsen af sure lægemidler, der kunne være tilbage i infusionsslangen, skal denne skylles før og efter indgivelsen af Pedea med 1, 5 til 2 ml enten 9 mg/ ml (0, 9%) natriumkloridopløsning til injektion eller 50 mg/ ml (5%) glukoseopløsning.
In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
Indhold (koncentration)
EU Number EU/ 1/ 02/ 221/ 001
Pakningsstørrelse
Invented name PEGASYS
EU/ 1/ 02/ 221/ 001 PEGASYS 135 µg
Strength 135 µg
Injektionsvæske, opløsning
Pharmaceutical form Route of administration Solution for injection Subcutaneous use
Subkutan anvendelse
Packaging Vial (glass)
EU/ 1/ 02/ 221/ 002 PEGASYS 135 µg
EU/ 1/ 02/ 221/ 002
Injektionsvæske, opløsning
PEGASYS
Subkutan anvendelse
Solution for injection Subcutaneous use
EU/ 1/ 02/ 221/ 003 PEGASYS 180 µg
EU/ 1/ 02/ 221/ 003
EU/ 1/ 02/ 221/ 004 PEGASYS 180 µg
EU/ 1/ 02/ 221/ 004
EU/ 1/ 02/ 221/ 005 PEGASYS 135 µg
EU/ 1/ 02/ 221/ 005
EU/ 1/ 02/ 221/ 006 PEGASYS 135 µg
EU/ 1/ 02/ 221/ 006
EU/ 1/ 02/ 221/ 007 PEGASYS 180 µg
EU/ 1/ 02/ 221/ 007
EU/ 1/ 02/ 221/ 008 PEGASYS 180 µg
EU/ 1/ 02/ 221/ 008
EU/ 1/ 02/ 221/ 009 PEGASYS 135 µg
EU/ 1/ 02/ 221/ 009
12 fyldte injektionssprøjter + 12 kanyler
12 pre-filled syringes + 12 injection needles
EU/ 1/ 02/ 221/ 010 PEGASYS 180 µg
EU/ 1/ 02/ 221/ 010
Det forkla - rer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte under - søgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Hvis du ønsker yderligere oplysninger om din sygdomstilstand eller behandling, kan du læse indlægs - sedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Pegasys er et lægemiddel, der indeholder det aktive stof peginterferon alfa- 2a.
Pegasys is a medicine that contains the active substance peginterferon alfa-2a.
Det leveres som injek - tionsvæske, opløsning, i et hætteglas og i en fyldt injektionssprøjte (135 og 180 mikrogram).
It is available as a solution for injection in a vial and as a pre-filled syringe (135 and 180 micrograms).
Pegasys anvendes til behandling af voksne patienter med følgende sygdomme: • kronisk (langvarig) hepatitis B (en leversygdom, der skyldes betændelse med hepatitis B- virus).
Pegasys is used to treat adult patients with the following diseases: • chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Det anvendes ved kompenseret leversygdom (dvs. leveren er beskadiget, men fungerer normalt), når der desuden er tegn på, at virus stadig formerer sig, og tegn på leverbeskadigelse (blodets indhold af leverenzymet alaninaminotransferase (ALT) er forhøjet, og levervævet fremtræder be - skadiget ved mikroskopisk undersøgelse), • kronisk hepatitis C (en leversygdom forårsaget af betændelse med hepatitis C- virus).
It is used in patients who have compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of alanine aminotransferase [ALT], a liver enzyme, and signs of damage when liver tissue is examined under a microscope); • chronic hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Det kan anvendes ved levercirrose (ardannelse) og ved samtidig smitte med hiv (humant immundefektvi - rus).
It can be used in patients with liver cirrhosis (scarring) and in patients also infected with human immunodeficiency virus (HIV).
Den bedste måde at anvende Pegasys på er sammen med ribarivin (et antiviralt lægemiddel).
The best way to use Pegasys is with ribavirin (an antiviral medicine).
Denne kombination er egnet til ikke tidligere behandlede patienter og til patienter, hvor tidligere behandling med enhver type interferon alfa, med eller uden ribavirin, ikke har virket.
This combination is suitable for treatment-naïve patients (who have not been treated before) and for patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Pegasys kan anvendes alene, hvis patienten ikke tåler ribarivin eller ikke skal have det.
Pegasys can be used on its own if the patient does not tolerate or must not receive ribavirin.
Behandlingen med Pegasys bør startes og overvåges af en læge med erfaring i behandling af patienter med hepatitis B eller C.
Treatment with Pegasys should be started by a doctor who has experience in the treatment of hepatitis B or C.
Pegasys gives ved indsprøjtning under huden i maveskindet eller i låret.
Pegasys is given by injection under the skin in the abdomen (tummy) or thigh.
Det gives normalt i en dosis på 180 mikrogram én gang ugentligt i 48 uger, selvom nogle patienter med hepatitis C kan have brug for 16, 24 eller 72 ugers behandling.
It is usually given as 180 micrograms once a week for 48 weeks, although some hepatitis C patients may need 16, 24 or 72 weeks of treatment.
Fuldstændige oplysninger om doseringen fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
For full dosing information, see the Summary of Product Characteristics (also part of the EPAR).
Det aktive stof i Pegasys, peginterferon alfa- 2a, tilhører interferon- gruppen.
The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘ interferons’.
Interferoner er naturlige stoffer, der produceres af kroppen som forsvar mod f. eks. virusinfektioner.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Reproduction is authorised provided the source is acknowledged Peginterferon alfa- 2a svarer i høj grad til interferon alfa- 2a, der allerede markedsføres i Den Europæi - ske Union (EU) under navnet Roferon.
Peginterferon alfa-2a is very similar to interferon alfa-2a, which is already available in the European Union (EU) as Roferon.
I Pegasys r interferon alfa- 2a blevet "pegyleret" (dvs. over - trukket med det kemiske stof polyethylenglycol).
In Pegasys, the interferon alfa-2a has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere interferon alfa- 2a.
The interferon alfa-2a in Pegasys is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2a.
Det kunstigt fremstillede interferon alfa virker på samme måde som det naturlige.
The replacement acts in same way as naturally produced interferon alpha.
Ved kronisk hepatitis C er Pegasys blevet undersøgt som eneste behandling i tre undersøgelser af i alt 1 441 patienter samt i én undersøgelse, hvor det blev anvendt i kombination med ribavirin hos 1 149 patienter.
In chronic hepatitis C, Pegasys has been studied on its own in three studies involving a total of 1,441 patients, and in combination with ribavirin in one study involving 1,149 patients.
Alle undersøgelser varede 48 uger og sammenlignede virkningen af Pegasys med virkningen af interferon alfa- 2a.
All of these studies lasted 48 weeks, and compared the effectiveness of Pegasys with that of interferon alfa-2a.
Disse undersøgelser omfattede en undersøgelse, hvori to forskellige doser og to behandlingsvarigheder (24 og 48 uger) blev sammenlignet hos 1 285 patienter; en undersøgelse, hvori 16 og 24 ugers behand - ling blev sammenlignet hos 1 469 patienter, en undersøgelse af 514 patienter med normale ALT - værdier, en undersøgelse af 860 patienter, der desuden var smittet med hiv, og endelig en undersøgelse af 950 patienter, som ikke har reageret på tidligere behandling med peginterferon alfa- 2b og ribavarin.
Additional studies looking at the combination of Pegasys and ribavirin included one study comparing two doses and two durations of treatment (24 or 48 weeks) in 1,285 patients, one study comparing 16 and 24 weeks of treatment in 1,469 patients, one study in 514 patients with normal ALT levels, one study in 860 patients who were also infected with HIV, and a final study in 950 patients who did not respond to previous treatment with peginterferon alfa-2b and ribavirin.
Den ene omfattede 820 patienter, der var HBeAg- positive (dvs. smit - tet med den almindelige type hepatitis B- virus).
In chronic hepatitis B, two studies have been carried out comparing Pegasys with lamivudine (another antiviral medicine) in 820 ‘ HBeAg-positive’ patients (infected with the common type of the hepatitis B virus) and in 552 ‘ HBeAg-negative ’ patients (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Den anden omfattede 552 patienter, der var HBeAg - negative (dvs. smittet med et virus, der har muteret (ændret sig) og er årsag til en form for kronisk hepatitis B, som er vanskeligere at behandle).
In all cases, the main measure of effectiveness was the disappearance of the markers of hepatitis virus infection from the blood after treatment and at ‘ follow-up’ six months later.
Ved kronisk hepatitis C var Pegasys, anvendt alene, mere effektivt end interferon alfa- 2a.
In chronic hepatitis C, Pegasys on its own was more effective than interferon alfa-2a.
I interferon alfa- 2a- gruppen var den til - svarende procentdel 8 til 19%.
More patients responded to treatment, with 28 to 39% of patients in the Pegasys group having no markers of hepatitis virus infection in their blood at follow-up, compared with 8 to 19% in the interferon alfa-2a group.
Denne kombination var mindst lige så effektivt som kombinationen af interferon alfa- 2a og ribavirin (som virkede hos 39% af patienterne).
When it was used in combination with ribavirin, Pegasys was more effective than when it was used on its own (45% responders at follow-up compared with 24%), and was as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Virkningen af Pegasys bekræftedes af de supplerende undersøgelser, herunder også hos hiv- smittede patienter og patienter, som ikke havde reageret på tidli - gere behandling.
The additional studies confirmed the effectiveness of Pegasys, including in patients with HIV and those who did not respond to previous treatment.
Ved kronisk hepatitis B var Pegasys mere effektivt end lamivudin hos både HBeAg- positive og - negative patienter.
In chronic hepatitis B, Pegasys was more effective than lamivudine in both HBeAg-positive and -negative patients.
Hos de HBeAg- negative patienter var de tilsvarende tal 43% med Pegasys og 29% med lami - vudin.
The proportions of patients with no signs of viral activity in their blood at follow- up were 32% with Pegasys and 22% with lamivudine in the HBeAg-positive patients, and 43% with Pegasys and 29% with lamivudine in the HBeAg-negative patients.
De almindeligste bivirkninger ved Pegasys (der optræder hos flere end 1 ud af 10 patienter) er appetit - løshed, hovedpine, søvnløshed, irritabilitet, depression, svimmelhed, kvalme, diarré, mavesmerter, hårtab, kløe, muskelsmerter, ledsmerter, træthed, feber, kulderystelser samt reaktioner på indstiksste - det og smerter.
The most common side effects with Pegasys (seen in more than 1 patient in 10) are anorexia (loss of appetite), headache, insomnia (difficulty sleeping), irritability, depression, dizziness, nausea (feeling sick), diarrhoea, abdominal (tummy) pain, alopecia (hair loss), pruritus (itching), myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), pyrexia (fever), rigors (shaking chills), reactions at the site of the injection and pain.
Den fuldstændige liste over de indberettede bivirkninger for Pegasys fremgår af ind - lægssedlen.
For the full list of all side effects reported with Pegasys, see the Package Leaflet.
Pegasys bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for alfa interfe - roner eller nogen af indholdsstofferne.
Pegasys should not be used in people who may be hypersensitive (allergic) to alpha interferons or any of the other ingredients.
Pegasys bør ikke anvendes hos: • patienter med autoimmun hepatitis (en sygdom, hvor kroppen angriber leveren) • patienter med svær leversygdom • patienter med tidligere svær hjertesygdom • hiv- smittede patienter med tegn på svær leversygdom Den fuldstændige liste over begrænsningerne for anvendelsen af Pegasys fremgår af indlægssedlen.
For a list of all restrictions with Pegasys, see the Package Leaflet.
2/ 3 Hvorfor blev Pegasys godkendt?
2/ 3 Why has Pegasys been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pegasys opvejer risiciene til behandling af kronisk hepatitis B og C.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pegasys’ s benefits are greater than its risks for treatment of chronic hepatitis B and C.
Udvalget anbefalede udstedelse af markedsførings - tilladelse for Pegasys.
The Committee recommended that Pegasys be given marketing authorisation.
Andre oplysninger om Pegasys:
Other information about Pegasys:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pegasys til Roche Registration Limited den 20. juni 2002.
The European Commission granted a marketing authorisation valid throughout the EU for Pegasys to Roche Registration Limited on 20 June 2002.
Markedsføringstilladelsen blev fornyet den 20. juni 2007.
The marketing authorisation was renewed on 20 June 2007.
Den fuldstændige EPAR for Pegasys findes her.
The full EPAR for Pegasys is available here.
peginterferon alfa- 2a *..................................................................................... 135 mikrogram Hvert hætteglas på 1 ml opløsning indeholder 135 mikrogram peginterferon alfa- 2a *.
peginterferon alfa-2a*.................................................................................... .135 micrograms Each vial of 1 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.
* Det aktive indholdsstof, peginterferon alfa- 2a, er et kovalent konjugat af proteinet interferon alfa- 2a produceret ved rekombinant DNA- teknologi ud fra Escherichia coli 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].
Styrken af dette lægemiddel bør ikke sammenlignes med det fra et andet pegyleret eller non- pegyleret protein i den samme terapeutiske klasse.
The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
4. 4 og 5. 1).
Pegasys is indicated for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/ or fibrosis (see sections 4.4 and 5.1).
4. 4).
Pegasys is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/ or co-infected with clinically stable HIV (see section 4.4).
Den optimale måde at anvende Pegasys på hos patienter med kronisk hepatitis C er i kombination med ribavirin.
The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin.
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.
Monoterapi er kun indiceret, hvis der er intolerans eller kontraindikation overfor ribavirin.
Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.
Hvis Pegasys skal anvendes i kombination med ribavirin, henvises der også til produktresuméet for ribavirin.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when Pegasys is to be used in combination with ribavirin.
Dosering og behandlingsvarighed
Dose to be administered and duration of treatment
Den anbefalede dosis og behandlingsvarighed af Pegasys til såvel HBeAg- positiv og HBeAg- negativ kronisk hepatitis B er 180 mikrogram én gang ugentlig i 48 uger, administreret subkutant i abdomen eller lår.
The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative chronic hepatitis B is 180 micrograms once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
Kronisk hepatitis C - behandlingsnaive patienter:
Chronic hepatitis C – treatment-naïve patients:
Patienter, som er smittet med HCV- genotype 1, som har påviselig HCV- RNA ved uge 4, uanset viral belastning ved baseline, skal have 48 ugers behandling.
Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre- treatment viral load should receive 48 weeks of therapy.
Behandling i 24 uger bør overvejes hos patienter inficeret med
Treatment for 24 weeks may be considered in patients infected with
- genotype 1 med lav viral belastning (≤ 800. 000 IE/ ml) ved baseline eller
- genotype 1 with low viral load (LVL) (≤ 800,000 IU/ mL) at baseline or
- genotype 4
- genotype 4
som bliver HCV- RNA- negative ved uge 4 og forbliver negative ved uge 24.
who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
5. 1).
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).
Årsagen er, at der er begrænset data tilgængelige, der antyder, at forkortet behandling signifikant vil påvirke det vedvarende virologiske respons negativt.
Shortening the treatment duration in patients with genotype 1 and high viral load (HVL) (> 800, 000 IU/ ml) at baseline who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24 should be considered with even more caution since the limited data available suggest that this may significantly negatively impact the sustained virologic response.
Patienter, som er smittet med HCV- genotype 2 eller 3, og som har detekterbar HCV- RNA ved uge 4, uanset viral belastning ved baseline, skal have 24 ugers behandling.
Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
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.
5. 1).
Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24 week treatment duration (see section 5.1).
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).
Data for patienter inficeret med genotype 5 og 6 er begrænset; derfor anbefales kombinationsbehandling med 1000/ 1200 mg ribavirin i 48 uger.
Available data for patients infected with genotype 5 or 6 are limited; therefore combination treatment with 1000/ 1200 mg of ribavirin for 48 weeks is recommended.
3 Tabel 1:
3 Table 1:
Anbefalet dosering for kombinationsbehandling til HCV- patienter Genotype
Dosing Recommendations for Combination Therapy for HCV Patients Genotype
Pegasys- dosis
Pegasys Dose
Ribavirin- dosis
Ribavirin Dose
Genotype 1 Lav viral belastning med RVR *
Genotype 1 LVL with RVR*
uger eller 48 uger
24 weeks or 48 weeks
Genotype 1 Høj viral belastning med RVR *
Genotype 1 HVL with RVR*
Genotype 4 med RVR *
Genotype 4 with RVR*
Genotype 1 eller 4 uden RVR *
Genotype 1 or 4 without RVR*
Genotype 2 eller 3 uden RVR **
Genotype 2 or 3 without RVR**
Genotype 2 eller 3 Lav viral belastning med RVR **
Genotype 2 or 3 LVL with RVR**
16 uger eller 24 uger
weeks or 24 weeks
Genotype 2 eller 3 Høj viral belastning med RVR ** *
Genotype 2 or 3 HVL with RVR**
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
Den endelige kliniske betydning af en kortere initial behandling på 16 uger i stedet for 24 uger er ikke kendt med hensyn til behovet for at genbehandle patienter, som ikke reagerer på behandling, og patienter, som recidiverer.
The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for retreating non-responding and relapsing patients.
Kronisk hepatitis C – behandlingserfarne patienter:
Chronic hepatitis C – treatment-experienced patients:
For patienter < 75 kg og ≥75 kg bør der administreres daglig henholdsvis 1000 mg og 1200 mg af ribavirin.
For patients < 75 kg and ≥ 75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, should be administered.
5. 1).
If patients infected with virus genotype 1, not responding to prior treatment with PEG-IFN and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).