natgillin/translations-raw huggingface dataset:
Den relative non- toxicitet af monomethoxy- polyethylenglycol (mPEG), som frigøres fra PegIntron ved metabolisme in vivo er blevet påvist i prækliniske akutte og subkroniske toksicitetsundersøgelser hos gnavere og aber, standard embryofoetale udviklingsundersøgelser og i in vitro mutagenicitetsforsøg.
The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from PegIntron by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Dinatriumphosphat, vandfri Natriumdihydrogenphosphatdihydrat,
Disodium phosphate, anhydrous, Sodium dihydrogen phosphate dihydrate, Sucrose, Polysorbate 80.
22 Saccharose, Polysorbat 80.
22 Water for injections.
6. 6).
This medicinal product should only be reconstituted with the solvent provided (see section 6.6).
Efter tilberedning:
After reconstitution:
- Kemisk og fysisk holdbarhed under brug er påvist for 24 timer ved 2°C - 8ºC.
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
- Fra et mikrobiologisk synspunkt skal præparatet anvendes straks.
- From a microbiological point of view, the product is to be used immediately.
Hvis det ikke anvendes straks,
If not used
er opbevaringstider og – betingelser under brug indtil indgift brugerens ansvar og skal normalt ikke være længere end 24 timer ved 2°C - 8°C.
immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Pulveret er påfyldt i et 2 ml hætteglas, Type I flint glas, med en butylgummiprop i et aftageligt aluminiumsegl med en polypropylenhætte.
The powder is contained in a 2 ml vial, Type I flint glass, with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet.
Solvens findes i en 2 ml ampul, Type I flint glas.
The solvent is presented in a 2 ml ampoule, Type I flint glass.
PegIntron 50 mikrogram leveres som:
PegIntron 50 micrograms is supplied as:
- 1 hætteglas pulver til injektionsvæske, opløsning og 1 ampul solvens til parenteralt brug;
- 1 vial of powder for solution for injection and 1 ampoule of solvent for parenteral use;
- 1 hætteglas pulver til injektionsvæske, opløsning, 1 ampul solvens til parenteralt
- 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection
brug, 1 injektionssprøjte, 2 kanyler og 1 renseserviet;
syringe, 2 injection needles and 1 cleansing swab;
- 4 hætteglas pulver til injektionsvæske, opløsning og 4 ampuller solvens til parenteralt brug;
- 4 vials of powder for solution for injection and 4 ampoules of solvent for parenteral use;
- 4 hætteglas pulver til injektionsvæske, opløsning, 4 ampuller solvens til parenteralt
- 4 vials of powder for solution for injection, 4 ampoules of solvent for parenteral use, 4 injection
brug, 4 injektionssprøjter, 8 kanyler og 4 renseservietter;
syringes, 8 injection needles and 4 cleansing swabs;
- 6 hætteglas pulver til injektionsvæske, opløsning og 6 ampuller solvens til parenteralt brug.
- 6 vials of powder for solution for injection and 6 ampoules of solvent for parenteral use.
- 12 hætteglas pulver til injektionsvæske, opløsning, 12 ampuller solvens til parenteralt
- 12 vials of powder for solution for injection, 12 ampoules of solvent for parenteral use, 12 injection
brug, 12 injektionssprøjter, 24 kanyler og 12 renseservietter.
syringes, 24 injection needles and 12 cleansing swabs.
PegIntron leveres som et pulver peginterferon alfa- 2b i en styrke på 50 mikrogram til éndosis brug.
PegIntron is supplied as a powder of peginterferon alfa-2b at a strength of 50 micrograms for single use.
Hvert hætteglas skal tilberedes med 0, 7 ml vand til injektionsvæsker for indgift af op til 0, 5 ml opløsning.
Each vial must be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Et lille volumen går tabt under færdigtilberedningen af PegIntron til injektion, når dosen afmåles og injiceres.
A small volume is lost during preparation of PegIntron for injection when the dose is measured and injected.
Hvert hætteglas indeholder derfor en ekstra mængde af solvens og PegIntron pulver for at sikre indgift af den anførte dosis i 0, 5 ml PegIntron, injektionsvæske.
Therefore, each vial contains an excess amount of solvent and PegIntron powder to ensure delivery of the labelled dose in 0.5 ml of PegIntron, solution for injection.
Den tilberedte opløsning har en koncentration på 50 mikrogram/ 0, 5 ml.
The reconstituted solution has a concentration of 50 micrograms/0.5 ml.
Ved hjælp af en steril injektionssprøjte og kanyle injiceres 0, 7 ml vand til injektionsvæsker i hætteglasset med PegIntron.
Using a sterilised injection syringe and injection needle, inject 0.7 ml of water for injections into the vial of PegIntron.
Omryst blidt for at fuldende opløsningen af pulveret.
Agitate gently to complete dissolution of powder.
Den foreskrevne dosis kan herefter udtages med en steril injektionssprøjte og injiceres.
The appropriate dose can then be withdrawn with a sterilised injection syringe and injected.
23 Som ved alle parenterale lægemidler, inspicer visuelt den tilberedte opløsning før indgift.
As for all parenteral medicinal products, inspect visually the reconstituted solution prior to administration.
Den tilberedte opløsning bør være klar og farveløs.
The reconstituted solution should be clear and colourless.
Må ikke anvendes, hvis der er misfarvning eller bundfald.
Do not use if discolouration or particulate matter is present.
Bortkast en eventuel rest.
Discard any unused material.
25. maj 2000 Dato for seneste fornyelse:
25 May 2000 Date of last renewal:
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this product is available on the web-site of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Hvert hætteglas PegIntron, pulver til injektionsvæske, opløsning, indeholder 80 mikrogram peginterferon alfa- 2b målt på proteinbasis.
Each vial of PegIntron, powder for solution for injection contains 80 micrograms of peginterferon alfa-2b as measured on a protein basis.
Hvert hætteglas giver 80 mikrogram/ 0, 5 ml peginterferon alfa- 2b efter tilberedning som anbefalet.
Each vial provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
5. 1. * produceret ved hjælp af rDNA teknologi i E. coli celler indeholdende et genetisk fremstillet plasmahybrid med et interferon alfa- 2b gen fra humane leukocytter
For more inform ation, see section 5.1. *produced by rDNA technology in E.coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes
25 Kombinationsbehandling PegIntron 1, 5 mikrogram/ kg/ uge i kombination med ribavirin kapsler.
25 Combination therapy PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Den foreskrevne dosis PegIntron 1, 5 μg/ kg til anvendelse i kombination med ribavirin kan indgives ifølge kategorier efter patientens vægt og styrken af pen/ hætteglas, som anført i Tabel 1.
The intended dose of 1.5 μg/kg of PegIntron to be used in combination with ribavirin may be delivered in weight categories with the pen/vial strengths according to Table 1.
Styrke af
Vial/Pen Strength
hætteglas/ pen (μg/ 0, 5ml)
(μg/0.5ml)
For patienter, som udviser virologisk respons ved uge 12, bør behandling fortsættes i en yderligere ni måneders periode (det vil sige i alt 48 uger).
For patients who exhibit virological response at week 12, treatment should be continued for another nine month period (i.e., a total of 48 weeks).
I undergruppen af patienter med genotype 1 og lav virusmængde (< 600. 000 IU/ ml) som bliver HCV- RNA negative ved behandlingsuge 4 og som stadig er HCV- RNA negative ved uge 24, kan behandlingen enten stoppe efter denne 24 ugers behandlingsperiode eller blive videreført i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
Det anbefales, at alle patienter behandles i 24 uger, undtaget er HCV/ HIV co- inficerede patienter, der bør modtage 48 ugers behandling. • Genotype 4:
It is recommended that all patients be treated for 24 weeks, except for HCV/HIV co-infected patients who should receive 48 weeks of treatment. • Genotype 4:
Samtidig infektion med HCV/ HIV Den anbefalede doseringsvarighed af HCV/ HIV co- inficerede patienter er 48 uger uanset genotype.
HCV/HIV Co-infection The recommended duration of dosing for HCV/HIV co-infected patients is 48 weeks, regardless of genotype.
Forudsigelighed af respons og non- respons ved HCV/ HIV co- infektion Tidlig virologisk respons i Uge 12, defineret som et 2 log viralt fald i load eller ikke- detekterbare niveauer af HCV- RNA, har vist sig at være forudsigeligt for et vedvarende respons.
Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
En positiv
The negative predictive value for sustained response in HCV/HIV co-infected patients treated with PegIntron in combination with ribavirin was 99% (67/68; Study 1) (see section 5.1).
26 forudsigelig værdi på 50% (52/ 104; Undersøgelse 1) blev observeret for HCV/ HIV co- inficerede patienter, der modtog kombinationsbehandling.
A positive predictive value of 50% (52/104; Study 1) was observed for HCV/HIV co-infected patients receiving combination therapy.
Behandlingsvarighed – Genbehandling Forudsigelighed af vedvarende virologisk respons:
26 Duration of treatment - Retreatment Predictability of sustained virological response:
PegIntron monoterapi Ved monoterapi er PegIntron regimen 0, 5 eller 1, 0 mikrogram/ kg/ uge.
PegIntron monotherapy As monotherapy the PegIntron regimen is 0.5 or 1.0 microgram/kg/week.
Doser til patienter, der foreskrives 0, 5 μg/ kg/ uge, skal således justeres ved volumen, som vist i Tabel 2.
The lowest vial or pen strength available is 50 μg/0.5 ml; therefore for patients prescribed 0.5 μg/kg/week, doses must be adjusted by volume as shown in Table 2.
For dosen 1, 0 μg/ kg kan der foretages en tilsvarende justering af volumen, eller der kan anvendes hætteglas med andre styrker, som vist i Tabel 2.
For the 1.0 μg/kg dose, similar volume adjustments can be made or alternate vial strengths can be used as shown in Table 2.
PegIntron monoterapi blev ikke undersøgt i HCV/ HIV co- inficerede patienter.
PegIntron monotherapy was not studied in HCV/HIV co-infected patients.
Indgives en gang Styrke af
Administer Vial/Pen Once Weekly Strength
hætteglas/ pen (μg/ 0, 5ml)
(μg/0.5 ml)
om ugen hætteglas/ pen (ml) (μg/ 0, 5ml)
(ml) (μg/0.5ml)
Mindste indgift med pen er 0, 3 ml. ** Ved patienter > 120 kg anvendes hætteglas med 80 μg/ 0, 5 ml.
Minimum delivery for pen is 0.3 ml. ** For patients > 120 kg, use 80 μg/0.5 ml vial
Behandlingsvarighed Hos patienter, som udviser virologisk respons ved uge 12, bør behandlingen fortsættes i en periode på mindst tre måneder mere (svarende til totalt seks måneder).
Duration of treatment For patients who exhibit virological response at Week 12, treatment should be continued for at least another three-month period (i.e., a total of six months).
27 Kombinationsbehandling - vejledninger for dosisreduktion
27 Combination Therapy Dose Reduction Guidelines
600 mg/ dag *
ribavirin dose to 600 mg/day* if:
12 g/ dl efter ugers dosis - reduktion < 1, 0 x 109/ l < 0, 5 x 109/ l
12 g/dl after four weeks of dose reduction < 1.0 x 109/l < 0.5 x 109/l
< 25 x 109/ l 2, 5 x ULN ** > 4 mg/ dl (i > 4 uger)
< 25 x 109/l 2.5 x ULN ** > 4 mg/dl (for > 4 weeks)
> 2, 0 mg/ dl
Creatinine ALT/AST
ALT/ AST
- - - -
x baseline og
> 2.0 mg/dl 2 x baseline and > 10 x ULN**
Styrke af
Vial/Pen
reducerede dosis (μg)
Dose (μg)
om ugen (ml)
(μg/0.5 ml)
mængde (μg)
(ml)
PegIntron monoterapi - vejledninger for dosisreduktion
PegIntron Monotherapy Dose Reduction Guidelines
Vejledninger for dosisjustering hos patienter, som anvender PegIntron monoterapi, fremgår af Tabel 3a.
Dose modification guidelines for patients who use PegIntron monotherapy are shown in Table 3a.
28 Tabel 3a Dosisjusteringsvejledninger for PegIntron monoterapi Laboratorieværdier
Table 3a Dose modification guidelines for PegIntron monotherapy
Dosisreduktion hos patienter, som anvender PegIntron 0, 5 μg/ kg som monoterapi, skal ske ved at reducere det foreskrevne volumen med halvdelen.
28 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Hætteglasset 50 μg/ 0, 5 ml skal om nødvendigt anvendes, da pennen som minimum kun kan afgive et volumen på 0, 3 ml.
The 50 μg/0.5 ml vial must be used if necessary since the pen can only deliver a minimum volume of 0.3 ml.
Hos patienter, som anvender PegIntron 1, 0 μg/ kg som monoterapi, kan dosisreduktion ske ved at reducere det foreskrevne volumen med halvdelen eller ved at bruge en lavere styrke, som vist i Tabel 3b.
For patients who use 1.0 μg/kg PegIntron monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Tabel 3b – Reduceret PegIntron dosis for 1, 0 μg/ kg monoterapiregimen
Table 3b – Reduced PegIntron Dose for the 1.0 μg/kg Monotherapy Regimen
hætteglas/ pen (μg/ 0, 5ml)
Strength
om ugen (ml)
Once Weekly
mængde (μg)
Delivered
30- 35
(μg/0.5 ml)
50 *
(ml)
0, 15
(μg)
PegIntron bør anvendes med forsigtighed hos patienter med moderat til kraftig nedsættelse af nyrefunktionen.
Peg Intron should be used with caution in patients with moderate to severe renal impairment.
Hos patienter med moderat nedsat nyrefunktion (creatinin clearance 30- 50 ml/ minut) bør initialdosis af PegIntron reduceres med 25%.
In patients with moderate renal dysfunction (creatinine clearance 30- 50 ml/minute), the starting dose of PegIntron should be reduced by 25%.
Patienter med kraftigt nedsat nyrefunktion (creatinin clearance 15- 29 ml/ minut) bør have initialdosis af PegIntron reduceret med 50%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of PegIntron reduced by 50%.
5. 2).
Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Patienter med creatinin clearance < 50 ml/ minut må ikke behandles med PegIntron i kombination med ribavirin (se ribavirin SPC).
Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SPC).
29 Anvendelse ved nedsat leverfunktion:
Use in hepatic impairment:
for et eller flere af hjælpestofferne;
29
- Anamnese med alvorlig forud eksisterende hjertesygdom, inklusive ustabil eller ukontrolleret
- A history of severe pre-exist ing cardiac disease, including unstable or uncontrolled cardiac disease
- Epilepsi og/ eller påvirket centralnervesystem (CNS) funktion;
- Epilepsy and/or compromised central nervous system (CNS) function;
- Initiering af PegIntron er kontraindiceret i HCV/ HIV patienter med cirrhose og en Child- Pugh
- Initiation of PegIntron is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh
Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) har været set sjældent under interferon alfa- 2b behandling.
Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Hvis en sådan reaktion udvikles 30 under behandling med PegIntron, seponer behandlingen og indsæt omgående passende medicinsk behandling.
If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Som med interferon alfa- 2b kræver patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/ eller tidligere eller nuværende arytmilidelser, der får PegIntron behandling, tæt monitoring.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving PegIntron therapy require close monitoring.
Hydrering:
30 Hydration:
31 Mitokondriel toksicitet og mælkesyre acidose:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Hepatisk dekompensering hos HCV/ HIV co- inficerede patienter med fremskreden cirrose:
Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis:
Hæmatologiske anomalier hos HCV/ HIV co- inficerede patienter:
31 Haematological abnormalities in HCV/ HIV co-infected patients:
Patienter, der samtidig er inficeret med HCV/ HIV, og som modtager peginterferon alfa- 2b/ ribavirin - behandling og HAART, kan have øget risiko for at udvikle hæmatologiske anomalier (som neutropeni, thrombocytopeni og anæmi) sammenlignet med HCV mono- inficerede patienter.
HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
4. 2 og under ” Laboratorieanalyser ” og pkt.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Blandt patienter, der er co- inficeret med HCV/ HIV, er der, for patienter med CD4- tællinger mindre end 200 celler/ μl, begrænsede effekt - og sikkerhedsdata (N = 25) tilgængelige.
In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik PegIntron og ribavirin kombinationsbehandling.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Peg Intron and ribavirin combination therapy.
32 • • •
• • •
Forsigtighed bør udvises ved administration af peginterferon alfa- 2b med lægemidler, som metaboliseres af CYP2D6 og CYP2C8/ 9, specielt dem med snævert terapeutisk vindue, såsom warfarin og phenytoin (CYP2C9) og flecainid (CYP2D6).
Caution should be used when admin istering peginterferon alfa-2b with medicinesmetabolised by CYP2D6 and CYP2C8/9, especially those with narrow therapeutic window, such as warfarin and phenytoin (CYP2C9) and flecainide (CYP2D6).
Der sås ingen farmakokinetiske interaktioner mellem PegIntron og ribavirin i en flerdosis farmakokinetisk undersøgelse.
No pharmacokinetic interactions were noted between Peg Intron and ribavirin in a multiple-dose pharmacokinetic study.
33 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Der forligger ikke tilstrækkelige data om brugen af interferon alfa- 2b hos gravide kvinder.
There are no adequate data from the use of interferon alfa-2b in pregnant women..
PegIntron skal kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko for fosteret.
PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
Fertile kvinder og deres partnere skal begge anvende en effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
33 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
34 Tabel 4
Table 4
Meget almindelig:
34 Metabolism and nutrition disorders Very common:
35 Hyppighed ikke kendt:
Frequency not known:
Interstitiel lungesygdom
Interstitial lung disease 35
36 Sjælden:
Rare:
4. 4).
36 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
37 Laboratorieværdier for samtidig infektion med HCV/ HIV Selvom hæmatologisk toksicitet af neutropeni, thrombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/ HIV, kunne hovedparten afhjælpes med en modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Hæmatologiske anomaliteter blev rapporteret mere hyppigt hos patienter, der modtog PegIntron i kombination med ribavirin end hos patienter, der modtog interferon alfa- 2b i kombination med ribavirin.
Haematological abnormalities were more frequently reported in patients receiving PegIntron in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Der findes ingen specifik antidot til PegIntron; i tilfælde af overdosering anbefales der derfor symptomatisk behandling og tæt observation af patienten.
No specific antidote for PegIntron is available; therefore, symptomatic
38 Når først interferon er bundet til cellemembranen, så udløser det en kompleks række af intracellulære virkninger, som inkluderer induktion af visse enzymer.
Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
PegIntron kliniske undersøgelser - Naive patienter To pivotale undersøgelser er blevet udført, en (C/ I97- 010) med PegIntron monoterapi; den anden (C/ I98- 580) med PegIntron i kombination med ribavirin.
Peg Intron clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with PegIntron mono therapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
I PegIntron kombinationsundersøgelsen blev 1. 530 naive patienter behandlet i et år med et af følgende kombinationsregimen: • PegIntron (1, 5 mikrogram/ kg/ uge) + ribavirin (800 mg/ dag), (n = 511). • PegIntron (1, 5 mikrogram/ kg/ uge i en måned efterfulgt af 0, 5 mikrogram/ kg/ uge i 11 måneder) + ribavirin (1. 000/ 1. 200 mg/ dag), (n = 514). • Interferon alfa- 2b (3 MIE tre gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag) (n = 505).
38 In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
Responsraterne i denne undersøgelse blev imidlertid vist også at være afhængige af dosen af ribavirin indgivet i kombination med PegIntron eller interferon alfa- 2b.
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with PegIntron or interferon alfa-2b.
respons (% patienter HCV negative) PegIntron monoterapi PegIntron + ribavirin 39
PegIntron + ribavirin
P 1, 5 PegIntron 1, 5 mikrogram/ kg P 1, 0 PegIntron 1, 0 mikrogram/ kg P 0, 5 PegIntron 0, 5 mikrogram/ kg I Interferon alfa- 2b 3 MIE P 1, 5/ R P 0, 5/ R I/ R * **
P 1.5 Peg Intron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/R * **
Genotype 2/ 3
39 Genotype 2/3
Alle ≤ 10, 6 > 10, 6
80%
PegIntron (1, 5 mikrogram/ kg) + ribavirin (800 mg) PegIntron (1, 5 til 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 MIE) + ribavirin (1. 000/ 1. 200 mg)
Peg Intron (1.5 microgr ams/kg) + ribavirin (800 mg) PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg)