natgillin/translations-raw huggingface dataset:
STORING PEDEA
SHRANJEVANJE PEDEE
18 Č eská republika Orphan Europe GmbH Max-Planck Str.
18 Česká republika Orphan Europe GmbH Max- Planck Str.
Eesti Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Rootsi Tlf: +46 8 545 80 230
Eesti Orphan Europe Nordic AB Banérgatan 37 S - 11522 Stockholm Rootsi Tlf: +46 8 545 80 230
As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Kot vse parenteralne pripravke je Pedeo potrebno pregledati glede prisotnosti delcev in integritete embalaže.
Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Zdravljenje s Pedeo se lahko izvaja le v neonatalnih intenzivnih enotah pod nadzorom izkušenega neonatologa.
A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
20 Zdravljenje s Pedeo sestoji iz treh intravenskih odmerkov apliciranih v 24- urnih intervalih.
- 1st injection:
Odmerek Ibuprofena se prilagaja glede na telesno maso: - 1. odmerek:
20 If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.
V primeru neizboljšanja stanja po drugem zdravljenju, bo verjetno potrebno kirurško zdravljenje odprtega duktusa arteriozusa.
Pedea should be administered as a short infusion over 15 minutes, preferably undiluted.
Pedeo aplicirajte v kratkih 15- minutnih infuzijah, najbolje nerazredčeno.
To facilitate the administration an infusion pump may be used.
Dajanje se lahko olajša z uporabo črpalke za infuzijo.
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.
Če je potrebno, prilagodite volumen z 0, 9 -% raztopino (9 mg/ ml) natrijevega klorida za injiciranje ali 5 -% raztopino (50 mg/ ml) glukoze za injiciranje.
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.
Tega zdravila ne smete mešati z drugimi zdravili, razen z 0, 9 -% (9 mg/ ml) raztopino natrijevega klorida za injiciranje ter 5 -% (50 mg/ ml) raztopino glukoze za injiciranje.
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.
V izogib pomembnim spremembam pH- ja zaradi prisotnosti kislih zdravil, ki bi lahko ostali v infuzijskih sistemih, je potrebno le- te pred aplikacijo Pedee sprati z 1, 5 do 2 ml 0. 9 -% (9 mg/ ml) raztopine natrijevega klorida za injiciranje ali 5 -% (50 mg/ ml) raztopine glukoze za injiciranje.
EU Number EU/ 1/ 02/ 221/ 001
številka EU
Invented name PEGASYS
zaščiteno ime
Strength 135 µg
jakost 135 µg
Pharmaceutical form Route of administration Solution for injection Subcutaneous use
raztopina za injiciranje subkutana uporaba
Packaging Vial (glass)
viala (steklo)
Package size 1 vial
1 viala
Solution for injection Subcutaneous use
raztopina za injiciranje subkutana uporaba
Subcutaneous use
raztopina za injiciranje subkutana uporaba
1 pre-filled syringe + 1 injection needle
1 napolnjena injekcijska brizga + 1 injekcijska igla
4 pre-filled syringes + 4 injection needles
4 napolnjene injekcijske brizge + 4 injekcijske igle
12 pre-filled syringes + 12 injection needles
12 napolnjenih injekcijskih brizg + 12 injekcijskih igel
Pegasys is a medicine that contains the active substance peginterferon alfa-2a.
Pegasys je zdravilo, ki vsebuje zdravilno učinkovino peginterferon alfa- 2a.
It is available as a solution for injection in a vial and as a pre-filled syringe (135 and 180 micrograms).
Na voljo je kot raztopina za injiciranje v viali in kot predhodno napolnjena injekcijska brizga (135 in 180 mikrogramov).
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).
Zdravilo Pegasys se uporablja za zdravljenje odraslih bolnikov z naslednjimi boleznimi: • kroničnim (dolgotrajnim) hepatitisom B (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa B).
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).
Uporablja se pri bolnikih, ki imajo kompenzirano jetrno bolezen (tj. poškodovana jetra, ki pa delujejo normalno), ki kažejo tudi znake, da se virus še vedno razmnožuje, ter imajo znake poškodbe jeter (zvišane vrednosti alanin aminotransferaze [ALT], jetrnega encima ter vidne znake poškodb jetrnega tkiva pri preiskavi pod mikroskopom); • kroničnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
It can be used in patients with liver cirrhosis (scarring) and in patients also infected with human immunodeficiency virus (HIV).
Uporabljati ga je mogoče pri bolnikih s cirozo jeter (brazgotinjenjem) in pri bolnikih, ki so okuženi tudi z virusom humane imunske pomanjkljivosti (HIV).
The best way to use Pegasys is with ribavirin (an antiviral medicine).
Najboljši način uporabe zdravila Pegasys je v kombinaciji z ribavirinom (protivirusnim zdravilom).
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.
Ta kombinacija je primerna za predhodno nezdravljene bolnike in bolnike, pri katerih predhodno zdravljenje, vključno s katero koli vrsto interferona alfa, z ribavirinom ali brez njega, ni bilo uspešno.
Pegasys can be used on its own if the patient does not tolerate or must not receive ribavirin.
Zdravilo Pegasys se lahko uporablja samostojno, če bolnik ne prenaša ali ne sme jemati ribavirina.
Treatment with Pegasys should be started by a doctor who has experience in the treatment of hepatitis B or C.
Zdravljenje z zdravilom Pegasys mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hepatitisa B ali C.
Pegasys is given by injection under the skin in the abdomen (tummy) or thigh.
Zdravilo Pegasys se injicira v podkožje trebuha ali stegna.
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.
Ponavadi se daje v odmerku 180 mikrogramov enkrat tedensko v obdobju 48 tednov, čeprav utegnejo nekateri bolniki s hepatitisom C potrebovati le 16 -, 24 - ali 72- tedensko zdravljenje.
The dose may need to be adjusted for patients who experience side effects.
Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo odmerek morda treba prilagoditi.
For full dosing information, see the Summary of Product Characteristics (also part of the EPAR).
Za vse informacije o odmerjanju glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘ interferons’.
Zdravilna učinkovina zdravila Pegasys, peginterferon alfa- 2a, spada v skupino interferonov.
The exact way alpha interferons work in viral diseases in not fully understood, but it is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Natančen način delovanja interferonov alfa pri virusnih boleznih ni v celoti znan, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. thought that they act as immunomodulators (substances that modify how the immune system, the body’ s defence system, works).
Reproduction is authorised provided the source is acknowledged. vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema, obrambnega sistema telesa).
Alpha interferons may also block the multiplication of viruses.
Interferoni alfa lahko tudi blokirajo razmnoževanje virusov.
Peginterferon alfa-2a is very similar to interferon alfa-2a, which is already available in the European Union (EU) as Roferon.
Peginterferon alfa- 2a je zelo podoben interferonu alfa- 2a, ki je že na voljo v Evropski uniji (EU) pod imenom Roferon.
In Pegasys, the interferon alfa-2a has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
V zdravilu Pegasys je interferon alfa- 2a „ pegiliran “ (prevlečen s kemično snovjo, imenovano polietilenglikol).
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
To zmanjšuje hitrost izločanja te snovi iz telesa in omogoča manj pogosto dajanje zdravila.
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.
Interferon alfa- 2a v zdravilu Pegasys proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori interferon alfa- 2a.
The replacement acts in same way as naturally produced interferon alpha.
Nadomestek deluje na enak način kot naravno proizvedeni interferon alfa.
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.
Pri kroničnem hepatitisu C so zdravilo Pegasys v samostojni uporabi proučevali v treh študijah, v katere je bilo vključenih 1 441 bolnikov, v kombinaciji z ribavirinom pa v eni študiji, ki je vključevala 1 149 bolnikov.
All of these studies lasted 48 weeks, and compared the effectiveness of Pegasys with that of interferon alfa-2a.
Vse te študije so trajale 48 tednov in so primerjale učinkovitost zdravila Pegasys z učinkovitostjo interferona alfa- 2a.
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.
Dodatne študije, ki so proučevale kombinacijo zdravila Pegasys in ribavirina, so obsegale eno študijo, ki je primerjala dva odmerka in dva cikla trajanja zdravljenja (24 ali 48 tednov) pri 1 285 bolnikih, eno študijo, ki je primerjala 16 in 24 tednov zdravljenja pri 1 469 bolnikih, eno študijo s 514 bolniki z normalnimi vrednostmi ALT, eno študijo s 860 bolniki, ki so bili okuženi tudi z virusom HIV, ter končno študijo z 950 bolniki, ki se niso odzivali na predhodno zdravljenje s peginterferonom alfa- 2b in ribavirinom.
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).
Pri kroničnem hepatitisu B sta bili izvedeni dve študiji, ki sta primerjali zdravilo Pegasys z lamivudinom (drugim protivirusnim zdravilom) pri 820 bolnikih, ki so bili „ HBeAg pozitivni “ (okuženi z običajno vrsto virusa hepatitisa B), ter pri 552 bolnikih, ki so bili „ HBeAg negativni “ (okuženi z virusom, ki je mutiral [se je spremenil], kar je privedlo do oblike hepatitisa B, ki jo je težje zdraviti).
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.
V vseh primerih je bilo glavno merilo učinkovitosti izginotje označevalcev okužbe z virusom hepatitisa iz krvi po zdravljenju in ob kontrolnem pregledu šest mesecev kasneje.
In chronic hepatitis C, Pegasys on its own was more effective than interferon alfa-2a.
Pri kroničnem hepatitisu C je bilo zdravilo Pegasys, uporabljeno samostojno, učinkovitejše od interferona alfa- 2a.
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.
Na zdravljenje se je odzvalo več bolnikov: ob kontrolnem pregledu 28 do 39% bolnikov iz skupine, ki je prejemala zdravilo Pegasys, ni imelo označevalcev okužbe z virusom hepatitisa v krvi, v primerjavi z 8 do 19% bolnikov iz skupine, ki je prejemala interferon alfa- 2a.
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).
Pri uporabi v kombinaciji z ribavirinom je bilo zdravilo Pegasys učinkovitejše kot pri samostojni uporabi (45% odzivnih bolnikov ob kontrolnem pregledu v primerjavi s 24%) in je bilo tako učinkovito kot kombinacija interferona alfa- 2a in ribavirina (39% odzivnih bolnikov).
The additional studies confirmed the effectiveness of Pegasys, including in patients with HIV and those who did not respond to previous treatment.
Dodatne študije so potrdile učinkovitost zdravila Pegasys, med drugim tudi pri bolnikih s HIV in bolnikih, ki se niso odzivali na predhodna zdravljenja.
In chronic hepatitis B, Pegasys was more effective than lamivudine in both HBeAg-positive and -negative patients.
Pri kroničnem hepatitisu B je bilo zdravilo Pegasys učinkovitejše od lamivudina tako pri HBeAg pozitivnih kot HBeAg negativnih bolnikih.
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.
Delež bolnikov brez znakov virusne aktivnosti v krvi ob kontrolnem obisku je bil pri HBeAg pozitivnih bolnikih 32% pri uporabi zdravila Pegasys oziroma 22% pri uporabi lamivudina, pri HBeAg negativnih bolnikih pa 43% pri uporabi zdravila Pegasys oziroma 29% pri uporabi lamivudina.
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.
Najpogostejši neželeni učinki zdravila Pegasys (opaženi pri več kot 1 bolniku od 10) so anoreksija (izguba teka), glavobol, nespečnost, razdražljivost, depresija, omotica, navzeja (slabost), driska, bolečine v trebuhu, alopecija (izpadanje las), pruritus (srbenje), mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), utrujenost, pireksija (povišana telesna temperatura), rigorji (mrazenje), reakcije na mestu injiciranja in bolečina.
For the full list of all side effects reported with Pegasys, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Pegasys, glejte navodilo za uporabo.
Pegasys should not be used in people who may be hypersensitive (allergic) to alpha interferons or any of the other ingredients.
Zdravila Pegasys ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) interferone alfa ali katero koli drugo sestavino zdravila.
For a list of all restrictions with Pegasys, see the Package Leaflet.
Zdravilo Pegasys se ne sme uporabljati pri: • bolnikih z avtoimunskim hepatitisom (telo napada jetra), • bolnikih z resnimi težavami z jetri, • bolnikih s hudo srčno boleznijo v anamnezi, • bolnikih, okuženih s HIV, ki kažejo znake hudega obolenja jeter.
2/ 3 Why has Pegasys been approved?
2/ 3 Za celoten seznam omejitev za zdravilo Pegasys glejte navodilo za uporabo.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Pegasys pri zdravljenju kroničnega hepatitisa B in C večje od z njim povezanih tveganj.
The Committee recommended that Pegasys be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Pegasys odobri dovoljenje za promet.
Other information about Pegasys:
Druge informacije o zdravilu Pegasys:
The European Commission granted a marketing authorisation valid throughout the EU for Pegasys to Roche Registration Limited on 20 June 2002.
Evropska komisija je dovoljenje za promet z zdravilom Pegasys, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 20. junija 2002.
The marketing authorisation was renewed on 20 June 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno 20. junija 2007.
The full EPAR for Pegasys is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pegasys je na voljo tukaj.
peginterferon alfa-2a*.................................................................................... .135 micrograms Each vial of 1 ml solution contains 135 micrograms peginterferon alfa-2a*.
peginterferon alfa- 2a *......................................................................................... 135 mikrogramov Ena viala z 1 ml raztopine vsebuje 135 mikrogramov peginterferona alfa- 2a *.
*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].
Vrednost se nanaša na vsebnost interferona alfa- 2a v molekuli peginterferona alfa- 2a, brez upoštevanja polietilenglikolnih verig. * Zdravilna učinkovina peginterferon alfa- 2a je kovalentni konjugat beljakovine interferona alfa- 2a, pridobljene iz celične kulture Escherichia coli s tehnologijo rekombinantne DNA, z molekulo bis - [monometoksipolietilenglikol].
The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Jakosti tega zdravila ne smete primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda.
For a full list of excipients, see section 6.1.
Za dodatne informacije glejte poglavje 5. 1.
Benzyl alcohol (10 mg/ 1 ml)
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Chronic hepatitis B:
Kronični hepatitis B
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).
Zdravilo Pegasys je indicirano za zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki so HBeAg pozitivni ali negativni, imajo kompenzirano jetrno bolezen, dokazano virusno replikacijo, zvišane vrednosti ALT ali histološko potrjeno vnetje jeter in/ ali fibrozo (glejte poglavji 4. 4 in 5. 1).
Chronic hepatitis C:
Kronični hepatitis C
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).
Zdravilo Pegasys je indicirano za zdravljenje odraslih bolnikov, ki imajo kronični hepatitis C in pozitivne HCV RNA v serumu, vključno z bolniki s kompenzirano cirozo in/ ali klinično stabilni bolniki, ki so sočasno okuženi z virusom HIV (glejte poglavje 4. 4).
The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin.
Optimalen način uporabe zdravila Pegasys pri bolnikih s kroničnim hepatitisom C je v kombinaciji z ribavirinom.
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.
Kombinacija zdravila Pegasys in ribavirina je indicirana pri bolnikih, ki se še niso zdravili, in bolnikih, pri katerih prejšnje zdravljenje s samim interferonom alfa (pegiliranim ali nepegiliranim) ali v kombinaciji z ribavirinom ni bilo uspešno.
Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.
Samostojno zdravljenje je indicirano zlasti pri intoleranci ali kontraindikacijah ribavirina.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when Pegasys is to be used in combination with ribavirin.
Če zdravilo Pegasys uporabljate v kombinaciji z ribavirinom, si preberite tudi povzetek glavnih značilnosti (SPC) ribavirina.
Dose to be administered and duration of treatment
Odmerek za aplikacijo in trajanje zdravljenja
Chronic hepatitis C – treatment-naïve patients:
Kronični hepatitis C – bolniki, ki se še niso zdravili
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.
Bolnike, okužene s HCV genotipom 1, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo neglede na virusno breme pred začetkom zdravljenja 48 tednov.
Treatment for 24 weeks may be considered in patients infected with
24- tedensko zdravljenje lahko vpeljemo pri bolnikih, ki so okuženi:
- genotype 1 with low viral load (LVL) (≤ 800,000 IU/ mL) at baseline or
- z genotipom 1 in imajo nizko virusno breme pred začetkom zdravljenja (≤ 800. 000 i. e. / ml) ali
- genotype 4
- z genotipom 4,
who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
pri katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja.
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).
Vendar pa je skupna dolžina zdravljenja 24 tednov lahko povezana z večjim tveganjem ponovitve bolezni kot pri skupni dolžini zdravljenja 48 tednov (glejte poglavje 5. 1).
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.
Pri skrajševanju trajanja zdravljenja pri bolnikih z genotipom 1 in visokim virusnim bremenom pred začetkom zdravljenja (> 800. 000 i. e. / ml), ki postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja, je potrebna še večja pozornost, saj so na voljo le omejeni podatki, ki kažejo, da to lahko signifikantno negativno vpliva na trajen virološki odziv.
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.
Bolnike okužene s HCV genotipom 2 ali 3, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo neglede na virusno breme pred začetkom zdravljenja 24 tednov.
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.
Krajše 16- tedensko zdravljenje lahko vpeljemo pri izbranih bolnikih, ki so okuženi z genotipom 2 ali 3 in imajo nizko virusno breme pred začetkom zdravljenja (≤ 800. 000 i. e. / ml) ter pri bolnikih, katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 16. tednu zdravljenja.