natgillin/translations-raw huggingface dataset:
19
19 19 klikov on
20
20 4 polni obrati (20 klikov) * uk
60 million IU in doses ranging from 5 to 20 million IU.
Presnikje oblikovan tako, da njegovo vsebino 60 milijonov i. e., lahko odmerjamo v razponu od 5 do 20 milijonov i. e.
The pen will deliver a maximum of 12 doses of 5 million IU over a period not to exceed 4 weeks. i dic Me
S peresnikom lahko dajemo največ 12 odmerkov po 5 milijonov i. e., v časovnem obdobju, ki ni daljše kot 4 tedne. ks
411 The push button scale will show you the dose set (see Diagram N below).
Na lestvici pritisnega gumba je viden nastavljeni odmerek (glejte sliko N spodaj).
For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
Za odmerke, ki ustrezajo polnim obratom, se mora lestvica poravnati s pravilno oznako odmerka, za tiste odmerke, ki ustrezajo klikom med polnimi obrati, pa se mora poravnati med dvema ustreznima oznakama odmerka za Lie
ori uth ra Diagram N
433 ie ác r ist eg Slika N
If you
Če ste
ge have set a wrong dose, simply turn the cap back (anti-clockwise) as far as you can until the push button is fully home and start again.
ur nastavili napačen odmerek, preprosto obrnite pokrovček nazaj (nasprotno smeri urnega kazalca) do konca, dokler ne bo pritisni gumb spet v začetnem položaju, in začnite ponovno.
Once the correct dose is set you are ready to give the injection. lon
Ko bo nastavljen pravilen odmerek, boste pripravljeni za injiciranje.
no
sťo no lat up
Diagram O Injecting the solution rod
Slika O no
Select the injection site.
Injiciranje raztopine Izberite si mesto, kamor boste injicirali zdravilo.
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Najboljša mesta za injiciranje so tkiva s plastjo maščevja med kožo in mišicami: stegno, zunanja površina nadlahti (tu boste morda potrebovali pomoč druge osebe), če
Change your injection site each time. lp
Pri vsakem injiciranju menjavajte injekcijsko mesto.
Wait for the area to dry. na
S on
With one hand, pinch a fold of loo se skin.
prstoma ene roke oblikujte kožno gubo.
Insert the needle into the pinched skin at an angle of approximately 45°. i
Vbodite iglo v kožno gubo pod kotom približno 45°. uk
Then press the push button down fully (see Diagram P). dic Me
Zdaj do konca pritisnite na gumb (glejte sliko P). ks Lie
412 Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon, solution for injection, to distribute under the skin, then remove.
434 Še naprej pritiskajte na gumb in pustite injekcijsko iglo v koži nekaj sekund, da se bo lahko Viraferon raztopina za injiciranje porazdelila pod kožo, potem potegnite iglo ven.
ori uth ra Diagram Q
ie ác r ist eg ur sťo Slika Q
Then carefully l ift it off the pen and discard the capped injection needle (see Diagram S). lon
Do konca odvijte sklop injekcijske igle, nasprotno smeri urnega kazalca, kot je prikazano na sliki R. no Potem ga previdno dvignite s peresnika in zavrzite pokrito injekcijsko iglo (glejte sliko S). lat up no če on uk
413 Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T.
Pokrovček peresnika postavite nazaj na peresnik, pri čemer naj bo trikotnik spet nasproti kazalnika ks
ed
435 Lie ks uk on če no up
ori uth Diagram T
436 Slika T
t
r
no
ác
414
ie
ViraferonPeg is a medicine containing the active substance peginterferon alfa-2b.
ViraferonPeg je zdravilo, ki vsebuje zdravilno učinkovino peginterferon alfa- 2b.
It is available as a powder and solvent to be made up into a solution for injection, and as a single use pre-filled pen.
Na voljo je v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje, ter napolnjenega injekcijskega peresnika za enkratno uporabo.
ViraferonPeg is used to treat adult patients with chronic (long-term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Zdravilo ViraferonPeg se uporablja za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
ViraferonPeg is used in patients whose liver is still functioning but who have signs of the disease (raised transaminases [liver enzymes] and markers of infection in the blood, such as viral RNA or antibodies against the virus).
Zdravilo ViraferonPeg se uporablja pri bolnikih, katerih jetra še vedno delujejo, vendar kažejo znake bolezni (zvišane vrednosti transaminaz [jetrnih encimov] in označevalce okužbe v krvi, kot so virusna RNA ali protitelesa proti virusu).
The best way to use ViraferonPeg is with ribavirin (an antiviral medicine).
Najboljši način uporabe zdravila ViraferonPeg 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 (ki dotlej še niso prejemali zdravil) in za bolnike, pri katerih predhodno zdravljenje, vključno s katerokoli vrsto interferonov alfa, z ribavirinom ali brez njega, ni bilo učinkovito.
ViraferonPeg can be used alone if the patient does not tolerate or should not take ribavirin.
Zdravilo ViraferonPeg je mogoče uporabljati samostojno, če bolnik ne prenaša ali ne sme jemati ribavirina.
ViraferonPeg treatment should be initiated and supervised by a doctor who has experience in the management of patients with hepatitis C.
Zdravljenje z zdravilom ViraferonPeg mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hepatitisom C.
ViraferonPeg is given once a week as a subcutaneous injection (under the skin).
Zdravilo ViraferonPeg se daje enkrat tedensko s subkutano injekcijo (pod kožo).
It used on its own at a dose of 0.5 or 1 microgram per kilogram body weight per week, or at a dose of 1.5 micrograms/ kg/ week when used with ribavirin.
Če se uporablja samostojno, znaša njegov odmerek 0, 5 ali 1 mikrogram na kilogram telesne mase na teden oziroma 1, 5 mikrograma/ kg/ teden, če se uporablja v kombinaciji z ribavirinom.
ViraferonPeg has to be stored in a refrigerator (2°C - 8°C).
Zdravilo ViraferonPeg hranite v hladilniku (2°C – 8ºC).
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘ interferons’.
Zdravilna učinkovina zdravila ViraferonPeg, peginterferon alfa- 2b, sodi v skupino interferonov.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Interferoni so naravne spojine, ki jih proizvaja telo z namenom obrambe proti napadom, kot so 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged immune system, the body’ s defence system, works).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged okužbe, ki jih povzročajo virusi.
In ViraferonPeg, the interferon alfa-2b has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
V zdravilu ViraferonPeg je interferon alfa- 2b „ pegiliran “ (prevlečen s kemično snovjo, imenovano polietilenglikol).
The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Interferon alfa- 2b, ki ga vsebuje zdravilo ViraferonPeg, se proizvaja po metodi, imenovani „ tehnologija rekombinantne DNA “: interferon alfa- 2b proizvaja bakterija, ki je prejela gen (DNA), ki ji omogoča njegovo tvorjenje.
The use of ViraferonPeg alone in chronic hepatitis C has been studied in one study in 1,224 treatment- naïve adult patients.
Samostojna uporaba zdravila ViraferonPeg pri kroničnem hepatitisu C je bila preučevana v eni študiji s 1. 224 predhodno nezdravljenimi odraslimi bolniki.
ViraferonPeg used once a week for 48 weeks (at 0.5, 1 or 1.5 micrograms/ kg) was compared with interferon alfa-2b used at 3 million international units (IU) three times a week.
Zdravilo ViraferonPeg, dajano enkrat tedensko v obdobju 48 tednov (v odmerku 0, 5, 1 ali 1, 5 mikrogramov/ kg), so primerjali z interferonom alfa- 2b, dajanim v odmerku 3 milijone mednarodnih enot (i. e.) trikrat tedensko.
The use of ViraferonPeg with ribavirin has been studied over 48 weeks in 1,580 treatment-naïve patients.
Uporabo zdravila ViraferonPeg v kombinaciji z ribavirinom so preučevali pri 1. 580 predhodno nezdravljenih bolnikih v obdobju 48 tednov.
This study compared two schedules of ViraferonPeg used with ribavirin with the combination of interferon alfa-2b and ribavirin.
V tej študiji so primerjali dve shemi zdravljenja: zdravilo ViraferonPeg, uporabljeno v kombinaciji z ribavirinom, v primerjavi s kombinacijo interferona alfa- 2b in ribavirina.
An additional two studies have looked at the use of ViraferonPeg in combination with ribavirin in 565 patients also infected with HIV, and a further study looked at the use of this combination in 1,354 patients whose previous treatment including interferon alfa (pegylated or non-pegylated) did not work or whose disease had come back after previous treatment.
V dveh dodatnih študijah so preučevali uporabo zdravila ViraferonPeg v kombinaciji z ribavirinom pri 565 bolnikih, ki so bili okuženi tudi s HIV, v dodatni študiji pa so preučevali uporabo te kombinacije pri 1. 354 bolnikih, pri katerih predhodno zdravljenje, vključno z interferonom alfa (pegiliranim ali nepegiliranim), ni bilo učinkovito ali pri katerih se je bolezen ponovno pojavila po predhodnem zdravljenju.
The main measure of effectiveness was the level of hepatitis C virus RNA circulating in the blood before and during treatment, and at ‘ follow-up’, 24 weeks later.
Glavno merilo učinkovitosti je bila raven virusne RNA (HCV RNK), prisotne v krvi pred in med zdravljenjem ter ob pregledu po obdobju spremljanja, 24 tednov kasneje.
What benefit has ViraferonPeg shown during the studies?
Kakšne koristi je zdravilo ViraferonPeg izkazalo med raziskavami?
In the first study, ViraferonPeg was more effective than interferon alfa-2b.
V prvi študiji je bilo zdravilo ViraferonPeg učinkovitejše od interferona alfa- 2b.
More patients had no circulating viral RNA after 24 weeks of treatment with ViraferonPeg than with interferon alfa-2b:
Po 24 tednih zdravljenja je bilo brez virusne RNA v obtoku več bolnikov, ki so se zdravili z zdravilom ViraferonPeg, kot bolnikov, ki so se zdravili z interferonom alfa- 2b:
46% with ViraferonPeg 1.5 microgram/ kg/ week compared with 24% with the comparator.
46% tistih, ki so se zdravili z zdravilom ViraferonPeg v odmerku 1, 5 mikrograma/ kg/ teden, v primerjavi s 24% tistih, ki so se zdravili s primerjalnim zdravilom.
Combining ribavirin and ViraferonPeg (as a once-weekly injection of 1.5 micrograms/ kg) was more effective than the combination with interferon alfa-2b (3 million IU three times a week): more patients had responded to treatment at the end of the study (65% compared with 54%).
Kombinacija ribavirina in zdravila ViraferonPeg (v obliki injekcije z odmerkom 1, 5 mikrograma/ kg enkrat tedensko) je bila učinkovitejša od kombinacije z interferonom alfa- 2b (3 milijone i. e. trikrat tedensko): ob koncu študije se je na zdravljenje odzvalo več bolnikov (65% v primerjavi s 54%).
The combination of ViraferonPeg with ribavirin was also effective for the treatment of hepatitis C in patients also infected with HIV.
Kombinacija zdravila ViraferonPeg z ribavirinom je bila učinkovita tudi pri zdravljenju hepatitisa C pri bolnikih, ki so bili okuženi tudi s HIV.
In the study of patients whose previous treatment did not work, around a fifth of the patients responded to treatment with ViraferonPeg and ribavirin.
V študiji z bolniki, pri katerih predhodno zdravljenje ni bilo učinkovito, se je približno petina bolnikov odzvala na zdravljenje z zdravilom ViraferonPeg in ribavirinom.
The most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, weight loss, depression, irritability, insomnia (difficulty sleeping), anxiety, impaired concentration, emotional lability (mood swings), headache, dry mouth, dyspnoea (difficulty breathing), pharyngitis (sore throat), coughing, vomiting, nausea (feeling sick), abdominal (tummy) pain, diarrhoea, anorexia (loss of appetite), alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, injection site reaction (pain and redness), dizziness, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms and asthenia (weakness).
Najpogostejši neželeni učinki zdravila ViraferonPeg (opaženi pri več kot 1 bolniku od 10) so virusne okužbe, izguba telesne mase, depresija, razdražljivost, nespečnost (težave s spanjem), anksioznost, motnje koncentracije, čustvena labilnost (nihanje razpoloženja), glavobol, suha usta, dispneja (oteženo dihanje), faringitis (vneto žrelo), kašljanje, bruhanje, navzeja (slabost), bolečine v trebuhu, driska, anoreksija (izguba teka), alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišičnoskeletne bolečine (bolečine v mišicah in kosteh), vnetje na mestu injiciranja, reakcije na mestu injiciranja (bolečine in rdečina), omotica, utrujenost, mrzlica (drgetanje), povišana telesna temperatura, gripi podobni simptomi in astenija (šibkost).
For the full list of all side effects reported with ViraferonPeg, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ViraferonPeg, glejte Navodilo za uporabo.
ViraferonPeg should not be used in people who may be hypersensitive (allergic) to any interferon or any of the other ingredients.
Zdravila ViraferonPeg se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) katerokoli vrsto interferona ali katero drugo sestavino zdravila.
In combination with ribavirin, ViraferonPeg should not be used in patients with kidney problems.
Zdravilo ViraferonPeg se ne sme uporabljati pri: • bolnikih s hudo srčno boleznijo v anamnezi,
Why has ViraferonPeg been approved?
• bolnikih z resnim zdravstvenim stanjem,
The Committee for Medicinal Products for Human Use (CHMP) decided that ViraferonPeg’ s benefits are greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum hepatitis C virus (HCV) RNA or anti-HCV including naïve patients with clinically stable HIV co-infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila ViraferonPeg pri zdravljenju odraslih bolnikov s kroničnim hepatitisom C, ki imajo zvišane vrednosti transaminaz brez dekompenzacije jeter in pozitiven izvid na serumsko HCV- RNA ali anti- HCV, vključno s predhodno nezdravljenimi bolniki s klinično stabilno sočasno okužbo s HIV, večje od z njim povezanih tveganj.
The Committee recommended that ViraferonPeg be given marketing authorisation.
Odbor je priporočil, da se za zdravilo ViraferonPeg odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for ViraferonPeg to SP Europe on 29 May 2000.
Evropska komisija je dovoljenje za promet z zdravilom ViraferonPeg, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 29. maja 2000.
The marketing authorisation was renewed on 29 May 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. maja 2005.
The full EPAR for ViraferonPeg is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ViraferonPeg je na voljo tukaj.
Content (concentration
Vsebina (koncentracija)
50 micrograms
50
powder: vial (glass); solvent: ampoule (glass)
prašek: viala
0.7 ml (50 µg/ 0.5 ml)
0, 7 ml (50 µg/ 0, 5
80 micrograms
80
100 micrograms
100
0.7 ml (100 µg/ 0.5 ml)
0, 7 ml (100
120 micrograms
120
0.7 ml (120 µg/ 0.5 ml)
0, 7 ml (120
150 micrograms
150
0.7 ml (150 µg/ 0.5 ml)
0, 7 ml (150
12 vials + 12 ampoules + 12 injection sets1
12 vial + 12 ampule + 12 injekcijskih setov1
3/ 6 EU Number
mikrogramov
Route of Administration
raztopino za injiciranje
Packaging
uporaba
Content (concentration
(steklena); topilo: ampula (steklena)
Package size
µg/ 0, 5 ml)
5/ 6 1 Injection set = injection syringe + 2 injection needles + cleansing swab.
1 injekcijski set = injekcijska brizga + 2 injekcijski igli + čistilni tampon
ViraferonPeg 50 micrograms powder and solvent for solution for injection
ViraferonPeg 50 mikrogramov, prašek in vehikel za raztopino za injiciranje
Each vial of ViraferonPeg, powder for solution for injection contains 50 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Vsaka viala zdravila ViraferonPeg, prašek za raztopino za injiciranje, vsebuje 50 mikrogramov peginterferona alfa- 2b, merjeno glede na beljakovine.
Each vial provides 50 micrograms/ 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 50 mikrogramov/ 0, 5 ml peginterferona alfa- 2b.
The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Učinkovina zdravila je kovalentni konjugat rekombinantnega interferona alfa- 2b * z monometoksi polietilenglikolom.
The potency of this product should not be compared to that 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 more information, 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
Za dodatne informacije glejte poglavje 5. 1. * izdelan s tehnologijo rekombinantne DNA na celicah E. coli, v katere so z genetskim inženiringom vstavili plazmidni hibrid z genom za interferon alfa- 2b iz človeških levkocitov
ViraferonPeg contains 40 mg of sucrose per 0.5 ml.
ViraferonPeg vsebuje 40 mg saharoze na 0, 5 ml zdravila.
Powder and solvent for solution for injection White powder.
Prašek in vehikel za raztopino za injiciranje Bel prašek.
ViraferonPeg is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).
Zdravilo ViraferonPeg je indicirano za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo zvišane vrednosti transaminaz brez dekompenzacije jeter in pozitiven izvid na serumsko HCV - RNK ali anti- HCV, vključno z nezdravljenimi bolniki, ki imajo klinično stabilno okužbo s HIV (glejte poglavje 4. 4).
The best way to use ViraferonPeg in this indication is in combination with ribavirin.
Pri navedeni indikaciji je ViraferonPeg najbolje uporabljati v kombinaciji z ribavirinom.
This combination is indicated in naïve patients including patients with clinically stable HIV co- infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Ta kombinacija je indicirana tako pri še nezdravljenih bolnikih, vključno z bolniki, ki imajo klinično stabilno okužbo s HIV in pri tistih, pri katerih je bila prejšnja kombinirana terapija z interferonom alfa (pegiliranim ali nepegiliranim) in ribavirinom oziroma monoterapija z interferonom alfa neuspešna (glejte poglavje 5. 1).
Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Interferon v monoterapiji, vključno z zdravilom ViraferonPeg, je indiciran predvsem v primeru, da bolnik ne prenaša zdravila ali ima kontraindikacijo za uporabo ribavirina.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when ViraferonPeg is to be used in combination with ribavirin.
Če bo bolnik ViraferonPeg uporabljal sočasno z ribavirinom, morate upoštevati tudi Povzetek glavnih značilnosti zdravila (SPC) za ribavirin.
Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
Zdravljenje s tem zdravilom lahko uvede in spremlja le zdravnik, ki ima izkušnje iz zdravljenja bolnikov s hepatitisom C.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
2 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
The dose administered depends on whether it is used in combination with ribavirin or as monotherapy.
Odmerek zdravila je odvisen od tega, ali se le- to uporablja skupaj z ribavirinom ali v obliki monoterapije.
2 Combination therapy ViraferonPeg 1.5 micrograms/ kg/ week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
The intended dose of 1.5 μ g/ kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the pen/ vial strengths according to Table 1.
Predpisani odmerek 1, 5 mikrogramov/ kg zdravila ViraferonPeg, ki se uporablja skupaj z ribavirinom, določite glede na skupine telesne mase in jakosti peresnika ali vial po preglednici 1.
Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Kapsule ribavirina jemlje bolnik peroralno vsak dan, v dveh deljenih odmerkih s hrano (zjutraj in zvečer).
Table 1 - Dosing for Combination Therapy
Preglednica 1 – Odmerjanje pri kombinirani terapiji
Ribavirin Capsules
Kapsule ribavirina
Administer
Jakost vial oz. peresnika (μg/ 0, 5 ml)
Once Weekly (ml)
Enkrat na teden (ml)
Dose (mg)
Skupni dnevni odmerek (mg)
Capsules (200 mg)
Število kapsul (200 mg) 4a
5b 5b 6c 7d
1. 400
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).
Pri bolnikih, ki imajo virološki odziv v 12. tednu, nadaljujte z zdravljenjem še eno 9- mesečno obdobje (t. j. skupaj 48 tednov).
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:
Priporočljivo je, da vse bolnike zdravite 24 tednov, razen pri tistih, ki imajo sočasno okužbo s HCV in HIV.
Predictability of response and non-response in HCV/ HIV Co-infection 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.
Napovedovanje odziva oziroma odsotnosti odziva na zdravljenje pri bolnikih, ki imajo sočasno okužbo s HCV in HIV
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99% (67/ 68; Study 1) (see section 5.1).
3 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.