natgillin/translations-raw huggingface dataset:
What Ratiograstim looks like and contents of the pack Ratiograstim is a solution for injection or infusion in a pre-filled syringe.
Izgled zdravila Ratiograstim in vsebina pakiranja Zdravilo Ratiograstim je raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi.
Ratiograstim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Zdravilo Ratiograstim je mogoče dobiti v pakiranjih po 1, 5 ali 10 napolnjenih injekcijskih brizg ali v obliki skupnih pakiranj po 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg.
Latvija ratiopharm Latvijas pā rstā vniecī ba Tel: +371 67499110
59 ratiopharm Latvijas pārstāvniecība Tel: +371 67499110
59 This section contains information on how to give yourself an injection of Ratiograstim.
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Ratiograstim.
- a pre-filled syringe of Ratiograstim,
- napolnjeno injekcijsko brizgo z zdravilom Ratiograstim,
Push the plunger up to the number (ml) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Ratiograstim, ki vam ga je predpisal vaš zdravnik.
If someone else is injecting you, they can also use the back of your arms (see picture 4).
61 Če vam daje injekcijo kdo drug, vam jo lahko da tudi v zadnji del nadlakti (glejte sliko 4).
Accidental exposure to freezing temperatures does not adversely affect the stability of Ratiograstim.
62 Če je zdravilo Ratiograstim pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
When diluted in glucose 50 mg/ ml (5%) solution for
Če je razredčeno v glukozi 50 mg/ ml (5%) raztopini za infundiranje, je zdravilo Ratiograstim kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
Rebetol is a medicine containing the active substance ribavirin.
Rebetol je zdravilo, ki vsebuje zdravilno učinkovino ribavirin.
It is available as capsules (200 mg) and as an oral solution (40 mg/ ml).
Na voljo je v kapsulah (200 mg) in kot peroralna raztopina (40 mg/ ml).
Rebetol is used to treat adults and children aged 3 years and older who have chronic (long term) hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
Zdravilo Rebetol se uporablja za zdravljenje odraslih in otrok, starih 3 leta ali več, ki imajo kronični (dolgotrajni) hepatitis C (bolezen jeter zaradi okužbe z virusom hepatitisa C).
Rebetol must never be used on its own but only together with an interferon (another type of medicine used in hepatitis).
Zdravilo Rebetol se ne sme nikoli uporabljati samostojno, temveč samo v kombinaciji z interferonom (drugo vrsto zdravila, ki se uporablja pri hepatitisu).
In adults, Rebetol can be used in ‘ naïve’ patients (who have not been treated before) or in patients who have relapsed after treatment with interferon, either in combination with interferon alfa-2b or peginterferon alfa-2b (including for patients also infected with human immunodeficiency virus [HIV]).
Pri odraslih se lahko zdravilo Rebetol uporablja pri predhodno nezdravljenih bolnikih (ki dotlej še niso prejemali zdravil) ali pri bolnikih s ponovitvijo bolezni po zdravljenju z interferonom bodisi v kombinaciji z interferonom alfa- 2b bodisi peginterferonom alfa- 2b (vključno z bolniki, ki so okuženi tudi z virusom humane imunske pomanjkljivosti [HIV]).
In children and adolescents, Rebetol can only be used in combination with interferon alfa-2b to treat naïve patients.
Pri otrocih in mladostnikih se lahko zdravilo Rebetol uporablja v kombinaciji z interferonom alfa- 2b za zdravljenje predhodno nezdravljenih bolnikov.
Treatment with Rebetol should be initiated and monitored by a doctor who has experience in the management of chronic hepatitis C.
Zdravljenje z zdravilom Rebetol mora predpisati in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
The dose of Rebetol is based on the patient’ s body weight, and ranges from 3 to 6 capsules a day in patients weighing more than 47 kg.
Odmerek zdravila Rebetol je odvisen od bolnikove telesne mase in znaša od 3 do 6 kapsul dnevno pri bolnikih, ki tehtajo več kot 47 kg.
For patients of a lower weight, the oral solution is used to provide a dose of 15 mg per kilogram body weight a day.
Pri bolnikih z nižjo telesno maso se uporablja peroralna raztopina v odmerku 15 mg na kilogram telesne mase dnevno.
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje ter traja od 24 tednov do enega leta.
The dose may need to be adjusted for patients who experience side effects.
Pri bolnikih, pri katerih se pojavijo neželeni učinki, je odmerek morda potrebno prilagoditi.
The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘ nucleoside analogues’.
Zdravilna učinkovina zdravila Rebetol, ribavirin, je protivirusna učinkovina, ki sodi v razred nukleozidnih analogov.
Rebetol is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Zdravilo Rebetol naj bi vplivalo na nastajanje ali delovanje virusne DNA in RNA, brez katerih virusi ne morejo preživeti ali se razmnoževati.
Rebetol on its own has no effect on eliminating the hepatitis C virus from the body.
Rebetol kot samostojno zdravilo nima nikakršnega učinka na uničenje virusa hepatitisa C v telesu.
(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 How has Rebetol been studied?
(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 Kako je bilo zdravilo Rebetol raziskano?
In adults, the use of Rebetol with interferon alfa-2b has been studied in four main studies, two in a total of 1,744 treatment-naïve patients and two in a total of 345 patients who had relapsed after previous treatment with interferon.
Pri odraslih so uporabo zdravila Rebetol v kombinaciji z interferonom alfa- 2b preučevali v štirih glavnih študijah, dveh s skupno 1744 predhodno nezdravljenimi bolniki in dveh s skupno 345 bolniki, pri katerih se je bolezen ponovila po prehodnem zdravljenju z interferonom.
All of these studies compared the effectiveness of adding either Rebetol or placebo (a dummy treatment) to interferon alfa-2b with using the interferon alone.
V vseh teh študijah so primerjali učinkovitost dodajanja zdravila Rebetol ali placeba (zdravila brez zdravilne učinkovine) interferonu alfa- 2b z učinkovitostjo interferona, dajanega samostojno.
The use of Rebetol with peginterferon alfa-2b has been studied in 1,580 treatment-naïve patients, comparing two schedules of Rebetol added to peginterferon alfa-2b with Rebetol added to interferon alfa-2b.
Uporabo zdravila Rebetol v kombinaciji s peginterferonom alfa- 2b so preučevali pri 1580 predhodno nezdravljenih bolnikih, pri čemer so primerjali dve shemi zdravila Rebetol, dajanega v kombinaciji s peginterferonom alfa- 2b, z zdravilom Rebetol, dajanim v kombinaciji z interferonom alfa- 2b.
In addition, a further two studies have looked at its use in 565 patients also infected with HIV, where it was used in combination with either interferon alfa-2b or peginterferon alfa-2b.
Poleg tega so njegovo uporabo preučevali tudi v dveh študijah s 565 bolniki, ki so bili okuženi tudi s HIV, pri čemer je bilo zdravilo Rebetol uporabljeno v kombinaciji z interferonom alfa- 2b ali peginterferonom alfa- 2b.
Rebetol used in combination with interferon alfa-2b has also been studied in 70 treatment-naïve children aged 3 to 16 years.
Zdravilo Rebetol v kombinaciji z interferonom alfa- 2b je bilo preučevano tudi pri 70 predhodno nezdravljenih otrocih, starih med 3 in 16 let.
In most studies, the main measure of effectiveness was the level of viral RNA circulating in the blood before and after 24 or 48 weeks of treatment, and at follow up (24 weeks later).
V večini študij je bilo glavno merilo učinkovitosti delež virusne RNA v krvnem obtoku pred in po 24 ali 48 tednih zdravljenja ter ob pregledu 24 tednov kasneje.
Some studies also looked at signs of improvement of the condition of the liver.
V nekaterih študijah so preučevali tudi znake izboljšanja stanja jeter.
What benefit has Rebetol shown during the studies?
Kakšne koristi je zdravilo Rebetol izkazalo med raziskavami?
Rebetol used with interferon alfa-2b was more effective than interferon alfa-2b used on its own.
Zdravilo Rebetol v kombinaciji z interferonom alfa- 2b je bilo učinkovitejše od interferona alfa- 2b, uporabljenega samostojno.
In treatment-naïve adult patients, 41% had responded to treatment when checked at follow up (48 weeks) compared with 16% of those who received only interferon alfa-2b.
Pri predhodno nezdravljenih odraslih bolnikih je bilo ob pregledu po 48 - tedenskem spremljanju ugotovljeno, da se je na zdravljenje odzvalo 41% bolnikov v primerjavi s 16% bolnikov, ki so prejemali samo interferon alfa- 2b.
In relapsed patients, the responder rates at the follow up visit were 37% in the patients who received the combination, compared with 3.5% of the patients who only received interferon alfa-2b.
Pri bolnikih s ponovitvijo bolezni je bila ob pregledu po obdobju spremljanja stopnja odziva pri bolnikih, ki so prejemali kombinacijo, 37%, pri bolnikih, ki so prejemali samo interferon alfa- 2b, pa 3, 5%.
The effectiveness of Rebetol used with peginterferon alfa-2b (as a once weekly 1.5 micrograms per kg bodyweight) was more effective than the combination with interferon alfa-2b.
Zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b (1, 5 mikrograma na kg telesne mase na teden) je bilo učinkovitejše kot v kombinaciji z interferonom alfa- 2b.
Rebetol used in combination with peginterferon alfa-2b has also shown its effectiveness in the treatment of hepatitis C infection inpatients also infected with HIV.
Zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b je bilo učinkovito tudi pri zdravljenju okužbe s hepatitisom C pri bolnikih, okuženih tudi s HIV.
In children, Rebetol combined with interferon alfa-2b was effective with 49% of the patients having responded to treatment at the 48-week follow-up visit.
Pri otrocih je bilo zdravilo Rebetol v kombinaciji z interferonom alfa- 2b učinkovito pri 49% bolnikov, za katere je pregled po 48 tednih pokazal, da so se odzvali na zdravljenje.
The most common side effects with Rebetol used in combination with interferon alfa-2b or peginterferon alfa-2b (seen in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low white blood cell counts), hypothryroidism (underactive thyroid gland), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), emotional lability (mood swings), anxiety, dry mouth, headache, dizziness, impaired concentration, cough, dyspnoea (difficulty breathing), nausea, diarrhoea, abdominal (tummy) pain, vomiting, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), fever, rigors (shaking chills), flu-like symptoms, asthenia (weakness), malaise (feeling unwell), irritability, weight loss and decreased growth rate.
Najpogostejši neželeni učinki zdravila Rebetol v kombinaciji z interferonom alfa- 2b ali peginterferonom alfa- 2b (opaženi pri več kot 1 izmed 10 bolnikov) so virusne okužbe, faringitis (vneto žrelo), anemija (nizko število rdečih krvničk), nevtropenija (nizko število belih krvničk), hipotiroidizem (zmanjšana funkcija ščitnice), anoreksija (izguba teka), depresija, nespečnost, čustvena labilnost (nihanje razpoloženja), anksioznost, suha usta, glavobol, omotica, motnje koncentracije, kašelj, dispneja (oteženo dihanje), navzeja, driska, bolečine v trebuhu, bruhanje, alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišičnoskeletne bolečine (bolečine v mišicah in kosteh), reakcije na mestu injekcije, vključno z vnetjem, utrujenost, povišana telesna temperatura, mrzlica (drgetanje), gripi podobni simptomi, astenija (šibkost), občutek slabosti (slabo počutje), razdražljivost, izguba telesne mase in upočasnitev rasti.
For the full list of all side effects reported with Rebetol, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Rebetol, glejte Navodilo za uporabo.
Rebetol should not be used in people who may be hypersensitive (allergic) to ribavirin or any of the other ingredients.
Zdravila Rebetol se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) ribavirin ali katero drugo sestavino.
Rebetol should not be used in: • pregnant women, • women who are breast-feeding, • patients with severe heart disease, • patients with a severe medical condition, including kidney failure and severe liver disease. • patients with certain blood disorder that affect haemoglobin, • patients with a history of certain disorders of the immune system, or are taking medicine that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
Zdravilo Rebetol se ne sme uporabljati pri: • nosečnicah, • doječih ženskah, • bolnikih s hudo srčno boleznijo, • bolnikih z resnim zdravstvenim stanjem, vključno z ledvično odpovedjo in hudo jetrno boleznijo. • bolnikih s katero od krvnih motenj, ki vpliva na hemoglobin, • bolnikih z anamnezo motenj imunskega sistema ali ki jemljejo zdravilo za zaviranje delovanja imunskega sistema, • otrocih in mladostnikih z anamnezo hude duševne bolezni, še posebej hude depresije, samomorilnih misli ali poskusa samomora.
For the full list of all restrictions, see the Package Leaflet.
Za celoten seznam vseh omejitev glejte Navodilo za uporabo.
interferon alfa-2b (adults, children of 3 years and older and adolescents).
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Rebetol pri zdravljenju kroničnega hepatitisa C kot del kombiniranega režima s peginterferonom alfa- 2b (pri odraslih, vključno s predhodno nezdravljenimi bolniki s klinično stabilno sočasno okužbo s HIV) ali interferonom alfa- 2b (pri odraslih, otrocih, starih 3 leta ali več, in mladostnikih), večje od z njimi povezanih tveganj.
The Committee recommended that Rebetol be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Rebetol odobri dovoljenje za promet.
Other information about Rebetol:
Druge informacije o zdravilu Rebetol:
The European Commission granted a marketing authorisation valid throughout the European Union for Rebetol to SP Europe on 7 May 1999.
Evropska komisija je dovoljenje za promet z zdravilom Rebetol, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 7. maja 1999.
The full EPAR for Rebetol is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rebetol je na voljo tukaj.
Capsule, hard
trde kapsule Peroralna uporaba
blister (PVC/ PE/ PVDC)
Stična ovojnina (pretisni omot) (PVC/ PE/ PVdC)
Each Rebetol capsule contains 200 mg of ribavirin.
Ena kapsula zdravila Rebetol vsebuje 200 mg ribavirina.
Rebetol contains 40 mg of lactose monohydrate.
FARMACEVTSKA OBLIKA
PHARMACEUTICAL FORM
Trda kapsula
Hard capsule White, opaque and imprinted with blue ink.
Bele, neprozorne in imajo natisnjen napis z modrim črnilom.
Rebetol monotherapy must not be used.
Zdravila Rebetol ne smete uporabljati v monoterapiji.
There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i. e., not alfa-2b), or on the use of Rebetol with peginterferon alfa-2b in children or adolescents.
Ni podatkov o varnosti ali učinkovitosti uporabe zdravila Rebetol skupaj z drugimi oblikami interferona (tj. ne alfa- 2b) ali uporabe Rebetola z peginterferonom alfa- 2b pri otrocih ali mladostnikih.
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Prosimo, da gledate tudi Povzetek glavnih značilnosti zdravila (SPC) za peginterferon alfa- 2b ali interferon alfa- 2b za podatke o predpisovanju teh dveh zdravil.
Naïve patients Adult patients:
Predhodno nezdravljeni bolniki Odrasli bolniki:
Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4).
Rebetol je indiciran v kombinaciji s interferonom alfa- 2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alanin- aminotransferaze (ALT) in so pozitivni na serumsko HCV- RNA (glejte poglavje 4. 4).
Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
Poleg tega je zdravilo Rebetol v kombinaciji s peginterferonom alfa - 2b indicirano za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki pred tem niso bili zdravljeni in nimajo jetrne dekompenzacije, imajo pa zvišane vrednosti alanin aminotransferaze (ALT) in pozitiven izvid na serumsko RNA virusa HCV, vključno z bolniki, ki imajo klinično stabilno okužbo s HIV (glejte poglavje 4. 4).
Rebetol is intended for use, in a combination regimen with interferon alfa- 2b, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Zdravilo Rebetol je namenjeno uporabi v kombinirani terapiji z interferonom alfa- 2b za zdravljenje otrok, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven izvid na serumsko HCV RNA.
Previous treatment failure patients Adult patients:
Bolniki, pri katerih je bilo prejšnje zdravljenje neuspešno Odrasli bolniki:
Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Rebetol je indiciran v kombinaciji z interferonom alfa- 2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki so se predhodno odzvali (z normalizacijo vrednosti ALT na koncu zdravljenja) na monoterapijo z interferonom alfa, a se je bolezen kasneje ponovila.
Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
2 kroničnim hepatitisom C, pri katerih je bilo bodisi prejšnje kombinirano zdravljenje z interferonom alfa (pegiliranim ali nepegiliranim) in ribavirinom bodisi monoterapija z interferonom alfa neuspešna (glejte poglavje 5. 1).
2 4.2 Posology and method of administration
4. 2 Odmerjanje in način uporabe
Dose to be administered The dose of Rebetol is based on patient body weight (Table 1).
Odmerek za dajanje Odmerek zdravila Rebetol se določi na podlagi bolnikove telesne mase (Preglednica 1).
Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Kapsule zdravila Rebetol naj jemlje bolnik peroralno vsak dan v dveh deljenih odmerkih( zjutraj in zvečer) s hrano
Rebetol must be used in combination with either peginterferon alfa-2b (1.5 micrograms/ kg/ week) or interferon alfa-2b (3 million international units [MIU] three times a week).
Zdravilo Rebetol morate uporabljati v kombinaciji bodisi s peginterferonom alfa- 2b (1, 5 mikrograma/ kg na teden) ali z interferonom alfa- 2b (3 milijone mednarodnih enot (mio i. e.) trikrat na teden).
The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Izbira režima kombiniranega zdravljenja je odvisna od značilnosti bolnika, izbira terapevtske sheme pa mora temeljiti na pričakovani učinkovitosti in varnosti kombinirane terapije za vsakega posameznega bolnika (glejte poglavje 5. 1).
Table 1
bolnika (kg)
Rebetol dose based on body weight
Število 200 mg kapsul 4a
1,000 mg
1. 000 mg
86 - 105 > 105
86 – 105
1,200 mg 1,400 mg
1. 200 mg
2 morning, 2 evening b:
2 zjutraj, 2 zvečer b:
2 morning, 3 evening c:
2 zjutraj, 3 zvečer c:
3 morning, 3 evening d:
3 zjutraj, 3 zvečer d:
3 morning, 4 evening
3 zjutraj, 4 zvečer
Rebetol Capsules in combination with pegylated interferon alfa-2b:
Rebetol kapsule v kombinaciji s pegiliranim interferonom alfa- 2b:
Duration of treatment – Naïve patients Predictability of sustained virological response:
Dolžina zdravljenja – Nezdravljeni bolniki Predvidljivost trajnega virološkega odziva:
Patients infected with virus genotype 1 who fail to achieve virological response at Week 12 are highly unlikely to become sustained virological responders (see also section 5.1). • Genotype 1:
Pri bolnikih, okuženih z virusom genotipa 1, ki ne dosežejo virološkega odziva v 12. tednu, je verjetnost, da bodo razvili trajen virološki odziv, izredno majhna (glejte tudi poglavje 5. 1). • Genotip 1:
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).
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).
V podskupini bolnikov, ki so okuženi z virusom genotipa 1 in imajo majhno virusno obremenitev (< 600. 000 i. e. / ml) ter katerih izvidi na HCV- RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja, lahko zdravljenje bodisi ustavite po ciklusu terapije v 24. tednu, ali pa ga nadaljujete še za dodatnih 24 tednov (tako da bo skupno trajanje zdravljenja 48 tednov).
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). • Genotypes 2 or 3:
Skupna dolžina zdravljenja 24 tednov pa je lahko povezana z večjim tveganjem za relaps kot pri skupni dolžini zdravljenja 48 tednov (glejte poglavje 5. 1). • Genotip 2 ali 3:
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:
Pri njih naj zdravljenje traja 48 tednov. • Genotip 4:
In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment as for genotype 1.
Omejeni podatki iz študij (n=66) kažejo, da so ti bolniki primerni za enako dolžino zdravljenja kot pri genotipu 1.