natgillin/translations-raw huggingface dataset:
Elderly In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs.
Starejši Pri bolnikih, starejših od 62 let, je bila po enkratni podkožni injekciji 180 mikrogramov zdravila Pegasys v primerjavi z mlajšimi zdravimi prostovoljci absorpcija zakasnjena, vendar pa ne zmanjšana.
The AUC was slightly increased (1663 vs.
Pri bolnikih, starejših od 62 let, je bil tmax 115 ur, pri mlajših pa 82 ur.
10.3 ng/ ml) were similar in subjects older than 62 years.
AUC je bila pri mlajših malo večja (1663 proti 1295 ng· h/ ml), največje koncentracije pa so bile podobne kot pri bolnikih, starejših od 62 let (9, 1 pri mlajših in 10, 3 ng/ ml pri starejših).
Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see section 4.2).
Glede na izpostavljenost, farmakodinamični odziv in prenašanje pri starejših bolnikih ni potreben nižji odmerek zdravila Pegasys (glejte poglavje 4. 2).
Hepatic impairment The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C.
Motnje jetrnega delovanja Pri zdravih prostovoljcih in bolnikih s hepatitisom B ali C je bila farmakokinetika zdravila Pegasys podobna.
Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Primerljivo izpostavljenost in farmakokinetične profile so opazili pri bolnikih s cirozo (Child- Pugh stopnja A) in pri bolnikih brez ciroze.
Site of administration Subcutaneous administration of Pegasys should be limited to the abdomen and thigh, as the extent of absorption based on AUC was about 20% to 30% higher upon injection in the abdomen and thigh.
25 Mesto injiciranja Podkožno dajanje zdravila Pegasys moramo omejiti na predel trebuha in stegen, kjer je bil obseg absorpcije na podlagi AUC 20 do 30% višji.
The Non-clinical toxicity studies conducted with Pegasys were limited due to species specificity of interferons.
Predklinične študije toksičnosti, ki so jih opravili z zdravilom Pegasys, so bile omejene zaradi specifičnosti interferonov pri posameznih vrstah.
Acute and chronic toxicity studies have been carried out in cynomolgus monkeys, and the findings observed in peginterferon dosed animals were similar in nature to those produced by interferon alfa-2a.
Rezultati, ki so jih opazili pri živalih, ki so prejemale peginterferon, so bili po naravi podobni rezultatom, ki so jih opazili pri interferonu alfa- 2a.
As with other alpha interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Kot pri drugih interferonih alfa so pri samicah opic pri jemanju peginterferona alfa- 2a opazili podaljšanje menstrualnega cikla.
Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys.
Zdravljenje z interferonom alfa- 2a je pri opicah rhesus povzročilo statistično značilno povečanje splavov.
Pegasys plus ribavirin When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Zdravilo Pegasys in ribavirin Ko so zdravilo Pegasys uporabili v kombinaciji z ribavirinom, zdravilo Pegasys pri opicah ni povzročilo nobenih dodatnih neželenih učinkov, ki jih prej ne bi videli pri posameznih učinkovinah.
sodium chloride polysorbate 80 benzyl alcohol (10 mg/ 1 ml) sodium acetate acetic acid water for injections
natrijev klorid polisorbat 80 benzilalkohol (10 mg/ 1 ml) natrijev acetat ocetna kislina voda za injekcije
1 ml of solution for injection in vial (siliconised Type I glass) with stopper (rubber butyl).
Viala (silikonsko steklo tipa I) z zamaškom (butil guma) z 1 ml raztopine za injiciranje.
Available in packs of 1 or 4.
Na trgu so pakiranja po 1 ali 4.
20 June 2002/ 20 June 2007
20. junij 2002/ 20. junij 2007
peginterferon alfa-2a*.................................................................................... .180 micrograms Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*.
peginterferon alfa- 2a *..................................................................................... 180 mikrogramov Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa- 2a *.
The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Vrednost se nanaša na vsebnost interferona alfa- 2a v molekuli peginterferona alfa- 2a, brez upoštevanja polietilenglikolnih verig.
*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].
* Zdravilna učinkovina peginterferon alfa- 2a je kovalentni konjugat interferona alfa- 2a, beljakovine pridobljene iz celične kulture Escherichia coli s tehnologijo rekombinantne DNA, z molekulo bis - [monometoksipolietilenglikol].
28 4.2 Posology and method of administration
28 4. 2 Odmerjanje in način uporabe
29 Table 1:
29 Preglednica 1.
Predictability of response and non-response – treatment-naïve patients 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 (see Tables 2 and 6).
30 Napoved odzivnosti in neodzivnosti – bolniki, ki se še niso zdravili Zgodnji virološki odziv do 12. tedna, opredeljen kot zmanjšanje virusnega bremena za dve logaritemski enoti ali kot nemerljiva koncentracija HCV RNA, se je pokazal kot napovedovalen za trajni odziv (glejte preglednici 2 in 6).
30 The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
Negativna napovedna vrednost trajnega odziva pri bolnikih, zdravljenih z zdravilom Pegasys pri samostojnem zdravljenju, je bila 98%.
31 Table 3:
Preglednica 3.
Dose Adjustment for Adverse Reaction (For further guidance see also text above)
Prilagajanje odmerkov zaradi neželenih učinkov (za nadaljnja navodila glejte tudi zgornje besedilo)
If ALT increase is progressive or persistent, the dose should be reduced initially to135 micrograms.
Če je zvišanje koncentracij ALT progresivno ali vztrajno, odmerek v začetku znižamo na 135 mikrogramov.
Special populations
32 Posebne skupine
Pegasys is contraindicated in neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.3 and 4.4).
Zdravilo Pegasys je kontraindicirano pri novorojencih in otrocih starih do 3 let zaradi pomožne snovi benzilalkohola (glejte poglavji 4. 3 in 4. 4).
32 Patients with hepatic impairment In patients with compensated cirrhosis (eg, Child-Pugh A), Pegasys has been shown to be effective and safe.
Bolniki z motenim jetrnim delovanjem Pri bolnikih s kompenzirano cirozo (stopnja Child- Pugh A) se je zdravilo Pegasys pokazalo kot učinkovito in varno zdravilo.
• Hypersensitivity to the active substance, to alpha interferons, or to any of the excipients • Autoimmune hepatitis • Severe hepatic dysfunction or decompensated cirrhosis of the liver • Neonates and young children up to 3 years old, because of the excipient benzyl alcohol (see section 4.4 for benzyl alcohol) • A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4) • Initiation of Pegasys is contraindicated in HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6
33 • novorojenčki in otroci do tretjega leta starosti, zaradi pomožne snovi benzilalkohola (glejte poglavje 4. 4 za benzilalkohol), • anamneza težkega srčnega obolenja, vključno z nestabilnim ali nekontroliranim srčnim obolenjem v predhodnih 6 mesecih (glejte poglavje 4. 4), • zdravljenja z zdravilom Pegasys ne smemo pričeti pri bolnikih, ki so sočasno okuženi s HIV in HCV, imajo cirozo in število točk po Child- Pughovi klasifikaciji ≥ 6.
33 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Če se taki simptomi pojavijo, mora lečeči zdravnik upoštevati možnost, da so ti neželeni učinki lahko resni in da bolnik lahko potrebuje ustrezno terapevtsko obravnavo.
- Adequately controlled thyroid function (TSH and T4).
- ustrezno nadzirano delovanje ščitnice (TSH in T4).
In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and absolute neutrophil count (ANC), usually starting within the first 2 weeks of treatment (see section 4.8).
34 Med kliničnimi preskušanji je bilo zdravljenje z zdravilom Pegasys povezano z zmanjšanjem celokupnega števila belih krvnih celic in zmanjšanjem absolutnega števila nevtrofilcev, ki se je običajno pojavilo v prvih 2 tednih zdravljenja (glejte poglavje 4. 8).
34 The occurrence of anaemia (haemoglobin < 10 g/ dl) has been observed in up to 15% of chronic hepatitis C patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Pojavnost anemije (hemoglobin < 10 g/ dl) so opazili pri do 15% bolnikov s kroničnim hepatitisom C v kliničnih preskušanjih kombiniranega zdravljenja zdravila Pegasys in ribavirina.
The use of Pegasys and ribavirin combination therapy in chronic hepatitis C patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for hematological adverse events.
Uporaba kombinacije zdravila Pegasys in ribavirina pri bolnikih s kroničnim hepatitisom C, pri katerih prejšnje zdravljenje ni bilo uspešno, ni zadostno raziskana pri tistih, ki so prejšnje zdravljenje prekinili zaradi hematoloških neželenih učinkov.
In clinical trials with Pegasys in HBV, marked transaminase flares have been accompanied by mild changes in other measures of hepatic function and without evidence of hepatic decompensation.
35 V kliničnih preskušanjih zdravila Pegasys pri bolnikih s HBV so znatna nihanja transaminaze spremljale blage spremembe drugih meritev jetrne funkcije brez dokazov jetrne dekompenzacije.
Patients predisposed to the development of autoimmune disorders may be at
Možno je, da so bolniki, podvrženi razvoju avtoimunske bolezni, izpostavljeni večjemu tveganju.
35 increased risk.
Bolnike, pri katerih opazimo znake ali simptome, skladne z avtoimunsko boleznijo, je treba skrbno pregledati.
Ocular changes As with other interferons retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with Pegasys.
Spremembe na očeh Med zdravljenjem z zdravilom Pegasys so se v redkih primerih, podobno kakor pri zdravljenju z drugimi interferoni, pojavile retinopatije vključno z retinalnimi krvavitvami, pege, papiloedem, očesna nevropatija in obstrukcija retinalne arterije ali vene, kar lahko povzroči izgubo vida.
In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/ or lactic acidosis was 3% (12/ 398).
36 bolnikih, sočasno zdravljenih s stavudinom in interferonom z dodanim ribavirinom ali brez, 3% (12/ 398).
36 In patients co-infected with HIV-HCV, limited efficacy and safety data (N = 51) are available in subjects with CD4 counts less than 200 cells/ uL.
Pri bolnikih, okuženih s HIV in HCV, so na voljo le omejeni podatki o učinkovitosti in varnosti pri bolnikih (n = 51), ki imajo število celic CD4+ nižje od 200 celic/ μl.
Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
37 Podatki farmakokinetičnih podštudij v fazi III ključnih preskušanj dokazujejo, da med lamivudinom in zdravilom Pegasys pri bolnikih s HBV ali zdravilom Pegasys in ribavirinom pri bolnikih s HCV ne prihaja do farmakokinetičnih interakcij.
37 Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
O poslabšanju anemije zaradi ribavirina so poročali, kadar je bil zidovudin del sheme zdravljenja HIV, čeprav natančen mehanizem ni znan.
With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 4). Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Med študijami so se resni neželeni dogodki pojavili pri 6% bolnikov, zdravljenih z zdravilom Pegasys in pri 4% bolnikov, ki so se zdravili z lamivudinom.
The percentage of patients with
Neželeni dogodki ali laboratorijske nepravilnosti so vodili do prekinitve zdravljenja z zdravilom Pegasys pri 5% bolnikov, zdravljenje z lamivudinom pa je zaradi enakih razlogov prekinil manj kot 1% bolnikov.
38 cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
Delež bolnikov s cirozo, ki so prenehali z zdravljenjem, je bil podoben deležu pri celotni populaciji v vsaki zdravljeni skupini.
In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13%, respectively, in the 72 week arms.
V skupini, ki se je zdravila 72 tednov pa 12% (zaradi neželenih učinkov) in 13% (zaradi laboratorijskih nenormalnosti).
idiopathic or thrombotic thrombocytopenic purpura
idiopatična ali trombotična trombocitopenična purpura
Depression*, anxiety, insomnia*
depresija *, anksioznost, nespečnost *
Emotional disorders, mood alteration Aggression, nervousness, libido decreased
čustvene motnje, spremembe razpoloženja, agresivnost, nervoznost, zmanjšan libido
Suicide, psychotic disorder
samomor, psihotične motnje
Headache, dizziness*, concentration impaired
glavobol, omotica *, motnje koncentracije
Memory impairment, syncope, weakness, migraine, hypoaesthesia, hyperaesthesia, paraesthesia, tremor, taste disturbance, nightmares, somnolence
motnje spomina, sinkopa, oslabelost, migrena, hipestezija, hiperestezija, parestezija, tremor, motnje okusa, nočne more, somnolenca
Coma, convulsions,, facial palsy
koma, konvulzije, paraliza obraza
Eye disorders
40 Organski sistem
Vision blurred, eye pain, eye inflammation, xerophthalmia
Zelo pogosti ≥ 1/ 10
Retinal hemorrhage
Pogosti ≥ 1/ 100 do < 1/ 10
Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Občasni ≥ 1/ 1. 000 do < 1/ 100
Vision loss
Redki ≥ 1/ 10. 000 do < 1/ 1. 000
Ear and labyrinth disorders
Zelo redki < 1/ 10. 000
Vertigo, earache
Očesne bolezni
Hearing loss
zamegljen vid, bolečina v očesu, vnetje očesa, kseroftalmija
Cardiac disorders
krvavitev mrežnice
Tachycardia, palpitations, oedema peripheral
očesna nevropatija, edem papile, okvara žil mrežnice, retinopatija, razjeda na roženici
Myocardial infarction, congestive heart failure, angina, supraventricular tachycardia, arrhythmia, atrial fibrillation, pericarditis, cardiomyopathy
Ušesne bolezni, vključno z motnjami labirinta
Vascular disorders
vrtoglavica, bolečina v ušesu
Flushing
izguba sluha
Hypertension
Srčne bolezni
Cerebral haemorrhage, vasculitis
tahikardija, palpitacije, periferni edem
40 Body system
miokardni infarkt, kongestivno srčno popuščanje, angina pektoris, supraventrikularna tahikardija,
Very Common ≥ 1/ 10
aritmija, fibrilacija atrijev, perikarditis, kardiomiopatija
Common ≥ 1/ 100 to < 1/ 10
Žilne bolezni
Uncommon ≥ 1/ 1000 to < 1/ 100
rdečica
Rare ≥ 1/ 10,000 to < 1/ 1000
hipertenzija
Very rare < 1/ 10,000
krvavitve v možganih, vaskulitis
Dyspnoea exertional, epistaxis, nasopharyngitis, sinus congestion, nasal congestion, rhinitis, sore throat
dispneja po naporu, epistaksa, nazofaringitis, zamašitev sinusov, zamašitev nosu, rinitis, vneto grlo
Diarrhoea*, nausea*, abdominal pain*
driska *, navzea *, bolečina v trebuhu *
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
bruhanje, dispepsija, disfagija, razjeda v ustih, krvavitev dlesni, glositis, stomatitis, flatulenca suha usta
Gastrointestinal bleeding
krvavitev v prebavilih
Alopecia, dermatitis,
alopecija, dermatitis, pruritus, suha koža
Rash, sweating increased,
kožni izpuščaj, povečano znojenje, psoriaza, urtikarija, ekcem, motnje na koži, fotosenzitivnostna reakcija, nočno znojenje
Toxic epidermal necrolysis,
41 Organski sistem Zelo pogosti
tissue disorders
Občasni
pruritis, dry skin
Zelo redki
psoriasis, urticaria, eczema, skin disorder, photosensitivity reaction, night sweats
≥ 1/ 100 do < 1/ 10 ≥ 1/ 1. 000 do < 1/ 100
Stevens-Johnson syndrome, angioedema, erythema multiforme
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Musculoskeletal Myalgia, connective tissue arthralgia and bone disorders
mialgija, artralgija
Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskeletal pain, muscle cramps
bolečina v hrbtu, artritis, mišična oslabelost, bolečina v kosteh, bolečina v vratu, mišičnoskeletna bolečina, mišični krči
Renal and urinary disorders Reproductive system and breast disorders
Bolezni sečil
Impotence
Motnje reprodukcije in dojk
Renal insufficiency
pireksija, rigorji *,
General disorders Pyrexia, and rigors*, administration pain*, site conditions asthenia, fatigue, injection site reaction*, irritability*
mestu aplikacije bolečina *, astenija, utrujenost, reakcija na mestu injiciranja *, razdražljivost *
Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
influenci, občutek neugodja, letargija, vročinski valovi, žeja
Investigations Injury and poisoning
zmanjšanje telesne mase
Weight decreased
Poškodbe in zastrupitve in zapleti pri posegih
41 Post marketing adverse events
Neželeni dogodki po prihodu zdravila na trg
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (ie, 1260 micrograms/ week) have been reported.
Poročali so o prevelikih odmerjanjih, ki so se pojavila med dvema injekcijama v zaporednih dnevih (namesto tedenskega intervala) in pri dnevnih injekcijah do 1 tedna (to je 1260 mikrogramov na teden).
Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/ mole of protein.
Interferon alfa- 2a je konjugiran z molekulo bis - [monometoksipolietilenglikol] pri stopnji substitucije en mol polimera na mol proteina.
The average molecular mass is approximately 60 000 of which the protein moiety constitutes approximately 20 000.
Povprečna molekulska masa je približno 60. 000, od tega predstavlja beljakovinski del približno 20. 000.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
43 Pri odzivnih bolnikih s hepatitisom C, ki so prejeli zdravljenje s 180 mikrogrami zdravila Pegasys, se koncentracije HCV RNA zmanjšajo v dveh fazah.
43 Table 5:
Preglednica 5.
All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
44 Vsi bolniki, ki so zaključili fazo III študij, so bili primerni za vključitev v dolgotrajno študijo sledenja (WV16866).
Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR™ HCV Test, version 2.0
Virološki odziv je bil definiran kot nezaznavna HCV RNA, merjena s testom COBAS AMPLICOR™ HCV, verzija 2. 0 (meja detekcije 100 kopij/ ml ekvivalentno 50 mednarodnih enot/ ml).
44 (limit of detection 100 copies/ ml equivalent to 50 International Units/ ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Trajni odziv pa je bil definiran kot en negativni vzorec približno 6 mesecev po končanem zdravljenju.
Table 6:
Preglednica 6.
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 7 and Table 8, respectively.
45 Virološki odzivi bolnikov, okuženih le s HCV, ki so se zdravili le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v odvisnosti od genotipa in virusnega bremena pred začetkom zdravljenja ter v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in hitrega virološkega odziva v 4. tednu, prikazani v preglednicah 7 in 8.
The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 7and 8).
Rezultati študije NV15942 predstavljajo osnovo za priporočila za zdravljenje v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in virološkega odziva v 4. tednu (glejte preglednice 1, 7 in 8).
45 Table 7:
Preglednica 7.
46 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 9).
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 10)
V retrospektivni analizi podskupine bolnikov, ki so bili HCV RNA negativni do 4. tedna in so imeli pred začetkom zdravljenja nizko virusno breme, so preučili tudi trajni virološki odziv dosežen s 16 - tedenskim in 24- tedenskim zdravljenjem (glejte preglednico 10).
Table 10:
47 Preglednica 10.
Sustained Virological Response Overall and Based on Rapid Viral Response by Week4 for Genotype 2 or 3 after Pegasys Combination Therapy with Ribavirin in HCV Patients Study NV17317
Študija NV17317
47 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
Podatki kažejo, da je skrajšanje zdravljenja na 16 tednov povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 11).
48 Table 12:
Preglednica 12.
49 HIV-HCV co-infected patients The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV co- infected patients are summarised below in Table 14
Bolniki sočasno okuženi s HIV in HCV Virološki odzivi bolnikov, zdravljenih le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja za bolnike, okužene s HCV in HIV, prikazani v preglednici 14.
Ribavirin 800 mg
ribavirin 800 mg
48 weeks 48 weeks
48 tednov 48 tednov
5.2 Pharmacokinetic properties
50 5. 2 Farmakokinetične lastnosti
50 Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
Povečanje izpostavljenosti zdravila Pegasys v odvisnosti od odmerka so opazili tako pri zdravih ljudeh kot tudi pri bolnikih s kroničnim hepatitisom B ali C po odmerjanju enkrat na teden.