natgillin/translations-raw huggingface dataset:
Dose reduction to 90 micrograms is recommended if the platelet count is 25,000 to < 50,000 cells/mm3.
Zmanjšanje odmerka na 90 mikrogramov je priporočljivo, če je število trombocitov 25.000 do < 50.000 celic/mm3.
Table 12: Serological, virological and biochemical responses in chronic hepatitis B HBeAg positive Study WV16240
Preglednica 12: Serološki, virološki in biokemični odzivi pri CHB HBeAg pozitivni študija WV16240
When the increase in ALT levels is progressive and clinically significant, despite dose reduction, or is accompanied by increased direct bilirubin, therapy should be discontinued (see sections 4.2 and 4.8).
Če je kljub znižanju odmerka zvečanje koncentracij ALT progresivno ali klinično značilno ali če ga spremlja zvišan direktni bilirubin, moramo zdravljenje prekiniti (glejte poglavji 4.2 in 4.8).
Growth inhibition was observed in paediatric patients (see section 4.4).
Pri pediatričnih bolnikih so opazili zastoj rasti (glejte poglavje 4.4).
The SVRs reported in the treatment arms of this study were similar to the corresponding treatment arms from study NV15942.
Trajni virološki odziv, o katerem so poročali v skupinah bolnikov te študije, je bil podoben kot v primerljivih skupinah bolnikov študije NV15942.
All clinical trials recruited patients with CHB who had active viral replication measured by HBV DNA, elevated levels of ALT and a liver biopsy consistent with chronic hepatitis.
Vsi bolniki s CHB, ki so bili vključeni v klinična preskušanja, so imeli aktivno virusno replikacijo, izmerjeno s HBV DNA, zvišane vrednosti ALT in jetrno biopsijo v skladu s kroničnim hepatitisom.
Wash your hands carefully before handling any of the items.
Priprava Pazljivo si najprej operite roke.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever, particularly serious infections (bacterial, viral, fungal) must be ruled out, especially in patients with neutropenia.
Čeprav je zvišana telesna temperatura lahko povezana z gripi podobnim sindromom, ki ga pogosto opisujejo med zdravljenjem z interferoni, moramo izključiti druge vzroke dolgotrajne zvišane telesne temperature, še posebno resne okužbe (bakterijske, virusne, glivične), zlasti pri bolnikih z nevtropenijo.
With both Pegasys monotherapy, and also the combined treatment with ribavirin, up to 2% of patients experienced increased ALT levels that led to dose modification or discontinuation of the treatment.
Pri samostojnem in kombiniranem zdravljenju zdravila Pegasys z ribavirinom so se pri do 2 % bolnikov pojavile zvečane koncentracije ALT, zaradi katerih so odmerek spremenili ali pa so zdravljenje prekinili.
Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.
Farmakokinetiko zdravila Pegasys so ovrednotili z uporabo populacijske farmakokinetike pri pediatričnih bolnikih s CHB (YV25718) in pri pediatričnih bolnikih s CHC (NR16141).
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Pri bolnikih, ki so sočasno okuženi z virusom HIV in prejemajo visoko aktivno protiretrovirusno terapijo (HAART - Highly Active Anti-Retroviral Therapy), obstaja večje tveganje za nastanek laktacidoze.
Side effects with unknown frequency:
Neželeni učinki, katerih pogostnost ni znana:
<1 log10 decline
< 1 log10
Pegasys use is restricted to children and adolescents with chronic hepatitis C aged 5 years and above or children and adolescents with chronic hepatitis B aged 3 years and above.
Uporaba zdravila Pegasys je omejena na otroke in mladostnike s kroničnim hepatitisom C, stare 5 let ali več, in na otroke in mladostnike s kroničnim hepatitisom B, stare 3 leta ali več.
Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SmPC).
Pri uvajanju zdravila Pegasys in ribavirina v HAART je zato potrebna previdnost (glejte SmPC za ribavirin).
Clean the area using the alcohol pad and put the pad aside to wipe the site again after injection, if necessary.
Očistite mesto z alkoholnim zložencem in ga odložite, če ga boste ponovno potrebovali po injiciranju.
Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 16).
Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 16).
A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes.
Metaanaliza 9 kliničnih študij zdravila Pegasys na ravni bolnikov (n = 1423) pri bolnikih s kroničnim hepatitisom B, ki so HBeAg pozitivni ali negativni, je pokazala, da ravni HBsAg in HBV DNA v 12. tednu zdravljenja za določene genotipe napovedujejo končni izid zdravljenja v 24. tednu po končanem zdravljenju.
In a clinical trial (YV25718) with 111 paediatric patients (3 to 17 years of age) treated with Pegasys for 48 weeks, the safety profile was consistent with that seen in adults with CHB and in paediatric patients with CHC.
V kliničnem preskušanju (YV25718) s 111 pediatričnimi bolniki (starimi od 3 do 17 let), ki so jih zdravili z zdravilom Pegasys 48 tednov, je bil varnostni profil skladen s tistim pri odraslih s CHB in pri pediatričnih bolnikih s CHC.
For a few subjects who were more than 15 percentiles below their baseline height curve at 2 years post-treatment, they either returned to baseline comparable height percentiles at 6 years post-treatment or a non-treatment related causative factor has been identified.
Nekateri preizkušanci, ki so dve leti po zdravljenju ostali več kot 15 percentilov pod svojo izhodiščno rastno krivuljo z začetka zdravljenja, so se šest let po zdravljenju vrnili k percentilom višine, ki so primerljivi z začetkom zdravljenja, ali pa je bil ugotovljen z zdravljenjem nepovezan vzročni dejavnik.
The AUC was slightly increased (1663 vs. 1295 ng·h/ml) but peak concentrations (9.1 vs. 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).
After the injection: Wipe the injection site with the alcohol pad, if necessary.
Obrišite mesto injiciranja z alkoholnim zložencem, če je potrebno.
The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 18).
Podatki kažejo, da je skrajšanje zdravljenja na 16 tednov povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 18).
Breathing disorders: Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
Bolezni dihal: intersticijska pljučnica (vnetje pljuč, vključno s smrtnim izidom), krvni strdki v pljučih.
● use if medicine is cloudy, hazy, discoloured or has particles in it.
• uporabljajte peresnika, če je zdravilo motno, nejasno, obarvano ali vsebuje delce;
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 recommended duration of Pegasys monotherapy is 48 weeks.
Priporočeno trajanje samostojnega zdravljenja z zdravilom Pegasys je 48 tednov.
Fever/infections
Zvišana telesna temperatura/okužbe
● if the patient is a child who has ever had serious psychiatric conditions such as severe depression or thoughts of committing suicide.
• je bolnik otrok, ki se je kadar koli nahajal v hudem psihičnem stanju, kot je huda depresija ali misli o samomoru,
2) Allow the pre-filled pen to adjust to room temperature
2) Pustite, da se napolnjeni injekcijski peresnik ogreje na sobno temperaturo
Patients infected with HCV genotypes other than genotype 1 should receive 800 mg daily of ribavirin.
Bolnikom, ki so okuženi z drugimi HCV genotipi, razen genotipa 1, dajemo 800 mg ribavirina na dan.
Patients with substance use/abuse: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alfa interferon.
Bolniki z anamnezo uporabe/zlorabe psihoaktivnih substanc: Pri bolnikih, ki so okuženi z virusom hepatitisa C in imajo sočasno anamnezo zlorabe psihoaktivnih substanc (alkohol, kanabis, ipd.), obstaja povečano tveganje za nastanek novih ali poslabšanje že obstoječih psihiatričnih motenj, če jih zdravimo z interferonom alfa.
In these patients, tolerability to combination therapy and additional prognostic factors such as degree of fibrosis should be taken into account when deciding on treatment duration.
Pri teh bolnikih je pri odločanju o trajanju zdravljenja treba razmisliti o prenašanju kombiniranega zdravljenja in dodatnih prognostičnih dejavnikih, kot je stopnja fibroze.
b Patients who achieved viral suppression at week 12 but were missing HCV RNA results at the end of follow-up were considered to be non-responders.
Bolnike, ki so dosegli virusno supresijo v 12. tednu, a podatkov o njihovi koncentraciji HCV RNA na koncu spremljanja ni bilo, so smatrali za neodzivne.
There was no difference in response rate between these patients and those without advanced fibrosis or cirrhosis.
Med temi bolniki in bolniki brez napredovale fibroze ali ciroze ni bilo razlik v deležu odziva.
The most frequently reported adverse reactions with Pegasys 180 micrograms were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Najpogosteje opisani neželeni učinki pri odmerku 180 mikrogramov zdravila Pegasys so bili večinoma blagi do srednje hudi in so jih lahko odpravili brez prilagajanja odmerka ali prekinitve zdravljenja.
MONITOR Assay (limit of detection 200 copies/ml).
(meja detekcije 200 kopij/ml).
There are no data in paediatric patients coinfected with HCV/HIV or with renal impairment.
Podatkov o pediatričnih bolnikih, sočasno okuženih z HCV in HIV ali z okvaro ledvic, ni na voljo.
● if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).
• če se pri vas pojavi Vogt-Koyanagi-Haradov sindrom ali imate kombinacijo težav, ki vključujejo trd vrat, glavobol, razbarvanje kože ali las, težave z očmi (kot je moten vid) in/ali motnje sluha (kot je zvonjenje v ušesih).
Blood disorders: Aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets)
Bolezni krvi: aplastična anemija (kostni mozeg ni sposoben tvoriti rdečih krvnih celic, belih krvnih celic in trombocitov).
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
Prosimo, glejte ustrezne povzetke glavnih značilnosti protiretrovirusnih zdravil, ki se morajo sočasno jemati pri zdravljenju HCV, za seznanitev s toksičnostmi, specifičnimi za posamezno zdravilo, njihovim zdravljenjem ter možnostjo prekrivanja le-teh z zdravilom Pegasys, če ga uporabljamo skupaj z ribavirinom ali brez.
For persistent ALT values ≥10 x ULN discontinue treatment.
Pri dolgotrajno zvišanih vrednostih ALT ≥ 10-krat ULN - prekinitev zdravljenja.
Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
Preglednica 24: Deleži serokonverzije HBeAg (%) glede na znižanje HBV-DNA od izhodišča do 12. tedna zdravljenja z zdravilom Pegasys pri pediatričnih bolnikih
Lift the pre-filled pen straight up (90° angle).
Dvignite peresnik navpično (kot 90°).
● Take the long needle and place it firmly on to the tip of the syringe (2).
● Vzemite dolgo iglo in jo trdno namestite na vrh injekcijske brizge (2).
Chronic Hepatitis C: Pegasys is used in combination with other medicines, for the treatment of chronic hepatitis C (CHC).
Kronični hepatitis C: zdravilo Pegasys uporabljamo v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C.
Allow the refrigerated pre-filled pen to adjust to room temperature for about 20 minutes.
Potem ko ste vzeli napolnjeni injekcijski peresnik iz hladilnika, ga 20 minut pustite na sobni temperaturi.
Place used pre-filled pen and cap in a puncture-proof disposable container that is available through your pharmacy or healthcare provider.
Uporabljeni napolnjeni injekcijski peresnik in pokrovček dajte v zabojnik za ostre predmete, ki ga lahko dobite v lekarni ali pri zdravstvenem delavcu.
Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC <750 cells/mm3), and thrombocytopenia (13% experienced a platelet count <50,000 cells/mm3) (see section 4.4).
Hematološke laboratorijske nenormalnosti, ki so jih opazili v prvih 20 tednih preskušanja, so vključevale anemijo (26 % bolnikov je imelo hemoglobin < 10 g/dl), nevtropenijo (30 % je imelo ANC < 750 celic/mm3) in trombocitopenijo (13 % je imelo število trombocitov < 50.000 celic/mm3) (glejte poglavje 4.4).
The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).
Pogostnost in resnost najpogostejših neželenih učinkov, ki so jih opazili pri zdravilu Pegasys, je bila podobna učinkom, ki so jih opazili pri interferonu alfa-2a (glejte preglednico 9).
For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.
Za specifično aktivnost glede genotipa virusa hepatitisa C (HCV) glejte poglavji 4.2 in 5.1.
Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Priporočljivo je, da v primeru ponovnega pojava ali pojava novih psihiatričnih motenj in jemanja psihoaktivnih substanc, ukrepamo zgodaj.
Avoid your navel and areas that could be irritated by a belt or waistband.
Izogibajte se popka in mestom, kjer bi lahko prišlo do draženja zaradi pasu.
Platelet <25,000 cells/mm3: discontinue treatment.
Trombociti < 25.000 celic/mm3: prekinitev zdravljenja.
In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/97) and 59% (58/99), respectively.
Pri bolnikih, ki so v študiji WV16241 prejemali le zdravilo Pegasys, je 12 mesecev po koncu zdravljenja delež HBV DNA odziva znašal 42 % (41/97), normalizacija ALT pa 59 % (58/99).
In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close haematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicinal products should be stopped (see section 4.4).
V posameznih primerih, kjer je korist sočasnega zdravljenja z ribavirinom in azatioprinom večja kot možno tveganje, je med sočasnim zdravljenjem z azatioprinom priporočljivo skrbno spremljanje hematoloških parametrov, da se lahko ugotovijo znaki mielotoksičnosti.
Infections: Lung infection, skin infections
Okužbe: okužba pljuč, okužbe kože.
Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Pri zdravljenju z zdravilom Pegasys se je pojavilo zmanjšanje hematoloških vrednosti (levkopenija, nevtropenija, limfopenija, trombocitopenija in hemoglobin), ki se je v večini primerov popravilo s spremembo odmerka in se po 4 do 8 tednih po prekinitvi zdravljenja vrnilo na raven pred začetkom zdravljenja (glejte poglavji 4.2 in 4.4).
Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours.
Absorpcija Po enkratni subkutani injekciji 180 mikrogramov zdravila Pegasys pri zdravih prostovoljcih so serumske koncentracije peginterferona alfa-2a lahko merili v 3 do 6 urah.
Available in packs of 1 pre-filled syringe.
Na voljo je pakiranje z 1 napolnjeno injekcijsko brizgo.
There is no further accumulation after 8 weeks of once weekly dosing.
Po 8 tednih zdravljenja enkrat na teden do kumulacije ne prihaja več.
500 to < 750 cells/mm3: Immediate 1 level adjustment.
500 do < 750 celic/mm3: takojšnje zmanjšanje odmerka 1. stopnje.
Treatment difference [95%CI]
Razlika med zdravljenjema [95% interval zaupanja]
Tap the syringe gently to bring the bubbles to the top.
Nežno potrkajte po injekcijski brizgi, da se mehurčki pomaknejo proti vrhu.
The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Odmerek ribavirina, ki se uporablja v kombinaciji z zdravilom Pegasys, je naveden v preglednici 1.
Take your next injection on the regularly scheduled day.
Naslednjo injekcijo si injicirajte kot predvideno.
Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Preglednica 11: Značilnosti posameznih bioloških označevalcev v 12. tednu zdravljenja pri HBeAg pozitivnih in HBeAg negativnih bolnikih s kroničnim hepatitisom B glede na genotip
Muscle and bone disorders: Serious muscle damage and pain Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
* For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
kopij/ml za HBeAg-negativne /anti-HBe-pozitivne bolnike: HBV DNA < 2 x 104 kopij/ml
● if you have had an organ transplant (liver or kidney) or have one planned in the near future.
• če ste kdaj imeli ali imate načrtovano transplantacijo organa (jeter ali ledvic),
Therapy should initially be re-instituted at 90 micrograms Pegasys and the neutrophil count monitored.
Zdravljenje ponovno vpeljemo z odmerkom 90 mikrogramov zdravila Pegasys, število nevtrofilcev pa moramo spremljati.
Table 16: Relapse of virological response at the end of treatment for rapid virological response population
Preglednica 16: Ponovitev bolezni ob koncu zdravljenja za bolnike s hitrim virološkim odzivom
Pegasys injection is normally taken at bedtime.
Zdravilo Pegasys ponavadi injiciramo v času.
With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Ko je brizga obrnjena navzgor, preverite, če je vrh igle potopljen v raztopino zdravila Pegasys.
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.
Podkožno dajanje zdravila Pegasys moramo omejiti na predel trebuha in stegen, kjer je bil obseg absorpcije na podlagi AUC 20 do 30 % višji.
• Severe hepatic dysfunction or decompensated cirrhosis of the liver
• avtoimunski hepatitis, • huda motnja jetrnega delovanja ali dekompenzirana ciroza jeter,
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so se pojavili značilni teratogeni in/ali embriocidni učinki.
Both studies compared Pegasys plus placebo vs Pegasys plus lamivudine vs lamivudine alone.
Obe študiji sta primerjali kombinacijo zdravila Pegasys in placeba, zdravila Pegasys in lamivudina ter lamivudin.
It is unknown whether peginterferon alfa-2a/metabolites are excreted in human milk.
Ni znano, ali se peginterferon alfa-2a/presnovki izločajo v materino mleko.
In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ml.
V študiji WV16240 sta bila primarna cilja raziskave HBeAg serokonverzija in število HBV DNA pod 105 kopij/ml.
There are no data on the effects of peginterferon alfa-2a on fertility in women.
Podatkov o vplivu peginterferona alfa-2a na plodnost žensk ni.
Cardiovascular system
Srčnožilni sistem
A clinical trial evaluated 50 CHC patients with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment, or with end stage renal disease (ESRD) requiring chronic hemodialysis (HD).
V kliničnem preskušanju so ovrednotili 50 bolnikov s CHC, ki so imeli zmerno (kreatininski očistek 30 do 50 ml/min), hudo (kreatininski očistek manj kot 30 ml/min) ledvično okvaro ali končno ledvično odpoved, pri kateri je potrebna kronična hemodializa.
Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
Med bolniki iz študije WV16240, ki so prejemali le zdravilo Pegasys in so bili vključeni v dolgotrajno študijo sledenja, je delež trajne HBeAg serokonverzije 12 mesecev po zaključku zdravljenja znašal 48 % (73/153).
The solution for injection is for single use only.
Raztopina za injiciranje je za enkratno uporabo.
Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24-week treatment duration (see section 5.1).
16tedensko zdravljenje je lahko povezano z manjšo možnostjo odziva in tveganje za ponovitev bolezni je večje kot pri 24-tedenskem zdravljenju (glejte poglavje 5.1).
It is important to consider the treatment with Pegasys +/- ribavirin induced a growth inhibition during treatment, the reversibility of which is uncertain.
Pomembno je upoštevati, da zdravljenje z zdravilom Pegasys z ribavirinom ali brez povzroči zastoj rasti med zdravljenjem, za katerega ne moremo zagotovo reči, da je reverzibilen.
Educational problem
Socialne okoliščine težave z učenjem
Dispose of the syringe and needle safely in a closed container.
V zaprt vsebnik varno spravite injekcijsko brizgo in iglo.
HBV-DNA was measured by the COBAS AMPLICOR HBV
HBV DNA so merili s testom COBAS AMPLICORTM HBV MONITOR
Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Zdravilo Pegasys uporabljamo za zdravljenje kroničnega hepatitisa B ali kroničnega hepatitisa C pri odraslih.
Other medicines and Pegasys
Druga zdravila in zdravilo Pegasys
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 manjši odmerek zdravila Pegasys (glejte poglavje
Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Študije na živalih z interferonom alfa-2a so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Sočasna uporaba ribavirina in zidovudina ni priporočljiva zaradi povečanega tveganja za nastanek anemije (glejte poglavje 4.5).