natgillin/translations-raw huggingface dataset:
- Absolute neutrophil counts ≥ 1500/ mm3
absolutno število nevtrofilcev ≥ 1500/ mm3,
Additional testing should be performed periodically during therapy.
Med zdravljenjem moramo periodično opravljati dodatne preiskave.
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).
8 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).
Progressive decreases after 8 weeks of therapy were infrequent.
Progresivno znižanje po 8 tednih zdravljenja je bilo redko.
The decrease in ANC was reversible upon dose reduction or cessation of therapy (see section 4.2), reached normal values by 8 weeks in the majority of patients and returned to baseline in all patients after about 16 weeks.
Zmanjšanje absolutnega števila nevtrofilcev je bilo po znižanju odmerka ali prekinitvi zdravljenja reverzibilno (glejte poglavje 4. 2), v 8 tednih po prekinitvi zdravljenja je pri večini bolnikov doseglo normalne vrednosti, po približno 16 tednih pa se je na izhodiščno vrednost vrnilo pri vseh bolnikih.
Pegasys treatment has been associated with decreases in platelet count, which returned to pre- treatment levels during the post-treatment observation period (see section 4.8).
Zdravljenje z zdravilom Pegasys je bilo povezano z zmanjšanjem števila trombocitov, ki pa se je v opazovanem obdobju po zdravljenju vrnilo na število pred zdravljenjem (glejte poglavje 4. 8).
In some cases, dose modification may be necessary (see section 4.2).
V nekaterih primerih je treba odmerek prilagoditi (glejte poglavje 4. 2).
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 frequency depends on the treatment duration and the dose of ribavirin (see section 4.8,).
Pogostnost je odvisna od trajanja zdravljenja in od odmerka ribavirina (glejte poglavje 4. 8).
As with other interferons, caution should be exercised when administering Pegasys in combination with other potentially myelosuppressive agents.
Kakor pri drugih interferonih je previdnost potrebna tudi pri dajanju zdravila Pegasys v kombinaciji z drugimi zdravili z možnim mielosupresivnim delovanjem.
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
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.
Endocrine system Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alpha interferons, including Pegasys.
Endokrini sistem Pri jemanju interferonov alfa, vključno z zdravilom Pegasys, so opazili nepravilno delovanje ščitnice ali poslabšanje predhodno obstoječih motenj delovanja ščitnice.
Pegasys treatment may be initiated or continued if TSH levels can be maintained in the normal range by medication.
Zdravljenje z zdravilom Pegasys lahko začnemo ali nadaljujemo, če lahko z zdravilom vzdržujemo koncentracije TSH v normalnih mejah.
TSH levels should be determined during the course of therapy if a patient develops clinical symptoms consistent with possible thyroid dysfunction (see section 4.8).
Če se pri bolniku med zdravljenjem pojavijo klinični simptomi, povezani z možno motnjo delovanja ščitnice, moramo določiti koncentracije TSH (glejte poglavje 4. 8).
As with other interferons, hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Kot pri drugih interferonih so tudi med zdravljenjem z zdravilom Pegasys poročali o hipoglikemiji, hiperglikemiji in sladkorni bolezni (glejte poglavje 4. 8).
Patients with these conditions who cannot be effectively controlled by medication should not begin Pegasys monotherapy nor Pegasys/ ribavirin combination therapy.
Bolniki s temi stanji, ki jih ne moremo ustrezno uravnavati z zdravili, naj ne začnejo samostojnega zdravljenja z zdravilom Pegasys ali kombiniranega zdravljenja z zdravilom Pegasys in ribavirinom.
Patients who develop these conditions during treatment and cannot be controlled with medication should discontinue Pegasys or Pegasys/ ribavirin therapy.
Bolniki, pri katerih se ta stanja razvijejo med zdravljenjem in jih ne moremo ustrezno uravnati z zdravili, morajo zdravljenje z zdravilom Pegasys ali kombinirano zdravljenje z zdravilom Pegasys in ribavirinom prekiniti.
Cardiovascular system Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alpha interferon therapies, including Pegasys.
Srčnožilni sistem Zdravljenje z interferoni, vključno z zdravilom Pegasys, povezujejo z neželenimi učinki, kot so hipertenzija, supraventrikularne aritmije, kongestivno srčno popuščanje, bolečina v prsih in miokardni infarkt.
In patients with cardiovascular disease, anaemia may necessitate dose reduction or discontinuation of ribavirin (see section 4.2).
Pri bolnikih z motenim srčnim delovanjem je zaradi anemije treba zmanjšati odmerek ribavirina ali zdravljenje z ribavirinom prekiniti (glejte poglavje 4. 2).
Liver function In patients who develop evidence of hepatic decompensation during treatment, Pegasys should be discontinued.
Delovanje jeter Zdravljenje z zdravilom Pegasys moramo pri bolnikih, pri katerih se med zdravljenjem pojavijo znaki jetrne dekompenzacije, prekiniti.
As with other alpha interferons, increases in ALT levels above baseline have been observed in patients treated with Pegasys, including patients with a viral response.
Kakor pri zdravljenju z drugimi interferoni alfa so tudi pri zdravljenju z zdravilom Pegasys opazili zvišanje koncentracij ALT glede na izhodiščne vrednosti tudi pri bolnikih z virološkim odzivom.
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 zvišanje koncentracij ALT progresivno ali klinično značilno, ali če ga spremlja zvišan direktni bilirubin, moramo zdravljenje prekiniti (glejte poglavji 4. 2 in 4. 8).
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.
9 V kliničnih preskušanjih zdravila Pegasys pri bolnikih s HBV so znatna nihanja transaminaze spremljale blage spremembe drugih meritev jetrne funkcije brez dokazov jetrne dekompenzacije.
In approximately half the case of flares exceeding 10 times the upper limit of normal, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
Preostanek zdravljenja je potekal nespremenjeno.
Hypersensitivity Serious, acute hypersensitivity reaction (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed during alpha interferon therapy.
Preobčutljivost Med zdravljenjem z interferoni alfa so redko poročali o hudi akutni preobčutljivostni reakciji (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksa).
Autoimmune disease The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Avtoimunska bolezen Med zdravljenjem z interferoni alfa so poročali o nastanku avtoprotiteles in avtoimunskih boleznih.
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also Endocrine System in sections 4.4 and 4.8).
Ponovno je treba ovrednotiti korist in tveganje nadaljevanja zdravljenja z interferoni (glejte tudi Endokrini sistem poglavji 4. 4 in 4. 8).
Fever/ infections 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.
Zvišana telesna temperatura/ okužbe 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.
Serious infections (bacterial, viral, fungal) have been reported during treatment with alpha interferons including Pegasys.
Med zdravljenjem z interferoni alfa, vključno z zdravilom Pegasys, so poročali o resnih okužbah (bakterijskih, virusnih in glivičnih).
Appropriate anti-infective therapy should be started immediately and discontinuation of therapy should be considered.
Potrebno je takoj pričeti z ustreznim zdravljenjem proti okužbam in razmisliti o prekinitvi zdravljenja.
9 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.
Patients with preexisting ophthalmologic disorders (eg, diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
Bolniki s predhodnimi oftalmološkimi boleznimi (npr. diabetična ali hipertenzivna retinopatija) morajo med zdravljenjem z zdravilom Pegasys opravljati periodične oftalmološke preglede.
Pulmonary changes As with other alpha interferons, pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Pulmonalne spremembe Med zdravljenjem z zdravilom Pegasys so podobno kot pri zdravljenju z drugimi interferoni alfa poročali o pulmonalnih simptomih, kot so dispneja, pljučni infiltrati, pljučnica in pnevmonitis.
Skin disorder Use of alpha interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis.
Bolezni kože Uporaba interferonov alfa je bila povezana s poslabšanjem ali pojavom psoriaze in sarkoidoze.
Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered.
Če pride do pojavov ali poslabšanj psoriatičnih lezij, moramo razmisliti o prekinitvi zdravljenja.
Transplantation The safety and efficacy of Pegasys treatment have not been established in patients with liver transplantation.
Presaditve Varnosti in učinkovitosti zdravljenja z zdravilom Pegasys pri bolnikih s presajenimi jetri niso proučevali.
HIV-HCV coinfection 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.
V študiji NR15961 je bila incidenca pankreatitisa in/ ali laktacidoze pri
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).
10 bolnikih, sočasno zdravljenih s stavudinom in interferonom z dodanim ribavirinom ali brez, 3% (12/ 398).
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.
Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SPC).
Pri uvajanju zdravila Pegasys in ribavirina v HAART je zato potrebna previdnost (glejte SPC za ribavirin).
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).
Co-infected patients should be closely monitored, assessing their Child-Pugh score during treatment, and should be immediately discontinued if they progress to a Child-Pugh score of 7 or greater.
Zdravljenje je treba takoj prekiniti, če število točk po lestvici naraste na 7 ali več.
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.
Dental and periodontal disorders Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Zobne in periodontalne bolezni Pri bolnikih, ki prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali o zobnih in periodontalnih boleznih, ki lahko vodijo do izgube zob.
Patients should brush their teeth thoroughly twice daily and have regular
Bolniki si morajo dvakrat na dan temeljito umiti zobe in imeti redne preglede pri zobozdravniku.
Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/ week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Pomembnega zmanjšanja hitrosti napredovanja fibroze ali z njo povezanih kliničnih dogodkov niso opazili.
Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
To nakazuje, da zdravilo Pegasys ne vpliva na presnovno aktivnost 3A4, 2C9, 2C19 in 2D6 izoencimov citokroma P450 in vivo.
In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
V isti študiji so opazili tudi 25 -% povečanje AUC za teofilin (označevalec aktivnosti citokroma P450 1A2), kar dokazuje, da je zdravilo Pegasys zaviralec aktivnosti citokroma P450 1A2.
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.
11 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.
In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
V farmakokinetični študiji, v kateri je 24 bolnikov s HCV sočasno prejemalo vzdrževalno zdravljenje z metadonom (mediana odmerka 95 mg, razpon od 30 mg do 150 mg), je bilo zdravljenje z zdravilom Pegasys v odmerku 180 mikrogramov, danim subkutano enkrat na teden 4 tedne, povezano z 10 do 15 -% dvigom srednjih koncentracij metadona glede na vrednosti pred zdravljenjem.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Še posebej je treba tveganje za podaljšanje QTc intervala upoštevati pri bolnikih, ki prejemajo visoke odmerke metadona.
HIV-HCV co-infected patients No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12 week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
Bolniki sočasno okuženi s HIV in HCV V 12- tedenski farmakokinetični podštudiji, kjer so raziskovali učinek ribavirina na intracelularno fosforilacijo nekaterih nukleozidnih zaviralcev reverzne transkriptaze (lamivudin in zidovudin ali stavudin), pri 47 bolnikih sočasno okuženih s HIV in HCV, ki so zaključili podštudijo, jasnih dokazov o interakcijah med zdravili niso opazili.
However, due to high variability, the confidence intervals were quite wide. Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
Sočasno jemanje nukleozidnih zaviralcev reverzne transkriptaze (NRTIs) na plazemsko izpostavljenost ribavirinu ni vplivalo.
Exposure to didanosine or its active metabolite (dideoxyadenosine 5’ -triphosphate) is increased in vitro when didanosine is co- administered with ribavirin.
Izpostavljenost didanozinu ali njegovemu aktivnemu presnovku (dideoksiadenozin 5` - trifosfat) je povečana in vitro, če didanozin jemljemo sočasno z ribavirinom.
Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/ lactic acidosis have been reported with use of ribavirin.
Pri jemanju ribavirina so poročali o smrti zaradi jetrne odpovedi, periferni nevropatiji, pankreatitisu in simptomatski hiperlaktatemiji/ laktacidozi.
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Sočasno jemanje ribavirina in zidovudina ni priporočljivo zaradi povečanega tveganja za nastanek anemije (glejte poglavje 4. 4).
Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established.
Če je bila ugotovljena anemija, je smiselno razmisliti o zamenjavi zidovudina v kombinaciji protivirusnih zdravil.
There are no adequate data on the use of peginterferon alfa-2a in pregnant women.
Ni zadostnih podatkov o uporabi peginterferona alfa- 2a pri nosečnicah.
Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Možno tveganje za ljudi ni znano.
It is not known whether the components of this medicinal product are excreted in human milk.
Ni znano, ali se pri ljudeh sestavine tega zdravila izločajo v materino mleko.
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Zaradi možnih neželenih učinkov pri dojenih otrocih je treba pred začetkom zdravljenja dojenje prekiniti.
Use with ribavirin Significant teratogenic and/ or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Uporaba z ribavirinom Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so se pojavili značilni teratogeni in/ ali embriocidni učinki.
Female patients of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Med zdravljenjem in 4 mesece po končanem zdravljenju morajo tako bolnice v rodni dobi kot njihovi partnerji uporabljati učinkovito kontracepcijsko zaščito.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Med zdravljenjem in še 7 mesecev po končanem zdravljenju morajo tako bolniki moškega spola kot tudi njihove partnerke uporabljati učinkovito kontracepcijsko zaščito.
Please refer to the ribavirin SPC.
Prosimo, glejte SmPC za ribavirin.
Pegasys has a minor or moderate influence on the ability to drive and use machines.
Zdravilo Pegasys ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.
Bolnike, pri katerih se pojavi omotičnost, zmedenost, somnolenca ali utrujenost, moramo opozoriti, naj se izogibajo vožnji ali upravljanju s stroji.
Experience from clinical trials
Podatki kliničnih preskušanj
The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 4).
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 4).
In clinical trials of 48 week treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C.
V kliničnih preskušanjih zdravljenja, ki je trajalo 48 tednov in v obdobju sledenja bolnikov, ki je trajalo 24 tednov, je bil varnostni profil zdravila Pegasys pri bolnikih s kroničnim hepatitisom B podoben kot pri kroničnem hepatitisu C.
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.
Adverse events or laboratory abnormalities led to 5% of patients withdrawing from Pegasys treatment, while less than 1% of patients withdrew from lamivudine treatment for these reasons.
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.
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
V kliničnem preskušanju pri bolnikih, ki se na prejšnje zdravljenje s pegiliranim interferonom alfa- 2b/ ribavirinom niso odzvali, in ki so se v preskušanju zdravili 48 tednov, je bilo prekinitev zdravljenja zaradi neželenih učinkov 6% in laboratorijskih nenormalnosti 7%.
12 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).