natgillin/translations-raw huggingface dataset:
Heart and blood vessel disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle, bleeding in the brain and inflammation in the vessels
Srčne in žilne bolezni: srčni napad, srčna odpoved, bolečina v srcu, hiter srčni ritem, motnje ritma in vnetje poprsnice ter srčne mišice, krvavitev v možganih in vnetje žil.
In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/week and ribavirin 800 milligrams/day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
V študiji NR16071 so randomizirani bolniki s HCV, ki so imeli normalne vrednosti ALT, prejemali zdravilo Pegasys v odmerku 180 mikrogramov na teden in 800 miligramov ribavirina na dan 24 ali 48 tednov, ki jim je sledilo 24-tedensko obdobje sledenja brez zdravljenja ali 72 tednov brez zdravljenja.
Ask your healthcare provider any questions you may have.
Nanj se obrnite, če imate vprašanja.
Breathing disorders: Shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat
Bolezni dihal: zasoplost pri telesni aktivnosti, krvavitev iz nosu, vnetje nosu in grla, okužbe nosu in sinusov (v kosteh obraza in glave so našli prostore, napolnjene z zrakom), izcedek iz nosu, vnetje grla.
Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
O hudih neželenih učinkih so poročali pri 2 bolnikih v skupini, ki je bila zdravljena s kombinacijo zdravila Pegasys in ribavirina (hiperglikemija in holecistektomija).
Comprehensive instructions for the preparation and administration of Pegasys in pre-filled pen are given in the package leaflet.
Natančna navodila za pripravo in dajanje zdravila Pegasys v napolnjenem injekcijskem peresniku so v navodilu za uporabo.
Study NV15942
Študija NV15942
In non-responder patients re-treated for 48 or 72 weeks, viral suppression at week 12 (undetectable HCV RNA defined as <50 IU/ml) has been shown to be predictive for sustained virological response.
Pri bolnikih, ki se na zdravljenje niso odzvali in so jih ponovno zdravili 48 ali 72 tednov, je bila virusna supresija v 12. tednu (nemerljiva koncentracija HCV RNA, definirana kot < 50 i.e./ml)
Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Če opazite, da postajate depresivni, imate samomorilske misli ali opažate spremembe v svojem vedenju, takoj poiščite zdravniško pomoč.
Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
Med kliničnimi preskušanji so pri karcinomu ledvic dajali tedenske odmerke do 540 mikrogramov, pri kronični mieloični levkemiji pa do 630 mikrogramov.
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
Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon.
Zdravilo Pegasys vsebuje zdravilno učinkovino peginterferon alfa-2a, ki je interferon z dolgotrajnim delovanjem.
A subsequent study (NV18209) in patients co-infected with HCV genotype 1 and HIV compared treatment using Pegasys 180 mcg/week and either ribavirin 800 mg or 1000 mg (<75 kg)/1200 mg (≥75 kg) daily for 48 weeks.
Kasnejša študija (NV18209) pri bolnikih, sočasno okuženih s HCV genotipom 1 ter HIV, je primerjala zdravljenje z zdravilom Pegasys 180 µg/teden v kombinaciji bodisi z 800 mg ribavirina bodisi s 1000 mg (bolniki < 75 kg)/1200 mg ribavirina (bolniki ≥ 75 kg) na dan, 48 tednov.
List of subsections on how to proceed:
Seznam korakov postopka:
Chronic hepatitis C in prior non-responder patients
Kronični hepatitis C pri bolnikih, ki se na prejšnje zdravljenje niso odzvali
HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
HBV DNA < 20.000 i.e./ml* HBV DNA < 2.000 i.e./ml ALT normalizacija
*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 beljakovine interferona alfa-2a, pridobljene iz celične kulture Escherichia coli s tehnologijo rekombinantne DNA, z molekulo bis[monometoksipolietilenglikol].
In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), and injection-site reaction (45%).
V pediatrični študiji so bili pri bolnikih, zdravljenih s kombinacijo zdravila Pegasys in ribavirina do 48 tednov, prevladujoči neželeni učinki gripi podobna bolezen (91 %), glavobol (64 %), gastrointestinalne motnje (56 %), in reakcije na mestu injiciranja (45 %).
From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
Iz študije NR16141 je 14 otrok, starih od 2 do 8 let, s kroničnim hepatitisom C prejemalo zdravilo Pegasys z odmerkom: 180 µg/1,73 m2 x telesna površina (TP) otroka.
Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C Genotype
Preglednica 2: Napovedna vrednost virološkega odziva v 12. tednu pri priporočenem odmerjanju med kombiniranim zdravljenjem z zdravilom Pegasys pri odraslih bolnikih s kroničnim hepatitisom C
Patient ‘weight for age' and ‘height for age' percentiles of the normative population decreased during treatment.
Med zdravljenjem so se bolnikovi percentili telesne mase in višine bolnikov za njihovo starost glede na normativno populacijo zmanjšali.
The probabilities of achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was achieved at week 12 were 35% (20 of 57) and 57% (57 of 100), respectively.
Če so bolniki v 12. tednu zdravljenja dosegli virusno supresijo, pa je bila verjetnost, da bodo dosegli trajen virološki odziv, pri 48-tedenskem zdravljenju 35 % (20 od 57), pri 72-tedenskem pa 57 % (57 od 100).
During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Med zdravljenjem z zdravilom Pegasys v kombinaciji z ribavirinom ali brez, ki je trajalo do 48 tednov, sta bila pri bolnikih, starih od 3 do 17 let, izguba telesne mase in zastoj rasti pogosta (glejte poglavji 4.8 in 5.1).
In a clinical trial with 114 paediatric patients (5 to 17 years of age) treated with Pegasys alone or in combination with ribavirin (see section 5.1), dose modifications were required in approximately onethird of patients, most commonly for neutropenia and anaemia.
zdravljenih z zdravilom Pegasys samim ali v kombinaciji z ribavirinom (glejte poglavje 5.1), je bilo treba prilagoditi odmerke pri približno eni tretjini bolnikov, najpogosteje zaradi nevtropenije in anemije.
Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
Zdravilo Pegasys ima enake protivirusne in protiproliferativne značilnosti in vitro kot interferon alfa-2a.
Combination therapy with ribavirin in chronic hepatitis C In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.
Kombinirano zdravljenje z ribavirinom pri kroničnem hepatitisu C Pri kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom upoštevajte odmerjanje, ki vam ga je predpisal zdravnik.
In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration.
Pri teh bolnikih je pri odločanju o odstopanju od standardnega 24-tedenskega zdravljenja treba razmisliti o prenašanju kombiniranega zdravljenja in prisotnosti dodatnih kliničnih ali prognostičnih dejavnikov, kot je stopnja fibroze.
Chronic hepatitis B - adult patients
Odmerjanje Kronični hepatitis B - odrasli bolniki
135 micrograms/0.5 ml
135 μg/0,5 ml
Pegasys 180 mcg Ribavirin mg (N=453) 48 weeks
Pegasys 180 µg in ribavirin mg (n = 453) 48 tednov
Replace the needle guard and place the syringe in a horizontal position until ready for use.
Ponovno namestite igelno zaščito in dajte injekcijsko brizgo v vodoravno lego, dokler ne boste pripravljeni za injiciranje.
At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment).
Ob zaključku 2-letnega obdobja spremljanja bolnikov po zdravljenju so vrednosti večine bolnikov ponovno dosegale percentile telesne mase in višine normativne krivulje rasti izhodiščnih vrednosti (povprečnni percentil telesne mase je bil 64 % ob izhodišču in 60 % 2 leti po zdravljenju; povprečen percentil telesne višine je bil 54 % ob izhodišču in 56 % 2 leti po zdravljenju).
● If you have any further questions, ask your doctor, pharmacist or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Confirmatory clinical trials in adult treatment-naïve patients All clinical trials recruited interferon-naïve patients with CHC confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
potrjen z merljivimi koncentracijami serumske HCV RNA, zvečane koncentracije ALT (z izjemo študije NR16071) in biopsijo jeter, ki ustreza kroničnemu hepatitisu.
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
0,5 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (silikonsko steklo tipa I) z zamaškom in batom ter pokrovom na vrhu (iz butilirane gume, prevlečene z laminatom in fluorescinom na strani, ki je obrnjena proti zdravilu), injekcijska igla.
HBsAg Seroconversion
HBsAg sero konverzija
Use with ribavirin
Uporaba z ribavirinom
Shortening the treatment duration in patients infected with genotype 2 or 3 with HVL (> 800,000 IU/ml) at baseline who become HCV negative by week 4 should be considered with more caution as this may significantly negatively impact the sustained virological response (see Table 1).
Pri skrajševanju zdravljenja pri bolnikih z genotipom 2 ali 3 in visokim virusnim bremenom pred začetkom zdravljenja (> 800.000 i.e./ml), katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja, je potrebna večja pozornost, saj lahko to signifikantno negativno vpliva na trajni virološki odziv (glejte preglednico 1).
All patients should have a baseline eye examination.
Pri vseh bolnikih je treba opraviti splošni oftalmološki pregled.
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).
V študiji NR15961 je bila incidenca pankreatitisa in/ali laktacidoze pri bolnikih, sočasno zdravljenih s stavudinom in interferonom z dodanim ribavirinom ali brez, 3 %
Response by week
Odziv do 12. tedna
For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%).
Za HBeAg pozitivne bolnike, okužene z virusom hepatitisa B genotipov B in C, HBsAg > 20.000 i.e./ml ali HBV DNA > 8 log10 i.e./ml v 12. tednu po začetku zdravljenja obstaja velika verjetnost nedoseganja serokonverzije HBeAg in HBV DNA < 2000 i.e./ml v 24. tednu po končanem zdravljenju (NPV > 90 %).
The recommended dosage for Pegasys, alone or in combination with ribavirin, is 180 micrograms once weekly subcutaneously for 48 weeks.
Priporočeni odmerek zdravila Pegasys, samega ali v kombinaciji z ribavirinom, je 180 mikrogramov enkrat na teden subkutano 48 tednov.
Chronic hepatitis C in adult patients
Kronični hepatitis C pri odraslih bolnikih
● if you have, so called autoimmune hepatitis.
• imate bolezen avtoimunski hepatitis,
Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Glejte tudi navodila za uporabo drugih zdravil, ki jih uporabljate v kombinaciji z zdravilom Pegasys.
Low viral load High viral load
Nizko virusno breme Visoko virusno breme
*These adverse reactions were common (≥1/100 to < 1/10) in CHB patients treated with Pegasys monotherapy § Class label for interferon products, see below Pulmonary arterial hypertension.
*Ti neželeni učinki so bili pogosti (≥ 1/100 do < 1/10) pri bolnikih, ki so imeli kronični hepatitis B in so bili zdravljeni le z zdravilom Pegasys.
3 level reduction (mcg)
Zmanjšanje odmerka 3. stopnje (mikrogrami)
Anaemia (haemoglobin < 10 g/dl) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
O anemiji (hemoglobin < 10 g/dl) so poročali pri 7 % bolnikov, ki so se zdravili le z zdravilom Pegasys, in pri 14 % bolnikov, ki so prejemali kombinirano zdravljenje.
Infectious mononucleosis, pharyngitis streptococcal, influenza, gastroenteritis viral, candidiasis, gastroenteritis, tooth abscess, hordeolum, urinary tract infection, nasopharyngitis
Infekcijske in parazitske bolezni infekcijska mononukleoza, streptokokni faringitis, gripa, virusni gastroenteritis, kandidaza, gastroenteritis, zobni absces, hordeol, okužba sečil, nazofaringitis
Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 so opazili pri 13 % bolnikih, ki so jemali zdravilo Pegasys samostojno, in pri 11 % bolnikov, ki so jemali zdravilo Pegasys v kombinaciji.
Choose a place on your stomach or thigh (see the picture).
4) Izberite in pripravite mesto vboda Izberite mesto na trebuhu ali stegnih (glejte sliko).
● Allow the solution to reach room temperature before injection or warm the syringe between your palms.
● Pred injiciranjem naj ima raztopina sobno temperaturo, brizgo lahko ogrejete tudi med dlanmi.
Patients with moderate renal impairment receiving Pegasys 180 mcg once weekly exhibited similar peginterferon alfa-2a plasma exposures compared to patients with normal renal function.
Pri bolnikih z zmerno ledvično okvaro, ki so prejemali zdravilo Pegasys 180 µg enkrat na teden, so v primerjavi z bolniki z normalnim ledvičnim delovanjem opazili podobne izpostavljenosti peginterferonu alfa-2a v plazmi.
Dose increases to or towards the original dose may be considered when the adverse reaction abates (see sections 4.4 and 4.8).
Če neželeni učinki izzvenijo, razmislimo o ponovnem zvečanju odmerka proti prvotnemu ali na prvotni odmerek (glejte poglavji 4.4 in 4.8).
Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
Zdravilo Pegasys je v kombinaciji z ribavirinom indicirano za zdravljenje otrok in mladostnikov, starih 5 let ali več, ki imajo predhodno nezdravljen CHC in so pozitivni na ribonukleinsko kislino virusa hepatitisa C (HCV RNA) v serumu.
Pegasys 360/180 or 180 mcg
Pegasys 360/180
No biomarker can be identified with acceptable performance for HBeAg-negative patients with HBV genotype B or C infection.
Biološki označevalec s primernimi značilnostmi pri HBeAg negativnih bolnikih, okuženih z virusom hepatitisa B genotipov B in C, ni znan.
Genotype 1 or 4 without RVR*
Genotip 1 ali 4, brez hitrega virološkega odziva*
Common
Skupno
You are now back on your regularly scheduled day and should continue your injections every Monday.
Z odmerjanjem nadaljujete vsak ponedeljek.
For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Pri bolnikih, ki so okuženi s HIV in HCV in prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali tudi o drugih neželenih učinkih pri ≥ 1 % do ≤ 2 % bolnikov: hiperlaktacidemija/laktacidoza, gripa, pljučnica, čustvena labilnost, apatičnost, tinitus, bolečina v žrelu in grlu, heilitis, pridobljena lipodistrofija in kromaturija.
How to inject Pegasys
Kako injicirate zdravilo Pegasys
2 level reduction (mcg)
Zmanjšanje odmerka 2. stopnje (mikrogrami)
Table 9 summarises the undesirable effects reported with Pegasys monotherapy in CHB or CHC adult patients and with Pegasys in combination with ribavirin in CHC patients.
Seznam neželenih učinkov v preglednici Preglednica 9 povzema neželene učinke, o katerih so poročali pri samostojnem zdravljenju z zdravilom Pegasys pri odraslih bolnikih s CHB ali CHC ter pri bolnikih s CHC, ki so prejemali zdravilo Pegasys v kombinaciji z ribavirinom.
The duration of treatment with Pegasys in combination with ribavirin in paediatric patients with CHC depends on viral genotype.
Trajanje zdravljenja z zdravilom Pegasys v kombinaciji z ribavirinom pri pediatričnih bolnikih s CHC je odvisno od virusnega genotipa.
Table 7: Ribavirin dosing recommendations for paediatric patients with chronic hepatitis C aged 5 to 17 years
Preglednica 7: Priporočila za odmerjanje ribavirina pri pediatričnih bolnikih s kroničnim hepatitisom C, starih od 5 do 17 let
A reduced dose of 135 mcg once weekly is recommended in adult patients with severe renal impairment or end stage renal disease (see section 5.2).
Pri odraslih bolnikih s hudo ledvično okvaro ali končno ledvično odpovedjo je priporočen zmanjšan odmerek 135 mikrogramov enkrat na teden (glejte poglavje 5.2).
● Clean the rubber top of the vial with a cleansing swab.
● Na viali pokrovček iz gume očistite z dezinfekcijsko krpico.
1 level reduction (mcg)
Zmanjšanje odmerka 1. stopnje (mikrogrami)
Duration of treatment - dual therapy with Pegasys and ribavirin The duration of combination therapy with ribavirin for CHC depends on viral genotype.
Trajanje zdravljenja - dvojno zdravljenje z zdravilom Pegasys in ribavirinom Trajanje kombiniranega zdravljenja z ribavirinom pri CHC je odvisno od virusnega genotipa.
Digestive system disorders: Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums, inflammation of tongue and mouth, flatulence (excess amount of air or gases), dry mouth and loss of weight
Bolezni prebavil: bruhanje, slaba prebava, težave s požiranjem, razjede v ustih, krvavitev iz dlesni, vnetje jezika in ust, napenjanje (prevelika količina zraka ali plinov), suha usta in izguba telesne mase.
It is available in packs containing 1 or 4 single dose vials.
Pakiranje vsebuje 1 ali 4 enoodmerne viale.
The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
S konjugacijo reagenta PEG (bis-monometoksipolietilenglikol) z interferonom alfa-2a dobimo pegiliran interferon alfa-2a (zdravilo Pegasys).
The major treatment-related change was reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Glavni neželeni učinek, ki je bil povezan z zdravljenjem, je bila reverzibilna blaga do srednje huda anemija, ki pa je bila hujša kot v primeru vsake posamezne učinkovine.
HBsAg > 20,000 HBV DNA > 6.5 log10
HBV DNA > 6,5 log10
In chronic hepatitis B the duration of Pegasys treatment is 48 weeks.
Zdravljenje z zdravilom Pegasys pri kroničnem hepatitisu B traja 48 tednov.
Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB11
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC:
In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
V drugem kliničnem preskušanju so neodzivne bolnike z napredovalo fibrozo ali cirozo (stopnja 3 do 6 po Ishaku) in izhodiščno koncentracijo trombocitov tudi tako majhno, kot je 50.000 celic/mm3,
Some children and adolescents treated with Pegasys for chronic hepatitis B for 48 weeks did not grow or gain weight as much as expected for their age.
nekateri otroci in mladostniki s kroničnim hepatitisom C niso zrastli oziroma pridobili toliko telesne mase kot pričakovano.
Influenza-like illness, injection site reaction, irritability, fatigue
Bolezen, podobna gripi, reakcija na mestu injiciranja, razdražljivost,
Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or
24-tedensko zdravljenje lahko vpeljemo pri bolnikih, ki so okuženi: - z genotipom 1 in imajo nizko virusno breme pred začetkom zdravljenja (≤ 800.000 i.e./ml) ali
The recommended dose for Pegasys is 180 micrograms once weekly given in combination with oral ribavirin or as monotherapy.
Priporočeni odmerek zdravila Pegasys je 180 mikrogramov enkrat na teden , ki je dan v kombinaciji s peroralnim ribavirinom ali kot monoterapija.
Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Histološko izboljšanje pa se je značilno pojavilo z večjo verjetnostjo pri bolnikih, ki so po 24 tednih po zaključku zdravljenja pokazali trajen odziv.
At the end of treatment, 43% of patients experienced a weight percentile decrease of 15 percentiles or more, and 25% (13 of 53) experienced a height percentile decrease of 15 percentiles or more on the normative growth curves.
Po koncu zdravljenja se je pri 43 % bolnikov percentil telesne mase zmanjšal za 15 percentilov ali več glede na normativne krivulje rasti.
Absent Slight Moderate
Ascites odsoten blag močan
In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
Pri 13 bolnikih s končno ledvično odpovedjo, pri kateri je potrebna kronična hemodializa, je bila pri dajanju zdravila Pegasys 135 µg enkrat na teden izpostavljenost peginterferonu alfa-2a 34 % manjša kot pri bolnikih z normalnim delovanjem ledvic.
All patients
Bolnike,
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 velike odmerke metadona.
Immune system disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders: Loss of vision
Bolezni imunskega sistema: idiopatična (ali trombotična) trombocitopenična purpura (povečano nastajanje modric, krvavitev, zmanjšano število trombocitov, anemija in ekstremna šibkost).