FrancophonIA/ELRC3.0 huggingface dataset:
English: A high proportion of patients (approximately 62%) went on to receive a variety of nonprotocol specified anti- cancer therapies, which may have impacted the analysis of overall survival.
Slovenian: Velik delež bolnikov (približno 62 %) je v nadaljevanju prejemal različna zdravila za zdravljenje novotvorb, ki jih niso določili s protokolom, kar je lahko vplivalo na analizo celokupnega preživetja.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in Table 6 for trial NO16966.
Slovenian: V skupini, ki je prejemala kemoterapijo, so pri zdravljenju po shemi FOLFOX-4 uporabljali enake odmerke in shemo odmerjanja, kot prikazuje preglednica 6 za preskušanje NO16966.
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Slovenian: S tem so zavrli napredovanje metastatske bolezni in zmanjšali mikrovaskularno prepustnost.
English: The results for all secondary endpoints (investigator assessed EFS, and ORR and OS) were consistent in showing no improvement associated with the addition of bevacizumab to the RT/T arm compared with the RT/T arm alone.
Slovenian: Rezultati za vse sekundarne opazovane dogodke (EFS po oceni raziskovalca, ORR in OS) so bili skladni in niso pokazali izboljšanja, povezanega z dodatkom bevacizumaba v skupini, ki je prejemala RT/T, v primerjavi s skupino, ki je prejemala samo RT/T.
English: In an exploratory analysis, the extent of bevacizumab benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Slovenian: V raziskovalni analizi so ugotovili, da je bila korist bevacizumaba za celokupno preživetje manj izrazita v podskupini bolnikov, ki niso imeli histologije adenokarcinoma.
English: Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Slovenian: Obvestite zdravnika, če ste pred kratkim prejeli ali prejemate zdravljenje z obsevanjem.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see section 5.1).
Slovenian: Zdravljenje je priporočljivo nadaljevati do napredovanja osnovne bolezni ali nesprejemljive toksičnosti (glejte poglavje 5.1).
English: Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Slovenian: Bevacizumab se veže na vaskularni endotelijski rastni faktor (VEGF - vascular endothelial growth factor), ki je ključno gonilo vaskulogeneze in angiogeneze, s čimer zavira vezavo VEGF na njegova receptorja Flt-1 (VEGFR-1) in KDR (VEGFR-2) na površini endotelijskih celic.
English: ● if you have problems with wound healing following surgery,
Slovenian: ● če imate težave s celjenjem ran po kirurškem posegu,
English: • loss of appetite,
Slovenian: • pomanjkanje apetita,
English: In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Slovenian: Rezultati so pokazali, da pri odraslih ni pomembnih razlik v farmakokinetiki bevacizumaba glede na starost.
English: 0.80 (p=0.003) 95% CI (0.69; 0.93)
Slovenian: 0,80 (p = 0,003) 95 % IZ (0,69; 0,93)
English: Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Slovenian: Bevacizumab v kombinaciji z interferonom alfa-2a v prvi liniji zdravljenja napredovalega in/ali metastatskega raka ledvičnih celic (BO17705)
English: These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the bevacizumab treatment regimen.
Slovenian: Krvavitev je bila najpogosteje epistaksa stopnje 1 po NCI-CTCAE v.3, ki je trajala manj kot 5 minut, je izzvenela brez zdravniške pomoči in ni zahtevala sprememb režima zdravljenja z bevacizumabom.
English: Prior anthracyclines exposure and/or prior radiation to the chest wall may be possible risk factors for the development of CHF.
Slovenian: Predhodna izpostavljenost antraciklinom in/ali predhodno obsevanje prsnega koša sta lahko morebitna dejavnika tveganja za razvoj KSP.
English: • blood clot in the arteries which can lead to a stroke or a heart attack,
Slovenian: • krvne strdke v arterijah, ki lahko vodijo do možganske kapi ali srčnega infarkta,
English: • a hole in the cartilage wall separating the nostrils of the nose,
Slovenian: • predrtje stene iz hrustanca, ki ločuje nosnici,
English: The safety and efficacy of bevacizumab, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Slovenian: Varnost in učinkovitost bevacizumaba, ki so ga dodali kemoterapiji na osnovi platine v prvi liniji zdravljenja bolnikov z neploščatoceličnim nedrobnoceličnim rakom pljuč (NSCLC), so proučevali v preskušanjih E4599 in BO17704.
English: Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
Slovenian: O vplivu bevacizumaba na farmakokinetiko gemcitabina ni mogoče sklepati.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab treated patients.
Slovenian: O smrtnem izidu so poročali pri približno tretjini resnih primerov perforacij prebavil, kar predstavlja med 0,2 % in 1 % vseh bolnikov, ki so se zdravili z bevacizumabom.
English: Infusion solutions should be used immediately after dilution.
Slovenian: Infuzijsko raztopino je treba uporabiti takoj po redčenju.
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Slovenian: Tveganja za krvavitev v CŽS pri teh bolnikih torej niso prospektivno ocenili v randomiziranih kliničnih preskušanjih (glejte poglavje 4.8).
English: Dose and frequency of administration
Slovenian: Odmerjanje in pogostnost dajanja
English: • sores in the mouth and the tube from the mouth to the stomach, which may be painful and cause difficulty swallowing,
Slovenian: • razjede v ustih in cevi med usti in želodcem, ki so lahko boleče in povzročajo težave pri požiranju,
English: Table 2 also includes adverse reactions which are considered by the MAH to be clinically significant or severe.
Slovenian: Preglednica 2 vključuje tudi neželene učinke, za katere je imetnik dovoljenja za promet z zdravilom ocenil, da so klinično pomembni ali hudi.
English: Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance.
Slovenian: O razmerju med koristmi in tveganji zdravila ni mogoče dokončno sklepati, dokler ne bodo na voljo dokončni rezultati glede OS in podatki o varnosti.
English: Table 11 Efficacy results for trial E4599
Slovenian: Preglednica 11 Rezultati učinkovitosti v preskušanju E4599
English: % pts with objective response p-value
Slovenian: % bolnikov z objektivnim odzivom p-vrednost
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete katerokoli zdravilo.
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Slovenian: Klinično korist pri bolnikih z NSCLC so dokazali tako za odmerek 7,5 mg/kg kot za 15 mg/kg (glejte poglavje 5.1).
English: • decreased number of cells in the blood, including white cells that help to fight against infections (this may be accompanied by fever), and cells that help the blood to clot,
Slovenian: • zmanjšano število krvnih celic, vključno z belimi krvnimi celicami, ki pomagajo v boju proti okužbam (ob tem se lahko pojavi vročina), in celicami, ki pomagajo pri strjevanju krvi,
English: Bevacizumab has no or negligible influence on the ability to drive and use machines.
Slovenian: Bevacizumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In terms of safety, there was a higher overall incidence of Grade 3-5 AEs in study E3200 relative to study ML18147.
Slovenian: Kar zadeva varnost, je bila pojavnost neželenih učinkov stopnje 3-5 v študiji E3200 celokupno večja glede na študijo ML18147.
English: Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Slovenian: Adjuvantno kemoterapijo je pred tem prejemalo 65 % bolnikov, od tega 19 % taksane in 49 % antracikline.
English: (p-value
Slovenian: (p-vrednost
English: Bevacizumab is contraindicated in pregnancy (see section 4.3).
Slovenian: Bevacizumab je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: The incidence of CNS bleeding in patients with untreated CNS metastases receiving bevacizumab has not been prospectively evaluated in randomised clinical trials.
Slovenian: Pojavnosti krvavitev v CŽS pri bolnikih z nezdravljenimi metastazami v CŽS, ki so prejemali bevacizumab, niso prospektivno ocenili v randomiziranih kliničnih preskušanjih.
English: Other medicines and Zirabev
Slovenian: Druga zdravila in zdravilo Zirabev
English: 0.65 (p < 0.0001) 95% CI (0.56; 0.76)
Slovenian: 0,65 (p < 0,0001) 95 % IZ (0,56; 0,76)
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Slovenian: Tipična vrednost za volumen centralnega prostora (Vc) je bila 2,73 l pri bolnicah in 3,28 l pri bolnikih, kar je v območju, ki so ga opisali za IgG in druga monoklonska protitelesa.
English: Pfizer România S.R.L Tel: +40 (0) 21 207 28 00
Slovenian: Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
English: Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 8).
Slovenian: Opazili so tudi statistično pomembna izboljšanja v preživetju brez napredovanja bolezni in objektivnem odzivu na zdravljenje (glejte preglednico 8).
English: Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications.
Slovenian: V preglednicah 1 in 2 so našteti neželeni učinki, ki so povezani z uporabo bevacizumaba v kombinaciji z različnimi kemoterapevtskimi shemami pri več indikacijah.
English: ● This medicine may cause bleeding, especially tumour-related bleeding.
Slovenian: ● To zdravilo lahko povzroči krvavitve, posebno krvavitve, povezane s tumorjem.
English: • Increased eye pressure,
Slovenian: • povišanje tlaka v očesu,
English: In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
Slovenian: Pri bolnikih, pri katerih je med zdravljenjem prišlo do zapleta pri celjenju ran, moramo zdravljenje prekiniti, dokler se rana popolnoma ne zaceli.
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Slovenian: To vključuje zmanjšanje števila belih krvnih celic, zlasti nevtrofilcev (vrsta belih krvnih celic, ki pomaga varovati pred okužbami), prisotnost beljakovin v urinu, zmanjšanje vrednosti kalija, natrija ali fosforja (mineral) v krvi, zvečanje vrednosti sladkorja v krvi, zvečanje vrednosti alkalne fosfataze (encim) v krvi, zvečanje vrednosti kreatinina v serumu (beljakovina, ki jo merijo v preiskavah krvi, da ocenijo, kako dobro delujejo vaše ledvice) ter zmanjšanje vrednosti hemoglobina (nahaja se v rdečih krvnih celicah, ki prenašajo kisik), ki je lahko hudo.
English: Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Slovenian: Bolnike z nezdravljenimi metastazami v centralnem živčnem sistemu (CŽS) so rutinsko izključili iz kliničnih preskušanj z bevacizumabom na podlagi slikovnih preiskav ali znakov in simptomov.
English: Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.
Slovenian: V preskušanje niso vključili bolnikov z metastazami v centralnem živčnem sistemu, vključno s predhodno zdravljenimi ali odstranjenimi možganskimi lezijami.
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Slovenian: Med 110 bolniki, ki so jih randomizirali v skupino 3 (5-FU/FA + bevacizumab), je bila mediana celokupnega preživetja pred prekinitvijo zdravljenja v tej skupini 18,3 meseca, mediana preživetja brez napredovanja bolezni pa 8,8 meseca.
English: No AEs leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Slovenian: Neželeni učinki, ki bi bili smrtni, se niso pojavili v nobeni od zdravljenih skupin; vsi smrtni primeri so bili posledica napredovanja bolezni.
English: I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Slovenian: I-bevacizumaba je pokazala, da ima bevacizumab podoben presnovni profil, kot je pričakovani presnovni profil za izvorne molekule IgG, ki se ne vežejo na VEGF.
English: All treatments were continued until disease progression.
Slovenian: Vsa zdravljenja so izvajali do napredovanja bolezni.
English: After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Slovenian: Po prilagoditvi glede na telesno maso so imeli bolniki večji očistek bevacizumaba (+ 17 %) kot bolnice.
English: The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy in clinical trials.
Slovenian: Celoten varnostni profil bevacizumaba temelji na podatkih več kot 5.700 bolnikov z različnimi malignimi boleznimi, ki so se v kliničnih preskušanjih večinoma zdravili z bevacizumabom v kombinaciji s kemoterapijo.
English: Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.
Slovenian: Z nevtralizacijo biološkega delovanja VEGF zmanjša ožiljenost tumorja, normalizira preostalo žilje tumorja in zavira nastajanje novega žilja tumorja, s čimer zavira rast tumorja.
English: Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer.
Slovenian: Obvestite zdravnika, če za zdravljenje pljučnega raka ali metastatskega raka dojk uporabljate zdravila, ki vsebujejo platino ali taksane.
English: Table 15 Overall survival results from study GOG-0240 by trial treatment
Slovenian: Preglednica 15 Rezultati celokupnega preživetja v študiji GOG-0240 glede na zdravljenje v okviru preskušanja
English: In both studies, bevacizumb exposure trended lower as body weight decreased.
Slovenian: V obeh študijah se je izpostavljenost bevacizumabu zmanjševala z manjšanjem telesne mase.
English: Zirabev contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Slovenian: Zdravilo Zirabev vsebuje učinkovino bevacizumab, ki je humanizirano monoklonsko protitelo (vrsta beljakovine, ki jo običajno proizvaja imunski sistem, da pomaga telesu pri obrambi proti okužbam in raku).
English: Patients may be at risk of developing infusion/hypersensitivity reactions.
Slovenian: Pri bolnikih lahko obstaja tveganje za pojav reakcij na infuzijo/preobčutljivostnih reakcij.
English: Common (may affect up to 1 in 10 people) side effects, which were not severe, include: • voice changes and hoarseness.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) neželeni učinki, ki niso bili hudi, vključujejo: • spremembo glasu in hripavost.
English: The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies using a population pharmacokinetic model.
Slovenian: Farmakokinetiko bevacizumaba so ovrednotili pri 152 otrocih, mladostnikih in mlajših odraslih (od 7 mesecev do 21 let; od 5,9 kg do 125 kg) v 4 kliničnih študijah z uporabo populacijskega farmakokinetičnega modela.
English: Patients were nephrectomised for primary renal cell carcinoma.
Slovenian: Bolnikom so zaradi primarnega karcinoma ledvičnih celic opravili nefrektomijo.
English: In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Slovenian: V večini kliničnih preskušanj bevacizumaba so bolnike z obstoječim KSP stopnje II-IV po razvrstitvi Newyorškega združenja za srce (NYHA - New York Heart Association) izključili iz preskušanja, zato informacije o tveganju za KSP pri tej populaciji niso na voljo.
English: Objective response rate (%) in Patients with measurable disease N Response rate
Slovenian: Objektivni odziv na zdravljenje (%) pri bolnikih z merljivo boleznijo stopnja odziva
English: • fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
Slovenian: • fistule: nenormalne cevaste povezave med notranjimi organi in kožo ali drugimi tkivi, ki normalno niso povezana, vključno s povezavami med nožnico in črevesjem pri bolnicah z rakom materničnega vratu.
English: Zirabev should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Slovenian: Zdravljenje z zdravilom Zirabev je treba trajno prekiniti, če klinično pomembne hipertenzije ni mogoče ustrezno obvladati z antihipertenzivnimi zdravili ali če se pri bolniku pojavi hipertenzivna kriza ali hipertenzivna encefalopatija.
English: • shortness of breath or low levels of oxygen in the blood,
Slovenian: • zasoplost ali nizke vrednosti kisika v krvi,
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab.
Slovenian: Opaženo zvečanje koncentracije kreatinina v serumu ni bilo povezano z večjo pojavnostjo kliničnih znakov ledvične okvare pri bolnikih, ki so se zdravili z bevacizumabom.
English: Combinations of Zirabev with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Slovenian: Kombinacija zdravila Zirabev z drugim zdravilom, imenovanim sunitinibijev malat (ki ga predpisujejo za zdravljenje raka ledvic in prebavil), lahko povzroči hude neželene učinke.
English: As bevacizumab may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Slovenian: Ker bevacizumab lahko negativno vpliva na celjenje ran, bolnikov, ki so imeli v zadnjih 28 dneh pred začetkom zdravljenja večji kirurški poseg, niso vključili v klinična preskušanja 3. faze.
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
Slovenian: Hipertenzijo so na splošno ustrezno obvladali s peroralnimi antihipertenzivi, kot so zaviralci angiotenzinske-konvertaze, diuretiki in zaviralci kalcijevih kanalčkov.
English: Table 8 Efficacy results for trial E3200
Slovenian: Preglednica 8 Rezultati učinkovitosti v preskušanju E3200
English: Pre-existing hypertension should be adequately controlled before starting Zirabev treatment.
Slovenian: Obstoječo hipertenzijo je treba pred začetkom zdravljenja z zdravilom Zirabev ustrezno obvladati.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Slovenian: Sekundarne analize PFS, ki so temeljile na ocenah odziva med zdravljenjem, so potrdile pomembno superiorno klinično korist za bolnike, ki so se zdravili z bevacizumabom (analize so prikazane v preglednici 7), kar je skladno s statistično pomembno koristjo, ki so jo opazili v združeni analizi.
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Slovenian: *Bevacizumab je rekombinantno humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA iz ovarijskih celic kitajskega hrčka.
English: The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Slovenian: Analiza primarnega opazovanega dogodka je pokazala, da ni bilo razlike med skupino, ki je prejemala bevacizumab + placebo, in skupino, ki je prejemala bevacizumab + erlotinib (mediano PFS 8,5 meseca v primerjavi z 9,9 meseca).
English: ● an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
Slovenian: ● neobičajna cevasta povezava ali prehod med sapnikom in požiralnikom, med notranjimi organi in kožo, med nožnico in katerimkoli delom črevesja ali med drugimi tkivi, ki normalno niso povezana (fistula), in jih zdravnik oceni kot resne,
English: ● Zirabev may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Slovenian: ● Zdravilo Zirabev lahko poveča tveganje za razvoj neobičajne povezave ali prehoda med dvema organoma ali žilama.
English: IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Slovenian: IFN alfa-2a so prejemali največ 52 tednov ali do napredovanja bolezni v priporočenem začetnem odmerku 9 mio i.e. trikrat na teden, ki so ga smeli zmanjšati v 2 korakih na 3 mio i.e. trikrat na teden.
English: The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Slovenian: Presnova in izločanje bevacizumaba sta podobna presnovi in izločanju endogenega IgG, in sicer potekata predvsem prek proteolitične razgradnje po celem telesu, tudi v endotelijskih celicah, in nista primarno odvisna od izločanja preko ledvic in jeter.
English: Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Slovenian: Bevacizumab so prejemali v odmerku 10 mg/kg vsaka 2 tedna do napredovanja bolezni.