FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline 3% of patients required IOP-lowering medication(s).
Slovenian: V izhodišču je zdravila za nižanje očesnega tlaka potrebovalo 3 % bolnikov.
English: Adverse reaction
Slovenian: Končni rezultat
English: OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm)
Slovenian: Srednja povprečna sprememba debeline centralnega podpolja očesne mrežnice, izmerjena z OKT, v 3 letih,
English: Before your OZURDEX injection tell your doctor if: - You have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye - You are taking any medicines to thin the blood - You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye - You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye)
Slovenian: - ste imeli kirurški poseg zaradi katarakte (sive mrene), kirurški poseg na šarenici (barvnem delu očesa, ki nadzira količino svetlobe, ki vstopi v oko) oziroma kirurški poseg za odstranitev steklovine (imenovane »vitreus«) iz očesa;
English: EXP
Slovenian: Placebo
English: Ocular hypertension, cataract subcapsular, vitreous haemorrhage**, visual acuity reduced*, visual impairment/ disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema* conjunctival hyperaemia*
Slovenian: Očesna hipertenzija, subkapsularna katarakta, vitrealna krvavitev**, zmanjšana ostrina vida*, slabovidnost/motnje vida,
English: The following side effects may be seen with OZURDEX:
Slovenian: Če uporabljate zdravilo OZURDEX, se lahko pojavijo naslednji neželeni učinki:
English: Vitreous Haze Score of Zero BCVA improvement from baseline of ≥15 letters
Slovenian: Ničta stopnja motnosti steklovine Izboljšanje ≥ 15 črk od izhodiščne vrednosti pri najboljši vidni ostrini s korekcijo (BCVA)
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila OZURDEX Vsebina pakiranja in dodatne informacije
English: A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the two Phase III studies.
Slovenian: V dveh študijah 3. faze so v skupino, ki je prejemala zdravilo OZURDEX, naključno razporedili skupno 427 bolnikov, v skupino, ki je prejemala placebo, pa
English: BCVA ≥ 15-letter improvement from baseline at Year 3/Final (%) P-value
Slovenian: letu/zadnji obisk (%) p-vrednost
English: 17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP (24.0% vs 16.6%).
Slovenian: ** v 24-mesečni opazovalni študiji v realnem svetu zdravljenja bolnikov z makularnim edemom po okluziji retinalne vene in nenalezljivim uveitisom posteriornega dela očesa so o teh neželenih učinkih pogosteje poročali pri bolnikih, ki so prejeli več kot dve injekciji, v primerjavi z bolniki, ki so prejeli manj kot dve injekciji; nastanek katarakte (24,7 % v primerjavi s 17,7 %), napredovanje katarakte (32,0 % v primerjavi s 13,1 %), vitrealna krvavitev (6,0 % v primerjavi z 2,0 %) ter povišan očesni tlak (24,0 % v primerjavi s 16,6 %).
English: Dexamethasone is excreted in breast milk No effects on the child are anticipated due to the route of administration and the resulting systemic levels.
Slovenian: Zaradi poti uporabe in posledičnih sistemskih ravni se ne pričakujejo učinki na otroka, vendar pa se zdravilo OZURDEX med dojenjem ne priporoča, razen če je to nujno potrebno.
English: Non-steroidal anti-inflammatory medications.
Slovenian: - jemljete steroidna ali nesteroidna protivnetna zdravila peroralno ali z zunanjim nanosom na oko;
English: 28 February 2011
Slovenian: 28. februar 2011
English: The European Commission issued a decision on 28 February 2011.
Slovenian: Evropska komisija je odločbo izdala dne 28. februarja 2011.
English: Currently, four fibrates are available in the European Union:
Slovenian: Trenutno so v Evropski uniji na voljo štirje fibrati:
English: However, a number of them questioned the restriction.
Slovenian: Kljub temu so številne med njimi izrazile pomisleke glede omejitve.
English: These medicines have all been authorised via national procedures.
Slovenian: Vsa ta zdravila so bila odobrena z nacionalnimi postopki.
English: There are no new safety concerns with the medicines.
Slovenian: Za ta zdravila ni novih pomislekov glede varnosti.
English: Fibrates have been in use since the 1960s.
Slovenian: Fibrati se uporabljajo že od 60. let prejšnjega stoletja.
English: This means that they activate a type of receptor called the ‘peroxisome proliferator activated receptor'.
Slovenian: To pomeni, da aktivirajo vrsto receptorja, ki se imenuje „s peroksisomsko proliferacijo aktivirani receptor“.
English: Fibrates are ‘PPAR agonists'.
Slovenian: Fibrati so „agonisti PPAR“.
English: The European Medicines Agency has completed a review of the safety and effectiveness of fibrates.
Slovenian: Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti fibratov.
English: The Committee recommended specific changes to the information to doctors and patients for all four fibrates.
Slovenian: Odbor je priporočil določene spremembe informacij za zdravnike in bolnike za vse štiri fibrate.
English: It is sold in all EU Member States except Denmark and the Netherlands, as well as in Iceland and Norway;
Slovenian: Prodaja se v vseh državah članicah EU, razen Danske in Nizozemske, ter na Islandiji in Norveškem;
English: Why were fibrates reviewed?
Slovenian: Zakaj so bili fibrati ponovno preučeni?
English: What are fibrates?
Slovenian: Kaj so fibrati?
English: As a result the working party undertook a review of the benefits and risks of all fibrates-containing medicines, on behalf of the medicines regulatory authorities of the countries where the medicines are marketed.
Slovenian: Posledično je delovna skupina opravila pregled koristi in tveganj za vsa zdravila, ki vsebujejo fibrate, v imenu regulativnih organov za zdravila v državah, v katerih se ta zdravila tržijo.
English: Consequently, the UK medicines regulatory agency referred the matter to the CHMP on 20 October 2009, to carry out a full assessment of the benefit-risk balance of fibrates and to issue an opinion on whether the marketing authorisations for fibrates-containing medicines should be maintained or varied across the European Union.
Slovenian: Posledično je regulatorna agencija za zdravila v Združenem kraljestvu 20. oktobra 2009 zadevo napotila k odboru CHMP, ki naj bi celovito presodil razmerje med koristmi in tveganji fibratov ter izdal mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo fibrate, po vsej Evropski uniji ohranijo ali spremenijo.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of fibrates continue to outweigh their risks within these restrictions.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP, je ta zaključil, da koristi fibratov še vedno odtehtajo z njimi povezana tveganja, če se uporabljajo z upoštevanjem teh omejitev.
English: The CHMP looked at the information gathered by PhVWP during its review, as well as the responses provided by the companies to specific questions.
Slovenian: Odbor CHMP je pregledal informacije, ki jih je med pregledom zbrala delovna skupina PhVWP, in odgovore družb na posebna vprašanja.
English: The conclusions of the PhVWP were transmitted to the companies that market fibrates, so that they could implement the changes recommended by the working party.
Slovenian: Ti zaključki so bili predloženi družbam, ki tržijo fibrate, da bi lahko te uveljavile spremembe, ki jih je priporočila delovna skupina.
English: • Patients who are currently taking fibrates to lower their blood lipid levels should continue to do so.
Slovenian: • Bolniki, ki trenutno jemljejo fibrate za zniževanje ravni lipidov v krvi, naj to nadaljujejo.
English: Fibrates should be used only when statins are contraindicated or not tolerated.
Slovenian: Fibrati se smejo uporabljati samo, kadar so statini kontraindicirani ali jih bolnik ne prenaša.
English: Blood lipid disorders are a risk factor of heart disease (such as heart attack and stroke) and fibrates are used to improve lipid levels in patients in whom dietary restrictions and exercise have not been enough.
Slovenian: Motnje lipidov v krvi so dejavnik tveganja za bolezen srca (kot sta srčni napad ali kap), fibrati pa se uporabljajo za izboljšanje ravni lipidov pri bolnikih, ki jim prehranske omejitve in telesna vadba ne zadostujejo.
English: This means that newlydiagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat).
Slovenian: To pomeni, da se na novo diagnosticirani bolniki z motnjami lipidov v krvi ne smejo začeti zdraviti s temi zdravili, razen če imajo zelo visoke ravni trigliceridov (vrsto maščob).
English: As a result, the Committee also allowed the use of fenofibrate together with a statin in some circumstances for patients at risk when using a statin on its own was not enough to completely control blood lipid levels.
Slovenian: Posledično je dovolil tudi uporabo fenofibrata skupaj s statinom v nekaterih okoliščinah pri bolnikih, ki so v nevarnosti, ker jim uporaba samega statina ne zadostuje za popolno obvladovanje ravni lipidov v krvi.
English: This receptor can be found in many cells throughout the body, where it is involved in breaking down dietary fat, especially triglycerides and cholesterol.
Slovenian: Ta receptor se pojavlja v številnih celicah po vsem telesu, kjer sodeluje pri razgradnji zaužitih maščob, zlasti trigliceridov in holesterola.
English: • Doctors are reminded that fibrates should not be used as first-line treatment in patients with high lipid levels, except in specific groups: patients with severe hypertriglyceridaemia; patients for whom statins are contra-indicated or who cannot tolerate them.
Slovenian: • Zdravniki morajo upoštevati, da se fibrati ne smejo uporabljati kot zdravljenje prve izbire pri bolnikih z visokimi ravnmi lipidov, razen v posebnih skupinah: bolniki s hudo hipertrigliceridemijo; bolniki, pri katerih so statini kontraindicirani ali ki teh zdravil ne prenašajo.
English: However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels).
Slovenian: Kljub temu se smejo fibrati uporabljati pri bolnikih, ki ne morejo jemati statinov (druge vrste zdravil, ki se uporabljajo za zniževanje ravni lipidov v krvi).
English: Fibrates are a class of medicines that can be used to lower the level of lipids, such as cholesterol and triglycerides, in the blood.
Slovenian: Fibrati so skupina zdravil, ki se lahko uporabljajo za zniževanje ravni lipidov, kot so holesterol in trigliceridi, v krvi.
English: The aim of the review was to establish how fibrates should now be used, taking into account their safety, their effectiveness in lowering lipid levels and the availability of other lipid-lowering medicines that were not around when fibrates were first used.
Slovenian: Cilj pregleda je bil ugotoviti, kako bi se fibrati morali uporabljati zdaj, ob upoštevanju njihove varnosti, učinkovitosti pri zniževanju ravni lipidov in razpoložljivosti drugih zdravil za zniževanje ravni lipidov, ki jih na začetku uporabe fibratov še ni bilo.
English: In 2005, the CHMP's PharmacoVigilance Working Party (PhVWP) noted that there was limited evidence of the long-term benefit of fibrates in reducing cardiovascular risk, compared with the stronger evidence for statins (another type of medicines used for lowering blood cholesterol).
Slovenian: Leta 2005 je Delovna skupina za farmakovigilanco (PhVWP) odbora CHMP opazila, da je dokazov o dolgoročni koristi fibratov za zmanjšanje tveganja za bolezni srca in ožilja malo v primerjavi z močnejšimi dokazi za statine (drugo vrsto zdravil, ki se uporabljajo za zniževanje ravni holesterola v krvi).
English: The Committee also looked at the latest data from clinical studies including a trial looking at the effect of using fenofibrate as an ‘add-on' to statins.
Slovenian: Upošteval je tudi najnovejše podatke iz kliničnih študij, vključno s preskušanjem, v katerem so raziskali učinek fenofibrata, kadar se ta uporablja kot „dodatek“ pri zdravljenju s statini.
English: However, the Committee noted that fibrates are more effective than statins in lowering triglyceride levels and therefore their use as a first-line treatment in patients with severe hypertriglyceridaemia (very high blood levels of triglycerides) is still appropriate.
Slovenian: Vendar je Odbor dodal, da fibrati v primerjavi s statini učinkoviteje znižujejo ravni trigliceridov, zato je njihova uporaba kot zdravljenje prve izbire pri bolnikih s hudo hipertrigliceridemijo (zelo visokimi ravnmi trigliceridov v krvi) še vedno ustrezna.
English: When the receptors are activated, the break down of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Slovenian: Ko so receptorji aktivirani, se maščobe pospešeno razgrajujejo, kar pomaga pri odstranjevanju holesterola in trigliceridov iz krvi.
English: The Committee endorsed the conclusions of the PhVWP that fibrates are still a safe option for lowering lipid levels, but that their use as first-line treatment is not justified.
Slovenian: Odbor je podprl zaključke delovne skupine PhVWP, da so fibrati še vedno varna izbira za zniževanje ravni lipidov, vendar njihova uporaba kot zdravljenje prve izbire ni upravičena.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of fibrates continue to outweigh their risks but that they should not be used as ‘first line' in the treatment of blood lipids (fats) disorders, such as high cholesterol, except in rare cases.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zaključil, da koristi fibratov še vedno odtehtajo z njimi povezana tveganja, vendar pa se ne smejo uporabljati kot „prva izbira“ za zdravljenje motenj lipidov (maščob) v krvi, kot je visoka raven holesterola, razen v redkih primerih.
English: • However, patients taking a fibrate-containing medicine should arrange to see their doctor to check that the medicine is the most appropriate option to lower their blood lipid levels.
Slovenian: • Vendar morajo bolniki, ki jemljejo zdravilo z vsebnostjo fibratov, obiskati zdravnika, ki se bo prepričal, ali je to zdravilo zanje najustreznejša možnost za zniževanje ravni lipidov v krvi.
English: Looking at the data, the PhVWP came to the conclusion that there were no new safety issues with fibrates and that fibrate-containing medicines still had a role to play in improving lipid levels, but that they should not be used as first-line treatment.
Slovenian: Med pregledom podatkov je delovna skupina ugotovila, da v zvezi s fibrati ni nobenih novih varnostnih vprašanj in da imajo zdravila, ki vsebujejo fibrate, še vedno vlogo pri izboljšanju ravni lipidov, vendar se ne smejo uporabljati kot zdravljenje prve izbire.
English: • They should review the treatment of patients who are receiving fibrates to help control their lipid levels to ensure that the patient is receiving the most appropriate treatment.
Slovenian: • Zdravniki, ki predpisujejo zdravilo, morajo znova oceniti zdravljenje bolnikov, ki dobivajo fibrate za obvladovanje ravni lipidov, da bi tako zagotovili, da se vsak bolnik zdravi z najustreznejšim zdravilom.
English: It is sold in Belgium, Bulgaria,
Slovenian: Prodaja se v Avstriji, Belgiji, na
English: The Committee also noted that there were new data for fenofibrate that supported a change to the PhVWP recommendations, based on the results of the add-on study.
Slovenian: Odbor je ugotovil tudi, da so iz študije dodatnega zdravljenja na voljo novi podatki o fenofibratu, ki podpirajo spremembo priporočil delovne skupine.
English: Malta, the Netherlands, Portugal, Romania, Spain, Sweden and the United Kingdom;
Slovenian: Nizozemskem, Portugalskem, v Romuniji, Španiji, na Švedskem in v Združenem kraljestvu;
English: It is marketed mainly under the trade names Bezalip, Cedur, Eulitop and Befizal, as well as generic medicines.
Slovenian: Bezalip, Cedur, Eulitop in Befizal ter kot generična zdravila.
English: It is sold in Austria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, the Netherlands, Portugal, Slovenia, Slovakia, Spain, Sweden and the United Kingdom.
Slovenian: Prodaja se v Avstriji, na Cipru, Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Islandiji, Irskem, v Italiji, na Nizozemskem, Portugalskem, v Sloveniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu.
English: This medicine has been available since 1977.
Slovenian: • bezafibrat - to zdravilo je na voljo od leta 1977.
English: This medicine has been available since 1975.
Slovenian: • fenofibrat - to zdravilo je na voljo od leta 1975.
English: It is marketed mainly under the trade name Lipanthyl, as well as generic medicines.
Slovenian: Trži se večinoma pod lastniškim imenom Lipanthyl in kot generična zdravila.
English: It is marketed mainly under the trade name Lopid, as well as generic medicines.
Slovenian: Trži se večinoma pod lastniškim imenom Lopid in kot generična zdravila.
English: This medicine has been available since 1981.
Slovenian: • gemfibrozil - to zdravilo je na voljo od leta 1981.
English: Cyprus, the Czech Republic, Estonia, France, Greece, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia and the United Kingdom;
Slovenian: v Estoniji, Franciji, Grčiji, na Madžarskem, v Latviji, Litvi, Luksemburgu, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem in v Združenem kraljestvu;
English: This medicine has been available since 1995.
Slovenian: • ciprofibrat- to zdravilo je na voljo od leta 1995.
English: Austria, Belgium, Cyprus, Finland, France, Germany; Greece, Hungary, Italy, Luxembourg,
Slovenian: Cipru, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, v Italiji, Luksemburgu, na Malti,
English: It is marketed mainly under the trade name Lipanor or Modalim, as well as generic medicines.
Slovenian: Lipanor in Modalim ter kot generična zdravila.
English: Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
Slovenian: Datum prve odobritve: 6. januar 2011 Datum zadnjega podaljšanja: 5. oktober 2015
English: Each pack contains one vial.
Slovenian: Vsako pakiranje vsebuje eno vialo.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: Study results Study GOG-0179
Slovenian: Preglednica 2: Rezultati študije GOG-0179
English: Vials 4 years.
Slovenian: Viale 4 leta
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Ker vam bo to zdravilo dal vaš zdravnik ali medicinska sestra je malo verjetno, da boste dobili prevelik odmerek.
English: This treatment cycle will normally be repeated every three weeks.
Slovenian: Tak ciklus zdravljenja boste praviloma prejemali vsake 3 tedne.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < /1.000), zelo redki (< 1/10.000) in pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The experience in children and adolescents is limited and treatment is therefore not recommended.
Slovenian: Izkušenj pri otrocih in mladostnikih je malo, zato zdravljenje s tem zdravilom ni priporočljivo.
English: Median time to progression (weeks)
Slovenian: Mediani čas do napredovanja (tedni)
English: It must be reconstituted and further diluted before use (see section 6.6).
Slovenian: Pred uporabo ga je treba rekonstruirati in nato še nadalje razredčiti (glejte poglavje 6.6).
English: The preparation should be performed in a designated area under aseptic conditions.
Slovenian: Zdravilo je treba pripraviti v za to namenjenem prostoru in v aseptičnih pogojih.
English: alopecia
Slovenian: alopecija
English: Always wash hands after removing gloves.
Slovenian: Po snetju rokavic, si je treba vedno umiti roke.
English: Your dose of Potactasol may need to be adjusted.
Slovenian: Morda bo treba odmerek zdravila Potactasol prilagoditi.
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Slovenian: Topotekan ima tudi velik volumen porazdelitve, približno 132 l (s standardno deviacijo 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
English: - Allergic (hypersensitivity) reactions (including rash).
Slovenian: - Alergijske (preobčutljivostne) reakcije (vključno z izpuščajem).
English: - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Slovenian: - Oteklost zaradi kopičenja tekočine (angioedema), npr. okrog oči in ustnic ter v dlaneh,
English: Your dose of Potactasol will depend on: - the disease being treated, - your body surface area (m2), - the results of blood tests carried out before and during treatment, - how well you tolerate treatment.
Slovenian: Odmerek zdravila Potactasol bo odvisen od: - bolezni, zaradi katere se zdravite, - vaše telesne površine (m2), - izvidov preiskav krvi, opravljenih pred zdravljenjem in med njim, - tega, kako dobro prenašate zdravljenje.
English: What you need to know before you use Potactasol Do not use Potactasol
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Potactasol Ne jemljite zdravila Potactasol
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Slovenian: Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid v urinu predstavljata manj kot 2,0 %.
English: sepsis1
Slovenian: sepsa1
English: - Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Slovenian: - Občutek splošne šibkosti in utrujenosti, kar sta lahko simptoma zmanjšanega števila rdečih krvnih celic (anemije).
English: - Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.
Slovenian: - Blage bolečine in vnetje na mestu injiciranja zaradi naključnega prehajanja zdravila v okoliško tkivo (ekstravazacija), npr. zaradi iztekanja.
English: Potactasol should not be used in pregnant women, unless clearly necessary.
Slovenian: Zdravila Potactasol se pri nosečnicah ne sme uporabiti, če ni nujno potrebno.
English: What Potactasol is and what it is used for What you need to know before you use Potactasol How to use Potactasol
Slovenian: Kaj je zdravilo Potactasol in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Potactasol Kako jemati zdravilo Potactasol
English: As would be expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Slovenian: Kot je mogoče pričakovati, se bolniki s slabšo telesno zmogljivostjo (performance status, PS > 1) slabše odzivajo na zdravilo, večja pa je tudi pogostnost zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Slovenian: Poleg tega je pri 5 % vseh zdravljenih bolnikov (v 1% ciklusov zdravljenja) prišlo do sepse (glejte poglavje 4.4).