FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Slovenian: Glavni zadržek odbora CHMP je bil, da koristi zdravila Winfuran pri zdravljenju uremičnega pruritusa niso bile zadovoljivo dokazane.
English: What was Winfuran expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Winfuran uporabljalo?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Slovenian: Na podlagi pregleda podatkov je odbor v času umika vloge izrazil negativno mnenje in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Winfuran za zdravljenje hudega uremičnega pruritusa.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Slovenian: Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, ker je odbor CHMP menil, da na podlagi predloženih podatkov ni mogoče zaključiti, da je razmerje med koristmi in tveganji zdravila pozitivno.
English: How is Winfuran expected to work?
Slovenian: Kako naj bi zdravilo Winfuran delovalo?
English: The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Slovenian: Priporočeni odmerek je ena kapsula, ki se jemlje enkrat na dan skupaj s hrano v obdobju 12 ali 24 tednov.
English: What measures are being taken to ensure the safe and effective use of Olysio?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Olysio?
English: This is a summary of the European public assessment report (EPAR) for Olysio.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olysio.
English: The full EPAR and risk management plan summary for Olysio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Olysio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Olysio is available as 150 mg capsules.
Slovenian: Zdravilo Olysio je na voljo v obliki 150-miligramskih kapsul.
English: The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Slovenian: Agencija je zato menila, da razpoložljivi podatki podpirajo uporabo zdravila Olysio v kombinaciji s sofosbuvirjem.
English: What is Olysio and what is it used for?
Slovenian: Kaj je zdravilo Olysio in za kaj se uporablja?
English: What benefits of Olysio have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Olysio izkazalo v študijah?
English: The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Olysio večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: What are the risks associated with Olysio?
Slovenian: Kakšna tveganja so povezana z zdravilom Olysio?
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Olysio, veljavno po vsej Evropski uniji, izdala
English: The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Slovenian: Najpogostejši neželeni učinki zdravljenja z zdravilom Olysio (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost), izpuščaji, pruritus (srbenje) in dispneja (oteženo dihanje).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Olysio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za
English: It is not intended to provide practical advice on how to use Olysio.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
Slovenian: Študija je zajela bolnike s cirozo ali brez nje ter bolnike, ki se niso odzvali na predhodno zdravljenje.
English: Olysio is an antiviral medicine that contains the active substance simeprevir.
Slovenian: Olysio je protivirusno zdravilo, ki vsebuje zdravilno učinkovino simeprevir.
English: For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact
Slovenian: Za več informacij o zdravljenju z zdravilom Olysio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
English: Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Slovenian: Obstaja več vrst (genotipov) virusa hepatitisa C, zdravilo Olysio pa je priporočeno za bolnike z virusom genotipa 1 in 4.
English: How does Olysio work?
Slovenian: Kako zdravilo Olysio deluje?
English: Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Slovenian: Kar zadeva varnost, so bolniki zdravilo Olysio dobro prenašali, neželeni učinki pa so bili obvladljivi.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Slovenian: Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, ki se zdravijo s temi zdravili in so preboleli raka jeter, obstaja tveganje zgodnje ponovitve raka.
English: An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.
Slovenian: Analiza teh študij je pokazala, da je bilo zdravilo Olysio manj učinkovito pri podskupini bolnikov, ki so bili okuženi z virusom hepatitisa C genotipa 1a, ki ima mutacijo Q80K.
English: Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Slovenian: V treh glavnih študijah pri 1 178 bolnikih z virusom hepatitisa C genotipa 1 so proučevali kombinacijo s peginterferonom alfa in ribavirinom.
English: Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Slovenian: Pri podaljšanju zdravljenja na 24 tednov je bil virus odstranjen pri več kot 90 % bolnikov.
English: Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Slovenian: Predpisovanje in izdaja zdravila Olysio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
English: Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
Slovenian: Pred začetkom zdravljenja z zdravilom Olysio, je treba pri bolnikih z genotipom 1a opraviti krvne preiskave, da se ugotovi, ali ima virus, s katerim so okuženi, mutacijo (spremembo genetskega materiala virusa) Q80K, ker je pri teh bolnikih zdravilo Olysio manj učinkovito.
English: The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Slovenian: Zdravilna učinkovina v zdravilu Olysio, simeprevir, zavira delovanje encima v virusu hepatitisa C, imenovanega „serinska proteaza NS3/4A“, ki ima ključno vlogo pri razmnoževanju virusa.
English: The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Slovenian: Ugotovila je, da je dodajanje zdravila Olysio k zdravljenju s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih in bolnikih, ki so se pred tem že zdravili, znatno povečalo število bolnikov, ki niso imeli nobenih znakov okužbe.
English: The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio.
Slovenian: Družba, ki trži zdravilo Olysio, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Olysio, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
English: Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Slovenian: Več raziskav potrjuje, da zdravilo Olysio v kombinaciji s peginterferonom alfa in ribavirinom ali sofosbuvirjem po 12 ali 24 tednih zdravljenja učinkovito odstranjuje virus hepatitisa C iz krvi.
English: Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Slovenian: V dodatnih študijah kombinacije s peginterferonom alfa in ribavirinom, v katere so vključili bolnike z virusom hepatitisa C genotipa 4 in bolnike, ki so bili sočasno okuženi z virusom HIV, so zabeležili rezultate, ki so bili skladni s tistimi pri
English: For practical information about using Olysio, patients should read the package leaflet or contact their
Slovenian: Za praktične informacije o uporabi zdravila Olysio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
Slovenian: Študija, v kateri so pri 167 bolnikih proučevali jemanje zdravila Olysio v kombinaciji s sofosbuvirjem, je pokazala, da je kombinacija (z ribavirinom ali brez njega) 12 tednov po koncu zdravljenja odpravila okužbo z virusom hepatitisa C genotipa 1 pri približno 90 % bolnikov.
English: In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
Slovenian: V dveh dodatnih študijah simeprevirja v kombinaciji s sofosbuvirjem pri 413 bolnikih je bil po 12 tednih jemanja zdravila Olysio skupaj s sofosbuvirjem virus odstranjen pri 97 % bolnikih brez ciroze, medtem ko je bil pri bolnikih s cirozo virus odstranjen pri 83 %.
English: It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Slovenian: Zdravilo Olysio je protivirusno zdravilo, namenjeno zdravljenju odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C. Uporablja se v kombinaciji z
English: Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Slovenian: Zdravilo Olysio se mora uporabljati v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C, na primer s peginterferonom alfa
English: In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Slovenian: V dveh študijah, v katerih so sodelovali prej nezdravljeni bolniki, so bili 12 tednov po končanem zdravljenju izidi preiskav za hepatitis C negativni pri približno 80 % (419 od 521) bolnikov, ki so jemali zdravilo Olysio, v primerjavi s 50 % (132 od 264) bolnikov, ki so
English: In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
Slovenian: V tretji študiji pri bolnikih, pri katerih se je okužba ponovila po zdravljenju z zdravili na osnovi interferona, so bili 12 tednov po končanem zdravljenju izidi preiskav za hepatitis C negativni pri približno 80 % (206 od 260) bolnikov, ki so jemali zdravilo Olysio, v primerjavi s približno 37 % (49 od
English: Date of first authorisation: 04 January 2017
Slovenian: Datum prve odobritve: 04. januar 2017
English: The required dose is determined using the following formula:
Slovenian: Potrebni odmerek določimo z uporabo naslednje formule:
English: The amount of AFSTYLA you need to take and the duration of treatment depend on:
Slovenian: Količina zdravila AFSTYLA, ki ga morate vzeti, in trajanje zdravljenja sta odvisna od:
English: Your doctor should inform you of the early signs of allergic reactions.
Slovenian: Zdravnik vas bo poučil o zgodnjih znakih alergijskih reakcij.
English: Monitoring laboratory tests
Slovenian: Spremljanje laboratorijskih testov
English: Paediatric population <12 years of age
Slovenian: Pediatrična populacija <12 let
English: The regimen may be adjusted based on patient response.
Slovenian: Ta režim je mogoče prilagoditi glede na odziv bolnika.
English: • your clinical condition and response
Slovenian: • vašega kliničnega stanja in odziva,
English: Osmolality: 500 - 600 mOsm/kg
Slovenian: Osmolalnost: 500 - 600 mOsm/kg
English: Repeat injection every 12 to 24 hours.
Slovenian: Ponovite injiciranje vsakih 12 do 24 ur.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Slovenian: Zato se lahko faktor VIII uporablja med nosečnostjo in dojenjem le, če je jasno indicirano.
English: Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
Slovenian: Starejši V klinične študije zdravila AFSTYLA niso bile vključene osebe, starejše od 65 let.
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 48 hours at room temperature (below 25 °C).
Slovenian: Po rekonstituciji so kemijsko in fizikalno obstojnost med uporabo dokazali za 48 ur pri sobni temperaturi (pod 25 °C).
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Da bi izboljšali sledljivost bioloških zdravil, je treba ime in serijsko številko zdravila natančno zabeležiti.
English: The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila AFSTYLA je 7400 - 16000 i.e./mg proteinov.
English: Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Slovenian: Pomanjkanje tega faktorja pomeni, da se kri ne strjuje tako hitro kot bi se morala in je zato povečana verjetnost za krvavitve.
English: No paediatric subjects <18 years of age were included in the surgery population.
Slovenian: Otroci <18 let niso bili vključeni v kirurško populacijo.
English: AFSTYLA can be used for all age groups.
Slovenian: Zdravilo AFSTYLA se lahko uporablja za vse starostne skupine.
English: The product contain traces of hamster proteins (see also “Do not use AFSTYLA”).
Slovenian: Zdravilo vsebuje sledi beljakovin hrčka (glejte tudi podpoglavje "Ne uporabljajte zdravila AFSTYLA").
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Slovenian: • Če so vam povedali, da imate bolezen srca ali da pri vas obstaja tveganje za bolezen srca, o tem obvestite zdravnika ali farmacevta.
English: Factor VIII is involved in blood clotting.
Slovenian: Faktor VIII je vključen v proces strjevanja krvi.
English: Without opening the vials, warm the AFSTYLA powder and the liquid to room or body temperature.
Slovenian: Brez da bi odprli viali, segrejte prašek AFSTYLA in tekočino na sobno ali telesno temperaturo.
English: VWF stabilizes factor VIII and protects it from degradation.
Slovenian: VWF stabilizira faktor VIII in ga varuje pred razgradnjo.
English: (pre- and postoperative)
Slovenian: (pred- in po operaciji)
English: Do not expose the vials to direct heat.
Slovenian: Ne izpostavljajte vial neposredni vročini.
English: May be stored at room temperature up to 25 °C for a single 3 months period.
Slovenian: Lahko shranjujete pri sobni temperaturi do 25°C za eno 3-mesečno obdobje.
English: Frequencies have been evaluated on a per patient basis according to the following convention: 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), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so bile ocenjene na podlagi bolnikov z naslednjimi dogovorjenimi izrazi: zelo pogosti (≥1/10), pogosti (≥1/100 do < 1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: • Store in a refrigerator (2 °C to 8 °C).
Slovenian: • Shranjujte v hladilniku (2 °C - 8 °C).
English: The solvent will automatically flow into the powder vial.
Slovenian: Vehikel bo samodejno stekel v vialo s praškom.
English: No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Slovenian: Ni poročil o medsebojnem delovanju zdravil humanega koagulacijskega faktorja VIII z drugimi zdravili.
English: Other medicines and AFSTYLA
Slovenian: Druga zdravila in zdravilo AFSTYLA
English: AFSTYLA can be used in children and adolescents of all ages.
Slovenian: Zdravilo AFSTYLA se lahko uporablja pri otrocih in mladostnikih vseh starosti.
English: No patient developed an inhibitor or experienced an anaphylactic reaction.
Slovenian: Pri nobenem bolniku se ni razvil inhibitor, prav tako ni pri nobenem prišlo do anafilaktične reakcije.
English: Repeat injection every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Slovenian: Ponovite injiciranje vsakih 8 do 24 ur do zaceljenja rane; zatem naj zdravljenje traja še vsaj naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 % - 60 % (i.e./dl).
English: The study participants accumulated a total of 5,239 EDs with rVIIISingleChain.
Slovenian: Udeleženci študije so skupno zbrali 5.239 ED enoverižnemu rVIII.
English: • AFSTYLA must not be mixed with other medicines or solvents except those mentioned in section 6.
Slovenian: • Zdravila AFSTYLA ne smemo mešati z drugimi zdravili ali vehikli, razen s tistimi, ki so navedeni v poglavju 6.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII/von Willebrandovega faktorja je sestavljen iz dveh molekul (faktor VIII in von Willebrandov faktor) z različnimi fiziološkimi funkcijami.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in sections 2 and 6.5.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili ali vehikli, razen s tistimi, ki so omenjena v poglavjih 2 in 6.5.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestna terapija s faktorjem VIII poveča srčno-žilno tveganje.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Slovenian: Na podlagi redke pojavnosti hemofilije A pri ženskah, podatki o izkušnjah glede uporabe faktorja VIII med nosečnostjo in dojenjem niso na voljo.
English: If you or your child´s bleeding is not being controlled with AFSTYLA, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom AFSTYLA ni obvladana, morate to nemudoma povedati zdravniku.
English: Children above 12 years of age can use the same dose as adults.
Slovenian: Otroci, starejši od 12 let, lahko uporabljajo enak odmerek kot odrasli.
English: Animal reproduction studies have not been conducted with factor VIII.
Slovenian: Študije na živalih o vplivu na sposobnost razmnoževanja s faktorjem VIII niso bile opravljene.
English: The chromogenic assay result most accurately reflects the clinical hemostatic potential of AFSTYLA and is preferred.
Slovenian: Rezultat kromogenega preskusa najbolj natančno odraža klinični hemostatični potencial zdravila AFSTYLA in je najustreznejši.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Slovenian: Tveganje za nastanek zaviralcev je odvisno od resnosti bolezni in izpostavljenosti faktorju VIII - največje je v prvih 50 dneh izpostavljenosti, vendar se nadaljuje vse življenje, čeprav je tveganje manj pogosto.
English: What AFSTYLA is and what it is used for
Slovenian: Kaj je zdravilo AFSTYLA in za kaj ga uporabljamo
English: General instructions - The solution should be almost colourless, clear or slightly opalescent.
Slovenian: Splošna navodila - Raztopina mora biti brezbarvna, bistra ali nekoliko opalescentna.
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Slovenian: • Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Slovenian: Zlasti pri velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja VIII v plazmi).
English: Hemostatic efficacy of rVIII-SingleChain in surgical prophylaxis was rated as excellent or good in all surgeries.
Slovenian: Učinkovitost hemostaze enoverižnega rVIII v kirurški profilaksi je bila ocenjena kot odlično ali kot dobro pri vseh kirurških posegih.
English: What you need to know before you use AFSTYLA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo AFSTYLA
English: Repeat injection every 8 to 24 hours until threat is resolved.
Slovenian: Ponovite injiciranje vsakih 8 do 24 ur, dokler nevarnost ne preneha.
English: All patients had been diagnosed with severe haemophilia A with <1% factor VIII.
Slovenian: Vsi bolniki so imeli diagnozo hude hemofilije A s faktorjem VIII <1 %.
English: Inject every 24 hours, at least 1 day, until healing is achieved.
Slovenian: Injicirajte vsakih 24 ur vsaj 1 dan, dokler ne pride do zaceljenja.