natgillin/translations-raw huggingface dataset:
In adults, the most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Pri odraslih bolnikih so bili najpogostejši neželeni učinki zdravila ViraferonPeg (opaženi pri več kot 1 bolniku od 10) virusne okužbe, faringitis (vneto žrelo), anemija (nizke ravni rdečih krvnih celic), nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic), izguba teka, depresija, anksioznost, čustvena labilnost (nihanje razpoloženja), motnje koncentracije, nespečnost (težave s spanjem), glavobol, omotica, dispneja (oteženo dihanje), kašelj, bruhanje, navzeja (občutek slabosti), bolečine v trebuhu, driska, suha usta, alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišično-skeletne bolečine (bolečine v mišicah in kosteh), reakcije na mestu injiciranja, vnetje na mestu injiciranja, utrujenost, astenija (šibkost), razdražljivost, mrzlica, pireksija (povišana telesna temperatura), gripi podobna bolezen in izguba telesne mase.
The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year.
Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje ter traja od šestih mesecev do enega leta.
The replacement acts in the same way as naturally produced interferon alpha.
Nadomestek deluje enako kot naravno proizvedeni interferon alfa.
Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).
Glede na resnost neželenih učinkov bo morda treba z zdravljenjem (tudi z boceprevirjem) popolnoma prenehati.
It must not be used in patients who have had severe heart disease or an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue), or in children or adolescents who have had severe mental disorders, particularly severe depression, thoughts about committing suicide or suicide attempts.
Ne sme se uporabljati pri bolnikih s hudim srčnim obolenjem ali avtoimunsko boleznijo (boleznijo, ki jo povzroča lastni obrambni sistem telesa, ki napada normalno tkivo) ter otrocih in mladostnikih s hudimi duševnimi boleznimi, zlasti hudo depresijo, samomorilnimi mislimi ali poskusi samomora.
For more information about treatment with ViraferonPeg, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom ViraferonPeg preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The CHMP decided that ViraferonPeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila ViraferonPeg večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Because ViraferonPeg is linked to side effects such as depression, patients must be closely monitored during treatment.
Ker je zdravilo ViraferonPeg povezano z neželenimi učinki, kot je depresija, je treba bolnike med zdravljenjem pozorno spremljati.
This document is a summary of the European Public Assessment Report (EPAR) for ViraferonPeg.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ViraferonPeg.
In children and adolescents, the dose is 60 micrograms per square metre body surface area (calculated using the patient's height and weight).
Pri otrocih in mladostnikih znaša odmerek 60 mikrogramov na kvadratni meter telesne površine (ki se izračuna na podlagi bolnikove telesne višine in mase).
These contain 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b in 0.5 ml.
Obe obliki v 0,5 ml vsebujeta 50, 80, 100, 120 ali 150 mikrogramov peginterferona alfa-2b.
The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.
Glavno merilo učinkovitosti v teh študijah je bilo število bolnikov, pri katerih 24 tednov po koncu zdravljenja v krvi ni bilo mogoče zaznati virusa hepatitisa C in je bilo zato mogoče šteti, da so ozdravljeni.
Other information about ViraferonPeg:
Druge informacije o zdravilu ViraferonPeg:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ViraferonPeg.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo ViraferonPeg, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Peginterferon alfa-2b is similar to interferon alfa-2b, which has been available in the European Union (EU) for a number of years.
Peginterferon alfa-2b je podoben interferonu alfa-2b, ki je v Evropski uniji (EU) na voljo že več let.
The first study involved previously untreated patients while the second study involved patients who had failed previous treatment.
Prva študija je vključevala predhodno nezdravljene bolnike, druga pa bolnike, pri katerih predhodno zdravljenje ni bilo uspešno.
Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
Dvotirno zdravljenje z ribavirinom se uporablja tudi pri predhodno nezdravljenih otrocih in mladostnikih (starih od 3 do 17 let), v kolikor njihova jetra še vedno delujejo normalno.
The main measure of effectiveness was the level of hepatitis C virus circulating in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later.
Glavno merilo učinkovitosti je bila raven hepatitisa C v krvi pred zdravljenjem, po šestih mesecih ali enem letu zdravljenja ter ob kontrolnem pregledu šest mesecev pozneje.
The Committee noted that the dual combination with ribavirin was shown to be effective against longterm hepatitis C virus infection in adults and children.
Odbor je opozoril, da se je dvotirno zdravljenje z ribavirinom izkazalo za učinkovito pri dolgotrajni okužbi z virusom hepatitisa C pri odraslih in otrocih.
In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Če se pri odraslih uporablja v kombinaciji z drugimi zdravili, znaša njegov odmerek 1,5 mikrograma na kilogram telesne mase, pri uporabi kot samostojno zdravilo pa 0,5 ali 1 mikrogram na kilogram telesne mase.
What benefit has ViraferonPeg shown during the studies?
Kakšne koristi je zdravilo ViraferonPeg izkazalo med študijami?
ViraferonPeg is also linked to weight loss and reduced growth in children and adolescents.
Zdravilo ViraferonPeg je povezano z izgubljanjem telesne mase in zmanjšano telesno rastjo pri otrocih in mladostnikih.
ViraferonPeg must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Zdravilo ViraferonPeg se ne sme uporabljati pri bolnikih z resnim obolenjem, s hudimi težavami z jetri, z nenadzorovanim obolenjem ščitnice, epilepsijo ali drugimi motnjami delovanja osrednjega živčnega sistema.
Treatment with ViraferonPeg should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. ViraferonPeg is given once a week as an injection under the skin.
Zdravljenje z zdravilom ViraferonPeg mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hepatitisom C. Zdravilo ViraferonPeg se daje enkrat tedensko z injekcijo v podkožje.
ViraferonPeg must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Zdravila ViraferonPeg ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katero koli vrsto interferona ali katero drugo sestavino zdravila.
For a full list of restrictions, see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
The combination of ViraferonPeg with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Kombinacija zdravila ViraferonPeg in ribavirina je bila učinkovita pri bolnikih s cirozo in bolnikih, okuženih z virusom HIV.
It is available as a powder and solvent that are made up into a solution for injection, and as a single-use prefilled pen.
Na voljo je v obliki praška in vehikla za pripravo raztopine za injiciranje ter napolnjenega injekcijskega peresnika za enkratno uporabo.
The combination of ViraferonPeg and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Kombinacijo zdravila ViraferonPeg in ribavirina so proučevali tudi v študiji s 1 354 odraslimi bolniki, pri katerih predhodno zdravljenje ni bilo uspešno, in študiji s 107 otroki in mladostniki, starimi od 3 do 17 let, ki pred tem še niso bili zdravljeni.
ViraferonPeg, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Zdravilo ViraferonPeg, uporabljeno sočasno z ribavirinom ali brez njega, so primerjali z interferonom alfa-2b v petih glavnih študijah s skupno več kot 6 000 odraslih bolnikov s hepatitisom C, ki predhodno še niso bili zdravljeni, vključno s 328 bolniki s cirozo in 507 bolniki, ki so bili okuženi tudi z virusom HIV.
In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Ostalim odraslim z virusom hepatitisa C v krvi, vključno z bolniki, ki so okuženi tudi z virusom humane imunske pomanjkljivosti (HIV), se ViraferonPeg daje bodisi z ribavirinom (dvotirno zdravljenje) bodisi kot samostojno zdravilo, če bolniki ne morejo jemati ribavirina.
ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Zdravilo ViraferonPeg se lahko daje v okivru trotirnega zdravljenja v kombinaciji z ribavirinom in boceprevirjem odraslim bolnikom s hepatitisom C tipa 1, katerih jetra so poškodovana, vendar še vedno normalno delujejo (kompenzirana bolezen jeter).
In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Pri otrocih in mladostnikih, ki so prejemali kombinacijo zdravila ViraferonPeg in ribavirina, so bili neželeni učinki podobni kot pri odraslih, čeprav je bila pri več kot 1 bolniku od 10 opažena tudi manjša telesna rast.
For the full list of all side effects reported with ViraferonPeg, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ViraferonPeg, glejte navodilo za uporabo.
The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Interferon alfa-2b, ki ga vsebuje zdravilo ViraferonPeg, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori interferon alfa-2b.
A 40% increase was seen among patients who had been treated before.
Pri predhodno zdravljenih bolnikih je to povečanje znašalo 40 %.
What is the risk associated with ViraferonPeg?
Kakšna tveganja so povezana z zdravilom ViraferonPeg?
ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b.
ViraferonPeg je zdravilo, ki vsebuje zdravilno učinkovino peginterferon alfa-2b.
Triple therapy led to an increase of about 30% in the number of previously early responders who were cured after six months.
Pri trotirnem zdravljenju se je število predhodno nezdravljenih bolnikov, ki so se zgodaj odzvali na zdravljenje in so bili po šestih mesecih ozdravljeni, povečalo za približno 30 %.
Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ViraferonPeg in a triple therapy combination with ribavirin and boceprevir compared with ViraferonPeg and ribavirin alone.
V dveh glavnih študijah, v katerih so sodelovali 1 503 odrasli bolniki s hepatitisom C tipa 1 in kompenzirano boleznijo jeter, so preučevali učinek zdravila ViraferonPeg v trotirnem zdravljenju z ribavirinom in boceprevirjem v primerjavi z njegovim učinkom v kombinaciji zgolj z ribavirinom.
In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed.
Zdravilo ViraferonPeg se lahko uporablja pri odraslih bolnikih (starih vsaj 18 let), ki še niso bili zdravljeni oziroma pri katerih predhodno zdravljenje ni bilo uspešno.
ViraferonPeg is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Zdravilo ViraferonPeg se uporablja za zdravljenje bolnikov, starejših od treh let, z dolgotrajnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin.
Pri odraslih bolnikih, ki še niso bili zdravljeni, je bilo zdravilo ViraferonPeg učinkovitejše od interferona alfa-2b, pri čemer se jih je približno četrtina odzvala na zdravilo, vzeto samostojno, približno polovica pa na kombinacijo zdravila ViraferonPeg in ribavirina.
In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone.
V študijah trotirnega zdravljenja bolnikov s hepatitisom C tipa 1 in kompenzirano boleznijo jeter se je zdravljenje z zdravilom ViraferonPeg v kombinaciji z ribavirinom in boceprevirjem izkazalo za učinkovitejše od dvotirnega zdravljenja z zdravilom ViraferonPeg in ribavirinom.
Why has ViraferonPeg been approved?
Zakaj je bilo zdravilo ViraferonPeg odobreno?
In ViraferonPeg, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
V zdravilu ViraferonPeg je interferon alfa-2b „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Opaziti je tudi znatno povečanje deleža ozdravljenih bolnikov z dolgotrajno okužbo s hepatitisom C tipa 1 pri trotirnem zdravljenju z zdravilom ViraferonPeg v kombinaciji z ribavirinom in boceprevirjem.
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons'.
Zdravilna učinkovina zdravila ViraferonPeg, peginterferon alfa-2b, spada v skupino interferonov.
How has ViraferonPeg been studied?
Kako je bilo zdravilo ViraferonPeg raziskano?
What is ViraferonPeg?
Kaj je zdravilo ViraferonPeg?
What is ViraferonPeg used for?
Za kaj se zdravilo ViraferonPeg uporablja?
How is ViraferonPeg used?
Kako se zdravilo ViraferonPeg uporablja?
Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
Na zdravljenje s kombinacijo zdravila ViraferonPeg in ribavirina se je odzvala približno četrtina odraslih bolnikov, pri katerih predhodno zdravljenje ni bilo uspešno, in okoli dve tretjini otrok in mladostnikov.
The doses of ribavirin and ViraferonPeg may need to be adjusted for patients who experience side effects.
Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo odmerek ribavirina in zdravila ViraferonPeg morda treba prilagoditi.
How does ViraferonPeg work?
Kako zdravilo ViraferonPeg deluje?
Ref. EMEA/266786/2008
EMEA/304454/2008
International non-proprietary name (INN): beclomethasone dipropionate
Mednarodno nelastniško ime (INN): beklometazon dipropionat
It was to be available as two separate tablets, to be taken together: one immediate-release tablet (immediate-release means that the tablet has been made to allow the active substance to be released immediately) and one gastro-resistant tablet (gastro-resistant means that the tablet's content passes through the stomach without being broken down until it reaches the intestine).
Na voljo naj bi bilo v obliki dveh ločenih tablet, ki bi se naj jemali skupaj: ena tableta s takojšnjim sproščanjem (takojšnje sproščanje pomeni, da je tableta narejena tako, da omogoča takojšnje sproščanje zdravilne učinkovine), druga tableta pa je gastrorezistentna (gastrorezistentnost pomeni, da lahko vsebina tablete preide skozi želodec, ne da bi se pri tem razkrojila, dokler ne doseže črevesja).
orBec was designated as an orphan medicinal product on 13 March 2002.
Zdravilo orBec je bilo dne 13. marca 2002 določeno kot zdravilo sirota.
It works by dampening down the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell.
Deluje tako, da zavira delovanje imunskega sistema (naravni obrambni mehanizem telesa), in sicer tako, da se veže na receptorje v različnih vrstah imunskih celic.
The CHMP had also concerns that most of the patients who took part in the study came from one study centre, and therefore the results were not representative for the overall population.
CHMP je bil zaskrbljen tudi zaradi dejstva, da je bila večina v študiji sodelujočih bolnikov iz enega samega študijskega centra, tako da rezultati niso bili reprezentativni za celotno populacijo.
The applicant presented data on experimental models for beclomethasone dipropionate from the scientific literature.
Predlagatelj je predstavil podatke o poskusnih modelih za beklometazon dipropionat iz znanstvene literature.
The CHMP was concerned that the single main study did not demonstrate orBec's effectiveness.
CHMP je izrazil zaskrbljenost, da edina glavna študija ni izkazala učinkovitosti zdravila orBec.
orBec was not significantly better than placebo in increasing the time until the disease came back during the 50-day treatment period.
Zdravilo orBec ni bilo bistveno učinkovitejše od placeba pri podaljševanju časa do ponovnega pojava bolezni v okviru 50-dnevnega zdravljenja.
It was expected to block receptors in the stomach and intestine, reducing locally the production of substances that are involved in recognising foreign cells and in the inflammation process.
Zdravilo naj bi blokiralo receptorje v želodcu in črevesju ter tako zmanjšalo lokalno proizvajanje snovi, ki sodelujejo pri prepoznavanju tujih celic in pri vnetnih procesih.
What is orBec?
Kaj je zdravilo orBec?
Graft-versus-host disease can occur in patients following tissue or organ transplantation, when the cells in the transplanted tissue or organ recognise the patient as ‘foreign' and attack the body.
Gastrointestinalna bolezen presadka proti gostitelju se lahko pojavi pri bolnikih po presaditvi tkiv ali organov, ko celice v presajenem tkivu ali organu telo bolnika prepoznajo kot „tujek“ in napadejo njegovo telo.
On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease.
Družba DOR BIOPHARMA UK Ltd je dne 22. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom orBec, namenjenim zdravljenju gastrointestinalne bolezni presadka proti gostitelju.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ORBEC
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom ORBEC
Patients with gastrointestinal graft-versus-host disease have damage to the stomach and the intestine, which causes severe inflammation of these organs.
Bolniki z gastrointestinalno boleznijo presadka proti gostitelju imajo poškodovan želodec in črevesje, kar lahko povzroči huda vnetja teh organov.
This was expected to lead to a reduction in damage to the stomach and intestine.
To naj bi posledično ugodno vplivalo na zmanjševanje poškodb želodca in črevesja.
The main measure of effectiveness was how long it took for treatment to fail during the 50 days of treatment.
Glavno merilo učinkovitosti je bil čas v okviru 50-dnevnega zdravljenja, v katerem se je pokazalo, da zdravljenje ni bilo uspešno.
The active substance of orBec, beclomethasone dipropionate, is a corticosteroid that has been used in inhaled, nasal and skin medicines since the 1970s.
Zdravilna učinkovina v zdravilu orBec, beklometazon dipropionat, je kortikosteroid, ki se od 1970-ih uporablja v zdravilih za vdihavanje ter zdravilih za nos in kožo.
Based on the review of the data and the company's response to the CHMP list of question at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that orBec could not have been approved for the treatment of gastrointestinal graft-versus-host disease.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila orBec ni mogoče odobriti za zdravljenje gastrointestinalne bolezni presadka proti gostitelju.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with orBec?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila orBec?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with orBec.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila orBec.
What was orBec expected to be used for?
Za kaj naj bi se zdravilo orBec uporabljalo?
In addition, the Committee noted that there was a lack of data to demonstrate how the active substance in orBec works in the stomach and intestine, when used for treatment of gastrointestinal graft-versus-host disease.
Poleg tega je Odbor izpostavil tudi pomanjkanje podatkov o načinu delovanja zdravilne učinkovine zdravila orBec v želodcu in črevesju pri zdravljenju gastrointestinalne bolezni presadka proti gostitelju.
In orBec, beclomethasone dipropionate was to be taken orally so that it could act within the stomach and intestine.
Beklometazon dipropionat v zdravilu orBec bi se naj jemal peroralno, tako da bi lahko zdravilna učinkovina delovala v želodcu in črevesju.
orBec was expected to be used for the treatment of gastrointestinal graft-versus-host disease.
Zdravilo orBec naj bi se uporabljalo za zdravljenje gastrointestinalne bolezni presadka proti gostitelju.