natgillin/translations-raw huggingface dataset:
The carcinogenic potential of telotristat etiprate was studied in transgenic mice (26 weeks) and rats (104 weeks).
Kancerogeni potencial telotristatijevega etiprata so raziskovali pri transgenskih miših (26 tednov) in podganah (104 tedne).
Number of patients Responder, n (%)
Število bolnikov Bolniki z odzivom, n (%)
The maximum dose of Xermelo is 750 mg in 24 hours.
Največji odmerek zdravila Xermelo je 750 mg v 24 urah.
QOL was generally stable over the course of the study.
Kakovost življenja je bila v času študije v splošnem stabilna.
LP-951757 was pharmacologically inactive at TPH1 in vitro.
LP-951757 je bil farmakološko neaktiven pri TPH1 in vitro.
• octreotide.
• oktreotidom.
Xermelo should be taken with food (see sections 5.1 and 5.2).
Zdravilo Xermelo je treba jemati skupaj s hrano (glejte poglavji 5.1 in 5.2).
A total of 135 patients were evaluated for efficacy.
Učinkovitost je bila ovrednotena pri skupno 135 bolnikih.
Moreover, in the long-term safety study (LX1606.1-302-CS), the incidence of depression was 21% and there is a probable biological mechanism that telotristat reduces the production of serotonin that may lead to symptoms of depression.
Poleg tega je v študiji dolgoročne varnosti (LX1606.1-302-CS) pojavnost depresije znašala 21 % in obstaja verjeten biološki mehanizem, preko katerega telotristat zmanjšuje nastajanje serotonina, kar lahko vodi do simptomov depresije.
Women should use effective methods of contraception while taking this medicine.
Ženske morajo med jemanjem tega zdravila uporabljati učinkovito metodo kontracepcije.
Breast Cancer Resistance Protein (BCRP)
Protein odpornosti za raka dojke (BCRP; “Breast Cancer Resistance Protein”)
Therapy with telotristat should not be resumed unless the liver injury can be explained by another cause.
Zdravljenja s telotristatom se ne sme znova uvesti, razen če se okvara jeter lahko pojasni z drugim vzrokom.
A cumulative search identified 62 relevant cases some of which with a close temporal relationship with the initiation of treatment with telotristat.
Kumulativna preiskava je odkrila 62 relevantnih primerov, nekateri od njih pa so bili tesno časovno povezani z uvedbo zdravljenja s telotristatom.
The blisters are packaged in a carton.
Pretisni omoti so pakirani v škatle.
You should tell your doctor about every medicine.
Zdravnika morate obvestiti o vseh zdravilih,
The increases were largely reversible on dose interruption or reduction, or recovered whilst maintaining treatment at the same dose.
Zvišanja so bila v veliki meri reverzibilna po prekinitvi ali zmanjšanju odmerka oziroma so izzvenela pri vzdrževalnem zdravljenju z enakim odmerkom.
The secondary objective of this study was to evaluate changes in patients' quality of life (QOL) through Week 84.
Sekundarni cilj te študije je bil ovrednotiti spremembe v kakovosti življenja bolnikov do 84. tedna.
Xermelo was taken within 15 minutes before, or within 1 hour after food.
Bolniki so zdravilo Xermelo jemali 15 minut pred hrano ali v 1 uri po njej.
Questions were asked to blinded participants to further characterise the degree of change experienced during the trial.
Vprašanja so bila zastavljena udeležencem dvojno slepega zdravljenja, da bi nadalje opredelili stopnjo sprememb, do katerih je prišlo med preskušanjem.
Adverse reactions are listed by MedDRA body system organ class and by frequency using 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) and not known (cannot be estimated from the available data).
Neželeni učinki so navedeni po MedDRA klasifikaciji glede na organski sistem in pogostnost v skladu z naslednjim dogovorom: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In the event of a missed dose, patients should take their subsequent dose at the next scheduled time point.
V primeru izpuščenega odmerka mora bolnik vzeti naslednji odmerek ob naslednjem predvidenem času.
Relevance of these gastrointestinal findings to humans is unknown.
Pomen teh ugotovitev v prebavilih za človeka ni znan.
Based on the small increase observed, clinically meaningful interactions with P-gp and MRP-2 substrates are unlikely.
Glede na opaženo majhno povečanje, so klinično pomembne interakcije s substrati za P-gp in MRP-2 malo verjetne.
The tablets are packaged in a PVC/PCTFE/PVC/Al blister.
Tablete so pakirane v pretisne omote iz PVC/PCTFE/PVC/Al.
Patients should be monitored for signs and symptoms of constipation.
Bolnike je treba spremljati glede znakov in simptomov zaprtja.
Clinical signs were limited to increase in frequency of liquid faeces at all doses.
Klinični znaki so bili omejeni na povečanje pogostnosti tekočega blata pri vseh odmerkih.
The clinical significance of the decrease in brain 5-HIAA with or without a concomitant decrease in brain 5-HT is unknown.
Klinični pomen zmanjšanja vrednosti 5-HIAA v možganih s sočasnim zmanjšanjem vrednosti 5-HT v možganih ali brez njega ni znan.
This is because Xermelo can affect the way some other medicines work, or other medicines can affect the way Xermelo works.
Zdravilo Xermelo namreč lahko vpliva na delovanje nekaterih drugih zdravil, ali pa lahko druga zdravila vplivajo na delovanje zdravila Xermelo.
This medicine works by reducing the amount of serotonin made by the tumour.
To zdravilo deluje tako, da zmanjša količino serotonina, ki ga proizvaja tumor.
• Swelling (build-up of fluid in the body)
• otekanje (kopičenje tekočine v telesu)
• if you have signs of constipation, as telotristat reduces the number of your bowel movements.
• če imate znake zaprtja, saj telotristat zmanjša število odvajanj blata.
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
This could mean that your doctor needs to change the dose(s) that you take.
Zdravnik bo morda moral spremeniti odmerek (odmerke), ki ga (jih) jemljete.
Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.
Večina bolnikov (92,1 %) je imela manj kot 4 odvajanja blata na dan in vsi, razen 9 bolnikov, so se zdravili z analogom somatostatina.
There are no data from the use of telotristat in pregnant women.
Podatkov o uporabi telotristata pri nosečnicah ni.
In a phase 3 study of similar design (TELECAST), a total of 76 patients were evaluated for efficacy.
V študiji 3. faze s podobno zasnovo (TELECAST) je bila varnost ovrednotena pri skupno 76 bolnikih.
This includes:
vključno z/s:
Most events were mild or moderate and did not limit study treatment.
V večini primerov so bili neželeni učinki blagi ali zmerni, zdravljenje v študiji pa zaradi tega ni bilo omejeno.
No specific study has been performed in the elderly population.
Posebne študije pri starostnikih niso bile izvedene.
These have not been associated with concomitant elevations in total serum bilirubin.
Ta zvišanja niso bila povezana s sočasnim zvišanjem vrednosti skupnega bilirubina v serumu.
Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome.
Serotonin ima ključno vlogo pri regulaciji številnih pomembnih fizioloških procesov, vključno s sekrecijo, gibljivostjo, vnetjem in zaznavanjem v gastrointestinalnem traktu, ter se prekomerno izloča pri bolnikih s karcinoidnim sindromom.
The European Medicines Agency has waived the obligation to submit the results of studies with telotristat in all subsets of the paediatric population in the treatment of carcinoid syndrome (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s telotristatom za vse podskupine pediatrične populacije za zdravljenje karcinoidnega sindroma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Your doctor will do blood tests to check your liver and will decide whether you should keep taking this medicine.
Zdravnik bo s krvnimi preiskavami preveril delovanje jeter in presodil, če lahko to zdravilo jemljete še naprej.
In phase 3 clinical trials, telotristat was routinely combined with loperamide with no evidence of safety concerns.
V kliničnih preskušanjih 3. faze so telotristat rutinsko uporabljali v kombinaciji z loperamidom, pri čemer niso opazili težav z varnostjo.
Depressive disorders
Depresivne motnje
Patients having participated in any Xermelo phase 2 or phase 3 carcinoid syndrome study were eligible to enter the study at the same dose level and regimen as identified in their original study, for at least 84 weeks of treatment.
Bolniki, ki so bili vključeni v katerokoli Xermelo študijo 2. ali 3. faze v povezavi s karcinoidnim sindromom, so lahko vstopili v zadevno študijo z enakim odmerkom in režimom, kot sta bila opredeljena v njihovi prvotni študiji, za vsaj 84 tednov zdravljenja.
The recommended dose is one tablet (250 mg) three times a day.
Priporočeni odmerek je ena tableta (250 mg) trikrat na dan.
Prenatal development in rats and rabbits was affected by increased prenatal lethality (increased early and late resorptions), while no adverse effects were noted on postnatal development in rats.
Prenatalni razvoj pri podganah in kuncih je bil prizadet z večjo prenatalno umrljivostjo (pogostejše zgodnje in pozne resorpcije), neželenih učinkov na postnatalni razvoj pri podganah pa niso opazili.
The tablets are white to off-white, film-coated and oval shaped.
Tablete so bele do umazanobele, filmsko obložene in ovalne oblike.
Following administration of 500 mg tid, the apparent terminal half-life was approximately 11 hours.
Pri uporabi odmerka 500 mg trikrat na dan je navidezni končni razpolovni čas znašal približno 11 ur.
Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.
Telotristat z zaviranjem periferne TPH1 zmanjšuje nastajanje serotonina, kar ublaži simptome, povezane s karcinoidnim sindromom.
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If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
In rats, there were no adverse effects on male and female fertility.
Pri podganah ni bilo neželenih učinkov na plodnost samcev in samic.
• if you feel down, depressed, or if you feel you have no interest or take any pleasure in doing your normal activities, whilst taking this medicine
• če se med jemanjem tega zdravila počutite potrti, depresivni ali nimate zanimanja ali ne uživate v običajnih dejavnostih.
Talk to your doctor or pharmacist:
Posvetujte se z zdravnikom ali farmacevtom:
Patients should be advised to report any symptoms of depression, depressed mood and decreased interest to their physicians.
Bolnikom je treba svetovati, da morajo v primeru pojava kakršnega koli simptoma depresije, depresivnega razpoloženja ali zmanjšanja zanimanja o tem obvestiti zdravnika.
Overall, severe to moderate renal impairment did not result in a clinically meaningful change in the PK profile or safety of telotristat ethyl and its metabolite telotristat.
V splošnem huda do zmerna okvara ledvic ni povzročila klinično pomembne spremembe v farmakokinetičnem profilu ali varnosti etiltelotristata in njegovega presnovka telotristata.
b. Statistical tests used a blocked 2-sample Wilcoxon Rank Sum statistic (van Elteren test) stratified by the u5-HIAA stratification at randomization.
b. Za statistično testiranje je bil uporabljen »blokiran 2-vzorčni Wilcoxon Rank-sum test (van Elterenov test)«, stratificiran glede na u5-HIAA stratifikacijo ob randomizaciji.
Therefore, intake of higher doses is not recommended (see section 5.2).
Uporaba višjih odmerkov zato ni priporočljiva (glejte poglavje 5.2).
Distribution Both telotristat ethyl and its active metabolite are > 99% bound to human plasma proteins.
Porazdelitev Tako etiltelotristat kot njegov aktivni presnovek se > 99 % vežeta na humane proteine v plazmi.
The renal clearance of telotristat was 0.126 L/h.
Ledvični očistek telotristata je znašal 0,126 l/h.
The adverse event was observed in clinical trials with frequency “very common” and is being reported from post-marketing setting.
Neželeni učinek so opazili v kliničnih preskušanjih s pogostnostjo “zelo pogosti”, o njem pa so poročali tudi po prihodu zdravila na trg.
If you need treatment with octreotide subcutaneous injections, you should have your injection at least 30 minutes after taking Xermelo.
Če potrebujete zdravljenje s podkožno injekcijo oktreotida, morate prejeti injekcijo vsaj 30 minut po jemanju zdravila Xermelo.
After oral administration to healthy volunteers, telotristat ethyl was rapidly absorbed, and almost completely converted to its active metabolite.
Po peroralni uporabi pri zdravih prostovoljcih se je etiltelotristat hitro absorbiral in skoraj popolnoma pretvoril v svoj aktivni presnovek.
Do not stop taking Xermelo without talking with your doctor.
Ne prenehajte z jemanjem zdravila Xermelo, ne da bi se prej o tem posvetovali z zdravnikom.
Tell your doctor straight away if you notice any of the following signs and symptoms that suggest that your liver may not be working properly:
Nemudoma obvestite zdravnika, če opazite katerega koli od naslednjih znakov in simptomov, ki lahko kažejo na morebitno nepravilno delovanje jeter:
• medicines to treat depression, such as bupropion or sertraline.
• zdravili za zdravljenje depresije, kot sta bupropion ali sertralin.
The long-term safety and tolerability of telotristat was evaluated in a nonpivotal (nonrandomized), phase 3, multicentre, open-label, long-term extension study.
Dolgoročno varnost in prenašanje telotristata so ovrednotili v neključni (nerandomizirani), multicentrični, odprti, dolgoročni podaljšani študiji 3. faze.
The microscopic changes in the gastrointestinal tract reversed with a 4-week recovery period.
Mikroskopske spremembe v prebavilih so bile reverzibilne, obdobje okrevanja pa je trajalo 4 tedne.
• Wind
• vetrovi
The influence of age on the pharmacokinetics of telotristat ethyl and its active metabolite has not been conclusively evaluated.
Vpliv starosti na farmakokinetiko etiltelotristata in njegovega aktivnega presnovka ni bil dokončno ovrednoten.
When the tumour releases too much serotonin into your bloodstream you can get diarrhoea.
Ko tumor sprošča preveč serotonina v vaš krvni obtok, se pojavi driska.
If constipation develops, the use of telotristat and other concomitant therapies affecting bowel motility should be re-evaluated.
V primeru pojava zaprtja je treba uporabo telotristata in drugih sočasno uporabljenih zdravil, ki vplivajo na gibljivost črevesja, znova ovrednotiti.
Effect of Xermelo on other medicinal products
Vpliv zdravila Xermelo na druga zdravila
No studies on the effect of telotristat on human fertility have been conducted.
Študij o vplivu telotristata na plodnost pri človeku niso izvedli.
• medicines used to treat high blood pressure, such as amlodipine.
• zdravili za zdravljenje visokega krvnega tlaka, kot je amlodipin.
The pharmacokinetics of telotristat ethyl and its active metabolite have been characterised in healthy volunteers and patients with carcinoid syndrome.
Farmakokinetiko etiltelotristata in njegovega aktivnega presnovka so ovrednotili pri zdravih prostovoljcih in bolnikih s karcinoidnim sindromom.
Management of overdose Treatment of an overdose should include general symptomatic management.
Ukrepanje v primeru prevelikega odmerjanja Zdravljenje v primeru prevelikega odmerjanja mora vključevati splošno obvladovanje simptomov.
The potential for in vivo drug interaction via inhibition of BCRP is considered low.
Možnost interakcij med zdravili in vivo preko zaviranja BCRP je ocenjena kot majhna.
The efficacy and safety of telotristat for the treatment of carcinoid syndrome in patients with metastatic neuroendocrine tumours who were receiving SSA therapy was established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial in adult patients, which included a 36-week extension during which all patients were treated with open-label telotristat (TELESTAR Study).
Učinkovitost in varnost telotristata pri zdravljenju karcinoidnega sindroma pri bolnikih z metastatskimi nevroendokrinimi tumorji, ki so se zdravili z analogi somatostatina, sta bili dokazani v 12-tedenskem, dvojno slepem, s placebom nadzorovanem, randomiziranem, multicentričnem preskušanju 3. faze pri odraslih bolnikih, ki je vključevalo 36-tedensko podaljšanje, med katerim so se vsi bolniki odprto zdravili s telotristatom (študija TELESTAR).
• oral contraceptives, such as ethinyloestradiol.
• peroralnimi kontraceptivi, kot je etinilestradiol.
Telotristat induced CYP2B6 in vitro (see section 5.2).
Telotristat in vitro inducira CYP2B6 (glejte poglavje 5.2).
Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products, ATC code: A16AX15
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove: razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX15
Table 1 - Adverse reactions reported in patients treated with Xermelo System organ class
Preglednica 1 - Neželeni učinki, o katerih so poročali pri bolnikih, ki so se zdravili z zdravilom Xermelo
Xermelo and these medicines reduce the number of your bowel movements and taken together, they can cause severe constipation.
Zdravilo Xermelo in ta zdravila zmanjšajo število odvajanj blata in lahko povzročijo hudo zaprtje, če se jih jemlje skupaj.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Xermelo Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The efficacy and safety in patients with end-stage renal disease who require dialysis (eGFR < 15 mL/min/1.73 m² requiring dialysis) has not been established.
Učinkovitost in varnost pri bolnikih s končno odpovedjo delovanja ledvic, ki potrebujejo zdravljenje z dializo (eGFR < 15 ml/min/1,73 m², ki zahteva zdravljenje z dializo), nista bili dokazani.
Although patients with carcinoid syndrome may have a predisposition for depression, there were 38 post-marketing cases indicative of depression and depression-related events including two cases with positive dechallenge.
Pri bolnikih s karcinoidnim sindromom sicer lahko obstaja predispozicija za depresijo, vendar pa so po prihodu zdravila na trg poročali o 38 primerih, ki so kazali na depresijo in z depresijo povezane dogodke, vključno z dvema primeroma, ko je neželeni učinek zdravila po prekinitvi zdravljenja izzvenel.
Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded.
Na osnovi opažene visoke variabilnosti med posameznimi bolniki, kopičenja pri podskupini bolnikov s karcinoidnim sindromom ni mogoče izključiti.
In a 39-week repeat-dose toxicity study in dogs NOAEL of 300 mg/kg/day was determined.
V 39-tedenski študiji toksičnosti ponavljajočih se odmerkov pri psih je bila ugotovljena NOAEL 300 mg/kg/dan.
Your doctor will decide for how long you should take Xermelo.
Zdravnik bo odločil, kako dolgo boste jemali zdravilo Xermelo.
Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521)
Filmska obloga polivinilalkohol (delno hidroliziran) (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b)
Table 2: BM response (TELESTAR Study) Parameter
Preglednica 2: Odziv v obliki odvajanja blata (študija TELESTAR)
The mean age was 63 years (range 35 to 84 years), 55% were male and 97% were white.
Povprečna starost bolnikov je bila 63 let (razpon od 35 do 84 let), 55 % bolnikov je bilo moškega spola in 97 % bolnikov je bilo belcev.
Depression, depressed mood
Psihiatrične motnje depresija, depresivno razpoloženje
A high variability (% CV range of 18% to 99%) in telotristat ethyl and its active metabolite parameters was observed within the overall PK.
Visoka variabilnost (% koeficienta variacije (KV) v razponu od 18 % do 99 %) parametrov etiltelotristata in njegovega aktivnega presnovka je bila opažena pri celotni farmakokinetiki.
The use of Xermelo is not recommended in patients with end-stage renal disease requiring dialysis (eGFR < 15 mL/min requiring dialysis) because efficacy and safety of Xermelo in these patients has not been established.
Uporaba zdravila Xermelo ni priporočljiva pri bolnikih s končno odpovedjo ledvic, ki potrebujejo zdravljenje z dializo (ocenjena hitrost glomerulne filtracije [eGFR] < 15 ml/min, ki zahteva zdravljenje z dializo), saj učinkovitost in varnost zdravila Xermelo pri teh bolnikih nista bili dokazani.
Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition).
Etiltelotristat je zaviral z MRP-2 posredovan prenos (98-% inhibicija).
If you forget to take a dose, take your next dose when it is due, skipping the missed dose.
Če ste pozabili vzeti odmerek, vzemite naslednji odmerek ob predvidenem času, pozabljeni odmerek pa izpustite.
The only metabolite of telotristat (active metabolite) representing consistently > 10% of total plasma drug-related material was its oxidative decarboxylated deaminated metabolite, LP-951757.
Edini presnovek telotristata (aktivni presnovek), ki konsistentno predstavlja > 10 % skupnega, z zdravilom povezanega materiala v plazmi, je njegov oksidativno dekarboksiliran in deaminiran presnovek LP-951757.
Pack sizes of 90 and 180 tablets.
Velikost pakiranj: 90 in 180 tablet.
Elderly patients (65 years of age and above) No specific dose recommendations are available for elderly patients (see section 5.2).
Starostniki (bolniki, stari 65 let in starejši) Pri starostnikih ni posebnih priporočil za odmerjanje (glejte poglavje 5.2).
In vitro, telotristat ethyl inhibited CES2 with an IC50 approximately of 6.4 μM.
Etiltelotristat je in vitro zaviral CES2, pri čemer je IC50 znašala približno 6,4 μM.
The majority was eliminated in the faeces.
Večina se je izločila z blatom.
The mean PK parameters for telotristat ethyl and the active metabolite appeared unchanged between week 24 and week 48, suggesting the achievement of steady-state conditions at or prior to week 24.
Povprečni farmakokinetični parametri etiltelotristata in aktivnega presnovka so med 24. in 48. tednom ostali nespremenjeni, kar kaže, da je stanje dinamičnega ravnovesja doseženo v ali pred 24. tednom.
They were generally of mild or moderate intensity.
Ti neželeni učinki so bili običajno blagi ali zmerni.
In patients with carcinoid syndrome, telotristat resulted in reductions in u5-HIAA (refer to Table 3 for TELESTAR and information provided for TELECAST).
Pri bolnikih s karcinoidnim sindromom je bila uporaba telotristata povezana z zmanjšanjem vrednosti u5-HIAA (glejte preglednico 3 za študijo TELESTAR in informacije, navedene za študijo TELECAST).
The mean age was 64 years (range 37 to 88 years), 52% were male and 90% were white.
Povprečna starost bolnikov je bila 64 let (razpon od 37 do 88 let), 52 % bolnikov je bilo moškega spola in 90 % bolnikov belcev.
Hepatic enzymes elevations
Zvišane vrednosti jetrnih encimov
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SK-90301 Senec Tel: +421 905 667 410
Xermelo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila Xermelo ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
• medicines used to avoid transplant rejection, such as cyclosporine.
• zdravili za preprečevanje zavrnitve presadka, kot je ciklosporin.