natgillin/translations-raw huggingface dataset:
Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months.
Nadaljevanje zdravljenja pri bolnikih, ki po 6 mesecih ne kažejo znakov izboljšanja, je treba skrbno pretehtati.
Data on the safety and efficacy of natalizumab beyond 2 years are not available.
Podatkov o varnosti in učinkovitosti natalizumaba za več kot 2 leti ni.
Continued therapy beyond this time should be considered only following a reassessment of the potential for benefit and risk.
O nadaljevanju zdravljenja po tem času se je treba odločati na podlagi ponovnega ovrednotenja potencialnih koristi in tveganj.
TYSABRI is contraindicated in children and adolescents (see section 4.3).
Zdravilo TYSABRI je kontraindicirano pri otrocih in mladostnikih (glejte poglavje 4. 3).
The efficacy of re-administration has not been established, for safety see section 4.4.
Napotke v zvezi z varnostjo najdete v poglavju 4. 4.
Hypersensitivity to natalizumab or to any of the excipients.
Preobčutljivost za natalizumab ali katerokoli pomožno snov.
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e. g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
Bolniki, pri katerih je povečano tveganje oportunističnih okužb, vključno z bolniki z oslabljenim imunskim sistemom (vključno s tistimi, ki so nedavno prejemali terapijo za zaviranje imunskega odziva ali tisti z oslabljenim imunskim sistemom zaradi prejšnjega zdravljenja npr. z mitoksantronom ali ciklolofosfamidom, glejte tudi poglavji 4. 4 in 4. 8).
Use of TYSABRI has been associated with an increased risk of PML.
Z jemanjem zdravila TYSABRI je povezano povečanje tveganja PML.
Before initiation of treatment with TYSABRI, a recent (usually within 3 months) Magnetic Resonance Image should be available.
Pred začetkom zdravljenja z zdravilom TYSABRI, morajo biti na voljo nedavno (v roku 3 mesecev) pridobljeni rezultati slikanja z magnetno resonanco.
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Bolnike je treba redno opazovati zaradi novih nevroloških znakov poslabšanja ali znakov, ki lahko kažejo na PML.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Pri sumu na progresivno multifokalno levkoencefalopatijo (PML) morate s terapijo prenehati, dokler se PML ne izključi.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are typical of MS or possibly suggestive of PML.
S pregledom bolnika mora zdravnik ugotoviti, ali simptomi kažejo na nevrološko disfunkcijo, in če je tako, ali so ti simptomi značilni za MS ali morda kažejo na PML.
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre- treatment MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
V primeru dvoma je treba razmisliti o nadaljnji ocenitvi, vključno z magnetnoresonančnim slikanjem, po možnosti s kontrastom (primerjalno z MRT prejšnjega stanja), testiranjem CSF glede JC virusne DNK in ponovno nevrološko ocenitvijo, kot je opisano v informacijah za zdravnika in smernicah za obvladovanje bolezni (glejte smernice za usposabljanje).
Once the clinician has excluded PML (if necessary, by repeating clinical, imaging and/ or laboratory investigations if clinical suspicion remains), dosing of natalizumab may resume.
Ko zdravnik izključi PML (po potrebi s ponovnimi kliničnimi, slikovnimi in/ ali laboratorijskimi preiskavami, če klinični dvom ni odstranjen), je mogoče nadaljevati z odmerjanjem natalizumaba.
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e. g. cognitive or psychiatric symptoms).
Zdravnik mora biti še posebno pozoren na simptome, ki nakazujejo PML, katerih bolnik sam morda ne opazi (npr. kognitivni ali psihiatrični simptomi).
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Bolniku je treba svetovati, da naj svojega partnerja ali negovalca o zdravljenju obvesti, ker le- ta lahko opazi simptome, katerih se bolnik sam morda ne zaveda.
Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen (see section 5.2).
Po ponovni vzpostavitvi imunskega sistema pri bolnikih z oslabljenim imunskim sistemom s PML je bila opažena stabilizacija ali izboljšan izid (glejte poglavje 5. 2).
It remains unknown if early detection of PML and suspension of TYSABRI therapy may lead to similar stabilisation or improved outcome.
Neznano je, ali vodi zgodnje odkritje PML in ukinitev zdravljenja z zdravilom TYSABRI v podobno stabilizacijo ali izboljšan izid.
Other Opportunistic Infections
Druge oportunistične okužbe
Other opportunistic infections have been reported with use of TYSABRI, primarily in patients with Crohn’ s disease who were immunocompromised or where significant co-morbidity existed, however increased risk of other opportunistic infections with use of TYSABRI in patients without these co- morbidities cannot currently be excluded.
Poročali so o drugih oportunističnih okužbah v zvezi z uporabo zdravila TYSABRI, primarno pri bolnikih s Crohnovo boleznijo z oslabljenim imunskim sistemom, ali pri katerih je obstajala znatna so - obolevnost, vendar pa povečanega tveganja drugih oportunističnih okužb pri uporabi zdravila TYSABRI pri bolnikih brez so- obolenj trenutno ni mogoče izključiti.
Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8).
Oportunistične okužbe so bile odkrite tudi pri bolnikih z MS, zdravljenih z zdravilom TYSABRI v obliki monoterapije (glejte poglavje 4. 8).
Prescribers should be aware of the possibility that other opportunistic infections may occur during TYSABRI therapy and should include them in the differential diagnosis of infections that occur in TYSABRI-treated patients.
Zdravniki, ki predpisujejo zdravilo, se morajo zavedati možnosti, da se lahko pri zdravljenju z zdravilom TYSABRI pojavijo tudi druge oportunistične okužbe, in jih morajo vključiti v diferencialno diagnozo okužb, ki se se pojavijo pri bolnikih, zdravljenih z zdravilom TYSABRI.
If a patient receiving TYSABRI develops an opportunistic infection, dosing of TYSABRI must be permanently discontinued.
Če bolnik, ki prejema zdravilo TYSABRI, razvije oportunistično okužbo, je treba zdravljenje z zdravilom TYSABRI trajno prekiniti.
Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
4 Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti kartico s posebnimi opozorili.
4 Physicians should counsel patients on the importance of uninterrupted dosing, particularly in the early months of treatment (see hypersensitivity).
Zdravniki morajo bolnikom razložiti, da je neprekinjeno odmerjanje izjemno pomembno, še posebej v prvih mesecih zdravljenja (glejte odstavek o preobčutljivosti).
Hypersensitivity reactions have been associated with TYSABRI, including serious systemic reactions (see section 4.8).
Z zdravilom TYSABRI so povezane preobčutljivostne reakcije, vključno z resnimi sistemskimi reakcijami (glejte poglavje 4. 8).
Patients are to be observed during the infusion and for 1 hour after the completion of the infusion (see section 4.8).
Bolnika se v času infundiranja in 1 uro po končanem infundiranu opazuje za znake in simptome preobčutljivostnih reakcij (glejte poglavje 4. 8).
Concurrent or prior treatment with immunosuppressants
Sočasno ali predhodno zdravljenje z zaviralci imunskega odziva
The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Varnost in učinkovitost zdravila TYSABRI v kombinaciji z drugimi zaviralci imunskega odziva in antineoplastičnimi zdravili ni bila povsem ugotovljena.
Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Sočasno jemanje teh učinkovin z zdravilom TYSABRI lahko poveča tveganje okužb, vključno z oportunističnimi okužbami in je kontraindicirano (glejte poglavje 4. 3).
Patients with a treatment history of immunosuppressant medications, including cyclophosphamide and mitoxantrone, may experience prolonged immunosuppression and therefore may be at increased risk for PML.
Pri bolnikih z zgodovino zdravljenja z zaviralci imunskega odziva, vključno s ciklofosfamidom in mitoksantronom, se lahko pojavi podaljšano zaviranje imunskega odziva, zato je pri njih tveganje PML večje.
Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3).
Zdravnik mora oceniti vsak posamični primer, da ugotovi znake poslabšanja imunske odzivnosti, preden se začne zdravljenje z zdravilom TYSABRI (glejte poglavje 4. 3).
In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
V teh primerih je treba preveriti prisotnost protiteles in če potrditveni test po šestih tednih pokaže njihovo prisotnost, je treba zdravljenje prekiniti, saj stalna prisotnost protiteles zmanjša učinkovitost zdravila TYSABRI ter poveča pojav preobčutljivostnih reakcij (glejte poglavje 4. 8).
Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are more at risk for hypersensitivity upon redosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after 6 weeks treatment should not be resumed.
Ker so bolniki, ki so bili izpostavljeni začetnemu kratkotrajnemu odmerjanju zdravila TYSABRI, nato pa so za dalj časa prekinili zdravljenje, bolj izpostavljeni preobčutljivostnim reakcijam po ponovnem odmerjanju zdravila, je pri njih potrebno oceniti pristotnost protiteles in če potrditveni test po šestih tednih pokaže njihovo prisotnost, se z zdravljenjem ne sme nadaljevati.
Hepatic Events
Težave z jetri
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
5 Po začetku trženja so poročali o spontanih hudih neželenih reakcijah zaradi okvare jeter.
Some patients with a past
V nekaterih primerih so se težave pojavile pri ponovnem odmerjanju zdravila TYSABRI.
5 medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
Pri nekaterih bolnikih, katerih testi so v preteklosti pokazali nepravilnosti v delovanju jeter, so se vrednosti med jemanjem zdravila TYSABRI še poslabšale.
Patients should be monitored as appropriate for impaired liver function, and be instructed to contact their physician in case signs and symptoms suggestive of liver injury occur, such as jaundice and vomiting.
Bolnike je treba pouciti, da morajo takoj obvestiti svojega zdravnika, ce se pojavijo znaki, ki kažejo na okvaro jeter, kot sta zlatenica ali bruhanje.
If a decision is made to stop treatment with natalizumab, the physician needs to be aware that natalizumab remains in the blood, and has pharmacodynamic effects (e. g increased lymphocyte counts) for approximately 12 weeks following the last dose.
V primeru odločitve, da se zdravljenje z natalizumabom prekine, mora zdravnik vedeti, da ostane natalizumab v krvi in ima farmakodinamične učinke (npr. v obliki povečanega števila limfocitov) še približno 12 tednov po zadnjem odmerku.
For drugs such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials.
V kliničnih preskušanjih sočasna izpostavljenost zdravilnim učinkovinam, kot sta interferon in glatiramer acetat, v tem času ni pokazala povezave s tveganjem za varnost.
Use of these medicines soon after the discontinuation of natalizumab may lead to an additive immunosuppressive effect.
Uporaba teh zdravil kmalu po prenehanju dajanja natalizumaba lahko povzroči dodatni učinek zaviranja imunskega odziva.
See section 4.3.
Glejte poglavje 4. 3.
There are no adequate data from the use of natalizumab in pregnant women.
Ni zadostnih podatkov o uporabi natalizumaba pri nosečnicah.
Natalizumab should not be used during pregnancy unless clearly necessary.
Natalizumaba ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
If a woman becomes pregnant while taking TYSABRI, discontinuation of TYSABRI should be considered.
Ženske, ki zanosijo med jemanjem zdravila TYSABRI, morajo razmisliti o prekinitvi zdravljenja z zdravilom TYSABRI.
It is not known whether TYSABRI is excreted in human milk, but it has been observed in animal studies (see section 5.3).
Ni znano, ali se zdravilo TYSABRI izloča v materino mleko, vendar pa je bilo izločanje opaženo pri študijah na živalih (glejte poglavje 5. 3).
Patients receiving TYSABRI should not breastfeed their infants.
Doječe ženske, ki se zdravijo z zdravilom TYSABRI, naj dojenje prekinejo.
Based on the pharmacological mechanism of action of natalizumab, the use of TYSABRI is not expected to affect patient's ability to drive and use machines.
Na podlagi farmakoloških mehanizmov delovanja natalizumaba ni za pričakovati, da bi uporaba zdravila TYSABRI vplivala na bolnikovo sposobnost vožnje ali upravljanja s stroji.
In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo:
V s placebom kontroliranih preskušanjih pri 1. 617 obolelih za MS, zdravljenih z natalizumabom do 2 leti (placebo:
1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo:
1. 135) je prišlo do neželenih učinkov, zaradi katerih je bilo zdravljenje prekinjeno, pri 5, 8% bolnikov, zdravljenih z natalizumabom (placebo:
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse drug reactions (placebo:
V študijah, ki so trajale 2 leti je 43, 5% bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila (placebo:
Adverse drug reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Neželeni učinki zdravila, o katerih so poročali pri natalizumabu z 0, 5% višjo incidenco kot je bila poročana pri placebu, so prikazani spodaj.
The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Neželeni učinki so navedeni z izrazi, ki jih priporoča MedRA in glede na MedRA organske sisteme.
Common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100).
Pogosti (> 1/ 100 do < 1/ 10), občasni (> 1/ 1. 000 do < 1/ 100).
1 An adverse event judged related to therapy by the investigating physician.
1 Neželen učinek, ki ga je raziskovalec ocenil v zvezi z zdravljenjem.
6 Nervous system disorders Common
6 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Headache Dizziness
Bolezni prebavil
Gastrointestinal disorders Common
Pogosti
Vomiting Nausea
Bruhanje Slabost
Musculoskeletal and connective tissue disorders Common
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti
Infections and infestations Common
Infekcijske in parazitske bolezni Pogosti
Urinary tract infection Nasopharyngitis
Okužbe sečil Nazofaringitis
and administration site conditions
spremembe na mestu aplikacije
Rigors Pyrexia Fatigue
Rigor Pireksija Utrujenost
Immune system disorders Common Uncommon
Bolezni imunskega sistema Pogosti Občasni
Urticaria Hypersensitivity
Urtikarija Preobčutljivost
In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS so dogodek, povezan z infuzijo, opredelili kot neželen učinek, ki se pojavi med infundiranjem ali v eni uri od zaključenega infundiranja.
These occurred in 23.1% of MS patients treated with natalizumab (placebo:
Pojavil se je pri 23, 1% bolnikov z MS, ki so dobivali natalizumab (placebo:
In 2-year controlled clinical trials in MS patients, hypersensitivity reactions occurred in up to 4% of patients.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS se je preobčutljivostna reakcija pojavila pri do 4% bolnikov.
Anaphylactic/ anaphylactoid reactions occurred in less than 1% of patients receiving TYSABRI.
Anafilaktična/ anafilaktoidna reakcija se je pojavila pri manj kot 1% bolnikov, ki so prejemali zdravilo TYSABRI.
Hypersensitivity reactions usually occurred during the infusion or within the 1-hour period after the completion of the infusion (See section 4.4).
Preobčutljivostne reakcije so se običajno pojavile med infundiranjem ali do 1 uro po zaključenem infundiranju (glejte poglavje 4. 4).
In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following associated symptoms: hypotension, hypertension, chest pain, chest discomfort, dyspnoea, angioedema, in addition to more usual symptoms such as rash and urticaria.
V izkušnjah po začetku trženja so poročali o preobčutljivostnih reakcijah, ki so se pojavile z enim ali več od naslednjih simptomov: hipotenzija, hipertenzija, bolečine v prsih, nelagodje v prsih, dispneja, angioedem, poleg bolj običajnih simptomov kot sta izpuščaj in urtikarija.
In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS so bila pri 10% bolnikov odkrita protitelesa proti natalizumabu.
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Pri približno 6% bolnikov so se razvila obstojna proti- natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
Antibodies were detected on only one occasion in an additional 4% of patients.
Protitelesa so bila odkrita v le enem primeru od dodatnih 4% bolnikov.
Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Dodatne reakcije zaradi infuzije, povezane z obstojnimi protitelesi, vključujejo rigor, slabost, bruhanje in vročinske valove (glejte poglavje 4. 4).
If, after approximately 6 months of therapy, persistent antibodies are suspected, either due to reduced efficacy or due to occurrence of infusion-related events, they may be detected and confirmed with a subsequent test 6 weeks after the first positive test.
7 Če obstaja po približno 6 mesecih zdravljenja sum na obstojna protitelesa, bodisi zaradi zmanjšane učinkovitosti ali zaradi pojava z infuzijo poveznih dogodkov, jih je mogoče odkriti in potrditi s ponovnim testom 6 tednov po prvem pozitivnem testu.
7 Infections, including PML and opportunistic infections
Okužbe, vključno s PML in oportunističnimi okužbami
In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bila stopnja okužbe približno 1, 5 na leto na bolnika, tako pri bolnikih zdravljenih z natalizumabom, kot pri bolnikih, zdravljenih s placebom.
A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Pri kliničnih preskušanjih v zvezi z MS so poročali o primeru diareje, povzročene s cryptosporidiumom.
In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
V kliničnih preskušanjih so bile okužbe s herpesom (virus Varicella- Zoster, virus Herpes- simplex) pri bolnikih, zdravljenih z natalizumabom nekoliko bolj pogoste kot pri bolnikih, zdravljenih s placebom.
See section 4.4.
V postmarketinških raziskavah so poročali o resnih primerih, vključno z enim smrtnim primerom herpetičnega encefalitisa (glejte poglavje 4. 4).
The majority of patients did not interrupt natalizumab therapy during infections and recovery occurred with appropriate treatment.
Večina bolnikov v času okužbe ni prekinila zdravljenja z natalizumabom in je z ustreznim zdravljenjem okrevala.
In clinical trials, cases of PML have been reported.
V kliničnih preskušanjih so poročali o primerih PML.
PML usually leads to severe disability or death (see section 4.4).
PML navadno vodi do hude prizadetosti ali smrti (glejte poglavje 4. 4).
In pivotal clinical trials, two cases, including one fatality, occurred in MS patients who were being treated with concomitant interferon beta-1a therapy for more than 2 years.
V ključnih kliničnih preskušanjih sta se pri bolnikih z MS, ki so se več kot 2 leti sočasno zdravili z interferonom beta- 1a, pojavila dva primera, med katerima je bil en smrten.
In another trial, one patient with Crohn’ s disease, who had a long history of treatment with immunosuppressants and associated lymphopenia also developed PML and died.
V drugem preskušanju je en bolnik s Crohnovo boleznijo in dolgo zgodovino zdravljenja z zaviralci imunskega odziva in s tem povezano limfopenijo prav tako obolel za PML in umrl.
PML has been reported in post-marketing experience in patients treated with TYSABRI monotherapy.
Med izkušnjami v obdobju trženja so poročali o PML pri bolnikih, ki so bili zdravljeni samo z zdravilom TYSABRI.
Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4).
Po začetku trženja so poročali o primerih resnih okvar jeter, povišanih jetrnih encimih in hiperbilirubinemiji (glejte poglavje 4. 4).
No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
V času 2- letnega zdravljenja ni bilo razlik v incidenci in v naravi malignosti med bolniki zdravljenimi z natalizumabom in tistimi, ki so prejemali placebo.
TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
Zdravljenje z zdravilom TYSABRI je povezano s povišanim obtokom limfocitov, monocitov, eozinofilcev, bazofilcev in eritrocitov z jedrom.
Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Povišanje limfocitov, monocitov, eozinofilcev in bazofilcev od izhodišča je bilo 35% do 140% za posamezne tipe celic, toda povprečno število celic je ostalo v normalnem razponu.
During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/ dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/ l) were seen.
Med zdravljenjem z zdravilom TYSABRI je bilo opaženo majhno zmanjšanje hemoglobina (povprečno zmanjšanje 0, 6 g/ dl), hematokrita (povprečno zmanjšanje 2%) in števila eritrocitov (povprečno zmanjšanje 0, 1 x 106/ l).
All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of TYSABRI and the changes were not associated with clinical symptoms.
Spremembe niso bile povezane s kliničnimi simptomi.
Selective Immunosuppressive Agent, ATC code:
Zdravila za selektivno zaviranje imunskega odziva, oznaka ATC: