natgillin/translations-raw huggingface dataset:
What TYSABRI is and what it is used for What you need to know before you use TYSABRI How to use TYSABRI
Kaj je zdravilo TYSABRI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI Kako uporabljati zdravilo TYSABRI
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).
• Treatment initiation and treatment continuation forms
• Obrazca za uvedbo in nadaljevanje zdravljenja
A group of symptoms caused by a serious infection of the brain including: - Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
Skupina simptomov, ki jih povzroča resna okužba možganov, vključno z/s: - spremembami osebnosti in vedenja, kot so zmedenost, delirij ali izguba zavesti, napadi (krči), glavobol, slabost/bruhanje, trd vrat, pretirana občutljivost na močno svetlobo, zvišana telesna temperatura, izpuščaj (kjer koli na telesu).
TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Zdravilo TYSABRI povečuje tveganje za razvoj encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex in varicella zoster.
If you have previously not been treated with immunosuppressants and have received TYSABRI for 2 years or longer, the level of your anti-JCV antibody response may be associated with the risk of getting PML.
Če se pred tem še niste zdravili z imunosupresivi in ste zdravilo TYSABRI prejemali 2 leti ali dlje, je lahko raven odziva protiteles proti JCV povezana s tveganjem, da dobite PML.
Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium-enhancing lesion.
Bolniki morajo imeti vsaj 1 recidiv v preteklem letu zdravljenja in vsaj 9 T2-hiperintenzivnih lezij pri kranialnem magnetnoresonančnem slikanju (MRS) ali vsaj 1 lezijo, vidno z gadolinijem.
• You will also find this information in the Patient Alert Card you have been given by your doctor.
• Te informacije najdete tudi v kartici s posebnimi opozorili za bolnika, ki vam jo je dal vaš zdravnik.
Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Preobčutljivost na natalizumab ali katero koli pomožno snov, navedeno v poglavju 6.1.
Care should be taken with patients who have previously received immunosuppressants to allow sufficient time for immune function recovery to occur.
Pri bolnikih, ki so predhodno prejemali zaviralce imunskega odziva, je treba biti previden in zagotoviti dovolj časa za ponovno vzpostavitev funkcije imunskega sistema.
Remove flip-top from the vial.
Z viale odstranite dvižno zaporko.
PHARMACEUTICAL FORM Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje.
• Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
• potrditev da se je zdravnik z bolnikom pogovoril o tveganju PML ter tveganju IRIS, če se zdravljenje prekine zaradi suma na PML
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.
eozinofilcev in bazofilcev od izhodišča je bilo 35 % do 140 % za posamezne tipe celic, toda povprečno število celic je ostalo v normalnem razponu.
Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
V primerih iz objavljene literature so poročali o prehodni blagi do zmerni trombocitopeniji in anemiji, ki so jo opazili pri dojenčkih, ki so bili rojeni ženskam, izpostavljenim zdravilu TYSABRI v tretjem trimesečju nosečnosti.
The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Srednji (± SD) očistek v stanju dinamičnega ravnovesja je bil 13,1 ± 5,0 ml/h, s srednjim (± SD) razpolovnim časom 16 ± 4 dni.
These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Ta zdravila lahko podaljšajo imunosupresijo tudi po prekinitvi zdravljenja.
Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Natalizumab je selektivni zaviralec adhezijskih molekul in se veže na podenoto α4 humanega integrina, ki se v močno izraženem številu nahaja na površini vseh levkocitov razen nevtrofilcev.
• Chest pain or discomfort
• bolečine ali nelagodje v prsih
Cases of asymptomatic PML based on MRI and positive JCV DNA in the cerebrospinal fluid have been reported.
Poročali so o primerih asimptomatske PML na podlagi MRS in pozitivne DNK za JCV v cerebrospinalni tekočini.
A benefit-risk evaluation of the use of TYSABRI during pregnancy should take into account the patient's clinical condition and the possible return of disease activity after stopping the medicinal product.
Ocena razmerja med koristmi in tveganji uporabe zdravila TYSABRI med nosečnostjo mora upoštevati tudi klinično stanje bolnice in možno aktivacijo bolezni po prenehanju jemanja zdravila.
• Date treatment started
• datum začetka zdravljenja
Mean number of new or newlyenlarging T2-hyperintense lesions
Povprečno število novih ali na novo povečanih hiperintenzivnih lezij T2
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.
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 v obdobju 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.
These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon or glatiramer acetate.
Bolniki, ki se niso odzivali na celoten in ustrezen potek zdravljenja (običajno najmanj eno leto zdravljenja) z interferonom beta ali glatiramer acetatom.
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).
Before initiation of treatment with TYSABRI, a recent (usually within 3 months) MRI should be available as a reference, and be repeated at least on a yearly basis.
Pred začetkom zdravljenja z zdravilom TYSABRI morajo biti na voljo nedavno (v roku 3 mesecev) pridobljeni rezultati MRS kot referenca, preglede je treba nato ponavljati vsaj enkrat letno.
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).
Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Farmakoterapevtska skupina: Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA23.
However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Ker pa se pogosto pojavi omotica, je treba bolnikom, ki doživijo neželene učinke, svetovati, naj ne vozijo ali upravljajo s stroji, dokler ta neželeni učinek ne mine.
o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Possibility of other opportunistic infections o The need to inform the National Competent Authority about any cases of PML
Če naj bi zdravljenje trajalo dlje kot 24 mesecev, zahtevo, da se bolnike obvesti o povečanem tveganju za razvoj PML in se jim da kopijo obrazca za nadaljnje zdravljenje o Možnost drugih oportunističnih okužb o Zahtevo, da se nacionalni pristojni organ obvesti o vseh primerih PML
In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 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 vsaj 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).
Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
Proces migracije levkocitov skozi BBB vključuje interakcijo med adhezijskimi molekulami na vnetnih celicah in endotelijskimi celicami žilne stene.
TYSABRI is contraindicated in children and adolescents below the age of 18 years (see section 4.3).
Zdravilo TYSABRI je kontraindicirano pri otrocih, starih do 18 let (glejte poglavje 4.3).
Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Pogostnost je bila definirana kot sledi: Pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100).
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 pojavijo pri bolnikih, zdravljenih z zdravilom TYSABRI.
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.
TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
4.1 Terapevtske indikacije Zdravilo TYSABRI je indicirano kot terapija, ki spreminja potek bolezni pri zelo aktivni recidivno remitentni multipli sklerozi, za sledeči skupini bolnikov:
To be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
All changes were observed at doses in excess of the human dose and were reversed upon clearance of natalizumab.
Vse spremembe so bile opazovane pri odmerkih, višjih od odmerkov za zdravljenje ljudi, ki so bile po očistku natalizumaba reverzibilne.
In one study in guinea pigs, a small reduction in pup survival was noted.
V eni študiji z budrami so opazili majhen upad preživetja mladičev.
• You must not use TYSABRI if you are being treated with other medicines to treat your MS, such as beta-interferons or glatiramer acetate.
• Zdravila TYSABRI ne smete uporabljati, če se zdravite z drugimi zdravili za zdravljenje multiple skleroze, kot so interferoni beta ali glatiramer acetatom.
Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Srednja povprečna koncentracija natalizumaba v stanju dinamičnega ravnovesja se je v obdobju dajanja gibala od 23 μg/ml do 29 μg/ml.
MRI screening for PML
Pregled z MRS za PML
TYSABRI can also have other side effects.
Zdravilo TYSABRI ima lahko tudi druge neželene učinke.
In MS, lesions are believed to occur when activated T-lymphocytes cross the blood-brain barrier (BBB).
Predvideva se, da se lezije pri MS pojavljajo, ko aktivirani T-limfociti prodrejo skozi hematocefalno bariero (BBB).
Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Imunogenost Poslabšanje bolezni ali z infuzijo povezani dogodki lahko kažejo na razvoj protiteles proti natalizumabu.
In such cases where TYSABRI therapy was discontinued the elevated eosinophil levels resolved.
V primerih, ko so zdravljenje z zdravilom TYSABRI prekinili, so se zvišane ravni eozinofilcev vrnile na normalno raven.
Persistent antibodies were associated with a substantial decrease in the effectiveness of TYSABRI and an increased incidence of hypersensitivity reactions.
Obstojna protitelesa so povezana z občutno slabšim učinkom zdravila TYSABRI in povečano incidenco preobčutljivostnih reakcij.
These changes were associated with increased splenic extramedullary haematopoiesis, thymic atrophy and decreased hepatic haematopoiesis.
Spremembe so povezane s povečano vranično ekstramedularno hematopoezo, atrofijo priželjca in zmanjšano jetrno hematopoezo.
TYSABRI must not be administered as a bolus injection.
Zdravila TYSABRI se ne sme dajati kot bolusna injekcija.
Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Iglo injekcijske brizge zabodite v vialo skozi središče gumijastega zamaška in izvlecite 15 ml koncentrata za raztopino za infundiranje.
Completing 1 years Completing 2 years
Randomizirano Dopolnjeno 1 leto Dopolnjeni 2 leti
Patients should be instructed that if they develop any infection then they should inform their physician that they are being treated with TYSABRI.
Bolnikom je treba naročiti, da morajo v primeru razvoja kakršnekoli okužbe svojega zdravnika obvestiti, da se zdravijo z zdravilom TYSABRI.
Combination with beta-interferons or glatiramer acetate.
Kombinacija z interferoni beta ali glatiramer acetatom.
Keep the leaflet and Alert Card with you during treatment and for six months after the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
Kartico s posebnimi opozorili shranite med zdravljenjem in šest mesecev po zadnjem odmerku zdravila TYSABRI, ker se lahko neželeni učinki pojavijo celo po končanem zdravljenju.
The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients.
Učinke zamenjave plazme na očistek in farmakodinamiko natalizumaba so ocenili v študiji, kjer je sodelovalo 12 bolnikov z multiplo sklerozo.
There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Poročali so o primerih redke okužbe možganov, imenovane PML (progresivna multifokalna levkoencefalopatija), ki se je pojavila pri bolnikih, zdravljenih z zdravilom TYSABRI.
You should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment.
Na morebiten pojav simptomov morate biti pozorni še do 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI.
After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
Po 2 letih zdravljenja je treba bolnike ponovno informirati o tveganjih v zvezi z zdravilom TYSABRI, posebej še o povečanem tveganju progresivne multifokalne levkoencefalopatije (PML), skupaj z njihovimi skrbniki pa jih je treba tudi poučiti o zgodnjih znakih in simptomih PML.
When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack).
Izbruh teh simptomov se imenuje recidiv (tudi poslabšanje bolezni ali zagon).
o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o Diagnosis and prognosis of symptomatic and asymptomatic PML differentiation between PML and MS
o Opredelitev tveganja za razvoj PML na podlagi znanih dejavnikov tveganja in predstavitev tveganja za PML v danem časovnem intervalu zdravljenja ter kumulativno tveganje za PML o Diagnoza in prognoza simptomatske in asimptomatske PML, diferenciacija PML in multiple skleroze o Algoritem obvladovanja PML
Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Nekateri bolniki so bili morda zdravljeni z zaviralci imunskega odziva (npr. mitoksantron, ciklofosfamid, azatioprin).
The pharmacokinetics of natalizumab in paediatric MS patients or in patients with renal or hepatic insufficiency has not been studied.
Farmakokinetike natalizumaba pri otrocih, obolelih za MS in pri bolnikih z ledvično ali jetrno insuficienco niso raziskovali.
Due to this increased risk of developing PML, the benefits and risks of TYSABRI treatment should be individually reconsidered by the specialist physician and the patient; patients must be monitored at regular intervals throughout and should be instructed together with their caregivers on early signs and symptoms of PML.
Zaradi tega povečanega tveganja za razvoj PML, morata tako zdravnik specialist kot tudi bolnik v vsakem primeru posebej ponovno preučiti koristi in tveganja z zdravilom TYSABRI; bolnike je treba ves čas spremljati v rednih intervalih in jih skupaj z njihovimi skrbniki poučiti o zgodnjih znakih in simptomih PML.
TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks.
Zdravilo TYSABRI 300 mg se daje kot intravenska infuzija enkrat na 4 tedne.
Uncommon side effects that may affect up to 1 in 100 people:
Občasni neželeni učinki, ki lahko prizadenejo največ 1 od 100 bolnikov:
For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines.
Za dodatne informacije o testiranju za protitelesa proti JCV glejte Informacije za zdravnike in smernice za zdravljenje bolezni.
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).
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
Vsaka 15 ml viala koncentrata vsebuje 300 mg natalizumaba (20 mg/ml).
It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose.
Možnost, da bi natalizumab vplival na plodnost pri človeku pri uporabi največjega priporočenega odmerka, ni verjetna.
In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
Pri podskupini bolnikov, pri katerih je bilo indicirano zdravljenje hitro razvijajoče se hude recidivne remitentne MS (bolniki z najmanj 2 recidivoma in vsaj 1 lezijo, vidno z gadolinijem), je letna stopnja recidivov pri skupini, ki je prejemala zdravilo TYSABRI (n = 148) znašala 0,282, in pri skupini, ki je prejemala placebo (n = 61) 1,455 (p <0,001).
Anti-JCV antibody testing
Testiranje za protitelesa proti JCV
Store in a refrigerator (2˚C - 8˚C).
Shranjujte v hladilniku (2 ˚C - 8 ˚C).
For storage conditions after dilution of the medicinal product see section 6.3.
Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
• If you are taking either beta-interferon or glatiramer acetate.
• če jemljete bodisi interferon beta ali glatiramer acetat.
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 the medicinal product in patients without these co-morbidities cannot currently be excluded.
Okužbe, vključno z drugimi oportunističnimi okužbami 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 pri bolnikih brez so-obolenj trenutno ni mogoče izključiti.
• If you have antibodies to the JC virus in your blood.
• Če imate v krvi protitelesa proti virusu JC.
15 ml concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
15 ml koncentrat v viali (steklo vrste I) z brombutilnim gumijastim zamaškom in aluminijastim zapiralom z dvižno zaporko.
Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended.
Priporoča se testiranje na serumska protitelesa proti JCV pred uvedbo zdravljenja z zdravilom TYSABRI ali pri bolnikih, ki zdravilo prejemajo, če status protiteles še ni znan.
Natalizumab is excreted in human milk.
Natalizumab se izloča v materino mleko.
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline 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 MRS po možnosti s kontrastom (primerjalno z izhodiščnim MRS 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).
Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Kaj morate vedeti, preden boste uporabili zdravilo TYSABRI Preden začnete z zdravljenjem z zdravilom TYSABRI, je pomembno, da se z zdravnikom pogovorite o pričakovanih koristih tega zdravljenja in o tveganjih, ki so z njim povezana.
Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment.
Testiranje za protitelesa proti JCV daje podporne informacije za opredelitev tveganja zdravljenja z zdravilom TYSABRI.
If a patient receiving TYSABRI develops an opportunistic infection, dosing of the medicinal product must be permanently discontinued.
Če bolnik, ki prejema zdravilo TYSABRI, razvije oportunistično okužbo, je treba zdravljenje z zdravilom trajno prekiniti.
Following reconstitution of the immune system in immunocompromised patients with PML improved outcome has been seen.
Po ponovni vzpostavitvi imunskega sistema pri bolnikih z oslabljenim imunskim sistemom s PML so opazili stabilizacijo ali izboljšan izid.
Infusion reactions
Reakcije na infuzijo