natgillin/translations-raw huggingface dataset:
Do not use after the expiry date stated on the pack.
Ne primjenjivati nakon isteka roka valjanosti navedenog na pakiranju.
The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Farmakokinetika basiliksimaba određivana je u 39 pedijatrijskih bolesnika u de novo presađivanju bubrega.
The primary efficacy endpoint, time to first biopsy-proven acute rejection (BPAR) episode or treatment failure defined as graft loss, death or presumptive rejection within the first 6 months post transplantation, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients.
Primarni ishod djelotvornosti, vrijeme do prve biopsijom dokazane epizode akutnog odbacivanja (BPAR) ili neuspjeh liječenja definiran kao gubitak presatka, smrt ili vjerojatno odbacivanje u roku od prvih 6 mjeseci poslije presađivanja, nastupio je u 16,7% ispitanika liječenih basiliksimabom te u 21,7% ispitanika liječenih placebom.
It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
Također sadrži kalijev dihidrogenfosfat; natrijev hidrogenfosfat, bezvodni; natrijev klorid; saharozu; manitol (E421); glicin.
No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys following injections of up to 5 mg/kg basiliximab administered twice weekly during the organogenesis period.
Toksičnost kod majke, embriotoksičnost kao ni teratogenost nisu opažene u cinomolgus majmuna nakon injekcija do 5 mg/kg basiliksimaba primjenjivanih dvaput tjedno tijekom perioda organogeneze.
These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.
Radilo se o lijekovima koji uključuju sistemske antivirusne, antibakterijske i antimikotičke lijekove, analgetike, antihipertenzive poput beta blokatora i blokatora kalcijevih kanala te diuretike.
Of the 202 patients, 104 were randomised to basiliximab and 98 to placebo.
Od 202 ispitanika, 104 je slučajnom metodom raspoređeno u skupinu koja prima basiliksimab, a 98 u skupinu koja prima placebo.
The second dose should be given 4 days after transplantation.
Drugu dozu treba dati 4 dana nakon presađivanja.
In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no increase in adverse events or infections in the basiliximab group as compared to placebo.
U originalnim studijama faze III, tijekom prva 3 mjeseca nakon presađivanja, 14% bolesnika u skupini s basiliksimabom i 27% bolesnika u skupini s placebom imalo je akutnu epizodu odbacivanja koja je liječena antitijelima (OKT 3 ili antitimocitni globulin/antilimfocitni globulin [ATG/ALG]), bez porasta štetnih događaja ili infekcija u basiliksimab skupini u usporedbi prema placebu.
The first dose is given just before the transplant operation, and the second dose 4 days after the operation.
Prva se doza daje neposredno prije operacije presađivanja, a druga doza 4 dana nakon presađivanja.
There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
U određenoj podskupini bolesnika sve je više dokaza o povećanom riziku od razvoja reakcija preosjetljivosti.
Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
Rekonstituirani Simulect se može primjenjivati kao intravenska bolus injekcija ili kao intravenska infuzija kroz 20-30 minuta.
In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).
U objedinjenoj analizi dviju petogodišnjih proširenih studija incidencija i uzrok smrti ostali su slični u obje liječene skupine (basiliksimab 15%, placebo 11%), a primarni uzrok smrti bili su poremećaji vezani uz srce kao što su zatajenje srca i infarkt miokarda (basiliksimab 5%, placebo 4%).
In infants and children (age 1-11 years, n=25), the steady-state distribution volume was 4.82.1 l, half-life was 9.54.5 days and clearance was 176 ml/h.
U dojenčadi i djece (dob 1-11 godina, n=25) volumen distribucije u ravnotežnom stanju bio je 4,8±2,1 l, poluvrijeme života bilo je 9,5±4,5 dana, a klirens je bio 17±6 ml/h.
Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Basiliksimab je korišten istovremeno s ciklosporinom u mikroemulziji i steroidima u nekontroliranoj studiji u 41 pedijatrijskog de novo primatelja bubrežnog presatka.
Overall, lymphoma/lymphoproliferative disease occurred in 0.1% (1/701) of patients in the basiliximab group compared with 0.3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
U cjelini, limfom/limfoproliferativna bolest se pojavila u 0,1% (1/701) bolesnika u skupini liječenoj basiliksimabom u usporedbi s 0,3% (2/595) bolesnika koji su primili placebo, u oba slučaja u kombinaciji s dvojnim ili trojnom imunosupresivnom terapijom.
How to store Simulect
Kako čuvati Simulect
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/substances and should always be given through a separate infusion line.
Budući da nema podataka o kompatibilnosti Simulecta s drugim intravenskim tvarima, Simulect se ne smije miješati s drugim lijekovima/tvarima i uvijek ga treba davati odvojenom infuzijskom linijom.
Incidence of malignant neoplasms: The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups.
Incidencija zloćudnih novotvorina: Ukupna incidencija zloćudnih bolesti u pojedinačnim studijama među svim bolesnicima koji su primali basiliksimab i uspoređivane skupine bila je slična.
The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allografts other than renal have not been demonstrated.
Djelotvornost i sigurnost Simulecta za prevenciju akutnog odbacivanja u primatelja presadaka solidnih organa, osim presadaka bubrega, nisu dokazane.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
Budući da nema podataka o kompatibilnosti Simulecta s drugim lijekovima za intravensku primjenu, Simulect se ne smije miješati s drugim lijekovima i uvijek ga treba davati odvojenom infuzijskom linijom.
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, sneezing, wheezing or trouble breathing, severely decreased urine output, or fever and flu-like symptoms, tell your doctor or nurse immediately.
Ako uočite iznenadne znakove alergije, poput kožnog osipa, svrbeža ili koprivnjače, oticanja lica, usana, jezika ili drugih dijelova tijela, ubrzanog kucanja srca, omaglice, ošamućenosti, nedostatka zraka, kihanja, piskanja pri disanju ili otežanog disanja, teško smanjenje izlučivanja urina ili vrućica i simptoma nalik gripi, odmah se javite svome liječniku ili medicinskoj sestri.
Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil.
U tri kliničke studije istraživana je primjena basiliksimaba u kombinaciji s trostrukim režimom terapije koji je uključivao bilo azatioprin ili mikofenolat mofetil.
Basiliximab does not cause myelosuppression.
Basiliksimab ne izaziva mijelosupresiju.
Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Basiliksimab je kao indukcijski lijek ispitivan u 4 randomizirane, dvostrukoslijepe, placebokontrolirane studije u bolesnika kojima je presađen bubreg u kombinaciji sa sljedećim imunosupresivnim režimima: ciklosporin u mikroemulziji i kortikosteroidi u dvije studije (346 i 380 bolesnika), ciklosporin u mikroemulziji, azatioprin i kortikosteroidi u jednoj studiji (340 bolesnika) te ciklosporin u mikroemulziji, mikofenolat mofetil i kortikosteroidi u drugoj studiji (123 bolesnika).
In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant medications routinely administered in organ transplantation have been administered in clinical trials without any incremental adverse reactions.
Uz dodatnu primjenu ciklosporina u mikroemulziji, steroida, azatioprina i mikofenolat mofetila, istovremena primjena ostalih uobičajenih lijekova u presađivanju organa u kliničkim studijama nije dovela do porasta nuspojava.
The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class.
Na temelju spontanih prijava nakon stavljanja lijeka u promet zabilježene su sljedeće nuspojave, a organizirane su prema klasama organskih sustava.
In adolescents (age 12-16 years, n=14), the steady-state distribution volume was 7.85.1 l, half-life was 9.13.9 days and clearance was 3119 ml/h.
U adolescenata (dob 12-16 godina, n=14) volumen distribucije u stanju dinamičke ravnoteže bio je 7,8±5,1 l, poluvrijeme života bilo je 9,1±3,9 dana, a klirens je bio 31±19 ml/h.
Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
Basiliksimab se s visokim afinitetom (KD-vrijednost 0,1 nM) specifično veže na CD25 antigen na aktiviranim T-limfocitima pokazujući visoki afinitet za interleukin-2 receptor (IL-2R) i na taj način sprječava vezanje interleukina-2 što je presudan signal za proliferaciju T-stanica u staničnom imunološkom odgovoru uključenom u odbacivanju alogeničnog presatka.
The solvent ampoule contains 5 ml water for injections.
Ampula otapala sadrži 5 ml vode za injekcije.
Simulect 10 mg must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect 10 mg se ne smije primjenjivati ako ne postoji potpuna sigurnost da će bolesnik dobiti presadak i prateću imunosupresiju.
Reconstituted products should be inspected visually for particulate matter prior to administration.
Rekonstituiranu otopinu treba vizualno pregledati prije primjene kako bi se provjerilo ima li vidljivih čestica.
In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.
Najčešće nuspojave zabilježene u djece bile su zatvor, prekomjeran rast normalne kose, curenje iz nosa ili začepljen nos, vrućica, povišeni krvni tlak i različite vrste infekcija.
It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Potrebno ga je koristiti uz istovremenu primjenu imunosupresije bazirane na ciklosporinu u mikroemulziji i kortikosteroidima, u bolesnika s nalazom panela reaktivnih antitijela nižim od 80%, ili u trostrukom režimu za održavanje imunosupresije koji sadržava ciklosporin u mikroemulziji, kortikosteroide i bilo azatioprin ili mikofenolat mofetil.
* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
* rekombinantno mišje/ljudsko kimerično monoklonsko protutijelo usmjereno protiv interleukin-2 receptora -lanca (CD25 antigen) proizvedeno u mišjoj staničnoj liniji mijeloma koristeći tehnologiju rekombinantne DNK.
There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)).
Između bolesnika liječenih basiliksimabom i onih koji su primali placebo nije bilo značajne razlike glede preživljavanja presatka nakon 6 i 12 mjeseci (nakon 12 mjeseci 32 gubitka presatka s basiliksimabom (9%) i 37 gubitaka presatka s placebom (10%)).
Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Odrasle osobe Standardna ukupna doza iznosi 40 mg, a daje se u dvije doze od po 20 mg.
The second dose should not be given if severe hypersensitivity reactions to Simulect or graft loss occur.
Druga doza se ne smije primijeniti u slučaju teških reakcija preosjetljivosti na Simulect ili pojave gubitka presatka.
Other malignancies were reported among 1.0% (7/701) of patients in the basiliximab group compared with 1.2% (7/595) of placebo patients.
Ostale zloćudne bolesti zabilježene su u 1,0% (7/701) bolesnika u skupini s basiliksimabom u odnosu na 1,2% (7/595) bolesnika koji su primili placebo.
This solvent is used to dissolve the powder before it is given to you.
To otapalo se koristi za otapanje praška prije primjene.
These events were not influenced by basiliximab.
Basiliksimab nije imao utjecaja na ove događaje.
Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Farmakokinetičke studije provedene su s pojedinačnim i višekratnim dozama u odraslih bolesnika podvrgnutih presađivanju bubrega.
Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation.
Rezultati dviju ključnih 12-mjesečnih multicentričnih studija (ukupno 722 bolesnika), u kojima je basiliksimab uspoređen s placebom, pokazuju da basiliksimab uz istovremenu primjenu ciklosporina u mikroemulziji i kortikosteroida, značajno smanjuje incidenciju akutnih epizoda odbacivanja unutar 6 (31% naspram 45%, p<0,001) i 12 (33% naspram 48%, p<0,001) mjeseci nakon presađivanja.
In a pooled analysis of two fiveyear extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/295) and placebo 7% (21/291) (see section 4.4).
Objedinjena analiza dviju petogodišnjih proširenih studija pokazala je jednaku incidenciju limfoproliferativnih poremećaja i zloćudnih bolesti između basiliksimaba 7% (21/295) i placeba 7% (21/291) (vidjeti dio 4.4).
Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
Upotrijebiti odmah nakon rekonstitucije (kemijski i fizikalno stabilan 24 sata na temperaturama 2°C - 8°C ili 4 sata na sobnoj temperaturi).
INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
UPUTE ZA REKONSTITUCIJU
There is no animal or human data available concerning excretion of basiliximab into breast milk.
Nema podataka glede izlučivanja basiliksimaba u mlijeko životinja ili u majčino mlijeko.
A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric renal allograft recipients.
Dvanaestomjesečna, randomizirana, placebom kontrolirana, dvostruko slijepa, multicentrična studija kojom se ocjenjivao basiliksimab u kombinaciji s ciklosporinom u mikroemulziji, mikofenolat mofetilom i steroidima u pedijatrijskih primatelja bubrežnog presatka.
The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs.  35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Najčešće zabilježeni (>20%) štetni događaji nakon dvostruke terapije u obje (<35 kg naspram ≥35 kg tjelesne težine) kohorte bile su infekcija mokraćnog sustava, hipertrihoza, rinitis, vrućica, hipertenzija, infekcija gornjih dišnih puteva, virusna infekcija, sepsa i konstipacija.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I PRIMJENU
The first 20 mg dose should be given within 2 hours prior to transplantation surgery.
Prvu dozu od 20 mg treba dati unutar 2 sata prije kirurškog presađivanja.
The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
Prvu dozu treba dati unutar 2 sata prije kirurškog presađivanja, a drugu dozu 4 dana nakon presađivanja.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
U odraslih su najčešće zabilježene nuspojave bile zatvor, mučnina, proljev, porast tjelesne težine, glavobolja, bol, oticanje ruku, zglobova ili stopala, povišeni krvni tlak, anemija, promjene nalaza krvnih pretraga (npr. kalija, kolesterola, fosfata, kreatinina), komplikacije kirurške rane i različite vrste infekcija.
Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
Rekonstituirani Simulect se primjenjuje intravenskom infuzijom kroz 20 do 30 minuta ili bolus injekcijom.
The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).
U dvostrukom, kao i u trostrukom režimu terapije, incidencija CMV infekcija bila je slična u obje skupine (14,6% naspram 17,3%) (vidjeti dio 4.4).
sodium chloride; sucrose; mannitol (E421); glycine.
saharoza; manitol (E421); glicin.
The first dose should be given within 2 hours prior to transplantation surgery.
Prvu dozu treba dati unutar 2 sata prije kirurškog presađivanja.
Disposition parameters were not influenced to a clinically relevant extent by age (1-11 years), body weight (9-37 kg) or body surface area (0.44-1.20 m
U ovoj dobnoj skupini starost (1-11 godina), tjelesna težina (9-37 kg) ili tjelesna površina (0,44-1,20 m nisu u klinički značajnoj mjeri utjecali na farmakokinetičke parametre.
Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%).
Rezultati dviju dvostrukoslijepih multicentričnih studija u kojima je basiliksimab uspoređivan s placebom (ukupno 463 bolesnika) pokazuju da basiliksimab značajno smanjuje incidenciju akutnih epizoda odbacivanja unutar 6 mjeseci nakon presađivanja, ako se istovremeno koristi s ciklosporinom u mikroemulziji, kortikosteroidima i bilo azatioprinom (21% naspram 35%) ili mikofenolat mofetilom (15% naspram 27%).
In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
Za pedijatrijske bolesnike tjelesne težine manje od 35 kg preporučena ukupna doza iznosi 20 mg, koja se daje u dvije doze od po 10 mg.
The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
Ukupni tjelesni klirens basiliksimaba bio je smanjen za prosječno 22% kada je azatioprin bio dodan režimu koji se sastojao od ciklosporina u emulziji i kortikosteroida.
Disposition in adolescents was similar to that in adult renal transplantation patients.
Farmakokinetika u adolescenata bila je slična kao u odraslih bolesnika s presađenim bubregom.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression.
Simulect se treba koristiti uz istovremenu primjenu imunosupresije bazirane na ciklosporinu u mikroemulziji i kortikosteroidima.
Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Bezbojna staklena ampula, staklo tipa I, sadržava 5 ml vode za injekcije.
One ml of the reconstituted solution contains 4 mg basiliximab.
Jedan ml rekonstituirane otopine sadrži 4 mg basiliksimaba.
If you are unsure about anything, ask your doctor, nurse or pharmacist.
Ako u bilo što niste sigurni, upitajte svog liječnika, medicinsku sestru ili ljekarnika.
In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each.
Za pedijatrijske bolesnike tjelesne težine 35 kg ili više, preporučena doza odgovara dozi za odrasle, tj. ukupna doza iznosi 40 mg, koja se daje u dvije doze od po 20 mg.
Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect se ne smije primjenjivati ako ne postoji potpuna sigurnost da će bolesnik dobiti presadak i prateću imunosupresiju.
The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Najčešće zabilježeni (>20%) štetni događaji nakon dvostruke ili trostruke terapije u obje skupine (basiliksimab naspram placebo) bile su konstipacija, infekcija mokraćnog sustava, bol, mučnina, periferni edemi, hipertenzija, anemija, glavobolja, hiperkalijemija, hiperkolesterolemija, postoperativna komplikacija rane, porast tjelesne težine, povišeni kreatinin u krvi, hipofosfatemija, proljev i infekcija gornjih dišnih putova.
When borderline rejections were included, the rates were 20.8% and 19.6%, respectively (HR: 1.01, 90% CI: [0.59; 1.72]).
Kad su uključeni i granični slučajevi odbacivanja, stope su bile 20,8% odnosno 19,6% (HR: 1,01, 90% CI: [0,59; 1,72]).
Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
U periodu do 6 mjeseci, gubitak presatka javio se u 6% bolesnika koji su primali basiliksimab i 10% koji su primali placebo.
Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability.
U kliničkoj studiji s 172 bolesnika liječenih basiliksimabom zabilježene su reakcije na ljudska antimišja antitijela (HAMA) bez prediktivne vrijednosti za kliničku podnošljivost.