FrancophonIA/ELRC3.0 huggingface dataset:
English: Solvent for Simulect Water for injections
Croatian: Otopina za Simulect Voda za injekcije
English: The rates of BPAR were 9.4% in the basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]).
Croatian: Stope BPAR-a bile su 9,4% u skupini na basiliksimabu i 17,4% u skupini na placebu (HR: 0,50, 90% CI: [0,25; 0,99]).
English: Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy.
Croatian: Teške akutne (manje od 24 sata) reakcije preosjetljivosti opažene su prilikom početnog uzimanja Simulecta, kao i prilikom njegova ponovnog uzimanja u nastavku terapije.
English: The primary objective of the study was to demonstrate superiority of this combination versus treatment with ciclosporin for microemulsion, mycophenolate mofetil and steroids in the prevention of acute rejections.
Croatian: Primarni cilj studije bio je pokazati superiornost ove kombinacije nasuprot liječenju ciklosporinom u mikroemulziji, mikofenolat mofetilom i steroidima u sprečavanju akutnog odbacivanja.
English: The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
Croatian: Učinak Simulecta u prevenciji odbacivanja organa u de novo presađivanju bubrega pokazan je u dvostrukoslijepim, placebo-kontroliranim studijama.
English: Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Croatian: Simulect je kontraindiciran u trudnoći i tijekom dojenja (vidjeti dio 4.3).
English: The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being infections (basiliximab = 1.3%, placebo = 1.4%).
Croatian: Incidencija i uzroci smrti nakon dvostruke ili trostruke terapije bili su slični u skupinama s basiliksimabom (2,9%) i placebom (2,6%), a infekcije su bile najčešći uzrok smrti u obje ispitivane skupine (basiliksimab = 1,3%, placebo = 1,4%).
English: Incidence of adverse events: In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo.
Croatian: Incidencija štetnih događaja: U četiri gore navedene placebom kontrolirane studije, uzorak nuspojava u 590 bolesnika liječenih preporučenom dozom basiliksimaba bio je usporediv s onim uočenim u 595 bolesnika koji su primali placebo.
English: Overall the adverse event profile was consistent with general clinical experience in the paediatric renal transplantation population and with the profile in the controlled adult transplantation studies.
Croatian: Ukupni profil nuspojava bio je ujednačen s općim kliničkim iskustvom u pedijatrijskoj populaciji s bubrežnim presatkom, kao i s profilom u kontroliranim studijama presađivanja u odraslih.
English: The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
Croatian: Incidencija akutne epizode odbacivanja bila je bitno niža u bolesnika koji su dobivali basiliksimab i trostruki režim imunosupresivne terapije.
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK
Croatian: KUTIJA ZA 1 BOČICU I 1 AMPULU KAO POJEDINAČNO PAKIRANJE
English: Simulect can be given to older patients, but the information available is limited.
Croatian: Stariji bolesnici (u dobi od 65 godina i stariji) Simulect se može davati starijim bolesnicima, no dostupne informacije su ograničene.
English: The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.
Croatian: Primjena basiliksimaba ne isključuje naknadno liječenje pripravcima s mišjim antilimfocitnim antitijelima.
English: Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Croatian: Podaci o sigurnosti primjene u pedijatrijskih bolesnika dobiveni su iz jedne otvorene farmakokinetičke i farmakodinamičke studije u djece kojoj je presađen bubreg (41 bolesnik).
English: In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes.
Croatian: Studije in vitro uz upotrebu ljudskih tkiva ukazuju da se basiliksimab veže samo na aktivirane limfocite i makrofage/monocite.
English: In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).
Croatian: Objedinjenom analizom dviju petogodišnjih proširenih studija nije nađena nikakva razlika u incidenciji zloćudnih bolesti i limfoproliferativnih poremećaja između imunosupresivnih režima sa ili bez basiliksimaba (vidjeti dio 4.8).
English: If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered.
Croatian: Ako se pojavi teška reakcija preosjetljivosti, terapiju Simulectom treba trajno ukinuti i ne primjenjivati sljedeću dozu.
English: You must not breast-feed after being given Simulect or up to 4 months after the second dose.
Croatian: Ne smijete dojiti dok primate Simulect ili do 4 mjeseca nakon zadnje doze.
English: Mannitol (E421) Glycine
Croatian: Manitol (E421)
English: Elimination half-life was not influenced by age, gender, or race.
Croatian: Životna dob, spol i rasa ne utječu na poluvrijeme eliminacije.
English: Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.
Croatian: Uobičajena doza za odrasle iznosi 20 mg u svakoj infuziji ili injekciji.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake Rok valjanosti, odnosno EXP.
English: Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).
Croatian: Bolesnici s presatkom koji primaju imunosupresivne režime, uključujući kombinacije sa ili bez basiliksimaba, podložni su povećanom riziku za razvoj limfoproliferativnih poremećaja (poput limfoma) i oportunističkih infekcija (poput citomegalovirusa [CMV], BK virusa).
English: There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested.
Croatian: Postoji proporcionalan porast Cmax i AUC od 20 mg do 60 mg, u rasponu ispitivanih pojedinačnih doza.
English: It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Croatian: Nakon rekonstitucije se preporučuje odmah koristiti bezbojnu, bistru do opalascentnu otopinu.
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Novartis Europharm Limited
English: No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients.
Croatian: U odraslih bolesnika nije opažen klinički značajan utjecaj tjelesne težine ili spola na volumen distribucije ili klirens.
English: No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly for 39 weeks followed by a 13-week withdrawal period.
Croatian: Toksičnost nije uočena kada su rezus majmuni primali intravenske doze ili do 5 mg/kg basiliksimaba dvaput tjedno tijekom 4 tjedna nakon čega je slijedio 8-tjedni period bez primjene ili do 24 mg/kg basiliksimaba tjedno tijekom 39 tjedana nakon čega je slijedio 13-tjedni period bez primjene.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1).
English: The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo (see section 4.8).
Croatian: Upotreba basiliksimaba u režimu trostruke terapije koja je uključivala azatioprin ili mikofenolat mofetil nije izazvala porast štetnih događaja ili infekcija u basiliksimab skupini u usporedbi prema placebu (vidjeti dio 4.8).
English: The second 20 mg dose should be given 4 days after transplantation.
Croatian: Drugu dozu od 20 mg treba dati 4 dana nakon presađivanja.
English: The overall incidence of treatment-related adverse events among all patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) and the placebo (7.6% - 39%) treatment groups.
Croatian: Ukupna incidencija s liječenjem povezanih štetnih događaja među svim bolesnicima u pojedinačnim studijama nije se značajno razlikovala između skupine liječene basiliksimabom (7,1% - 40%) i skupine koja je primala placebo (7,6% - 39%).
English: When borderline rejections were included in the primary efficacy endpoint, the rates were 26.0% and 23.9% respectively, with no statistically significant difference between the basiliximaband placebo-treated groups (HR: 1.04, 90% CI: [0.64; 1.68]).
Croatian: Kad su granični slučajevi odbacivanja bili uključeni u primarni ishod djelotvornosti, stope su bile 26,0% odnosno 23,9% bez statistički značajne razlike između skupina liječenih basiliksimabom odnosno placebom (HR: 1,04, 90% CI: [0,64; 1,68]).
English: Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.
Croatian: Basiliksimab ima potencijalno opasne imunosupresivne učinke na tijek trudnoće i dojenče izloženo basiliksimabu preko majčinog mlijeka.
English: Do not use after the expiry date stated on the pack.
Croatian: Ne primjenjivati nakon isteka roka valjanosti navedenog na pakiranju.
English: The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Croatian: Farmakokinetika basiliksimaba određivana je u 39 pedijatrijskih bolesnika u de novo presađivanju bubrega.
English: 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.
Croatian: 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.
English: It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
Croatian: Također sadrži kalijev dihidrogenfosfat; natrijev hidrogenfosfat, bezvodni; natrijev klorid; saharozu; manitol (E421); glicin.
English: 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.
Croatian: 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.
English: These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.
Croatian: Radilo se o lijekovima koji uključuju sistemske antivirusne, antibakterijske i antimikotičke lijekove, analgetike, antihipertenzive poput beta blokatora i blokatora kalcijevih kanala te diuretike.
English: Of the 202 patients, 104 were randomised to basiliximab and 98 to placebo.
Croatian: Od 202 ispitanika, 104 je slučajnom metodom raspoređeno u skupinu koja prima basiliksimab, a 98 u skupinu koja prima placebo.
English: The second dose should be given 4 days after transplantation.
Croatian: Drugu dozu treba dati 4 dana nakon presađivanja.
English: 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.
Croatian: 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.
English: The first dose is given just before the transplant operation, and the second dose 4 days after the operation.
Croatian: Prva se doza daje neposredno prije operacije presađivanja, a druga doza 4 dana nakon presađivanja.
English: There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
Croatian: U određenoj podskupini bolesnika sve je više dokaza o povećanom riziku od razvoja reakcija preosjetljivosti.
English: Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
Croatian: Rekonstituirani Simulect se može primjenjivati kao intravenska bolus injekcija ili kao intravenska infuzija kroz 20-30 minuta.
English: 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%).
Croatian: 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%).
English: 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.
Croatian: 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.
English: Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Croatian: Basiliksimab je korišten istovremeno s ciklosporinom u mikroemulziji i steroidima u nekontroliranoj studiji u 41 pedijatrijskog de novo primatelja bubrežnog presatka.
English: 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.
Croatian: 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.
English: How to store Simulect
Croatian: Kako čuvati Simulect
English: 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.
Croatian: 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.
English: 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.
Croatian: Incidencija zloćudnih novotvorina: Ukupna incidencija zloćudnih bolesti u pojedinačnim studijama među svim bolesnicima koji su primali basiliksimab i uspoređivane skupine bila je slična.
English: 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.
Croatian: Djelotvornost i sigurnost Simulecta za prevenciju akutnog odbacivanja u primatelja presadaka solidnih organa, osim presadaka bubrega, nisu dokazane.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil.
Croatian: U tri kliničke studije istraživana je primjena basiliksimaba u kombinaciji s trostrukim režimom terapije koji je uključivao bilo azatioprin ili mikofenolat mofetil.
English: Basiliximab does not cause myelosuppression.
Croatian: Basiliksimab ne izaziva mijelosupresiju.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class.
Croatian: Na temelju spontanih prijava nakon stavljanja lijeka u promet zabilježene su sljedeće nuspojave, a organizirane su prema klasama organskih sustava.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: The solvent ampoule contains 5 ml water for injections.
Croatian: Ampula otapala sadrži 5 ml vode za injekcije.
English: Simulect 10 mg must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Croatian: Simulect 10 mg se ne smije primjenjivati ako ne postoji potpuna sigurnost da će bolesnik dobiti presadak i prateću imunosupresiju.
English: Reconstituted products should be inspected visually for particulate matter prior to administration.
Croatian: Rekonstituiranu otopinu treba vizualno pregledati prije primjene kako bi se provjerilo ima li vidljivih čestica.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: * 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.
Croatian: * rekombinantno mišje/ljudsko kimerično monoklonsko protutijelo usmjereno protiv interleukin-2 receptora -lanca (CD25 antigen) proizvedeno u mišjoj staničnoj liniji mijeloma koristeći tehnologiju rekombinantne DNK.