FrancophonIA/ELRC3.0 huggingface dataset:
English: Older patients (aged 65 years and over)
Slovenian: Starejši bolniki (stari 65 let ali več)
English: Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up to 4-6 weeks after administration).
Slovenian: Popolna in dosledna zavora receptorja za interlevkin 2 traja, dokler serumska koncentracija baziliksimaba presega 0,2 g/ml (običajno do 4-6 tednov po uporabi).
English: Neoplasms and infections
Slovenian: Tumorji in okužbe
English: What do you need to know before you are given Simulect
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Simulect
English: Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
Slovenian: Porazdelitveni volumen in očistek sta bila v primerjavi z odraslimi bolniki z ledvičnim presadkom manjša za okrog 50 %.
English: There is no animal or human data available concerning excretion of basiliximab into breast milk.
Slovenian: Na voljo ni nobenih podatkov, pridobljenih na živalih ali pri ljudeh, o izločanju baziliksimaba v materino mleko.
English: Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2).
Slovenian: Zdravilo Simulect je indicirano za profilakso akutne zavrnitve organa pri de novo alogeni presaditvi ledvice pri odraslih in pediatričnih bolnikih (1-17 let) (glejte poglavje 4.2).
English: These events were not influenced by basiliximab.
Slovenian: Na te dogodke baziliksimab ni vplival.
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.
Slovenian: V celoti gledano se je profil neželenih dogodkov ujemal s splošnimi kliničnimi izkušnjami v populaciji pediatričnih prejemnikov ledvičnih presadkov in s profilom v kontroliranih raziskavah presaditev pri odraslih.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če uporabnik zdravila, pripravljenega za uporabo, ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren sam.
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK
Slovenian: ŠKATLA ZA 1 VIALO IN 1 AMPULO KOT ENOTA PAKIRANJA
English: Talk to your doctor, nurse or pharmacist before you are given Simulect: - if you have previously received a transplant that failed after only a short time or, - if you have previously been in the operating theatre for a transplantation that in the end was not performed.
Slovenian: Preden dobite zdravilo Simulect, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom: - če ste kdaj prej prejeli presadek, ki se je že čez kratek čas pokazal za neuspešnega, ali, - če ste bili kdaj prej že v operacijski dvorani zaradi presaditve, ki na koncu ni bila opravljena.
English: In this situation, you may have received Simulect.
Slovenian: Možno je, da ste v takem primeru prejeli zdravilo Simulect.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients.
Slovenian: Razmerje med serumsko koncentracijo in nasičenostjo receptorjev je bilo ocenjeno pri 13 bolnikih in je bilo podobno kot pri odraslih bolnikih po presaditvi ledvice.
English: What Simulect is and what it is used for What do you need to know before you are given Simulect How Simulect is given
Slovenian: Kaj je zdravilo Simulect in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Simulect Kako boste prejeli zdravilo Simulect Možni neželeni učinki
English: 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
Slovenian: V tej starostni skupini niso na kazalce porazdelitve v klinično pomembnem obsegu vplivali starost (1-11 let), telesna teža (9-37 kg) ali telesna površina (0,44-1,20 m
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.
Slovenian: Hude akutne preobčutljivostne reakcije (v manj kot 24 urah) so opažali tako pri prvi izpostavljenosti zdravilu Simulect kot pri ponovni izpostavljenosti ob kasnejši ponovitvi zdravljenja.
English: Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Slovenian: Podatki o varnosti za pediatrične bolnike so bili pridobljeni iz ene odprte farmakokinetične in farmakodinamske raziskave na prejemnikih ledvičnih presadkov (41 bolnikov).
English: Other medicines and Simulect
Slovenian: Druga zdravila in zdravilo Simulect
English: No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients.
Slovenian: Pri odraslih bolnikih ni bil opažen klinično pomemben vpliv telesne teže ali spola na porazdelitveni volumen ali na očistek.
English: It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Slovenian: Priporočljivo je, da se brezbarvna, bistra do opalescenčna raztopina uporabi takoj po pripravi.
English: Simulect should be administered under qualified medical supervision.
Slovenian: Zdravilo Simulect naj se uporablja pod strokovnim medicinskim nadzorom.
English: Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load.
Slovenian: Imunosupresivne sheme, ki vključujejo kombinacije zdravil, povečujejo dovzetnost za okužbe, vključno z oportunističnimi okužbami, s smrtnimi okužbami in sepso, pri čemer je tveganje večje pri večji imunosupresivni obremenitvi.
English: The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly.
Slovenian: Incidenca je bila 2/138 pri bolnikih, ki niso bili izpostavljeni muromonabu-CD3 (OKT3), in 4/34 pri bolnikih, ki so sočasno dobili muromonab-CD3.
English: You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Slovenian: Za preprečevanje nosečnosti morate uporabljati ustrezno kontracepcijo v času zdravljenja in še 4 mesece po zadnjem odmerku zdravila Simulect.
English: Incidence of infectious episodes: The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups.
Slovenian: Incidenca okužb: Celotna incidenca in profil virusnih, bakterijskih in glivičnih okužb pri bolnikih, ki so bili zdravljeni z baziliksimabom ali s placebom v kombinaciji z dvotirnim ali tritirnim imunosupresivnim zdravljenjem, je bila primerljiva med obema skupinama.
English: Immunosuppressants reduce the body's response to anything that it sees as “foreign” - which includes transplanted organs.
Slovenian: Zdravila za zaviranje imunske odzivnosti zmanjšajo odgovor organizma na snovi, ki jih telo spozna za ”tujek” - to so med drugim tudi presajeni organi.
English: 2.5 ml of the sterile water is used to dissolve the powder before it is given to you.
Slovenian: 2,5 ml sterilne vode se uporabi, da se pred uporabo raztopi prašek.
English: However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Slovenian: Ker pa je baziliksimab IgG1, lahko pričakujemo njegovo izločanje v mleko.
English: You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.
Slovenian: Prejeli boste še druga zdravila, kot so ciklosporin in kortikosteroidi, ki bodo pomagala obvarovati vašo novo ledvico v tem časovnem obdobju in tudi po zapustitvi bolnišnice.
English: Simulect belongs to a group of medicines called immunosuppressants.
Slovenian: Simulect spada v vrsto zdravil, ki se imenujejo zdravila za zaviranje imunske odzivnosti (imunosupresivi).
English: The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
Slovenian: Pogostost akutnih zavrnitvenih reakcij je bila bistveno manjša pri bolnikih, ki so dobivali baziliksimab in imunosupresivno shemo treh zdravil.
English: There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Slovenian: Glede zdravljenja starejših z zdravilom Simulect je na voljo malo podatkov, vendar ni dokazov, ki bi narekovali pri starejših bolnikih drugačne odmerke kot pri mlajših odraslih bolnikih.
English: 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).
Slovenian: Incidenca okužb s citomegalovirusom (CMV) je bila podobna v obeh skupinah (14,6 % v primerjavi s 17,3 %) tako po dvotirnem kot po tritirnem zdravljenju (glejte poglavje 4.4).
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.
Slovenian: Incidenca neželenih učinkov: V zgoraj navedenih štirih raziskavah, kontroliranih s placebom, je bil vzorec neželenih učinkov pri 590 bolnikih, zdravljenih s priporočenim odmerkom baziliksimaba, primerljiv z vzorcem, opaženim pri 595 bolnikih, ki so dobili placebo.
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.
Slovenian: Primarni cilj študije je bil dokazati prednosti te kombinacije v primerjavi z zdravljenjem s ciklosporinom v mikroemulziji, z mofetilmikofenolatom in s steroidi pri preprečevanju akutne zavrnitve.
English: You should also tell your doctor if you are breast-feeding.
Slovenian: Zdravniku morate prav tako povedati, če dojite.
English: Vaccination
Slovenian: Cepljenje
English: In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.
Slovenian: V nekaj manjših kliničnih študijah presaditve srca so pri prejemnikih o resnih srčnih neželenih dogodkih, kot so zastoj srca (2,2 %), atrijska undulacija (1,9 %) in palpitacije (1,4 %), poročali bolj pogosto pri uporabi zdravila Simulect kot pri uporabi katerega od drugih uvodnih (indukcijskih) zdravil.
English: Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.
Slovenian: Baziliksimab ima možne nevarne imunosupresivne učinke na potek nosečnosti in na dojenčka, ki je izpostavljen baziliksimabu v materinem mleku.
English: In the 39-week study, the highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients given the recommended clinical dose together with concomitant immunosuppressive therapy.
Slovenian: V 39-tedenski raziskavi je bila pri največjem odmerku njihova sistemska izpostavljenost zdravilu (AUC) približno 1.000-krat večja kot pri bolnikih, ki so dobili priporočeni klinični odmerek skupaj s sočasnim zdravljenjem z zdravili za zaviranje imunske odzivnosti.
English: Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
Slovenian: Od 339 bolnikov z ledvičnimi presadki, zdravljenih z baziliksimabom in testiranih na antiidiotipska protitelesa, se je pri 4 bolnikih (1,2 %) razvil odziv antiidiotipskih protiteles.
English: Simulect powder
Slovenian: Prašek Simulect
English: The incidence rates of adverse events and the pattern of adverse events were comparable between the two treatment groups and to be expected for the treatment regimens and the underlying diseases.
Slovenian: Pogostnost pojavljanja neželenih dogodkov in vzorec neželenih dogodkov sta bila primerljiva med obema obravnavanima skupinama in v skladu s pričakovanji glede na shemo zdravljenja in osnovne bolezni.
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.
Slovenian: Nikakršne toksičnosti za mater ali zarodek ter teratogenosti niso opazili pri opicah cinomolgus po injekcijah do 5 mg/kg baziliksimaba, odmerjenih dvakrat tedensko med obdobjem organogeneze.
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.
Slovenian: Varnost in učinkovitost uporabe zdravila Simulect za profilakso akutne zavrnitve po alogeni presaditvi čvrstega organa, ki ni ledvica, nista bili dokazani.
English: Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.
Slovenian: Običajni odmerek za odrasle Običajni odmerek za odrasle je 20 mg v vsaki infuziji ali injekciji.
English: The adverse event profile remained comparable between treatment groups.
Slovenian: Profil neželenih dogodkov je med obema skupinama ostal primerljiv.
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%).
Slovenian: Incidenca smrtnih izidov in vzrokov smrti po dvotirnem ali tritirnem zdravljenju je bila v skupini z baziliksimabom (2,9 %) in placebom (2,6 %) podobna; najpogostejši vzrok smrti v obeh tretiranih skupinah so bile okužbe (baziliksimab = 1,3 %, placebo = 1,4 %).
English: The overall incidence of infections was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious infections was 26.1% and 24.8%, respectively.
Slovenian: Celotna incidenca okužb je bila 75,9 % v skupini z baziliksimabom in 75,6 % v skupini s placebom; incidenca hudih okužb je bila 26,1 % v skupini z zdravilom Simulect in 24,8 % v skupini s placebom.
English: The available clinical data on the use of muromonabCD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.
Slovenian: Razpoložljivi klinični podatki o uporabi muromonaba-CD3 pri bolnikih, predhodno zdravljenih z baziliksimabom, kažejo, da to ne ovira kasnejše uporabe muromonaba-CD3 ali drugih pripravkov glodalskih protilimfocitnih protiteles.
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).
Slovenian: Pri bolnikih s presajenimi organi, ki prejemajo imunosupresivno shemo zdravljenja s kombinacijo z baziliksimabom ali brez njega, je povečana nevarnost nastanka limfoproliferativnih bolezni (LPD), kot je na primer limfom, in oportunističnih okužb, kot je na primer okužba s citomegalovirusom (CMV) ali z virusom BK.
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Slovenian: Posvetujte se z zdravnikom, medicinsko sestro ali s farmacevtom, preden v nosečnosti ali med dojenjem vzamete katerokoli zdravilo.
English: These will be given in hospital, around the time of your transplant operation.
Slovenian: Prejeli boste samo dva odmerka zdravila Simulect in sicer v bolnišnici približno ob času vaše presaditvene operacije.
English: In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups.
Slovenian: V združeni analizi dveh petletnih odprtih podaljšanih raziskav (skupaj 586 bolnikov) se kombinirani pogostnosti preživetja presadka in bolnika v skupini z baziliksimabom in skupini s placebom nista statistično razlikovali.
English: An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Slovenian: Če ste dobili večji odmerek zdravila Simulect, kot bi smeli Ni verjetno, da bi prevelik odmerek zdravila Simulect takoj imel stranske učinke, vendar lahko oslabi vaš imunski sistem za dalj časa.
English: The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
Slovenian: Učinkovitost baziliksimaba pri preprečevanju zavrnitve organa pri de novo presajeni ledvici je bila prikazana v dvojno slepih raziskavah, v katerih so kontrolne skupine dobivale placebo.
English: The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Slovenian: Farmakokinetika baziliksimaba je bila ocenjena pri 39 pediatričnih bolnikih z de novo presaditvijo ledvice.
English: Cytokine release syndrome.
Slovenian: Sindrom sproščanja citokinov.
English: Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Slovenian: Zdravilo Simulect je kontraindicirano med nosečnostjo in dojenjem (glejte poglavje 4.3).
English: If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.
Slovenian: Če ste imeli hudo alergijsko reakcijo na zdravilo Simulect ali če je po operaciji prišlo do zapletov, kot je izguba presadka, ne smete prejeti drugega odmerka zdravila Simulect.
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.
Slovenian: Pri dojenčkih in otrocih (starost 1-11 let, n = 25) je bil porazdelitveni volumen v stanju ravnovesja 4,8  2,1 l, razpolovni čas je bil 9,5  4,5 dni, očistek pa 17  6 ml/h.
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.
Slovenian: Incidenca malignih neoplazem: Celotna incidenca malignih bolezni med vsemi bolniki v posameznih raziskavah je bila podobna v skupinah z baziliksimabom in v skupinah s primerjanimi načini zdravljenja.
English: The second dose should not be given if severe hypersensitivity reactions to Simulect or graft loss occur.
Slovenian: Drugega odmerka ne smemo dati, če nastopijo hude preobčutljivostne reakcije na zdravilo Simulect ali izguba presadka.
English: Disposition in adolescents was similar to that in adult renal transplantation patients.
Slovenian: Porazdelitev pri mladostnikih je bila podobna kot pri odraslih bolnikih po presaditvi ledvice.
English: Solvent for Simulect Water for injections
Slovenian: vehikel za zdravilo Simulect voda za injekcije
English: Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Slovenian: Baziliksimab je bil uporabljen skupaj s ciklosporinom v mikroemulziji in s steroidi v nekontrolirani raziskavi pri 41 pediatričnih de novo prejemnikih ledvičnih presadkov.
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.
Slovenian: Ta sočasno aplicirana zdravila vključujejo sistemska protivirusna, protibakterijska in protiglivična zdravila, analgetike, antihipertenzivna zdravila, na primer zaviralce adrenergičnih receptorjev beta ali zaviralce kalcijevih kanalčkov, in diuretike.
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.
Slovenian: Baziliksimab se specifično veže z veliko afiniteto (vrednost KD 0,1 nmol) na antigen CD25 na aktiviranih limfocitih T, z izraženim receptorjem za interlevkin-2 (IL-2R) velike afinitete, in tako prepreči vezavo interlevkina 2, ki je odločilen signal za proliferacijo celic T pri celičnem imunskem odzivu, ki je vpleten v zavrnitev presadka.
English: Basiliximab does not cause myelosuppression.
Slovenian: Baziliksimab ne povzroči mielosupresije.
English: The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class.
Slovenian: Na podlagi postmarketinških spontanih poročil so odkrili naslednje neželene učinke, ki so razvrščeni glede na organski sistem.
English: The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.
Slovenian: Dajanje baziliksimaba ne izključuje poznejšega zdravljenja s pripravki glodalskih protilimfocitnih protiteles.
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.
Slovenian: Pri otrocih so najpogosteje poročani neželeni učinki zapeka, čezmerna rast normalnih las in dlak, izcedek iz nosu ali zamašen nos, vročina, zvišan krvni tlak in različne vrste okužb.
English: Other malignancies were reported among 1.0% (7/701) of patients in the basiliximab group compared with 1.2% (7/595) of placebo patients.
Slovenian: O drugih malignih boleznih so poročali pri 1,0 % bolnikov (7/701) v skupini z baziliksimabom v primerjavi z 1,2 % bolnikov (7/595) v skupini s placebom.
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).
Slovenian: Uporaba baziliksimaba v programu trotirnega zdravljenja skupaj z azatioprinom ali mofetilmikofenolatom ni povečala obsega neželenih dogodkov ali okužb v skupini z baziliksimabom v primerjavi s placebom (glejte poglavje 4.8).
English: In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect.
Slovenian: V kliničnih preskušanjihje bila pogostnost oportunističnih okužb podobna pri bolnikih, ki uporabljali imunosupresivne sheme zdravljenja, ne glede na to, ali je shema vsebovala zdravilo Simulect ali ne.
English: In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes.
Slovenian: Raziskave in vitro na človeških tkivih so pokazale, da se baziliksimab veže samo na aktivirane limfocite in makrofage oziroma monocite.
English: 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).
Slovenian: V združeni analizi dveh petletnih podaljšanih raziskav so ugotovili, da je bila pogostnost limfoproliferativnih bolezni in raka enaka pri baziliksimabu (7 % - 21/295) in placebu (7 % - 21/291) (glejte poglavje 4.4).