natgillin/translations-raw huggingface dataset:
Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected. 
S obzirom da je basiliksimab imunoglobulin, ne treba očekivati metaboličke interakcije među lijekovima.
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. 
U nekoliko malih kliničkih ispitivanja provedenih na primateljima presađenog srca, ozbiljni srčani štetni događaji poput srčanog zastoja (2,2%), undulacije atrija (1,9%) i palpitacija (1,4%) zabilježeni su češće uz Simulect nego uz druge indukcijske lijekove.
set, Abbott - Infusion set, Codan - Infusomat, Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000Plumset Microdrip, Abbott - Vented basic set, Baxter - Flashball device, Baxter - Vented primary administration set, Imed 
Infuzijski setovi - Luer Lock™, H. Noolens - Sterile vented i.v. set, Abbott - Infusion set, Codan - Infusomat™, Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000™ Plumset Microdrip, Abbott - Vented basic set, Baxter - Flashball device, Baxter - Vented primary administration set, Imed
What Simulect contains - The active substance is basiliximab. 
Što Simulect sadrži - Djelatna tvar je basiliksimab.
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. 
Ukupna incidencija infekcija bila je 75,9% u basiliksimab skupini i 75,6% u placebo skupini, a incidencija ozbiljnih infekcija bila je 26,1%, odnosno 24,8%.
Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response. 
Od 339 bolesnika s presađenim bubregom koji su liječeni basiliksimabom i testirani na antiidiotipska antitijela, 4 (1,2%) su razvila reakciju na antiidiotipska antitijela.
Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients. 
Volumen distribucije i klirens smanjeni su za oko 50% u usporedbi prema odraslim bolesnicima s presađenim bubregom.
The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly. 
Incidencija je bila 2/138 u bolesnika koji nisu bili izloženi muromonabu-CD3 (OKT3), a 4/34 u bolesnika koji su muromonab-CD3 dobivali istovremeno.
Cytokine release syndrome. 
Sindrom otpuštanja citokina.
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). 
Simulect je indiciran za prevenciju akutnog odbacivanja organa u de novo alogeničnom presađivanju bubrega u odraslih i pedijatrijskih bolesnika (1-17 godina) (vidjeti dio 4.2).
The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients. 
Odnos između koncentracije u serumu i zasićenja receptora određivan je u 13 bolesnika i bio je sličan onom okarakteriziranom u odraslih bolesnika s presađenim bubregom.
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect. 
U kliničkim studijama incidencija oportunističkih infekcija bila je slična u bolesnika koji su na imunosupresivnoj terapiji sa ili bez Simulecta.
An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer. 
Nije vjerojatno da će se pri predoziranju Simulectom odmah javiti nuspojave ali je moguće da će Vaš imunološki sustav duže vrijeme biti oslabljen.
The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect. 
Primjenu živih atenuiranih cjepiva je stoga potrebno izbjegavati u bolesnika liječenih Simulectom.
Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue France 
Novartis Pharma S.A.S. Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue Francuska
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. 
Incidencija infektivnih epizoda: Ukupna incidencija i profil virusnih, bakterijskih i gljivičnih infekcija u bolesnika koji su primali basiliksimab ili placebo u kombinaciji s dvostrukom i trostrukom imunosupresivnom terapijom bila je usporediva između skupina.
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. 
Simulect smiju propisivati samo liječnici s iskustvom u imunosupresivnoj terapiji nakon presađivanja organa.
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4). 
Druga doza se ne smije primijeniti u slučaju teške reakcije preosjetljivosti na Simulect ili u slučaju postoperativnih komplikacija kao što je gubitak presatka (vidjeti dio 4.4).
For information on preclinical toxicology see section 5.3. 
Za obavijesti o nekliničkoj toksičnosti vidjeti dio 5.3.
2.5 ml of the sterile water is used to dissolve the powder before it is given to you. 
2,5 ml sterilne vode se koristi za otapanje praška prije primjene.
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. 
U objedinjenoj analizi dviju petogodišnjih otvorenih proširenih studija (ukupno 586 bolesnika) kombinirane stope preživljavanja presatka i bolesnika nisu bile statistički značajno različite za skupine na basiliksimabu i placebu.
In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects. 
U kliničkim studijama basiliksimab je bio davan bolesnicima u pojedinačnim dozama do 60 mg i višekratnim dozama do 150 mg, tijekom 24 dana, bez akutnih nuspojava.
Cumulative doses ranged from 20 mg up to 60 mg. 
Kumulativne doze kretale su se između 20 mg do 60 mg.
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20-30 minutes or as an intravenous injection using a syringe. 
Simulect se daje dva puta, u bolnici, ili polako kroz iglu u veni kao infuzija u trajanju od 20-30 minuta ili kao intravenska injekcija pomoću štrcaljke.
Solvent for Simulect Water for injections 
Otopina za Simulect Voda za injekcije
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]). 
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]).
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. 
Teške akutne (manje od 24 sata) reakcije preosjetljivosti opažene su prilikom početnog uzimanja Simulecta, kao i prilikom njegova ponovnog uzimanja u nastavku terapije.
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. 
Primarni cilj studije bio je pokazati superiornost ove kombinacije nasuprot liječenju ciklosporinom u mikroemulziji, mikofenolat mofetilom i steroidima u sprečavanju akutnog odbacivanja.
The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies. 
Učinak Simulecta u prevenciji odbacivanja organa u de novo presađivanju bubrega pokazan je u dvostrukoslijepim, placebo-kontroliranim studijama.
Simulect is contraindicated in pregnancy and lactation (see section 4.3). 
Simulect je kontraindiciran u trudnoći i tijekom dojenja (vidjeti dio 4.3).
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%). 
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%).
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. 
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.
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. 
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.
The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen. 
Incidencija akutne epizode odbacivanja bila je bitno niža u bolesnika koji su dobivali basiliksimab i trostruki režim imunosupresivne terapije.
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK 
KUTIJA ZA 1 BOČICU I 1 AMPULU KAO POJEDINAČNO PAKIRANJE
Simulect can be given to older patients, but the information available is limited. 
Stariji bolesnici (u dobi od 65 godina i stariji) Simulect se može davati starijim bolesnicima, no dostupne informacije su ograničene.
The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations. 
Primjena basiliksimaba ne isključuje naknadno liječenje pripravcima s mišjim antilimfocitnim antitijelima.
Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients). 
Podaci o sigurnosti primjene u pedijatrijskih bolesnika dobiveni su iz jedne otvorene farmakokinetičke i farmakodinamičke studije u djece kojoj je presađen bubreg (41 bolesnik).
In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/monocytes. 
Studije in vitro uz upotrebu ljudskih tkiva ukazuju da se basiliksimab veže samo na aktivirane limfocite i makrofage/monocite.
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). 
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).
If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered. 
Ako se pojavi teška reakcija preosjetljivosti, terapiju Simulectom treba trajno ukinuti i ne primjenjivati sljedeću dozu.
You must not breast-feed after being given Simulect or up to 4 months after the second dose. 
Ne smijete dojiti dok primate Simulect ili do 4 mjeseca nakon zadnje doze.
Mannitol (E421) Glycine 
Manitol (E421)
Elimination half-life was not influenced by age, gender, or race. 
Životna dob, spol i rasa ne utječu na poluvrijeme eliminacije.
Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection. 
Uobičajena doza za odrasle iznosi 20 mg u svakoj infuziji ili injekciji.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake Rok valjanosti, odnosno EXP.
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). 
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).
There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested. 
Postoji proporcionalan porast Cmax i AUC od 20 mg do 60 mg, u rasponu ispitivanih pojedinačnih doza.
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately. 
Nakon rekonstitucije se preporučuje odmah koristiti bezbojnu, bistru do opalascentnu otopinu.
Marketing Authorisation Holder Novartis Europharm Limited Vista Building 
Nositelj odobrenja za stavljanje lijeka u promet Novartis Europharm Limited
No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients. 
U odraslih bolesnika nije opažen klinički značajan utjecaj tjelesne težine ili spola na volumen distribucije ili klirens.
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. 
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1).
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). 
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).
The second 20 mg dose should be given 4 days after transplantation. 
Drugu dozu od 20 mg treba dati 4 dana nakon presađivanja.
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. 
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%).
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]). 
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]).
Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk. 
Basiliksimab ima potencijalno opasne imunosupresivne učinke na tijek trudnoće i dojenče izloženo basiliksimabu preko majčinog mlijeka.
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.