natgillin/translations-raw huggingface dataset:
Nevertheless, live vaccines are not recommended for immunosuppressed patients.
No, ipak, živa se cjepiva ne preporučuju za imunosuprimirane bolesnike.
No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving Simulect.
Nema dostupnih podataka ni o učincima živog i inaktivnog cjepiva niti o prijenosu infekcije putem živog cjepiva u bolesnika koji primaju Simulect.
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.
Tijekom tog vremena primati ćete i druge lijekove koji će pomoći da se novi bubreg zaštiti, kao što su ciklosporin i kortikosteroidi, a morati ćete ih uzimati i nakon što napustite bolnicu.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.
Što prije obavijestite svog liječnika ili medicinsku sestru pojavi li se bilo koji neočekivani simptom dok dobivate Simulect ili tijekom narednih 8 tjedana, čak i ako mislite da to nije povezano s primjenom lijeka.
You must not be given Simulect - if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under “What Simulect contains”.
Ne smijete dobiti Simulect - ako ste alergični (preosjetljivi) na basiliksimab ili neki drugi sastojak lijeka Simulect naveden u dijelu 6. pod „Što Simulect sadrži“.
However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Međutim, na temelju IgG1 prirodi basiliksimaba, može se očekivati izlučivanje u majčino mlijeko.
Pregnancy and lactation (see section 4.6).
Trudnoća i dojenje (vidjeti dio 4.6).
As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1-2 weeks.
Padom koncentracija ispod te razine, ekspresija CD25 antigena vraća se na vrijednosti prije terapije unutar 1-2 tjedna.
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.
Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego dobijete Simulect: - ako ste ranije dobili presadak koji je odbačen nakon kratkog vremena, ili, - ako ste ranije bili u operacijskoj dvorani radi presađivanja koje na kraju nije obavljeno.
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).
Potpuno i dosljedno blokiranje interleukin-2 receptora održano je toliko dugo dok su razine basiliksimaba u serumu iznad 0,2 g/ml (obično do 4-6 tjedana nakon primjene).
What Simulect is and what it is used for What do you need to know before you are given Simulect How Simulect is given
Što je Simulect i za što se koristi Što morate znati prije nego počnete dobivati Simulect Kako primjenjivati Simulect Moguće nuspojave
Compatibility with a number of infusion sets has been verified.
Provjerena je kompatibilnost s nekim infuzijskim setovima.
Total body clearance was 4119 ml/h.
Ukupni tjelesni klirens iznosi 41±19 ml/h.
Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Bolesnici koji dobivaju Simulect trebaju biti smješteni u zdravstvene ustanove opremljene odgovarajućim laboratorijem i potrebnim medicinskim resursima, koji uključuju lijekove za liječenje ozbiljnih reakcija preosjetljivosti.
Shake the vial gently to dissolve the powder, avoiding foaming.
Pažljivo protresite bočicu da se prašak otopi, izbjegavajući stvaranje pjene.
If you need to have a vaccination, seek your doctor's advice first.
Ako Vam je potrebno cijepljenje, prethodno se posavjetujte s liječnikom.
Simulect belongs to a group of medicines called immunosuppressants.
Simulect pripada skupini lijekova poznatih pod imenom imunosupresivi.
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.
Ako ste imali teške alergijske reakcije na Simulect ili ako ste imali komplikacije nakon kirurškog zahvata kao što je gubitak presatka, ne trebate dobiti drugu dozu Simulecta.
Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression, therefore vaccination during treatment with Simulect may be less effective.
Inaktivirana cjepiva mogu se primjenjivati u imunosuprimiranih bolesnika no, odgovor na cjepivo može ovisiti o stupnju imunosupresije pa bi cijepljenje za vrijeme terapije Simulectom moglo biti manje djelotvorno.
It is given in hospital to adults, adolescents and children who are having a kidney transplant.
Daje se u bolnici odraslim osobama, adolescentima i djeci s presađenim bubregom.
Elm Park, Merrion Road Dublin 4
Vista Building Elm Park, Merrion Road Dublin 4
Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l.
Najviša koncentracija u serumu nakon intravenske infuzije od 20 mg tijekom 30 minuta iznosi 7,1±5,1 mg/l.
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.
Stope incidencije štetnih događaja i obrazac štetnih događaja bili su usporedivi među dvjema terapijskim skupinama i očekivani za režime liječenja i temeljne bolesti.
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.
U 39tjednoj studiji, najviša doza je rezultirala približno 1000 puta većom sistemskom izloženošću (AUC) od one uočene u bolesnika koji su primili preporučenu kliničku dozu zajedno s istovremenom imunosupresivnom terapijom.
There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.
Nema dokaza koji ukazuju da Simulect utječe na sposobnost vožnje ili upravljanja strojevima.
The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Doza za djecu tjelesne težine manje od 35 kg niža je od one koja se obično daje odraslima.
You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Morate koristiti učinkovite metode kontracepcije kako biste spriječili trudnoću tijekom liječenja i do 4 mjeseca nakon što ste primili zadnju dozu Simulecta.
Paediatric population The efficacy and safety of basiliximab were evaluated in two paediatric studies.
Pedijatrijska populacija Djelotvornost i sigurnost basiliksimaba ocijenjeni su u dvije pedijatrijske studije.
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.
Imunosupresivne sheme liječenja koje uključuju kombinaciju lijekova povećavaju mogućnost za infekcije, uključujući oportunističke infekcije, infekcije sa smrtnim ishodom i sepsu; rizik je povećan uz ukupno opterećenje imunosupresivima.
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
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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.