natgillin/translations-raw huggingface dataset:
Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX.
Ograničite izlaganje sunčevom svjetlu i ultraljubičastom (UV) zračenju dok primate NULOJIX.
The recommended dose is based on patient body weight (kg).
Preporučena doza ovisi o tjelesnoj težini bolesnika (kg).
Tell your doctor immediately if you or your family notice any symptoms listed below:
Odmah obavijestite liječnika ako Vi ili netko iz Vaše obitelji primijeti da imate sljedeće simptome:
The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well.
U ispitivanju belatacepta nije bio utvrđen virusni status, no kako je ovaj virus čest u majmuna, najvjerojatnije je bio prisutan i u ovih majmuna.
However, NULOJIX can cause serious side effects that may need treatment.
Međutim, NULOJIX može uzrokovati ozbiljne nuspojave koje će možda trebati liječiti.
The most common CNS infection was cryptococcal meningitis.
Najčešća infekcija središnjeg živčanog sustava bila je kriptokokni meningitis.
People who use NULOJIX have a higher risk of getting certain other types of cancer, especially skin cancer.
Osobe koje primaju NULOJIX imaju povišen rizik od dobivanja određenih drugih vrsta raka, osobito raka kože.
If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account the risk to the graft.
Ako se postavi dijagnoza PML-a, preporučuje se smanjiti ili obustaviti imunosupresiju uzimajući pritom u obzir rizik za presadak.
There are no adequate data from use of belatacept in pregnant women.
Ne postoje prikladni podaci o primjeni belatacepta u trudnica.
This will avoid foam formation.
Tako će se izbjeći stvaranje pjene.
Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek dok primate NULOJIX.
If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before.
Ako tijekom dužeg razdoblja prestanete primati NULOJIX i za to vrijeme ne uzimate druge lijekove za sprječavanje odbacivanja organa, a zatim ponovno počnete primati belatacept, nije poznato hoće li taj lijek imati isti učinak kao prije.
Belatacept was shown to cross the placenta in rats and rabbits.
Pokazalo se da belatacept prelazi placentu u štakora i kunića.
With NULOJIX treatment, this more often develops in the brain and can lead to death.
Uz liječenje lijekom NULOJIX, ta se bolest češće razvija u mozgu i može imati smrtni ishod.
Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Belatacept se nije ispitivao u bolesnika s panelom reaktivnih protutijela (PRA, Panel Reactive Antibody) većim od 30% (kojima je često potrebna pojačana imunosupresija).
It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Nije poznato ukazuju li ovi nalazi na rizik od razvoja autoimune bolesti u ljudi izloženih in utero abataceptu ili belataceptu.
At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
U 3. godini incidencija NODM iznosila je 8% uz belatacept i 10% uz ciklosporin.
In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
U 153 bolesnika pregledanih na protutijela najmanje 56 dana (približno 7 poluvremena) nakon prestanka primjene belatacepta, još je 10 (6,5%) razvilo protutijela.
NULOJIX weakens the body's ability to fight infections.
NULOJIX slabi sposobnost tijela da se obrani od infekcija.
There are no data on use of belatacept and effect on fertility in humans.
Nema podataka o primjeni belatacepta i njegovom učinku na plodnost u ljudi.
The powder is a white to off-white whole or fragmented cake.
Prašak je bijele do bjelkaste boje u obliku cijelog ili razlomljenog kolačića.
Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml.
Štrcaljke su označene u jedinicama od 0,5 ml; stoga, izračunata doza treba se zaokružiti na najbližu oznaku od 0,5 ml.
Tell your family or caregiver about your treatment.
Obavijestite svoju obitelj ili njegovatelja o svom liječenju.
During the first month post-transplantation, 85% saturation of CD86 was maintained.
Tijekom 1. mjeseca nakon presađivanja organa zadržalo se 85% zasićenosti CD86.
It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Najvjerojatnije je povećana osjetljivost na oportunističke infekcije primijećena u mladih štakora povezana s izloženošću abataceptu prije razvoja memorijskog odgovora.
One patient on belatacept MI regimen developed Guillian-Barré syndrome which led to treatment discontinuation and subsequently resolved.
Jedan bolesnik koji je primao MI režim belatacepta razvio je Guillian-Barréov sindrom, koji je doveo do prekida liječenja i nakon toga se povukao.
However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Međutim, normalizirana učestalost imunogeničnosti tijekom trajanja izloženosti dosljedno je iznosila 2,0 do 2,1 na 100 bolesnik-godina u tri ispitivanja.
Therapeutic monitoring of belatacept is not required.
Nije potrebno terapijsko praćenje belatacepta.
If you have not been exposed to the Epstein-Barr virus (EBV) or are uncertain of previous exposure, you must not be treated with NULOJIX.
Ako niste bili izloženi Epstein-Barrovom virusu (EBV) ili niste sigurni jeste li mu bili izloženi, ne smijete se liječiti lijekom NULOJIX.
CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection.
Preporučuje se primjenjivati profilaksu CMV-a tijekom najmanje 3 mjeseca nakon presađivanja organa, osobito u bolesnika s povećanim rizikom od CMV infekcije.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA28.
T-cells are cells responsible for maintaining your body's ability to resist disease and infections.
T-stanice odgovorne su za održavanje sposobnosti tijela da se obrani od bolesti i infekcija.
The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis.
U većine slučajeva tuberkuloza se razvila u bolesnika koji su u to vrijeme ili prethodno živjeli u zemljama s visokom prevalencijom tuberkuloze.
Efficacy was similar between MI and LI while the overall safety profile was better for the LI.
Djelotvornost MI i LI režima je bila slična, dok je LI režim imao bolji ukupni sigurnosni profil.
In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment.
Titar protutijela općenito je bio nizak, obično nije dugo trajao i često je prestajao biti mjerljiv s nastavkom liječenja.
Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation.
Primjena profilakse pneumocistične upale pluća preporučuje se tijekom najmanje 6 mjeseci nakon presađivanja organa.
Tell your doctor if you need to have vaccinations.
Obavijestite svog liječnika ako se trebate cijepiti.
Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections.
Liječnik će Vas možda trebati pregledati zbog tih simptoma kako bi isključio PML, PTLD ili druge infekcije.
This was despite the presence in the abatacept study of a virus, lymphocryptovirus, known to cause these lesions in immunosuppressed monkeys within the time frame of these studies.
To je bilo usprkos tome što je u ispitivanju abatacepta bio prisutan virus, limfokriptovirus, za koji se zna da uzrokuje ove lezije u imunosuprimiranih majmuna unutar vremenskog okvira u kojem su provedena ta ispitivanja.
Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%.
Do 3. mjeseca nakon presađivanja organa uz preporučeni režim doziranja, razina zasićenosti CD86 održala se na približno 70%, a u 12. mjesecu na približno 65%.
By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Do 3. su godine recidivi akutnog odbacivanja bili slični u svim skupinama (< 3%), a supkliničko akutno odbacivanje utvrđeno u 1. godini protokolnom biopsijom iznosilo je 5% u obje skupine.
Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes.
Reverzibilni farmakološki učinci sastojali su se od minimalnog smanjenja serumskog IgG i minimalne do teške limfoidne deplecije germinalnih centara u slezeni i/ili limfnim čvorovima.
Patients are not required to be pre-treated to prevent allergic reactions (see section 4.8).
Bolesnici ne moraju prethodno biti liječeni zbog sprječavanja alergijskih reakcija (vidjeti dio 4.8).
The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Razrijeđena otopina mora se primijeniti intravenskom infuzijom relativno stalne brzine u razdoblju od 30 minuta.
Although there were few patients that developed antibodies and there was no apparent correlation of antibody development to clinical response or adverse events, the data are too limited to make a definitive assessment (see section 4.8).
Iako je svega nekoliko bolesnika razvilo protutijela i nije bilo očite korelacije između razvoja protutijela i kliničkog odgovora ili nuspojava, podaci su previše ograničeni da bi se mogla napraviti konačna procjena (vidjeti dio 4.8).
Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A.
Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - SAD
There have been reports of a rare type of brain infection called progressive multifocal leukoencephalopathy (PML) that have occurred in patients who have been given NULOJIX.
Zabilježeni su slučajevi rijetke vrste infekcije mozga koja se zove progresivna multifokalna leukoencefalopatija (PML) i nastala je u bolesnika kojima se davao NULOJIX.
The pharmacokinetics of belatacept was linear and the exposure to belatacept increased proportionally in healthy subjects after a single intravenous infusion dose of 1 to 20 mg/kg.
Farmakokinetika belatacepta bila je linearna i izloženost belataceptu se u zdravih ispitanika proporcionalno povećala nakon jednokratne doze od 1 do 20 mg/kg primijenjene intravenskom infuzijom.
Up to Year 1
Do 1. godine
Anti-belatacept antibody development was not associated with altered clearance of belatacept.
Razvoj protutijela na belatacept nije bio povezan s promijenjenim klirensom belatacepta.
There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy).
2. U skupini koja je primala ciklosporin prijavljen je jedan slučaj PML-a (Ispitivanje 1) 82 mjeseca nakon presađivanja (više od 56 dana nakon prekida terapije).
Within each frequency category adverse reactions are presented in order of decreasing seriousness.
Unutar svake učestalosti kategorije nuspojave su navedene prema sve manjoj ozbiljnosti.
If you miss receiving NULOJIX when you are supposed to, ask your doctor when to schedule your next dose.
Ako propustite primiti NULOJIX kad ste trebali, upitajte liječnika kada trebate doći zbog primanja sljedeće doze.
Do not store any unused portion of the solution for infusion for reuse.
Nemojte čuvati neiskorišteni dio otopine za infuziju za ponovnu primjenu.
Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors
Tablica 5: Ključne mjere djelotvornosti u 1. i 3. godini Ispitivanje 1: živi darivatelji i preminuli koji zadovoljavaju standardne kriterije
As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Posljedično, belatacept blokira CD28 posredovanu kostimulaciju T-stanica, inhibirajući njihovu aktivaciju.
Belatacept is not expected to interrupt the enterohepatic recirculation of MPA.
Ne očekuje se da će belatacept ometati enterohepatičku cirkulaciju MPA.
Chemical and physical in-use stability of the solution for infusion has been demonstrated for 24 hours when stored in a refrigerator (2°C - 8°C).
Kemijska i fizikalna stabilnost u primjeni otopine za infuziju dokazana je tijekom 24 sata ako se čuva u hladnjaku (2°C - 8°C).
Acute infusion-related reactions (reactions occurring within one hour of infusion) occurred in 5.5% of patients in the belatacept MI group and 4.4% of patients in the belatacept LI group up to Year 3.
Akutne reakcije povezane s infuzijom (reakcije koje nastaju u roku od jednoga sata nakon infuzije) nastale su u 5,5% bolesnika u skupini liječenoj MI režimom belatacepta i u 4,4% bolesnika liječenih LI režimom belatacepta do 3. godine.
NULOJIX will be given to you by a healthcare professional.
NULOJIX će Vam davati zdravstveni radnik.
If you have been given a therapy for treatment of acute rejection, such as antithymocyte globulin to reduce T-cells.
ako ste primili terapiju za liječenje akutnog odbacivanja, kao što je antitimocitni globulin za smanjenje broja T-stanica.
The potential impact of pre-existing antibodies to belatacept should be taken into account when considering retreatment with belatacept following prolonged discontinuation, particularly in patients who have not received continuous immunosuppression.
Mogući učinak već postojećih protutijela na belatacept treba uzeti u obzir kad se razmatra ponovno uvođenje liječenja belataceptom nakon duljeg prekida, osobito u bolesnika u kojih imunosupresija nije bila kontinuirana.
Packs of either 1 glass vial and 1 syringe or 2 glass vials and 2 syringes.
Pakiranja od 1staklene bočice i 1 štrcaljke ili 2 staklene bočice i 2 štrcaljke.
If you have not been exposed to it, you are at a higher risk of getting a type of cancer called posttransplant lymphoproliferative disorder (PTLD).
Ako mu niste bili izloženi, imate povećan rizik od dobivanja jedne vrste raka koji se zove posttransplantacijska limfoproliferativna bolest (PTLD).
The trough concentration of belatacept was consistently maintained up to 5 years post-transplant.
Najniža koncentracija belatacepta dosljedno se održavala do 5 godina nakon presađivanja.
What NULOJIX contains
Što NULOJIX sadrži
Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers.
Izgleda da belatacept nema nikakve značajne izravne učinke na razine citokina u primatelja transplatanata jetre ili u zdravih dobrovoljaca.
Studies in rats have shown excretion of belatacept in milk.
Ispitivanja na štakorima pokazala su da se belatacept izlučuje u mlijeko.
What NULOJIX is and what it is used for 2.
Što je NULOJIX i za što se koristi 2.
New Onset Diabetes Mellitus and Blood Pressure
Novonastala šećerna bolest i krvni tlak
Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Informacije za medicinsko osoblje i zdravstvene radnike o izračunavanju doze, pripremi i primjeni lijeka NULOJIX nalaze se na kraju ove upute.
Initial phase
Početna faza
NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.
NULOJIX sadrži djelatnu tvar belatacept i pripada skupini lijekova koji se zovu imunosupresivi.
Important information about some of the ingredients of NULOJIX Tell your doctor if you are on a low-sodium (low-salt) diet before you are treated with NULOJIX.
Važne informacije o nekim sastojcima lijeka NULOJIX Obavijestite liječnika ako ste na dijeti s ograničenim unosom natrija (soli) prije nego što započnete liječenje lijekom NULOJIX.
Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats) as well as inflammation of the thyroid and pancreas (both juvenile and adult rats).
Ispitivanja u štakora izloženih abataceptu pokazala su abnormalnosti imunološkog sustava uključujući nisku incidenciju infekcija koje dovode do smrti (mladi štakori) kao i upalu štitne žlijezde i gušterače (i u mladih i u odraslih štakora).
The European Medicines Agency has deferred the obligation to submit the results of studies with belatacept in one or more subsets of the paediatric population in renal transplantation (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka belatacepta u jednoj ili više podskupina pedijatrijske populacije u presađivanju bubrega (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
NULOJIX should not be used with siliconised syringes in order to avoid aggregate formation (see section 6.6).
NULOJIX se ne smije primjenjivati silikoniziranim štrcaljkama kako bi se izbjeglo stvaranje agregata (vidjeti dio 6.6).
It is used with other immunosuppressive medicines, including mycophenolic acid and corticosteroids.
Koristi se s drugim imunosupresivima, uključujući mikofenolnu kiselinu i kortikosteroide.
Common depression
Često depresija
This will avoid aggregate formation.
Tako će se izbjeći stvaranje agregata.
The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
Koncentracija belatacepta u infuziji treba biti između 2 mg i 10 mg belatacepta po ml otopine.
Belatacept is therefore not expected to affect cytochrome P450 enzymes via effects on cytokines.
Stoga se ne očekuje da će belatacept utjecati na enzime citokroma P450 preko učinaka na citokine.
Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Ovisno o vrsti bubrežnog presatka koji ste dobili, možete imati povišen rizik od zgrušavanja krvi u presađenom bubregu.
Exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Potrebno je ograničiti izlaganje sunčevom svjetlu i ultraljubičastom (UV) zračenju nošenjem zaštitne odjeće i uporabom preparata s visokim faktorom zaštite.
Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.
Belatacept ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, budući da može izazvati umor, malaksalost i/ili mučninu.
Activated T cells are the predominant mediators of immunologic response to the transplanted kidney.
Aktivirane Tstanice glavni su posrednici imunološkog odgovora na presađeni bubreg.
Dates of NULOJIX Treatment:
Datumi primanja lijeka NULOJIX:
Gently mix the infusion container.
Nježno promiješajte spremnik infuzije.
The active substance is belatacept.
Djelatna tvar je belatacept.
Tests may show:
Pretrage mogu pokazati:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Datum prvog odobrenja: 17. lipnja 2011.
Please make sure you have this card with you at all times and a list of all your other medicines with you at any visit to a healthcare professional.
Pazite da prilikom svakog posjeta zdrastvenom radniku uvijek sa sobom donesete ovu karticu i popis svih drugih lijekova koje uzimate.
Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents.
Zbog sličnosti strukture i mehanizma djelovanja abatacepta i belatacepta te jačeg djelovanja abatacepta u glodavaca, abatacept se koristio kao djelatniji homolog belatacepta u glodavaca.
For more details on the dose calculation, see section 6.6.
Za detaljniji opis izračunavanja doze, vidjeti dio 6.6.
Up to Year 3*
Do 3. godine*
When the clinical suspicion for PML is high, brain biopsy should be considered in subjects if the diagnosis of PML cannot be established via CSF PCR and neuroimaging.
Kad se ozbiljno klinički sumnja na PML, potrebno je razmotriti biopsiju mozga ako se dijagnoza PML-a u bolesnika ne može utvrditi putem PCR-a cerebrospinalnog likvora i neuroslikovnih pretraga.
Too rapid reduction of steroid intake can increase the risk that your body may reject the transplanted kidney.
Prebrzo smanjenje unosa steroida može povećati rizik od odbacivanja presađenoga bubrega.
Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Belatacept se nije ispitivao u bolesnika u kojih je PRA > 30% (vidjeti dio 4.2).
Cancer and non-cancerous growths of the skin
Rak i nekancerozne izrasline na koži
In Study 2, approximately 40% reduction in this risk was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
U Ispitivanju 2 primijećeno je smanjenje tog rizika za približno 40% u bolesnika u skupinama liječenima belataceptom u odnosu na one randomizirane za primanje ciklosporina.
This should be taken into consideration when treating patients on a controlled sodium diet.
To se treba uzeti u obzir kod liječenja bolesnika na dijeti s kontroliranim unosom natrija.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
U slučaju predoziranja preporučuje se pratiti bolesnika zbog znakova ili simptoma nuspojava i uvesti odgovarajuće simptomatsko liječenje.
NULOJIX powder for concentrate for solution for infusion (powder for concentrate) is a white to offwhite powder that can appear solid or broken into pieces.
NULOJIX prašak za koncentrat za otopinu za infuziju (prašak za koncentrat) bijeli je do bjelkasti prašak koji može izgledati kao jedan ili više komada krutine.
The safety and efficacy of retreatment with belatacept has not been studied.
Djelotvornost i sigurnost ponovnog liječenja belataceptom nije ispitana.
The safety and efficacy of belatacept have not been established in liver transplant patients, and therefore such use is not recommended.
Nije utvrđena djelotvornost i sigurnost primjene belatacepta u bolesnika kojima je presađena jetra, pa se stoga takva primjena ne preporučuje.
At the recommended dosing regimen, serum concentration generally reached steady-state by Week 8 in the initial phase following transplantation and by Month 6 during the maintenance phase.
Kod režima doziranja u preporučenim dozama, serumske koncentracije općenito su postizale stanje dinamičke ravnoteže do 8. tjedna u početnoj fazi nakon presađivanja i do 6. mjeseca u fazi održavanja.
Study 1 and 2: Phase 3 studies in renal transplant recipients The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Ispitivanja 1 i 2: ispitivanja Faze III u primatelja bubrežnog presatka Djelotvornost i sigurnost primjene belatacepta u sklopu imunosupresivnog režima nakon presađivanja bubrega procjenjivale su se u dva randomizirana, djelomično slijepa, multicentrična ispitivanja u trajanju od 3 godine s primarnom završnom točkom specificiranom u 1. godini.
This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction.
Taj povećani afinitet osigurava razinu imunosupresije koja je neophodna za sprječavanje imunološki posredovanog zatajenja presatka i gubitka njegove funkcije.
Table 3: Malignancies occurring by treatment group (%) Up to Year 1
Tablica 3: Zloćudne bolesti u terapijskim skupinama (%) Do 1. godine