FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV {direct acting antiviral / DAA} treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije lijekom {direktno djelujući antivirotik / DAA}, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Croatian: U slučaju promjene raspoloženja i simptoma depresije, uključujući razdoblje ubrzo nakon početka liječenja, ženama je potrebno savjetovati da se obrate liječniku.
English: Please open here.
Croatian: Molimo otvoriti ovdje.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima:
English: You must not be given Simulect if you are pregnant.
Croatian: Ne smijete dobiti Simulect ako ste trudni.
English: Powder: 3 years
Croatian: Prašak: 3 godine.
English: Breastfeeding must therefore be avoided.
Croatian: Dojenje stoga treba izbjegavati.
English: The overall safety profiles were similar in both groups.
Croatian: Ukupni sigurnosni profili bili su slični u objema skupinama.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, proizvod treba odmah koristiti.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete dobivati ovaj lijek jer sadrži Vama važne podatke.
English: In this situation, you may have received Simulect.
Croatian: U tom ste slučaju možda dobili Simulect.
English: The terminal half-life was 7.23.2 days.
Croatian: Konačni poluvijek iznosi 7,2±3,2 dana.
English: If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.
Croatian: Ako zatrudnite tijekom ovog vremena unatoč korištenju kontracepcijskih mjera, odmah se obratite svom liječniku.
English: Children and adolescents (1-17 years)
Croatian: Djeca i adolescenti (1-17 godina)
English: Simulect may harm your baby.
Croatian: Simulect može naštetiti Vašem djetetu.
English: • Risk Management Plan (RMP) Not applicable.
Croatian: • Plan upravljanja rizikom (RMP)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se odmah ne koristi, vrijeme čuvanja i uvjeti prije primjene odgovornost su korisnika.
English: Follow your doctor's instructions carefully.
Croatian: Pažljivo slijedite sve upute dobivene od vašeg liječnika.
English: You will only be given two doses of Simulect.
Croatian: Primiti ćete samo dvije doze Simulecta.
English: It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant.
Croatian: Vrlo je važno da prije presađivanja kažete svom liječniku ako ste trudni ili mislite da biste mogli biti trudni.
English: Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past.
Croatian: Obavijestite svog liječnika ako sumnjate da ste ranije imali alergijsku reakciju na bilo koji od tih sastojaka.
English: What Simulect is and what it is used for
Croatian: Što je Simulect i za što se koristi
English: Do not use if foreign particles are present.
Croatian: Nemojte ju koristiti ako su prisutne strane čestice.
English: No mutagenic potential was observed in vitro.
Croatian: In vitro nije opažen mutageni potencijal.
English: Infusion bag - Baxter minibag NaCl 0.9%
Croatian: Vrećica za infuziju - Baxter minibag NaCl 0,9%
English: Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
Croatian: Liječnik će to provjeriti i raspraviti s Vama mogućnost ponovnog liječenja Simulectom.
English: Other medicines and Simulect
Croatian: Drugi lijekovi i Simulect
English: Immunosuppressants reduce the body's response to anything that it sees as “foreign” - which includes transplanted organs.
Croatian: Imunosupresivi smanjuju odgovor organizma na sve što on prepoznaje kao „strano“ - što uključuje i presađene organe.
English: Date of first authorisation: 09/10/1998 Date of latest renewal: 09/10/2008
Croatian: Datum posljednje obnove odobrenja: 09.10.2008.
English: Neoplasms and infections
Croatian: Neoplazme i infekcije
English: These will be given in hospital, around the time of your transplant operation.
Croatian: One će vam biti dane u bolnici u vrijeme presađivanja.
English: - if you are pregnant or breast-feeding.
Croatian: - ako ste trudni ili dojite.
English: Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection.
Croatian: Proširene studije su također pokazale da su bolesnici koji su doživjeli akutnu epizodu odbacivanja tijekom prve godine nakon presađivanja imali više gubitaka presatka i smrti tijekom petogodišnjeg perioda praćenja u odnosu na bolesnike koji nisu imali odbacivanja.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Croatian: Kako takve nuspojave dobrovoljno prijavljuje populacija neutvrđene veličine, nije uvijek moguće pouzdano procijeniti njihovu učestalost.
English: Use in heart transplantation
Croatian: Primjena kod presađivanja srca
English: Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom i do 16 tjedana nakon liječenja.
English: What do you need to know before you are given Simulect
Croatian: Što morate znati prije nego počnete dobivati Simulect
English: Simulect powder
Croatian: Simulect prašak
English: You should also tell your doctor if you are breast-feeding.
Croatian: Također trebate reći svom liječniku ako dojite.
English: Clinical studies
Croatian: Kliničke studije
English: Compatibility with the following infusion sets has been verified:
Croatian: Potvrđena je kompatibilnost sa sljedećim infuzijskim setovima:
English: You will only be given Simulect if you are receiving a new kidney.
Croatian: Simulect ćete dobiti samo ako primate novi bubreg.
English: Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely.
Croatian: Simulect se daje kako bi se spriječilo da Vaš organizam odbaci novi organ u prvih 4 do 6 tjedana nakon presađivanja kad je mogućnost odbacivanja najveća.
English: Discard the reconstituted solution if not used within that time.
Croatian: Rekonstituiranu otopinu treba odbaciti ako se ne upotrijebi unutar tog vremena.
English: Your doctor will watch out for any effects on your immune system and treat them if necessary.
Croatian: Vaš će liječnik pratiti moguće učinke na imunološki sustav i, bude li potrebno, odrediti liječenje.
English: Simulect should be administered under qualified medical supervision.
Croatian: Simulect treba primjenjivati pod stručnim medicinskim nadzorom.
English: Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02.
Croatian: Farmakoterapijska skupina: inhibitori interleukina, ATK oznaka: L04AC02.
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.
Croatian: Podaci o primjeni Simulecta u starijih osoba su ograničeni, no ne postoji dokaz da stariji bolesnici trebaju različito doziranje od mlađih odraslih osoba.
English: Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Croatian: Akutno odbacivanje pojavilo se u 14,6% bolesnika do 6 mjeseci nakon presađivanja, a u 24,3% do 12 mjeseci.
English: These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
Croatian: To su bolesnici u kojih je, nakon početne primjene Simulecta, istovremena imunosupresija prerano prekinuta zbog, npr. odustajanja od presađivanja ili ranog gubitka presatka.
English: Nevertheless, live vaccines are not recommended for immunosuppressed patients.
Croatian: No, ipak, živa se cjepiva ne preporučuju za imunosuprimirane bolesnike.
English: 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.
Croatian: Nema dostupnih podataka ni o učincima živog i inaktivnog cjepiva niti o prijenosu infekcije putem živog cjepiva u bolesnika koji primaju Simulect.
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.
Croatian: 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.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: 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.
Croatian: 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.
English: 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”.
Croatian: Ne smijete dobiti Simulect - ako ste alergični (preosjetljivi) na basiliksimab ili neki drugi sastojak lijeka Simulect naveden u dijelu 6. pod „Što Simulect sadrži“.
English: However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Croatian: Međutim, na temelju IgG1 prirodi basiliksimaba, može se očekivati izlučivanje u majčino mlijeko.
English: Pregnancy and lactation (see section 4.6).
Croatian: Trudnoća i dojenje (vidjeti dio 4.6).
English: As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1-2 weeks.
Croatian: Padom koncentracija ispod te razine, ekspresija CD25 antigena vraća se na vrijednosti prije terapije unutar 1-2 tjedna.
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.
Croatian: 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.
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).
Croatian: 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).
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
Croatian: Što je Simulect i za što se koristi Što morate znati prije nego počnete dobivati Simulect Kako primjenjivati Simulect Moguće nuspojave
English: Compatibility with a number of infusion sets has been verified.
Croatian: Provjerena je kompatibilnost s nekim infuzijskim setovima.
English: Total body clearance was 4119 ml/h.
Croatian: Ukupni tjelesni klirens iznosi 41±19 ml/h.
English: 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.
Croatian: 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.
English: Shake the vial gently to dissolve the powder, avoiding foaming.
Croatian: Pažljivo protresite bočicu da se prašak otopi, izbjegavajući stvaranje pjene.
English: If you need to have a vaccination, seek your doctor's advice first.
Croatian: Ako Vam je potrebno cijepljenje, prethodno se posavjetujte s liječnikom.
English: Simulect belongs to a group of medicines called immunosuppressants.
Croatian: Simulect pripada skupini lijekova poznatih pod imenom imunosupresivi.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: It is given in hospital to adults, adolescents and children who are having a kidney transplant.
Croatian: Daje se u bolnici odraslim osobama, adolescentima i djeci s presađenim bubregom.
English: Elm Park, Merrion Road Dublin 4
Croatian: Vista Building Elm Park, Merrion Road Dublin 4
English: Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l.
Croatian: Najviša koncentracija u serumu nakon intravenske infuzije od 20 mg tijekom 30 minuta iznosi 7,1±5,1 mg/l.
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.
Croatian: Stope incidencije štetnih događaja i obrazac štetnih događaja bili su usporedivi među dvjema terapijskim skupinama i očekivani za režime liječenja i temeljne bolesti.
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.
Croatian: 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.
English: There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.
Croatian: Nema dokaza koji ukazuju da Simulect utječe na sposobnost vožnje ili upravljanja strojevima.
English: The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Croatian: Doza za djecu tjelesne težine manje od 35 kg niža je od one koja se obično daje odraslima.
English: You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Croatian: Morate koristiti učinkovite metode kontracepcije kako biste spriječili trudnoću tijekom liječenja i do 4 mjeseca nakon što ste primili zadnju dozu Simulecta.
English: Paediatric population The efficacy and safety of basiliximab were evaluated in two paediatric studies.
Croatian: Pedijatrijska populacija Djelotvornost i sigurnost basiliksimaba ocijenjeni su u dvije pedijatrijske studije.
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.
Croatian: 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.
English: Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Croatian: S obzirom da je basiliksimab imunoglobulin, ne treba očekivati metaboličke interakcije među lijekovima.
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.
Croatian: 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.
English: 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
Croatian: 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
English: What Simulect contains - The active substance is basiliximab.
Croatian: Što Simulect sadrži - Djelatna tvar je basiliksimab.
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.
Croatian: 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%.
English: Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
Croatian: Od 339 bolesnika s presađenim bubregom koji su liječeni basiliksimabom i testirani na antiidiotipska antitijela, 4 (1,2%) su razvila reakciju na antiidiotipska antitijela.
English: Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
Croatian: Volumen distribucije i klirens smanjeni su za oko 50% u usporedbi prema odraslim bolesnicima s presađenim bubregom.
English: The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly.
Croatian: 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.
English: Cytokine release syndrome.
Croatian: Sindrom otpuštanja citokina.
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).
Croatian: 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).
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.
Croatian: 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.
English: In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect.
Croatian: U kliničkim studijama incidencija oportunističkih infekcija bila je slična u bolesnika koji su na imunosupresivnoj terapiji sa ili bez Simulecta.
English: An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Croatian: Nije vjerojatno da će se pri predoziranju Simulectom odmah javiti nuspojave ali je moguće da će Vaš imunološki sustav duže vrijeme biti oslabljen.
English: The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect.
Croatian: Primjenu živih atenuiranih cjepiva je stoga potrebno izbjegavati u bolesnika liječenih Simulectom.
English: Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue France
Croatian: Novartis Pharma S.A.S. Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue Francuska
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.
Croatian: 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.
English: Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Croatian: Simulect smiju propisivati samo liječnici s iskustvom u imunosupresivnoj terapiji nakon presađivanja organa.
English: 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).
Croatian: 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).
English: For information on preclinical toxicology see section 5.3.
Croatian: Za obavijesti o nekliničkoj toksičnosti vidjeti dio 5.3.
English: 2.5 ml of the sterile water is used to dissolve the powder before it is given to you.
Croatian: 2,5 ml sterilne vode se koristi za otapanje praška prije primjene.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Cumulative doses ranged from 20 mg up to 60 mg.
Croatian: Kumulativne doze kretale su se između 20 mg do 60 mg.
English: 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.
Croatian: 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.