FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.
Croatian: Rekonstituirane otopine ponekad mogu opalescirati; takve otopine se mogu primjenjivati.
English: Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Croatian: Prethodno zračenje mozga ili kraniospinalno zračenje mogu doprinjeti teškim toksičnim reakcijama (npr. encefalopatija).
English: The total excreted amount of thiotepa and its identified metabolites accounts for 54-100% of the total alkylating activity, indicating the presence of other alkylating metabolites.
Croatian: Ukupna količina izlučene tiotepe i njenih identificiranih metabolita predstavlja 54-100% od ukupne alkilirajuće aktivnosti, što upućuje na prisustvo drugih alkilirajućih metabolita.
English: What TEPADINA is and what it is used for
Croatian: Što je TEPADINA i za što se koristi
English: In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
Croatian: U ovim ispitivanjima je ukupno 6588 odraslih bolesnika i 902 pedijatrijska bolesnika primalo tiotepu kao pripremnu terapiju prije transplantacije hematopoetskih matičnih stanica.
English: Thiotepa is a highly lipophilic compound.
Croatian: Tiotepa je vrlo lipofilan spoj.
English: Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Croatian: Alkilirajući kemoterapeutici, uključujući tiotepu, inhibiraju plazmatsku pseudokolinesterazu za 35% do 70%.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Croatian: Liječnik će redovito nadgledati broj krvnih stanica kao i enzime jetre kako bi otkrio i kontrolirao takve događaje.
English: Specific interactions with thiotepa
Croatian: Specifične interakcije s tiotepom
English: You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
Croatian: Obavijestite liječnika ako imate: - probleme s jetrom ili bubrezima, - probleme sa srcem ili plućima, - napadaje (epilepsiju), ili ako ste ih imali u prošlosti (ako se liječite s fenitoinom ili fosfofenitoinom).
English: Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Croatian: Ne preporučuje se promjena doziranja u slučaju prolaznih promjena jetrenih parametara (vidjeti dio 4.4).
English: Toxic shock syndrome
Croatian: Toksični šok sindrom
English: 20867 Caponago (MB) Italy
Croatian: 20867 Caponago (MB) Italija
English: Filtering does not alter solution potency.
Croatian: Filtriranje ne mijenja djelotvornost otopine.
English: The pharmacokinetics of high dose thiotepa in children between 2 and 12 years of age do not appear to vary from those reported in children receiving 75 mg/m2 or adults receiving similar doses.
Croatian: Farmakokinetika visokih doza tiotepe u djece u dobi između 2 i 12 godina se ne razlikuje od one koja je prijavljena u djece koja su primala 75 mg/m ili u odraslih kojima se daju slične doze.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Croatian: Prihvat transplantata: Ostvaren je prihvat (92% -100%) u svim pripremnim liječenjima i smatra se da je do toga došlo u očekivano vrijeme.
English: There is no known antidote for thiotepa.
Croatian: Nema poznatog antidota za tiotepu.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Croatian: Treba razmotriti profilaktičku ili empirijsku uporabu antiinfektivnih lijekova (bakterijskih, gljivičnih, virusnih) za prevenciju i liječenje infekcija za vrijeme trajanja neutropenije.
English: An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Croatian: Alternativno, koristite inaktivirano cjepivo gdje je to moguće (poliomijelitis).
English: The fraction unbound to proteins in plasma is 70-90%; insignificant binding of thiotepa to gamma globulin and minimal albumin binding (10-30%) has been reported.
Croatian: Dio koji nije vezan na proteine plazme iznosi 70-90%; utvrđeno je neznatno povezivanje tiotepe s gama globulinima i minimalno povezivanje s albuminima (10-30%).
English: Further dilution in the infusion bag
Croatian: Daljnje razrjeđenje u infuzijskoj vrećici
English: Respiratory arrest
Croatian: Respiratorni arest
English: Mental status changes
Croatian: Promjene mentalnog stanja
English: Each carton contains 1 vial.
Croatian: Svaka kutija sadrži 1 bočicu.
English: Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Croatian: Mokraćno izlučivanje tiotepe i TEPA je gotovo potpuno nakon 6 odnosno 8 sati.
English: White crystalline powder.
Croatian: Bijeli kristalinični prašak.
English: GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Croatian: Bolest transplantata protiv domaćina (GvHD): sva procijenjena pripremna liječenja su osigurala nisku incidenciju akutnog GvHD, razreda III-IV (od 4% do 24%).
English: These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Croatian: Ove metabolite se ne može naći u mokraći, a ako se formiraju, vjerojatno se izlučuju u žuči ili se kao intermedijarni metaboliti brzo pretvaraju u tiotepu merkapturat.
English: Gastrointestinal ulcer
Croatian: Gastrointestinalni ulkus
English: Therefore, thiotepa is contraindicated during pregnancy.
Croatian: Dakle, primjena tiotepe je kontraindicirana u trudnoći.
English: Frequency of administration and duration of treatment depend on your disease.
Croatian: Učestalost davanja lijeka i trajanje liječenja ovise o bolesti.
English: Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja; potrebno je prije početka liječenja napraviti test za trudnoću.
English: Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Croatian: Živa atenuirana cjepiva (osim cjepiva protiv žute groznice): rizik od sistemske bolesti, potencijalno fatalno.
English: It is not known whether this medicinal product is excreted in breast milk.
Croatian: Nije poznato izlučuje li se ovaj lijek u majčinom mlijeku.
English: In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Croatian: U nekim slučajevima, prijavljene su stope recidiva od 35% i 45% nakon pet godina, odnosno nakon šest godina.
English: Delirium Nervousness Hallucination Agitation
Croatian: Delirij Nervoza Halucinacije Agitacija
English: As a precautionary measure, women must not breast-feed during treatment with TEPADINA.
Croatian: Kao mjera predostrožnosti, žene ne smiju dojiti tijekom liječenja lijekom TEPADINA.
English: The mean urinary recovery of thiotepa and its metabolites is 0.5% for the unchanged medicinal product and monochlorotepa, and 11% for TEPA and thiotepa-mercapturate.
Croatian: Srednja vrijednost eliminacije tiotepe i njenih metabolita u mokraći je 0,5% za nepromijenjeni lijek i monoklorotepu, a 11% za TEPA i tiotepa merkapturat.
English: For instructions on reconstitution and further dilution prior to administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju prije primjene, vidjeti dio 6.6.
English: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Germany
Croatian: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Njemačka
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk of hepatic veno-occlusive disease (see section 4.8).
Croatian: Bolesnici u kojih je prethodno provedena radioterapija, veća ili jednaka trima ciklusima kemoterapije, ili u kojih je prethodno provedena transplantacija matičnih stanica, mogu imati povećani rizik za razvoj veno-okluzivne bolesti (vidjeti dio 4.8).
English: During the concomitant use of thiotepa and inhibitors of CYP2B6 or CYP3A4, patients should be carefully monitored clinically (see section 4.5).
Croatian: Tijekom istodobne uporabe tiotepe i inhibitora CYP2B6 ili CYP3A4, potrebno je pažljivo kliničko praćenje bolesnika (vidjeti dio 4.5).
English: The total clearance of thiotepa ranged from 11.4 to 23.2 l/h/m2.
Croatian: Eliminacija Ukupni klirens tiotepe je u rasponu od 11,4 do 23,2 l/h/m2.
English: This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.
Croatian: Na taj način, omogućuje transplantaciju novih stanica koštane srži (hematopoetske progenitorne stanice), koje će pak omogućiti tijelu proizvodnju zdravih krvnih stanica.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6. 6.3 Rok valjanosti
English: The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Croatian: Metaboliti su aktivni alkilirajući agensi, ali njihova uloga u antitumorskoj aktivnosti tiotepe ostaje nejasna.
English: Cases of leukoencephalopathy have been observed following treatment with thiotepa in adult and paediatric patients with multiple previous chemotherapies, including methotrexate and radiotherapy.
Croatian: Slučajevi leukoencefalopatije zabilježeni su nakon liječenja tiotepom u odraslih i pedijatrijskih bolesnika uz višestruke prethodne kemoterapije, uključujući metotreksat i radioterapiju.
English: TEPADINA is unstable in acid medium.
Croatian: TEPADINA je nestabilna u kiselom mediju.
English: After dilution, use within 24 hours when stored in a refrigerator.
Croatian: Nakon razrjeđivanja, primijeniti u roku od 24 sata, ako se čuva u hladnjaku.
English: These include infection and Graft-versus host disease (GvHD) which, although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Croatian: GvHD = graft versus host disease) koje su, iako nisu izravno povezane, bile vodeći uzrok pobola i smrtnosti, posebno kod alogene TKMS.
English: This risk is increased in subjects who are already immunosuppressed by their underlying disease.
Croatian: Rizik je veći kod bolesnika koji već imaju oslabljeni imunološki sustav zbog osnovne bolesti.
English: Disease Free Survival (DFS): Percentages of 40% - 75% with follow-up of more than 1 year have been reported.
Croatian: Preživljenje bez bolesti (DFS - Disease Free Survival): Prijavljeni su postotci od 40% - 75% uz periode praćenja duže od 1 godine.
English: Interaction common to all cytotoxics
Croatian: Interakcije zajedničke za sve citotoksike
English: - if you are allergic to thiotepa, - if you are pregnant or think you may be pregnant, - if you are breast-feeding, - if you are receiving yellow fever vaccination, live virus and bacterial vaccines.
Croatian: Nemojte primjenjivati lijek TEPADINA: - ako ste alergični na tiotepu, - ako ste trudni ili ako sumnjate na moguću trudnoću, - ako dojite, - ako primate cjepivo protiv žute groznice, cjepiva sa živim virusima ili bakterijama.
English: The haematological status needs to be closely monitored and vigorous supportive measures instituted as medically indicated.
Croatian: Potrebno je pažljivo praćenje hematološkog statusa i provođenje učinkovitih potpornih mjera prema medicinskim indikacijama.
English: No dose adjustment was deemed necessary.
Croatian: Nije bilo potrebe za prilagodbom doze.
English: The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine.
Croatian: Radiomimetičko djelovanje tiotepe se najvjerojatnije ostvaruje putem oslobađanja radikala etilen imina koji, slično kao kod radioterapije, uzrokuju razbijanje DNA veza, na primjer alkilacijom gvanina na N-7 poziciji, s odvajanjem purina od šećerne baze i oslobađanjem alikiliranog gvanina.
English: After intravenous administration, CSF medicinal product exposure is nearly equivalent to that achieved in plasma; the mean ratio of AUC in CSF to plasma for thiotepa is 0.93.
Croatian: Nakon intravenske primjene, izloženost lijeku u likvoru je gotovo jednaka onoj dobivenoj u plazmi; znači, srednja vrijednost omjera AUC likvora/plazme za tiotepu je 0,93.
English: Disease Free Survival (DFS): With a follow-up of 36 to 57 months, DFS ranged from 46% to 70% in the reported studies.
Croatian: Preživljenje bez bolesti (DFS - Disease Free Survival): Uz razdoblja praćenja od 36 do 57 mjeseci, DFS je bilo u rasponu od 46% do 70% u navedenim studijama.
English: • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
Croatian: • uz ili bez zračenja cijelog tijela, kao pripremno liječenje prije alogene ili autologne transplantacije krvotvornih matičnih stanica (TKMS) u hematoloških bolesti u odraslih i pedijatrijskih bolesnika;
English: The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Croatian: Navedeni su sažeti rezultati objavljenih kliničkih studija koje podupiru djelotvornost tiotepe:
English: The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Croatian: Otopina za infuziju se mora primijeniti u bolesnika putem seta za infuziju koji je opremljen linijskim filtrom od 0,2 µm.
English: Growth retardation
Croatian: Zaostajanje u rastu
English: TEPADINA is for single use only.
Croatian: TEPADINA je isključivo za jednokratnu uporabu.
English: Thiotepa must not be concurrently administered with cyclophosphamide when both medicinal products are present in the same conditioning treatment.
Croatian: Tiotepa se ne smije primjenjivati istodobno s ciklofosfamidom, kada su oba lijeka prisutna u istom pripremnom liječenju.
English: Thiotepa appears to be metabolised via CYP2B6 and CYP3A4.
Croatian: Čini se da se tiotepa metabolizira putem CYP2B6 i CYP3A4.
English: Pulmonary arterial hypertension
Croatian: Plućna arterijska hipertenzija
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane prema redoslijedu smanjenja ozbiljnosti.
English: TEPADINA is indicated, in combination with other chemotherapy medicinal products:
Croatian: TEPADINA je indicirana, u kombinaciji s drugim kemoterapeuticima:
English: During conversion of GSH conjugates to N-acetylcysteine conjugates, GSH, cysteinylglycine, and cysteine conjugates are formed.
Croatian: Tijekom pretvorbe GSH-konjugata u N-acetilcistein konjugate, formiraju se GSH, cisteinil-glicin i cisteinski konjugati.
English: Infection susceptibility increased Sepsis
Croatian: Povećana sklonost infekcijama Sepsa
English: Side effects of TEPADINA may occur with certain frequencies, which are defined as follows:
Croatian: Do nuspojava lijeka TEPADINA može doći s određenim učestalostima, koje su definirane kako slijedi:
English: Like all medicines, TEPADINA can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Generalised oedema
Croatian: Generalizirani edem
English: Thiotepa might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents (busulfan, fludarabine and cyclophosphamide) (see section 4.8).
Croatian: Tiotepa može izazvati plućnu toksičnost, koja može pojačati učinke uzrokovane drugim citotoksičnim agensima (busulfan, fludarabin i ciklofosfamid) (vidjeti 4.8).
English: GENETIC DISEASES
Croatian: GENETSKE BOLESTI
English: Due to its lack of extramedullary toxicity despite dose escalation beyond myelotoxic doses, thiotepa has been used for decades in combination with other chemotherapy medicinal products prior to autologous and allogeneic HPCT.
Croatian: Zbog toga što nema izvanmedularnu toksičnost, unatoč povećanju doze iznad mijelotoksične doze, tiotepa se desetljećima koristi u kombinaciji s drugim kemoterapijskim lijekovima prije autologne i alogene TKMS.
English: Concomitant use with live attenuated vaccines (except yellow fever vaccines), phenytoin and fosphenytoin is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobno korištenje sa živim atenuiranim cjepivima (osim cjepiva protiv žute groznice), fenitoinom i fosfenitoinom (vidjeti dio 4.5).
English: The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia.
Croatian: Najvažnije nuspojave koje se mogu očekivati kod predoziranja su mijeloablacija i i pancitopenija.
English: Due to the increase of thrombotic risk in case of malignancy, the use of anticoagulative treatment is frequent.
Croatian: Imajući u vidu povećani rizik za trombozu u bolesnika s malignim bolestima, korištenje antikoagulansa prilikom liječenja je vrlo često.
English: Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Croatian: Tiotepa podliježe brzom i opsežnom metabolizmu u jetri i u roku od sat vremena od infuzije je bilo moguće identificirati metabolite u urinu.
English: Due to its pharmacological properties and its potential toxicity for breast-fed newborns/infants, breast-feeding is contraindicated during treatment with thiotepa.
Croatian: Zbog svojih farmakoloških svojstava i potencijalne toksičnosti za novorođenčad/dojenčad, dojenje je kontraindicirano tijekom liječenja s tiotepom.
English: The apparent volume of distribution of thiotepa appears independent of the administered dose.
Croatian: Volumen raspodjele tiotepe je, čini se, neovisan o danoj dozi.
English: The conditioning treatment must provide cytoreduction and ideally disease eradication.
Croatian: Pripremno liječenje mora osigurati citoredukciju i teorijski, iskorijeniti bolest.
English: You must not use TEPADINA during pregnancy.
Croatian: Ne smijete koristiti lijek TEPADINA u trudnoći.
English: From a microbiological point of view, the product should be used immediately after dilution.
Croatian: Sa mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon razrjeđivanja.
English: Due to its highly myeloablative characteristics, thiotepa enhances recipient immunosuppression and myeloablation, thus strengthening engraftment; this compensates for the loss of the GvHD-related GvL effects.
Croatian: Zbog svojih veoma visokih mijeloablativnih osobina, tiotepa pojačava imunosupresiju i mijeloablaciju u primatelja, jačajući time prihvat transplantata; to kompenzira gubitak učinka GvL povezanih sa GvHD.
English: TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
Croatian: TEPADINA sadrži djelatnu tvar tiotepu, koja pripada skupini lijekova koji se nazivaju alkilirajući agensi.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Croatian: Sve procedure za prijenos zahtijevaju strogo pridržavanje aseptičkih tehnika, po mogućnosti koristeći sigurnosni kabinet s okomitim laminarnim protokom zraka.
English: • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Croatian: • kada je visoko-dozna kemoterapija, uz potporu sa TKMS, prikladna za liječenje solidnih tumora u odraslih i pedijatrijskih bolesnika.
English: Only colourless solutions, without any particulate matter, must be used.
Croatian: Smiju se primijeniti samo bezbojne otopine bez čestica.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Croatian: Ozbiljne toksičnosti, uključujući hematološku i jetrenu toksičnost te toksičnost dišnog sustava su smatrane očekivanim posljedicama pripremne terapije i transplantacije.
English: Therefore, the use of gloves is recommended in preparing the solution for infusion.
Croatian: Stoga se preporučuje uporaba rukavica prilikom pripreme otopine za infuziju.
English: Thiotepa was shown to impair fertility and interfere with spermatogenesis in male mice, and to impair ovarian function in female mice.
Croatian: Također je pokazano da tiotepa oštećuje plodnost i ometa spermatogenezu kod mužjaka miševa i utječe na funkciju jajnika u ženki.
English: Therefore, a clinical monitoring should be exercised during the concomitant use of thiotepa and these medicinal products.
Croatian: Zbog toga je potrebno pažljivo kliničko praćenje bolesnika tijekom istodobne uporabe tiotepe i ovih lijekova.
English: MULTIPLE MYELOMA
Croatian: MULTIPLI MIJELOM
English: These data support the efficacy of conditioning regimens based on thiotepa in all haematological diseases.
Croatian: Ovi podaci potvrđuju djelotvornost pripremnih terapija koje se temelje na tiotepi kod svih hematoloških bolesti.
English: Concomitant use to take into consideration Ciclosporine, tacrolimus: excessive immunosuppression with risk of lymphoproliferation.
Croatian: Istodobna primjena koju treba procijeniti Ciklosporin, takrolimus: pretjerana imunosupresija s rizikom limfoproliferativnih bolesti.
English: In allogeneic HPCT, the conditioning treatment must be sufficiently immunosuppressive and myeloablative to overcome host rejection of the graft.
Croatian: U alogene TKMS, pripremno liječenje mora biti dovoljno imunosupresivno i mijeloablativno kako bi se spriječilo odbacivanje transplantata.
English: Constipation Gastrointestinal perforation Ileus
Croatian: Konstipacija Gastrointestinalna perforacija Ileus
English: The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Croatian: Posljedica liječenja sa tiotepom, u preporučenim dozama i prema preporučenom rasporedu, je izrazita mijelosupresija koja se javlja kod svih bolesnika.
English: Contraindications of concomitant use Yellow fever vaccine: risk of fatal generalized vaccine-induced disease.
Croatian: Kontraindikacije prilikom istodobne primjene Cjepivo protiv žute groznice: rizik od cjepivom uzrokovane generalizirane bolesti s fatalnim ishodom.