FrancophonIA/ELRC3.0 huggingface dataset:
English: The relevance of this interaction e.g. central nervous system (CNS) toxicity has not been established.
Croatian: Važnost te interakcije, primjerice toksičnosti za središnji živčani sustav (SŽS), nije utvrđena.
English: In clinical trials, there were no pre-defined limits to the number of cycles administered.
Croatian: U kliničkim ispitivanjima nije bilo prethodno definiranih ograničenja broja primijenjenih ciklusa.
English: In very severe cases this could lead to kidney failure.
Croatian: U vrlo ozbiljnim slučajevima to može dovesti do zatajenja bubrega.
English: Alcohol consumption must be avoided during treatment with Yondelis as this may harm the liver.
Croatian: Mora se izbjegavati konzumacija alkohola tijekom liječenja Yondelisom jer to može oštetiti jetru.
English: Yondelis must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Croatian: Yondelis se ne smije miješati ni razrjeđivati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet.
English: Thus the trabectedin extraction ratio can be considered moderate.
Croatian: Stoga se omjer ekstrakcije trabektedina može smatrati umjerenim.
English: The distribution volume at steady state of trabectedin in human subjects exceeds 5,000 l.
Croatian: Volumen distribucije pri stanju dinamičke ravnoteže trabektedina u ljudi premašuje 5000 l.
English: Dizziness Dysgeusia Peripheral sensory neuropathy Syncope*
Croatian: Omaglica Disgeuzija Periferna senzorna neuropatija Sinkopa*
English: Second reduction
Croatian: Drugo smanjenje
English: If a pregnancy should occur you must tell your doctor immediately and genetic counselling is recommended since Yondelis can cause genetic damage.
Croatian: U slučaju trudnoće morate o njoj odmah obavijestiti svog liječnika, a preporučuje se i genetičko savjetovanje jer Yondelis može prouzročiti genetsko oštećenje.
English: No significant differences were detected in overall survival (OS).
Croatian: Nisu zabilježene znatnije razlike u ukupnom preživljavanju (OS, prema engl.
English: Yondelis with alcohol
Croatian: Yondelis s alkoholom
English: The primary analysis of progression free survival (PFS) was performed in 645 patients with measurable disease and assessed by independent radiology review.
Croatian: Primarna analiza preživljenja bez progresije bolesti (PFS) provedena je na 645 bolesnika s mjerljivom bolešću te je procijenjena na temelju neovisnog radiološkog očitanja.
English: What Yondelis looks like and contents of the pack
Croatian: Kako Yondelis izgleda i sadržaj pakiranja
English: Colony stimulating factors can be administered for haematologic toxicity according to local standard practice.
Croatian: Čimbenici stimulacije kolonije mogu se primijeniti u slučaju hematološke toksičnosti, a u skladu s lokalnom standardnom praksom.
English: Trabectedin was administered as a 24-hour intravenous infusion every 21 days.
Croatian: Trabektedin se primjenjivao kao 24-satna intravenska infuzija svakih 21 dan.
English: Prior to re-treatment, patients must fulfil the baseline criteria defined above.
Croatian: Prije početka ponovnog liječenja bolesnici moraju ispuniti gore definirane osnovne uvjete.
English: Most transaminase elevations improved to grade 1 or to pre-retreatment levels within 15 days, and less than 2% of cycles had recovering times longer than 25 days.
Croatian: Većina povišenja transaminaza poboljšala su se na 1. stupanj ili na razine prije početka liječenja u roku od 15 dana te je manje od 2 % ciklusa imalo vrijeme oporavka dulje od 25 dana.
English: The frequencies are classified as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1000).
Croatian: Učestalost je određena kao vrlo česta (≥ 1/10), česta (≥ 1/100 i < 1/10), manje česta (≥ 1/1000 i < 1/100) i rijetka (≥ 1/10 000 i < 1/1000).
English: • You may also have blood infections (sepsis) if your immune system is greatly compromised.
Croatian: • Možete imati infekciju krvi (sepsu) ako dođe do velikog oštećenja vašeg imunosnog sustava.
English: If you use any of the following medicines during your treatment with Yondelis, you need to be closely monitored as the effects of Yondelis are:
Croatian: Ako koristite bilo koji od sljedećih lijekova tijekom liječenja Yondelisom, morat ćete biti pomno nadzirani jer učinci Yondelisa su u tom slučaju:
English: Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Croatian: Mijelosupresija i hepatotoksičnost identificirane su kao primarne toksičnosti trabektedina.
English: Other medicines and Yondelis
Croatian: Drugi lijekovi i Yondelis
English: You must not use Yondelis if you will receive yellow fever vaccine and it is not recommended that you use Yondelis if you will receive a vaccine containing live virus particles.
Croatian: Ne smijete koristiti Yondelis ako ćete primiti cjepivo protiv žute groznice te nije preporučljivo koristiti Yondelis ako ćete primiti cjepivo koje sadrži čestice živog virusa.
English: There is limited data on the effects of trabectedin overdose.
Croatian: Postoje ograničeni podaci o učincima predoziranja trabektedinom.
English: ALT and AST increases did not follow a cumulative pattern but showed a tendency towards less severe elevations over time.
Croatian: Povišene razinae ALT-a i AST-a nisu slijedile kumulativni uzorak, ali su tijekom vremena pokazale tendenciju prema manjim povišenjima.
English: Additional monitoring of haematological parameters bilirubin, alkaline phosphatase, aminotransferases and CPK should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.
Croatian: Dodatno praćenje hematoloških parametara bilirubina, alkalne fosfataze, aminotransferaza i CPK se mora provoditi jednom tjedno tijekom prva dva ciklusa liječenja te najmanje jednom između liječenja u sljedećim ciklusima.
English: If any of these toxicities reappear in subsequent cycles in a patient exhibiting clinical benefit, the dose may be further reduced (see below).
Croatian: Ako se bilo koja od tih toksičnosti ponovno pojavi u sljedećim ciklusima kod bolesnika s kliničkom dobrobiti od lijeka, doza se može dodatno smanjiti (vidjeti u tekstu koji slijedi).
English: In a placebo-controlled QT/QTc study, trabectedin did not prolong the QTc interval in patients with advanced solid malignancies.
Croatian: U placebom kontroliranom istraživanju QT/QTc-a, trabektedin nije produljio QTc interval kod bolesnika s uznapredovalim solidnim zloćudnim bolestima.
English: Effects of other substances on trabectedin
Croatian: Učinci drugih tvari na trabektedin
English: It will take 3 hours for the treatment of ovarian cancer.
Croatian: Za jedan ciklus liječenja raka jajnika potrebna su 3 sata.
English: Neutropenic infection Sepsis
Croatian: Neutropenijska infekcija Sepsa
English: If symptoms of possible CLS develop, such as unexplained oedema with or without hypotension, the treating physician should reassess serum albumin level.
Croatian: Ako se pojave simptomi mogućeg sindroma kapilarnog curenja, kao što su neobjašnjeni edem s ili bez hipotenzije, nadležni liječnik mora ponovno procijeniti razinu albumina u serumu.
English: First reduction
Croatian: Prvo smanjenje
English: Thus the use of any of these medicines together with Yondelis should be avoided, if possible.
Croatian: Stoga je potrebno izbjegavati primjenu ovih lijekova zajedno sa Yondelisom, ako je to moguće.
English: Appropriate aseptic techniques must be used to prepare the infusion solution (see Instructions for reconstitution and for dilution).
Croatian: Za pripremu infuzijske otopine moraju se primijeniti odgovarajuće aseptičke tehnike (vidjeti upute za rekonstituciju i razrjeđivanje).
English: The requirements for submission of periodic safety update reports of 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 any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti 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: What Yondelis is and what it is used for
Croatian: Što je Yondelis i za što se koristi
English: No cumulative toxicities have been observed in patients treated with multiple cycles.
Croatian: Kumulativna toksičnost nije primijećena kod bolesnika koji su liječeni s više ciklusa.
English: Yondelis should not be used in children below 18 years with paediatric sarcomas because of efficacy concerns (see 5.1 for results of paediatric sarcoma study).
Croatian: Yondelis se ne smije primjenjivati u djece mlađe od 18 godina s pedijatrijskim sarkomima zbog razloga djelotvornosti (vidjeti dio 5.1 za rezultate ispitivanja pedijatrijskih sarkoma).
English: The results of the main efficacy analyses are summarised in the table below:
Croatian: Rezultati glavnih analiza djelotvornosti sažeti su u tablici koja slijedi.
English: Once the infusion is prepared, it should be administered immediately.
Croatian: Jednom kada se infuzija pripremi, mora se odmah upotrijebiti.
English: BSA = Body Surface Area
Croatian: Body Surface Area)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2007
Croatian: Datum prvog odobrenja: 17. rujna 2007.
English: All patients must receive corticosteroids e.g. 20 mg of dexamethasone intravenously 30 minutes prior to PLD (in combination therapy) or Yondelis (in monotherapy); not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Croatian: Svi bolesnici moraju primiti kortikosteroide, primjerice 20 mg deksametazona intravenski 30 minuta prije PLD-a (u kombiniranoj terapiji) ili Yondelisa (u monoterapiji), ne samo kao antiemetičku profilaksu, već i zato što se čini da to ima hepatoprotektivne učinke.
English: If trabectedin is used at the end of pregnancy, potential adverse reactions should be monitored carefully in the newborns.
Croatian: Ako se trabektedin primjenjuje pred kraj trudnoće, moraju se pažljivo pratiti potencijalne nuspojave u novorođenčadi.
English: In this population febrile neutropenia occurred in 2% of patients and in < 1% of cycles.
Croatian: U toj se populaciji febrilna neutropenija pojavila u 2 % bolesnika i u < 1 % ciklusa.
English: The 3 assessors are independent, have no conflict of interest, are all specialists on CLS, and they provided a relevant description of their methodology and criteria, a distinction between possible and probable CLS and for the probable CLS cases, that are fatal, an evaluation of trabectedin causality.
Croatian: Tri ocjenjivača ovog povjerenstva su neovisni, nisu u sukobu interesa, svi su stručnjaci za CLS i pružili su relevantan opis svoje metodologije i kriterija, opis razlika između mogućeg i vjerojatnog CLS-a, a za smrtne slučajeve u kojima je prisutnost CLS-a ocijenjena kao vjerojatna pružili su procjenu uzročne uloge trabektedina.
English: Following intravenous administration, trabectedin demonstrates a high apparent volume of distribution, consistent with extensive tissue and plasma protein binding (94 to 98% of trabectedin in plasma is protein bound).
Croatian: Nakon intravenske primjene trabektedin pokazuje veliki prividni volumen distribucije koji je sukladan s produženim vezanjem za proteine tkiva i plazme (94 do 98 % trabektedina u plazmi vezano je na proteine).
English: Eight patients were treated with a dose of 1.3 mg/m2 and 42 with 1.5 mg/m2.
Croatian: Osam bolesnika liječeno je dozom od 1,3 mg/m2 i 42 s 1,5 mg/m2.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za trabektedin, znanstveni zaključci CHMP-a su sljedeći:
English: The powder has a white to off-white colour and comes in a glass vial.
Croatian: Prašak je bijele do bjelkaste boje te se isporučuje u staklenoj bočici.
English: Log rank test b Fisher's test
Croatian: *Analize primarne djelotvornosti a Log rank test b Fisherov test
English: Yondelis should not be used during pregnancy.
Croatian: Yondelis se ne smije primjenjivati tijekom trudnoće.
English: A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Croatian: Raspored jednosatne infuzije odabran je za postizanje najviših razina u plazmi (Cmax vrijednosti) u rasponu klinički primijećenih razina.
English: Dehydration Hypokalaemia
Croatian: Dehidracija Hipokalijemija
English: Some potential risk factors that may have contributed to increased trabectedin toxicity observed in these cases were dose management inconsistent with recommended guidelines, potential CYP3A4 interaction due to multiple competing CYP3A4 substrates or CYP3A4 inhibitors, or lack of dexamethasone prophylaxis.
Croatian: Neki mogući čimbenici rizika koji su možda doprinijeli porastu toksičnosti zabilježenoj u tim slučajevima bili su upravljanje dozom neusklađeno s preporučenim smjernicama, moguća interakcija CYP3A4 zbog više konkurentnih supstrata CYP3A4 ili inhibitora CYP3A4, ili zbog pomanjkanja profilakse deksametazonom.
English: If severe neutropenia (ANC < 500 cells/mm3) lasting more than 5 days or associated with fever or infection occurs, dose reduction is recommended (see section 4.2).
Croatian: U slučaju teške neutropenije (ABN < 500 stanica/mm3) koja traje više od 5 dana ili je povezana s vrućicom ili infekcijom, preporučuje se smanjenje doze (vidjeti dio 4.2).
English: The monotherapy and combination regimens have been used for up to 38 and 21 cycles respectively.
Croatian: Monoterapija i kombinirani režimi su korišteni u do 38, odnosno 21 ciklusa.
English: Three patients achieved stable disease (one with rhabdomyosarcoma after 15 cycles, one with spindle cell sarcoma after 2 cycles, and one with Ewing sarcoma after 4 cycles.
Croatian: U tri bolesnika postignuto je stanje stabilne bolesti (jedan s rabdomiosarkomom nakon 15 ciklusa, jedan sa sarkomom vretenastih stanica nakon 2 ciklusa i jedan s Ewingovim sarkomom nakon 4 ciklusa).
English: It is recommended to monitor patients for clinical cardiac signs or symptoms.
Croatian: Srčana disfunkcija Preporučuje se nadzirati bolesnike za kliničke znakove ili simptome bolesti srca.
English: See also PLD Summary of Product Characteristics for more detailed information on warnings and precautions.
Croatian: Vidjeti također sažetak opisa svojstava lijeka PLD za iscrpnije informacije o upozorenjima i mjerama opreza.
English: If this is not possible, close monitoring of toxicities are required and dose reductions of trabectedin should be considered.
Croatian: Ako to nije moguće, potrebno je pomno pratiti toksičnosti, a smanjenje doze trabektedina se mora razmotriti.
English: Skin hyperpigmentation*
Croatian: Hiperpigmentacija kože*
English: • If you develop a fever as Yondelis may cause side-effects affecting your blood and liver.
Croatian: • ako dobijete vrućicu jer Yondelis može prouzročiti nuspojave koje utječu na krv i jetru.
English: Neutropenia:
Croatian: Neutropenija:
English: If pregnancy occurs during treatment, the patient must be informed of the potential risk to the foetus (see section 5.3) and be monitored carefully.
Croatian: Ako tijekom liječenja dođe do trudnoće, bolesnicu se mora obavijestiti o mogućem riziku za fetus (vidjeti dio 5.3.) te je pomno pratiti.
English: The main secondary endpoints are summarized in the table below:
Croatian: Glavni sekundarni ishodi su sažeti u tablici koja slijedi:
English: It followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Croatian: Nastupa predvidivo brzo, uz reverzibilnost te se rijetko povezuje s vrućicom ili infekcijom.
English: The median patient age was 56 years (range 17 to 81), 30% were male, 77% Caucasian, 12% African American and 4% Asian.
Croatian: Medijan dobi bolesnika iznosio je 56 godina (raspon od 17 do 81), 30 % su bili muškarci, 77 % bijelci, 12 % afroamerikanci i 4 % azijati.
English: The low recovery (< 9% in all studied patients) of total radioactivity in the urine after a single dose of 14C-labelled trabectedin indicates that renal impairment has little influence on the elimination of trabectedin or its metabolites.
Croatian: Nizak stupanj prikupljene (< 9 % u svih bolesnika iz ispitivanja) ukupne radioaktivnosti u mokraći nakon pojedinačne doze 14C-označenog trabektedina upućuje na to da oštećenje bubrega ima malo utjecaja na eliminaciju trabektedina ili njegovih metabolita.
English: Volume (ml) = BSA (m2) x individual dose (mg/m2) 0.05 mg/ml
Croatian: Volumen (ml) = BSA (m2) x individualna doza (mg/m2) 0,05 mg/ml
English: Yondelis should not be used in children below 18 years of age with paediatric sarcomas.
Croatian: Yondelis se ne smije primjenjivati kod djece mlađe od 18 godina s pedijatrijskim sarkomima.
English: Trabectedin should not be used during pregnancy.
Croatian: Trabektedin se ne smije primjenjivati tijekom trudnoće.
English: Patients may develop a potentially severe injection site reaction when trabectedin is administered through a peripheral venous line.
Croatian: Bolesnici mogu razviti potencijalno tešku reakciju na mjestu injiciranja kad se trabektedin primjenjuje kroz periferni venski put.
English: Fertility studies with trabectedin were not performed but limited histopathological changes were observed in the gonads in the repeat dose toxicity studies.
Croatian: Ispitivanja plodnosti s trabektedinom nisu provedena, ali ograničene histopatološke promjene primijećene su na gonadama u ispitivanjima toksičnosti s ponovljenim dozama.
English: There could also be damage to your nerves which may result in muscle pain, weakness and numbness.
Croatian: Može doći i do oštećenja živaca, što može prouzročiti bol u mišićima, slabost i obamrlost.
English: An infection could also give you a raised temperature
Croatian: Od infekcije možete dobiti povišenu temperaturu (vrućicu).
English: • You could have increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes).
Croatian: • Možete imati povišene razine žutog pigmenta bilirubina u krvi koji može prouzročiti žuticu (žutilo kože, sluznice i očiju).
English: It may present as red skin of the palms, fingers, and soles of the feet that later may become swollen and violaceous.
Croatian: Može se manifestirati kao crvenilo kože na dlanovima, prstima i tabanima stopala, koje kasnije može prijeći u oticanje i ljubičastu boju.
English: Secondary CLSs are mostly due to malignant hematological diseases, viral infections, and treatments such as chemotherapies and therapeutic growth factors.
Croatian: Sekundarni CLS-ovi uglavnom su posljedica malignih hematoloških bolesti, virusnih infekcija i liječenja kao što su kemoterapije i terapijske primjene čimbenika rasta.
English: Since the systemic exposure to trabectedin is on average approximately doubled (see section 5.2) due to hepatic impairment and therefore the risk of toxicities might be increased, patients with clinically relevant liver diseases, such as active chronic hepatitis, must be closely monitored and the dose adjusted if needed.
Croatian: Budući da je sistemska izloženost trabektedinu u prosjeku otprilike podvostručena (vidjeti dio 5.2) zbog oštećenja funkcije jetre te bi stoga i rizik od toksičnosti mogao biti povećan, bolesnici s klinički značajnom bolešću jetre, kao što je aktivni kronični hepatitis, moraju se pomno nadzirati, a doza se mora po potrebi prilagoditi.
English: In the event that further dose reductions are necessary, treatment discontinuation should be considered.
Croatian: U slučaju potrebe za daljnjim smanjenjem doze, mora se uzeti u obzir prekid liječenja.
English: Yondelis must be reconstituted and further diluted prior to infusion (see also section 3).
Croatian: Yondelis se mora rekonstituirati i potom razrijediti prije infuzije (vidjeti također dio 3.).
English: Their finding of possible or probable trabectedin causality in 5 of 6 fatal cases among 14 probable CLS cases warrants an update of the SmPC within this procedure to reflect there are cases with a fatal outcome.
Croatian: Njihovi nalazi moguće ili vjerojatne uzročne uloge trabektedina u 5 od 6 smrtnih slučajeva od svekupno 14 vjerojatnih slučajeva CLS-a opravdavaju ažuriranje SmPC-a u okviru ovog postupka kako bi se prikazalo da postoje slučajevi sa smrtnim ishodom.
English: Each carton contains one vial.
Croatian: Svaka kutija sadržava jednu bočicu.
English: Serious side effects caused by the treatment with Yondelis:
Croatian: Ozbiljne nuspojave prouzročene liječenjem Yondelisom:
English: No data are available in patients with a creatinine clearance of less than 30.3 ml/min.
Croatian: Nisu dostupni podaci na bolesnicima s klirensom kreatinina manjim od 30,3 ml/min.
English: - The active substance is trabectedin.
Croatian: - Djelatna tvar je trabektedin.
English: All the previously described, could be a sign of damage to your muscles (rhabdomyolysis).
Croatian: Sve navedeno može biti znak oštećenja mišića (rabdomioliza).
English: • feel an excess of fluid in the body (oedema)
Croatian: • imati prekomjernu tekućinu u tijelu (edem).
English: You also may experience a darkening of the urine colour.
Croatian: Mogli biste također imati mokraću tamnije boje.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksičan lijek: rukovati s oprezom.
English: • You may experience, loss of water from the body, weight loss, digestive discomfort and a change in your sense of taste.
Croatian: • Možete imati gubitak vode iz tijela, gubitak tjelesne težine, probavne tegobe i promjenu u osjetu okusa.
English: Most patients treated with Yondelis can be expected to have adverse reactions of any grade (91% in monotherapy and 99% in combination therapy) and less than one third serious adverse reactions of grade 3 or 4 severity (10% in monotherapy and 25% in combination therapy).
Croatian: U većine bolesnika liječenih Yondelisom mogu se očekivati nuspojave bilo kojeg stupnja (91 % u monoterapiji i 99 % u kombiniranoj terapiji), a kod manje od jedne trećine mogu se očekivati ozbiljne nuspojave 3. ili 4. stupnja težine (10 % u monoterapiji i 25 % u kombiniranoj terapiji).
English: This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle.
Croatian: Vezanje na DNK potiče niz događaja koji utječu na nekoliko transkripcijskih čimbenika, proteine koji se vežu na DNK te mehanizme popravka DNK-a, što sve zajedno uzrokuje poremećaje u staničnom ciklusu.
English: • Higher skin pigmentation could occur in patients receiving Yondelis with PLD for ovarian cancer.
Croatian: • Može se pojaviti pojačana pigmentacija kože u bolesnika koji primaju Yondelis s PLD-om za liječenje raka jajnika.
English: The reconstituted solution results in a clear, colourless or slightly yellowish solution, essentially free of visible particles.
Croatian: Rekonstituirana je otopina bistra, bezbojna ili blago žućkaste boje, u osnovi bez vidljivih čestica.
English: The benefit in OS with Yondelis plus PLD was not due to the effect of subsequent therapies, which were well balanced between the two treatment arms.
Croatian: Korist u OS-u kod Yondelisa i PLD-a nije bila posljedica učinka naknadnih terapija koje su bile dobro usklađene između dvije skupine koje su liječene.