natgillin/translations-raw huggingface dataset:
Genetic counselling is also recommended for patients wishing to have children after therapy.
Gensko svetovanje se priporoča tudi za bolnike, ki želijo po terapiji imeti otroke.
* Primary efficacy analysis a
* Analiza primarne učinkovitosti a
If this occurs, active supportive therapy should be started immediately.
Če se to pojavi, je treba nemudoma uvesti aktivno podporno terapijo.
Treatment continued whilst clinical benefit was noted.
Zdravljenje se je nadaljevalo, dokler so se kazale klinične koristi.
A total of 76 Japanese patients were enrolled in the study, among which 73 patients were included in the final analysis set.
V študijo je bilo vključenih skupno 76 japonskih bolnikov, od katerih jih je bilo 73 zajetih v končni nabor za analizo.
No relevant differences in the safety profile were seen in this patient population.
Pomembnih razlik v profilu varnosti pri tej populaciji bolnikov niso opazili.
The required volume should be calculated as follows:
Potreben volumen se izračuna tako:
Independent radiology review, measurable disease *
Neodvisna radiološka ocena, merljiva bolezen *
Forty patients were fully evaluable for response.
Odziv štiridesetih bolnikov je bil popoln.
The length of your whole treatment period will depend on your progress and how well you feel.
Trajanje zdravljenja bo odvisno od vašega napredka in splošnega počutja.
Some of the symptoms or signs of extravasation may not be visible until several hours after it occurred.
Nekateri od simptomov ali znakov ekstravazacije lahko postanejo opazni šele nekaj ur zatem,
Appropriate aseptic techniques must be used.
Uporabljajte ustrezne aseptične tehnike.
CLS can be idiopathic (Clarkson's disease) or secondary to various conditions and treatments.
CLS je lahko idiopatski (Clarksonova bolezen) ali sekundarni pri različnih stanjih in zdravljenjih.
The same criteria as above must be met prior to re-treatment.
Isti pogoji kot zgoraj morajo biti izpolnjeni tudi pred ponovnim zdravljenjem.
• If you have an allergic reaction (hypersensitivity).
• Če imate alergično reakcijo (preobčutljivost).
Prior to re-treatment, patients must fulfil the baseline criteria defined above.
Pred ponovnim zdravljenjem morajo bolniki izpolniti osnovne kriterije, opredeljene zgoraj.
Once the infusion is prepared, it should be administered immediately.
Ko je infuzija pripravljena, jo je treba nemudoma aplicirati.
In very severe cases this could lead to kidney failure.
V hudih primerih lahko to povzroči odpoved ledvic.
Renal elimination of unchanged trabectedin in humans is low (less than 1%).
Izločanje Izločanje nespremenjenega trabektedina skozi ledvice je pri ljudeh nizko (manj kot 1 %).
From a microbiological point of view, the reconstituted solution should be diluted and used immediately.
Iz mikrobiološkega vidika je treba rekonstituirano raztopino nemudoma razredčiti in porabiti.
It is possible for it to take a few days before the full extent of tissue damage is visible.
Včasih lahko traja več dni, preden postane opazen celoten obseg poškodb tkiva.
It will take 3 hours for the treatment of ovarian cancer.
Za zdravljenje karcinoma jajčnikov bo trajalo 3 ure.
Patients who experience any of these adverse reactions during therapy must not drive or operate machines.
Bolniki, ki izkusijo katere koli od teh neželenih učinkov med terapijo, naj ne vozijo in ne upravljajo strojev.
Mortality in the presence of hepatic injury occurred in less than 1% of patients in both regimens.
Smrtnost v prisotnosti poškodb jeter se je pojavila pri manj kot 1 % bolnikov pri obeh režimih.
Maximum fetal tissue radioactivity concentration was similar to that in maternal plasma or blood.
Največja koncentracija radioaktivnosti v fetalnem tkivu je bila podobna kot v materini plazmi ali krvi.
These signs could be indicative of the inability of the liver to perform its normal function.
Ti znaki lahko pomenijo nezmožnost jeter, da bi opravljala svojo normalno funkcijo.
• be more prone to infections.
• ste bolj nagnjeni k okužbam.
BSA = Body Surface Area
PT = površina telesa
The median time to reach the peak values was 5 days for both AST and ALT.
Mediani čas za dosego najvišjih vrednosti je bil 5 dni za AST in ALT.
- if you will receive yellow fever vaccine.
- če boste prejeli cepivo proti rumeni mrzlici.
Trabectedin is genotoxic both in vitro and in vivo.
Trabektedin je genotoksičen in vitro in in vivo.
This value is approximately one-half the rate of human hepatic blood flow.
Ta vrednost je približno enaka polovici jetrnega krvnega pretoka pri človeku.
If you are not sure what the side effects below are, you should ask your doctor to explain them to you in more detail.
Če niste prepričani, kaj pomenijo neželeni učinki, navedeni spodaj, vprašajte zdravnika, da vam jih bolj podrobno razloži.
A rapid decline in serum albumin level may be indicative of CLS.
Hiter padec ravni serumskega albumina je lahko znak CLS.
Considering the nature of the compound (cytotoxic and mutagenic), it is likely to affect the reproductive capacity.
Ob upoštevanju narave spojine (citotoksična in mutagena učinkovina), je verjetno, da bo vplivala na sposobnost razmnoževanja.
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.
Trije ocenjevalci so neodvisni, ni navzkrižja interesov, so vsi specialist za CLS in so zagotovili ustrezen opis svoje metodologije in meril, razlikovanje med možnim in verjetnim CLS ter za verjetne primere CLS, ki so smrtni, oceno trabektedina kot možnega vzroka.
In some patients, a compartment syndrome can occur.
Pri nekaterih bolnikih se lahko pojavi utesnitveni sindrom.
If pregnancy occurs during treatment the possibility of genetic counselling should be considered.
Če nosečnost nastopi med zdravljenjem, je treba razmisliti o možnosti genskega svetovanja.
• You could have an allergic reaction.
• Morda imate alergijsko reakcijo.
The terminal half-life is long (population value of the terminal elimination phase: 180-hr).
Končna razpolovna doba je dolga (populacijska vrednost končne faze izločanja je: 180 ur).
The relevance of this interaction e.g. central nervous system (CNS) toxicity has not been established.
Pomembnosti tega medsebojnega delovanja, npr. toksičnosti za centralni živčni sistem (CŽS), niso ugotavljali.
Overall 20% of the 1,164 patients in the integrated safety analysis of monotherapy clinical trials were over 65 years.
Skupaj 20 % od 1.164 bolnikov, vključenih v analizo varnosti kliničnih preskušanj z monoterapijo, je bilo starih več kot 65 let.
You also may experience a darkening of the urine colour.
Morda boste opazili potemnitev barve urina.
Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Zdravila, ki vsebujejo statine (za nižanje ravni holesterola in preprečevanje kardiovaskularnih bolezni), so primer zdravil, ki lahko povzročijo poškodbo mišic.
Like all medicines, this medicine or its combination with PLD can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo ali njegova kombinacija s PLD neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Electrocardiogram (ECG) investigations
Elektrokardiografske preiskave (EKG)
Allergic Reactions
Alergične reakcije
Thus the use of any of these medicines together with Yondelis should be avoided, if possible.
Zato se je treba uporabi katerega koli od teh zdravil v kombinaciji z zdravilom Yondelis izogniti, če je to mogoče.
The same dose should be given for all cycles provided that no grade 3-4 toxicities are seen and that the patient fulfils the re-treatment criteria.
Za vse cikle se daje enak odmerek pod pogojem, da pri bolniku niso zaznane toksičnosti stopnje 3-4 in da izpolnjuje pogoje za ponovno zdravljenje.
Neutropenia is the most common haematological toxicity.
Nevtropenija je najpogostejša hematološka toksičnost.
The secondary endpoints included objective response analysed using the RECIST and Choi criteria.
Sekundarni opazovani dogodki so zajemali objektivni odziv, analiziran po merilih RECIST in Choi.
First reduction
Prvo zmanjšanje
Once a dose has been reduced because of toxicity, dose escalation in the subsequent cycles is not recommended.
Ko se odmerek zaradi toksičnosti enkrat zniža, se stopnjevanje odmerka v naslednjih ciklih ne priporoča.
If any of the following events occur at any time between cycles, the dose must be reduced one level, according to table 1 below, for subsequent cycles:
Če se kadar koli med cikli pojavijo naslednji dogodki, je treba odmerek zmanjšati za eno stopnjo v skladu s tabelo 1 spodaj, za naslednje cikle:
• You may experience headache and sleeping problems.
• Lahko se pojavi glavobol in težave s spanjem.
Trabectedin can have genotoxic effects.
Trabektedin ima lahko genotoksične učinke.
The excretion of trabectedin in milk has not been studied in animals.
Izločanja trabektedina v mleko niso raziskali na živalih.
It is recommended to monitor patients for clinical cardiac signs or symptoms.
Priporoča se spremljanje bolnikov glede kliničnih znakov in simptomov v zvezi z delovanjem srca.
Store in a refrigerator (2ºC - 8ºC).
Shranjujte v hladilniku (2 ºC - 8 ºC).
No specific studies in older people have been performed.
Starejši Posebnih študij na starejših ljudeh niso izvedli.
Therefore you must stop breast-feeding before you start your treatment and you must not begin breast-feeding again until your doctor has confirmed that it is safe to do so.
Z dojenjem je treba prenehati pred začetkom zdravljenja in ga ne smete nadaljevati, dokler vam zdravnik ne potrdi, da je to varno.
The primary analysis of progression free survival (PFS) was performed in 645 patients with measurable disease and assessed by independent radiology review.
Primarna analiza preživetja brez napredovanja (PBN) je bila opravljena pri 645 bolnikih z merljivo boleznijo in ocenjena v neodvisni radiološki oceni.
If symptoms of possible CLS develop, such as unexplained oedema with or without hypotension, the treating physician should reassess serum albumin level.
Če pride do razvoja simptomov morebitnega CLS, kot je na primer nepojasnjen edem z ali brez hipotenzije, mora lečeči zdravnik znova oceniti raven serumskega albumina.
• Your doctor will order regular blood tests to detect any abnormalities in the blood.
• Zdravnik bo naročil redne krvne teste, da odkrije morebitne nepravilnosti v krvi.
Date of latest renewal: 03 August 2012
Datum prve odobritve: 17. september 2007 Datum zadnjega podaljšanja: 3. avgust 2012
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).
Pogostnosti so razvrščene kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in redki (≥ 1/10.000 do < 1/1000).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom jemanja natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
• You may:
• Lahko:
It requires further dilution and is for single-use only.
Treba jo je še razredčiti in je samo za enkratno uporabo.
Most of the values had decreased to grade 1 or resolved by day 14-15 (see section 4.4).
Večina vrednosti je padla na stopnjo 1 ali se je 14-15 dan vrnila na izhodiščno vrednost (glejte poglavje 4.4).
ALT and AST increases did not follow a cumulative pattern but showed a tendency towards less severe elevations over time.
Porast ALT in AST ni sledil kumulativnemu vzorcu, vendar je čez čas kazal nagnjenje v smer manj resnih porastov.
Second reduction
Drugo zmanjšanje
If any of these toxicities reappear in subsequent cycles in a patient exhibiting clinical benefit, the dose may be further reduced (see below).
Če se kateri koli od teh toksičnih učinkov ponovno pojavi v naslednjih ciklih, se pri bolniku, kjer se kaže klinična korist, odmerek lahko še dodatno zniža (glejte spodaj).
The main secondary endpoints are summarized in the table below:
Glavni sekundarni opazovani dogodki so povzeti v spodnji preglednici:
(See also PLD Summary of Product Characteristics for specific handling instructions).
(Glejte tudi povzetek glavnih značilnosti zdravila PLD za posebna navodila za ravnanje z zdravilom).
Treatment with Yondelis should be discontinued until the patient fully recovers.
Zdravljenjem z zdravilom Yondelis je treba prekiniti, dokler bolnik povsem ne okreva.
If this is not possible, close monitoring of toxicities are required and dose reductions of trabectedin should be considered.
Če to ni možno, je treba skrbno nadzirati toksičnost in razmisliti o zmanjšanjih odmerka trabektedina.
Therefore, CPK should be closely monitored whenever a patient may be experiencing any of these toxicities or muscle weakness or muscle pain.
Zato je treba CPK skrbno nadzirati vedno, ko se pri bolniku pojavi kateri koli od teh toksičnih učinkov, oslabelost mišic ali bolečina mišic.
Yondelis must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Zdravila Yondelis ne smemo mešati ali raztapljati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• You could also feel pain in your muscles (myalgia).
• Čutite lahko tudi bolečine v mišicah (mialgija).
Effects of other substances on trabectedin
Učinki drugih učinkovin na trabektedin
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.
Večina povečanj transaminaze se je popravila na raven stopnje 1 ali tisto pred ponovnim apliciranjem v roku 15 dni in manj kot 2 % ciklov je imela čase do vrnitve na izhodiščne vrednosti daljše od 25 dni.
• feel difficulty breathing and coughing
• imate težave z dihanjem in kašljate
Additional anti-emetics may be administered as needed.
Po potrebi je treba dati dodatne antiemetike.
Overall Survival (Final analysis - n=522 events)
Splošno preživetje (končna analiza - n = 522 dogodkov)
• have nose bleeds
• krvavite iz nosu
Pharmacotherapeutic group: Antineoplastic agent, ATC code: L01CX01.
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01CX01.
Withdraw the appropriate amount of reconstituted solution from the vial.
Iz viale potegnite ustrezno količino rekonstituirane raztopine.
Instructions for handling and disposal
Navodila za ravnanje in odstranjevanje
Eight patients were treated with a dose of 1.3 mg/m2 and 42 with 1.5 mg/m2.
Osem bolnikov je bilo zdravljenih z odmerkom 1,3 mg/m2 in 42 s 1,5 mg/m2.
Trabectedin was administered as a 24-hour intravenous infusion every 21 days.
Trabektedin je bil uporabljen kot 24-urna intravenska infuzija vsakih 21 dni.
Of the 333 patients with ovarian cancer who received trabectedin in combination with PLD, 24% were 65 years of age or older and 6% were over 75 years.
Od 333 bolnic s karcinomom jajčnika, ki so prejemale trabektedin v kombinaciji s PLD, jih je bilo 24 % starih 65 ali več let in 6 % več kot 75 let.
However, the incidences of clinical complications related to haematological toxicity such as severe infections or bleeding, or those leading to death or treatment termination, were similar in both subpopulations.
Vendar pa je incidenca kliničnih zapletov, povezana s hematološko toksičnostjo, kot so okužbe ali krvavitve, ali takih, ki so povzročili smrt ali zaključek zdravljenja, podobna v obeh pod-populacijah.
Do not use this medicine if you notice visible particles after the reconstitution or dilution of the medicine.
Ne uporabljajte tega zdravila, če po rekonstituciji ali redčenju zdravila opazite vidne delce.
Creatinine clearance must be monitored prior to and during treatment.
Pred in med zdravljenjem je treba nadzirati očistek kreatinina.
There is no specific antidote for trabectedin currently available.
Trenutno ni na voljo posebnega antidota za trabektedin.
It may present as red skin of the palms, fingers, and soles of the feet that later may become swollen and violaceous.
Prisoten je lahko v obliki rdeče kože na dlaneh, prstih in podplatih, ki lahko kasneje otečejo in postanejo vijolični.
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.
Dodatno nadziranje hematoloških parametrov bilirubina, alkalne fosfataze, aminotransferaz in CPK je potrebno vsak teden prva dva cikla terapije, in vsaj enkrat med zdravljenji v naslednjih ciklih.
Information on in-use stability of the reconstituted and diluted solutions is included in the section for medical and healthcare professionals.
Informacije o stabilnosti za uporabo rekonstituirane in razredčene raztopine so vključene v poglavje za zdravstveno osebje.
These trials evaluated a total of 100 patients with lipo- and leiomyosarcoma and 83 patients with other types of sarcoma.
V teh preskušanjih je bilo ocenjenih skupaj 100 bolnikov z liposarkomom in leiomiosarkomom in 83 bolnikov z drugimi vrstami sarkoma.
If rhabdomyolysis occurs, supportive measures such as parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
Če se pojavi rabdomioliza, je treba hitro uvesti podporne ukrepe, kot je parenteralna hidracija, alkalizacija urina in dializa, kot je indicirano.
Ovarian cancer
Karcinom jajčnikov
• You may have a reaction at the site of injection.
• Lahko se pojavijo reakcije na mestu injiciranja.
If trabectedin is used at the end of pregnancy, potential adverse reactions should be monitored carefully in the newborns.
Pri uporabi trabektedina ob koncu nosečnosti je treba skrbno nadzirati potencialne neželene učinke pri novorojencu.
Therefore, dose adjustments based uniquely on age criteria are not routinely recommended.
Zato se ne priporoča rutinska prilagoditev odmerka samo na podlagi kriterija starosti.
Other P450 enzymes may contribute to metabolism.
Drugi encimi P450 lahko prispevajo k presnovi.
If a diagnosis of CLS is confirmed after exclusion of other causes, the treating physician should discontinue trabectedin and initiate CLS treatment according to institutional guidelines (see sections 4.2 and 4.8).
Če je po izključitvi ostalih vzrokov potrjena diagnoza CLS, mora lečeči zdravnik prenehati uporabljati trabektin in začeti z zdravljenjem, skladnim z institucionalnimi smernicami (glejte poglavji 4.2 in 4.8).
If a pregnancy should occur you must tell your doctor immediately and genetic counselling is recommended since Yondelis can cause genetic damage.
Če pride do nosečnosti, morate o tem nemudoma obvestiti zdravnika, priporoča pa se tudi gensko svetovanje, saj lahko zdravilo Yondelis povzroči poškodbe genov.
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.
Nekateri možni dejavniki tveganja, ki so morda prispevali k povečani toksičnosti trabektedina, ki so jih opazili v tovrstnih primerih, so bili dajanje odmerka v neskladju s priporočenimi smernicami, morebitna interakcija s CYP3A4 zaradi mnogih konkurenčnih substratov za CYP3A4 ali inhibitorjev CYP3A4, oziroma pomanjkanje profilakse z deksametazonom.
Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Predklinični podatki so pokazali, da je trabektedin substrat za P-gp.
* Adverse drug reaction only for Ovarian cancer
* neželeni učinek zdravila le za karcinom jajčnika
In the event that further dose reductions are necessary, treatment discontinuation should be considered.
V primeru, da je treba odmerek še znižati, je treba razmisliti o prenehanju zdravljenja.
In a placebo-controlled QT/QTc study, trabectedin did not prolong the QTc interval in patients with advanced solid malignancies.
V s placebom kontrolirani študiji QT/QTc trabektedin ni podaljšal intervala QTc pri bolnikih z napredovalimi trdimi malignostmi.
In this population febrile neutropenia occurred in 2% of patients and in < 1% of cycles.
V tej populaciji se je febrilna nevtropenija pojavila pri 2 % bolnikov in < 1% ciklov.
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.
Ta vezava na DNK sproži zaporedje dogodkov, ki vplivajo na številne transkripcijske faktorje, na DNA vezane beljakovine in poti popravila DNK, kar končno povzroči motnjo celičnega cikla.
The Pharmacovigilance and Risk Assessment Committee (PRAC) considered the results of the IAC report highly credible.
Odbor za oceno tveganja na področju farmakovigilance (PRAC) je menil, da je poročilo Zunanjega neodvisnega presojevalnega odbora (IAC) zelo verjetno.
See also PLD Summary of Product Characteristics for more detailed information on warnings and precautions.
Glejte tudi povzetek glavnih značilnosti PLD za podrobnejše informacije glede opozoril in previdnostnih ukrepov.
If such combinations are needed, appropriate dose adjustments should be applied in the event of toxicities (see sections 4.2 and 4.4).
Če so takšne kombinacije potrebne, je treba v primeru toksičnosti ustrezno prilagoditi odmerke (glejte poglavji 4.2 in 4.4).
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.
Koristi pri splošnem preživetju z zdravilom Yondelis+PLD ni bilo zaradi učinka kasnejših zdravljenj, ki so bila dobro razporejena med dve skupini zdravljenja.
Trabectedin pharmacokinetic profile is consistent with a multiple-compartment disposition model.
Farmakokinetične profil trabektedina je v skladu z dispozicijskim modelom z več predelki.
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.
Ker je sistemska izpostavljenost trabektedinu povprečno podvojena (glejte poglavje 5.2) zaradi okvarjenega delovanja jeter in je zato tveganje toksičnosti večje, je treba bolnike s klinično pomembnimi boleznimi jeter, kot je aktivni kronični hepatitis, skrbno nadzirati in po potrebi prilagoditi odmerek.
Dose adjustments during treatment
Prilagoditev odmerka med zdravljenjem
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).
Po intravenskem dajanju kaže trabektedin velik navidezni volumen porazdelitve, v skladu z obsežno vezavo v tkiva in na beljakovine plazme (94 do 98 % trabektedina v plazmi je vezanega na beljakovine).
Colony stimulating factors can be administered for haematologic toxicity according to local standard practice.
Za hematološko toksičnost se lahko v skladu z lokalno standardno prakso uporabijo kolonije stimulirajoči faktorji.
Patients may develop a potentially severe injection site reaction when trabectedin is administered through a peripheral venous line.
Bolniki lahko razvijejo potencialno resne reakcije na mestu injiciranja, ko se trabektedin daje skozi periferno vensko linijo.
On the basis of the scientific conclusions for trabectedin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trabectedin is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za trabektedin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) trabektedin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.