natgillin/translations-raw huggingface dataset:
A population pharmacokinetic analysis indicated that the plasma clearance of trabectedin is not influenced by age (range 19-83 years), or gender.
Farmakokinetična analiza populacije je pokazala, da na očistek trabektedina v plazmi ne vplivata niti starost (od 19- 83 let), niti spol.
The effects of race and ethnicity on trabectedin pharmacokinetics have not been studied.
Učinkov rasne in etnične pripadnosti na farmakokinetiko trabektedina niso preiskali.
There is no relevant influence of renal function measured by creatinine clearance on trabectedin pharmacokinetics within the range of values (≥ 34.4 ml/ min) present in the patients included in the clinical studies.
Ledvična funkcija, merjena kot očistek kreatinina, nima pomembnega vpliva na farmakokinetiko trabektedina znotraj obsega vrednosti (≥ 34, 4 ml/ min), pri bolnikih, vključenih v klinične študije.
No data are available in patients with a creatinine clearance of less than 34.4 ml/ min.
Pri bolnikih z očistkom kreatinina manj kot 34, 4 ml/ min, ni podatkov.
The low recovery (< 9% in all studied patients) of total radioactivity in the urine after a single dose of 14 C-labelled trabectedin indicates that renal impairment has little influence on the elimination of trabectedin or its metabolites.
Nizka stopnia skupne rekuperacije radioaktivnosti (< 9% pri vseh preiskanih bolnikih) v urinu po enkratnem odmerku trabektedina z radioaktivno oznako 14C kaže, da je vpliv ledvične okvare na izločanje trabektedina ali njegovih presnovkov majhen.
Although the population analysis showed no relationship between the serum liver enzymes concentrations and the plasma clearance of trabectedin, systemic exposure to trabectedin may be increased in patients with hepatic impairment; therefore close monitoring of toxicity is warranted.
Zato je treba zagotoviti skrbno nadziranje toksičnih učinkov.
A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Za določitev najvišjih plazemskih koncentracij Cmax) je bil izbran 1- uren infuzijski režim,, med tistimi, ki so bili opazovani v kliniki.
The plasma trabectedin levels attained were 10.6 ± 5.4 (Cmax), higher than those reached in patients after infusion of 1500 μ g/ m2 for 24 (Cmax of 1.8 ± 1.1 ng/ ml) and similar to those reached after administration of the same dose by 3 hour infusion (Cmax of 10.8 ± 3.7 ng/ ml).
Dobljene ravni trabektedina v plazmi so bile 10, 6 ± 5, 4 (Cmax), višje kot so jih dosegli pri bolnikih po infuziji 1. 500 μg/ m2 za 24 (Cmax 1, 8 ± 1, 1 ng/ ml) in podobni tistim, doseženim po apliciranju istega odmerka v 3- urni infuziji (Cmax 10, 8 ± 3, 7 ng/ ml).
11 Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Ugotovili so, da sta mielosupresija in hepatotoksičnost glavna toksična učinka trabektedina.
These findings were secondary to severe local reaction at the administration site, and therefore uncertainly attributable to trabectedin; however, caution must be guaranteed in the interpretation of these renal findings, and treatment-related toxicity cannot be excluded.
Vendar pa je potrebna pri razlagi takih ledvičnih izsledkov previdnost, toksičnosti, povezane z zdravljenjem, pa ni možno izključiti.
Sucrose.
Saharoza.
Potassium dihydrogen phosphate.
Kalijev dihidrogenfosfat.
Phosphoric acid (for pH-adjustment).
Fosforna kislina (za prilagoditev pH).
Potassium hydroxide (for pH-adjustment).
Kalijev hidroksid (za prilagoditev pH).
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, navedenimi v poglavju 6. 6.
From a microbiological point of view, the reconstituted solution should be diluted and used immediately.
Iz mikrobiološkega vidika je treba rekonstituirano raztopino nemudoma raztopiti in porabiti.
If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted product are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če se rekonstituirana raztopina ne razredči in porabi takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila ekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstruiranega in razredčenega zdravila glejte poglavje 6. 3.
12 Yondelis is supplied in a Type I colourless glass vial with a bromobutyl rubber stopper covered with an aluminium flip-off seal.
Zdravilo Yondelis je dobavljeno v viali iz prozornega stekla tipa I z zamaškom iz bromobutilne gume, pokritim z aluminijasto zaporko tipa „ flip- off “.
Each vial contains 0.25 mg of trabectedin.
Viala vsebuje 0, 25 mg trabektedina.
Each outer carton contains one vial.
Vsaka škatla vsebuje eno vialo.
Preparation for intravenous infusion
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom 12 Priprava inravenske infuzije
Yondelis must be reconstituted and further diluted prior to infusion.
Zdravilo Yondelis je treba pred infundiranjem rekonstituirati in razredčiti.
Each vial containing 0.25 mg of trabectedin is reconstituted with 5 ml of sterile water for injections.
Vsaka viala, ki vsebuje 0, 25 mg trabektedina, se rekonstituira s 5 ml sterilne vode za injekcije.
The solution obtained has a concentration of 0.05 mg/ ml and is for single-use only.
Koncentracija dobljene raztopine, ki je za enkratno uporabo, je 0, 05 mg/ ml.
This reconstituted solution contains 0.05 mg/ ml of trabectedin.
Rekonstituirana raztopina vsebuje 0, 05 mg/ ml trabektedina.
The reconstituted solution should be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion.
Rekonstituirano raztopino je treba redčiti z natrijevim kloridom 9 mg/ ml (0, 9%) raztopino za infundiranje ali glukozo 50 mg/ ml (5%) raztopino za infundiranje.
BSA = Body Surface Area
Volumen (ml) = PT (m2) x individualen odmerek (mg/ m2) 0, 05 mg/ ml
If administration is to be made through a central venous line, the appropriate amount of reconstituted solution should be withdrawn from the vial and added to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion), being the concentration of trabectedin in the infusion solution ≤ 0.030 mg/ ml.
Če bo potekalo dajanje prek centralne venske linije, potegnite iz viale ustrezno količino rekonstituirane raztopine in jo dodajte v infuzijsko vrečko, ki vsebuje ≥ 50 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje ali glukoza 50 mg/ ml (5%) raztopina za infundiranje), pri čemer je koncentracija trabektedina v raztopini za infundiranje ≤ 0, 030 mg/ ml..
If central venous access is not feasible and a peripheral venous line has to be used, the reconstituted solution should be added to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion).
Če dostop prek centralne vene ni možen in je treba uporabiti periferno vensko linijo, je treba rekonstituirano raztopino dodati v vrečko za infundiranje, ki vsebuje ≥ 1. 000 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje ali glukoza 50 mg/ ml (5%) raztopina za infundiranje).
Personnel should be trained in the correct techniques to reconstitute and dilute the medicinal product and should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Osebje je treba naučiti pravilnih tehnik rekonstitucije in redčenja zdravila.
Pregnant staff must be excluded from working with this medicinal product.
Ob rekonstituciji in redčenju morajo vedno nositi zaščitna oblačila, vključno z masko, očali in rokavicami.
13 Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
Ob nezgodnem stiku s kožo, očmi ali sluznicami je treba prizadeto mesto nemudoma splahniti z obilico vode.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Vsa neuporabljena zdravila ali odpadne snovi je treba odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
Avda. de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Avda. de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
Yondelis 1 mg powder for concentrate for solution for infusion.
Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje.
Each vial contains 1 mg of trabectedin.
Vsaka viala vsebuje 1 mg trabektedina.
Each vial contains 8 mg of potassium and 0.4 g of sucrose.
Vsaka viala vsebuje 8 mg natrija in 0, 4 g saharoze.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Ppodatki o učinkovitosti temeljijo pretežno na bolnikih z liposarkomom in leiomiosarkomom.
- Bilirubin ≤ upper limit of normal (ULN)
Bilirubin ≤ zgornja meja normale (ULN)
- Alkaline phosphatase ≤ 2.5 ULN (consider hepatic isoenzymes 5-nucleotidase or GGT, if the
Alkalna fosfataza ≤ 2, 5 ULN (preučite jetrne izoencime 5- nukleotidazo ali GGT, če je je kost
elevation could be osseous in origin).
izvor povišanja).
15
15 Alanin aminotransferaza (ALT) in aspartat aminotransferaza (AST) ≤ 2, 5 x ULN
- Creatine phosphokinase (CPK) ≤ 2.5 ULN
Kreatina fosfokinaza (CPK) ≤ 2, 5 ULN
In clinical trials, there were no pre-defined limits to the number of cycles administered.
V kliničnih preskšanjih ni bilo predhodno opredeljenih omejitev števila apliciranih odmerkov.
Trabectedin has been administered for 6 or more cycles in 168 out of 569 (29.5%) patients treated with the proposed dose and schedule.
Trabektedin je bil apliciran še 6 ali več ciklov pri 168 od 569 (29, 5%) bolnikov, zdravljenih s predlaganim odmerkom in režimom.
No relevant differences in the safety profile were seen in this patient population.
Pomembnih razlik v profile varnosti pri tej populaciji bolnikov niso opazili.
It seems that plasma clearance and distribution volume of trabectedin are not influenced by age.
Kaže, da starost ne vpliva na plaezmski očistek in porazdelitveni volumen trabektedina.
Patients with impaired hepatic function
Bolniki z okvarjenim delovanjem jeter
16 No studies with the proposed regime have been conducted in patients with liver dysfunction.
16 Pri bolnikih z motenim delovanjem jeter niso izvajali študij s predlaganim režimom.
Patients with elevated bilirubin must not be treated with Yondelis (see section 4.4).
Bolnikov s povišano ravnjo bilirubina ni dovoljeno zdraviti z zdravilom Yondelis (glejte poglavje 4. 4).
Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/ or renal failure.
O rabdomiolizi poročajo redko, običajno v povezavi z mielotoksičnostjo, resnimi nenormalnostmi testov delovanja jeter in/ ali odpovedjo ledvic.
Therefore, CPK should be closely monitored whenever a patient may be experiencing any of these toxicities.
Zato je treba CPK skrbno nadzirati vedno, ko se pri bolniku pojavijo katere koli od teh toksičnih učinkov.
If rhabdomyolysis occurs, supportive measures such as
Če se pojavi rabdomioliza, je treba hitro uvesti podporne
17 parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
17 ukrepe kot je parenteralna hidracija, alkalizacija urina in dializa, kot je indicirano.
Liver Function Test (LFT) abnormalities
Nenormalnost testov delovanja jeter
This medicine contains potassium, less than 1 mmol (39 mg) per vial, i. e. essentially “ potassium-free”.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na vialo, tj. zdravilo je v bistvu „ brez kalija ”.
Since trabectedin is metabolised mainly by CYP3A4, co-administration of substances that inhibit this isoenzyme e. g. ketoconazole, fluconazole ritonavir or clarithromycin could decrease metabolism and increase trabectedin concentrations.
Ker trabektedin presnavlja predvsem CYP3A4, lahko hkratno dajanje učinkovin, ki zavirajo ta izoencim, npr. ketokonazol, flukonazol ritonavir ali klaritromicin zmanjša presnovo in poveča koncentracijo trabektedina.
Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Predklinični podatki so pokazali, da je trabektedin substrat P- gp.
Concomitant administration of inhibitors of Pgp, e. g. cyclosporine and verapamil, may alter trabectedin distribution and/ or 18 elimination.
Hkratno dajanje zaviralcev Pgp, npr. ciklosporina in verapamila lahko spremenijo porazdelitev in/ ali izločanje trabektedina.
CNS toxicity has not been established.
Pomembnosti 18 tega medsebojnega delovanja, npr. toksičnosti za CNS, niso ugotavljali.
Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis.
Pred zdravljenjem se je treba posvetovati o konservaciji sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
Unless otherwise specified, the following safety profile of Yondelis is based on the evaluation in clinical trials of 569 patients treated up to April 2007 with the recommended treatment regime in several cancer types including soft tissue sarcoma, breast cancer, osteosarcoma, ovarian cancer, GIST, melanoma and renal carcinoma.
Razen če je drugače navedeno, temelji profil varnosti za zdravilo Yondelis v nadaljevanju na ocenitvi kliničnih preskušani na 569 bolnikih, zdravljenih do aprila 2007 s priporočenim režimom zdravljenja pri različnih vrstah raka vključno s sarkomom mehkega tkiva, karcinomom dojk, osteosarkomom, karcinomom jajčnikov, GIST, melanomom in karcinomom ledvic.
The frequencies of the adverse reactions reported below are classified as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1000 to < 1/ 100).
V nadaljevanju navedeni neželeni učinki so razvrščeni kot zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 to < 1/ 10) in občasni (≥ 1/ 1. 000 to < 1/ 100).
19 The table below displays the adverse reactions reported in ≥ 1% of patients according to the standard MedDRA system organ class.
19 Preglednica v nadaljevanju prikazuje neželene učinke, o katerih so poročali pri ≥ 1% bolnikov, v skladu z organskimi sistemi po MedDRA.
20 System Organ Class Investigations
20 Organski sistem
21 Most frequent adverse reactions
21 Najpogostejši neželeni učinki
The median time to reach the peak values was 5 days for both AST and ALT.
Mediani čas za doseg najvišjih vrednosti je bil 5 dni za AST in ALT.
Grade 3 or 4 increases of CPK were observed in 4% of patients.
Pri 4% bolnikov so opazili zvišane CPK stopnje 3 ali 4.
22 Dyspnoea:
22 Alopecija:
There is limited data on the effects of trabectedin overdose.
Podatki o učinkih prevelikega odmerka trabektedina je so omejeni.
The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity.
Glavne pričakovane toksični učinki so gastrointestinalne, supresija kostnega mozga in toksičnost za jetra.
Antineoplastic agent, ATC code:
Zdravila za delovanje na novotvorbe (citostatiki), ATC oznaka:
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 efficacy and safety of trabectedin is based in a randomised trial in patients with locally advanced or metastatic liposarcoma or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.
Učinkovitost in varnost trabektedina temelji na randomiziranem preskušanju pri bolnikih z lokalno napredovanim ali ponovljenim liposarkomom ali leiomiosarkomom, pri katerih je bolezen napredovala ali se ponovila po zdravljenju z vsaj antraciklini in ifosfamidi.
The protocol specified final time to progression (TTP) analysis showed a 26.6% reduction in the relative risk of progression for patients treated in the 24-h q3wk group (Hazard Ratio = 0.734 CI 0.554-0.974).
Po protokolu določen končni čas do napredovanja (TTP – „ time to progression “) je pokazal 26, 6% zmanjšanje relativnega tveganja napredovanja za bolnike, zdravljene v skupini 24- h q3wk (razmerje tveganja = 0, 734 CI 0, 554- 0, 974).
23 Systemic exposure after administration as a 24 hour constant rate intravenous infusion is dose proportional at doses up to and including 1.8 mg/ m2.
Sistemska izpostavljenost po odmerjanju v obliki 24- urne intravenske infuzije stalne hitrosti je odmerek, sorazmeren z odmerki do vključno 1, 8 mg/ m2.
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).
23 Po intravneskem 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).
The distribution volume at steady state of trabectedin in human subjects exceeds 5000 l.
Porazdelitveni volumen trabektedina v stanju dinamičnega ravnovesja pri ljudeh presega 5000 l.
A population pharmacokinetic analysis indicated that the plasma clearance of trabectedin is not influenced by age (range 19-83 years), or gender.
Farmakokinetska analiza populacije je pokazala, da na očistek trabektedina v plazmi ne vplivata niti starost (od 19- 83 let), niti spol.
There is no relevant influence of renal function measured by creatinine clearance on trabectedin pharmacokinetics within the range of values (≥ 34.4 ml/ min) present in the patients included in the clinical studies.
Ledvična funkcija, merjena kot očistek kreatinina, nima pomembnega vpliva na farmakokinetiko trabektedina znotraj obsega vrednosti (≥ 34, 4 ml/ min) pri bolnikih, vključenih v klinične študije.
A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Za določitev najvišjih plazemskih koncentracij Cmax) je bil izbran 1 - uren infuzijski režim med tistimi, ki so bili opazovani v kliniki.
24 Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Ugotovili so, da sta mielosupresija in hepatotoksičnost glavni toksična učinka trabektedina.
After reconstitution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Kemična in fizična stabilnost po rekonstituciji je bila 30 ur do 25 ºC.
25 Yondelis is supplied in a Type I colourless glass vial with a bromobutyl rubber stopper covered with an aluminium flip-off seal.
Zdravilo Yondelis je dobavljeno v viali iz prozornega stekla tipa I z zamaškom iz bromobutilne gume, pokritim z aluminijasto zaporko tipa „ flip- off “.
Each vial contains 1 mg of trabectedin.
Viala vsebuje 1 mg trabektedina.
6.6 Special precautions for disposal and other handling
25 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of sterile water for injections.
Vsaka viala, ki vsebuje 1 mg trabektedina, se rekonstituira s 20 ml sterilne vode za injekcije.
Shake the vial until complete dissolution.
Vialo stresajte, dokler raztapljanje ni končana.
BSA = Body Surface Area
Volumen (ml) = POT (m2) x individualen odmerek (mg/ m2) 0, 05 mg/ ml
If administration is to be made through a central venous line the appropriate amount of reconstituted solution should be withdrawn from the vial and added to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion), being the concentration of trabectedin in the infusion solution ≤ 0.030 mg/ ml.
Če bo potekalo dajanje prek centralne venske linije, potegnite iz viale ustrezno količino rekonstituirane raztopine in jo dodajte v infuzijsko vrečko, ki vsebuje ≥ 50 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje ali glukoza 50 mg/ ml (5%) raztopina za infundiranje), pri čemer je koncentracija trabektedina v raztopini za infundiranje ≤ 0, 030 mg/ ml..
If central venous access is not feasible and a peripheral venous line has to be used, the reconstituted solution should be added to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion).
Če dostop prek centralne vene ni možen in je treba uporabiti periferno vensko linijo, je treba rekonstituirano raztopino dodati v vrečko za infundiranje, ki vsebuje ≥ 1. 000 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje) ali glukoza 50 mg/ ml (5%) raztopina za infundiranje.
Pregnant staff must be excluded from working with this medicinal product.
Ob rekonstituciji in redčenju morajo vedno nositi zaščitno opremo, vključno z masko, očali in rokavicami.
26 Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
Ob nezgodnem stiku s kožo, očmi ali sluznicami je treba prizadeto mesto nemudoma splahniti z obilico vode.
Polígono Industrial La Mina Avda. de los Reyes, 1 E-28770 Colmenar Viejo Madrid Spain
Polígono Industrial La Mina Avda. de los Reyes, 1 E- 28770 Colmenar Viejo Madrid Španija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 1. 0, predstavljen v Modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1. 0 načrta za obvladovanje tveganja (RMP), z dne 10. avgusta 2006, predstavljenem v Modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
- kadar se pridobijo nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije,
29 C.
29
To conduct further investigations in order to elucidate whether predictors of response to Yondelis in patients with soft tissue sarcoma can be identified.
Izvajanje dodatnih raziskav z namenom pojasniti, ali je mogoče opredeliti prediktorje odziva na zdravilo Yondelis pri bolnikih s sarkomom mehkega tkiva.
This should include a proposal to assess the efficacy and safety of Yondelis in a sub-group of patients with myxoid liposarcoma and will be submitted to the EMEA by 4Q 2007.
To zajema predlog za ocenitev učinkovitosti in varnosti zdravila Yondelis pri podskupini bolnikov z miksoidnim liposarkomom, ki bo Evropski agenciji za zdravila (EMEA) predložen do 4. četrtletja leta 2007.
Outer carton – 0.25 mg vial
Škatla – 0, 25 mg viala