natgillin/translations-raw huggingface dataset:
The study primary endpoint was PFS, that showed a statistically significant improvement in favour of trabectedin over BSC [HR=0.07; 95% CI: 0.03-0.16; p<0.0001], with a median PFS in the trabectedin group of 5.6 months [95% CI: 4.1-7.5] and in the BSC group of 0.9 months [95% CI: 0.7-1.0].
Primarni opazovani dogodek študije je bilo preživetje brez napredovanja bolezni (PFS), ki je pokazalo statistično značilno izboljšanje v korist trabektedina v primerjavi z BSC [razmerje tveganj = 0,07; 95-odstotni IZ: 0,03-0,16; p < 0,0001] z medianim PFS 5,6 meseca [95-odstotni IZ: 4,1-7,5] v skupini s trabektedinom in 0,9 meseca v skupini z BSC [95-odstotni IZ: 0,7-1,0].
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.
Ob rekonstituciji in redčenju morajo vedno nositi zaščitna oblačila, vključno z masko, očali in rokavicami.
Yondelis should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3.
1.500 celic/mm3 in številom trombocitov manj kot 100.000 celic/mm3.
Based on independent oncology review, patients with platinum-free interval (PFI) < 6 months (35% in Yondelis+PLD and 37% in PLD arm) had similar PFS in the two arms with both showing median PFS of 3.7 months (HR=0.89, CI: 0.67-1.20).
Na podlagi neodvisne onkološke ocene so imeli bolniki s intervalom preživetja brez platine (platinumfree interval - PFI) < 6 mesecev (35 % pri zdravilu Yondelis+PLD in 37 % v kraku s PLD) podobno PBN v obeh krakih z medianim PBN 3,7 mesecev (RT = 0,89, IZ: 0,67-1,20).
Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes).
Pri uporabi trabektedina so poročali o primerih sindroma povečane prepustnosti kapilar (CLS) (vključno s primeri smrtnih izidov).
Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.
Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte navodila za uporabo.
For the treatment of ovarian cancer, the usual dose is 1.1 mg/m2 body surface area after the administration of 30 mg/m2 body surface area of PLD.
Za zdravljenje karcinoma jajčnikov je običajni odmerek 1,1 mg/m2 površine telesa po apliciranju 30 mg/m2 PLD na površino telesa.
Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
Ena viala praška vsebuje 2 mg kalija in 0,1 g saharoze.
Trabectedin must not be used in patients with CPK > 2.5 x ULN (see section 4.2).
Rabdomioliza in resno povišanje ravni CPK (> 5 x ULN) Trabektedina ni dovoljeno uporabljati pri bolnikih s CPK > 2,5 ULN (glejte poglavje 4.2).
Patients who develop fever should promptly seek medical attention.
Pri bolnikih, pri katerih se razvije zvišana telesna temperature, je treba hitro ukrepati z ustreznimi zdravili.
Volume (ml) = BSA (m2) x individual dose (mg/m2)
Potreben volumen izračunajte kot sledi: Volumen (ml) = PT (m2) x individualni odmerek (mg/m2)
When Yondelis is used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Ko se zdravilo Yondelis uporablja v kombinaciji s PLD, je treba intravensko linijo dobro sprati s 50 mg/ml (5-odstotno) raztopino glukoze po infundiranju PLD in pred apliciranjem zdravila Yondelis.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mg trabectedin
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 mg trabektedina
The analysis per cycle performed in these patients showed thrombocytopenia of grade 3 and 4 in approximately 3% and < 1% of cycles respectively.
Analiza na cikel, opravljena pri teh bolnikih, je pokazala, da se je trombocitopenija stopnje 3 in 4 pojavila pri približno 3 % oz. < 1 % ciklov.
In the final analysis, the effect of the Yondelis+PLD combination vs. PLD alone on overall survival was more pronounced in patients with PFI ≥ 6 months (platinum-sensitive population: 27.0 vs. 24.1 months, HR=0.83, CI: 0.67-1.04) than in those with PFI < 6 months (platinum-resistant population: 14.2 vs. 12.4 months, HR=0.92, CI: 0.
na splošno preživetje bolj izrazit pri bolnikih s PFI ≥ 6 mesecev (populacija, občutljiva na platino: 27,0 v primerjavi s 24,1 mesecem, RT = 0,83, IZ: 0,67-1,04) kot pri PFI < 6 mesecev (populacija, rezistentna na platino: 14,2 v primerjavi z 12,4 meseci, RT = 0,92, IZ: 0,70-1,21).
When used in combination with PLD the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Ko se uporablja v kombinaciji s PLD, je treba intravensko linijo dobro sprati s 50 mg/ml (5-odstotno) raztopino glukoze po infundiranju PLD in pred apliciranjem zdravila Yondelis.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala z 1 mg trabektedina
To minimize the risk of PLD infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
hitrost začetnega odmerka ne sme biti višja kot 1 mg/minuto.
The analysis per cycle performed in patients treated with the monotherapy regimen showed neutropenia of grade 3 and 4 in approximately 19% and 8% of cycles respectively.
Analiza na cikel, opravljena pri bolniki, zdravljenih z monoterapijo, je pokazala, da se je nevtropenija stopnje 3 in 4 pojavila pri približno 19 % oz. 8 % ciklov.
There may be blistering, peeling and darkening of the skin over the site.
Lahko pride do nastanka mehurjev, luščenja ali potemnitve kože na mestu injiciranja.
If no infusion reaction is observed, subsequent PLD infusions may be administered over a 1-hour period (see also PLD Summary of Product Characteristics [SmPC] for specific administration advice).
1-urnem obdobju infuzija PLD nadaljuje (glejte tudi povzetek glavnih značilnosti zdravila [SmPC] za PLD za posebne nasvete glede dajanja).
Concomitant administration of inhibitors of P-gp, e.g. cyclosporine and verapamil, may alter trabectedin distribution and/or elimination.
npr. ciklosporina in verapamila lahko spremenijo porazdelitev in/ali izločanje trabektedina.
Hyperbilirubinemia: Bilirubin peaks approximately a week after onset and resolves approximately two weeks after onset.
Bilirubin dosega najvišje vrednosti približno en teden po začetku in se vrne na izhodiščne vrednosti približno dva tedna po začetku.
It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery.
Lahko namreč pride do poškodb in odmiranja tkivnih celic okoli mesta injiciranja (nekroza tkiva), zaradi česar je lahko potreben kirurški poseg.
Reconstituted solution After reconstitution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Po rekonstituciji je kemična in fizikalna stabilnost dokazana za 30 ur pri temperaturi do 25 ºC.
The analysis per cycle performed in patients treated with the monotherapy regimen showed anaemia of grade 3 and 4 in approximately 3% and 1% of cycles respectively.
Analiza na cikel, opravljena pri bolnikih, zdravljenih z režimom monoterapije, je pokazala anemijo stopnje 3 in 4 pri približno 3 % oz. 1 % ciklov.
Yondelis is a powder for concentrate for solution for infusion.
Zdravilo Yondelis je prašek za koncentrat za raztopino za infundiranje.
Patients must meet specific criteria on hepatic function parameters to start treatment with Yondelis.
Za začetek zdravljenja z zdravilom Yondelis morajo bolniki izpolniti določene pogoje v zvezi s parametri jetrnega delovanja.
The solution obtained has a concentration of 0.05 mg/ml and is for single-use only.
Koncentracija dobljene raztopine za enkratno uporabo je 0,05 mg/ml.
Adequate contraceptive precautions must be used by men in fertile age when receiving Yondelis and for 5 months following the end of treatment.
Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Yondelis in še 5 mesecev po njem.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala z 0,25 mg trabektedina
Median PFS (95% CI) (months)
Mediano PBN (95 % IZ) (mesecev)
PLD Hazard/Odds ratio p-value Progression Free Survival
Trabektedin Dakarbazin Razmerje tveganj/razmerje obetov
If you get any of the previous described symptoms or signs, seek medical care immediately.
Če opazite katerega koli od opisanih simptomov ali znakov, nemudoma poiščite zdravniško pomoč.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 1 mg vial
PODATKI NA ZUNANJI OVOJNINI Škatla - 1 mg viala
- Platelet count ≥ 100,000/mm - Bilirubin ≤ upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 x ULN (consider hepatic isoenzymes 5-nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin).
- Absolutno število nevtrofilcev (ANC) ≥ 1.500/mm3 - Število trombocitov ≥ 100.000/mm - Bilirubin ≤ zgornja meja normale (ULN - „upper limit of normal“) - Alkalna fosfataza ≤ 2,5 x ULN (preučite jetrne izoencime 5-nukleotidazo ali gama-glutamil transpeptidazo (GGT), če je kost izvor povišanja).
- Increase of aminotransferases (AST or ALT) > 2.5 x ULN (monotherapy) or > 5 x ULN
- Zvišanje aminotransferaz (AST ali ALT) > 2,5 x ULN (monoterapija) ali > 5 x ULN (kombinirano zdravljenje), ki se ne vrnejo na izhodiščno vrednost do 21. dne
Adequate contraceptive precautions must be used by women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Yondelis in še 3 mesece po njem.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priprava intravenske infuzije
• bruise more easily
• hitro dobite modrice
Each vial of powder contains 1 mg of trabectedin.
Ena viala praška vsebuje 1 mg trabektedina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 0.25 mg vial
PODATKI NA ZUNANJI OVOJNINI Škatla - 0,25 mg viala
Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.6).
Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 5 mesecev po njem (glejte poglavje 4.6).
In-use stability of the solutions
Stabilnost raztopine med uporabo
Hepatic failure: Rare cases of hepatic failure (including cases with fatal outcomes) have been reported in patients with serious underlying medical conditions treated with trabectedin, both in clinical trials and in post marketing setting.
Odpoved jeter: Pri bolnikih z resnimi osnovnimi boleznimi, ki so bili zdravljeni s trabektedinom, so tako v okviru kliničnih preizkušanj kot tudi v okviru izkušenj v obdobju trženja poročali o redkih primerih odpovedi jeter (vključno s primeri smrtnih izidov).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg trabectedin
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,25 mg trabektedina
Caution should be taken if medicinal products associated with hepatotoxicity are administered concomitantly with trabectedin, since the risk of hepatotoxicity may be increased.
Previdnost je potrebna, če se zdravila, povezana s hepatotoksičnostjo, dajejo hkrati s trabektedinom,
Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.4).
Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 5 mesecev po njem (glejte poglavje 4.4).
How to store Yondelis
Shranjevanje zdravila Yondelis
This reconstituted solution contains 0.05 mg/ml of trabectedin.
Rekonstituirana raztopina vsebuje 0,05 mg/ml trabektedina.
During postmarketing experience, hypersensitivity reactions with very rare occurrence of fatal outcome, have been reported in association with trabectedin administration either alone or in combination with PLD (see sections 4.3 and 4.8).
V okviru izkušenj v obdobju trženja je prišlo do preobčutljivostnih reakcij z zelo redkim nastopom smrtnega izida, o katerih so poročali v povezavi z dajanjem trabektedina samega ali v kombinaciji s
During your treatment with Yondelis you may feel tired and experience a loss of strength.
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom Yondelis boste morda utrujeni in se počutili šibke.
• feel an excess of fluid in the body (oedema)
• imate bolečine v hrbtu in sklepih • imate preveč tekočine v telesu (edem)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija anemija levkopenija febrilna nevtropenija
Liver Function Test (LFT) abnormalities
Nenormalnosti testov delovanja jeter
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri do 1 od 100 bolnikov
Close monitoring of toxicities is required in patients receiving trabectedin in combination with potent CYP3A4 inhibitors (e.g. oral ketoconazole, fluconazole, ritonavir, clarithromycin or aprepitant) and such combinations should be avoided if possible.
Skrbno spremljanje toksičnosti je potrebno pri bolnikih, ki prejemajo trabektedin v kombinaciji z močnimi zaviralci CYP3A4 (npr. peroralni ketokonazol,
Capillary Leak Syndrome (CLS): Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes) (see section 4.4).
Sindrom povečane propustnosti kapilar (Capillary Leak Syndrome - CLS): Pri uporabi trabektedina so poročali o primerih sindroma povečane prepustnosti kapilar (CLS) (vključno s primeri smrtnih izidov)
Overall, 384 patients were randomized to the trabectedin group [1.5 mg/m once every 3 weeks (q3wk 24-h)] and
Skupno je bilo v skupino s trabektedinom randomiziranih 384 bolnikov [1,5 mg/m2 enkrat na 3 tedne (q3wk 24-h)], v skupino z dakarbazinom pa 193 bolnikov (1 g/m2 enkrat na 3 tedne).
Extravasation Soft tissue necrosis
reakcije na mestu injiciranja ekstravazacija nekroza mehkega tkiva
Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0,25 mg prašek za koncentrat za raztopino za infundiranje Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje
Pol. Ind. La Mina 28770 Colmenar Viejo (Madrid) Spain
La Mina 28770 Colmenar Viejo (Madrid) Španija
Vomiting Constipation Diarrhoea Stomatitis
Bolezni prebavil bolečine v trebuhu navzea bruhanje zaprtost driska stomatitis dispepsija
It followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Redko jo je spremljala zvišana telesna temperatura ali okužba.
1 ml of reconstituted solution contains 0.05 mg of trabectedin.
1 ml rekonstituirane raztopine vsebuje 0,05 mg trabektedina.
Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see section 4.3).
Kombinacija s cepivom proti rumeni mrzlici pa je kontraindicirana (glejte poglavje 4.3).
If you get any of the above symptoms or signs, seek medical care immediately.
Če opazite katerega koli od navedenih simptomov ali znakov, nemudoma poiščite zdravniško pomoč.
However, fatigue and/or asthenia have been reported in patients receiving trabectedin.
Pri bolnikih, ki prejemajo trabektedin so poročali o utrujenosti in/ali splošni oslabelosti.
Each vial of powder contains 0.25 mg of trabectedin.
Ena viala praška vsebuje 0,25 mg trabektedina.
• You could have mucosal inflammation as a swelling redness of the inside of the mouth leading to painful ulcers and mouth sores inflammation of the mouth (stomatitis), or as an inflammation of the gastrointestinal tract when Yondelis is used with PLD.
• Pri uporabi zdravila Yondelis skupaj s PLD se lahko v ustih pojavi vnetje sluznice ali oteklost s pordelostjo, kar povzroči boleče razjede in ustne rane (stomatitis), pojavi se lahko vnetje prebavil.
• Higher skin pigmentation could occur in patients receiving Yondelis with PLD for ovarian cancer.
• Pri bolnicah, ki prejemajo zdravilo Yondelis in PLD za raka na jajčnikih, se lahko pojavi večja pigmentacija kože.
Soft tissue sarcoma
Sarkom mehkega tkiva
Contents of the pack and other information
Shranjevanje zdravila Yondelis Vsebina pakiranja in dodatne informacije
A syringe is used to inject 20 ml of sterile water for injections into the vial.
Za injiciranje 20 ml sterilne vode za injekcije v vialo se uporabi injekcijska brizga.
Overall survival, n (%) Secondary endpoints n=345
Primarni opazovani dogodek n = 384 n = 193 Celokupno preživetje, n (%) Sekundarni opazovani dogodki n = 345 n = 173
Diluted solution After dilution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Po razredčitvi je kemična in fizikalna stabilnost dokazana za 30 ur pri temperaturi do 25 ºC.
Breast-feeding is contraindicated during treatment and 3 months thereafter (see section 4.3).
Med zdravljenjem in 3 mesece po njem je dojenje kontraindicirano (glejte poglavje 4.3).
A syringe is used to inject 5 ml of sterile water for injections into the vial.
Za injiciranje 5 ml sterilne vode za injekcije v vialo se uporabi injekcijska brizga.
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.
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 preko centralne venske linije 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).
The geometric mean dose normalized trabectedin exposure (AUC) increased by 97% (90% CI: 20%, 222%) in 6 patients with moderate hepatic impairment (increased serum bilirubin levels from 1.5 to 3 x ULN and increase of aminotransferases (AST or ALT) < 8 x ULN) following administration of a single trabectedin dose of 0.58 mg/m2 (n=3) or 0.9 mg/m2 (n=3) compared to 9 patients with normal liver function following administration of a single trabectedin dose of 1.3 mg/m2 (see sections 4.2 and 4.4).
povečala za 97 % (90 % CI: 20 %, 222 %) v primerjavi z devetimi bolniki z normalnim delovanjem jeter, ki jim je bil apliciran enkraten odmerek trabektedina 1,3 mg/m2 (glejte poglavji 4.2 in 4.4).
Efficacy analyses from ET743-OVA-301 Yondelis+PLD
Rezultati učinkovitosti iz študije ET743-SAR-3007
You should have received training on the correct techniques to reconstitute and dilute Yondelis or its combination with PLD and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Naučiti vas morajo pravilnih tehnik rekonstituiranja in redčenja zdravila Yondelis ali njegove kombinacije s PLD.
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se pri do 1 od 10 bolnikov
In this case you may experience fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting).
težave z dihanjem, rdečico ali vročinske oblive ali izpuščaj, občutek slabosti (navzea) ali bruhanje.
Pyrexia
ciklov.
Thrombocytopenia:
Hiperbilirubinemija:
- if you are allergic to trabectedin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na (preobčutljivi za) trabektedin ali katerokoli sestavino zdravila Yondelis,
Very common: may affect more than 1 in 10 people
Drugi manj resni neželeni učinki: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
One ml of reconstituted solution contains 0.05 mg of trabectedin.
En ml rekonstituirane raztopine vsebuje 0,05 mg trabektedina.
Potassium hydroxide (for pH-adjustment)
6.1 Seznam pomožnih snovi saharoza kalijev dihidrogenfosfat fosforna kislina (za prilagoditev pH) kalijev hidroksid (za prilagoditev pH)
Dilute the reconstituted solution with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Navodila za redčenje Rekonstituirano raztopino razredčite z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje ali glukozo 50 mg/ml (5 %) raztopino za infundiranje.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
IME ZDRAVILA IN POT(I) UPORABE Yondelis 0,25 mg prašek za koncentrat za raztopino za infundiranje trabektedin i.v.
12 months PFS rate (95% CI) (%) Independent oncology review, all randomised n=336
Neodvisna onkološka ocena, vse randomizirano n = 336
Placental transfer of trabectedin and fetal exposure to trabectedin were observed in a study in pregnant rats that received a single i.v.
V študiji na brejih podganah, ki so prejele enkraten i.v.
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), the concentration of trabectedin in the infusion solution being ≤ 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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
IME ZDRAVILA IN POT(I) UPORABE Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje trabektedin i.v.
If intravenous administration is to be made via a central venous line, add the reconstituted solution 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), the concentration of trabectedin in the infusion solution being ≤ 0.030 mg/ml.
Če bo intravensko dajanje potekalo prek centralne venske linije, dodajte rekonstituirano raztopino 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.
Serious side effects caused by the treatment with Yondelis:
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Yondelis:
Yondelis must not be given to patients who are breast-feeding.
Zdravila Yondelis se ne sme dajati bolnikom z izhodiščnim številom nevtrofilcev manj kot
Extravasation should be managed by local standard practice.
Posebnega antidota za ekstravazacijo trabektedina ni. Ekstravazacijo je treba obravnavati v skladu z uveljavljeno lokalno prakso.
Febrile neutropenia
Pri hudi nevtropeniji
Mucosal inflammation
Razredčena raztopina
NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0,25 mg prašek za koncentrat za raztopino za infundiranje trabektedin
A syringe is used to inject the correct amount of sterile water for injections into the vial.
Za injiciranje sterilne vode za injekcije v vialo se uporabi injekcijska brizga.
Yondelis 1 mg powder for concentrate for solution for infusion.
Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje trabektedin
Yondelis contains potassium
Yondelis+PLD