natgillin/translations-raw huggingface dataset:
Very common side effects (these can affect more than 1 in 10 patients treated) Feeling sick (nausea), dry mouth, and tiredness.
Zelo pogosti neželeni učinki (se lahko pojavijo pri več kot 1 od 10 zdravljenih bolnikov) Občutek slabosti (navzea), suha usta in utrujenost.
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling agitated, feeling disorientated, feeling sleepy, having a poor quality of sleep, lack of motivation or increased yawning. • Tasting things differently than usual, disturbance in attention or spasms and involuntary movements of the muscles. • Weight loss or weight gain, burping, indigestion or gastroenteritis. • Inflammation of the liver that may cause abdominal pain, tiredness or yellow coloration of the skin. • Vertigo, tinnitus (perception of sound in the ear when there is no external sound, ear pain. • Larger pupils (the dark centre of the eye) or visual disturbance.
Občasni neželeni učinki (se lahko pojavijo pri od 1 do 10 od 1. 000 zdravljenih bolnikov) • Vnetje grla. • Občutek razdraženosti, zmedenost, zaspanost, slaba kvaliteta spanja, pomanjkanje motivacije ali več zehanja. • Spremenjeno okušanje stvari, motnja pozornosti ali krči in nehoteni gibi mišic. • Zmanjšanje ali zvečanje telesne mase, riganje, slaba prebava ali gastroenteritis. • Vnetje jeter, ki lahko povzroči bolečine v trebuhu, utrujenost ali rumeno obarvanost kože. • Vrtoglavica, tinitus (zvonenje v ušesih, kljub temu da ni zunanjega zvoka), ušesna bolečina. • Večje zenice (temni osrednji del očesa) ali motnje vida. • Zardevanje, zvišan krvni tlak, občutek mraza v prstih in/ ali prstih na nogah, občutek omotičnosti (zlasti ob prehitrem vstajanju), hitro ali nepravilno bitje srca, nočno znojenje, hladen znoj, drgetanje ali omedlevica. • Spremembe v ejakulaciji, neobičajna menstruacija, vključno z močno ali podaljšano menstruacijo. • Alergične reakcije, povečano nagnjenje k modricam, mehurji ali občutljivost na sončno svetlobo. • Mišično trzanje.
44 • Flushing, increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), fast or irregular heart beat, night sweats, cold sweats, shivering or fainting. • Changes in ejaculation, abnormal periods, including heavy or prolonged periods • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight. • Muscle twitching. • Need to pass urine during the night or difficulty or inability to pass urine. • Grinding of teeth, dehydration, feeling hot/ cold, thirst, throat tightness or nose bleeds. • Increased level of cholesterol in the blood.
44 • Odvajanje urina ponoči ali težave oziroma nezmožnost odvajanja urina. • Škrtanje z zobmi, dehidracija, občutek vročine/ mraza, žeja, napeto grlo ali krvavitve iz nosu. • Zvišan nivo holesterola v krvi.
HOW TO STORE YENTREVE
SHRANJEVANJE ZDRAVILA YENTREVE
Do not use YENTREVE after the expiry date which is stated on the carton.
Zdravila YENTREVE ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What YENTREVE contains The active substance is duloxetine.
Kaj vsebuje zdravilo YENTREVE Zdravilna učinkovina je duloksetin.
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride)
Vsaka kapsula vsebuje 20 ali 40 mg duloksetina (v obliki klorida).
What YENTREVE looks like and contents of the pack YENTREVE is a hard gastro-resistant capsule.
Izgled zdravila YENTREVE in vsebina pakiranja Zdravilo YENTREVE je trda gastrorezistentna kapsula.
Each capsule of YENTREVE contains pellets of the active substance with a covering to protect them from stomach acid.
45 Vsaka kapsula zdravila YENTREVE vsebuje pelete zdravilne učinkovine z oblogo za zaščito pred želodčno kislino.
YENTREVE is available in 2 strengths:
Zdravilo YENTREVE je na voljo v dveh jakostih:
YENTREVE 40 mg is available in blister packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
Zdravilo YENTREVE 40 mg je na voljo v pretisnih omotih po 28, 56, 98, 140 in 196 (2 x 98) kapsul.
YENTREVE 20 mg is available in blister packs of 28, 56 and 98 capsules.
Zdravilo YENTREVE 20 mg je na voljo v pretisnih omotih po 28, 56 in 98 kapsul.
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EPAR summary for the public This document is a summary of the European Public Assessment Report (EPAR).
Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
Yondelis is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Yondelis je prašek za pripravo raztopine za infundiranje (dajanje v veno).
It contains the active substance trabectedin.
Vsebuje zdravilno učinkovino trabektedin.
Yondelis is used to treat patients with advanced soft tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
Zdravilo Yondelis se uporablja za zdravljenje bolnikov z napredovalim sarkomom mehkega tkiva, vrsto raka, ki se začne razvijati na mehkih vezivnih tkivih v telesu.
It is used when treatment with anthracyclines and ifosfamide (other anticancer medicines) have stopped working, or in patients who cannot be given these medicines.
Uporablja se v primerih, ko antraciklini in ifosfamidi (druga zdravila proti raku) prenehajo učinkovati, ali pri bolnikih, pri katerih uporaba teh zdravil ni primerna.
Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘ rare’, and Yondelis was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 30 May 2001.
Ker je število bolnikov s sarkomom mehkega tkiva majhno, velja ta bolezen za redko, zato je bilo zdravilo Yondelis 30. maja 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Yondelis must be given under the supervision of a doctor who is experienced in the use of chemotherapy.
Zdravilo Yondelis se mora dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines.
Uporabljati ga smejo samo usposobljeni onkologi (specialisti za zdravljenje raka) ali drugi zdravstveni delavci, ki so specializirani za dajanje citotoksičnih zdravil (zdravil, ki ubijajo celice).
The recommended dose of Yondelis is 1.5 mg per square metre of body surface (calculated using the patient ’ s height and weight), given as a single intravenous infusion (drip into a vein) over 24 hours every three weeks.
Priporočen odmerek zdravila Yondelis je 1, 5 mg na kvadratni meter površine telesa (izračunano s pomočjo bolnikove višine in mase), apliciran kot enkratna intravenska infuzija (dajanje v veno) s trajanjem 24 ur vsake tri tedne.
Treatment carries on for as long as the patient shows a benefit.
Zdravljenje se izvaja toliko časa, dokler še predstavlja korist za bolnika.
To prevent vomiting and to protect the liver, an infusion of dexamethasone (a corticosteroid) should be given before each Yondelis dose.
Za preprečevanje bruhanja in zaščito jeter je treba pred posameznim odmerkom zdravila Yondelis bolniku dati infuzijo deksametazona (kortikosteroida).
Infusion with Yondelis should be delayed or the dose of Yondelis reduced if the patient ’ s blood counts are abnormal (such as low counts of white blood cells or platelets).
Infudiranje zdravila Yondelis je treba odložiti ali zmanjšati njegov odmerek, če je bolnikova krvna slika nenormalna (npr. premajhno število belih krvničk ali krvnih ploščic).
It should be used with caution in patients who have problems with their liver.
Pri bolnikih, ki imajo težave z jetri, je treba zdravilo uporabljati previdno.
Yondelis must not be used in children until further information is available.
Dokler ne bodo na voljo nadaljnje informacije, se zdravilo Yondelis ne sme uporabljati pri otrocih.
It should not be used in those who have high bilirubin levels (a marker of certain liver problems) or who have severe problems with their kidneys.
Prav tako se ga ne sme uporabljati pri bolnikih, ki imajo visoke ravni bilirubina (znak določenih težav z jetri) ali ki imajo resne težave z ledvicami.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Za več informacij glejte Povzetek glavnih značilnosti zdravila (prav tako del EPAR).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged preventing some genes in human cells from turning up their activity.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo Yondelis deluje?
This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer, including sarcoma.
Je sintetična različica kemikalije, ki so jo prvotno pridobivali iz vrste plaščarja oz. mehkega kozolnjaka (morske živali).
The effects of Yondelis were first tested in experimental models before being studied in humans.
Učinki zdravila Yondelis so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effects of Yondelis were also studied in one main study involving 266 patients with liposarcoma (a sarcoma originating in fat cells) or leiomyosarcoma (a sarcoma originating in ‘ smooth’ or involuntary muscle cells) that was advanced or metastatic (had spread to other parts of the body).
Učinke zdravila Yondelis so preučevali tudi v eni glavni študiji, v katero je bilo vključenih 266 bolnikov z liposarkomom (sarkomom, ki se začne razvijati v maščobnih celicah) ali leiomiosarkomom (sarkomom, ki se začne razvijati v gladkih mišičnih celicah, tj. takih, ki se krčijo neodvisno od volje), ki je napredoval ali je bil metastatski (se je razširil na druge dele telesa).
All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working.
Vsi bolniki so se predhodno zdravili z antraciklini in ifosfamidi, vendar je zdravljenje prenehalo učinkovati.
The main measure of effectiveness was the time until the disease got worse.
Glavno merilo učinkovitosti je bil čas do poslabšanja bolezni.
The study was still ongoing at the time of assessment.
Študija je v trenutku ocenjevanja zdravila še potekala.
What benefit has Yondelis shown during the studies?
Kakšne koristi je zdravilo Yondelis izkazalo med raziskavami?
Yondelis was more effective when it was given once every three weeks than the alternative dosing schedule.
Zdravilo Yondelis, dajano enkrat na tri tedne, je bilo učinkovitejše od alternativne sheme odmerjanja.
In patients receiving it once every three weeks, it took an average of 3.8 months for their disease to get worse, compared with 2.1 months in those receiving Yondelis three times per month.
Pri bolnikih, ki so zdravilo Yondelis prejemali enkrat na tri tedne, je bil čas do poslabšanja bolezni v povprečju 3, 8 mesecev, v primerjavi z 2, 1 meseca pri bolnikih, ki so to zdravilo prejemali trikrat na mesec.
The most common side effects with Yondelis (seen in more than 1 patient in 10) are increased blood levels of creatine phosphokinase (marker of muscle breakdown) and of creatinine (a marker of kidney problems), decreased blood levels of albumin (a marker of liver problems), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low levels of platelets in the blood), anaemia (low levels of red blood cells), leucopenia (low levels of leucocytes, a type of white blood cell), headache, vomiting, nausea (feeling sick), constipation, anorexia (loss of appetite), fatigue (tiredness), asthenia (weakness), hyperbilirubinaemia (high levels of bilirubin in the blood) and increased levels of liver enzymes in the blood (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyltransferase).
Najpogostejši neželeni učinki zdravila Yondelis (opaženi pri več kot 1 izmed 10 bolnikov) so povečane ravni kreatin fosfokinaze (znak razgradnje mišic) in kreatinina (znak težav z ledvicami) v krvi, zmanjšane ravni albumina (znak težav z jetri) v krvi, nevtropenija (nizka raven nevtrofilov, vrste belih krvničk), trombocitopenija (nizka raven krvnih ploščic), anemija (nizka raven rdečih krvničk), levkopenija (nizka raven levkocitov, vrste belih krvničk), glavobol, bruhanje, navzeja (slabost), zaprtje, anoreksija (izguba teka), utrujenost, astenija (šibkost), hiperbilirubinemija (visoka raven bilirubina v krvi) in povečana raven jetrnih encimov v krvi (alanin aminotransferaze, aspartat aminotransferaze, alkalin fosfataze in gama glutamiltransferaze).
For the full list of all side effects reported with Yondelis, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Yondelis, glejte Navodilo za uporabo.
Yondelis should not be used in people who may be hypersensitive to trabectedin or any of the other ingredients.
Zdravila Yondelis ne smejo uporabljati osebe, ki utegnejo biti preobčutljive na trabektedin ali na katero koli drugo sestavino.
It must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in breast-feeding women.
Zdravilo se ne sme uporabljati pri bolnikih, ki imajo resno ali nenadzorovano okužbo, v kombinaciji s cepivom za rumeno mrzlico ali pri doječih ženskah.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Yondelis’ s benefits are greater than its risks for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila Yondelis pri zdravljenju bolnikov z napredovalim sarkomom mehkega tkiva po neuspelem zdravljenju z antraciklini in ifosfamidi ali pri bolnikih, pri katerih uporaba teh učinkovin ni primerna, večje od z njim povezanih tveganj.
The Committee noted that evidence of Yondelis’ s effects is mainly based on the treatment of liposarcoma and leiomyosarcoma.
Odbor je ugotovil, da temeljijo dokazi o učinkovitosti zdravila Yondelis v glavnem na zdravljenju liposarkoma in leiomiosarkoma.
The Committee recommended that Yondelis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Yondelis odobri dovoljenje za promet.
Yondelis has been authorised under “ Exceptional Circumstances”.
Zdravilo Yondelis je bilo odobreno v „ izjemnih okoliščinah “.
This means that because the disease is rare, it has not been possible to obtain complete information about Yondelis.
To pomeni, da glede na to, da je bolezen redka, še ni mogoče pridobiti celovitih informacij o zdravilu Yondelis.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala nove podatke, ki bodo morda postale dostopni, in po potrebi posodobila ta povzetek.
What information is still awaited for Yondelis?
Katere informacije o zdravilu Yondelis še pričakujemo?
The company that makes Yondelis will continue to assess which patients are more likely to respond to the medicine, and will carry out a study to investigate the effects of Yondelis in patients with a type of cancer called ‘ myxoid liposarcoma’.
Podjetje, ki izdeluje zdravilo Yondelis, bo še naprej preučevalo, pri katerih bolnikih obstaja večja verjetnost, da se bodo odzvali na zdravilo, in bo izvedlo študijo, v kateri bodo preučevali učinke zdravila Yondelis pri bolnikih z vrsto raka, imenovanim miksoidni liposarkom.
Other information about Yondelis:
Druge informacije o zdravilu Yondelis:
The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis to Pharma Mar, S. A. on 17 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Yondelis, veljavno po vsej Evropski uniji, odobrila družbi Pharma Mar, S. A. dne 17. septembra 2007.
The record of Yondelis’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila Yondelis kot zdravila sirote je na voljo tukaj.
The full EPAR for Yondelis can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yondelis je na voljo tukaj.
This summary was last updated in 08-2007.
Ta povzetek je bil nazadnje posodobljen 08- 2007.
Pharmaceutical Form Powder for concentrate for solution for infusion
prašek za koncentrat za raztopino za infundiranje
Packaging Vial (glass)
Viala (steklena)
Yondelis 0.25 mg powder for concentrate for solution for infusion.
Yondelis 0, 25 mg prašek za koncentrat za raztopino za infundiranje.
Each vial contains 0.25 mg of trabectedin.
Vsaka viala vsebuje 0, 25 mg trabektedina.
1 ml of reconstituted solution contains 0.05 mg of trabectedin.
1 ml rekonstruirane raztopine vsebuje 0, 05 mg trabektedina.
Each vial contains 2 mg of potassium and 0.1 g of sucrose.
Vsaka viala vsebuje 2 mg natrija in 0, 1 g saharoze.
Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Zdravilo Yondelis je indicirano za zdravljenje bolnikov z napredovanim sarkomom mehkega tkiva, po neuspešnem zdravljenju z antraciklini in ifosfamidom, ali pri bolnikih, pri katerih uporaba teh zdravil ni primerna.
The recommended dose is 1.5 mg/ m2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles.
Priporočeni odmerek je 1, 5 mg/ m2 površine telesa, apliciran kot intravenska infuzija v roku 24 ur s tritedenskimi presledki med cikli.
Administration through a central venous line is strongly recommended (see section 6.6).
Močno se priporoča odmerjanje skozi centralno vensko linijo (glejte poglavje 6. 6).
All patients must receive 20 mg of dexamethasone intravenously 30 minutes prior to Yondelis; not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Vsi bolniki morajo prejeti 20 mg deksametazona intravensko 30 minut pred dajanjem zdravila Yondelis; ne le kot antiemetično profilakso, temveč tudi zaradi hepatoprotektivnih učinkov.
- Absolute neutrophil count (ANC) ≥ 1,500/ mm3
Absolutno število nevtrofilcev (ANC) ≥ 1. 500/ mm3
- Platelet count ≥ 100,000/ mm3
Število trombocitov ≥ 100. 000/ mm3
- Bilirubin ≤ upper limit of normal (ULN)
Bilirubin ≤ zgornja meja normale (ULN - » upper limit of normal «)
- 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 kost
- Albumin ≥ 25 g/ l.
izvor povišanja).
2
2 Albumin ≥ 25 g/ l.
- Creatinine clearance ≥ 30 ml/ min
Očistek kreatinina ≥ 30 ml/ min
- Creatine phosphokinase (CPK) ≤ 2.5 ULN
Kreatin fosfokinaza (CPK) ≤ 2, 5 ULN
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.
If any of the following events occur at any time between cycles, the dose must be reduced to 1.2 mg/ m2 for subsequent cycles:
Če se kadar koli med cikli pojavijo naslednji dogodki, je treba odmerek zmanjšati na 1, 2 mg/ m2 za naslednje cikle:
- Neutropenia < 500/ mm3 lasting for more than 5 days or associated with fever or infection
Nevtropenija < 500/ mm3, ki traja več kot 5 dni ali jo spremlja zvišana telesna temperatura ali
- Thrombocytopenia < 25,000/ mm3
okužba trombocitopenija < 25. 000/ mm3
- Increase of bilirubin > ULN and/ or alkaline phosphatase > 2.5 x ULN
- Zvišan bilirubin > ULN in/ ali alkalna fosfataza > 2, 5 x ULN
- Increase of aminotransferases (AST or ALT) > 2.5 x ULN which has not recovered by day 21
do 21. dne
- Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
- Kakršni koli drugi neželeni učinki stopnje 3 ali 4 (kot je navzea, bruhanje, utrujenost)
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 eskalacija odmerka v naslednjih ciklih ne priporoča.
If any of these toxicities reappear in subsequent cycles in a patient exhibiting clinical benefit, the dose may be further reduced to 1 mg/ m2.
Če se kateri koli od teh toksičnih učinkov ponovno pojavi v naslednjih ciklih, se pri bolniku, kjer se kaže klinična korist, odmerek lahko zniža še na 1 mg/ m2.
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 6 ali več ciklov pri 168 od 569 (29, 5%) bolnikov, zdravljenih s predlaganim odmerkom in režimom.
This regime has been used for up to 38 cycles.
Ta režim se je uporabljal za do 38 ciklov.
The safety and efficacy of trabectedin in paediatric patients have not yet been established.
Varnosti in učinkovitosti trabektedina pri pediatričnih bolnikih niso ugotavljali.
Therefore, this medicinal product must not be used in children and adolescents until further data become available.
Zato tega zdravila ni dovoljeno uporabljati pri otrocih in mladostnikih, dokler ne bo zbranih več podatkov.
No specific studies in elderly patients have been performed.
Posebnih študij na starejših bolnikih niso izvedli.
Overall 20% of the 1164 patients in the integrated safety analysis were over 65 years.
Skupaj 20% od 1164 bolnikov, vključenih v analizo varnosti, je bilo starih več kot 65 let.
3 No studies with the proposed regime have been conducted in patients with liver dysfunction.
3 Bolniki z okvarjenim delovanjem jeter
Patients with elevated bilirubin must not be treated with Yondelis (see section 4.4).
Bolnikov s povišano ravnijo bilirubina ni dovoljeno zdraviti z zdravilom Yondelis (glejte poglavje 4. 4).
Studies including patients with severe renal insufficiency (creatinine clearance < 30 ml/ min) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
Študije, ki so vključevale bolnike z resnimi motnjami delovanja ledvic (očistek kreatinina < 30 ml/ min) niso bile izvedene, zato zdravila Yondelis ni dovoljeno uporabiti za to populacijo bolnikov (glejte poglavje 4. 4).