natgillin/translations-raw huggingface dataset:
Uncommon but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8). 
Po uporabi pegfilgrastima so poročali o občasnih, a v splošnem asimptomatskih primerih splenomegalije, in o občasnih primerih rupture vranice, vključno z nekaterimi smrtnimi primeri (glejte poglavje 4.8).
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1). 
Pri bolnikih z de novo akutno mieloično levkemijo omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5.1).
This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free' 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar pomeni, da je praktično brez natrija.
Each pre-filled syringe contains 0.6 ml of solution for injection. 
Vsaka napolnjena injekcijska brizga vsebuje 0,6 ml raztopine za injiciranje.
Women who become pregnant during Ristempa treatment are encouraged to enrol in Amgen's Pregnancy Surveillance Programme. 
Ženskam, ki med zdravljenjem z zdravilom Ristempa zanosijo, priporočamo vključitev v program družbe Amgen za spremljanje nosečnosti.
Instructions for injecting with the Ristempa pre-filled syringe 
Navodila za injiciranje zdravila Ristempa z uporabo napolnjene injekcijske brizge
A Discard the used pre-filled syringe and other supplies in a sharps disposal container. 
Zavrzite uporabljeno injekcijsko brizgo in drugo opremo v vsebnik za ostre odpadke.
There is insufficient information on the excretion of Ristempa / metabolites in human milk, a risk to the newborns/infants cannot be excluded. 
Ni dovolj podatkov o izločanju zdravila Ristempa/presnovkov v materino mleko.
Serious allergic reactions, including anaphylaxis can occur in patients receiving Ristempa (uncommon) (see section 4.4). 
Bolnikom, ki prejemajo zdravilo Ristempa, se lahko pojavijo resne alergijske reakcije, vključno z anafilaksijo (občasno) (glejte poglavje 4.4).
Ristempa is injected subcutaneously. 
Zdravilo Ristempa se injicira subkutano.
Injection site reactions, including injection site erythaema (uncommon (≥ 1/1000 to < 1/100)) as well as injection site pain (common events ≥ 1/100 to < 1/10) have occurred on initial or subsequent treatment with Ristempa. 
Med začetnim ali nadaljnjim zdravljenjem z zdravilom Ristempa so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasno (≥ 1/1.000 do < 1/100) kot tudi bolečino na mestu injiciranja (pogosti dogodki ≥ 1/100 do < 1/10).
One 6 mg dose (a single pre-filled syringe) of Ristempa is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. 
Za vsak cikel kemoterapije priporočajo en 6 miligramski odmerek (eno napolnjeno injekcijsko brizgo) zdravila Ristempa, ki je dana vsaj 24 ur po citotoksični kemoterapiji.
• a pre-filled syringe of Ristempa; and 
• napolnjeno injekcijsko brizgo zdravila Ristempa; in • alkoholne krpice ali podobno.
Syringe safety guard 
Varnostna vzmet igle
• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. 
• se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov: oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
If you are nursing during Ristempa treatment, you may be encouraged to enrol in Amgen's Lactation Surveillance programme. 
Če med zdravljenjem z zdravilom Ristempa dojite, vam lahko priporočijo, da se vključite v program družbe Amgen za spremljanje izpostavljenosti zdravilu med dojenjem.
You can use: • Upper part of your thigh. 
Zdravilo lahko injicirate v: • zgornji del stegna.
Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 ml). 
Raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle (0,6 ml) za enkratno uporabo.
This may be a sign of a problem with your spleen (splenomegaly) 
To je lahko znak, da imate težave
How to store Ristempa 
Shranjevanje zdravila Ristempa
How do I prepare my Ristempa injection? 
Kako si pripravim injekcijo zdravila Ristempa?
Tabulated summary of adverse reactions 
Tabeliran seznam neželenih učinkov
Uncommon events of cutaneous vasculitis have been reported in patients treated with Ristempa. 
Občasno so pri bolnikih, zdravljenih z zdravilom Ristempa, poročali o dogodkih kožnega vaskulitisa.
Ristempa 6 mg solution for injection. 
Ristempa 6 mg raztopina za injiciranje
Solution for injection in a single use pre-filled syringe (0.6 ml). 
Raztopina za injiciranje v napolnjeni injekcijski brizgi (0,6 ml) za enkratno uporabo.
Each pre-filled syringe contains 30 mg sorbitol (E420) Each pre-filled syringe contains less than 1 mmol (23 mg) sodium (see section 4.4). 
Ena napolnjena injekcijska brizga vsebuje manj kot 1 mmol (23 mg) natrija (glejte poglavje 4.4).
Push all the way down through the snap. 
PRETISNI OMOT Z BRIZGO
Sickle cell crisis2; Splenomegaly Splenic rupture2 
Bolezni krvi in limfatičnega sistema trombocitopenija1, levkocitoza srpastocelična kriza2, splenomegalija ruptura vranice2
- Keep this leaflet. 
A Držite kožno gubo.
Women who are breast-feeding during Ristempa treatment are encouraged to enrol in Amgen's Lactation Surveillance programme. 
Ženskam, ki med zdravljenjem z zdravilom Ristempa dojijo, je treba priporočiti vključitev v program družbe Amgen za spremljanje izpostavljenosti zdravilu med dojenjem.
If you use more Ristempa than you should contact your doctor, pharmacist or nurse. 
Če ste uporabili večji odmerek zdravila Ristempa, kot bi smeli Če uporabite več zdravila Ristempa, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) 
Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza)
Injection site reactions2 
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja2
Unless your doctor directs you otherwise, you must stop breast feeding if you use Ristempa. 
Če uporabljate zdravilo Ristempa, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
Allow the pre-filled syringe to reach room temperature before injecting. 
Pred injiciranjem naj se napolnjena injekcijska brizga segreje na sobno temperaturo.
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
Talk to your doctor, pharmacist or nurse before using Ristempa: 
Pred začetkom uporabe zdravila Ristempa se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
BLISTERED SYRINGE LABEL 
Nalepka brizge Uporabljeni valj brizge
9) was observed in younger children aged 0-5 yrs (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. 
9) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let
Ristempa 6 mg solution for injection in a pre-filled syringe pegfilgrastim 
Ristempa 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
Back- Ristempa reference guide: 
Hrbtna stran - Zdravilo Ristempa: kratka navodila
The safety and efficacy of Ristempa have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas. 
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti zdravila Ristempa niso ovrednotili.
Ristempa 6 mg solution for injection Pegfilgrastim 
Ristempa 6 mg raztopina za injiciranje pegfilgrastim
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
Front - Ristempa reference guide: 
Ločeni dodatni vložek: Sprednja stran - zdravilo Ristempa: kratka navodila
UNBLISTERED SYRINGE LABEL 
OZNAKA BRIZGE V PRETISNEM OMOTU
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for 
Ena napolnjena injekcijska brizga vsebuje 6 mg - Pomožne snovi so natrijev acetat, sorbitol (E420), polisorbat 20 in voda za injekcije.
Investigations 
Takšni ukrepi
Grab the pre-filled syringe safety guard to remove the 
Napolnjeno injekcijsko brizgo vzemite iz podloge tako, da jo primete za njen varnostni ščitnik.
ENGLISH 
SLOVENŠČINA
swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of 
oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
Upper arm 
Potem brizgo
‘Advanced' means that the cancer has started to spread. 
„Napredovali“ pomeni, da se je rak začel širiti.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 27 May 2015. 
Ker je družba zagotovila dodatne zahtevane informacije so izjemne okoliščine prenehale 27. maja 2015.
Treatment carries on for as long as the patient shows a benefit. 
Zdravljenje se izvaja tako dolgo, dokler še predstavlja korist za bolnika.
This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer. 
To lahko prepreči prehitro delitev celic in upočasni rast različnih vrst raka.
The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Yondelis, veljavno po vsej Evropski uniji, izdala 17. septembra 2007.
In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse. 
V obeh študijah je bilo glavno merilo učinkovitosti čas do poslabšanja bolezni.
Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty. 
Rak je bolezen, pri kateri se celice prehitro delijo, navadno zaradi okvare v načinu delovanja genov.
Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines. 
Okoli dve tretjini bolnic je imelo raka, občutljivega na zdravila, ki vsebujejo platino.
This is a summary of the European public assessment report (EPAR) for Yondelis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Yondelis.
The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks. 
V študiji so primerjali dve različni shemi odmerjanja zdravila Yondelis: trikrat mesečno ali enkrat na tri tedne.
What measures are being taken to ensure the safe and effective use of Yondelis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yondelis?
The CHMP concluded that Yondelis's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Yondelis večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Trabectedin works by attaching to the DNA, the chemical molecule that makes up genes, and preventing some genes in human cells from increasing their activity. 
Trabektedin deluje tako, da se veže na DNK, kemijsko molekulo, ki tvori gene, in preprečuje povečanje delovanje nekaterih genov v človeških celicah.
For the full list of restrictions, see the package leaflet. 
Za celoten seznam omejitev glejte navodilo za uporabo
• ovarian cancer; 
• rak jajčnikov;
All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working. 
Vsi bolniki so bili predhodno zdravljeni z antraciklini in ifosfamidi, vendar je zdravljenje postalo neučinkovito.
A risk management plan has been developed to ensure that Yondelis is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Yondelis je bil pripravljen načrt obvladovanja tveganj.
Yondelis 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 Yondelis se ne sme uporabljati pri bolnikih, ki imajo resno ali nenadzorovano okužbo, v kombinaciji s cepivom za rumeno mrzlico ali pri doječih ženskah.
Yondelis is used to treat adults with two types of cancer: 
Zdravilo Yondelis se uporablja za zdravljenje odraslih z dvema vrstama raka:
The most common side effects of any severity were neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), vomiting, increase in liver enzymes, anaemia (low red blood cell counts), tiredness, thrombocytopenia (low blood platelet counts), loss of appetite and diarrhoea. 
Najpogostejši neželeni učinki različnih stopenj resnosti so bili nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic), navzeja (slabost), bruhanje, povečano število jetrnih encimov, anemija (nizka raven rdečih krvničk), utrujenost, trombocitopenija (nizka raven krvnih ploščic), izguba teka in driska.
Other information about Yondelis 
Druge informacije o zdravilu Yondelis
The summary of the opinion of the Committee for Orphan Medicinal Products for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Yondelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
• ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum. 
• rakom jajčnikov, ki se je ponovil (znova pojavil po predhodnem zdravljenju) in je občutljiv za zdravila, ki vsebujejo platino.
If the patient's blood counts are abnormal, infusion with Yondelis should be delayed, the dose of Yondelis should be reduced or other medicines can be used to treat the blood problems. 
Če je bolnikova krvna slika nenormalna, je treba infundiranje zdravila Yondelis odložiti, njegov odmerek zmanjšati ali uporabiti druga zdravila za zdravljenje težav s krvjo.
For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Yondelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 uničujejo celice).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yondelis. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
EPAR summary for the public trabectedin 
Povzetek EPAR za javnost
Yondelis must be given under the supervision of a doctor who is experienced in the use of chemotherapy (medicines to treat cancer). 
Zdravilo Yondelis se mora dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije (zdravil za zdravljenje raka).
Most patients treated with Yondelis can be expected to have side effects. 
Pri večini bolnikov, ki se zdravijo z zdravilom Yondelis, je mogoče pričakovati neželene učinke.
What benefit has Yondelis shown during the studies? 
Kakšne koristi je zdravilo Yondelis izkazalo med študijami?
The full EPAR for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yondelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• advanced soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body. 
• napredovalim sarkomom mehkega tkiva, vrsto raka, ki se začne razvijati na mehkih vezivnih tkivih v telesu.
The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines. 
Učinek zdravila Yondelis je bil izrazitejši pri bolnicah, pri katerih je rak občutljiv na zdravila, ki vsebujejo platino.
Yondelis is used when treatment with anthracyclines and ifosfamide (other cancer medicines) have stopped working, or in patients who cannot be given these medicines; 
Zdravilo Yondelis se uporablja, ko je zdravljenje z antraciklini in ifosfamidi (drugimi zdravili proti raku) postalo neučinkovito, ali pri bolnikih, pri katerih uporaba teh zdravil ni primerna;
Yondelis was originally authorised under ‘exceptional circumstances', because, limited information was available at the time of approval on soft-tissue sarcoma. 
Zdravilo Yondelis je pridobilo dovoljenje za promet „v izjemnih okoliščinah“, ker so bilio v času izdaje dovoljenja na voljo omejeni podatki o sarkomu mehkega tkiva.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Yondelis, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because the numbers of patients with soft-tissue sarcoma and ovarian cancer are low, the diseases are considered ‘rare', and Yondelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 May 2001 (for soft-tissue sarcoma) and on 17 October 2003 (for ovarian cancer). 
Ker je bolnikov s sarkomom mehkega tkiva in rakom jajčnikov malo, veljata ti bolezni za redki, zato je bilo zdravilo Yondelis 30. maja 2001 (za sarkom mehkega tkiva) in 17. oktobra 2003 (za rak jajčnikov) določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
For soft-tissue sarcoma, Yondelis has been 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). 
Pri sarkomu mehkega tkiva so zdravilo Yondelis proučevali 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 ali nehotnih mišičnih celicah), ki je napredoval ali je bil metastatski (se je razširil na druge dele telesa).
It is available as a powder that is made up into a solution for infusion (drip into a vein). 
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Yondelis is used in combination with pegylated liposomal doxorubicin (PLD, another cancer medicine). 
Zdravilo Yondelis se uporablja v kombinaciji s pegiliranim liposomskim doksorubicinom (PLD, drugim zdravilom proti raku).
The active substance in Yondelis, trabectedin, is a synthetic version of a substance that was originally extracted from a species of tunicate or ‘sea squirt' (a marine animal). 
Zdravilna učinkovina zdravila Yondelis, trabektedin, je sintetična različica snovi, ki so jo prvotno pridobivali iz vrste plaščarja oziroma mehkega kozolnjaka (morske živali).
• soft-tissue sarcoma. 
• sarkom mehkega tkiva.
For soft-tissue sarcoma, the recommended dose of Yondelis is 1.5 mg per square metre of body surface area (calculated using the patient's height and weight), given as a single infusion lasting 24 hours every three weeks. 
Priporočeni odmerek zdravila Yondelis pri sarkomu mehkega tkiva je 1,5 mg/m2 telesne površine (izračunano na podlagi bolnikove telesne višine in mase), ki se da kot enkratna infuzija v trajanju 24 ur vsake tri tedne.
Patients receiving it once every three weeks lived for an average of 3.8 months without their disease getting 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 meseca v primerjavi z 2,1 meseca pri bolnikih, ki so zdravilo prejemali trikrat na mesec.
Around 10% of those patients treated with Yondelis as a single agent and 25% treated with Yondelis in combination therapy can be expected to have serious side effects. 
Pri približno 10 % bolnikov, ki se zdravijo z zdravilom Yondelis, vzetim samostojno, in 25 % bolnikov, ki se zdravijo z zdravilom Yondelis kot del kombiniranega zdravljenja, je mogoče pričakovati resne neželene učinke.
What is the risk associated with Yondelis? 
Kakšna tveganja so povezana z zdravilom Yondelis?
For ovarian cancer, it is given at a dose of 1.1 mg/m2 every three weeks as an infusion lasting three hours, immediately after the PLD infusion. 
Pri raku jajčnikov se zdravilo Yondelis daje v odmerku 1,1 mg/m2 kot infuzija v trajanju tri ure vsake tri tedne, takoj po infuziji pegiliranega liposomskega doksorubicina (PLD).
For soft-tissue sarcoma, Yondelis was more effective when it was given once every three weeks than when it was given with the alternative dosing schedule. 
Pri sarkomu mehkega tkiva je bilo zdravilo Yondelis, vzeto enkrat na tri tedne, učinkovitejše od alternativne sheme odmerjanja.
For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7.3 months without their disease getting worse, compared with 5.8 months in those receiving PLD alone. 
Pri raku jajčnikov je bila kombinacija zdravila Yondelis in pegiliranega liposomskega doksorubicina učinkovitejša od pegiliranega liposomskega doksorubicina, vzetega samostojno: bolnice, ki so prejemale kombinirano zdravljenje, so v povprečju živele 7,3 meseca brez poslabšanja bolezni v primerjavi s 5,8 meseca pri tistih, ki so pegilirani liposomski doksorubicin jemale samostojno.
For the full list of all side effects reported with Yondelis, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Yondelis, glejte navodilo za uporabo
To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment. 
Za preprečevanje bruhanja in zaščito jeter je treba pred posameznim odmerkom zdravila Yondelis bolniku dati infuzijo kortikosteroidov, kot je deksametazon.
It is recommended that Yondelis be given through a central venous line (a thin tube leading from the skin into the large veins just above the heart). 
Priporočljivo je, da se zdravilo Yondelis daje po centralnem venskem katetru (tanki cevki, speljani od kože v velike vene nad srcem).
Why has Yondelis been approved? 
Zakaj je bilo zdravilo Yondelis odobreno?
Fatal side effects have occurred in 1.9% and 0.9% of patients treated with Yondelis as a single agent and combination therapy, respectively. 
Neželeni učinki s smrtnim izidom so se zgodili pri 1,9 % bolnikov, ki so se zdravili z zdravilom Yondelis, vzetim samostojno, oziroma 0,9 % bolnikov, ki so se zdravili z zdravilom Yondelis kot del kombiniranega zdravljenja.
Yondelis is a cancer medicine that contains the active substance trabectedin. 
Zdravilo Yondelis je zdravilo proti raku, ki vsebuje zdravilno učinkovino trabektedin.
How has Yondelis been studied? 
Kako je bilo zdravilo Yondelis raziskano?