FrancophonIA/ELRC3.0 huggingface dataset:
English: Ristempa is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Estonian: Ristempa't kasutatakse tsütotoksilise keemiaravi (kiiresti kasvavaid rakke hävitavate ravimite) manustamisel tekkida võiva neutropeenia (valgete vereliblede arvu vähenemine) kestuse lühendamiseks ja palavikuga neutropeenia (valgete vereliblede arvu vähenemine koos palavikuga) esinemise vähendamiseks.
English: Long term outcome was not studied (see section 4.4).
Estonian: Kaugtulemusi ei uuritud (vt lõik
English: Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 ml).
Estonian: Süstelahus ühekordselt kasutatavas automaatse nõelakaitsega süstlis (0,6 ml).
English: Always take Ristempa exactly as your doctor has told you.
Estonian: Manustage Ristempa't alati vastavalt arstilt saadud juhistele.
English: 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).
Estonian: Iga süstel sisaldab vähem kui 1 mmol (23 mg) naatriumi (vt lõik 4.4).
English: 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.
Estonian: Iga keemiaravitsükli korral soovitatakse kasutada üks 6 mg annus (üks süstel) Ristempa't manustatuna vähemalt 24 tundi pärast tsütotoksilist keemiaravi.
English: Before administration, Ristempa solution should be inspected visually for particulate matter.
Estonian: Enne manustamist tuleb kontrollida, et Ristempa lahus ei sisaldaks nähtavaid osakesi.
English: • have sickle cell anaemia.
Estonian: • kui teil on sirprakuline aneemia.
English: Syringe safety guard
Estonian: Nõela ohutusvedru
English: 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.
Estonian: 9) kui vanematel lastel vanuses 6...11 aastat ja 12...21 aastat (vastavalt 6 päeva ja 3,7 päeva) ning täiskasvanutel.
English: Solution for injection in a single use pre-filled syringe (0.6 ml).
Estonian: Süstelahus ühekordselt kasutatavas süstlis (0,6 ml).
English: A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim,
Estonian: Väikeses (n = 83) II faasi topeltpimemeetodil teostatud kliinilises uuringus võrreldi de novo diagnoositud ägeda müeloidse leukeemiaga patsientidel pegfilgrastiimi (ühekordne annus 6 mg) filgrastiimiga, manustatuna induktsioonkemoteraapia vältel.
English: The safety and efficacy of Ristempa have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Estonian: Ristempa ohutust ja efektiivsust ei ole hinnatud keemiaravi (nt nitrosouread) saavatel haigetel hilise müelosupressiooni korral.
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Estonian: • teie veres võivad tekkida muutused, mis on leitavad tavapäraste vereproovidega; teie vere valgeliblede sisaldus võib lühiajaliselt tõusta; teie vereliistakute arv võib langeda, mis võib
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section
Estonian: Süstli nõelakate sisaldab kuiva naturaalset kummi (lateksi derivaat; vt lõik 4.4).
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Estonian: Ristempa't ei tohi kasutada tsütotoksilise keemiaravi kehtestatud annuste ületamiseks.
English: Side 2
Estonian: Vt lõik 2.
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).
Estonian: Need on üldiselt tekkinud kaugelearenenud pahaloomulise haigusega, sepsisega, mitme tsütotoksilise keemiaravimiga ravitavatel või afereesi saavatel patsientidel (vt lõik
English: BLISTERED SYRINGE LABEL
Estonian: BLISTERPAKEND SÜSTLIGA
English: The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions
Estonian: Süstli nõelakate sisaldab lateksi derivaati ja võib tekitada raskeid allergilisi reaktsioone;
English: 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).
Estonian: Pegfilgrastiimi manustamise järgselt on aeg-ajalt teatatud asümptomaatilise splenomegaalia tekkest ning aeg-ajalt põrnarebendi tekkest, sealhulgas mõnest letaalsest juhust (vt lõik 4.8).
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with Ristempa.
Estonian: Ristempa'ga ravitavatel patsientidel on teatatud ülitundlikkuse, k.a allergiliste reaktsioonide tekkest pärast esmakordset või korduvat manustamist.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Estonian: Enne süstimist tuleb lasta süstlil toatemperatuurini soojeneda.
English: Do not attempt to remove the peelable label on the pre-filled syringe barrel before
Estonian: Ärge üritage eemaldada äratõmmatavat etiketti süstli mahutilt enne süsti tegemist.
English: Sickle cell crisis2; Splenomegaly Splenic rupture2
Estonian: Splenomegaalia Põrna rebend2
English: Talk to your doctor, pharmacist or nurse before using Ristempa:
Estonian: Enne Ristempa kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega järgmistel juhtudel:
English: Permanently discontinue Ristempa in patients with clinically significant hypersensitivity.
Estonian: Kliiniliselt olulise ülitundlikkusega patsientidel tuleb ravi Ristempa'ga püsivalt lõpetada.
English: Push the plunger all the way down as far as it will go to inject all the liquid.
Estonian: Suruge kolb lõpuni alla, nii palju kui saab, et
English: Amgen Europe BV Minervum 7061
Estonian: Amgen Europe BV Minervum 7061 NL-4817 ZK Breda Holland
English: The safety and efficacy of Ristempa have not been investigated in patients receiving high dose chemotherapy.
Estonian: Ravimi ohutust ja efektiivsust kõrgdoosis keemiaravi saavatel patsientidel ei ole uuritud.
English: Ristempa 6 mg Pegfilgrastim SC
Estonian: Ristempa 6 mg Pegfilgrastim s.c.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Estonian: Iga süstel sisaldab 6 mg pegfilgrastiimi* 0,6 ml süstelahuses.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving Ristempa following cytotoxic chemotherapy.
Estonian: Tsütotoksilise keemiaravi järgselt Ristempa't saanud patsientidel oli aeg-ajalt kusihappe ja alkaalse fosfataasi kontsentratsioonide vähest kuni mõõdukat pöörduvat tõusu ilma kliiniliste ilminguteta ning aeg-ajalt laktaatdehüdrogenaasi kontsentratsiooni vähest kuni mõõdukat pöörduvat tõusu ilma kliiniliste ilminguteta.
English: Elevations in lactate dehydrogenase and alkaline phosphatase Transient elevations in LFT's for ALT or AST1
Estonian: Laktaatdehüdrogenaasi ja alkaalse fosfataasi sisalduse tõus1; maksafunktsiooni näitajate mööduv tõus (ALAT ja ASAT)1
English: This may be a sign of a problem with your spleen (splenomegaly)
Estonian: See võib olla põrnaprobleemi näht
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 yrs (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2).
Estonian: võrreldes vanemate lastega vanuses 6...11 aastat ja 12...21 aastat (vastavalt 70% ja 33%) ning täiskasvanutega (vt lõigud 4.8 ja 5.2).
English: • a pre-filled syringe of Ristempa; and
Estonian: • Ristempa süstlit ja
English: If there are particles in it, you must not use it.
Estonian: Kui lahuses on osakesi,
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Estonian: Granulotsüütide kolooniat stimuleeriva faktori kasutamisel on turustusjärgselt teatatud kapillaaride lekke sündroomi juhtudest.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with Ristempa (uncommon [≥ 1/1,000 to < 1/100]).
Estonian: Ravi alustamisel Ristempa'ga või ravi käigus tekkisid aeg-ajalt (≥ 1/1000 kuni < 1/100) ülitundlikkusreaktsioonid, sealhulgas nahalööve, utrikaaria, angiödeem, düspnoe, erüteem, õhetus ja hüpotensioon.
English: - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for
Estonian: Abiained on naatriumatsetaat, sorbitool (E420), polüsorbaat 20 ja süstevesi.
English: Uncommon events of cutaneous vasculitis have been reported in patients treated with Ristempa.
Estonian: Aeg-ajalt on Ristempa'ga ravitud patsientidel teatatud naha vaskuliidist.
English: Women who are breast-feeding during Ristempa treatment are encouraged to enrol in Amgen's Lactation Surveillance programme.
Estonian: Naisi, kes imetavad ravi ajal Ristempa'ga, kutsutakse osalema Amgen'i imetamise järelvalveprogrammis.
English: Before you use a Ristempa pre-filled syringe with automatic needle guard, read this important information:
Estonian: Lugege seda olulist teavet, enne kui kasutate Ristempa süstlit, millel on automaatne nõelakaitse.
English: No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Estonian: Neerukahjustusega, kaasa arvatud teriminaalse neerupuudulikkusega patsientidel ei ole annuse kohaldamine vajalik.
English: • spleen rupture.
Estonian: • süstekoha punetus.
English: Gastrointestinal disorders Skin and subcutaneous tissue disorders
Estonian: Seedetrakti häired Naha ja nahaaluskoe kahjustused
English: Ristempa contains sorbitol (E420) and sodium acetate
Estonian: Ristempa sisaldab sorbitooli (E420) ja naatriumatsetaati.
English: Front - Ristempa reference guide:
Estonian: Esikülg - Ristempa lühijuhis
English: Adverse reactions
Estonian: Süstekoha reaktsioonid
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Estonian: Patsientidel, kellele manustatakse pegfilgrastiimi tsütotoksilise keemiaravi järgselt, on aeg-ajalt täheldatud maksafunktsiooni näitajate - ALAT (alaniinaminotransferaasi) või ASAT (aspartaataminotransferaasi) - tõusu.
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving Ristempa (uncommon) (see section 4.4).
Estonian: Ristempa'ga ravitavatel patsientidel võib aeg-ajalt tekkida tõsine allergiline raktsioon, k.a anafülaksia (vt lõik 4.4).
English: Pack size of one pre-filled syringe, in either a blistered or non-blistered packaging.
Estonian: Blisterümbrisega või blisterümbriseta pakend, milles on üks süstel.
English: Each pre-filled syringe contains 0.6 ml of solution for injection.
Estonian: Iga süstel sisaldab 0,6 ml süstelahust.
English: Unless your doctor directs you otherwise, you must stop breast feeding if you use Ristempa.
Estonian: Ristempa kasutamisel peate rinnaga toitmise katkestama, välja arvatud arsti soovitusel.
English: 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.
Estonian: Ravi alustamisel Ristempa'ga või ravi käigus on sageli tekkinud süstekoha reaktsioonid, k.a süstekoha erüteem (aeg-ajalt (≥1/1000 kuni <1/100)) ja süstekoha valu (sage (≥1/100 kuni <1/10)).
English: There is insufficient information on the excretion of Ristempa / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Estonian: Riski vastsündinule ja imikule ei saa välistada.
English: If you use more Ristempa than you should contact your doctor, pharmacist or nurse.
Estonian: Kui te kasutate Ristempa't rohkem, kui ette nähtud Kui kasutate Ristempa't rohkem, kui ette nähtud, konsulteerige arsti, apteekri või meditsiiniõega.
English: Keep this medicine out of the sight and reach of children.
Estonian: Kuidas Ristempa't säilitada Hoidke seda ravimit laste eest varjatud ja kättesaamatus kohas.
English: Keep the container in the outer carton in order to protect from light.
Estonian: Hoida valguse eest kaitstult.
English: Ristempa 6 mg injection Pegfilgrastim
Estonian: Ristempa 6 mg süstelahus Pegfilgrastim
English: Method of administration
Estonian: Tehniline juhend
English: UNBLISTERED SYRINGE LABEL
Estonian: Sirprakuline aneemia
English: Grab the pre-filled syringe safety guard to remove the
Estonian: Süstli pakendist välja võtmiseks võtke kinni süstli
English: Instructions for injecting with the Ristempa pre-filled syringe
Estonian: Juhised süstimiseks Ristempa süstliga
English: Acute Respiratory Distress
Estonian: Pulmonaalsed kõrvalnähud
English: Back- Ristempa reference guide:
Estonian: Tagakülg - Ristempa lühijuhis
English: 9/l or greater have been observed in less than 1% of patients receiving Ristempa.
Estonian: Vähem kui 1% Ristempa'ga ravitavatel patsientidest on täheldatud valgete vererakkude üldarvu 100 x 10
English: Syringe label Used syringe barrel
Estonian: Süstla etikett Kasutatud süstla mahuti
English: Excipient(s) with known effect:
Estonian: Teadaolevat toimet omavad abiained:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: Hoida sisepakend välispakendis.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in
Estonian: Iga süstel sisaldab 6 mg pegfilgrastiimi 0,6 ml lahuses.
English: Nervous system disorders Vascular disorders
Estonian: Vaskulaarsed häired
English: Ristempa 6 mg solution for injection.
Estonian: Ristempa, 6 mg süstelahus.
English: Belly
Estonian: Naba
English: This summary was last updated in 05-2015.
Estonian: • Kokkuvõtte viimane uuendus: 05-2015.
English: • ovarian cancer;
Estonian: • munasarjavähk;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007.
Estonian: Euroopa Komisjon andis Yondelise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 17. septembril 2007.
English: This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer.
Estonian: Sel viisil saab ennetada rakkude liiga kiiret jagunemist ja aeglustada mitmesuguste vähivormide kasvu.
English: What measures are being taken to ensure the safe and effective use of Yondelis?
Estonian: Mis meetmed võetakse, et tagada Yondelise ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Yondelis is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Yondelise võimalikult ohutu kasutamine.
English: Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty.
Estonian: Vähk on haigus, mille korral rakud jagunevad liiga kiiresti, tavaliselt nende geenide talitlushäire tõttu.
English: Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines.
Estonian: Ligikaudu kahel kolmandikul patsientidest oli vähk, mis on tundlik plaatinat sisaldavate ravimite suhtes.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 27 May 2015.
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 27. mail 2015.
English: The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks.
Estonian: Uuringus võrreldi Yondelise kaht annustamisskeemi: kolm korda kuus või üks kord iga kolme nädala järel.
English: All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working.
Estonian: Kõiki patsiente oli varem ravitud antratsükliini ja ifosfamiidiga, kuid see ravi enam ei mõjunud.
English: • ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum.
Estonian: • munasarjavähk, mis on relapseerunud (pärast varasemat ravi taastunud) ja mis on tundlik plaatinat sisaldavate ravimite suhtes.
English: Treatment carries on for as long as the patient shows a benefit.
Estonian: Ravi tuleb jätkata, kuni sellest on kasu.
English: 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
Estonian: Harvikravimite komitee arvamuse kokkuvõtted Yondelise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: The CHMP concluded that Yondelis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Yondelise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Yondelis
Estonian: Muu teave Yondelise kohta
English: The full EPAR for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Yondelise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja haiguse süvenemiseni kulunud aeg.
English: It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines.
Estonian: Seda võivad kasutada ainult pädevad onkoloogid (vähiarstid) või muud tervishoiutöötajad, kes on spetsialiseerunud tsütotoksiliste (rakke hävitavate) ravimite manustamisele.
English: 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.
Estonian: Kui patsiendi verepilt on ebanormaalne, tuleb Yondelise infusioon edasi lükata, Yondelise annust vähendada või kasutada verehäirete raviks muid ravimeid.
English: 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.
Estonian: Kõige sagedamad kõrvalnähud olenemata raskusastmest olid neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus), iiveldus, oksendamine, maksaensüümide sisalduse suurenemine, aneemia (punaliblede vähesus), väsimus, trombotsütopeenia (vereliistakute vähesus), isutus ja kõhulahtisus.
English: Yondelis is used to treat adults with two types of cancer:
Estonian: Yondelist kasutatakse täiskasvanutel kahe järgmise vähivormi raviks:
English: 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).
Estonian: Yondelist on soovitatav manustada keskse veenikanüüli kaudu (peen voolik, mis ulatub nahalt vahetult südame kohal paiknevate suurte veenideni).
English: For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Yondelisega toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: 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.
Estonian: Patsientidel, kellele manustati ravimit üks kord iga kolme nädala järel, ei süvenenud haigus keskmiselt 3,8 kuud, Yondelist kolm korda kuus saanud patsientidel aga 2,1 kuud.
English: 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.
Estonian: Pehmekoesarkoomi ravis oli Yondelis manustamisel üks kord iga kolme nädala järel efektiivsem kui alternatiivse annustamisskeemi korral.
English: ‘Advanced' means that the cancer has started to spread.
Estonian: Kaugelearenenud tähendab, et vähk on levinud organismis ka mujale.
English: Most patients treated with Yondelis can be expected to have side effects.
Estonian: Enamikul Yondelisega ravitud patsientidest tekivad eeldatavasti kõrvalnähud.
English: 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.
Estonian: Selle alusel lisati Yondelise omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed
English: • soft-tissue sarcoma.
Estonian: • pehmekoesarkoom.
English: For the full list of all side effects reported with Yondelis, see the package leaflet.
Estonian: Yondelise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: 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.
Estonian: Trabektediin seondub DNA-ga (aine, millest koosnevad geenid) ja ennetab teatud inimrakkude geenide aktiveerumist.
English: 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).
Estonian: Et pehmekoesarkoomi ja munasarjavähiga patsiente on vähe ja need haigused esinevad harva, nimetati Yondelis harvikravimiks 30. mail 2001 (pehmekoesarkoomi ravi) ja 17. oktoobril 2003 (munasarjavähi ravi).
English: To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment.
Estonian: Oksendamise ennetamiseks ja maksa kaitsmiseks tuleb enne ravi infundeerida kortikosteroide (nt deksametasooni).
English: 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.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Yondelis is a cancer medicine that contains the active substance trabectedin.
Estonian: Yondelis on vähiravim, mis sisaldab toimeainena trabektediini.
English: 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.
Estonian: Umbes 10% ainult Yondelist ja 25% kombinatsioonravi saavatel patsientidel võivad tekkida rasked kõrvalnähud.