FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that an increased CV risk may also apply to patients for whom sibutramine can be prescribed since overweight or obese patients are likely to be at risk for cardiovascular disease.
Estonian: Inimravimite komitee arvestas, et suur kardiovaskulaarhaiguste risk võib kehtida ka patsientide suhtes, kellele määratakse sibutramiiniravi, sest ülekaalulistel või rasvunud patsientidel on suurem kardiovaskulaarhaiguste risk.
English: Convincing data to identify a patient population in which sustained and clinically-important efficacy of sibutramine-containing products can be demonstrated, and in which the benefit clearly outweighs its risks.
Estonian: Veenvad tõendid, mille põhjal tuvastada patsiendipopulatsioon, kelle kohta on tõendatud tulemused sibutramiini sisaldavate ravimite toime säilimisest ja kliiniliselt tähtsast efektiivsusest ning kelle korral on ravimi kasulikkuse ja riski suhe selgelt soodne.
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide convincing data to identify a patient population in which sustained and clinically-important efficacy of sibutraminecontaining products can be demonstrated, and in which the benefit clearly outweighs its risks (see Annex III)
Estonian: Peatamise lõpetamiseks peavad müügilubade hoidjad esitama veenvad andmed patsiendipopulatsioonidest, kelle kohta on tõendatud tulemused sibutramiini sisaldavate ravimite toime säilimisest ja kliiniliselt tähtsast efektiivsusest ja kellel on ravimi kasulikkuse ja riski suhe selgelt soodne (vt III lisa).
English: On the other hand, comparing sibutramine responders to placebo responders (a comparison that ignores the finding that more patients achieved 5% weight loss on sibutramine compared to placebo) reveals a number needed to be exposed to sibutramine of 347 for one extra CV event to occur.
Estonian: Teisest küljest näitab sibutramiiniga ravitud ravivastusega patsientide ja platseeboga ravitud ravivastusega patsientide tulemuste võrdlus (selline võrdlus jätab kõrvale tõiga, et sibutramiini saanute hulgas oli 5% kehakaalu vähenemise saavutanud patsientide arv suurem kui platseeborühmas), et 347 sibutramiini saanud patsiendi kohta esineb 1 kardiovaskulaarhaiguse lisajuhtum.
English: Teva Pharmaceuticals Europe B.V. European Headquarters Computerweg 10
Estonian: European Headquarters Computerweg 10
English: This was acknowledged, however the CHMP considered that the data shows that the risk of CV events for patients continued on sibutramine was higher than if continued on placebo.
Estonian: Seda asjaolu tunnustati, ent inimravimite komitee arvas, et andmete põhjal on patsientidel sibutramiiniravi jätkates kardiovaskulaarhaiguste juhtude risk suurem kui platseeboravi korral.
English: • The Committee further considered that a patient population in which sibutramine-containing medicinal products have a clear positive benefit/risk cannot be identified based on the current data,
Estonian: • inimravimite komitee arvas, et praeguste andmete põhjal ei ole võimalik tuvastada patsiendipopulatsiooni, kelle korral oleks sibutramiini sisaldavate ravimite korral kasulikkuse ja riski suhe selgelt soodne;
English: Czech Republic TEVA Pharmaceuticals ČR,s.r.o.
Estonian: TEVA Pharmaceuticals ČR,s.r.o.
English: Following the assessment of the MAHs responses, the CHMP considered that the SCOUT results provide evidence of increased cardiovascular and cerebrovascular risks associated with the use of sibutramine in high risk patients.
Estonian: Pärast müügiloa hoidjate vastuste hindamist otsustas inimravimite komitee, et uuringu SCOUT tulemused pakuvad piisavaid tõendeid suurenenud kardiovaskulaarsete ja ajuveresoonkonna riskide kohta seoses sibutramiini kasutamisega suurema riskiga patsientidel.
English: Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands
Estonian: Computerweg 10 3542 DR Utrecht Holland
English: The CHMP concluded that the benefit/risk balance of sibutramine-containing medicinal products is affected adversely by the results from the SCOUT study and is considered to be negative.
Estonian: Inimravimite komitee otsustas, et uuringu SCOUT tulemused mõjutavad sibutramiini sisaldavate ravimite kasulikkuse ja riski suhet negatiivselt ja see suhe ei ole soodne.
English: The SCOUT study was powered as a superiority study aiming to show a decrease in the POE rate in the sibutramine treated patients compared to placebo.
Estonian: Uuringut SCOUT peeti põhiuuringuks, mille alusel tõendada ravitulemuste esmajuhtude arvu vähenemist sibutramiini ravi korral võrrelduna platseeboraviga.
English: A procedure under Article 107 of Directive 2001/83/EC was triggered in November 2009 based on preliminary results from SCOUT that suggested an increased cardiovascular risk with sibutramine treatment compared with placebo.
Estonian: Uuringu SCOUT esialgsete tulemuste põhjal, mis viitasid sibutramiini ravi korral suuremale kardiovaskulaarsele riskile võrreldes platseeboga, alustati 2009. aasta novembris direktiivi 2001/83/EÜ artikli 107 kohast menetlust.
English: Sibutramine treatment resulted in a higher incidence of POEs (specifically non-fatal myocardial infarction and stroke were the drivers) compared with placebo in patients with a history of a cardiovascular disease (these patients were acknowledged as Summary of Product Characteristics (SPC) non-conformers).
Estonian: Võrreldes platseeboraviga oli sibutramiiniravi tulemuseks ravitulemuste esmaste tulemusnäitajate (eelkõige surma mitte põhjustanud südameinfarkt ja insult) sagedus suurem patsientidel, kellel oli esinenud kardiovaskulaarne haigus (ravimi omaduste kokkuvõttes nimetati neid patsiente väljapoole ravimi märgistust jäävateks (nn non-conformers)).
English: The CHMP noted that the SCOUT data clearly demonstrates that patients with obesity and known CV disease taking sibutramine are exposed to an increased risk for CV events compared with placebo.
Estonian: Inimravimite komitee märkis, et uuringu SCOUT andmed näitavad selgelt, et teadaoleva kardiovaskulaarhaigusega rasvunud patsientidel tekib sibutramiini võttes suurem kardiovaskulaarse juhu risk kui platseebo korral.
English: Similarly, the proposed yearly PSUR reporting cycle was considered unlikely to promote SPC compliance regarding prescription.
Estonian: Ei peetud ka tõenäoseks, et soovitatud perioodilise ohutusaruande üheaastane tsükkel soodustab ravimi väljakirjutamise vastavust ravimi ohutuse kokkuvõttele.
English: In addition, it is impossible to exclude patients with covert cardiovascular disease from receiving sibutramine even with risk minimisation measures in place.
Estonian: Samuti on isegi riski vähendamismeetmete korral võimatu välistada sibutramiini ravist patsiendid, kellel on diagnoosimata kardiovaskulaarhaigus.
English: In addition, an increase in duration of use tended to increase the risk of non-fatal POE in this subgroup and the point estimate for non-fatal POE tended towards harm at the three year time point.
Estonian: Lisaks kaldus ravimi kasutuse mis tahes pikendamine suurendama selles patsiendirühmas mittesurmavate esmaste tulemusnäitajate juhtude riski ja nende juhtude kriitiline periood, mil võisid tekkida kahjustused, oli kolm aastat.
English: Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in - Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.
Estonian: Sibutramiini kasutatakse koos kalorivaese dieedi ning suurendatud kehalise aktiivsusega järgmistel patsientidel: toitumuslikult rasvunud patsiendid, kelle kehamassi indeks on vähemalt 30 kg/m2; toitumusliku ülekaaluga patsiendid, kelle kehamassi indeks on vähemalt 27 kg/m2 ja kellel esineb ka muid ohutegureid, näiteks II tüüpi diabeet või düslipideemia.
English: Data stratified by CV risk group shows that the “CV + DM” (cardiovascular disease plus Type 2 diabetes) group carried the highest risk of POE, followed by the “CV Only” (cardiovascular disease) group and the “DM Only” (Type 2 diabetes) group.
Estonian: Andmed, mis on liigitatud kardiovaskulaarhaiguste rühma põhjal, tõendavad, et patsiendirühmas, kus patsientidel esineb lisaks kardiovaskulaarhaigusele II tüüpi diabeet, on suurim esmaste tulemusnäitajate juhtude risk, neile järgneb patsiendirühm, kellel esineb üksnes kardiovaskulaarhaigus ja seejärel üksnes II tüüpi diabeediga patsientide rühm.
English: Consequently the CHMP expressed concern that the increase in rates of POEs in the sibutramine arm compared with placebo was in fact sufficient to be statistically significant.
Estonian: Inimravimikomitee väljendas seejärel ettevaatlikkust, sest võrreldes platseeborühmaga oli sibutramiini rühma ravitulemuste esmaste tulemusnäitajate arvu suurenemine statistiliselt märkimisväärne.
English: United Kingdom Teva UK Limited Brampton Road
Estonian: Teva UK Limited
English: SIBUTRAL 10 mg, gélule 10 mg capsule oral use
Estonian: SIBUTRAL 10 mg, gélule 10 mg Kapsel
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic
Estonian: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Tšehhi
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic
Estonian: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Tšehhi
English: Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral
Estonian: Sibutril 10 mg capsules, hard 10 mg Kõvakapsel
English: 16929 Solna Sweden
Estonian: 16929 Solna Rootsi
English: SIBUTRAL 15 mg, gélule 15 mg capsule oral use
Estonian: SIBUTRAL 15 mg, gélule 15 mg Kapsel
English: Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral
Estonian: Sibutril 15 mg capsules, hard 15 mg Kõvakapsel
English: SE-169 29, Solna Sweden
Estonian: SE-169 29, Solna Rootsi
English: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Estonian: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Saksamaa
English: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Estonian: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Saksamaa
English: LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use
Estonian: LINDAXA 15 mg, capsule 15 mg Kõvakapsel
English: LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use
Estonian: LINDAXA 10 mg, capsule 10 mg Kõvakapsel
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Estonian: U kabelovny 130 102 37 Prague 10 Tšehhi
English: U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic
Estonian: U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Tšehhi
English: SE-169 29 Solna Sweden
Estonian: SE-169 29 Solna Rootsi
English: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic
Estonian: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Tšehhi
English: 1348 Ottignies/LLN Belgium
Estonian: Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgia
English: 169 29 Solna Sweden
Estonian: 169 29 Solna Rootsi
English: U Kabelovny 130 102 37 Praha 10 Czech Republic
Estonian: U Kabelovny 130 102 37 Praha 10 Tšehhi
English: Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use
Estonian: Sibutramin Sandoz 15 mg 15 mg Kõvakapsel
English: Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use
Estonian: Sibutramin Sandoz 10 mg 10 mg Kõvakapsel
English: Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use
Estonian: Sitrane 15 mg hard capsules 15 mg Kõvakapsel
English: 15 mg capsule oral use
Estonian: 15 mg Kapsel
English: Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use
Estonian: Sitrane 10 mg hard capsules 10 mg Kõvakapsel
English: 10 mg capsule oral use
Estonian: 10 mg Kapsel
English: MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use
Estonian: MINIMACIN 10 mg, capsule 10 mg Kõvakapsel
English: MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use
Estonian: MINIMACIN 15 mg, capsule 15 mg Kõvakapsel
English: Reductil 15 mg hard capsules 15 mg Capsule, hard oral use
Estonian: Reductil 15 mg hard capsules 15 mg Kõvakapsel
English: Reductil 10 mg hard capsules 10 mg Capsule, hard oral use
Estonian: Reductil 10 mg hard capsules 10 mg Kõvakapsel
English: Sibutramina West Pharma 10 mg Capsule, hard oral use
Estonian: Sibutramina West Pharma 10 mg Kõvakapsel
English: Sibutramina West Pharma 15 mg Capsule, hard oral use
Estonian: Sibutramina West Pharma 15 mg Kõvakapsel
English: SILUTON 10 mg, capsule 10 mg Capsule, hard oral use
Estonian: SILUTON 10 mg, capsule 10 mg Kõvakapsel
English: Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use
Estonian: Reductil 10 mg trde kapsule 10 mg Kõvakapsel
English: SILUTON 15 mg, capsule 15 mg Capsule, hard oral use
Estonian: SILUTON 15 mg, capsule 15 mg Kõvakapsel
English: Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use
Estonian: Reductil 10 mg - Hartkapseln 10 mg Kõvakapsel
English: Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use
Estonian: Reductil 15 mg - Hartkapseln 15 mg Kõvakapsel
English: Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use
Estonian: Zelium 15 mg Hartkapseln 15 mg Kõvakapsel
English: Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use
Estonian: Reductil 15 mg trde kapsule 15 mg Kõvakapsel
English: Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use
Estonian: Zelium 10 mg Hartkapseln 10 mg Kõvakapsel
English: Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use
Estonian: Reduxade 15 mg Hartkapseln 15 mg Kõvakapsel
English: Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use
Estonian: Reduxade 10 mg Hartkapseln 10 mg Kõvakapsel
English: REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use
Estonian: REDUCTIL 10 mg, capsule 10 mg Kõvakapsel
English: REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use
Estonian: REDUCTIL 15 mg, capsule 15 mg Kõvakapsel
English: SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use
Estonian: SIBUTRAMIN SANDOZ 10 mg Kõvakapsel
English: 10 mg Film-coated tablet oral use
Estonian: 10 mg Õhukese polümeerikattega tablett
English: Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use
Estonian: Reductil 10 mg Hartkapseln 10 mg Kõvakapsel
English: Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use
Estonian: Reductil 15 mg Hartkapseln 15 mg Kõvakapsel
English: 15 mg Film-coated tablet oral use
Estonian: 15 mg Õhukese polümeerikattega tablett
English: SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use
Estonian: SIBUTRAMIN SANDOZ 15 mg Kõvakapsel
English: Best Response
Estonian: Parim vastus
English: EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 1 vial
Estonian: EU/1/06/334/001 3 viaali EU/1/06/334/002 4 viaali EU/1/06/334/003 10 viaali EU/1/06/334/004 20 viaali EU/1/06/334/005 1 viaal
English: Other medicines and Evoltra
Estonian: Muud ravimid ja Evoltra
English: 5.2 hours
Estonian: 5,2 tundi
English: This is usually reversible and appears to be dosedependent.
Estonian: See on tavaliselt pöörduv ja näib olevat annusest sõltuv.
English: Your doctor will give you Evoltra once every day for 5 days.
Estonian: Arst manustab teile Evoltra't üks kord ööpäevas 5 päeva jooksul.
English: It is a clear, almost colourless solution that is prepared and diluted before it is used.
Estonian: See on selge, peaaegu värvitu lahus, mis enne kasutamist valmistatakse ja lahjendatakse.
English: ITT* patients (n = 61)
Estonian: ITT* patsientide arv (n = 61)
English: Estimates based on non-compartmental analysis (n = 14 / n = 14)
Estonian: Lahterdamata (non compartmental) analüüsil põhinevad hinnangud (n = 14 / n = 14)
English: However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Estonian: Teadaolevaid kliiniliselt olulisi koostoimeid teiste ravimitega või laboratoorsete testidega ei ole.
English: Evoltra may harm both male and female reproductive organs.
Estonian: Evoltra võib kahjustada nii meeste kui ka naiste suguelundeid.
English: Therefore, Evoltra should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Estonian: Seepärast ei tohi Evoltrat kasutada raseduse ajal, eriti selle esimeses kolmandikus, kui see ei ole hädavajalik (s.t ainult sel juhul, kui selle potentsiaalne kasulikkus emale kaalub üles lootele avalduva riski).
English: From a microbiological point of view, it should be used immediately.
Estonian: Mikrobioloogilise saastatuse vältimiseks tuleb see kohe ära kasutada.
English: 1 vial 3 vials 4 vials 10 vials 20 vials
Estonian: 1 viaal 3 viaali 4 viaali 10 viaali 20 viaali
English: Most of the cardiac adverse events were reported in the first 2 cycles.
Estonian: Enamikust südame kõrvaltoimetest teatati esimese 2 tsükli jooksul.
English: • This medicine has been prescribed for you only.
Estonian: − Ravim on välja kirjutatud üksnes teile.
English: Evoltra contains salt
Estonian: Evoltra sisaldab soola
English: Do not use this medicine after the expiry date which is stated on the vial label and box after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud viaali etiketil ja karbil pärast „EXP”.
English: Evoltra is for single use only.
Estonian: Evoltra on ainult ühekordseks kasutamiseks.
English: What Evoltra is and what it is used for
Estonian: Mis ravim on Evoltra ja milleks seda kasutatakse
English: • Complete disappearance of circulating blasts
Estonian: • ringlevate blastide täielik kadumine
English: Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Estonian: Üks karp sisaldab 1, 3, 4, 10 või 20 viaali, kuid kõik pakendi suurused ei pruugi olla müügil.
English: PR = Partial Remission
Estonian: PR (partial remission) = osaline ravivastus
English: (If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
Estonian: (Kui 0,2 mikromeetrist süstlafiltrit ei ole võimalik kasutada, tuleb kontsentraat eelfiltreerida 5 mikromeetrise filtriga, lahjendada ja manustada seejärel 0,22 mikromeetrise süsteemifiltri kaudu.)
English: Each box contains 1, 3, 4, 10 or 20 vials.
Estonian: Üks karp sisaldab 1, 3, 4, 10 või 20 viaali.
English: If you forget to use Evoltra
Estonian: Kui te unustate Evoltra't kasutada
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, ATC code: L01BB06.
Estonian: Farmakoterapeutiline rühm: kasvajavastased ained, antimetaboliidid, ATC-kood: L01BB06.
English: Estimated creatinine clearance (ml/min)
Estonian: Hinnanguline kreatiini kliirens (ml/min)
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Estonian: * = vt allpool ** Selles tabelis sisalduvad kõik kõrvaltoimed, mis tekkisid vähemalt kaks korda (st 2 või enam reaktsiooni (1,7%)).
English: In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Estonian: Samuti tuleb katkestada ravi klofarabiiniga, kui patsiendil tekib mistahes põhjusel hüpotensioon 5 manustamispäeva jooksul.
English: Evoltra must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Estonian: Evoltrat ei tohi segada ega manustada samaaegselt teiste ravimitega sama intravenoosse süsteemi kaudu (vt lõik 6.2).
English: Date of latest renewal: 14 January 2016
Estonian: Müügiloa esmase väljastamise kuupäev: 29. mai 2006 Müügiloa viimase uuendamise kuupäev: 14. jaanuar 2016
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Estonian: Selge, praktiliselt värvitu lahus, mille pH on 4,5...7,5 ja osmolaarsus 270...310 mOsm/l.
English: • DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
Estonian: • DNA polümeraas α inhibeerimine, mis lõpetab DNA ahela pikenemise ja/või DNA sünteesi/ parandamise;
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Estonian: Iga-aastaselt, samaaegselt perioodilise ohutusaruandega.
English: Tell your doctor if you are using or have recently used: - medicines for heart disease; - any medicine that changes your blood pressure; - medicines that affect your liver or kidneys; - any other medicines including those obtained without a prescription.
Estonian: Teatage oma arstile, kui te võtate või olete hiljuti võtnud: - südamehaiguste ravimeid; - vererõhku mõjutavaid ravimeid; - maksa või neerusid mõjutavaid ravimeid; - mingeid muid ravimeid, kaasa arvatud ilma retseptita ostetud ravimeid.
English: CR = Complete Remission
Estonian: CR (complete remission) = täielik ravivastus
English: CRp = Complete Remission in the Absence of Total Platelet Recovery
Estonian: CRp (complete remission in the absence of platelet recovery) = täielik ravivastus ilma trombotsüütide täieliku taastumiseta
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multiorgan failure.
Estonian: Need infektsioonid võivad põhjustada septilist šokki, hingamispuudulikkust, neerupuudulikkust ja/või hulgiorganpuudulikkust.
English: Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Estonian: Evoltra on tugev antineoplastiline aine potentsiaalselt oluliste hematoloogiliste ja mittehematoloogiliste kõrvaltoimetega (vt lõik 4.8).
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
Estonian: See on ekvivalentne 3,08 mmol (ehk 70,77 mg) naatriumiga.
English: Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
Estonian: Ravi Evoltra'ga on teile määranud kvalifitseeritud arst, kellel on leukeemia ravi kogemus.
English: Where follow-up data are available, the majority of bilirubin elevations returned to  grade 2 within 10 days.
Estonian: Saadaolevate jälgimisandmete alusel pöördus enamus bilirubiini tõuse 10 päeva jooksul tagasi ≤ 2. astmele.
English: CR + CRp + PR 18
Estonian: CR + CRp + PR 18 Ravi ebaõnnestunud
English: If a patient becomes pregnant during treatment with clofarabine, they should be informed of the possible hazard to the foetus.
Estonian: Kui patsient ravi ajal klofarabiiniga rasestub, tuleb teda teavitada võimalikust ohust lootele.
English: Paasheuvelweg 251105 BP Amsterdam The Netherlands Manufacturer
Estonian: Paasheuvelweg 25 1105 BP Amsterdam Holland
English: • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Estonian: • respiratoorne seisund, vererõhk, vedelikutasakaal ja kehakaal klofarabiini manustamise 5 päeva jooksul ja kohe pärast seda.
English: During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health.
Estonian: Ravi ajal Evoltra'ga teeb arst teie tervise jälgimiseks teile regulaarselt vereanalüüse.
English: CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse
Estonian: CR * Remissiooni kestus tsenseeritud siirdamise ajal ** Patsiendile tehti siirdamine pärast alternatiivset ravi *** Patsiendile tehti siirdamine pärast retsidiivi
English: 20 mg/20 ml
Estonian: 20 ml/20 ml
English: It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Estonian: See tuleb filtreerida läbi steriilse 0,2 mikromeetrise süstlafiltri ja lahjendada siis 9 mg/ml (0,9%) naatriumkloriidi intravenoosse infusiooniga, et saada kokku kogus, mis on esitatud allpool tabelis näidetes.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Estonian: Euroopa Ravimiamet vaatab igal aastal läbi ravimi kohta saadud uue teabe ja vajaduse korral ajakohastatakse seda infolehte.