FrancophonIA/ELRC3.0 huggingface dataset:
English: Of those with observed values at Month 15, a higher proportion of Spinraza treated subjects had improvement (73% vs 41%, respectively) and a lower proportion of Spinraza treated subjects had worsening (23% vs 44%, respectively) in total HFMSE score compared to sham-control.
Estonian: Neist uuritavatest, kellel olid fikseeritud 15. kuu väärtused, saavutati HFMSE üldskoori paranemine suuremal osakaalul Spinraza'ga ravitud patsientidest (vastavalt 73% vs. 41%) ja skoor halvenes väiksemal osakaalul Spinraza'ga ravitud patsientidest (vastavalt 23% vs. 44%) võrreldes imiteeriva kontrollrühmaga.
English: If clinically indicated, platelet and coagulation laboratory testing is recommended prior to administration of Spinraza.
Estonian: Enne Spinraza manustamist on soovitatav laboratoorselt kontrollida trombotsüüte ja hüübimisnäitajaid, kui see on kliiniliselt näidustatud.
English: 4Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 5According to Hammersmith Infant Neurological Examination (HINE) section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening, defined as a responder for this primary analysis.
Estonian: 5 Hammersmithi imikute neuroloogilise läbivaatuse (Hammersmith Infant Neurological Examination, HINE) 2. jaotise kohaselt: suurenemine ≥ 2 punkti võrra [või maksimaalne skoor] löömisvõimes VÕI suurenemine ≥ 1 punkti võrra pea liigutamise, keha pööramise, istumise, roomamise, seismise või kõndimise motoorsetes arengutähistes JA paranenud motoorsete arengutähiste kategooriaid rohkem kui halvenenud kategooriaid, mis olid määratletud selles esmases analüüsis ravivastusena.
English: - Each ml contains 2.4 mg of nusinersen.
Estonian: - 1 ml sisaldab 2,4 mg nusinerseeni.
English: Each ml contains 2.4 mg of nusinersen.
Estonian: Üks ml sisaldab 2,4 mg nusinerseeni.
English: Proportion with any improvement Proportion with any worsening p<0.0001
Estonian: 4-punktilise paranemise saavutanute osakaal p < 0,0001
English: Other products that are in the same group of medicines as Spinraza have been shown to affect the kidneys.
Estonian: Spinraza'ga samasse rühma kuuluvate teiste ravimite kasutamisel on täheldatud kahjustavat mõju neerudele.
English: If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza.
Estonian: Kui te ei ole kindel, pidage nõu oma arsti või meditsiiniõega, enne kui teile või teie lapsele manustatakse Spinraza't.
English: In these patients, a mean improvement of 28.6 meters (SD 47.22, n=12) at Day 253 and 86.5 metres (SD 40.58, n=8) at Day 1050.
Estonian: Neil patsientidel oli keskmine paranemine 253. päevaks 28,6 meetrit (standardhälve 47,22, n = 12) ja 1050. päevaks 86,5 meetrit (standardhälve 40,58, n = 8).
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen (2.4 mg/ml).
Estonian: Üks 5 ml viaal sisaldab naatriumnusinerseeni koguses, mis vastab 12 mg nusinerseenile (2,4 mg/ml).
English: The Spinraza vial should be inspected for particles prior to administration.
Estonian: Spinraza viaalis tuleb enne manustamist kontrollida nähtavate osakeste puudumist.
English: Patients were randomized 2:1 to either Spinraza (as per the approved dosing regimen) or sham-control, with a length of treatment ranging from 6 to 442 days.
Estonian: Patsiendid randomiseeriti suhtega 2:1 kas Spinraza rühma (kinnitatud annustamisskeemiga) või imiteerivasse kontrollrühma ja ravi kestus oli 6 kuni 442 päeva.
English: Patients in this study were deemed most likely to develop Type I or II SMA.
Estonian: Selles uuringus osalenud patsientidel tekkis kõige tõenäolisemalt I või II tüüpi SMA.
English: Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA).
Estonian: Ravi Spinraza'ga võib alustada ainult spinaalse lihasatroofia (spinal muscular atrophy, SMA) ravis kogenud arst.
English: Change from baseline in total HFMSE score at 15 months1,2,3
Estonian: HFMSE üldskoori muutus ravieelsega võrreldes 15. kuuks1,2,3
English: Pre-symptomatic infants
Estonian: Presümptomaatilised imikud
English: Study CS4 (CHERISH) was a Phase 3, randomised, double-blind, sham-procedure controlled study conducted in 126 symptomatic patients with later-onset SMA (symptom onset after 6 months of age).
Estonian: Uuring CS4 (CHERISH) oli III faasi randomiseeritud topeltpime imiteeriva protseduuriga kontrollrühmaga uuring 126 sümptomaatilisel patsiendil, kellel tekkis SMA hiljem (sümptomid tekkisid pärast 6 kuu vanuseks saamist).
English: No cases of overdose associated with adverse reactions were reported in clinical studies.
Estonian: Kliinilistes uuringutes kõrvaltoimetega seotud üleannustamise juhtumeid ei esinenud.
English: Of the 13 patients with infantile-onset SMA, 7 of out 9 patients (78%; 95%CI: 45, 94) in the Spinraza group and 0 out of 4 patients (0%; 95%CI: 0, 60) in the sham group met the criteria for motor milestone response (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking and improvement in more categories of motor milestones than worsening) .
Estonian: Imikuea SMA algusega 13-st patsiendist, vastasid 7 patsienti 9-st (78%; 95% CI: 45, 94) Spinraza rühmas ja 0 patsienti 4-st (0%; 95% CI: 0, 60) platseeborühmas motoorsustähise vastuskriteeriumidele (vastavalt HINEi 2. jaole: suurenemine ≥ 2
English: Renal toxicity has been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Estonian: Pärast teiste subkutaanselt või intravenoosselt manustatavate antisenss-oligonukleotiidide manustamist on täheldatud neerutoksilisust.
English: Spinraza is a clear colourless solution for injection.
Estonian: Spinraza on selge värvitu süstelahus.
English: Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 2, open-label study (NURTURE (SM201))
Estonian: Müügiloa saamise järgne ohutusuuring (PAES): nusinerseeni pikaajalise efektiivsuse ja ohutuse hindamiseks spinaalse lihasatroofiaga presümptomaatilistel patsientidel viib müügiloa hoidja läbi II faasi avatud uuringu (NURTURE (SM201)) ja esitab uuringutulemused.
English: Mean change from baseline to month 15 in total RULM score2,3
Estonian: RULM-i üldskoori keskmine muutus ravieelsega võrreldes 15. kuuks2,3
English: Other products that are in the same group of medicines as Spinraza have been shown to affect the cells in the blood which help clotting.
Estonian: Spinraza'ga samasse rühma kuuluvate teiste ravimite kasutamisel on täheldatud kahjustavat mõju verehüübimises osalevatele vererakkudele.
English: Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Estonian: Neil patsientidel täheldati uuringus CS11 stabiliseerumist või keskmiste näitajate HFMSE (1,4; SD 4,02) ja RULM (2,1; SD 2,56) paranemist uuringu algusest uuringupäevani 265.Neid tulemusi toetavad 2 avatud uuringut (uuring CS2 ja uuring CS12).
English: Don't stop treatment with Spinraza unless your doctor tells you to.
Estonian: Ravi Spinraza'ga võite lõpetada vaid sel juhul, kui arst on seda teile soovitanud.
English: sodium hydroxide, hydrochloric acid, water for injections.
Estonian: naatriumhüdroksiid, vesinikkloriidhape, süstevesi.
English: Spinraza 12 mg solution for injection nusinersen
Estonian: Spinraza 12 mg süstelahus nusinersenum
English: The proportion of patients developing clinically manifested SMA was assessed amongst patients who reached the Day 700 visit at the interim analysis (n=16).
Estonian: Patsientide seas, kes jõudsid vaheanalüüsis 700. päeva visiidini (n = 16), hinnati nende patsientide osakaalu, kellel tekkis kliiniliselt avaldunud SMA.
English: • Meningitis not caused by an infection (inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, nausea and vomiting)
Estonian: • Meningiit, mis ei ole põhjustatud infektsioonist (seljaaju ja aju ümber oleva membraani põletik,
English: How Spinraza is given
Estonian: Kuidas Spinraza't manustatakse
English: Figure 2: Mean change from baseline in HFMSE score over time at final analysis (ITT)Study CS4 1,2
Estonian: Ravieelse HFMSE skoori keskmised muutused ajas lõppanalüüsi hetkeks (ravikavatsuslik populatsioon) - uuring CS4 1,2
English: България ТП ЕВОФАРМА
Estonian: ТП ЕВОФАРМА Teл.
English: Secondary endpoints including functional measures and WHO motor milestone achievement were formally statistically tested and are described in Table 3.
Estonian: Tabelis 3 on kirjeldatud formaalselt statistiliselt testitud teisesed tulemusnäitajad, sealhulgas funktsioonide mõõtmistulemused ja Maailma Terviseorganisatsiooni (WHO) motoorsete arengutähiste saavutamine.
English: - Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Estonian: - Üks 5 ml viaal sisaldab naatriumnusinerseeni koguses, mis vastab 12 mg nusinerseenile.
English: The mean total score was13.8 (SD 3.09) at Day 253 and 15.7 (SD 1.92) at Day 1050.
Estonian: Keskmine üldskoor oli 253. päeval 13,8 (standardhälve 3,09) ja 1050. päeval 15,7 (standardhälve 1,92).
English: A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Estonian: II tüüpi SMA-ga patsientidel täheldati püsivat paranemist: nende ravieelse HFMSE-skoori keskmine paranemine oli 253. päeval 5,1 (standardhälve 4,05, n = 11) ja 1050. päeval 9,1 (standardhälve 6,61, n = 9).
English: Spinraza is used to treat a genetic disease called spinal muscular atrophy (SMA).
Estonian: Spinraza't kasutatakse geneetilise haiguse spinaalse lihasatroofia (SMA) raviks.
English: In patients with Type II SMA the Upper Limb Module test was conducted with mean improvement of 1.9 (SD 2.68, n=11) at Day 253 and 3.5 (SD 3.32, n=9) at Day 1050.
Estonian: II tüüpi SMA-ga patsientidel läbi viidud ülajäsemete mooduli testi kohaselt oli keskmine paranemine 253. päevaks 1,9 (standardhälve 2,68, n = 11) ja 1050. päevaks 3,5 (standardhälve 3,32, n = 9).
English: The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11.
Estonian: Pärast ravi alustamist Spinrazaga uuringus CS11 oli mediaanaeg surmani või püsiva ventilatsioonini 50,9 nädalat.
English: It is recommended that the volume of CSF, equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
Estonian: Enne Spinraza süstimist on soovitatav eemaldada süstitava Spinraza mahuga võrdne tserebrospinaalvedeliku kogus.
English: The mean total score was 49.8 (SD 12.46) at Day 253 and 52.6 (SD 12.78) at 1050 days.
Estonian: Keskmine üldskoor oli 253. päevaks 49,8 (standardhälve 12,46) ja 1050. päevaks 52,6 (standardhälve 12,78).
English: Not known (cannot be estimated from the available data) Table 1: Adverse reactions related to lumbar puncture procedure reported in CS4 (later onset SMA) with an incidence at least 5% higher in patients treated with Spinraza than sham-control
Estonian: Uuringus CS4 (SMA hilisem algus) teatatud lumbaalpunktsiooni protseduuri kõrvaltoimed, mille esinemissagedus Spinraza'ga ravitud patsientidel oli vähemalt 5% suurem võrreldes imiteeriva kontrollrühmaga
English: 56.8% (95% CI:45.6, 68.1) P=0.00065
Estonian: 56,8% (95% usaldusvahemik: P = 0,00065
English: Of patients who initiated Spinraza treatment in Study CS4 (n=39), stabilization or additional improvements in mean HFMSE (0.2; SD 3.06) and RULM (0.7; SD 2.69) scores were observed from baseline to Study Day 265 in Study CS11.
Estonian: Patsientidest, kes alustasid ravi Spinrazaga uuringus CS4 (n = 39), täheldati uuringus CS11 uuringu algusest kuni uuringupäevani 265 stabiliseerumist või täiendavaid keskmiste näitajate HFMSE (0,2; SD 3,06) ja RULM (0,7; SD 2,69) paranemist.
English: 4.2(95% CI: 3.4, 5.0) p=0.00000016
Estonian: 4,2 (95% usaldusvahemik: p = 0,00000016
English: Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050.
Estonian: III tüüpi SMA-ga patsientidel paranes ravieelne HFMSE skoor 253. päevaks 1,3 võrra (standardhälve 1,87, n = 16) ja 1050. päevaks 1,2 võrra (standardhälve 4,64, n = 11).
English: 3.9 (95% CI: 3.0, 4.9) p=0.0000001
Estonian: 3,9 (95% usaldusvahemik: p = 0,0000001
English: -1.0 (95% CI: -2.5, 0.5)
Estonian: usaldusvahemik: -2,5; 0,5)
English: Spinraza has not been studied in patients with hepatic impairment.
Estonian: Spinraza kasutamist neerukahjustusega patsientidel ei ole uuritud.
English: Further improvement in mean total motor milestone (HINE-Section 2) (2.1; SD 4.36; n=22) and CHOP INTEND (4.68; SD 3.993, n=22) scores were observed from baseline to Study Day 304 in Study CS11.
Estonian: jagu) (2,1; SD 4,36; n = 22) ja CHOP INTENDi (4,68; SD 3,993, n = 22) näitajate paranemist.
English: Aseptic technique should be used when preparing Spinraza solution for intrathecal administration.
Estonian: Spinraza lahuse ettevalmistamisel intratekaalseks manustamiseks tuleb järgida aseptika reegleid.
English: Statistically significant effects on event-free survival, overall survival, the proportion of patients achieving the definition of a motor milestone responder, and the percentage of patients with at least a 4-point improvement from baseline in Children's Hospital of Philadelphia
Estonian: Spinraza rühma patsientidel täheldati võrreldes imiteeriva kontrollrühma patsientidega statistiliselt olulist mõju sündmusteta elulemusele, üldisele elulemusele, ravivastusena määratletud motoorse arengutähise saavutanud patsientide osakaalule ja Philadelphia Lastehaigla imikute neuromuskulaarse haiguse testi (Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease, CHOP INTEND) skoori paranemist vähemalt 4 punkti võrra ravieelsega võrreldes (tabel 2).
English: Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides.
Estonian: Pärast teiste subkutaanselt või intravenoosselt manustatavate antisenss-oligonukleotiidide manustamist on täheldatud trombotsütopeeniat ja hüübimishäireid, kaasa arvatud äge raske trombotsütopeenia.
English: There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with nusinersen in the post-marketing setting.
Estonian: Turuletulekujärgselt on nusinerseeniga ravitud patsientidel teatatud kommunitseeruva hüdrotsefaalia juhtudest, mis ei olnud seotud meningiidi ega veritsemisega.
English: 1CS3B was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significantly greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (41%) compared to the sham-control group (0%), p<0.0001) 2At the final analysis, event-free survival and overall survival were assessed using the Intent to Treat population (ITT Spinraza n=80; Sham-control n=41).
Estonian: 1CS3B lõpetati pärast vaheanalüüsis tehtud esmase tulemusnäitaja statistilise analüüsi positiivseid tulemusi (Spinraza rühmas saavutas ravivastusena määratletud motoorse arengutähise statistiliselt oluliselt suurem protsent patsiente (41%) kui imiteerivas kontrollrühmas (0%), p < 0,0001).
English: Intrathecal use
Estonian: MANUSTAMISVIIS
English: Spinraza has not been studied in patients with renal impairment.
Estonian: Spinraza kasutamist maksakahjustusega patsientidel ei ole uuritud.
English: Hydrocephalus
Estonian: Hüdrotsefaalia
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Estonian: Üks 5 ml viaal sisaldab naatriumnusinerseeni koguses, mis vastab 12 mg nusinerseenile (nusinersenum).
English: Sham-control Patients
Estonian: Imiteeriva kontrollrühma patsiendid
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate Sodium chloride
Estonian: Naatriumdivesinikfosfaatdihüdraat Dinaatriumvesinikfosfaat Naatriumkloriid
English: Talk to your doctor before you or your child are given Spinraza.
Estonian: Enne Spinraza manustamist teile või teie lapsele pidage nõu oma arstiga.
English: Spinraza 12 mg solution for injection
Estonian: Spinraza 12 mg süstelahus
English: Adverse reactions associated with the administration of Spinraza by lumbar puncture have been observed.
Estonian: Täheldatud on kõrvaltoimeid, mis olid seotud Spinraza manustamisega lumbaalpunktsiooni teel.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
Estonian: naatriumkloriid, kaaliumkloriid, kaltsiumkloriiddihüdraat, magneesiumkloriidheksahüdraat,
English: Gastrointestinal disorders
Estonian: Spinraza Kontroll
English: Spinraza is given;
Estonian: Spinraza't manustatakse:
English: 5.9% (95% CI: 0.7,
Estonian: 5,9% (95% usaldusvahemik:
English: out of 20 patients (55%) met the endpoint of an increase in total CHOP INTEND score of ≥4 points as of the last study visit.
Estonian: mis seisnes CHOP INTEND koguskoori suurenemises ≥ 4 punkti võrra nende viimasel uuringuvisiidil.
English: Genesis Pharma Cyprus Ltd Τηλ: +357 22 769946
Estonian: Τηλ: +357 22 769946
English: Package leaflet: Information for the user Spinraza 12 mg solution for injection nusinersen
Estonian: Pakendi infoleht: teave kasutajale Spinraza 12 mg süstelahus nusinerseen (nusinersenum) Käesoleva ravimi suhtes kohaldatakse täiendavat järelevalvet, mis võimaldab kiiresti tuvastada uut ohutusteavet.
English: Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards.
Estonian: Spinraza manustamise ajal võivad esineda lumbaalpunktsiooniga seotud kõrvaltoimed.
English: Infantile onset
Estonian: Haiguse algus imikueas
English: The use of ultrasound or other imaging techniques to assist with intrathecal administration of Spinraza, can be considered at the physician's discretion.
Estonian: Vastavalt arsti äranägemisele saab Spinraza intratekaalsel manustamisel kaaluda assisteeriva vahendina ultraheli või muude piltuuringutehnikate kasutamist.
English: Later onset
Estonian: Neerukahjustus
English: 0.5 (95% CI: -0.6, 1.6)
Estonian: usaldusvahemik: -0,6; 1,6)
English: Ultrasound (or other imaging techniques) may be considered to guide intrathecal administration of Spinraza, particularly in younger patients and in patients with scoliosis.
Estonian: Eriti nooremate patsientide ning skolioosiga patsientide puhul võib kaaluda ultraheli (või muude piltuuringu meetodite) kasutamist Spinraza intratekaalse manustamise suunamiseks.
English: 1CS4 was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significant improvement from baseline HFMSE score was observed in Spinraza treated patients compared to the sham-control patients (Spinraza vs. sham-control: 4.0 vs. -1.9; p=0.0000002))
Estonian: (Spinraza'ga ravitud patsientidel täheldati ravieelse HFMSE skoori statistiliselt olulist paranemist võrreldes imiteeriva kontrollrühma patsientidega (Spinraza vs. imiteeriv kontrollrühm: 4,0 vs. -1,9; p = 0,0000002)) 2 Hinnati ravikavatsusliku populatsiooni (Spinraza n = 84; imiteeriv kontrollrühm n = 42) põhjal; 15. kuu visiidi andmeteta patsientide andmed tuletati mitmese imputeerimise meetodil 3 Vähimruutude keskmine
English: Pack size of one vial per carton.
Estonian: Igas karbis on üks viaal.
English: Single- and multiple-dose pharmacokinetics (PK) of nusinersen, administered via intrathecal injection, were determined in paediatric patients diagnosed with SMA.
Estonian: Lastel, kellel oli diagnoositud SMA, määrati kindlaks intratekaalse süstega manustatud nusinerseeni farmakokineetika ühe ja mitme annuse manustamisel.
English: Spinraza is given by injection into the lower back.
Estonian: Spinraza't manustatakse süstena alaselja piirkonda.
English: Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Gefitinib Mylan kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Gefitinib Mylan (gefitinib)
Estonian: Gefitinib Mylan (gefitiniib)
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Estonian: Seda kasutatakse patsientidel, kelle vähirakkudes esineb mutatsioon geenides, mis toodavad valku, mida nimetatakse epidermaalse kasvufaktori retseptoriks (EGFR).
English: Gefitinib Mylan (gefitinib) EMA/554427/20188
Estonian: Gefitinib Mylan (gefitiniib) EMA/556782/2018
English: What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Estonian: Mis meetmed võetakse, et tagada ravimi Gefitinib Mylan ohutu ja efektiivne kasutamine?
English: EGFR is involved in the growth and spread of cancer cells.
Estonian: EGFR osaleb vähirakkude kasvu ja levimise protsessides.
English: What is Gefitinib Mylan and what is it used for?
Estonian: Mis on Gefitinib Mylan ja milleks seda kasutatakse?
English: By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer.
Estonian: Blokeerides EGFR-i, aitab Gefitinib Mylan aeglustada vähi kasvu ja levikut.
English: Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Estonian: Gefitinib Mylanit turustatakse 250 mg suukaudsete tablettidena.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Gefitinib Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga Iressa.
English: Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.
Estonian: Gefitinib Mylan on retseptiravim ja ravi peab alustama ja jälgima vähiravis kogenud arst.
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Estonian: Need ensüümid esinevad vähirakkude pinnal, nt EGFR on mitteväikerakk-kopsuvähi rakkude pinnal.
English: This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
Estonian: See tähendab, et Gefitinib Mylan sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Iressa, millel juba on ELis müügiluba.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Estonian: Võrdlusravimiga Iressa on juba tehtud toimeaine heakskiidetud kasutamisviisi kasulikkuse ja riski uuringud ja neid ei ole vaja ravimiga Gefitinib Mylan korrata.
English: Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Gefitinib Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Estonian: Gefitinib Mylan toimib ainult mitteväikerakk-kopsuvähi rakkudele, millel on muteerunud EGFR.