FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, close monitoring for neurological reactions is strongly recommended, and nelarabine must be discontinued at the first sign of neurological reactions of NCI CTCAE Grade 2 or greater.
Estonian: Seetõttu tuleb patsiente hoolikalt jälgida närvisüsteemi kõrvaltoimete suhtes ning nelarabiiniga ravi lõpetada, kui ilmnevad NCI CTCAE 2. või enama raskusastme närvisüsteemi kõrvaltoimete esimesed nähud.
English: Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Estonian: Keskmised plasma ara-G Cmax ja AUCinf väärtused olid vastavalt 115 µM (16 %) ja 571 µM.h
English: Neurotoxicity is the dose-limiting toxicity of nelarabine.
Estonian: Neurotoksilisus on nelarabiini annust limiteeriv kõrvaltoime.
English: No data are available to provide a dose advice for patients with Clcr less than 50 ml/min.
Estonian: Puuduvad andmed, mille põhjal anda annustamissoovitusi patsientidele kreatiniini kliirensiga (Clcr) alla 50 ml/min.
English: Rhabdomyolysis and increased blood creatine phosphokinase have been identified during postapproval use of nelarabine.
Estonian: Rabdomüolüüs ja vere kreatiinfosfokinaasi taseme tõus on kõrvaltoimetena kindlaks tehtud nelarabiini registreerimisjärgse kasutamise käigus.
English: • a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Estonian: • teatud tüüpi leukeemia, mida nimetatakse T-rakuliseks ägedaks lümfoblastseks leukeemiaks.
English: • The active substance of Atriance is nelarabine.
Estonian: • Atriance toimeaine on nelarabiin.
English: Nelarabine at a dose of 1500 mg/m2/day was administered intravenously over two hours on days 1, 3 and 5 of a 21 day cycle.
Estonian: Nelarabiini manustati veenisiseselt annuses 1500 mg/m2/päevas kahe tunni jooksul 21-päevase tsükli päevadel 1, 3 ja 5.
English: To be taken into consideration by patients on a controlled sodium diet.
Estonian: Sellega tuleb arvestada patsientide puhul, kes on piiratud naatriumisisaldusega dieedil.
English: It is usually dripped into your arm over a period of about 2 hours.
Estonian: Tilkinfusioon käe veeni kestab tavaliselt umbes 2 tundi.
English: • The release of tumour cell contents (tumour lysis syndrome), which may put extra stress on your body.
Estonian: • Kasvajarakkude sisaldise vabanemine (tuumori lüüsi sündroom), mis on organismile koormav.
English: There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Estonian: Kirjeldatud on demüelinisatsiooniga seotud tüsistusi ja astsendeeruvat perifeerset neuropaatiat, mis sarnaneb kliiniliselt pildilt Guillain-Barré sündroomile.
English: • Feeling drowsy and sleepy; headache; dizziness.
Estonian: • Uimasus ja unisus; peavalu; pearinglus.
English: MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Estonian: Nendele patsientidele tehtud MRT uuringu leid ühtis lülisamba kaelaosa demüeliniseeriva protsessi leiuga.
English: Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Estonian: Nelarabiin on näidustatud T-rakulise ägeda lümfoblastse leukeemia (T-ALL) ja T-rakulise lümfoblastse lümfoomi (T-LBL) raviks patsientidel, kelle haigus ei ole allunud vähemalt kahele kemoteraapia skeemile või kelle haigus on ravijärgselt retsidiveerunud.
English: It is provided in clear glass vials with a rubber stopper and sealed with an aluminium cap.
Estonian: Ravim on läbipaistvates klaasviaalides, millel on kummikork ja mis on suletud alumiiniumkattega.
English: Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Estonian: Siiski on teada, et nelarabiin on imetajarakkudele genotoksilise toimega (vt lõik 5.3).
English: Paediatric patients After infusion of 400 or 650 mg/m nelarabine over one hour in 6 paediatric patients, mean (%CV) plasma nelarabine Cmax and AUCinf values, adjusted to a 650 mg/m dose, were 45.0 µM (40 %) and
Estonian: Lapsed Pärast nelarabiini 400 või 650 mg/m infusiooni ühe tunni jooksul 6 lapsele olid keskmised (%CV) plasma nelarabiini Cmax ja AUCinf väärtused (kohandatuna 650 mg/m annuse järgi) vastavalt 45,0 µM (40 %) ja 38,0 µM.h (39 %).
English: Very common: 10(12%)
Estonian: Väga sage: 10 (12%)
English: In clinical studies, the 650 mg/m and 1,500 mg/m dose have both been used in patients in the age range 16 to 21 years.
Estonian: Kliinilistes uuringutes on 16...21-aastastel patsientidel kasutatud nii 650 mg/m kui 1500 mg/m
English: Very common: 51 (50%) Common: 1 (1%)
Estonian: Väga sage: 51 (50%) Sage: 1 (1%)
English: (%CV) clearance (Cl) values for nelarabine are 138 l/h/m
Estonian: et 1. päeval on nelarabiini keskmine (%CV) kliirens (Cl) 138 l/h/m
English: Very common: 15 (15%) Very common: 14 (17%)
Estonian: Väga sage: 15 (15%) Väga sage: 14 (17%)
English: 6 x 50 ml vials
Estonian: 6 x 50 ml viaalid
English: This lymphoma is caused by a mass of lymphoblasts, a type of white blood cell.
Estonian: Seda lümfoomi põhjustab teatud tüüpi valgevereliblede, lümfoblastide mass.
English: Carcinogenicity testing of nelarabine has not been performed.
Estonian: Nelarabiiniga ei ole kartsinogeensuse uuringuid läbi viidud.
English: Children and adolescents (aged 21 years and younger) The recommended dose is 650 mg/m of body surface area per day.
Estonian: Lapsed ja noorukid (21-aastased ja nooremad) Soovitatav annus on 650 mg/m kehapinna kohta ööpäevas.
English: Sodium warning
Estonian: Naatriumisisalduse hoiatus
English: Very common: 18 (17%) Common: 5 (6%)
Estonian: Väga sage: 18 (17%) Sage: 5 (6%)
English: How to store Atriance
Estonian: Kuidas Atriancet säilitada
English: Very common: 42 (41%) Common: 2 (2%)
Estonian: Väga sage: 42 (41%) Sage: 2 (2%)
English: For patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Estonian: Allopurinooli kasutamist tuleb kaaluda patsientidel, kellel esineb risk hüperurikeemia tekkeks.
English: These may affect up to 1 in 1,000 people treated with Atriance
Estonian: Need võivad tekkida kuni ühel igast 1000-st Atriancega ravitud patsiendist
English: Adults and adolescents (aged 16 years and older) The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m administered intravenously over two hours on days 1, 3 and 5 and repeated every
Estonian: Täiskasvanud ja noorukid (16-aastased ja vanemad) Nelarabiini soovitatav annus täiskasvanutele ning 16-aastastele ja vanematele noorukitele on 1500 mg/m2, mis manustatakse veenisiseselt kahe tunni jooksul päevadel 1, 3 ja 5 ning seda korratakse iga 21 päeva järel.
English: Atriance 5 mg/ml solution for infusion nelarabine
Estonian: Atriance 5 mg/ml infusioonilahus nelarabiin (nelarabinum)
English: Atriance contains sodium
Estonian: Atriance sisaldab naatriumit
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that mean
Estonian: Kombineeritud I faasi farmakokineetilised andmed (nelarabiini annused 104...2900 mg/m 2) näitavad,
English: Severe nervous system side effects have been reported with the use of Atriance.
Estonian: Atriance kasutamise ajal on kirjeldatud raskete närvisüsteemi kõrvaltoimete teket.
English: Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
Estonian: Üks ml Atriance infusioonilahust sisaldab 5 mg nelarabiini.
English: Age has no effect on the pharmacokinetics of nelarabine or ara-G.
Estonian: Vanusel puudub mõju nelarabiini või ara-G farmakokineetikale.
English: There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Estonian: Nelarabiiniga ravi saavatel patsientidel on kirjeldatud mõnikord surmaga lõppenud oportunistlikke infektsioone.
English: Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Estonian: Nelarabiiniga ravi on seostatud leukopeenia, trombotsütopeenia, aneemia ja neutropeenia (sealhulgas febriilse neutropeenia) tekkega.
English: Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid.
Estonian: Guaniin N-deamineeritakse ksantiiniks, mille edasise oksüdatsiooni käigus tekib kusihape.
English: Children and adolescents (aged 21 years and younger) The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m administered intravenously over one hour daily for 5 consecutive days, repeated every
Estonian: Lapsed ja noorukid (21-aastased ja nooremad) Nelarabiini soovitatav annus lastele ja noorukitele (21-aastased ja nooremad) on 650 mg/m2, mis manustatakse veenisiseselt ühe tunni jooksul viiel järjestikusel päeval ning seda korratakse iga 21 päeva järel.
English: Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Estonian: Sugu ei mõjuta nelarabiini või ara-G farmakokineetikat.
English: Gait abnormal
Estonian: Ebatavaline kõnnak
English: Nervous system disorders Seizures (including convulsions, grand mal convulsions, status epilepticus)
Estonian: Krambid (sh tõmblused, grand mal hood, status epilepticus)
English: Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Estonian: Monofosfaatmetaboliit konverteeritakse seejärel aktiivseks 5'-trifosfaadiks, ara-GTP-ks. Ara-GTP kogunemine leukeemilistes blastides võimaldab ara-GTP eelistatud ühinemist desoksüribonukleiinhappega (DNA), mis viib DNA sünteesi inhibeerimiseni.
English: • Lowered blood pressure.
Estonian: • Vererõhu langus.
English: In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Estonian: Lisaks hüdrolüüsub osa nelarabiinist metüülguaniiniks, mis O-demetüleerub guaniiniks.
English: Very common: 15 (15%) Common: 3 (4%)
Estonian: Väga sage: 15 (15%) Sage: 3 (4%)
English: Very common: 26 (25%) N/A
Estonian: Väga sage: 26 (25%) Ei ole kohaldatav
English: Very common: 22 (21%) Very common: 10 (12%)
Estonian: Väga sage: 22 (21%) Väga sage: 10 (12%)
English: • a type of lymphoma, called T-cell lymphoblastic lymphoma.
Estonian: • teatud tüüpi lümfoom, mida nimetatakse T-rakuliseks lümfoblastseks lümfoomiks.
English: These may affect up to 1 in 10 people treated with Atriance:
Estonian: Need võivad tekkida kuni ühel igast 10-st Atriancega ravitud patsiendist:
English: Each vial contains 250 mg of nelarabine.
Estonian: Üks viaal sisaldab 250 mg nelarabiini.
English: The dose of Atriance you are given will be based on:
Estonian: Atriance annus sõltub järgnevast:
English: Very common: 12 (12%) Common: 1 (1%)
Estonian: Väga sage: 12 (12%) Sage: 1 (1%)
English: These may affect more than 1 in 10 people treated with Atriance.
Estonian: Need võivad tekkida rohkem kui ühel igast 10-st Atriancega ravitud patsiendist.
English: No studies have been conducted in animals to assess the effects of nelarabine on fertility.
Estonian: Nelarabiini toime hindamiseks viljakusele ei ole loomkatseid läbi viidud.
English: Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
Estonian: Muude kõrvaltoimete, sealhulgas hematoloogiliste kõrvaltoimete korral on üheks võimaluseks järgmise manustamiskorra edasilükkamine.
English: However, no undesirable effects were seen in the testes or ovaries of monkeys given nelarabine intravenously at doses up to approximately 32 % of the adult human dose on a mg/m basis for 30 consecutive days.
Estonian: Ent ahvidel, kes said 30 järjestikusel päeval nelarabiini veenisiseselt annustes, mis olid kuni umbes 32 % suuremad täiskasvanud inimese annusest mg/m baasil, ei täheldatud munandites või munasarjades muutusi.
English: Each ml contains 5 mg of nelarabine.
Estonian: Üks ml sisaldab 5 mg nelarabiini.
English: • Build up of fluid around the lungs leading to chest pain and difficulty in breathing (pleural effusion); wheezing
Estonian: • Vedeliku kogunemine kopsukelmeõõnes, mis põhjustab valu rinnus ja hingamisraskust
English: The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m2) and children (650 mg/m2) is based on data from 103 adults and 84 paediatric patients respectively.
Estonian: (650 mg/m2) soovitatavates annustes, on ohutusandmed saadud 103 täiskasvanult ja 84 lapselt.
English: Limited clinical pharmacology data are available for patients below the age of 4 years.
Estonian: Alla 4-aastaste patsientide kohta on kliinilis-farmakoloogilised andmed vähesed.
English: Very common: 24 (23%) Common: 6 (7%)
Estonian: Väga sage: 24 (23%) Sage: 6 (7%)
English: • Increases in blood levels of liver enzymes.
Estonian: • Maksaensüümide aktiivsuse suurenemine.
English: Very common: 22 (21%) Common: 1 (1%)
Estonian: Väga sage: 22 (21%) Sage: 1 (1%)
English: There have also been reports of reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
Estonian: Samuti on kirjeldatud demüelinisatsiooniga seotud tüsistusi ja astsendeeruvat perifeerset neuropaatiat, mis sarnaneb kliiniliselt pildilt Guillain-Barré sündroomile (vt lõik 4.8).
English: Very common: 23 (22%) Common: 8 (10%)
Estonian: Väga sage: 23 (22%) Sage: 8 (10%)
English: Two paediatric patients had fatal neurological events.
Estonian: Kahel lapsel tekkisid surmaga lõppenud närvisüsteemi kõrvaltoimed.
English: The pharmacokinetics of nelarabine and ara-G have not been specifically studied in renally impaired or haemodialysed patients.
Estonian: Neerukahjustusega või hemodialüüsi saavatel patsientidel ei ole nelarabiini ja ara-G farmakokineetikat eraldi uuritud.
English: What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Estonian: Atriance infusioonilahus on selge, värvitu lahus.
English: Each ml of solution contains 5 mg of nelarabine.
Estonian: Lahuse iga ml sisaldab 5 mg nelarabiini.
English: How Atriance is given
Estonian: Kuidas Atriancet manustada
English: • Feeling of an upset stomach (nausea); being sick/throwing up (vomiting); diarrhoea; constipation
Estonian: • Maoärritus (iiveldus); oksendamine; kõhulahtisus; kõhukinnisus
English: • the results of blood tests carried out before treatment Adults and adolescents (aged 16 years and older) The usual dose is 1,500 mg/m of body surface area per day.
Estonian: Täiskasvanud ja noorukid (16-aastased ja vanemad) Tavaline annus on 1500 mg/m kehapinna kohta ööpäevas.
English: Very common: 24 (23%) Common: 2 (2%)
Estonian: Väga sage: 24 (23%) Sage: 2 (2%)
English: Very common: 23 (22%) Common: 2 (2%)
Estonian: Väga sage: 23 (22%) Sage: 2 (2%)
English: (104 %) and 125 l/h/m
Estonian: (151 %) ja 2,6 l/h/m
English: Nelarabine and ara-G are extensively distributed throughout the body based on combined Phase I pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m2.
Estonian: Kombineeritud I faasi farmakokineetiliste andmete põhjal (nelarabiini annused 104...2900 mg/m jaotuvad nelarabiin ja ara-G laialdaselt kogu organismis.
English: Very common: 13 (13%) N/A
Estonian: Väga sage: 13 (13%) Ei ole kohaldatav
English: Musculoskeletal and connective tissue disorders Muscle weakness
Estonian: Lihas-skeleti ja sidekoe kahjustused Lihasnõrkus
English: If you get any of the side effects, talk to your doctor or pharmacist.
Estonian: Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: Very common: 11 (11%) N/A
Estonian: Väga sage: 11 (11%) Ei ole kohaldatav
English: • Swelling of parts of the body due to accumulation of abnormal amounts of fluid (oedema).
Estonian: • Liigsest vedeliku kogunemisest tingitud kehaosade tursed.
English: Very common: 15 (15%) N/A
Estonian: Väga sage: 15 (15%) Ei ole kohaldatav
English: Very common: 80 (95%)
Estonian: Väga sage: 102 (99%) Väga sage: 80 (95%)
English: Nelarabine has not been studied in individuals with renal impairment.
Estonian: Neerukahjustusega isikutel ei ole nelarabiini kasutamist uuritud.
English: Post-marketing data
Estonian: FARMATSEUTILISED ANDMED
English: Hepatobiliary disorders Hyperbilirubinaemia
Estonian: Maksa ja sapiteede häired Hüperbilirubineemia
English: Very common: 21 (20%) N/A
Estonian: Väga sage: 21 (20%) Ei ole kohaldatav
English: Renal clearance averaged 9.0 l/h/m
Estonian: 21 täiskasvanud patsiendil oli nelarabiini ja ara-G renaalne kliirens keskmiselt vastavalt 9,0 l/h/m
English: INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE
Estonian: ATRIANCE SÄILITAMISE JA HÄVITAMISE JUHISED
English: Nelarabine has not been studied in patients with hepatic impairment.
Estonian: Maksakahjustusega patsientidel ei ole nelarabiini kasutamist uuritud.
English: Wheezing
Estonian: Lihasvalu
English: Very common: 22 (21%) N/A
Estonian: Väga sage: 22 (21%) Ei ole kohaldatav
English: Aspartate aminotransferase increased
Estonian: Aspartaataminotransferaasi aktiivsuse suurenemine Sage: 6 (6%)
English: Other very common side effects These may affect more than 1 in 10 people treated with Atriance
Estonian: Need võivad tekkida rohkem kui ühel igast 10-st Atriancega ravitud patsiendist
English: Severe neurological reactions have been reported with the use of nelarabine.
Estonian: Nelarabiini kasutamise ajal on kirjeldatud raskete närvisüsteemi kõrvaltoimete teket.
English: • Muscle weakness (possibly associated with peripheral neuropathy - see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Estonian: • Lihasnõrkus (võimalikult seotud perifeerse neuropaatiaga - vt eespool), liigesvalu, seljavalu;
English: • hair loss: in most cases normal hair growth should return.
Estonian: • juuste väljalangemine: enamikul juhtudel peaks normaalne juuksekasv taastuma.
English: Tumour size ≤ 2 cm >2 cm
Estonian: Tuumori suurus 2 cm >2 cm
English: • if the number of white blood cells is too low.
Estonian: • kui teie valgete vereliblede arv on liiga madal;
English: North Harrow, Middlesex HA1 4HF United Kingdom
Estonian: North Harrow, Middlesex HA1 4HF Ühendkuningriik
English: Frequency not known (cannot be estimated from the available data):
Estonian: Esinemissagedus teadmata (ei saa hinnata olemasolevate andmete alusel):
English: Consideration should be given to possible effects on the central nervous system.
Estonian: Tuleb kaaluda võimalikke mõjusid kesknärvisüsteemile.
English: Date of latest renewal: 23rd February 2017
Estonian: Müügiloa viimase uuendamise kuupäev: 23. veebruar 2017
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2012
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 22. mai 2012
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Estonian: DFS andmed eierinenud statistilisel olulisel määral, kuid olid seotud positiivse suundumusega TAC kasuks.
English: Overall Age category 1 <50 years ≥50 years Age category 2 <35 years ≥35 years
Estonian: 2. vanusekategooria <35 aastat ≥35 aastat
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Estonian: Teatage oma arstile või haiglaapteekrile, kui te kasutate või olete hiljuti kasutanud mis tahes muid ravimeid, kaasa arvatud ilma retseptita ostetud ravimeid.
English: A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
Estonian: Kokku 1006 patsienti KPS  60 randomiseeriti järgmistesse ravigruppidesse:
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Estonian: Kõik vahendid, mida kasutatakse lahjendamiseks ja manustamiseks, tuleb hävitada vastavalt standardprotseduurile.
English: The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Estonian: Alkoholi kogus selles ravimis võib kahjustada kesknärvisüsteemi (osa närvisüsteemist, mis hõlmab aju ja seljaaju).
English: • raised liver enzymes (hence the need for regular blood tests)
Estonian: • maksaensüümide aktiivsuse tõus (millest tulenevalt vajadus teha regulaarseid vereanalüüse).
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, Taxanes, ATC Code: L01CD02
Estonian: Farmakoterapeutiline rühm: kasvajavastased ained, taimsed alkaloidid ja teised looduslikud ained, taksaanid, ATC kood: L01CD02
English: Such information will allow your doctor to decide whether a dose reduction is needed.
Estonian: See informatsioon võimaldab arstil otsustada annuse muutmise vajalikkuse üle.
English: Other medicines and Docetaxel Accord
Estonian: Muud ravimid ja Docetaxel Accord
English: This is because Docetaxel Accord or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Estonian: See on vajalik, kuna Docetaxel Accord või teised ravimid ei pruugi toimida ootuspäraselt ning teil on suurem tõenäosus kõrvaltoimete tekkeks.
English: If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Estonian: Kui patsiendil eelpool mainitud reaktsioonid jätkuvad annusega 60 mg/m2, tuleb ravi katkestada.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Estonian: Kui ravimit ei kasutata kohe, on kõlblikkusaeg ja säilitamistingimused kasutaja vastutusel ega tohiks tavaliselt ületada 6 tundi temperatuuril kuni 25C, sealhulgas infusiooniks kuluv üks tund.
English: Cases of permanent alopecia (frequency not known) have been reported.
Estonian: On teatatud (esinemissagedus teadmata) püsiva alopeetsia juhtudest.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Estonian: AINULAADNE IDENTIFIKAATOR - 2D VÖÖTKOOD Lisatud on 2D vöötkood, mis sisaldab ainulaadset identifikaatorit.
English: The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Estonian: Dotsetakseeli efektiivsust ja ohutust nasofarüngeaalse kartsinoomi ravis lastel vanuses 1 kuu kuni 18 eluaastat ei ole veel kindlaks tehtud.
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Estonian: • infektsioonid, punaste vereliblede arvu vähenemine (aneemia), valgete vereliblede arvu (on olulised infektsiooni vastu võitlemisel) ja vereliistakute arvu vähenemine
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Accord.
Estonian: Teie arst võib muuta ravimi annust ja annustamissagedust sõltuvalt teie vereanalüüside tulemustest, organismi üldseisundist ja reaktsioonist Docetaxel Accord'ile.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised.
Estonian: Esmane profülaktika G-CSF-iga muudeti kohustuslikuks TAC ravihaaras pärast 230 patsiendi randomiseerimist.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because docetaxel may be harmful for the unborn baby.
Estonian: Ravi ajal ei tohi te rasestuda ja te peate kasutama efektiivset rasestumisvastast vahendit, sest dotsetakseel võib kahjustada sündimata last.
English: The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Estonian: Esmane analüüs tehti, kui kõikide patsientide järelkontroll oli kestnud üle 5 aasta (järelkontrolli kestuse mediaan oli 77 kuud).
English: Use the medicine immediately after it is added into the infusion bag.
Estonian: Ravim tuleb kasutada kohe peale infusioonikotti lisamist.