FrancophonIA/ELRC3.0 huggingface dataset:
English: DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Estonian: Ravimit DuoResp Spiromax kasutatakse ka raske kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel, kellel on regulaarsele ravile vaatamata esinenud haiguse ägenemisi.
English: DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Estonian: DuoResp Spiromax on ravim, mis sisaldab toimeainetena budesoniidi ja formoterooli.
English: Because DuoResp Spiromax is a hybrid 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 DuoResp Spiromax on hübriidravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Estonian: Leevendava astmaravimina tohivad patsiendid võtta ööpäevas 1-2 ravimi DuoResp Spiromax tugevuse 160/4,5 μg lisaannust üksnes sümptomite leevendamiseks.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for DuoResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi DuoResp Spiromax omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: This is a summary of the European public assessment report (EPAR) for DuoResp Spiromax.
Estonian: See on ravimi DuoResp Spiromax Euroopa avaliku hindamisaruande kokkuvõte.
English: The Committee recommended that DuoResp Spiromax be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi DuoResp Spiromaxi müügiloa.
English: Studies in patients have been limited to tests to determine that DuoResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Estonian: Patsiendiuuringud piirdusid katsetega, milles näidati ravimi DuoResp Spiromax bioekvivalentsust võrdlusravimiga Symbicort Turbohaler.
English: The higher strength, DuoResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Estonian: Ravimi DuoResp Spiromax suuremat tugevust 320/9 µg (320 μg budesoniidi ja 9 μg formoterooli) tohib kasutada ainult astma regulaarseks raviks ja kroonilise obstruktiivse kopsuhaiguse raviks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that DuoResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Estonian: Inimravimite komitee järeldas, et on tõendatud ravimi DuoResp Spiromax tugevuste 160/4,5 μg ja 320/9 μg võrreldav kvaliteet ja bioekvivalentsus ravimi Symbicort Turbohaleri vastavate tugevustega.
English: The two active substances in DuoResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Estonian: Ravimi DuoResp Spiromax mõlemat toimeainet on põhjalikult uuritud ning need sisalduvad mitmes ravimis, mida kasutatakse kas eraldi või kombinatsioonis muude ravimitega astma ja kroonilise obstruktiivse kopsuhaiguse ravis.
English: What is DuoResp Spiromax and what is it used for?
Estonian: Mis on DuoResp Spiromax ja milleks seda kasutatakse?
English: For practical information about using DuoResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi DuoResp Spiromax kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but DuoResp Spiromax is given using a different inhaler.
Estonian: See tähendab, et DuoResp Spiromax on sarnane võrdlusravimiga, mis sisaldab samu toimeaineid, kuid ravimit DuoResp Spiromax manustatakse teise inhalaatoriga.
English: It is not intended to provide practical advice on how to use DuoResp Spiromax.
Estonian: Hindamisaruandes ei anta ravimi DuoResp Spiromax kasutamise praktilisi nõuandeid.
English: For more information about treatment with DuoResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga DuoResp Spiromax toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.
Estonian: Ravimi DuoResp Spiromax võrdlusravim on Symbicort Turbohaler.
English: Other information about DuoResp Spiromax
Estonian: Muu teave ravimi DuoResp Spiromax kohta
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Symbicort Turbohaleri korral, ületab ravimi DuoResp Spiromax kasulikkus sellega kaasnevad riskid.
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Estonian: Ravimi DuoResp Spiromax tugevust 160/4,5 mikrogrammi (160 μg budesoniidi ja 4,5 μg formoterooli) tohib kasutada regulaarse astmaravimina ja vajaduse korral leevendusravimina.
English: DuoResp Spiromax is a ‘hybrid medicine'.
Estonian: DuoResp Spiromax on hübriidravim.
English: Why is DuoResp Spiromax approved?
Estonian: Miks DuoResp Spiromax heaks kiideti?
English: How has DuoResp Spiromax been studied?
Estonian: Kuidas ravimit DuoResp Spiromax uuriti?
English: How does DuoResp Spiromax work?
Estonian: Kuidas DuoResp Spiromax toimib?
English: How is DuoResp Spiromax used?
Estonian: Kuidas ravimit DuoResp Spiromax kasutatakse?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Estonian: Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus Tugevus
English: Immediate Packaging
Estonian: Ravimvorm Manustamistee Pakendi iseloomustus Pakendi suurus
English: 169 29 Solna SWEDEN
Estonian: 169 29 Solna ROOTSI
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Estonian: I lisa Ravimi nimetuste, ravimvormide, tugevuste, manustamisviiside ja müügiloa hoidjate loetelu liikmesriikides
English: Kifissias 266, 152 32 Halandri, Athens GREECE
Estonian: Kifissias 266, 152 32 Halandri, Athens KREEKA
English: GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, FINLAND
Estonian: GlaxoSmithKline Oy P.O.Box 24 Piispansilta 9 A, FI-02231 Espoo, SOOME
English: GlaxoSmithKline 100, route de Versailles78163 Marly-le-Roi Cedex FRANCE
Estonian: Laboratoire GlaxoSmithKline 100, route de Versailles78163 Marly-le-Roi Cedex PRANTSUSMAA
English: Intravenous Use and Intramuscular use (Only one MA for 250 mg strength)
Estonian: Intravenoosne ja intramuskulaarne (ainult üks müügiluba 250 mg tugevusel)
English: GlaxoSmithKline S.p.A.Via A. Fleming, 237135 Verona ITALY
Estonian: GlaxoSmithKline S.p.A.Via A. Fleming, 237135 Verona ITAALIA
English: Middlex UB6 0NN UNITED KINGDOM
Estonian: Middlex UB6 0NN ÜHENDKUNINGRIIK
English: GlaxoWellcome Farmacêutica Lda Rua Dr António Loureiro Borges nº3
Estonian: Rua Dr António Loureiro Borges nº3
English: Middlesex UB6 0HE UNITED KINGDOM
Estonian: Middlesex UB6 0HE ÜHENDKUNINGRIIK
English: 1.5g/VIAL
Estonian: 1.5g/VIAAL
English: Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Estonian: Huis ter Heideweg 62 3705 LZ ZEIST HOLLAND
English: 250mg/VIAL
Estonian: 250mg/VIAAL
English: 250mg 2ml (intravenous) 250mg/1ml (intramuscular)
Estonian: 250mg/2ml (intravenoosne) 250mg/1ml (intramuskulaarne)
English: 750mg/VIAL
Estonian: 750mg/VIAAL
English: 250mg/1ml or 250mg/2-5ml
Estonian: 250mg/1ml või 250mg /2-5ml
English: Curocef 750 mgTrockenstechampull en
Estonian: Curocef 750 mgTrockenstechampullen
English: GlaxoSmithKline Pharma GmbH, Albert SchweitzerGasse 6,
Estonian: GlaxoSmithKline Pharma GmbH,
English: Laboratoire
Estonian: Süstelahus
English: 750mg/6ml (intravenous) 750mg/3ml (intramuscular)
Estonian: 750mg/6ml (intravenoosne) 750mg/3ml (intramuskulaarne)
English: SLOVENIA
Estonian: SLOVEENIA
English: Curocef 1500 mgTrockenstechampull en
Estonian: Curocef 1500mgTrockenstechampullen
English: Belgium
Estonian: BELGIA
English: Injection : 1.5g/15ml Infusion : 1.5g/15ml + 50ml or 100ml
Estonian: Süstelahus: 1.5g/15ml Infusioonilahus: 1.5g/15 ml + 50ml või 100ml
English: 750mg/3ml or 750 mg/6 - 10 ml
Estonian: 750mg/3 ml või 750mg/6 - 10 ml
English: 750mg +1 x 6ml solvent
Estonian: Intravenoosne 750mg +1 x 6ml lahusti
English: Curoxim 750mg
Estonian: Zinacef 750 mg
English: 250mg + 1 x 2ml solvent
Estonian: Intravenoosne 250mg + 1 x 2ml lahusti
English: A-1140 Wien AUSTRIA
Estonian: Albert Schweitzer-Gasse 6, A-1140 Wien
English: Glaxo Wellcome House Berkeley Avenue Greenford
Estonian: Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford
English: Nykaer 68, 2605 Broendby DENMARK
Estonian: GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby TAANI
English: Curocef 250 mgTrockenstechamupll en
Estonian: Curocef 250mgTrockenstechamupllen 250mg Süstelahuse pulber
English: Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,
Estonian: Glaxo Operations UK Limited, GlaxoSmithKline House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, ÜHENDKUNINGRIIK
English: Powder for solution/ suspension for injection/infusion
Estonian: Süste-/ infusioonilahuse/ -suspensiooni pulber
English: Intramuscular Use, Intravenous Use
Estonian: Intramuskulaarne, intravenoosne
English: Intravenous or IntramuscularUse
Estonian: Intravenoosne või intramuskulaarne
English: Powder for suspension for Injection
Estonian: Süstelahuse/ -suspensiooni pulber Intramuskulaarne
English: GlaxoSmithKline Pharma A/S
Estonian: GlaxoSmithKline s.a. / n.v.
English: Intramuscular Use/ Intravenous Use
Estonian: Intramuskulaarne/ intravenoosne
English: 250mg Powder for Injection Intramuscular Use
Estonian: 250mg Süstelahuse pulber Intramuskulaarne
English: Glaxo Group LtdGlaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN UNITED KINGDOM
Estonian: Glaxo Group LtdGlaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN ÜHENDKUNINGRIIK
English: Intravenous use, intramuscular use
Estonian: Intravenoosne, intramuskulaarne
English: Powder for solution for Injection
Estonian: Infusioonisuspensiooni pulber
English: Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN
Estonian: Glaxo Group Ltd., Glaxo Welcome House, Berkeley avenue, Greenford, Middlesex UB6 0NN ÜHENDKUNINGRIIK
English: GlaxoSmithKline s.a. / n.v. Rue du Tilleul 13
Estonian: Rue du Tilleul 13
English: 750mg Powder for Injection Intramuscular Use or Intravenous Use
Estonian: 750mg Süstelahuse pulber Intravenoosne või intramuskulaarne
English: Intravenous Use/ Intramuscular Use
Estonian: Intravenoosne/ intramuskulaarne
English: 750mg Powder for Injection Intravenous Use and intramuscular use
Estonian: 750mg Süstelahuse pulber Intravenoosne ja intramuskulaarne
English: Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN
Estonian: Glaxo Group Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN ÜHENDKUNINGRIIK
English: 750mg Powder for Injection Intramuscular Use
Estonian: 750mg Süstelahuse pulber Intramuskulaarne
English: Intravenous Use and Intramuscular use
Estonian: Intravenoosne ja intramuskulaarne
English: Powder for suspension for Infusion
Estonian: Süstelahuse või -suspensiooni pulber
English: ENGLAND
Estonian: ÜHENDKUNINGRIIK
English: Powder for suspension for injection or solution for injection and infusion
Estonian: Süstesuspensiooni või süste- ja infusioonilahuse pulber
English: 9 months.
Estonian: 9 kuud.
English: It will not be given to you again.
Estonian: Seda ei manustata teile uuesti.
English: This can take 3 to 6 hours and may need to be repeated.
Estonian: See võib kesta 3...6 tundi ja seda võib olla vaja korrata.
English: June 2022
Estonian: Juuni 2022
English: Name:
Estonian: Nimi:
English: * Frequency is based on laboratory values.
Estonian: * Esinemissagedus põhineb laboritulemustel.
English: These other medicines may include:
Estonian: Nendeks ravimiteks võivad olla:
English: • There may be an effect on the results of some types of HIV test - ask your doctor about this.
Estonian: • võib see mõjutada teatud tüüpi HIV testide tulemusi - küsige selle kohta oma arstilt.
English: • You have an infection.
Estonian: • kui teil on infektsioon.
English: In particular, you must not be given certain vaccines called live vaccines:
Estonian: Eriti ei tohi teile manustada teatud vaktsiine, mida kutsutakse elusvaktsiinideks:
English: • after treatment while the immune system is recovering.
Estonian: • pärast ravi, kui immuunsüsteem on taastumas.
English: ORR was consistent across all subgroups.
Estonian: ORR oli järjepidev kõigi alarühmade lõikes.
English: Other side effects are listed below.
Estonian: Teised kõrvaltoimed on loetletud allpool.
English: • if you are allergic to any of the ingredients of this medicine (listed in section 6).
Estonian: • kui olete selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Date of birth: {DD MMM YYYY} SEC:
Estonian: Sünnikuupäev: {PP KKK AAAA} SEC:
English: No such risks were identified based on these studies.
Estonian: Nende uuringute põhjal taolisi riske ei tuvastatud.
English: HBV reactivation
Estonian: HBV reaktiveerumine
English: Studies B2202 (N=75) + C2201 (N=111)
Estonian: Uuringud B2202 (N=75) + C2201 (N=111)
English: • You had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Estonian: • kui saite vaktsiini eelneva 6 nädala jooksul või kui kavatsete end lähikuudel vaktsineerida.
English: You may be given medicines to help prevent the condition.
Estonian: Teile võidakse anda ravimeid olukorra ennetamiseks;
English: The following information is intended for doctors only.
Estonian: Järgnev teave on ainult arstidele.
English: • Your white blood cells are frozen and sent away to make Kymriah.
Estonian: • Teie valgevererakud külmutatakse ja saadetakse Kymriahi valmistamiseks.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Estonian: Teatage oma arstile, kui te võtate, olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid, kaasa arvatud ilma retseptita ostetud ravimeid.
English: This usually takes less than 1 hour.
Estonian: Infusioon kestab tavaliselt alla 1 tunni.
English: Cmax (copies/μg)
Estonian: Cmax (koopiat/μg)
English: Tmax (day)
Estonian: Tmax (päev)
English: • Very severe inflammation around the body (due to syndrome of immune activation)
Estonian: • väga raske põletik kogu kehas (immuunaktivatsiooni sündroomi tõttu);
English: T½ (day)
Estonian: T½ (päev)
English: These patient are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Estonian: Need patsiendid on tõenäolisemalt allpool kirjeldatud kõrvaltoimete tagajärgede suhtes tundlikumad ja vajavad eritähelepanu.
English: Prolonged neutropenia has been associated with increased risk of infection.
Estonian: Pikaajalist neutropeeniat on seostatud suurenenud infektsiooniohuga.
English: Manufacture and release of Kymriah usually takes about 3-4 weeks.
Estonian: Kymriahi tootmine ja väljastamine võtab tavaliselt aega ligikaudu 3...4 nädalat.
English: • Kymriah is a one-time treatment.
Estonian: • Kymriah on ühekordne ravi.
English: These symptoms almost always occur within the first 10 days after infusion.
Estonian: Need sümptomid tekivad peaaegu alati esimese 10 päeva jooksul pärast infusiooni;
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: not yet assigned
Estonian: Farmakoterapeutiline rühm: teised kasvajavastased ained, ATC-kood: ei ole veel omistatud
English: Do not use this medicine if the infusion bag is damaged or leaking.
Estonian: Ärge kasutage seda ravimit, kui infusioonikott on kahjustatud või lekib.
English: • Blue lips, hands and feet
Estonian: • sinakad huuled, käed ja jalad;
English: Other medicines and Kymriah
Estonian: Muud ravimid ja Kymriah
English: This is to help prevent infusion reactions and fever.
Estonian: See aitab ennetada infusiooniga seotud reaktsioone ja palavikku.
English: Kymriah will always be given to you by a doctor.
Estonian: Kymriahit manustab teile alati arst.
English: AUC0-28d (copies/μg*day)
Estonian: AUC0-28p (koopiat/μg*päev)
English: • Check if your cancer is getting worse.
Estonian: • kontrollib, kas teie vähk süveneb;
English: Package leaflet: Information for the patient or carer
Estonian: Pakendi infoleht: teave patsiendile või hooldajale
English: Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Estonian: Osa teie valgevererakkudest eraldatakse verest ja ülejäänud veri viiakse veeni tagasi.
English: Infections and infestations presented reflect high-level group terms.
Estonian: Esitletud infektsioonid ja infestatsioonid kajastavad MedDRA HLGT (high-level group term) termineid.
English: ORR included CR and CRi.
Estonian: ORR hõlmas CR ja CRi.
English: 6.5 Nature and contents of container and special equipment for use, administration or implantation
Estonian: 6.5 Pakendi iseloomustus ja sisu ning kasutamise, manustamise või implanteerimise erivahendid
English: If these side effects become severe or serious, tell your doctor immediately.
Estonian: Kui need kõrvaltoimed muutuvad raskeks või tõsiseks, teavitage kohe oma arsti.
English: They usually happen in the first 8 weeks after the infusion, but can also develop later:
Estonian: Need probleemid tekivad tavaliselt esimese 8 nädala jooksul pärast infusiooni, kuid võivad ka hiljem areneda:
English: Common (≥1/100 to <1/10)
Estonian: Sage (≥1/100 to <1/10)
English: Very common: may affect more than 1 in 10 people
Estonian: Väga sage: võivad tekkida rohkem kui 1 inimesel 10st
English: The cellular composition and the final cell number varies between individual patient batches.
Estonian: Rakuline koostis ja lõplik rakkude arv erineb individuaalsete patsiendipartiide vahel.
English: • Failure of multiple organs
Estonian: • multiorganpuudulikkus;
English: If you miss an appointment, call your doctor or the hospital as soon as possible to reschedule.
Estonian: Kui teil jääb kohtumine vahele, helistage oma arstile või haiglasse niipea kui võimalik, et uus aeg kokku leppida.
English: Race/ethnicity
Estonian: Rass/etniline kuuluvus
English: Kymriah should only be given if the result shows you are not pregnant.
Estonian: Kymriahit tohib manustada ainult juhul, kui rasedustest näitab, et te pole rase.
English: Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Estonian: Arst kontrollib regulaarselt teie vererakkude arvu, sest vererakkude ja muude verekomponentide hulk võib väheneda;
English: No alternative adequate animal models are available.
Estonian: Puuduvad muud vastavad loommudelid.
English: Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <10 years ≥10 years and <18 years ≥18 years
Estonian: Keskmine (standardhälve) Mediaan (minimaalne - maksimaalne) Vanuserühm (aastad) - n (%) <10 aastat ≥10 aastat ja <18 aasta ≥18 aastat
English: It usually takes about 3 to 4 weeks to make Kymriah but the time may vary.
Estonian: Kymriahi valmistamiseks kulub tavaliselt 3...4 nädalat, kuid see aeg võib varieeruda.
English: Cerebral haemorrhage** Neuralgia
Estonian: Ajuhemorraagia** Neuralgia
English: Patients should be monitored for neurological events.
Estonian: Patsiente tuleb neuroloogiliste häirete suhtes jälgida.
English: One individual treatment dose comprises 1 to 3 infusion bags.
Estonian: Üks individuaalne raviannus koosneb 1 kuni 3 infusioonikotist.
English: The majority of patients (101/111, 91%) received bridging therapy for disease stabilisation.
Estonian: Enamik patsiente (101/111, 91%) said haiguse stabiliseerimiseks sildamist (bridging).
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Estonian: AINULAADNE IDENTIFIKAATOR - 2D-vöötkood
English: Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion.
Estonian: Teie arst soovitab teil vähemalt 10 päeva jooksul iga päev haiglasse jälgimisele tulla ja kaalub, kas peaksite 10 esimeseks infusioonijärgseks päevaks haiglasse jääma.
English: You should not be given Kymriah:
Estonian: Teile ei tohi Kymriahit manustada:
English: During the 30 to 60 minutes before you are given Kymriah you may be given other medicines.
Estonian: 30...60 minuti jooksul enne Kymriahi manustamist võite saada teisi ravimeid.
English: Approximately 30% of patients discontinued the study prior to Kymriah administration.
Estonian: Ligikaudu 30% patsientidest lõpetas uuringu enne Kymriahi manustamist.
English: This is so your doctor can check if your treatment is working and help you if you have any side effects.
Estonian: Nii saab arst kontrollida, kas teie ravi toimib ja aidata teid kõrvaltoimete tekkimise korral.
English: Juvenile toxicity studies were not conducted.
Estonian: Noorloomade toksilisusuuringuid ei ole läbi viidud.
English: • Additional risk minimisation measures
Estonian: • Riski minimeerimise lisameetmed Põhipunktid:
English: • Check your lungs, heart and blood pressure.
Estonian: • kontrollib teie kopse, südant ja vererõhku;
English: Therefore the risk/benefit of Kymriah has not been established in these populations.
Estonian: Seetõttu pole Kymriahi riski/kasu suhet nendes rühmades hinnatud.
English: DLBCL: No dose adjustment is required in patients over 65 years of age.
Estonian: DLBCL: üle 65-aastastel patsientidel ei ole vaja annust kohandada.
English: Adverse drug reactions from these clinical studies (Table 2) are listed by MedDRA system organ class.
Estonian: Nendes kliinilistes uuringutes täheldatud kõrvaltoimed (tabel 2) on loetletud MedDRA organsüsteemi klasside järgi.
English: Annual safety reports and 5-yearly interim reports
Estonian: Ajakohastatud aruanded: iga-aastased ohutusaruanded ja 5aasta vahearuanded
English: Updated reports: September 2019, November
Estonian: Ajakohastatud aruanded: september 2019, november 2020
English: Before you are given Kymriah tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of Kymriah.
Estonian: Enne Kymriahi manustamist öelge oma arstile või õele, kui võtate teie immuunsüsteemi nõrgestavaid ravimeid, nagu näiteks kortikosteroidid, kuna need ravimid võivad mõjutada Kymriahi toimet.
English: Early Tmax may not be representative of the true maximal expansion, rather the amount of transgene present in the catheter from which sample was collected.
Estonian: Varajane Tmax ei pruugi näidata tõelist maksimaalset ekspansiooni, pigem näitab see transgeeni hulka kateetris, kust proov koguti.
English: ‡ (day)
Estonian: ‡ (päev)
English: One patient died due to disease progression and the remaining three patients achieved a CR or CRi and remain alive 1.5-2 years after infusion.
Estonian: Üks patsient suri haiguse progresseerumise tõttu ja ülejäänud kolm patsienti saavutasid CR või CRi ja püsisid elus 1,5...2 aastat pärast infusiooni.