FrancophonIA/ELRC3.0 huggingface dataset:
English: Monkeys administered a single bolus intravenous dose of carfilzomib at 3 mg/kg (which corresponds to 36 mg/m2 and is similar to the recommended dose in humans of 27 mg/m2 based on BSA) experienced hypotension, increased heart rate, and increased serum levels of troponin T. The repeated bolus intravenous administration of carfilzomib at ≥ 2 mg/kg/dose in rats and 2 mg/kg/dose in monkeys using dosing schedules similar to those used clinically resulted in mortalities that were due to toxicities occurring in the cardiovascular (cardiac failure, cardiac fibrosis, pericardial fluid accumulation, cardiac haemorrhage/degeneration), gastrointestinal (necrosis/haemorrhage), renal (glomerulonephropathy, tubular necrosis, dysfunction), and pulmonary (haemorrhage/inflammation) systems.
Estonian: Karfilsomiib korduv intravenoosne manustamine boolusena rottidele annuses ≥ 2 mg/kg/annus ja ahvidele annuses 2 mg/kg/annus kliinilist annustamisskeemi järgides põhjustas suremust toksilisuse tõttu südame-veresoonkonnale (südamepuudulikkus, kardiaalne fibroos, vedeliku kogunemine perikardiõõnde, kardiaalne hemorraagia ja degeneratsioon), seedetraktile (nekroos, hemorraagia), neerudele (glomerulonefropaatia, tubulaarnekroos, düsfunktsioon) ja kopsudele (hemorraagia, põletik).
English: Pulmonary hypertension has been reported in patients treated with Kyprolis.
Estonian: Kyprolis'ega ravitud patsientidel on teatatud pulmonaalhüpertensioonist.
English: Peripheral oedema Asthenia
Estonian: Perifeerne turse Asteenia
English: Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis.
Estonian: Patsientidel, kellele on manustatud Kyprolis't, on teatatud infusioonireaktsioonidest, k.a eluohtlikud reaktsioonid.
English: The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
Estonian: Kyprolis'ega ravi taasalustamise ohutus patsientidel, kellel on varasemalt tekkinud trombootiline trombotsütopeeniline purpur ja hemolüütilis-ureemiline sündroom, ei ole teada.
English: • Liver problems including an increase in liver enzymes in the blood
Estonian: • probleemid maksaga, k.a maksaensüümide aktiivsuse tõus veres;
English: OS months median (95% CI) HR (95% CI); 1-sided p-valueb
Estonian: Mediaanne OS kuudes (95% CI) HR (95% CI); 1-suunaline p-väärtusb
English: 15 mg/m2 dose cycle 1, day 1 for mild, moderate, severe renal impairment and chronic dialysis versus normal renal function were 124.36%, 111.07%, 84.73% and 121.72%, respectively.
Estonian: Võrreldes normaalse neerutalitlusega oli AUClast geomeetrilise keskmise suhteline erinevus annusega 15 mg/m2 1. ravitsükli 1. päeval kerge neerukahjustuse korral 124,36%, mõõduka neerukahjustuse korral 111,07%, raske neerukahjustuse korral 84,73% ja kroonilise dialüüsravi korral 121,72%.
English: All patients should be routinely evaluated for hypertension while on Kyprolis and treated as needed.
Estonian: Ravi ajal Kyprolis'ega peab kõikide patsientide vererõhku regulaarselt jälgima ja vajadusel ravima.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1060/003
English: The pharmacokinetics of Kyprolis has not been evaluated in patients with severe hepatic impairment.
Estonian: Raske maksakahjustusega patsientidel ei ole Kyprolis'e farmakokineetikat hinnatud.
English: ARDS
Estonian: Lööve
English: 50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap.
Estonian: 50 ml I tüüpi läbipaistvast klaasist viaal, suletud fluoropolümeeriga lamineeritud elastomeerkorgiga ja alumiiniumist korgiümbrisega, millel on eemaldatav punakaslilla plastikkate.
English: Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion carfilzomib
Estonian: Kyprolis 10 mg infusioonilahuse pulber Kyprolis 30 mg infusioonilahuse pulber Kyprolis 60 mg infusioonilahuse pulber karfilsomiib
English: In study 2011 003 the incidence of venous thromboembolic events was 12.5% in the Kd arm and 3.3% in the bortezomib plus dexamethasone (Vd) arm. Grade ≥ 3 venous thromboembolic events were reported in 3.5% of patients in the Kd arm and 1.8% of patients in the Vd arm.
Estonian: Uuringus 2011-003 oli venoosse trombemboolia juhtude esinemissagedus Kd ravihaaras 12,5% ning bortesomiibi ja deksametasooni (Vd) ravihaaras 3,3%.
English: Kyprolis and dexamethasone
Estonian: Kyprolis ja deksametasoon
English: Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis.
Estonian: Patsientidel, kellele on manustatud Kyprolis't, on teatatud posterioorse pöörduva entsefalopaatia sündroomi juhtudest.
English: The geometric mean ratios in AUClast at the 27 mg/m2 dose cycle 1, day 16 and at the 56 mg/m2 dose cycle 2, day 1 for ESRD versus normal renal function were 139.72% and 132.75%, respectively.
Estonian: Võrreldes normaalse neerutalitlusega oli lõppstaadiumis neerupuudulikkuse korral AUClast geomeetrilise keskmise suhteline erinevus annusega 27 mg/m2 1. ravitsükli 16. päeval 139,72% ning annusega 56 mg/m2 2. ravitsükli 1. päeval 132,75%.
English: Influenza like illness Malaise
Estonian: Süstekoha reaktsioonid Gripilaadne haigestumine Halb enesetunne
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide, dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; IMWG = International Myeloma Working Group; EBMT = European blood and marrow transplantation; mo = months Note: The response and PD outcomes were determined using standard objective IMWG/EBMT response criteria.
Estonian: KRd = Kyprolis, lenalidomiid ja deksametasoon; Rd = lenalidomiid ja deksametasoon; PFS = progressioonivaba elulemus; HR = riskitiheduste suhe; CI = usaldusvahemik; IMWG = Müeloomi Rahvusvaheline Töörühm; EBMT = Vere ja Luuüdi Siirdamise Euroopa Ühendus
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis (see section 4.4).
Estonian: Kyprolis'ega ravitud patsientidel on teatatud venoosse trombemboolia juhtudest, k.a süvaveeni tromboos ja kopsuarteri trombemboolia, mis on lõppenud surmaga (vt lõik 4.4).
English: Febrile neutropenia HUS
Estonian: Febriilne neutropeenia
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Kyprolis 10 mg infusioonilahuse pulber Kyprolis 30 mg infusioonilahuse pulber Kyprolis 60 mg infusioonilahuse pulber
English: In patients who received prior bortezomib (54%), median PFS was 15.6 months in the Kd arm versus 8.1 months in the Vd arm (HR = 0.56, 95% CI: 0.44, 0.73), ORR was 71.2% versus 60.3%.
Estonian: Eelnevalt bortesomiibiga ravitud patsientide (54%) progresseerumisvaba elulemuse mediaan oli Kd ravihaaras 15,6 kuud ja Vd ravihaaras 8,1 kuud (HR = 0,56; 95% CI: 0,44; 0,73), üldine ravivastuse määr oli 71,2% vs 60,3%.
English: LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Estonian: ABIAINED Naatriumbetadekssulfobutüüleeter, veevaba sidrunhape (E330), naatriumhüdroksiid.
English: Kyprolis 60 mg powder for solution for infusion
Estonian: Kyprolis 60 mg infusioonilahuse pulber
English: Third Kyprolis dose reduction
Estonian: Kyprolis'e annuse kolmas vähendamine
English: Thrombocytopenia Neutropenia Anaemia
Estonian: Trombotsütopeenia Neutropeenia Aneemia
English: Cardiac failure Myocardial infarction Atrial fibrillation Tachycardia Ejection fraction decreased Palpitations
Estonian: Südamepuudulikkus Müokardiinfarkt Kodade virvendus Tahhükardia Väljutusmahu langus
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; OS = overall survival; mo = months; HR = hazard ratio; CI = confidence interval
Estonian: Kd = Kyprolis, deksametasoon, Vd = bortesomiib, deksametasoon, OS = üldine elulemus, HR = riskitiheduste suhe, CI = usaldusvahemik
English: Cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving carfilzomib who have had prior or concurrent immunosuppressive therapy.
Estonian: Karfilsomiibi saavatel patsientidel, kes on eelnevalt saanud või saavad samaaegselt immunosupressiivset ravi, on teatatud progresseeruva hulgikoldelise leukoentsefalopaatia (progressive multifocal leukoencephalopathy, PML) juhtudest.
English: Cases of acute renal failure have been reported in patients who received Kyprolis.
Estonian: Kyprolis'ega ravitud patsientidel on teatatud ägeda neerupuudulikkuse juhtudest.
English: Summary of efficacy analysis in relapsed multiple myeloma study PX-171-009 KRd combination therapy KRd arma (N = 396)
Estonian: Efektiivsuse analüüsi kokkuvõte taasägenenud hulgimüeloomi uuringus PX-171-009
English: Haemorrhage
Estonian: Südamehäired
English: No clinical trial was conducted with a dose of 56 mg/m2.
Estonian: Annusega 56 mg/m2 ei ole uuringuid tehtud.
English: Stop Kyprolis for grade 3 and 4 dyspnoea until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see sections 4.2 and 4.8).
Estonian: 3. ja 4. raskusastme düspnoe korral tuleb ravi Kyprolis'ega peatada kuni taandumise või lähteseisundi taastumiseni ning kasu/riski hindamise põhjal kaaluda, kas taasalustada ravi Kyprolis'ega (vt lõigud 4.2 ja 4.8).
English: There was an approximately 8%, 23% and 34% increase in the inhibition of LMP7, MECL1, and LMP2 subunits respectively at the dose of 56 mg/m2 compared to those at 15 to 20 mg/m2.
Estonian: Annus 56 mg/m2 pärssis LMP7 allühikut 8%, MECL1 allühikut 23% ja LMP2 allühikut 34% rohkem kui annused 15…20 mg/m2.
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.2).
Estonian: Ravieelse südamepuudulikkusega või sellest ohustatud patsientidel võib vedeliku kogumahtu kohandada vastavalt kliinilisele näidustusele (vt lõik 4.2).
English: Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome (TTP/HUS) have been reported in patients who received Kyprolis.
Estonian: Patsientidel, kellele on manustatud Kyprolis't, on teatatud trombootilise mikroangiopaatia juhtudest, k.a trombootiline trombotsütopeeniline purpur ja hemolüütilis-ureemiline sündroom.
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval
Estonian: Kd = Kyprolis, deksametasoon, Vd = bortesomiib, deksametasoon, PFS = progresseerumisvaba elulemus, HR = riskitiheduste suhe, CI = usaldusvahemik
English: Kyprolis in combination with lenalidomide and dexamethasonea
Estonian: Kyprolis kombinatsioonis lenalidomiidi ja deksametasooniga
English: • Dehydration
Estonian: • veetustumine (dehüdratsioon);
English: • Chills
Estonian: • iiveldus;
English: • Swelling of the hands, feet or ankles
Estonian: • käte, jalalabade või hüppeliigeste turse;
English: • Cataract
Estonian: • segasusseisund;
English: Kyprolis 30 mg powder for solution for infusion
Estonian: Kyprolis 30 mg infusioonilahuse pulber
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.4).
Estonian: Ravieelse südamepuudulikkusega või sellest ohustatud patsientidel võib vedeliku kogumahtu kohandada vastavalt kliinilisele näidustusele (vt lõik 4.4).
English: • Shortness of breath
Estonian: • vilistav hingamine;
English: Kyprolis 10 mg powder for solution for infusion
Estonian: Kyprolis 10 mg infusioonilahuse pulber
English: GRH0219EN v1
Estonian: GRH0296 v1
English: Progression/Death, n (%) Median PFS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Estonian: Progresseerumine, surm, n (%) PFS mediaan, kuud HR (Kd/Vd) (95% CI) p-väärtus (1-suunaline)
English: In case of hypertensive crises, stop Kyprolis until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Estonian: Hüpertensiivse kriisi korral tuleb ravi Kyprolis'ega peatada kuni taandumise või lähteseisundi taastumiseni ning kasu/riski hinnangu põhjal kaaluda, kas taasalustada ravi Kyprolis'ega (vt lõik 4.2).
English: Second Kyprolis dose reduction
Estonian: Kyprolis'e annuse teine vähendamine
English: This study evaluated Kyprolis at an initial dose of 20 mg/m2, which was increased to 27 mg/m2 on cycle 1, day 8, administered twice weekly for 3 out of 4 weeks as a 10 minute infusion.
Estonian: Selles uuringus hinnati Kyprolis't annuses 20 mg/m2, mida suurendati annuseni 27 mg/m2 1 ravitsükli 8. päeval, manustatuna 10-minutilise infusioonina 2 korda nädalas 3 nädalal 4-st. Kyprolis't manustati maksimaalselt 18 tsüklit, kui ravi ei katkestatud varem haiguse progresseerumise või ravimi talumatu toksilisuse tõttu.
English: Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical trials.
Estonian: Uuringutesse ei kaasatud patsiente, kellel oli III või IV raskusastme südamepuudulikkus New York'i Südameassotsiatsiooni (New York Heart Association, NYHA) määratluse alusel, äsjane müokardiinfarkt ja ravimata juhtehäire.
English: Death, n (%) Median OS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Estonian: Surm, n (%) OS mediaan, kuud HR (KRd/Rd) (95% CI) p-väärtus (1-suunaline)
English: The dose is calculated using the patient's baseline body surface area (BSA).
Estonian: Annus arvutatakse patsiendi kehapindala kohta ravi alguses.
English: Pneumonitis
Estonian: Hemorraagia
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 60 mg powder for solution for infusion carfilzomib
Estonian: RAVIMPREPARAADI NIMETUS Kyprolis 60 mg infusioonilahuse pulber karfilsomiib
English: Kd Arm (N = 464)
Estonian: Kd ravihaar (N = 464)
English: Death, n (%) Median OS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Estonian: Surm, n (%) OS mediaan, kuud HR (Kd/Vd) (95% CI) p-väärtus (1-suunaline)
English: • Lung infection
Estonian: • kopsuinfektsioon;
English: Caution should be used in the concomitant administration of other agents that may increase the risk of thrombosis (e.g. erythropoietic agents or hormone replacement therapy).
Estonian: Teiste, tromboosiriski suurendavate, ravimite (nt erütropoeesi stimuleerivad ravimid, hormoonasendusravi) samaaegsel manustamisel peab olema ettevaatlik.
English: Rd arma (N = 396)
Estonian: Rd rühma (N = 396)
English: For clinical management of hypertension during Kyprolis treatment, see section 4.4.
Estonian: Hüpertensiooni kliinilist käsitlust ravi ajal Kyprolis'ega vt lõik 4.4.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 30 mg powder for solution for infusion carfilzomib
Estonian: RAVIMPREPARAADI NIMETUS Kyprolis 30 mg infusioonilahuse pulber karfilsomiib
English: Cataract Blurred vision
Estonian: Katarakt Hägune nägemine
English: Kyprolis contains sodium
Estonian: Kyprolis kombinatsioonis deksametasooniga
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis.
Estonian: Patsientidel, kellele on manustatud Kyprolis't on teatatud venoosse trombemboolia juhtudest, k.a süvaveenitromboos ja kopsuarteri trombemboolia, mis on lõppenud surmaga.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Estonian: RAVIMPREPARAADI NIMETUS Kyprolis 10 mg infusioonilahuse pulber karfilsomiib
English: Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2.
Estonian: Patsientidele, kelle kehapindala on suurem kui 2,2 m2, tuleb manustada annus, mis vastab kehapindalale 2,2 m2. Kehakaalu muutuste korral 20% või vähem ei pea annust kohandama.
English: • Inflammation of the nose and throat
Estonian: • nina ja neelu põletik;
English: • Diarrhoea
Estonian: • ärevus;
English: • Wheezing
Estonian: • liigesvalu;
English: Stop Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Estonian: Pulmonaalse hüpertensiooni korral tuleb ravi Kyprolis'ega peatada kuni taandumise või lähteseisundi taastumiseni ning kasu/riski hinnangu põhjal kaaluda, kas taasalustada ravi Kyprolis'ega (vt lõik 4.2).
English: Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Estonian: Pärast Kyprolis'e manustamist eksikombel annuses 200 mg teatati ägeda algusega külmavärinatest, hüpotensioonist, neerupuudulikkusest, trombotsütopeeniast ja lümfopeeniast.
English: Oropharyngeal pain Dysphonia Wheezing
Estonian: Lihas-skeleti valu Rindkere lihasskeleti valu Luuvalu
English: Dyspnoea Cough
Estonian: Kaasuv ravi
English: • Flu-like symptoms (influenza)
Estonian: • gripitaolised sümptomid;
English: Evaluate and stop Kyprolis until resolved and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Estonian: Patsiendi seisundit tuleb hinnata, peatada ravi Kyprolis'ega kuni taandumiseni ning kasu/riski hindamise põhjal kaaluda, kas taasalustada ravi Kyprolis'ega (vt lõik 4.2).
English: For clinical management of hepatic toxicity during Kyprolis treatment, see section 4.4.
Estonian: Hepatotoksilisuse kliinilist käsitlust ravi ajal Kyprolis'ega vt lõik 4.4.
English: Women of childbearing potential/Contraception in males and females
Estonian: Meeste ja naiste kontratseptsioon
English: The pharmacokinetics of carfilzomib has not been studied in patients with severe hepatic impairment (bilirubin > 3 x ULN and any AST).
Estonian: Raske maksakahjustusega patsientidel (bilirubiin > 3 x normivahemiku ülapiir, ASAT mistahes väärtus) ei ole karfilsomiibi farmakokineetikat uuritud.
English: Kyprolis in combination with dexamethasone for the treatment of patients with relapsed multiple myeloma - study 2011-003 (ENDEAVOR)
Estonian: Kyprolis kombinatsioonis deksametasooniga retsidiveerunud hulgimüeloomiga patsientide ravisuuring 2011-003 (ENDEAVOR)
English: The doses on day 8 and 9 of each cycle will not be given from cycle 13 onwards if you are treated with Kyprolis in combination with lenalidomide and dexamethasone.
Estonian: Kui te saate ravi Kyprolis'ega koos lenalidomiidi ja deksametasooniga, siis alates 13. ravitsüklist ei manustata enam 8. ja 9. päeva annuseid.
English: Patients with a high tumour burden should be considered to be at greater risk for TLS.
Estonian: Kasvaja lahustussündroomi oht on suurem patsientidel, kellel on rohkelt kasvajakudet.
English: Instructions for reconstitution and preparation of Kyprolis powder for solution for infusion for intravenous administration
Estonian: Kyprolis'e infusioonilahuse pulbri lahustamise ja intravenoosse manustamise juhised Karfilsomiib on tsütotoksiline aine.
English: • Constipation
Estonian: Külmavärinad
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of carfilzomib.
Estonian: Üks viaal sisaldab 10 mg karfilsomiibi.
English: If tolerated, patients received 56 mg/m2 starting in cycle 2.
Estonian: Kui ravi oli talutav, manustati alates 2. ravitsüklist 56 mg/m2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib.
Estonian: Üks viaal sisaldab 60 mg karfilsomiibi.
English: Vd Arm (N = 465)
Estonian: Vd ravihaar (N = 465)
English: Hepatic impairment
Estonian: Ärevus Segasusseisund
English: • Low platelets, which may cause easy bruising or bleeding (thrombocytopenia)
Estonian: • vereliistakute arvu langus (trombotsütopeenia), mis võib põhjustada kergesti tekkivaid verevalumeid või veritsusi;
English: Stop Kyprolis for grade 3 or 4 cardiac events until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment (see section 4.2).
Estonian: 3. ja 4. raskusastme kõrvaltoimete korral tuleb ravi Kyprolis'ega peatada kuni taastumiseni ning kasu/riski hindamise põhjal kaaluda, kas taasalustada ravi Kyprolis'ega ühe astme võrra madalamas annuses (vt lõik 4.2).
English: For clinical management of thrombocytopenia during Kyprolis treatment, see section 4.4.
Estonian: Trombotsütopeenia kliinilist käsitlust ravi ajal Kyprolis'ega vt lõik 4.4.
English: Stop Kyprolis until TLS is resolved (see section 4.2).
Estonian: Kasvaja lahustussündroomi taandumiseni tuleb ravi Kyprolis'ega peatada (vt lõik 4.2).
English: • Perforation of the digestive system
Estonian: • Peatage manustamine
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Estonian: Üks viaal sisaldab 30 mg karfilsomiibi.
English: Concomitant medicinal products
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: • Heart attack
Estonian: • südameinfarkt;
English: Dyspnoea was commonly reported in patients treated with Kyprolis.
Estonian: Kyprolis'ega ravitud patsientidel teatati sageli düspnoest.
English: Pulmonary haemorrhage Interstitial lung disease
Estonian: Seljavalu Artralgia Valu jäsemetes Lihasspasmid
English: Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Estonian: Kyprolis'ega ravitud patsientidel on teatatud kasvaja lahustussündroomi juhtudest, k.a surmaga lõppenud juhud.
English: Haemorrhage and thrombocytopenia
Estonian: Raviskeem Kyprolis'e annus
English: This has now been harmonised.
Estonian: See on nüüdseks ühtlustatud.
English: Quality of the product is considered satisfactory.
Estonian: Ravimi kvaliteeti peetakse rahuldavaks.
English: Generally the infant dose stays below 0.5% of the maternal dose, often even lower.
Estonian: Üldiselt jääb imiku annus alla 0,5% ema annusest või veelgi madalamale.
English: No literature review to underpin that conclusion was provided.
Estonian: Selle järelduse kinnitamiseks ei ole esitatud kirjanduse ülevaadet.
English: A harmonised Module 3 was also adopted.
Estonian: Lisaks võeti vastu ühtlustatud 3. moodul.
English: Nevertheless, it was considered that the information on the risk of agranulocytosis was unclear.
Estonian: Siiski leiti, et teave agranulotsütoosi riski kohta oli ebaselge.
English: Common sources (Briggs et al., 2011; Reprotox Database) reviewed several case reports and some publications reporting on a limited series of pregnancies.
Estonian: Mitmes allikas (Briggs et al., 2011; Reprotoxi andmebaas) olid esitatud juhtumiaruanded ja teave rasedatega tehtud piiratud arvu uuringute kohta.
English: The proposal presented by the MAH reflected the latest scientific information.
Estonian: Müügiloa hoidja ettepanek kajastas uusimaid teaduslikke andmeid.
English: In several MSs there were discrepancies in section 4.2 due to the differences in the indications.
Estonian: Mitmes liikmesriigis oli näidustuste erinevuste tõttu lahknevusi lõigus 4.2.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Estonian: • komitee hindas direktiivi 2001/83/EÜ artikli 30 kohast esildist;
English: As a result of this harmonisation procedure, Module 3 was updated to harmonise the information between the Member States.
Estonian: Ühtlustamismenetluse tulemusena uuendati 3. moodulit, et liikmesriikide teave ühtlustada.
English: Several clinical studies have been published during recent years (e.g. Haberman et al 2013) indicating that there is no major teratogenic risk due to the use of atypical antipsychotics.
Estonian: Viimaste aastate jooksul on avaldatud mitu kliinilist uuringut (nt Haberman et al. 2013), mis näitavad, et atüüpiliste antipsühhootikumide kasutamine ei tekita suurt teratogeensuse riski.
English: Discussions held were mainly around the amount of data currently available for the first trimester.
Estonian: Arutelu hõlmas peamiselt esimese trimestri kohta saadaolevate andmete hulka.
English: It is known that excretion in milk is low.
Estonian: Teadaolevalt on eritumine piima väike.