FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with underlying cardiac disease, arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.8).
Estonian: Olemasoleva südamehaigusega patsientidel on Gazyvaro-ravi ajal tekkinud südame rütmihäired (nt kodade virvendusarütmia ja tahhüarütmia), stenokardia, äge koronaarsündroom, müokardiinfarkt ja südamepuudulikkus (vt lõik 4.8).
English: · fluids · medicines to reduce a fever · medicines to reduce pain (analgesics) · medicines to reduce inflammation (corticosteroids) · medicines to reduce an allergic reaction (anti-histamines)
Estonian: • allergilise reaktsiooni vastased ravimid (antihistamiinid)
English: Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Estonian: Patsiendid, kes saavutavad täieliku või osalise ravivastuse induktsioonravi toimel Gazyvaro ja kemoteraapia kombinatsiooniga, jätkavad säilitusravi ainult Gazyvaro'ga annuses 1000 mg üks kord iga 2 kuu järel 2 aasta jooksul või kuni haiguse progresseerumiseni (ükskõik kumb saabub enne).
English: Day 1 (1,000 mg)
Estonian: 1. päev (1000 mg)
English: Cycles 2 - 6
Estonian: 2.-6. tsükkel
English: Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro.
Estonian: Gazyvaro'ga ravitud patsientidel on 1. tsükli ajal kirjeldatud ka surmaga lõppenud hemorraagilisi seisundeid.
English: 2See section 5.1 for information on bendamustine dose
Estonian: Teave bendamustiini annuse kohta vt lõik 5.1
English: Molecular remission at end of treatmentd No. of patients included in the analysis MRD negativee (%)
Estonian: Analüüsi kaasatud patsientide arv MRD negatiivseid e
English: Constipation, haemorrhoids
Estonian: Kõhukinnisus, hemorroidid
English: Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction.
Estonian: Kui teil tekib tõsine infusiooniga seotud reaktsioon, võib arst otsustada, et lõpetab ravi Gazyvaro'ga.
English: If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr.
Estonian: Kui patsiendil tekkis IRR eelmise infusiooni ajal, alustada manustamist kiirusega 25 mg/tunnis.
English: No meaningful differences were seen between the arms in HRQOL or health status measures.
Estonian: Tervisega seotud elukvaliteedi või terviseseisundi mõõdikute põhjal rühmade vahel märkimisväärseid erinevusi ei olnud.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common
Estonian: Nasofarüngiit, riniit, gripp, suu herpes Hea-, pahaloomulised ja täpsustamata kasvajad (sealhulgas tsüstid ja polüübid) Sage
English: Diarrhoea, constipation§
Estonian: Kõhulahtisus, kõhukinnisus§
English: Cycles 2-6
Estonian: 2.- 6. tsükkel
English: The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Estonian: Infusioonikiirust võib suurendada kuni 50 mg/tunnis kaupa iga 30 minuti järel kuni maksimaalse kiiruseni 400 mg/tunnis.
English: Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Estonian: Gazyvaro intravenoosse infusiooni ajal võib infusiooniga seotud reaktsiooni sümptomina tekkida hüpotensioon.
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Estonian: RAVIMPREPARAADI NIMETUS Gazyvaro 1000 mg infusioonilahuse kontsentraat obinutuzumab
English: Musculoskeletal and connective tissue disorders Very common
Estonian: Lihaste, luustiku ja sidekoe kahjustused Väga sage
English: Investigator-assessed PFS§ (PFS-INV) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) 3 year PFS estimate [95% CI]
Estonian: Esmane tulemusnäitaja Uurija hinnatud PFS§ (PFS-INV) Juhtumiga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseeritud*)
English: The rate of infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Estonian: Infusioonikiirust võib suurendada 50 mg/tunnis kaupa iga 30 minuti järel kuni maksimaalse kiiruseni 400 mg/tunnis.
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2.
Estonian: MRD negatiivsust määratletakse kui tulemust alla 0,0001 f Hõlmab MRD positiivseid patsiente ja patsiente, kellel tekkis progresseerumine või kes surid enne ravi lõppu g Üldise elulemuse (OS) andmete keskmine vaatlusaeg vastab 62,5 kuu keskmisele vaatlusajale 1a staadiumis ja 59 kuu keskmisele jälgimisajale 2. staadiumis.
English: If the patient experienced an IRR during the previous infusion administer at 50 mg/hr.
Estonian: Kui patsiendil tekkis IRR eelmise infusiooni ajal, manustada kiirusega 50 mg/tunnis.
English: Patient-reported Outcomes
Estonian: FARMATSEUTILISED ANDMED
English: Cases of arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.4).
Estonian: Gazyvaro-ravi ajal on esinenud südame rütmihäireid (nagu kodade virvendusarütmia ja tahhüarütmia), stenokardiat, ägedat koronaarsündroomi, müokardiinfarkti ja südamepuudulikkust (vt lõik 4.4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Gazyvaro 1000 mg infusioonilahuse kontsentraat obinutuzumab
English: 1See section 5.1 for information on chlorambucil dose
Estonian: Teave kloorambutsiili annuse kohta vt lõik 5.1
English: # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Estonian: FL-iga patsiendid, kes ei saavutanud ravivastust või kellel tekkis haiguse progresseerumine rituksimabi või rituksimabi sisaldava raviskeemi kasutamise ajal või kuni 6 kuu jooksul pärast seda
English: NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion.
Estonian: RAVIMPREPARAADI NIMETUS Gazyvaro 1000 mg infusioonilahuse kontsentraat.
English: increase in potassium, phosphate or uric acid - which can cause kidney problems (part of tumour lysis syndrome)
Estonian: • muutused vereanalüüsides: - madal lümfotsüütide (teatud tüüpi valgeverelibled) arv - kaaliumi-, fosfaadi- või kusihappesisalduse suurenemine - mis võib põhjustada neeruprobleeme (osana tuumorilahustussündroomist) - kaaliumisisalduse vähenemine
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Estonian: Muud kõrvaltoimed Kui te märkate mõnda järgmistest kõrvaltoimetest, teavitage sellest oma arsti või meditsiiniõde:
English: The infusion must be stopped and therapy permanently discontinued if the patient experiences a second occurrence of a Grade 3 IRR.
Estonian: Kui patsiendil tekib teist korda 3. raskusastme IRR, tuleb infusioon peatada ja ravi püsivalt lõpetada.
English: Day of treatment
Estonian: Ravitsükli päev
English: Tumour lysis syndrome, hypokalaemia
Estonian: Tuumorilahustussündroom, hüpokaleemia
English: Contents of the pack and other information What Gazyvaro contains · The active substance is obinutuzumab: 1,000 mg/40 mL per vial corresponding to a concentration before dilution of 25 mg/mL.
Estonian: • Toimeaine on obinutuzumab: 1000 mg/40 ml viaali kohta, mis vastab lahjendamiseelsele kontsentratsioonile 25 mg/ml.
English: Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Estonian: Joonis 1 Uurija hinnatud progressioonivaba elulemuse Kaplan-Meieri kõver (uuringufaas 1a) KLL-iga patsientidel (uuring BO21004/CLL11)
English: Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Estonian: Joonis 3 Uurija hinnatud progressioonivaba elulemuse Kaplan-Meieri kõver (uuringufaas 2) KLL-iga patsientidel (uuring BO21004/CLL11)
English: Atrial fibrillation, cardiac failure Atrial fibrillation, cardiac failure,
Estonian: • südame rütmihäire (kodade virvendus), südamepuudulikkus
English: Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Estonian: Neutropeenia tekkerisk on suurem neerukahjustusega patsientidel (CrCl < 50 ml/min) (vt lõik 4.8).
English: Dose of Gazyvaro
Estonian: Ravi Gazyvaro'ga
English: Patients must not receive further Gazyvaro infusions if they experience: · acute life-threatening respiratory symptoms, · a Grade 4 (i.e. life threatening) IRR or, · a second occurrence of a Grade 3 (prolonged/recurrent) IRR (after resuming the first infusion or during a subsequent infusion).
Estonian: • teist korda 3. raskusastme (pikaajaline/korduv) IRR (pärast esimese infusiooni jätkamist või järgneva infusiooni ajal).
English: Prophylaxis and premedication for tumour lysis syndrome (TLS)
Estonian: Tuumorilahustussündroomi (TLS) profülaktika ja premedikatsioon
English: Key Endpoints
Estonian: • silmade punetus
English: Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Estonian: Joonis 4 Üldise elulemuse Kaplan-Meieri kõver 2. uuringufaasis KLL-iga patsientidel (uuring BO21004 / CLL11)
English: Standard dosing of CHOP and CVP was given.
Estonian: CHOP ja CVP kemoteraapiat manustati tavaskeemi järgi.
English: Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Estonian: Joonis 2 Üldise elulemuse Kaplan-Meieri kõver (uuringufaas 1a) KLL-iga patsientidel (uuring BO21004/CLL11)
English: Premedication
Estonian: Imendumine
English: No formal pharmacokinetic study has been conducted in patients with hepatic impairment.
Estonian: Maksakahjustusega patsientidel ei ole nõuetekohast farmakokineetika uuringut läbi viidud.
English: Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
Estonian: §, , kuseteede infektsioon, pneumoonia§, vöötohatis
English: The storage details are as follows: · Keep this medicine out of the sight and reach of children.
Estonian: • Hoidke seda ravimit laste eest varjatud ja kättesaamatus kohas.
English: Best Overall Response (BOR) (IRC-assessed) No. of patients included in the analysis Responders (%) (CR/PR) Difference in response rate (95% CI) p-value (Cochran-Mantel-Haenszel test) Complete Responders (%) Partial Responders (%) Stable Disease (%) Duration of response (DOR) (IRCassessed) No of patients included in the analysis No. (%) of patients with event Median duration (months) of DOR (95% CI)
Estonian: HR (95% CI) p-väärtus (logaritmiline astaktest, stratifitseeritud*) Teisesed tulemusnäitajad Uurija hinnatud PFS (PFS-INV) Juhtumiga patsientide arv (%) Mediaanaeg juhtumi tekkeni (kuud, 95% CI) HR (95% CI) p-väärtus (logaritmiline astaktest, stratifitseeritud*) Parim üldine ravivastus (BOR) (IRC hinnatud)§ Analüüsi kaasatud patsientide arv Ravile reageerinuid (%) (CR/PR) Ravivastuse määra erinevus (95% CI) p-väärtus (Cochran-Mantel-Haenszeli tes t) Täieliku ravivastuse saavutanuid (%) Osalise ravivastuse saavutanuid (%) Stabiilne haigus (%)
English: Cough, oropharyngeal pain
Estonian: Köha, orofarüngeaalne valu
English: Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Estonian: Infektsioonide, sh tõsiste infektsioonide tekkerisk on suurem patsientidel (KLL), kellel on nii CIRS > 6 kui CrCl < 70 ml/min (vt lõik 4.8).
English: Nasal congestion, rhinorrhoea, oropharyngeal pain
Estonian: • kuseteede infektsioon, ninaneelupõletik, vöötohatis
English: No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN.
Estonian: Uuringus GAO4753g/GADOLIN osalenud iNHL-i patsientidel ei täheldatud HAHA-sid (Human Anti-Human Antibody, inimese antikehade vastased antikehad).
English: Table 6 summarises the ADRs of the pivotal studies (BO21004/CLL11, BO21223/GALLIUM
Estonian: Uuringus BO21223/ GALLIUM
English: GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies.
Estonian: • eelnevalt ravimata iNHL-iga patsientidel, kes said Gazyvaro't pluss kemoteraapiat (bendamustiin, CHOP, CVP), millele järgnes säilitusravi Gazyvaro'ga ravivastuse saavutanud patsientidel, võrreldes rituksimabi pluss kemoteraapiaga, millele järgnes säilitusravi rituksimabiga ravivastuse saavutanud patsientidel (uuring BO21223/GALLIUM);
English: Gastro-Intestinal Perforation
Estonian: Seedetrakti perforatsioon
English: · red eye · cold sores · depression, anxiety · night sweats · flu (influenza) · weight increase · lymph node pain · runny or blocked nose · eczema · nose or throat inflammation · pain in mouth or throat
Estonian: • vilistav hingamine, hingamisraskus, survetunne rindkeres või kurguärritus
English: Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
Estonian: Düspepsia, koliit, hemorroidid
English: HR (95% CI) p-value (Log-Rank test, stratified*)
Estonian: Juhtumiga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseeritud*)
English: HR (95% CI) p-value (Log-Rank test, stratified*) Secondary Endpoints Investigator-assessed PFS (PFS-INV) Number (%) of patients with event Median time to event (months, 95% CI) HR (95% CI) p-value (Log-Rank test, stratified*)
Estonian: MRD positiivseidf (%) MRD määra erinevus, (95% CI) Haigusvaba elulemus Juhtumiga patsientide arv (%) Mediaanaeg juhtumi tekkeni (kuud) Riski suhtarv (95% CI) p-väärtus (logaritmiline astaktest, stratifitseeritud b)
English: Arthralgia, back pain, musculoskeletal chest pain, bone pain
Estonian: Liiges valu, s eljavalu, lihas -skeleti rindkerevalu, luuvalu
English: IRC-assessed PFS (PFS-IRC) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) Time to next anti-lymphoma therapy# Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, stratified*) Overall Survival
Estonian: Põhilised tulemusnäitajad IRC hinnatud PFS (PFS-IRC) Juhtumiga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseeritud*)
English: Hepatic impairment
Estonian: • valulik lööve
English: Efficacy results for patients with previously untreated FL are summarised in Table 8.
Estonian: Tabelis 8 on esitatud kokkuvõte eelnevalt ravimata FL-iga patsientidelt saadud efektiivsuse tulemustest.
English: The infusion rate may be escalated provided that the patient can tolerate it. For management of IRRs that occur during the infusion, refer to “Management of IRRs”.
Estonian: Infusiooni ajal tekkiva IRR-i korral vt „Tegevusjuhised IRR-ide tekkimisel“.
English: Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common
Estonian: Vere ja lümfisüsteemi häired Väga sage
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, NR = Not Reached # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen *Stratification factors for analysis were refractory type (rituximab monotherapy vs. rituximab + chemotherapy) and prior therapies (≤ 2 vs > 2).
Estonian: IRC: sõltumatu hindamiskogu; PFS: progressioonivaba elulemus; HR: riski suhtarv; CI: usaldusvahemikud, MRD: minimaalne jääkhaigus, NR = saavutamata a
English: The marketing authorisation was renewed on 8 June 2006.
Estonian: Müügiluba pikendati 8. juunil 2006.
English: What is the risk associated with Nespo?
Estonian: Millised on Nespoga kaasnevad riskid?
English: Nespo exists in various strengths, from 10 to 500 micrograms per millilitre.
Estonian: Nespot turustatakse mitmesuguste tugevustega, 10-500 mikrogrammi milliliitris.
English: This summary was last updated in 09-2007.©EMEA 2007
Estonian: Kokkuvõtte viimane uuendus: 09-2007.
English: The Committee recommended that Nespo be given marketing authorisation.
Estonian: Nespole soovitati anda müügiluba.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NESPO EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE NESPO Kokkuvõte üldsusele
English: What benefit has Nespo shown during the studies?
Estonian: Milles seisneb uuringute põhjal Nespo kasulikkus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nespo to Dompé Biotec S.p.A. on 8 June 2001.
Estonian: Euroopa Komisjon väljastas Nespo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Dompé Biotec S.p.A.
English: Nespo treatment should be initiated by a doctor who has experience in treating either of the two types of anaemia mentioned above.
Estonian: Nespo ravi peab alustama arst, kellel on kahest eelnimetatud aneemialiigist ükskõik kumma ravimise kogemus.
English: Doses and dose frequency (how often Nespo is given) are adjusted depending on the response.
Estonian: Annuseid ja annustamisskeeme (Nespo manustamise sagedust) kohandatakse vastavalt ravivastusele.
English: The dose used depends on why Nespo is used, varying from 0.45 micrograms per kilogram every week (or 0.75 micrograms/kg every other week) in adults and children with kidney failure aged 11 years or older, to 6.75 micrograms/kg every three weeks in cancer patients.
Estonian: Olenevalt Nespo kasutuseesmärgist on vajalik annus alates 0,45 mikrogrammist kehakaalu kilogrammi kohta nädalas (või 0,75 mikrogrammist kehakaalu kilogrammi kohta igal teisel nädalal) neerupuudulikkusega täiskasvanute ja vähemalt 11-aastaste laste raviks kuni 6,75 mikrogrammini kehakaalu kilogrammi kohta igal kolmandal nädalal vähipatsientide raviks.
English: • adults and children over one year of age with anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin,
Estonian: • täiskasvanud ja vähemalt üheaastased lapsed, kellel on pikaajalisest neerupuudulikkusest põhjustatud aneemia, mille korral organismis ei teki piisavalt looduslikku hormooni
English: The types of cancer where Nespo can be used are ‘non-myeloid' (do not affect the bone marrow).
Estonian: Vähktõve liigid, mille korral saab Nespot kasutada, on need, mis ei mõjuta luuüdi (mittemüeloidsed).
English: The effectiveness of Nespo has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
Estonian: Nespo efektiivsust uuriti pikaajalise neerupuudulikkusega patsientidel, võrreldes ravimit inimese rekombinantse erütropoetiiniga neljas uuringus, mis hõlmasid kokku üle 1200 patsienti, ning patsientidel, kes saavad keemiaravi selliste vähivormide vastu nagu kopsuvähk, müeloom ja lümfoom, võrreldes ravimit platseeboga (näiva ravimiga) kahes uuringus, mis hõlmasid kokku 669 patsienti.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet inimtervishoius kasutatavate ravimite komitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande
English: In all cases the doses are adjusted to obtain haemoglobin levels that remain within the recommended range.
Estonian: Kõikidel juhtudel tuleb annuseid kohandada nii, et saavutatav hemoglobiini sisaldus veres oleks soovituslike väärtuste piires.
English: Nespo has also been studied in 124 children with long-term kidney disease to check that it is absorbed in the same way as in adults.
Estonian: Nespot uuriti täiendavalt 124 lapsel, kellel oli pikaajaline neeruhaigus, et kontrollida, kas laste organism omastab ravimit samal viisil kui täiskasvanute organism.
English: Darbepoetin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
Estonian: Alfadarbepoetiini toodetakse rekombinant-DNA-tehnika abil: seda toodab rakk, millesse on viidud alfadarepoetiini teket võimaldav geen (DNA).
English: • adult patients with certain types of cancer who are receiving chemotherapy (the medicines used to treat cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
Estonian: • teatavat tüüpi vähktõbe põdevad täiskasvanud, kes saavad keemiaravi (vähi ravimravi), kui viimane pärsib piisava hulga vererakkude tekkimist luuüdis.
English: Nespo should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure.
Estonian: Nespot ei tohi kasutada patsiendid, kes võivad olla ülitundlikud (allergilised) alfadarbepoetiini või ravimi mis tahes muu koostisaine suhtes või kellel on ravile halvasti alluv kõrge vererõhk.
English: How is Nespo used?
Estonian: Kuidas Nespo toimib?
English: Nespo is injected intravenously (into a vein) or subcutaneously (under the skin).
Estonian: Nespo manustatakse intravenoosselt (veeni) või subkutaanselt (naha alla).
English: Nespo is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients:
Estonian: Nespot kasutatakse aneemia (punaliblede vähesus veres) raviks kahel patsiendirühmal:
English: For the full list of all side effects reported with Nespo, see the Package Leaflet.
Estonian: Nespo kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Nespo is supplied ready for use in a pre-filled syringe or pre-filled pen, which can be used by the patient or their carer.
Estonian: Nespot turustatakse muuhulgas kasutusvalmis eeltäidetud süstalde ja eeltäidetud pensüstaldena, mida saab patsient või tema hooldaja kasutada ise.
English: Lower doses may be necessary for children with kidney failure aged 10 years or below.
Estonian: Neerupuudulikkusega kuni 10-aastaste laste raviks võib olla vaja kasutada väiksemaid annuseid.