FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose titration as described under maintenance posology may be required in such cases to prevent moderate to severe hypokalaemia.
Estonian: Sellistel juhtudel võib keskmise kuni raske hüpokaleemia vältimiseks olla vajalik annuse kohandamine, nagu on kirjeldatud säilitusravi annustamise lõigus.
English: Correction phase
Estonian: Korrektsioonifaasi Lokelma annus
English: Figure 2 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Estonian: Joonisel 2 on esitatud keskmised seerumi kaaliumisisaldused uuringu korrektsioonravi faasis ja säilitusravi faasis.
English: A two-phase, multicenter, multi-dose, open-label safety and efficacy study The long term (up to 12 months) effects of Lokelma were assessed in this study in 751 subjects with hyperkalaemia (baseline average 5.59 mmol/L; range 4.3-7.6 mmol/L).
Estonian: Kahefaasiline mitmekeskuseline eri annustega avatud ohutuse ja efektiivsuse uuring Selles uuringus hinnati Lokelma pikaajalisi (kuni 12 kuud) toimeid 751 hüperkaleemiaga patsiendil (algtaseme keskmine kaaliumisisaldus 5,59 mmol/l; vahemik 4,3…7,6 mmol/l).
English: One hundred and twenty-six patients had a baseline serum potassium ≥ 6.0 mmol/L (mean baseline potassium 6.28 mmol/L).
Estonian: Algtaseme seerumi kaaliumisisaldus oli ≥ 6,0 mmol/l 126 patsiendil (algtaseme keskmine kaaliumisisaldus 6,28 mmol/l).
English: Lokelma contains the active substance sodium zirconium cyclosilicate.
Estonian: Lokelma sisaldab toimeainet naatriumtsirkooniumtsüklosilikaat.
English: There was a mean decrease in serum potassium of 0.77 mmol/L, 1.10 mmol/L, 1.19 mmol/L and 0.44 mmol/L, respectively, and the proportion of subjects who remained normokalaemic was 71%, 76%, 85% and 48% in the 5 g, 10 g, 15 g once daily doses of Lokelma and placebo groups, respectively.
Estonian: Üks kord ööpäevas 5 g, 10 g ja 15 g Lokelmat saanute rühmas ja platseeborühmas vähenes seerumi kaaliumisisaldus keskmiselt vastavalt 0,77 mmol/l, 1,10 mmol/l, 1,19 mmol/l ja 0,44 mmol/l ning normokaleemia säilitanud isikute osakaal oli see vastavalt 71%, 76%, 85% ja 48%.
English: Starting dose - to lower your high potassium level to normal:
Estonian: Algannus - suure kaaliumisisalduse normaliseerimiseks:
English: Sodium zirconium cyclosilicate is an inorganic, insoluble compound that is not subject to enzymatic metabolism.
Estonian: Naatriumtsirkooniumtsüklosilikaat on anorgaaniline, mittelahustuv ja ainevahetuses ensümaatiliselt lagundamatu ühend.
English: Patients with higher starting potassium levels had a greater response to Lokelma.
Estonian: Algse suurema kaaliumisisaldusega patsientide ravivastus Lokelmale oli parem.
English: Responses were larger in patients with more severe hyperkalaemia; serum potassium fell 0.8, 1.2 and 1.5 mmol/L in patients with baseline serum potassium < 5.5, 5.5-5.9 and ≥ 6 mmol/L, respectively.
Estonian: Raske hüperkaleemiaga patsientide ravivastus oli parem; seerumi kaaliumisisaldus vähenes seerumi algse kaaliumisisaldusega < 5,5, 5,5…5,9 ja ≥ 6 mmol/l patsientidel vastavalt 0,8, 1,2 ja1,5 mmol/l.
English: Maintenance fixed dose (day)
Estonian: Ravi säilitusfaasis (kord ööpäevas) Platseebo
English: Each sachet contains 5 g of sodium zirconium cyclosilicate.
Estonian: Üks kotike sisaldab 5 g naatriumtsirkooniumtsüklosilikaati.
English: The active substance is sodium zirconium cyclosilicate.
Estonian: Toimeaine on naatriumtsirkooniumtsüklosilikaat.
English: Patients on dialysis
Estonian: Dialüüsravi patsiendid
English: There is a reduction in urinary potassium excretion which is a consequence of a reduction in serum potassium concentration.
Estonian: Seerumi kaaliumikontsentratsiooni vähenemise tulemusena väheneb ka kaaliumi eritumine uriini kaudu.
English: Each sachet contains 10 g of sodium zirconium cyclosilicate.
Estonian: Üks kotike sisaldab 10 g naatriumtsirkooniumtsüklosilikaati.
English: 10g
Estonian: Päeva n
English: Oedema related events
Estonian: Tursega seotud sümptomid
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of powder.
Estonian: Lokelma 10 g suukaudse lahuse pulber Üks kotike sisaldab 10 g pulbrit.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of powder.
Estonian: Lokelma 5 g suukaudse lahuse pulber Üks kotike sisaldab 5 g pulbrit.
English: No events of intestinal perforation have been reported with Lokelma.
Estonian: Lokelma kasutamisel ei ole teatatud sooleperforatsiooni juhtudest.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of sodium zirconium cyclosilicate.
Estonian: Lokelma 5 g suukaudse lahuse pulber Üks kotike sisaldab 5 g naatriumtsirkooniumtsüklosilikaati.
English: What Lokelma is and what it is used for What you need to know before you take Lokelma How to take Lokelma
Estonian: 1. Mis ravim on Lokelma ja milleks seda kasutatakse 2. Mida on vaja teada enne Lokelma võtmist 3.
English: In 2 clinical studies with open label exposure of Lokelma up to 1 year in 874 subjects, the following events were reported as related by investigators: gastrointestinal events [constipation (2.9%), diarrhea (0.9%), abdominal pain/distension (0.5%), nausea (1.6%) and vomiting (0.5%)]; and hypersensitivity reactions [rash (0.3%) and pruritus (0.1%)].
Estonian: kõhulahtisus (0,9%), kõhuvalu/kõhupuhitus (0,5%), iiveldus (1,6%) ja oksendamine (0,5%)] ja ülitundlikkusreaktsioonid [lööve (0,3%) ja sügelus (0,1%)].
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of sodium zirconium cyclosilicate.
Estonian: Lokelma 10 g suukaudse lahuse pulber Üks kotike sisaldab 10 g naatriumtsirkooniumtsüklosilikaati.
English: Intestinal perforation
Estonian: Suukaudse lahuse pulber
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Estonian: Lokelma 5 g suukaudse lahuse pulber Lokelma 10 g suukaudse lahuse pulber naatriumtsirkooniumtsüklosilikaat
English: No more than 10 g once daily should be used for maintenance therapy.
Estonian: Säilitusannus ei tohi ületada 10 g ööpäevas.
English: What Lokelma looks like and contents of the pack The powder for oral suspension is a white, free flowing powder, essentially free of debris and particulates.
Estonian: Suukaudse lahuse pulber on valge vabalt voolav pulber, mis praktiliselt ei sisalda võõrosakesi.
English: Serum potassium 3.5 to 5.5 mmol/L, inclusive n/N Proportion 95% CI
Estonian: Seerumi kaaliumisisaldus 3,55,5 mmol/l (kaasaarvatud)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: Kuidas Lokelma välja näeb ja pakendi sisu
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension
Estonian: Lokelma 5 g suukaudse lahuse pulber Lokelma 10 g suukaudse lahuse pulber
English: Elimination Sodium zirconium cyclosilicate is eliminated via the faeces.
Estonian: Eritumine Naatriumtsirkooniumtsüklosilikaat väljutatakse roojaga.
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate
Estonian: Lokelma 5 g suukaudse lahuse pulber naatriumtsirkooniumtsüklosilikaat
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Estonian: Lokelma 10 g suukaudse lahuse pulber naatriumtsirkooniumtsüklosilikaat
English: (non-carbonated) water.
Estonian: (kasutatakse HIV-i infektsiooni raviks);
English: Powder for oral suspension.
Estonian: Pulber on kotikeses.
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Estonian: Lokelma 5 g suukaudse lahuse pulber naatriumtsirkooniumtsüklosilikaat Suukaudne
English: How to store Lokelma
Estonian: Kuidas Lokelmat säilitada
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Estonian: Lokelma 10 g suukaudse lahuse pulber naatriumtsirkooniumtsüklosilikaat Suukaudne
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: Contact our press officers Monika Benstetter or Martin Harvey
Estonian: Võtke ühendust meie pressisekretäridega Monika Benstetter või Martin Harvey
English: 20 February 2014 EMA/108793/20144
Estonian: 20. veebruar 2014 EMA/108793/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Estonian: Tel +44 (0) 207 418 8427 E-post: press@ema.europa.eu
English: More about the procedure
Estonian: Lisateave menetluse kohta
English: The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Estonian: Mõlema ravimi müügiloa hoidja on sama ettevõte, Bayer Pharma AG.
English: Information to healthcare professionals
Estonian: Teave tervishoiuspetsialistidele
English: • However, when all the evidence was assessed, including that from this study, there was not enough to support a genuine difference between the products.
Estonian: • Kui aga hinnati kõiki olemasolevaid tõendeid, sealhulgas ka eelmainitud uuringu tulemusi, ei olnud need siiski piisavad, et kinnitada tõepärast erinevust ravimite vahel.
English: • The products can continue to be used as recommended.
Estonian: • Ravimite kasutamist võib seniste juhiste kohaselt jätkata.
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all products.
Estonian: Nimetatud uuringus oli inhibiitorite tekke esinemissagedus kõigi ravimite korral vahemikus 28,2-37,7%.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Estonian: Ravimiohutuse riskihindamiskomitee soovitused saadeti edasi inimravimite komiteele, kes vastutab kõigi inimravimeid puudutavate küsimuste eest ja kes võttis vastu Euroopa Ravimiameti lõpliku arvamuse.
English: The review of Kogenate Bayer and Helixate NexGen was initiated on 5 March 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Estonian: Ravimite Kogenate Bayer ja Helixate NexGen hindamine algas 5. märtsil 2013 Euroopa Komisjoni nõudel määruse (EÜ) nr 726/2004 artikli 20 kohaselt.
English: These may be extracted from human blood (‘plasma-derived'), produced as full-length recombinant products with varying degrees of exposure to other blood-derived proteins (first, second, or third generation), or may contain a shortened, but still active, recombinant form of the factor VIII molecule.
Estonian: Need võivad olla eraldatud inimverest (vereplasmast pärinevad), toodetud täispikkuses rekombinantsete ravimitena, millel on erinev ekspositsiooniaste teiste verest pärinevate valkude suhtes (esimese, teise ja kolmanda põlvkonna ravimid), või võivad sisaldada lühendatud, ent endiselt aktiivset VIII hüübimisteguri molekuli rekombinantset vormi.
English: These antibodies (factor VIII inhibitors) reduce the effectiveness of the medicine and make bleeding more likely.
Estonian: Need antikehad (VIII hüübimisteguri inhibiitorid) vähendavad nimetatud ravimite efektiivsust ja suurendavad verejooksude tekke tõenäosust.
English: Kogenate Bayer and Helixate NexGen are identical medicines that were authorised throughout the European Union (EU) on 4 August 2000.
Estonian: Kogenate Bayer ja Helixate NexGen on identsed ravimid, mis said kogu Euroopa Liidus müügiloa 4. augustil 2000.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Estonian: Eelkirjeldatud andmed vaatas kõigepealt läbi ravimiohutuse riskihindamiskomitee.
English: In patients given Kogenate Bayer/Helixate NexGen, the incidence of inhibitor development was 64/183 (37.7%) when followed for up to 75 exposure days, of whom 40 had a high-titre inhibitor (25.2%).
Estonian: Patsientidel, kellel kasutati ravimeid Kogenate Bayer/Helixate NexGen, oli kuni 75 ekspositsioonipäeva hõlmanud jälgimisperioodi korral inhibiitorite tekke esinemissagedus 37,7% (64 patsiendil 183st), kusjuures 40 patsiendil (25,2%) oli tegemist inhibiitorite kõrge tiitriga.
English: However the product information has been updated to reflect the study results and ensure that healthcare professionals treating patients with haemophilia A are aware of them.
Estonian: Siiski ajakohastati ravimite omaduste kokkuvõtet, et see kajastaks uuringu tulemusi ja tagaks, et A-hemofiiliaga patsiente ravivad tervishoiuspetsialistid on neist teadlikud.
English: About a third of all the children in the RODIN study developed factor VIII inhibitors against their medicine, which reduces the benefit and makes bleeding more likely.
Estonian: Umbes kolmandikul kõigist uuringus RODIN osalenud lastest tekkisid neil kasutatud ravimi vastased VIII hüübimisteguri inhibiitorid, mis vähendab ravist saadavat kasulikkust ja suurendab verejooksude tekke tõenäosust.
English: • Quality data presented by the marketing authorisation holder also indicated that the biophysical and biochemical characteristics of Kogenate Bayer and Helixate Nexgen have not significantly changed since the initial marketing authorisation.
Estonian: • Müügiloa hoidja esitatud kvaliteediandmed näitasid samuti, et Kogenate Bayeri ja Helixate NexGeni biofüüsikalised ning biokeemilised näitajad ei olnud pärast esialgse müügiloa andmist olulisel määral muutunud.
English: • In addition, the product information for Kogenate Bayer and Helixate NexGen has been updated to reflect the results of the RODIN/PedNet study.
Estonian: • Lisaks ajakohastati Kogenate Bayeri ja Helixate NexGeni ravimiteavet, et kajastada uuringu RODIN/PedNet tulemusi.
English: Alternative products containing various forms of factor VIII are available and may be used similarly.
Estonian: Müügil on ka alternatiivseid erinevaid VIII hüübimisteguri vorme sisaldavaid ravimeid, mida võib samadel eesmärkidel kasutada.
English: • However, when all the available data were considered, they were consistent with the general clinical experience that most inhibitors develop within the first 20 days of exposure and that factor VIII products did not differ from each other in terms of inhibitor development in PUPs.
Estonian: • Kui aga arvesse võeti kõik olemasolevad andmed, olid need siiski kooskõlas üldise kliinilise kogemusega, et enamik inhibiitoritest tekib esimese 20 ekspositsioonipäeva jooksul ja et VIII hüübimistegurit sisaldavad ravimid ei erine varem ravimata patsientidel üksteisest inhibiitorite tekke poolest.
English: The CHMP opinion was then sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Estonian: Inimravimite komitee arvamus saadeti Euroopa Komisjonile, kes kiitis selle heaks ja võttis 20. veebruaril 2014 vastu kogu Euroopa Liidus õiguslikult siduva otsuse.
English: The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Estonian: Inhibiitorite tekke esinemissagedus varem ravimata patsientidel on kooskõlas olemasolevate tõenditega muudetud esinemissageduse kategooriaks „väga sage”.
English: They contain a form of factor VIII, octocog alfa, produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced which makes them able to produce the clotting factor.
Estonian: Nad sisaldavad VIII hüübimisteguri vormi, mida tuntakse nimetuse all alfaoktokog ja mida valmistatakse rekombinant-DNA-tehnika abil: seda toodavad rakud, millesse on viidud antud hüübimisteguri teket võimaldav geen (DNA).
English: More about the medicine
Estonian: Lisateave ravimite kohta
English: Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Estonian: Ravimata jätmise korral võib VIII hüübimisteguri vaegus põhjustada veritsusprobleeme, sealhulgas verejooksu liigestesse, lihastesse ja siseorganitesse, mis võib põhjustada raskeid kahjustusi.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision, valid across the EU, on 20 February 2014.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile, kes kiitis selle heaks ja võttis 20. veebruaril 2014 vastu kogu Euroopa Liidus õiguslikult siduva otsuse.
English: The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Estonian: Ravimites on alfaoktokog sama struktuuriga kui kehaomane VIII hüübimistegur (täispikkuses).
English: The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented.
Estonian: Inimravimite komitee arutas ravimiohutuse riskihindamiskomitee soovitusi ja otsustas ühehäälselt, et need tuleb rakendada.
English: The Agency's recommendations are based on the results of the RODIN/PedNet study, preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Estonian: Euroopa Ravimiameti soovitused põhinevad uuringu RODIN/PedNet tulemustel, EUHASSi esialgsetel andmetel ning kõigil esitatud olemasolevate kliiniliste uuringute, vaatlusuuringute ja kirjanduses avaldatud andmetel, samuti kvaliteediandmetel Kogenate Bayeri ja Helixate NexGeni kohta, mis puudutavad inhibiitorite tekke võimalikku riski varem ravimata patsientidel.
English: • Despite concerns raised by the RODIN/PedNet study, overall the current evidence does not confirm that there is an increased risk of inhibitor development against full-length second generation factor VIII products such as Kogenate Bayer and Helixate NexGen.
Estonian: • Vaatamata uuringu RODIN/PedNet tõstatatud kahtlustele, ei kinnita olemasolevad andmed suuremat inhibiitorite tekke riski teise põlvkonna täispikkuses VIII hüübimistegurit sisaldavate ravimite vastu, nagu Kogenate Bayer ja Helixate NexGen.
English: • Concerns about a potentially increased risk of factor VIII inhibitor development with full-length second generation factor VIII products were originally raised by the RODIN/PedNet study.
Estonian: • Kahtlused VIII hüübimisteguri inhibiitorite tekke võimaliku suurema riski kohta teise põlvkonna täispikkuses VIII hüübimistegurit sisaldavate ravimite kasutamisel tekkisid esimest korda uuringus RODIN/PedNet.
English: On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended.
Estonian: 20. detsembril 2013 kiitis Euroopa Ravimiameti inimravimite komitee heaks varasemad soovitused, milles järeldati, et ravimite Kogenate Bayer ja Helixate NexGen (nn teise põlvkonna VIII hüübimistegurit sisaldavad ravimid) kasulikkus on varem ravimata hüübimishäirega A-hemofiiliaga patsientidel endiselt suurem kui riskid, aga soovitas muuta ravimite ravimiteavet.
English: The benefits of treatment with Kogenate Bayer or Helixate NexGen continue to outweigh their risks in previously untreated patients.
Estonian: Ravimite Kogenate Bayer või Helixate NexGen kasulikkus on varem ravimata patsientidel endiselt suurem kui nendega setud riskid.
English: • Haemophilia A is an inherited bleeding disorder in which there is a lack of factor VIII, which is needed for blood to clot normally.
Estonian: • A-hemofiilia on pärilik veritsushäire, mille korral on tegemist vere normaalseks hüübimiseks vajaliku VIII hüübimisteguri vaegusega.
English: Post-hoc analysis of the study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitors than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08
Estonian: Uuringu post hoc analüüs näitas, et raske A-hemofiiliaga varem ravimata patsientidel, keda raviti Kogenate Bayeriga, oli suurem tõenäosus inhibiitorite tekkeks võrreldes patsientidega, keda raviti teise rekombinantse hemofiiliavastase VIII hüübimisteguriga (kohandatud riskisuhe 1,60; 95%-line usaldusvahemik 1,08-2,37).
English: • Different forms of factor VIII are available as medicines to replace the missing clotting factor.
Estonian: • Puuduva VIII hüübimisteguri asendamiseks on ravimitena müügil VIII hüübimisteguri eri vormid.
English: After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products.
Estonian: Pärast olemasolevate andmete ülevaatamist inhibiitorite tekke kohta varem ravimata patsientidel otsustas ravimiohutuse riskihindamiskomitee, et need andmed ei kinnitanud järeldust, mille kohaselt ravimite Kogenate Bayer või Helixate NexGen kasutamine on teiste ravimitega võrreldes seotud VIII hüübimisteguri inhibiitorite tekke suurema riskiga.
English: This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation fulllength recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product.
Estonian: See on teadaolev riskitegur kõigi VIII hüübimistegurit sisaldavate ravimite puhul, ent uuringu autorid järeldasid, et lastel, kellele manustati nn teise põlvkonna täispikkuses rekombinantseid VIII hüübimistegurit sisaldavaid ravimeid (nagu Kogenate Bayer või Helixate NexGen), oli suurem tõenäosus antikehade tekkeks võrreldes lastega, kellele manustati kolmanda põlvkonna rekombinantset ravimit.
English: Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
Estonian: Kogenate Bayer ja Helixate NexGen on teise põlvkonna VIII hüübimistegurit sisaldavad ravimid.
English: This was an observational study which examined inhibitor development in previously untreated patients (PUPs) with severe haemophilia A who were given recombinant or plasma-derived factor VIII products.
Estonian: Tegemist oli vaatlusuuringuga, milles hinnati inhibiitorite teket varem ravimata raske A-hemofiiliaga patsientidel, kellele manustati rekombinantset või vereplasmast pärinevat
English: The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS).
Estonian: Ravimiohutuse riskihindamiskomitee hindamise algatamise põhjuseks olid uuringu (RODIN/PedNet uuring1) tulemused varem ravimata A-hemofiiliaga patsientidel, kellele manustati erinevaid VIII hüübimistegurit sisaldavaid ravimeid, ja Euroopa hemofiilia ohutuse jälgimise süsteemi (EUHASS) esialgsed andmed.
English: Benefits continue to outweigh risks in previously untreated patients
Estonian: Varem ravimata patsientidel on kasulikkus endiselt suurem kui riskid.
English: An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
Estonian: Suuremat inhibiitorite teket ei täheldatud teiste rekombinantset või vereplasmast pärinevat VIII hüübimistegurit sisaldavate ravimite puhul.
English: • Kogenate Bayer and Helixate NexGen can continue to be prescribed and used as appropriate in the management of haemophilia A. Existing risk minimisation measures are considered adequate and should be continued.
Estonian: • Kogenate Bayerit ja Helixate NexGeni võib A-hemofiilia raviks vajaduse korral endiselt määrata ja kasutada.
English: Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
Estonian: A-hemofiiliaga patsientidel puudub VIII hüübimistegur, mida manustatakse neile ravimina vere normaalse hüübivuse tagamiseks.