FrancophonIA/ELRC3.0 huggingface dataset:
English: Avandamet is used in patients who have type 2 diabetes, particularly those who are overweight.
Estonian: Avandameti kasutatakse eelkõige ülekaaluliste patsientide II tüüpi diabeedi (suhkurtõve) raviks.
English: Avandamet was more effective than metformin alone and than placebo in reducing HbA1c.
Estonian: Avandamet vähendas HbA1c sisaldust tõhusamalt kui ainult metformiin või platseebo (näiv ravim).
English: rosiglitazone and metformin hydrochloride
Estonian: Kokkuvõte üldsusele rosiglitasoon ja metformiinvesinikkloriid
English: The medicine can only be obtained with a prescription.
Estonian: Avandamet on retseptiravim.
English: Avandamet is used in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own and at the maximum possible dose (‘dual therapy').
Estonian: Avandameti kasutatakse patsientidel, kelle haigus ei allu ravile üksnes metformiini (samuti diabeediravim) kasutamisel ka maksimaalse võimaliku annuse korral (kahe preparaadiga raviskeem).
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to
Estonian: Nii vähendavad mõlemad toimeained glükoosisisaldust veres, aidates sel viisil reguleerida II tüüpi diabeeti.
English: The studies of Avandia taken with metformin as separate tablets were used to support the use of Avandamet.
Estonian: Avandameti toetuseks kasutati uuringuid, milles Avandiat manustati koos metformiiniga, kumbagi eraldi tablettidena.
English: The dose of rosiglitazone may be added to metformin and adjusted before a patient is switched to Avandamet.
Estonian: Maksimaalne soovitatav ööpäevane annus on 8 mg / 2000 mg. Metformiinile võib lisada rosiglitasooni annuse ja kohandada annust enne patsiendi üleviimist Avandameti kasutamisele.
English: Avandamet can also be used with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled on metformin and a sulphonylurea at their maximum possible
Estonian: Avandameti võib kasutada ka koos sulfonüüluurearavimiga (teist liiki diabeediravim) patsientidel, kelle haigus ainult metformiini ja sulfonüüluurea maksimaalse võimaliku annuse korral ravile ei allu (kolme preparaadiga raviskeem e kolmikravi).
English: The full EPAR for Avandamet can be found here.
Estonian: Euroopa avaliku hindamisaruande täistekst Avandameti kohta on siin.
English: For more information about treatment with Avandamet, read the Package Leaflet (also part of the EPAR).
Estonian: Ravimi kasutamise üksikasjalik teave on pakendi infolehel, mis on samuti Euroopa avaliku hindamisaruande osa.
English: The rosiglitazone dose may need to be increased to 8 mg a day after eight weeks if better blood glucose control is needed, but this should be done with caution in patients who are also taking a sulphonylurea, due to the risk of fluid retention.
Estonian: Kui vere glükoosisisaldust tuleb tõhusamalt reguleerida, võib olla vaja kaheksa nädala pärast rosiglitasooni annust suurendada 8 mg-ni päevas,
English: The full list is available in the Package Leaflet.
Estonian: Selliste ravimite täieliku loetelu leiate pakendi infolehelt.
English: Invented Name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Estonian: RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES
English: Marketing authorisation holder
Estonian: Müügiloa hoidja Ravimi väljamõeldud nimetus Tugevus
English: Strength
Estonian: LISA I
English: The full EPAR and risk management plan summary for Duaklir Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Duaklir Genuairi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, the safety profile of the two components is well known, and there is no evidence that the combination is worse than the individual components.
Estonian: Lisaks on mõlema toimeaine ohutusprofiil teada ja puuduvad tõendid, et kombinatsioon oleks kahjulikum kui kumbki toimeaine eraldi.
English: Aclidinium bromide has been authorised in the EU as Bretaris Genuair and Eklira Genuair since July 2012; formoterol has been marketed in the EU since the 1990s.
Estonian: Aklidiiniumbromiid on Euroopa Liidus heaks kiidetud ravimitena Bretaris Genuair ja Eklira Genuair alates juulist 2012; formoterooli on Euroopa Liidus turustatud alates 1990. aastatest.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duaklir Genuair on 19 November 2014.
Estonian: Euroopa Komisjon andis Duaklir Genuairi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. novembril 2014.
English: A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Duaklir Genuairi võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Duaklir Genuair?
Estonian: Mis meetmed võetakse, et tagada Duaklir Genuairi ohutu ja efektiivne kasutamine?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Duaklir Genuairi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The recommended dose of Duaklir Genuair is one inhalation twice a day.
Estonian: Duaklir Genuairi soovitatav annus on üks inhalatsioon kaks korda ööpäevas.
English: The main measure of effectiveness was based on changes in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after six months.
Estonian: Efektiivsuse põhinäitaja aluseks oli, kuidas ravim suurendas patsientide forsseeritud ekspiratoorset mahtu (FEV1, suurim õhukogus, mida inimene suudab 1 sekundi jooksul välja hingata) pärast 6 kuu möödumist.
English: Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise any major safety concern.
Estonian: Ohutuse seisukohast oli Duaklir Genuairi kohta teatatud kõrvalnähtude arv väike ja suured ohutusprobleemid puudusid.
English: The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.
Estonian: Kõige sagedamad kõrvalnähud (esinenud enam kui 7 patsiendil 100st) on nasofarüngiit (nina-neelupõletik) ja peavalu.
English: Other information about Duaklir Genuair
Estonian: Muu teave Duaklir Genuairi kohta
English: What is Duaklir Genuair and what is it used for?
Estonian: Mis on Duaklir Genuair ja milleks seda kasutatakse?
English: Duaklir Genuair aclidinium bromide / formoterol fumarate dihydrate
Estonian: Duaklir Genuair aklidiiniumbromiid/formoteroolfumaraatdihüdraat
English: Why is Duaklir Genuair approved?
Estonian: Miks Duaklir Genuair heaks kiideti?
English: Duaklir Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Estonian: Duaklir Genuair on ravim, mida kasutatakse kroonilise obstruktiivse kopsuhaiguse (KOK) sümptomite leevendamiseks täiskasvanutel.
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone.
Estonian: Suurenemine võrreldes ainult formoterooli kasutamisega oli samas väike ja seda ei peeta kliiniliselt oluliseks: hommikul enne inhalatsiooni mõõdetud FEV1 oli Duaklir Genuairi kasutamisel 68 ml suurem kui ainult formoterooli kasutamisel.
English: This is a summary of the European public assessment report (EPAR) for Duaklir Genuair.
Estonian: See on ravimi Duaklir Genuair Euroopa avaliku hindamisaruande kokkuvõte.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duaklir Genuair, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi Duaklir Genuair omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Estonian: Duaklir Genuairi on uuritud kahes põhiuuringus, milles osales üle 3400 kroonilise obstruktiivse kopsuhaigusega patsienti ja milles võrreldi ravimit ainult aklidiiniga, ainult formoterooliga ja platseeboga (näiv ravim).
English: Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Estonian: Duaklir Genuair sisaldab kaht toimeainet: aklidiiniumbromiidi ja formoteroolfumaraatdihüdraati.
English: Side effects with Duaklir Genuair are similar to those with the individual components.
Estonian: Duaklir Genuairi kõrvalnähud sarnanevad üksikainete kõrvalnähtudega.
English: The inhaler delivers 340 micrograms of aclidinium and 12 micrograms of formoterol fumarate dihydrate for each inhalation.
Estonian: Igal inhalatsioonil manustatakse inhalaatoriga 340 µg aklidiini ja 12 µg formoteroolfumaraatdihüdraati.
English: It is not intended to provide practical advice on how to use Duaklir Genuair.
Estonian: Hindamisaruandes ei anta Duaklir Genuairi kasutamise praktilisi nõuandeid.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Duaklir Genuair than with placebo and 118 ml more with Duaklir Genuair than with aclidinium alone.
Estonian: Tulemuste järgi suurenes pärast 6-kuulist ravi FEV1 (mõõdetuna 1 tund pärast inhalatsiooni) Duaklir Genuairi kasutamisel 293 ml võrra rohkem kui platseebo kasutamisel ning Duaklir Genuairi kasutamisel 118 ml võrra rohkem kui ainult aklidiini kasutamisel.
English: For practical information about using Duaklir Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Duaklir Genuairi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Duaklir Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Duaklir Genuairiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Duaklir Genuair will provide the results of studies to further evaluate the cardiovascular safety of the medicine.
Estonian: Et pikatoimelised muskariiniretseptori antagonistid võivad tekitada südame-veresoonkonna kõrvalnähte, esitab Duaklir Genuairi turustaja ravimi kardiovaskulaarse ohutuse täiendava hindamise uuringutulemused.
English: Duaklir Genuair is available as an inhalation powder in a portable inhaler device.
Estonian: Duaklir Genuairi turustatakse inhalatsioonipulbrina kaasaskantavas inhalaatoris.
English: What are the risks associated with Duaklir Genuair?
Estonian: Mis riskid Duaklir Genuairiga kaasnevad?
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Estonian: Krooniline obstruktiivne kopsuhaigus on krooniline haigus, mille korral bronhid ja kopsualveoolid on kahjustunud või ummistunud, mis põhjustab hingamisraskusi.
English: The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Estonian: Duaklir Genuairi mõlemad toimeained, aklidiiniumbromiid ja formoteroolfumaraatdihüdraat, hoiavad hingamisteed avatuna ja võimaldavad patsiendil kergemini hingata.
English: For the full list of all side effects and restrictions with Duaklir Genuair, see the package leaflet.
Estonian: Duaklir Genuairi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.
Estonian: Inimravimite komitee märkis, et uuringutes suurendas Duaklir Genuair tunduvalt kroonilise obstruktiivse kopsuhaigusega patsientide kopsutalitlust, kuigi Duaklir Genuairi võrdlemisel selle ühe toimeaine formoterooliga oli suurenemine väike.
English: What benefits of Duaklir Genuair have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Duaklir Genuairi kasulikkus?
English: Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Estonian: Pikatoimeliste muskariiniretseptori antagonistide ja pikatoimeliste beeta-2-agonistide koos kasutamine on kroonilise obstruktiivse kopsuhaiguse ravis tavaline.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Estonian: Selle toimel lihased lõõgastuvad, hoides hingamisteed avatuna ja kergendades patsiendil hingamist.
English: This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic (also known as cholinergic) receptors, which control the contraction of muscles.
Estonian: Aklidiiniumbromiid on pikatoimeline muskariiniretseptori antagonist ehk aine, mis laiendab hingamisteid, blokeerides kopsu silelihasrakkude teatud retseptoreid (muskariiniretseptorid ehk kolinergilised retseptorid), mis juhivad lihaste kokkutõmbumist.
English: Duaklir Genuair is used for maintenance (regular) treatment.
Estonian: Duaklir Genuairi kasutatakse säilitusraviks.
English: How is Duaklir Genuair used?
Estonian: Kuidas Duaklir Genuairi kasutatakse?
English: How does Duaklir Genuair work?
Estonian: Kuidas Duaklir Genuair toimib?
English: Duaklir Genuair can only be obtained with a prescription.
Estonian: Duaklir Genuair on retseptiravim.
English: Duaklir Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Estonian: Samuti oli raskendatud hingamisega patsiente Duaklir Genuairi uuringurühmas vähem kui platseeborühmas.
English: These products were approved in the European Union on 04 August 2000.
Estonian: Mõlemad ravimid said Euroopa Liidus müügiloa 4. augustil 2000.
English: EUHASS study
Estonian: Uuring EUHASS
English: Nine of these changes had a potential impact on inhibitor formation.
Estonian: Neist muudatustest 9-l võib olla võimalik mõju inhibiitorite tekkele.
English: RODIN/PedNet study
Estonian: Uuring RODIN/PedNet
English: Annex IV Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Estonian: IV lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: Both registries were part of the risk management plan (RMP) of the respective products.
Estonian: Mõlemad registrid on antud ravimite korral riskijuhtimiskava osa.
English: The results of the RODIN/PedNet study (S. C. Gouw et al., N. Engl.
Estonian: Avaldatud RODIN-i/PedNet-i uuringu (S. C. Gouw et al, N. Engl.
English: • Quality data
Estonian: • Kvaliteediandmed
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annexes I and III.
Estonian: Ravimi omaduste kokkuvõtte ja pakendi infolehe vastavate lõikude muudatused on esitatud I ja III lisas.
English: The PRAC reviewed the preliminary 3-year data.
Estonian: Ravimiohutuse riskihindamiskomitee vaatas läbi registri esialgsed 3 aasta andmed.
English: • Observational studies
Estonian: • Vaatlusuuringud
English: One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Estonian: Üks patsientidest kadus järelkontrollist ja ühel patsiendil tekkisid uuringu järelkontrolli perioodil madalas tiitris inhibiitorid.
English: - the RODIN (Research of Determinants of Inhibitor development)/PedNet registry; and
Estonian: - RODIN (inhibiitorite tekke determinantide uurimise) / PedNet-i patsiendiregister; ja
English: - the EUHASS (European Haemophilia Safety Surveillance System) registry.
Estonian: - EUHASS (Euroopa hemofiilia ohutuse jälgimise süsteem) patsiendiregister.
English: • MAH sponsored and supported clinical trials
Estonian: • Müügiloa hoidja spondeeritud ja toetatud kliinilised uuringud
English: The PRAC noted that all parameters were within specification and that there is no correlation between changes and inhibitor events.
Estonian: Ravimiohutuse riskihindamiskomitee märkis, et kõik parameetrid vastasid spetsifikatsioonile ning et puudub seos tehtud muudatuste ja inhibiitorite põhjustatud sündmuste vahel.
English: Updated results from the EUHASS registry were also provided.
Estonian: Samuti esitati EUHASS patsiendiregistri ajakohastatud andmed.
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Estonian: Antud uuringus oli inhibiitorite tekke esinemissagedus kõigi VIII hüübimisfaktorit sisaldavate ravimite puhul vahemikus 28,2% kuni 37,7%.
English: The EUHASS study was established in 2008 as an adverse event reporting system for patients with inherited bleeding disorders, including Haemophilia A, in Europe.
Estonian: EUHASS-i patsiendiregister asutati 2008. aastal pärilike veritsushaiguste, sealhulgas A-hemofiiliaga patsientidel esinevatest kõrvalnähtudest teavitamiseks Euroopas.
English: Therefore, the European Commission (EC) initiated a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency to assess available data and its impact on the benefit-risk balance of the medicinal products concerned and to give its opinion as to whether the marketing authorisations should be maintained, varied, suspended or revoked.
Estonian: Saksamaa vaktsiinide ja bioloogiliste ravimite riiklik instituut teavitas 1. märtsil 2013 antud uuringutulemustest Euroopa Komisjoni, mistõttu Euroopa Komisjon algatas määruse (EÜ) nr 726/2004 artikli 20 kohase menetluse ning palus Euroopa Ravimiametil hinnata olemasolevaid andmeid ja nende mõju eelnimetatud ravimite kasulikkuse ja riski tasakaalule ning esitada arvamus müügilubade säilitamise, muutmise, peatamise või tühistamise kohta
English: No update of the RMP was considered necessary by the PRAC.
Estonian: Riskijuhtimiskava ajakohastamist ei pidanud ravimiohutuse riskihindamiskomitee vajalikuks.
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen
Estonian: Ravimite Kogenate Bayer ja Helixate NexGen teadusliku hindamise üldkokkuvõte
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Estonian: Ravimiohutuse riskihindamiskomitee märkis, et VIII hüübimisfaktori geeni mutatsiooni profiil uuringupopulatsioonis (uuringutes 200021EU ja 100074US) peegeldab antud mutatsiooni tüüpilist jaotust raske Ahemofiiliaga patsientidel, mis näitab, et patsientide kaasamine uuringusse ei ole kallutatud.
English: These studies were either sponsored or supported by the MAH.
Estonian: Müügiloa hoidja spondeeris või toetas nimetatud uuringute läbiviimist.
English: Post-hoc analysis of the RODIN study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitor than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08 -2.37).
Estonian: Uuringu RODIN post hoc analüüs näitas, et varem mitteravitud raske A-hemofiiliaga patsientidel, kellele manustati Kogenate Bayerit, tekkisid inhibiitorid suurema tõenäosusega kui patsientidel, kellel kasutati teist rekombinantset antihemofiilset VIII hüübimisfaktorit (kohandatud šansside suhe 1,60; 95% CI: 1,08-2,37).
English: As a consequence, the marketing authorisation holder (MAH) for Kogenate Bayer and Helixate NexGen supported two EU registries:
Estonian: Sellest tulenevalt toetas ravimite Kogenate Bayer ja Helixate NexGen müügiloa hoidja kahte Euroopa Liidu registrit:
English: Overall, 9 out of 60 (15%) developed inhibitors.
Estonian: Kokku tekkisid inhibiitorid 60 patsiendist 9-l (15%).
English: In patients given KOGENATE Bayer/Helixate NexGen, 64 out of 183 developed an inhibitor (37.7%), of which 40 had a high-titre inhibitor (25.2%).
Estonian: Patsientidest, kelle raviks kasutati Kogenate Bayerit / Helixate NexGeni, tekkisid inhibiitorid 183 patsiendist 64 -l (37,7%), kusjuures 40 patsiendil (25,2%) oli tegemist inhibiitorite kõrge tiitriga.
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Estonian: Müügiloa hoidja esitas samuti nelja sekkuva kliinilise uuringu ja kuue vaatlusuuringu andmed, milles hinnati ravimite Kogenate Bayeri / Helixate NexGeni ohutust ja efektiivsust A-hemofiiliaga patsientidel, sealhulgas uuringud 200021EU ja 100074US varem mitteravitud patsientidel ning minimaalset ravi saanud patsientidel.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC.
Estonian: Määruse (EK) nr 726/2004 artikli 20 sätete kohaselt on inimravimite komitee pärast ravimiohutuse riskihindamiskomitee 5. detsembri 2013. aasta soovitusega tutvumist arvamusel, et ravimite Kogenate Bayer ja Helixate NexGen müügilubasid tuleb ravimiohutuse riskihindamiskomitee soovituse kohaselt muuta.
English: In support of the above mentioned clinical data, the MAH provided information with regards to the manufacturing process (i.e. growth condition, purification) of Kogenate Bayer /Helixate Nexgen and discussed any change which took place since the studies 200021EU and 100074US.
Estonian: Peale eelkirjeldatud kliiniliste andmete esitas müügiloa hoidja teabe Kogenate Bayeri / Helixate NexGeni tootmisprotsessi kohta (kasvutingimused, puhastamine) ning arutelu kõigi muutuste kohta tootmisprotsessis, mis on tehtud alates uuringutest 200021EU ja 100074US.
English: The PRAC was of the view that the available data are consistent with the general experience that most inhibitors develop within the first 20 EDs and that the overall data does not provide evidence that factor VIII products differ from each other in terms of inhibitor development in PUPs.
Estonian: Ravimiohutuse riskihindamiskomitee oli arvamusel, et olemasolevad andmed langevad kokku üldise kogemusega, et enamik inhibiitoritest tekib esimese 20 ekspositsioonipäeva jooksul ja et üldkokkuvõttes ei näita olemasolevad andmed, et VIII hüübimisfaktorit sisaldavad ravimid erineksid varem mitteravitud patsientidel üksteisest inhibiitorite tekke poolest.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen.
Estonian: • ravimiohutuse riskihindamiskomitee arutas määruse (EK) nr 726/2004 artikli 20 kohast menetlust ravimite Kogenate Bayer ja Helixate NexGen küsimuses;