FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Viread, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Estonian: Vireadi toimeaine tenofoviirdisoproksiil on eelravim, mis muundub organismis tenofoviiriks.
English: In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo.
Estonian: Uuringus, milles osales 89 last vanuses 2-12 aastat, olid tulemused sarnased: 77%-l ravimit Viread kasutanud patsientidest vähenes viiruskoormus alla 400 koopia/ml pärast 48 nädalat, võrreldes 7%-ga platseeborühmas.
English: A fourth study, involving 280 adults who had not responded to treatment with lamivudine, compared Viread alone with a combination treatment of Viread and emtricitabine.
Estonian: Neljandas uuringus, milles osales 280 täiskasvanut, kellel puudus ravivastus lamivudiinile, võrreldi Vireadi kasutamist ainuravimina Vireadi ja emtritsitabiini kombinatsioonraviga.
English: Similar numbers of patients in the Viread and stavudine groups had viral loads below 400 copies/ml after 48 weeks.
Estonian: Vireadi ja stavudiini rühmades oli sarnane arv patsiente, kelle viiruskoormus oli alla 400 koopia/ml pärast 48 nädalat.
English: For the treatment of HIV, Viread was more effective than placebo (a dummy treatment) when added to existing treatment.
Estonian: Olemasolevale ravile lisatuna oli Viread HIV-infektsiooni ravis efektiivsem kui platseebo (näiv ravim).
English: A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo.
Estonian: Uuringus, milles osales 106 noorukit, kellel oli kas HBeAg-negatiivne või HBeAg-positiivne B-hepatiit, võrreldi Vireadi platseeboga ning leiti, et Vireadi kasutanud patsientidest oli neid, kellel pärast 72 nädalat viiruskoormus oli alla 400 koopia/ml, 88% ning platseeborühmas 0%.
English: How does Viread work?
Estonian: Kuidas Viread toimib?
English: A study in 97 children (aged 2 to 12 years) treated with stavudine or zidovudine, compared the effects of switching their treatment to Viread with continuing previous treatment.
Estonian: Uuring, milles osales 97 last (2-12 a), keda raviti stavudiini või zidovudiiniga, võrreldi raviskeemivahetuse mõju nendel, kui koos eelneva raviga hakati kasutama ka ravimit Viread.
English: Viread contains the active substance tenofovir disoproxil.
Estonian: Ravim sisaldab toimeainena tenofoviirdisoproksiili.
English: In a third study Viread was as effective as another medicine stavudine, when added to lamivudine and efavirenz.
Estonian: Kolmandas uuringus oli Viread lisatuna lamivudiinile ja efavirensile efektiivsem kui teine ravim stavudiin.
English: Overall, 70% of patients taking Viread or entecavir had a viral load below 400 copies/ml.
Estonian: Kokku oli Vireadi või entekaviiri kasutanud patsientidest neid, kellel viiruskoormus oli alla 400 koopia/ml, 70%.
English: Viread can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Viread, available as tablets and as granules, is taken once a day with food.
Estonian: Viread on retseptiravim ja ravi peab alustama HIV-infektsiooni või kroonilise B-hepatiidi ravis kogenud arst.
English: 89% of patients taking Viread had a viral load below 400 copies/ml after 96 weeks of treatment, compared with 86% of patients taking the combination treatment of Viread and emtricitabine.
Estonian: Vireadi kasutanud patsientidest oli neid, kelle viiruskoormus oli alla 400 koopia/ml pärast 96 ravinädalat, 89% ning Vireadi ja emtritsitabiini kombinatsioonravi kasutanute seas 86%.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Estonian: See on ensüüm, mida toodab HI-viirus ja mis võimaldab viirusel rakke nakatada ja paljuneda.
English: One of these studies involved patients with ‘HBeAg-negative' hepatitis B, a type that is more difficult to treat, while the other involved the more common ‘HBeAgpositive' hepatitis B. After 48 weeks, 71% of the HBeAg-negative and 67% of HBeAg-positive patients taking Viread had a complete response to treatment, compared with 49% and 12%, respectively, of the patients taking adefovir dipivoxil.
Estonian: Pärast 48 nädalat oli Vireadi kasutanud patsientidest neid, kellel tekkis täielik ravivastus, HBeAg-negatiivsest patsientidest 71% ja HBeAg-positiivsetest 67% ning adefoviirdipivoksiili saanute rühmas vastavalt 49% ja 12%.
English: --1 Recombinant verotoxin 2e of E. coli……………..RP* ≥ 1.50 * RP - relative potency (ELISA)
Estonian: --1 Rekombinantne E. coli verotoksiin 2e .................................................... RP* ≥ 1,50 * Suhteline tugevus (ELISA)
English: 10 vials
Estonian: 10 viaalI 0 päeva
English: Packaging Content Package size
Estonian: Pakendi suurus
English: EU (MA) number Invented name
Estonian: EL (ML) number
English: Strength Pharmaceutical form
Estonian: Ravimvorm Loomaliigid Manustamisviis Pakend
English: Target species
Estonian: Sisaldus
English: A procedure under Article 29(4) was therefore triggered in February 2012.
Estonian: Seetõttu algatati 2012. aasta veebruaris menetlus artikli 29 lõike 4 kohaselt.
English: • the CHMP assessed the entirety of the data submitted by the Applicant,
Estonian: • inimravimite komitee hindas kõiki taotleja esitatud andmeid;
English: Scientific conclusions and grounds for positive opinion
Estonian: Teaduslikud järeldused ja positiivse arvamuse alused
English: Overall summary of the scientific evaluation of Mometasone Furoate Sandoz and associated names (see Annex I)
Estonian: Mometasone Furoate Sandoze ja sarnaste nimetuste teadusliku hindamise üldkokkuvõte (vt I lisa)
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Estonian: Mometasoonfuroaat on toopiline glükokortikosteroid, millel on lokaalsed põletikuvastased omadused annustes, mis ei ole süsteemselt aktiivsed.
English: The Applicant provided in vitro data for both devices, however only Device 1 was investigated in vivo.
Estonian: Taotleja esitas in vitro andmed mõlema seadme kohta, kuid ainult pump 1 seadet oli uuritud in vivo.
English: In addition, the objecting CMS raised concerns regarding the statistical methodology applied.
Estonian: Lisaks tõstatas vastuolev asjaomane liikmesriik küsimused seoses kasutatud statistilise metoodikaga.
English: The CHMP noted that the Applicant had received scientific advice from the CHMP on the clinical program, stating that for locally applied, locally acting products containing known constituents, an in vitro approach could in principle be used for demonstration of equivalence, provided that this approach is justified.
Estonian: Inimravimite komitee märkis, et taotleja oli saanud inimravimite komiteelt teaduslikku nõu kliinilise programmi kohta, kus oli öeldud, et lokaalselt manustatavate ja lokaalselt toimivate ravimite puhul, mis sisaldavad tuntud koostisosi, võib ekvivalentsuse näitamiseks põhimõtteliselt kasutada in vitro lähenemist, kui see on õigustatud.
English: The CHMP also discussed the objections raised regarding the statistical methodology used for the in vitro comparison.
Estonian: Inimravimite komitee arutas ka vastuväiteid seoses in vitro võrdluses kasutatud statistiliste meetoditega.
English: • the CHMP considered the benefit-risk of the proposed products to be positive, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Mometasone Furoate Sandoz and associated names (see Annex I).
Estonian: • inimravimite komitee pidas väljapakutud ravimite kasulikkuse ja riski tasakaalu positiivseks; soovitab inimravimite komitee anda müügiload, milles ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht jäävad sellisteks nagu viimases versioonis, milleni jõuti kooskõlastusrühma menetluse jooksul, nagu on märgitud Mometasone Furoate Sandoze ja sarnaste nimetuste III lisas (vt I lisa).
English: The CHMP considered that this was supported by the evidence of equivalent therapeutic efficacy obtained from the phase III clinical study comparing the proposed product with the Device 1 spray pump and the reference product.
Estonian: Inimravimite komitee leidis, et seda toetavad samaväärse terapeutilise efektiivsuse tõendid, mis saadi III faasi kliinilisest uuringust, mis võrdles pump 1 spreipumbaga väljapakutud ravimit ja võrdlusravimit.
English: The objecting CMS considered that the available in vitro data is not a valid surrogate for the equivalence of the products, as the comparison was performed using the Population Bioequivalence (PBE) method, which consists of an aggregate criterion where the differences in means can be compensated by the differences in variability.
Estonian: Vastuolev asjaomane liikmesriik leidis, et olemasolevad in vitro andmed ei sobi ravimite samaväärsuse tõestamiseks, sest võrdlemiseks kasutati populatsiooni bioekvivalentsuse (PBE) meetodit, mis koosneb agregaatkriteeriumist, kus keskmiste erinevusi saab kompenseerida varieeruvuse erinevustega.
English: This was further supported by the clinical data obtained with the Device 1 spray pump.
Estonian: Seda toetasid esimese spreipumbaga saadud kliinilised andmed.
English: The PBE method may therefore be more permissive than the Average Bioequivalence (ABE) method described in the CHMP's Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 While noting that the Applicant had presented justifications for the use of PBE and that this use was pre-specified where
Estonian: Seetõttu võib PBE meetod olla vähem lubavam, kui keskmise bioekvivalentsuse (ABE) meetod, mida kirjeldatakse inimravimite komitee suukaudsete inhaleeritavate ravimite kliinilise dokumentatsiooni nõuete juhistes „Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 Märkides ära, et taotleja oli esitanud
English: The Applicant submitted an application for Mometasone Furoate Sandoz 50 mcg/dose, in the treatment of the symptoms of seasonal allergic or perennial rhinitis and of nasal polyps, as a nasal spray with two different spray pump devices (Device 1 and Device 2).
Estonian: Taotleja esitas taotluse Mometasone Furoate Sandoze (50 µg annus) osas hooajalise allergilise riniidi või püsiva riniidi ja ninapolüüpide sümptomite raviks kahe erineva spreipumbaseadmega (pump 1 ja pump 2) ninaspreina.
English: While the reference member state considered both devices to be approvable, the objecting concerned member state (CMS) did not consider in vitro data to be a valid surrogate of equivalence for nasal suspensions and therefore considered that equivalence had not been demonstrated for Device 2.
Estonian: Kuigi viiteliikmesriik pidas mõlemat seadet lubatavaks, ei pidanud vastuolev asjaomane liikmesriik in vitro andmeid sobivaks ninasuspensioonide samaväärsuse tõestamise jaoks ja leidis seetõttu, et pump 2 seadme kohta ei ole ekvivalentsust näidatud.
English: • the CHMP therefore considered it adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products, based on the available in vitro evidence and further supported by the clinical data obtained using the proposed product fitted with the Device 1 spray pump,
Estonian: • inimravimite komitee pidas piisavalt tõestatuks, et võimalikud erinevused esimese või teise pumbaga varustatud väljapakutud ravimi ja võrdlusravimi vahel ei mõjuta väljapakutud ravimite ohutust ning efektiivsust olemasolevate in vitro tõendite alusel, mida toetasid ka kliinilised andmed, mis saadi esimese spreipumbaga varustatud väljapakutud ravimi kasutamisel;
English: Having assessed the entirety of the available data, the CHMP concluded that the evidence of comparable particle size distribution as well as location and pattern of deposition between the proposed and the reference products indicates comparable dissolubility, which is in turn an indicator of comparable safety and efficacy.
Estonian: Olles hinnanud kõiki olemasolevaid andmeid, leidis inimravimite komitee, et tõendid võrreldava osakeste suuruse jaotumise kohta ning sadestumise lokalisatsiooni ja mustri kohta väljapakutud ning võrdlusravimite vahel näitavad võrreldavat lahustuvust, mis on omakorda võrreldava ohutuse ja efektiivsuse näitaja.
English: applied, the CHMP considered that the use of PBE in bioequivalence studies is not desirable as it may lead to the acceptance of higher levels of variability between drug products.
Estonian: põhjused PBE kasutamiseks ja see oli varem kindlaksmääratud, leidis inimravimite komitee, et PBE kasutamine bioekvivalentsuse uuringutes ei ole soovitatav, sest võib viia ravimitevahelise suurema varieeruvuse tunnistamiseni.
English: Considering that particle size distribution is an adequate indicator of dissolubility, the CHMP therefore concluded that the dissolution properties of the proposed and the reference products are equivalent, independently of the spray pump device used.
Estonian: Arvestades, et osakeste suuruse jaotumine on lahustuvuse adekvaatne näitaja, järeldas inimravimite komitee, et väljapakutud ja võrdlusravimi lahustuvusomadused on ekvivalentsed sõltumata kasutatavast spreipumbast.
English: • the CHMP considered that the results of the conducted in vitro comparisons confirm that the particle size distribution as well as the locations and patterns of deposition of the suspension in the nose of the proposed products and the reference product are comparable,
Estonian: • inimravimite komitee leidis, et läbiviidud in vitro võrdluste andmed kinnitavad, et väljapakutud ravimite ja võrdlusravimi osakeste suuruse jaotumine ning suspensiooni sadenemise piirkonnad ja mustrid ninas on võrreldavad;
English: Because of the low systemic bioavailability and the poor absorption from the gastrointestinal tract of mometasone furoate, the Applicant decided not to perform any pharmacokinetic or pharmacodynamic studies and instead performed comparative in vitro studies between the proposed and the reference products for both spray pump delivery devices.
Estonian: Mometasoonfuroaadi väikese süsteemse biosaadavuse ja halva imendumise tõttu seedetraktist otsustas taotleja mitte teha farmakokineetilisi või farmakodünaamilisi uuringuid.
English: However, in this specific case, the CHMP considered the adequacy of the applied statistical methods to be of secondary importance compared to the evaluation of the available in vitro data, as supported by the available in vivo data, which was considered sufficient to reach a conclusion.
Estonian: Siiski pidas inimravimite komitee konkreetsel juhul kasutatud statistiliste meetodite adekvaatsust sekundaarseks võrreldes in vitro andmete hindamisega.
English: In conclusion, considering the total body of available evidence, the CHMP considered it to be adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products and that the benefit-risk of the proposed products is therefore positive.
Estonian: Kokkuvõttes, kaaludes kõiki olemasolevaid tõendeid, leidis inimravimite komitee, et on piisavalt näidatud võimalikke erinevusi pump 1 või pump 2 pumbaga varustatud väljapakutud ravimi ja võrdlusravimi vahel, kuid need ei mõjuta väljapakutud ravimite ohutust ja efektiivsust.
English: • the CHMP considered particle size distribution and location and pattern of deposition to be adequate indicators of dissolubility and therefore concluded that the proposed and the reference products have comparable dissolution properties,
Estonian: • inimravimite komitee pidas osakeste suuruse jaotumist ja sadenemise lokalisatsiooni ning mustrit piisavateks lahustuvuse näitajateks ja leidis seetõttu, et väljapakutud ja võrdlusravimitel on võrreldavad lahustuvusomadused;
English: As the CHMP considered the rate of dissolution to determine the availability of the active substance locally, the CHMP further concluded that the data confirmed that potential differences between the proposed and the reference products would not impact the benefit-risk of the proposed products.
Estonian: Kuna inimravimite komitee leidis, et lahustumiskiirus määrab ära lokaalse toimeaine saadavuse, järeldas inimravimite komitee, et väljapakutud ja võrdlusravimite võimalikud erinevused ei mõjuta väljapakutud ravimite kasulikkuse ja riski tasakaalu.
English: Having assessed the performance of the spray pumps and the properties of the suspension in the spray, the CHMP agreed that there is adequate evidence of comparable particle size distribution of the active substance suspension between the proposed products and reference product, and also agreed that comparable locations and patterns of deposition were demonstrated.
Estonian: Olles hinnanud spreipumpade jõudlust ja spreis oleva suspensiooni omadusi, nõustus inimravimite komitee, et on piisavalt tõendeid toimeaine suspensiooni võrreldava osakeste suuruse jaotuse kohta väljapakutud ravimite ja võrdlusravimi vahel.
English: EU/1/14/923/001 Entyvio
Estonian: EU/1/14/923/001
English: 300 mg Powder for concentrate for solution for infusion
Estonian: 300 mg Infusioonilahuse kontsentraadi pulber
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: If you suffer from bleeding problems.
Estonian: Kui teil esineb veritsusprobleeme.
English: Adopted at the 8-11 July 2019 PRAC
Estonian: Vastu võetud ravimiohutuse riskihindamise komitee 8.-11. juuli 2019 koosolekul
English: The following information is intended for medical or healthcare professionals only.
Estonian: Järgmine teave on ainult tervishoiutöötajatele:
English: Section at the end of the package leaflet:
Estonian: Lõik pakendi infolehe lõpus:
English: Labelling text
Estonian: Pakendi märgistuse tekst
English: In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).
Estonian: 1,8 miljonit rasedust hõlmavas kohortuuringus seostati ondansetrooni manustamist esimesel kolmel raseduskuul huule-suulaelõhe esinemise suurenenud riskiga (3 lisajuhtu 10 000 ravitud naise kohta; korrigeeritud suhteline risk 1,24 (95% usaldusvahemik 1,03-1,48)).
English: 2 Indicated in neonates and children below 2 years
Estonian: 2 Näidustatud vastsündinutele ja alla 2-aastastele lastele.
English: If you are already pregnant, think you are might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking <product name>.
Estonian: Kui te olete juba rase või arvate, end olevat et võite olla rase, või kavatsete rasestuda, pidage enne ravimi <ravimi nimetus> kasutamist nõu oma arsti või apteekriga.
English: Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients.
Estonian: Aksitiniibi ei ole uuritud patsientidel, kellel on ravimata ajumetastaaside või hiljutise aktiivse gastrointestinaalse verejooksu tunnused, ning seda ei tohi neil kasutada.
English: If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.
Estonian: Kui veritsus nõuab meditsiinilist sekkumist, tuleb ravi aksitiniibiga ajutiselt katkestada.
English: Mesalazine - Nephrolithiasis (EPITT no 19405)
Estonian: Mesalasiin - nefrolitiaas (EPITT nr 19405)
English: In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Estonian: Aksitiniibi kliinilistes uuringutes on teatatud hemorraagiajuhtudest (vt lõik 4.8).
English: Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content.
Estonian: Mesalasiini kasutamisel on teatatud nefrolitiaasi juhtudest, sealhulgas 100% mesalasiini sisaldusega neerukividest.
English: Other side effects with Inlyta may include:
Estonian: Muud Inlyta kõrvaltoimed võivad olla:
English: Evaluation of experimental Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Estonian: Katseloomadega tehtud uuringute hindamine Loomkatsed ei näita otsest ega kaudset reproduktiivtoksilist toimet.
English: Women of childbearing potential should consider the use of contraception.
Estonian: Rasestumisvõimelised naised peavad kaaluma rasestumisvastaste vahendite kasutamist.
English: Symptoms may include pain in sides of abdomen and blood in urine.
Estonian: Sümptomid võivad olla kõhuvalu külgedel ja veri uriinis.
English: This is because <product name> can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth).
Estonian: Nimelt võib <ravimi nimetus> veidi suurendada riski, et laps sünnib huulelõhega ja/või suulaelõhega (avaus ülahuules ja/või suulaes).
English: • kidney stones and associated kidney pain (see also section 2)
Estonian: • neerukivid ja kaasnev neeruvalu (vt ka lõik 2)
English: Inlyta may increase your chance of bleeding.
Estonian: Inlyta võib suurendada verejooksu tõenäosust.
English: However, as animal studies are not always predictive of human response the use of ondansetron in pregnancy is not recommended.
Estonian: Et aga loomkatsete põhjal ei ole alati võimalik prognoosida toimet inimestel, ei soovitata ondansetrooni raseduse ajal kasutada.
English: Cases of ruptured aneurysms (including pre-existing aneurysms) have been reported, some with fatal outcome.
Estonian: Teatatud on aneurüsmide rebendite juhtudest (sh olemasolevate aneurüsmide), millest mõned lõppesid surmaga.
English: Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy.
Estonian: Epidemioloogilistest inimuuringutest saadud kogemuse põhjal esineb kahtlus, et esimesel kolmel raseduskuul manustatav ondansetroon põhjustab orofatsiaalseid defekte.
English: 3 Aflibercept; axitinib; bevacizumab; cabozantinib; lenvatinib; nintedanib; pazopanib; ponatinib; ramucirumab; regorafenib; sorafenib; sunitinib; tivozanib; vandetanib
Estonian: 3 Aflibertsept, aksitiniib, bevatsisumaab, kabosantiniib, lenvatiniib, nintedaniib, pasopaniib, ponatiniib, ramutsirumaab, regorafeniib, sorafeniib, sunitiniib, tivosaniib, vandetaniib
English: Ondansetron - Signal of birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications (EPITT no 19353)
Estonian: Ondansetroon - hiljutistest publikatsioonidest saadud signaal kaasasündinud väärarendist pärast in utero kokkupuudet esimesel kolmel raseduskuul (EPITT nr 19353)
English: Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration3 - Artery dissections and aneurysms (EPITT no 19330)
Estonian: Vaskulaarse endoteeli kasvufaktori (VEGF) inhibiitorid süsteemseks manustamiseks3 - arteridissektsioonid ja aneurüsmid (EPITT nr 19330)
English: What you need to know before you take Inlyta
Estonian: 2. Mida on vaja teada enne Inlyta võtmist
English: The available epidemiological studies on cardiac malformations show conflicting results.
Estonian: Olemasolevate epidemioloogiliste uuringute tulemused südamedefektide kohta on vastuolulised.