FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore the pooling of the pre-dose concentrations (Cmin) in the steady state study at day 10/11/12 as a proof of bioequivalence instead of standard non-pooled data (replicate design), was not considered to be acceptable by the CHMP.
Estonian: Inimravimite komitee ei lugenud bioekvivalentsuse tõestamisel vastuvõetavaks tasakaalukontsentratsiooni uuringu 10., 11. ja 12. päeva manustamiseelsete kontsentratsioonide (Cmin) koondamist, selle asemel et kasutada koondamata andmeid (kordustega ülesehitus).
English: Cminss and peak-trough fluctuation (PTF) were considered as secondary parameters as well as all pharmacokinetic parameters for the other two dosage strengths The multiple dose study was designed to mirror clinical conditions by up-titration of all three doses.
Estonian: Cmin väärtuste ning piikide ja lohkude vahelist kõikumist, samuti toimeaine kahe teise sisalduse kõiki farmakokineetilisi näitajaid käsitleti teiseste näitajatena.
English: 1) Cminss defined as the lowest concentration on a concentration-time curve at steady-state within one dosing interval including the pre-dose concentration value.
Estonian: mis asub tasakaalukontsentratsioonile vastava kontsentratsiooni-aja kõveral ühes annustamisvahemikus, mis hõlmab ka annustamiseelse kontsentratsiooni väärtust.
English: Three single dose studies and one steady state study have been conducted to establish bioequivalence of the prolonged release tablets Galantamine STADA in comparison to the reference product Reminyl prolonged release capsules.
Estonian: Galantamine STADA toimeainet prolongeeritult vabastavate tablettide ja võrdlusravimi Reminyl toimeainet prolongeeritult vabastavate kapslite bioekvivalentsuse kindlakstegemiseks viidi läbi kolm üksikannuse uuringut ning üks tasakaalukontsentratsiooni uuring.
English: GALANTAX XL 24 mg prolonged-release tablets 24 mg
Estonian: GALANTAX XL 24 mg prolonged-release tablets
English: Annex I
Estonian: II lisa
English: The CHMP were of the view that the requirements of this guideline are clear and they are based on the principle that using a derived parameter (such as %PTF) for the pharmacokinetic evaluation decreases the sensitivity to detect a possible difference between products
Estonian: Kuid inimravimite komitee rõhutas modifitseeritult vabastavate suukaudsete ja transdermaalsete ravimvormide jaoks praeguse ravimite kliinilise uurimise suunise 5. lõiku, milles väidetakse tasakaalukontsentratsiooniga uuringute kohta järgmist: „Bioekvivalentsuse hindamine peab põhinema AUCt, Cmax ja Cmin väärtustel, kohaldades samu statistilisi menetlusi kui toimeainet kiiresti vabastavate ravimvormide korral.” Inimravimite komitee arvamuse kohaselt olid juhistes esitatud seisukohad selged ja põhinesid printsiibil, mille alusel tuletatud näitaja (nt piikide ja lohkude kõikumise protsent) kasutamine farmakokineetilisel hindamisel vähendab ravimite vahelise võimaliku erinevuse avastamise tundlikkust.
English: Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním
Estonian: Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním 24 mg
English: Finland
Estonian: Soome
English: GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada
Estonian: GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada 8 mg
English: A single dose study with the 16 mg dose under fasting conditions
Estonian: tühja kõhuga võetava 16 mg üksikannuse uuring,
English: GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada
Estonian: GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada 16 mg
English: Invented Name
Estonian: Ravimi väljamõeldud nimetus Nimi Tugevus
English: A single dose study with the 8 mg dose under fasting conditions
Estonian: tühja kõhuga võetava 8 mg üksikannuse uuring,
English: Packaging
Estonian: Tugevus
English: Pharmaceutical Form
Estonian: Ravimvorm Manustamistee Pakendi iseloomustus
English: London, 24 January 2008 Doc.
Estonian: London, 24. jaanuar 2008 Dok.
English: Ref. EMEA/599866/2007
Estonian: nr EMEA/599866/2007
English: The application was at day 175 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 175 päeva, kui ettevõte taotluse tagasi võttis.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Estonian: Pärast inimtervishoius kasutatavate ravimite komitee otsust kulub Euroopa Komisjonil müügiloa andmiseks tavaliselt ligikaudu kaks kuud.
English: What is Sinerem?
Estonian: Mis on Sinerem?
English: This should help making a difference between normal lymph nodes that contain macrophages and therefore magnetic particles, and lymph nodes that are invaded with cancer cells and contain fewer macrophages and fewer magnetic particles.
Estonian: See peaks aitama eristada normaalseid lümfisõlmi, mis sisaldavad makrofaage ja seega magnetilisi osakesi, neist lümfisõlmedest, mida ründavad vähirakud ja mis sisaldavad vähem makrofaage ja vähem magnetilisi osakesi.
English: It was to be used as a ‘contrast agent' to help make internal body structure more visible on the scan.
Estonian: Seda kavatseti kasutada kontrastainena, mis aitab muuta keha siseelundid uuringul nähtavamaks.
English: There was one main study of the effectiveness of Sinerem, involving a total of 271 patients with pelvic cancers.
Estonian: Ühes Sineremi efektiivsuse põhiuuringus osales kokku 271 vaagnaelundite vähiga naist.
English: What was the recommendation of the CHMP at that time?
Estonian: Milline oli sel ajal inimtervishoius kasutatavate ravimite komitee soovitus?
English: The company informed the CHMP that compassionate use programmes using Sinerem are ongoing and will be reconsidered accordingly.
Estonian: Ettevõte teatas inimtervishoius kasutatavate ravimite komiteele, et Sineremi eriloaga kasutamise programmid on käimas ning need vaadatakse vastavalt läbi.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Sinerem?
Estonian: Mis on taotluse tagasivõtmise mõju praegu Sineremi kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele?
English: Active substance: Superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate
Estonian: Toimeaine: dekstraani ja naatriumtsitraadiga stabiliseeritud superparamagnetilised raudoksiidi nanoosakesed
English: These are part of the lymphatic system, a network of structures in the body involved in body defence (immune system).
Estonian: Need kuuluvad lümfisüsteemi, mis on keha kaitsemehhanismis (immuunsüsteemis) osalevate elundite süsteem.
English: What documentation did the company present to support its application to the CHMP?
Estonian: Mis dokumendid esitas ettevõte inimtervishoius kasutatavate ravimite komiteele oma taotluse toetuseks?
English: The patients underwent two MRI scans to detect any cancer cells in their lymph nodes, one with Sinerem and one without.
Estonian: Patsientidele tehti kaks MRI-uuringut võimalike vähirakkude avastamiseks nende lümfisõlmedes - üks Sineremiga ja üks ilma.
English: Sinerem is a powder to be made up into a solution for infusion (drip into a vein).
Estonian: Sinerem on pulber, millest valmistatakse infusioonilahus (tilgutamiseks veeni).
English: The CHMP normally takes up to 210 days to evaluate a new application.
Estonian: Uue taotluse hindamiseks kulub inimtervishoius kasutatavate ravimite komiteel enamasti kuni 210 päeva.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Estonian: Inimtervishoius kasutatavate ravimite komitee oli ettevõtte saadetud vastused esitatud küsimustele läbi vaadanud, kuid mõned probleemid olid veel lahendamata.
English: The patients then had an operation to remove the lymph nodes, and the results of the scans were compared by three different specialist readers to the results obtained when looking at the lymph nodes under a microscope to see if they contained any cancer cells.
Estonian: Seejärel tehti patsientidele lümfisõlmede eemaldamise operatsioon ja kolm eriarsti võrdlesid MRI-uuringute tulemusi nende tulemustega, mis saadi lümfisõlmede mikroskoobi all vaatlemisega, kui uuriti, kas lümfisõlmed sisaldavad vähirakke.
English: Pelvic cancers are cancers affecting organs in the lower abdomen, such as the prostate gland, the bladder, the womb or the cervix.
Estonian: Vaagnaelundite vähk on alakõhu elundite, nt eesnäärme, põie, emaka või emakakaela vähk.
English: When a cancer is in the process of spreading, the cancer cells travel within the lymphatic system, and can be detected in the lymph nodes.
Estonian: Vähi levimisel liiguvad vähirakud lümfisüsteemis ning on lümfisõlmedes avastatavad.
English: The very small size of the particles allows them to be carried in the body, and to enter the lymphatic system.
Estonian: Osakesed on ülipeened, mis võimaldab neil kehas edasi kanduda ja lümfisüsteemi siseneda.
English: It contains extremely small particles of iron oxide (nanoparticles).
Estonian: See sisaldab raudoksiidi ülipeeni osakesi (nanoosakesi).
English: How is Sinerem expected to work?
Estonian: Milline on Sineremi eeldatav toime?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SINEREM
Estonian: TEAVE MÜÜGILOA TAOTLUSE TAGASIVÕTMISE KOHTA
English: Sinerem was to be used as a diagnostic agent in patients undergoing an MRI scan.
Estonian: Sineremi kavatseti kasutada diagnostilise ainena patsientidel, kellele tehakse MRI-uuring.
English: Sinerem was to be used in patients with pelvic cancers.
Estonian: Sineremi kavatseti kasutada vaagnaelundite vähiga patsientidel.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefits of Sinerem as a diagnostic agent in the characterisation of lymph nodes in patients with pelvic cancer had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Inimtervishoius kasutatavate ravimite komitee oli seepärast taotluse tagasivõtmise ajal seisukohal, et Sineremi kasulikkus diagnostilise ainena vaagnaelundite vähiga patsientide lümfisõlmede iseloomustamiseks ei olnud piisavalt tõestatud ega ületa tuvastatud riske.
English: Sinerem was to be used to see if the cancer was spreading, by helping visualise the patients' lymph nodes.
Estonian: Sineremi kavatseti kasutada vähi võimaliku leviku kontrollimiseks, et aidata visualiseerida patsientide lümfisõlmi.
English: The active substance in Sinerem is iron oxide in the form of nanoparticles in a clear, colloidal (jellylike) solution of dextran, a type of sugar.
Estonian: Sinerem sisaldab toimeainena raudoksiidi, mis on läbipaistvas dekstraani (polüsahhariid) (želeetaolises) kolloidlahuses nanoosakeste kujul.
English: Once in the lymphatic system, the nanoparticles are taken up by a certain type of immune system cell called ‘macrophages' within the lymph nodes.
Estonian: Lümfisüsteemis omastavad nanoosakesi lümfisõlmede teatud liiki immuunsüsteemirakud - makrofaagid.
English: What were the main concerns of the CHMP?
Estonian: Mis olid inimtervishoius kasutatavate ravimite komitee ettevaatlikkuse peamised põhjused?
English: There were inconsistencies between readers regarding any improvement Sinerem may have brought in detecting cancer spread in lymph nodes during an MRI scan, and Sinerem could not therefore be considered as useful in the management of patients with such conditions.
Estonian: Kujutiste lugejad said Sineremi võimaliku mõju kohta vähi avastamisele lümfisõlmedes MRI-uuringu käigus erinevaid tulemusi ning seetõttu ei saanud Sineremi käsitada kasuliku vahendina selliste seisunditega patsientide ravis.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sinerem could not have been approved for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimtervishoius kasutatavate ravimite komitee poolt esitatud küsimustele, nägi inimtervishoius kasutatavate ravimite komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ning oli esialgsel seisukohal, et Sineremi kasutamist diagnostilisel eesmärgil MRI-uuringuga (magnetresonantsuuring) visualiseeritud lümfisõlmede iseloomustamiseks primaarse tuumori leviku hindamisel vaagnaelundite vähi korral ei või heaks kiita.
English: The effects of Sinerem were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Sineremi toimet muude katsetega.
English: What was Sinerem expected to be used for?
Estonian: Milleks kavatseti Sineremi kasutada?
English: The main concern of the CHMP was that the effectiveness of Sinerem in enhancing the images seen in the MRI scan had not been shown.
Estonian: Inimtervishoius kasutatavate ravimite komitee nägi põhjust ettevaatlikkuseks peamiselt sellepärast, et Sineremi efektiivsust MRI-uuringus nähtavate kujutiste parandamisel ei olnud tõestatud.
English: When exposed to the action of an external magnet as during an MRI scan, the particles become magnetic, and they can be seen more easily on the scan image.
Estonian: MRI-uuringu käigus muutuvad osakesed välise magneti toimel uuringu kujutisel selgesti nähtavaks.
English: On 13 December 2007, Guerbet officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sinerem, intended for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Estonian: 13. detsembril 2007 teatas ettevõte Guerbet ametlikult inimtervishoius kasutatavate ravimite komiteele oma soovist tagasi võtta ravimi Sinerem müügiloa taotlus.
English: 30 May 2013 EMA/318380/2013
Estonian: 25. juuli 2013 EMA/318380/2013
English: • Healthcare professionals will be sent a letter with further details.
Estonian: • Tervishoiutöötajatele saadeti kirjalik teade edasiste üksikasjadega.
English: More about the procedure
Estonian: Rohkem teavet menetluse kohta
English: • If you have any questions you should speak to your doctor or pharmacist.
Estonian: • Kui teil on mingeid küsimusi, rääkige oma arsti või apteekriga.
English: Diane 35 was first authorised in 1985.
Estonian: Diane 35 sai esmase müügiloa 1985. aastal.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Estonian: Kõigepealt vaatas need andmed üle ravimiohutuse järelevalve riskihindamise komitee (PRAC).
English: Its main responsibility is to resolve disagreements between Member States involved in mutual recognition or decentralised procedures, to ensure that patients have the same level of protection, no matter where they are in the EU.
Estonian: Selle peamine ülesanne on lahendada vastastikuses tunnustamises või detsentraliseeritud menetlustes osalevate liikmesriikide vahelisi eriarvamusi, et tagada patsientidele kaitse samal tasemel sellest sõltumata, kus nad ELis asuvad.
English: The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Estonian: Diane 35 ja selle geneeriliste ravimite läbivaatamine algatati veebruaris 2013 Prantsusmaa taotlusel direktiivi 2001/83/EÜ artikli 107i kohaselt, mida tuntakse ka ühenduse kiirmenetlusena.
English: These medicines work by blocking the effects of a class of hormones called androgens.
Estonian: Need ravimid blokeerivad androgeenideks nimetatava hormoonide klassi toimeid.
English: The French decision followed a national review of the medicine by ANSM.
Estonian: Prantsusmaa otsus järgnes ravimi riiklikule läbivaatamisele ANSMi poolt.
English: Healthcare professionals should follow these recommendations:
Estonian: Tervishoiutöötajad peavad järgima alltoodud soovitusi.
English: The risk of thromboembolism occurring with these medicines is low and well known.
Estonian: Nende ravimitega esinev trombemboolia risk on väike ja hästi teada.
English: However, to minimise this risk, further measures should be implemented in addition to the updated product information.
Estonian: Riski vähendamiseks tuleb siiski võtta edasisi meetmeid peale uuendatud ravimiteabe.
English: • You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines.
Estonian: • Lugege alati pakendi infolehte ja olge teadlik, et nende ravimitega esineb väike verehüüvete moodustumise risk.
English: The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Estonian: Efektiivsust seborröaga või ilma selleta mõõduka ja raske akne ja/või hirsutismi korral on näidatud enam kui 30 kliinilises uuringus.
English: This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
Estonian: Läbivaatamine rõhutas raskeid trombemboolilisi sündmusi ja nende ravimite laialdast kasutamist registreerimata näidustustel ainult kontratseptiivina.
English: Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Estonian: Tsüproteroon pärsib ka ovulatsiooni ja seetõttu on sel kontratseptiivne toime.
English: • You should not stop taking these medicines before speaking to your doctor.
Estonian: • Ärge lõpetage nende ravimite kasutamist oma arstiga nõu pidamata.
English: These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Estonian: Nende hulka kuulub õppematerjalide pakkumine arstidele ja patsientidele, mis rõhutavad trombemboolia riske, näiteks arsti kontroll-loend tagamaks, et riske koos nähtude ja sümptomitega on patsiendiga arutatud.
English: • You should be aware that there are factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility.
Estonian: • Peate teadma, et on tegureid, mis võivad suurendada veresoontes verehüüvete moodustumise riski, nagu kõrgem iga, suitsetamine, rasvumus ja pikaajaline liikumatus.
English: • If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
Estonian: • Kui te kasutate neid ravimeid muude seisundite tõttu, peate leppima oma arstiga kokku visiidi ravi läbivaatamiseks.
English: • In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
Estonian: • Androgeense kiilanemise ja ilma androgeensete tunnusteta akne ravis on andmed efektiivsuse kohta piiratud.
English: Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
Estonian: Hoolimata ravimiohutuse järelevalve riskihindamise komitee soovitusest jätkas ANSM nende ravimite müügilubade peatamist Prantsusmaal.
English: More about the medicine
Estonian: Rohkem teavet ravimi kohta
English: Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Estonian: 2 mg tsüproteroonatsetaati ja 35 µg etünüülöstradiooli sisaldavad ravimid on kõigis ELi liikmesriikides peale Küprose saanud müügiloa riiklike menetluste kaudu ja on müügil retseptiravimitena erinevate kaubanduslike nimetuste all.
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Estonian: Edasine teave ravimiohutuse järelevalve riskihindamise komitee soovituse ja läbivaatamise kohta on Euroopa Ravimiameti veebilehel.
English: • The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
Estonian: • Läbivaatamine näitas samuti, et venoosse trombemboolia ülemäärane risk on suurim Diane 35 ja selle geneeriliste ravimite esimesel kasutusaastal või ravi taasalustamisel või üleminekul muult hormonaalselt kontratseptiivilt Diane 35-le ja selle geneerilistele ravimitele pärast vähemalt ühe kuu pikkust pillidevaba intervalli.
English: You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.
Estonian: Peate kõigist asjakohastest sümptomitest, nagu valu ja turse jalgades või hingeldus ja terav valu rindkeres, kohe teatama oma arstile.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
Estonian: 29. mail 2013 kinnitas inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm häälteenamusega (26 : 1) Euroopa Ravimiameti ravimiohutuse riskihindamise nõuandekomitee soovituse, mis järeldas, et Diane 35 (tsüproteroonatsetaat 2 mg / etünüülöstradiool 35 µg) ja selle geneeriliste ravimite kasulikkus kaalub üles nende riskid tingimusel, et võetakse mitmed meetmed trombemboolia (soonesiseste verehüüvete moodustumine) riski vähendamiseks.
English: The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Estonian: Diane 35 ja selle geneeriliste ravimite läbivaatamise algatas Prantsusmaa ravimiamet (ANSM) pärast oma otsust peatada Diane 35 ja selle geneeriliste ravimite müügiload kolme kuu jooksul.
English: • Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
Estonian: • Arstid peavad arutama oma patsientidega trombemboolia riski ja erinevaid riskitegureid, nagu kõrgem iga, suitsetamine, rasvumus ja pikaajaline liikumatus.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Estonian: Ravimiohutuse järelevalve riskihindamise komitee soovitused suunati edasi inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühmale, kes võttis vastu lõpliku seisukoha.
English: • The review confirmed the rare and known risk of thromboembolism with Diane 35 and its generics.
Estonian: • Läbivaatamine kinnitas trombemboolia harvaesinevat ja teadaolevat riski Diane 35 ja selle geneeriliste ravimite korral.
English: Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.
Estonian: Peale selle tohib Diane 35 ja selle geneerilisi ravimeid kasutada akne raviks ainult siis, kui alternatiivsed ravimeetodid, nagu paikne ravi ja antibiootikumravi, on ebaõnnestunud.
English: • For the treatment of acne, these medicines should only be used after topical therapy or systemic antibiotic treatment has failed.
Estonian: • Neid ravimeid tohib akne raviks kasutada ainult siis, kui paikne ravi ja süsteemne antibiootikumravi on ebaõnnestunud.