FrancophonIA/ELRC3.0 huggingface dataset:
English: As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.
Estonian: Ajutise abinõuna soovitab ravimiohutuse riskihindamise komitee läbivaatamise ajal regulaarselt jälgida emakafibroidide tõttu Esmyat kasutavate naiste maksaanalüüse.
English: The full EPAR for Zypadhera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Zypadhera kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zypadhera on 19 November 2008.
Estonian: Euroopa Komisjon andis Zypadhera müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. novembril 2008.
English: Zypadhera is not recommended for patients over 65 years of age.
Estonian: Zypadherat ei soovitata kasutada üle 65-aastastel patsientidel.
English: Zypadhera olanzapine
Estonian: Zypadhera olansapiin
English: Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks.
Estonian: Zypadherat manustatakse annuses 150, 210 või 300 mg iga kahe nädala järel või 300 või 405 mg iga nelja nädala järel.
English: The main measures of effectiveness were the time taken for symptoms to get worse and the number of patients whose symptoms got worse over 24 weeks.
Estonian: Efektiivsuse põhinäitajad olid sümptomite halvenemiseni kulunud aeg ja nende patsientide arv, kelle sümptomid 24 nädala jooksul halvenesid.
English: Olanzapine has been authorised in the European Union (EU) since 1996.
Estonian: Olansapiinil on Euroopa Liidus müügiluba alates 1996. aastast.
English: Since these neurotransmitters are involved in schizophrenia, olanzapine helps to normalise the activity of the brain, reducing the symptoms of the disease.
Estonian: Et need neurotransmitterid osalevad skisofreenia tekkimisel, aitab olansapiin ajutegevust normaliseerida, vähendades haiguse sümptomeid.
English: All of the patients in this study had been stabilised with other treatments for schizophrenia and had been taking olanzapine by mouth for at least six weeks before the study began.
Estonian: Kõik selles uuringus osalevad patsiendid olid varem stabiliseeritud muude skisofreeniaravimitega ja olid võtnud olansapiini suu kaudu vähemalt kuus nädalat enne uuringu algust.
English: These will include information on what to do before and after each injection, the differences between Zypadhera and other injectable medicines containing olanzapine, and the recommendations on how patients should be monitored.
Estonian: Teave sisaldab juhiseid selle kohta, mida teha enne ja pärast iga süstet, erinevusi Zypadhera ja teiste olansapiini sisaldavate süstitavate ravimite vahel ning patsiendi jälgimisviisi soovitusi.
English: However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and welltolerated dose of oral olanzapine has been found.
Estonian: 65-75-aastased patsiendid või neeruvõi maksaprobleemidega patsiendid võivad Zypadherat siiski kasutada, kui on leitud olansapiini efektiivne ja hästi talutav suukaudne annus.
English: Patients who have symptoms of overdose should continue to be monitored until the symptoms have passed.
Estonian: Üleannustamise sümptomitega patsiente peab jälgima kuni sümptomite möödumiseni.
English: Because olanzapine has already been authorised in the EU as Zyprexa, the company used some of the data from Zyprexa to support the use of Zypadhera.
Estonian: Et olansapiin juba on Euroopa Liidus heaks kiidetud ravimina Zyprexa, kasutas ettevõte Zypadhera kasutamise toetamiseks mõningaid Zyprexa andmeid.
English: Three of the doses of Zypadhera were ‘high' (300 mg and 150 mg every two weeks, and 405 mg every four weeks) and one was ‘low' (45 mg every four weeks).
Estonian: Zypadhera kolm annust olid suured (300 mg ja 150 mg iga kahe nädala järel ning 405 mg iga nelja nädala järel) ja üks oli väike (45 mg iga nelja nädala järel).
English: However, it noted that prolonged-release injections are not suitable for use as initial treatment, because the medicine takes at least a week to reduce symptoms and patients may need rapid control of symptoms.
Estonian: Komitee märkis siiski, et toimeainet prolongeeritult vabastavad süsted ei sobi esmaseks raviks, sest sümptomeid vähendav toime tekib alles vähemalt nädala pärast ja patsientide sümptomeid võib olla vaja leevendada kiiresti.
English: In addition, it is not possible to stop treatment after giving a prolonged-release injection, which would not be suitable for patients experiencing side effects.
Estonian: Peale selle ei ole võimalik ravi pärast toimeainet prolongeeritult vabastavat süstet katkestada, mis ei sobi patsientidele, kellel tekivad kõrvalnähud.
English: As a result, the active substance is released slowly for more than four weeks after injection of Zypadhera.
Estonian: Selle tulemusena vabaneb toimeaine ravimist aeglaselt, rohkem kui nelja nädala jooksul pärast Zypadhera süstet.
English: Which measures are being taken to ensure the safe use of Zypadhera?
Estonian: Milliseid meetmed võetakse, et tagada Zypadhera kasutamise ohutus?
English: A lower starting dose may be necessary in patients whose bodies may break olanzapine down slowly, such as those with moderate liver problems.
Estonian: Väiksemat algannust võib olla vaja patsientidel, kelle organism võib olansapiini lagundada aeglasemalt, näiteks mõõdukate maksaprobleemidega patsiendid.
English: Other information about Zypadhera
Estonian: Muu teave Zypadhera kohta
English: Patients should be monitored closely for signs of relapse (a return of symptoms) during the first one to two months of treatment, and the dose adjusted if necessary.
Estonian: Patsiente peab ühe kuni kahe esimese ravikuu jooksul hoolikalt jälgima relapsi (sümptomite taastumise) suhtes ning vajaduse korral kohandama annust.
English: Zypadhera has been studied in two main studies involving adults with schizophrenia.
Estonian: Zypadherat uuriti kahes põhiuuringus, milles osalesid skisofreeniaga täiskasvanud.
English: Zypadhera must not be injected into a vein or under the skin.
Estonian: Zypadherat ei tohi süstida veeni ega naha alla.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Estonian: Arvatakse, et olansapiini kasulik toime seisneb neurotransmitterite 5-hüdroksütrüptamiini (serotoniini) ja dopamiini retseptorite blokeerimises.
English: For more information about treatment with Zypadhera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Zypadheraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The main measure of effectiveness was the change in symptoms measured on a standard scale for schizophrenia after eight weeks;
Estonian: Efektiivsuse põhinäitaja oli sümptomites pärast 8-nädalast ravi toimunud muutused, mida hinnati standardse skisofreeniaskaala järgi;
English: The company that makes Zypadhera will provide an educational programme for doctors, nurses and pharmacists and a card for patients in all Member States, reminding them of how to use the medicine safely.
Estonian: Zypadhera tootja pakub kõigi liikmesriikide arstidele, õdedele ja apteekritele õppeprogrammi ja patsientidele ravimi ohutusteabe kaardi.
English: The dose depends on the dose of olanzapine that the patient was previously taking by mouth.
Estonian: Annus sõltub olansapiini annusest, mida patsient võttis varem suu kaudu.
English: The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness), orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Estonian: Zyprexa kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on unisus, kehakaalu tõus, ortostaatiline hüpotensioon (madal vererõhk seismisel) ja prolaktiini (teatud hormooni) taseme tõus.
English: This is a summary of the European public assessment report (EPAR) for Zypadhera.
Estonian: See on ravimi Zypadhera Euroopa avaliku hindamisaruande kokkuvõte.
English: Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.
Estonian: Zypadherat kasutatakse sümptomite paranemise säilitamiseks skisofreeniaga patsientidel, kelle seisund on juba stabiliseeritud esmase suukaudse olansapiinravi kuuriga.
English: Olanzapine attaches to several different receptors on the surface of nerve cells in the brain.
Estonian: Olansapiin kinnitub aju närvirakkude pinnal mitmele eri retseptorile.
English: Zypadhera must not be used in patients who are hypersensitive (allergic) to olanzapine or any of the other ingredients.
Estonian: Zypadherat ei tohi kasutada patsiendid, kes on olansapiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The Committee decided that Zypadhera's benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Zypadhera kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth: 10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth.
Estonian: Olansapiinravi ravivastuse säilitamist jälgivas uuringus oli Zypadhera sama efektiivne kui suukaudne olansapiin: kahe nädala tagant Zypadherat saanud patsientidest halvenesid sümptomid 10%-l ning platseebot saanud patsientidest 7%-l. Zypadhera suured annused ennetasid sümptomite halvenemist efektiivsemini kui väike annus.
English: Because patients should be monitored by qualified staff for these symptoms for at least three hours after injection, they should receive Zypadhera at a centre with the appropriate facilities to deal with a potential overdose.
Estonian: Et patsiendid peavad vähemalt kolm tundi pärast süstimist olema meditsiinitöötajate järelevalve all, tohib Zypadherat manustada vaid ravikeskuses, kus on olemas asjakohased võimalused võimaliku üleannustamise raviks.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zypadhera.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Zypadhera is a medicine that contains the active substance olanzapine.
Estonian: Zypadhera on ravim, mis sisaldab toimeainena olansapiini.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Estonian: Toimeaine prolongeeritud (pikaajaline) vabastamine tähendab, et pärast süstimist vabaneb toimeaine ravimist aeglaselt paari nädala jooksul.
English: The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment:
Estonian: Esimeses uuringus vaadeldi skisofreenia esmast ravi ja teises olansapiinravi ravivastuse säilitamist:
English: Symptom scores were around 100 points at the start of the study, but had fallen by around 25 points in the patients receiving Zypadhera after eight weeks, compared with around 9 points in the patients receiving placebo.
Estonian: Zypadherat saanud patsientidel langes kaheksa nädala järel punktiarv ligikaudu 25 punkti võrra ja platseebot saanud patsientidel ligikaudu 9 punkti võrra.
English: In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo.
Estonian: Skisofreenia esmase ravi uuringus oli Zypadhera efektiivsem kui platseebo.
English: For the full list of all side effects reported with Zypadhera, see the package leaflet.
Estonian: Zypadhera kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines.
Estonian: Seda turustatakse tablettide, suus dispergeeruvate (lagunevate) tablettide ja kiiretoimeliste süstetena raviminimetuste Zyprexa, Zyprexa Velotab jt all.
English: • the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients.
Estonian: • esmase ravi uuringus võrreldi 404 patsiendil Zypadhera kolme annuse toimet platseeboga (toimeaineta süsted).
English: The CHMP noted that Zypadhera is effective both in the initial treatment of schizophrenia and in maintaining a response to treatment in schizophrenia.
Estonian: Inimravimite komitee leidis, et Zypadhera on efektiivne nii skisofreenia esmases ravis kui ka skisofreenia ravivastuse säilitusravis.
English: The effectiveness of Zypadhera was greater than placebo from the second week of treatment onwards.
Estonian: Zypadhera efektiivsus oli platseebost suurem alates teisest ravinädalast.
English: What is Zypadhera?
Estonian: Mis on Zypadhera?
English: Why has Zypadhera been approved?
Estonian: Miks Zypadhera heaks kiideti?
English: What is the risk associated with Zypadhera?
Estonian: Mis riskid Zypadheraga kaasnevad?
English: The active substance in Zypadhera, olanzapine, is an antipsychotic medicine.
Estonian: Zypadhera toimeaine olansapiin on antipsühhootikum (psühhoosivastane ravim).
English: Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection.
Estonian: Zypadherat manustab seda tüüpi süstimise väljaõppe läbinud arst või õde sügava süstega tuharalihasesse.
English: • the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients.
Estonian: • säilitava ravi uuringus võrreldi 1065 patsiendil Zypadhera nelja annuse toimet suukaudse olansapiini toimega.
English: The olanzapine in Zypadhera is presented as a ‘pamoate' salt, which makes the olanzapine less soluble.
Estonian: Zypadhera sisaldab olansapiini pamoaatsoolana, mis vähendab olansapiini lahustuvust.
English: How has Zypadhera been studied?
Estonian: Kuidas Zypadherat uuriti?
English: It is available as a powder and solvent that are made up into a prolonged-release suspension for injection.
Estonian: Zypadhera on pulber ja lahusti, millest valmistatakse toimeainet prolongeeritult vabastav süstesuspensioon.
English: What benefit has Zypadhera shown during the studies?
Estonian: Milles seisnes uuringute põhjal Zypadhera kasulikkus?
English: How is Zypadhera used?
Estonian: Kuidas Zypadherat kasutatakse?
English: What is Zypadhera used for?
Estonian: Milleks Zypadherat kasutatakse?
English: How does Zypadhera work?
Estonian: Kuidas Zypadhera toimib?
English: In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein.
Estonian: Harvadel juhtudel, kui ravim süstitakse juhuslikult veeni, võib Zypadherat saavatel patsientidel esineda olansapiini üleannustamise sümptomeid, näiteks sedatsioon (uimasus) ja deliirium (segasus).
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Estonian: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Estonian: {Toimeaine(te) nimetus(ed)} kohta tehtud teaduslike järelduste põhjal on inimravimite komitee arvamusel, et {toimeaine(te) nimetus(ed)} sisaldava(te) ravimpreparaadi (ravimpreparaatide) kasu/riski suhe ei muutu, kui ravimiteabes tehakse soovitatud muudatused.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Estonian: Võttes arvesse ravimiohutuse riskihindamise komitee hindamisaruannet {toimeaine(te) nimetus(ed)} perioodilise ohutusaruande (perioodiliste ohutusaruannete) kohta, on inimravimite komitee teaduslikud järeldused järgmised:
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Estonian: TEADUSLIKUD JÄRELDUSED JA MÜÜGILUBADE TINGIMUSTE
English: Outcome of a procedure under Article 36 of Directive 2001/83/EC as amended
Estonian: Muudetud direktiivi 2001/83/EÜ artikli 36 kohase esildismenetluse tulemused
English: The European Commission issued a decision on 16 September 2011.
Estonian: Euroopa Komisjon tegi otsuse 16. septembril 2011.
English: What is Goserelin?
Estonian: Mis on gosereliin?
English: Why was Goserelin reviewed?
Estonian: Miks gosereliini taotlus uuesti läbi vaadati?
English: EMA/CHMP/477156/2011 Rev. 1 EMEA/H/A-36/1295
Estonian: EMA/CHMP/477156/2011 Red.
English: It is a copy of the natural hormone (luteinizing hormone-releasing hormone) that regulates many processes in the body.
Estonian: See on paljudes organismi protsessides osaleva loodusliku hormooni (luteiniseerivat hormooni vabastava hormooni) koopia.
English: Goserelin is used to treat patients with advanced prostate cancer.
Estonian: Gosereliini kasutatakse kaugelearenenud eesnäärmevähiga patsientide raviks.
English: The marketing authorisation should therefore be suspended in all member states until the companies provide new studies showing therapeutic equivalence and being GCP compliant.
Estonian: Selle tõttu tuleb müügiluba kõikides liikmesriikides peatada, kuni ettevõtted esitavad uued uuringud, kus tõendatakse terapeutilist ekvivalentsust ning järgitakse head kliinilist tava.
English: In prostate cancer it works by depriving prostate cancer cells of the male hormone testosterone on which they depend to grow and spread.
Estonian: Eesnäärmevähi korral vähendab see eesnäärmevähi rakkudes meessuguhormooni testosterooni kogust, mille olemasolust sõltub vähirakkude kasv ja levik.
English: Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.
Estonian: Gosereliini turustatakse Zoladexi hübriidtootena nimetuste Novimp, Goserelin Cell Pharm, Novosis Goserelin ja sarnaste nimetuste all.
English: The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed.
Estonian: Saksamaa ravimiamet leidis, et juba heakskiidetud ravimite müügiluba tuleb peatada, sest ei olnud võimalik tagada terapeutilist ekvivalentsust võrdlusravimiga.
English: Based on the evaluation of the studies that were submitted in support of the marketing authorisation application and the scientific discussion within the Committee, the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative.
Estonian: Müügiloa taotluse toetuseks esitatud uuringute hindamise ja komitees toimunud teadusliku arutelu põhjal jõudis inimravimite komitee järeldusele, et terapeutilist ekvivalentsust ei ole tõendatud ning et seetõttu on kõnealuste hübriidravimite riskid suuremad kui nende kasulikkus.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.
Estonian: EMA inimravimite komitee jõudis järeldusele, et uuringute põhjal ei ole need ravimid ekvivalentsed võrdlusravimiga (Zoladex) ning seetõttu tuleb müügiluba kuni terapeutilise ekvivalentsuse tõendamiseni peatada.
English: Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin containing medicines were not conducted in accordance with Good Clinical Practice (GCP) and questioned whether their results could be relied on.
Estonian: Pärast üht kontrolli avastas Saksamaa ravimiamet, et gosereliini sisaldavate teatud ravimite müügiloa taotluse osana tehtud kliinilistes uuringutes ei järgitud head kliinilist tava ning nende uuringute tulemused ei pruugi olla usaldusväärsed.
English: The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).
Estonian: Euroopa Ravimiamet (EMA) on lõpetanud hübriidravimite (teatud tüüpi geneeriliste ravimite) Novosis Goserelin, Goserelin Cell Pharm, Novimp ja sarnaste nimetuste (gosereliin, 3,6 mg implantaat) müügiloa taotluse osana esitatud kliiniliste uuringute läbivaatamise.
English: whether the marketing authorisations for Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should be maintained, varied, suspended or withdrawn across the EU.
Estonian: 16. märtsil 2011 tegi Saksamaa ravimiamet esildise EMA inimravimite komiteele, et komitee avaldaks arvamust, kas ravimite Novosis Goserelin, Goserelin Cell Pharm, Novimp ja sarnaste nimetuste müügiluba tuleb kogu Euroopa Liidus säilitada, muuta, peatada või tagasi võtta.
English: The physician information should contain the following key messages:
Estonian: Arsti informatsioon peab sisaldama järgmist olulist teavet:
English: • Physician information
Estonian: • Arsti informatsioon
English: • The role and use of patient alert card.
Estonian: • Patsiendi ohutuskaardi ülesanne ja kasutamine.
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Estonian: • Vajadus uurida patsiente nii aktiivse kui ka inaktiivse tuberkuloosi suhtes enne ravi alustamist, kaasaarvatud sõeluuringute läbiviimine,
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Estonian: Liikmesriigid peavad tagama, et kõik allpoolkirjeldatud tingimused või piirangud, mis puudutavad ravimi ohutut ja tõhusat kasutamist, rakendatakse:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Estonian: Müügiloa hoidja peab tagama, et enne ravimi turuletoomist saavad kõik arstid, kes kirjutavad välja/kasutavad ravimit Cimzia, arsti informatsiooni paki, mis koosneb järgmistest osadest:
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Estonian: • Ägedate süstimisega seotud reaktsioonide ja hilinenud raskete süsteemsete ülitundlikkusreaktsioonide risk, vajadus õpetada patsientidele ravimi manustamise võtteid ja juhend tervishoiutöötajatele, kuidas teavitada manustamisvigadest,