FrancophonIA/ELRC3.0 huggingface dataset:
English: As required by Article 107, France informed the CHMP of its intention to suspend the marketing authorisations in France, so that the Committee could prepare an opinion on whether the marketing authorisations for products containing meprobamate should be maintained, changed, suspended or withdrawn across the EU.
Estonian: Prantsusmaa ravimiamet teavitas artikli 107 kohaselt inimravimite komiteed oma kavatsusest peatada meprobamaati sisaldavate ravimite müügiload Prantsusmaal, nii et inimravimite komitee saaks ette valmistada arvamuse, kas meprobamaati sisaldavate ravimite müügiload tuleb kogu Euroopa Liidus säilitada, muuta, peatada või tühistada.
English: It will be the responsibility of each Member State to set the precise timeframe for this market withdrawal at national level, within the 15 month framework, and to assess the need for other activities, such as recommendations for prescribers and patients on safe and effective alternatives.
Estonian: Iga liikmesriik kehtestab ravimi turult kõrvaldamiseks täpse riikliku ajakava, mis ei tohi ületada 15 kuud, ning kaalub ka muude meetmete vajalikkust, nagu soovitused ravimi määrajatele ja patsientidele ohutute ja efektiivsete ravimite kohta.
English: Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps and insomnia.
Estonian: Meprobamaat on rahusti, mida kasutatakse ärevuse ja sellega seotud seisundite raviks, sealhulgas kõigi ärevusseisundite, alkoholi võõrutusnähtude, migreenihoogude, seedehäirete, lihaspinge võikrampide ning unetuse korral.
English: They are available as tablets containing meprobamate on its own or in combination with other medicines.
Estonian: Neid ravimeid turustatakse nii ainult meprobamaati sisaldavate tablettidena kui ka kombinatsioonis teiste ravimitega.
English: Questions and answers on the suspension of the marketing authorisations for oral meprobamatecontaining medicines
Estonian: Teave suukaudsete meprobamaati sisaldavate ravimite müügilubade peatamise kohta
English: • Prescribers should be aware that the availability of meprobamate-containing medicines will decrease as the withdrawal from the market takes place according to national timeframes.
Estonian: • Arstid peavad teadma, et meprobamaati sisaldavate ravimite kättesaadavus väheneb vastavalt meprobamaadi turult kõrvaldamise riiklikule ajakavale.
English: • Patients currently using meprobamate-containing medicines should speak to their doctor at their next scheduled appointment to review their treatment.
Estonian: • Praegu meprobamaati sisaldavaid ravimeid võtvad patsiendid peaksid järgmisel kavandatud külastusel arutama oma arstiga ravi läbivaatamist.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Estonian: • Patsiendid peavad mis tahes küsimuses võtma ühendust oma arsti või apteekriga.
English: In July 2011, the French medicines regulatory agency announced its intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.
Estonian: 2011. aasta juulis teatas Prantsusmaa ravimiamet oma kavatsusest peatada suukaudsete meprobamaati sisaldavate ravimite müügiload nende kasutamisel täheldatud raskete kõrvalnähtude tõttu.
English: The Committee considered that these risks were increased by the danger of unintentional overdose due to the small difference between the treating dose and the dose that can harm patients, including elderly people.
Estonian: Inimravimite komitee leidis, et riske suurendab ravimi tahtmatu üleannustamise oht, sest erinevus meprobamaadi raviannuse ja patsienti, sh eakaid kahjustada võiva annuse vahel on väike.
English: Finally, the CHMP considered that there was limited data on the benefits of meprobamate.
Estonian: Inimravimite komitee arvas ka, et meprobamaadi kasulikkuse kohta on vähe andmeid.
English: The Committee also considered information requested from the companies that market meprobamatecontaining medicines in the EU.
Estonian: Inimravimite komitee võttis arvesse ka meprobamaati Euroopa Liidus turustavate ettevõte teavet.
English: • Doctors should not start new patients on meprobamate-containing medicines.
Estonian: • Arstid ei tohi alustada uute patsientide ravi meprobamaadiga.
English: The European Medicines Agency has completed a review of the safety and effectiveness of oral meprobamate-containing medicines, due to serious side effects seen with the medicine.
Estonian: Euroopa Ravimiamet lõpetas suukaudsete meprobamaati sisaldavate ravimite ohutuse ja efektiivsuse läbivaatamise, mille põhjuseks olid ravimi kasutamisel täheldatud rasked kõrvalnähud.
English: These included confusion and loss of consciousness, particularly in elderly people, and the risk of addiction to the medicine when used for prolonged periods, with severe withdrawal symptoms on stopping treatment abruptly.
Estonian: Nimetatud kõrvalnähud olid segasus ja teadvuse kadu, eelkõige eakatel patsientidel, ning oht ravimsõltuvuse tekkeks pikaajalisel kasutamisel, millega kaasnesid rasked võõrutusnähud ravimi kasutamise järsul katkestamisel.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of oral meprobamate-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations for oral meprobamate-containing medicines should be suspended throughout the EU.
Estonian: Olemasolevate andmete hindamise ja inimravimite komitees toimunud teaduslike arutelude põhjal otsustas inimravimite komitee, et suukaudsete meprobamaati sisaldavate ravimite kasulikkus ei ole suurem kui nendega seotud ohud ja soovitas ravimite müügiload Euroopa Liidus peatada.
English: What are the recommendations for prescribers?
Estonian: Mis on komitee soovitused ravimit määravatele arstidele?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks, and that all marketing authorisations for oral medicines containing meprobamate should be suspended throughout the European Union (EU).
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et meprobamaadi kasulikkus ei ole suurem kui sellega kaasuvad riskid, mistõttu tuleb suukaudsete meprobamaati sisaldavate ravimite müügiload kogu Euroopa Liidus peatada.
English: The Committee acknowledged that it is important to allow for patients currently taking meprobamatecontaining medicines to be transferred gradually to alternative treatments, particularly due to the risks of severe withdrawal symptoms on stopping treatment abruptly.
Estonian: Inimravimite komitee nõustus, et on tähtis võimaldada praegu meprobamaati sisaldavaid ravimeid võtvatel patsientidel minna üle teistele ravimitele järk-järgult, eelkõige raskete võõrutusnähtude tekkeohu tõttu, kui ravi peatatakse järsult.
English: These included restricting these medicines to patients who could not use alternative medicines and limiting treatment to a maximum of twelve weeks.
Estonian: Prantsusmaal olid juba võetud meetmed meprobamaadiga seotud ohtude minimeerimiseks: ravimit lubati kasutada üksnes patsientidel, kes ei saanud teisi ravimeid kasutada ja ravi kestust piirati kuni maksimaalselt 12 nädalani.
English: The CHMP also noted that some patients can become addicted to the medicine, leading to serious side effects if they stop treatment abruptly after using it for a long time.
Estonian: Inimravimite komitee märkis ka, et mõnel patsiendil võib tekkida ravimisõltuvus meprobamaadi suhtes, mis viib raskete kõrvalnähtudeni, kui pikaajaline ravi järsult peatada.
English: The Committee recommended that the suspension should be implemented gradually to avoid the risk of severe withdrawal symptoms in patients stopping treatment abruptly.
Estonian: Inimravimite komitee soovitas peatada müügiload järk-järgult, et vältida raskete võõrutusnähtude teket patsientidel, kes ravimi kasutamise järsult katkestavad.
English: The CHMP considered the benefit-risk assessment carried out by the French medicines agency for meprobamate-containing medicines marketed in France, covering data from the period 2009 to 2011.
Estonian: Inimravimite komitee uuris Prantsusmaa ravimiameti koostatud kasulikkuse ja riski suhte hinnangut Prantsusmaal turustatavate meprobamaati sisaldavate ravimite kohta.
English: Meprobamatecontaining medicines can only be obtained with a prescription.
Estonian: Meprobamaati sisaldavad ravimid on retseptiravimid.
English: The CHMP noted that there was a risk of serious and potentially fatal side effects in patients taking meprobamate-containing medicines under normal conditions of use, including coma.
Estonian: Inimravimite komitee märkis, et patsientidel, kes tavatingimustel kasutavad meprobamaati sisaldavaid ravimeid, on raskete ja potentsiaalselt surmaga lõppeda võivate kõrvalnähtude, sealhulgas kooma oht.
English: • Doctors should review the treatment of patients currently taking meprobamate-containing medicines with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated.
Estonian: • Arstid peavad praegu meprobamaati sisaldavaid ravimeid kasutavate patsientide ravi läbi vaatama,
English: What is Fanaptum?
Estonian: Mis on Fanaptum?
English: It measured the time until the patient's symptoms came back (first relapse).
Estonian: Selles mõõdeti aega patsiendi sümptomite taastumiseni (esimene relaps).
English: Refusal of the marketing authorisation for Fanaptum (iloperidone) EMA/729957/2017
Estonian: Fanaptumi (iloperidoon) müügiloa andmisest keeldumine EMA/729957/2017
English: How does Fanaptum work?
Estonian: Kuidas Fanaptum toimib?
English: The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines.
Estonian: Need olid näiteks kasutuse piiramine, et ravimit kasutaksid ainult patsiendid, kellel muu antipsühhootikumiravi ei toiminud või ei olnud enam talutav, ja keelata kasutamine patsientidel, kelle organismis ravim piisavalt ei lagune või kes võtavad teatud muid ravimeid.
English: The company that applied for authorisation is Vanda Pharmaceuticals Ltd.
Estonian: Müügiluba taotles Vanda Pharmaceuticals Ltd.
English: The company informed the CHMP that there are no ongoing clinical studies with Fanaptum in the EU at the present time.
Estonian: Ettevõtte teatas inimravimite komiteele, et Fanaptumi kliinilisi uuringuid Euroopa Liidus praegu ei toimu.
English: By blocking these receptors, iloperidone is expected to normalise the activity of the brain and reduce the symptoms of the disease.
Estonian: Eeldatakse, et neid retseptoreid blokeerides normaliseerib iloperidoon ajutegevuse ja vähendab haiguse sümptomeid.
English: In this study, the main measure of effectiveness was the change in the patients' symptoms after 4 weeks, assessed using a standard scale for schizophrenia.
Estonian: Selles uuringus oli efektiivsuse põhinäitaja patsientide sümptomites pärast 4-nädalast ravi toimunud muutus, mida hinnati skisofreeniasümptomite standardse hindamisskaala abil.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Estonian: Pärast taotluse põhjenduste arutamist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas 9. novembril 2017 müügiloa andmisest keeldumist.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia.
Estonian: 20. juulil 2017 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades keelduda andmast ravimi Fanaptum müügiluba.
English: At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest.
Estonian: Esialgse soovituse ajal oli inimravimite komitee arvamusel, et Fanaptumi efektiivsus uuringutes oli väike.
English: During the re-examination the CHMP looked again at the data submitted by the company and the company's proposal to introduce several new measures to manage the risk of QT prolongation.
Estonian: Taasläbivaatamise ajal analüüsis inimravimite komitee uuesti ettevõtte esitatud andmeid ja ettevõtte ettepanekut võtta QT-intervalli pikenemise vastu mitu uut riskivähendusmeedet.
English: What consequences does this refusal have for patients in clinical trials?
Estonian: Kuidas mõjutab tagasivõtmine praegu kliinilistes uuringutes osalevaid patsiente?
English: The longterm study, involving 193 patients, compared Fanaptum with placebo.
Estonian: Pikaajalises uuringus (193 patsienti) võrreldi Fanaptumit platseeboga.
English: The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia.
Estonian: Lisaks märkis inimravimite komitee, et ravimi toime algab 2-3 nädalat pärast ravi alustamist, mis on problemaatiline äkiliste (ägedate) skisofreeniaepisoodide ravis.
English: The Committee considered that this risk was significant despite the measures proposed by the company to minimise it.
Estonian: Inimravimite komitee leidis, et see risk on oluline vaatamata ettevõtte kavandatavatele riskivähendusmeetmetele.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone)
Estonian: Fanaptumi (iloperidoon) müügiloa andmisest keeldumine
English: As a result, some patients may have increased blood concentrations of Fanaptum, which would increase their risk of QT prolongation.
Estonian: See võib suurendada mõnel patsiendil Fanaptumi sisaldust veres, mis omakorda suurendab QTintervalli pikenemise riski.
English: Fanaptum was expected to be used to treat schizophrenia in adults.
Estonian: Fanaptumit kavatseti kasutada skisofreenia raviks täiskasvanutel.
English: In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm.
Estonian: Ohutusprobleemidega seoses väljendas inimravimite komitee ettevaatust seoses Fanaptumi toimega südamele: Fanaptum pikendab QT-intervalli (muudab südame elektrilist talitlust), mis võib põhjustada eluohtlikke südame rütmihäireid.
English: Fanaptum is a medicine that contains the active substance iloperidone.
Estonian: Fanaptum on ravim, mis sisaldab toimeainena iloperidooni.
English: However, the CHMP was still concerned about the risk of QT prolongation and considered that the measures proposed would not appropriately address this risk in clinical practice.
Estonian: Inimravimite komiteele väljendas siiski ettevaatust QT-intervalli pikenemise suhtes ja märkis, et kavandatavad meetmed ei ole kliinilises praktikas riski leevendamiseks asjakohased.
English: The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment).
Estonian: Lühiajalises uuringus (567 patsienti) võrreldi Fanaptumit tsiprasidooni (skisofreeniaravim) ja platseeboga (näiv ravim).
English: In addition, the Committee was still concerned by the modest effectiveness of Fanaptum and its delayed onset of action.
Estonian: Lisaks väljendas komitee ettevaatust ka selle suhtes, et Fanaptumi efektiivsus on väike ja selle toime algab hilja.
English: Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia.
Estonian: Oletatakse, et iloperidoon blokeerib skisofreeniaga seotud neurotransmitterite dopamiini ja 5-hüdroksütrüptamiini (serotoniin) retseptorid.
English: The company presented the results of 2 main studies of 4 and 26 weeks' duration.
Estonian: Üks uuring kestis 4 ja teine 26 nädalat.
English: Therefore, the CHMP concluded that the benefits of Fanaptum did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Estonian: Inimravimite komitee järeldas seetõttu, et Fantumi kasulikkus ei ole suurem kui sellega kaasnevad riskid, ja soovitas müügiloa andmisest keelduda.
English: Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines.
Estonian: Inimravimite komitee väljendas ettevaatust ka seoses sellega, et Fanaptumit lagundavad organismis maksaensüümid, mille talitlus on teatud patsientidel ja teatud muude ravimite võtmisel vähenenud.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Estonian: Neurotransmitterid on keemilised ained, mis vahendavad närvirakkudevahelisi signaale.
English: The active substance in Fanaptum, iloperidone, is an antipsychotic medicine.
Estonian: Fanaptumi toimeaine iloperidoon on antipsühhootikum.
English: The way it works is unclear, but it is thought to attach to certain receptors (targets) for neurotransmitters on nerve cells in the brain.
Estonian: Iloperidooni toimemehhanism ei ole selge, kuid oletatakse, et aine seondub aju närvirakkude pinnal teatud neurotransmitterite retseptoritega.
English: What was Fanaptum expected to be used for?
Estonian: Milleks kavatseti Fanaptumit kasutada?
English: Do not use in dogs less than 6 weeks of age.
Estonian: Mitte kasutada vähem kui 6 nädala vanustel koertel.
English: Date of first authorisation: 23/02/2012
Estonian: Esmase müügiloa väljastamise kuupäev: 23/02/2012
English: A clinical response is normally seen within 3-4 days.
Estonian: Kliiniline ravivastus tekib üldjuhul 3-4 päeva jooksul.
English: RevitaCAM is presented in:
Estonian: RevitaCAM turustatakse:
English: The mouth should not be opened any wider than necessary to facilitate application.
Estonian: Suud ei tohi avada laiemalt, kui on vajalik manustamise hõlbustamiseks.
English: Please carefully follow the instructions of the veterinarian.
Estonian: Järgige hoolikalt veterinaararsti juhiseid.
English: This product is for dogs and should not be used in cats as it is not suitable for use in this species.
Estonian: Ravim on ette nähtud koertele ning seda ei tohi kasutada kassidel, sest see ei sobi kasutamiseks sellel loomaliigil.
English: These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Estonian: Need kõrvaltoimed tekivad üldjuhul esimesel ravinädalal ja on enamikul juhtudel mööduvad ja kaovad pärast ravi lõppu, kuid võivad väga harvadel juhtudel olla ka tõsised või surmaga lõppeda.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Estonian: Veterinaarravimi ohutus tiinuse ja laktatsiooni perioodil ei ole tõestatud (vt lõik 4.3).
English: The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Estonian: Ravivaba perioodi kasutamisel tuleb siiski võtta arvesse varem kasutatud ravimite farmakoloogilisi omadusi.
English: The MAH must ensure that the system of pharmacovigilance as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Estonian: Müügiloa hoidja peab tagama, et müügiloa taotluse I osas kirjeldatud ravimiohutuse järelevalve süsteem on olemas ja toimib enne veterinaarravimi turule toomist ja turustamise ajal.
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Estonian: In vitro ja vivo uuringute tulemuste kohaselt inhibeerib meloksikaam tsüklooksügenaas-2 (COX-2) rohkem kui tsüklooksügenaas-1 (COX-1).
English: The pump should be depressed fully, ensuring no mist escapes from the mouth.
Estonian: Pump tuleb täielikult alla vajutada, jälgides, et pihustust suust ei väljuks.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Estonian: Eelravi põletikuvastaste ainetega võib tekitada täiendavaid kõrvaltoimeid või kõrvaltoimeid tugevdada ning seetõttu tuleb jätta ravivaba periood nende veterinaarravimitega vähemalt 24 tunniks enne ravi algust.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Estonian: Ligikaudu 75% manustatud annusest elimineerub väljaheitega ja ülejäänud osa uriiniga.
English: If RevitaCAM is not used for two days or more, re-prime with one or more sprays or until a fine spray appears.
Estonian: Kui RevitaCAMi ei ole kaks päeva või kauem kasutatud, eeltäitke see ühe või mitme pihustusega kuni peene pihustuse tekkimiseni.
English: Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Estonian: Meloksikaam imendub pärast suuõõnde manustamist täielikult ja maksimaalsed kontsentratsioonid vereplasmas saavutatakse ligikaudu 4,5 tunni pärast.
English: Remove Cap
Estonian: Eemaldage kork
English: If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought.
Estonian: Kõrvaltoimete tekkimisel tuleb ravi katkestada ja pidada nõu veterinaararstiga.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid): Üleannustamise korral tuleb alustada sümptomaatilist ravi.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Estonian: Vältida kasutamist dehüdreerunud, hüpovoleemilistel või hüpotensiivsetel loomadel, sest neil võib suureneda neerudele mürgisuse avaldumise risk.
English: The volume of distribution is 0.3 l/kg.
Estonian: Jaotusmaht on ligikaudu 0,3 1/kg.
English: Spray RevitaCAM into dog's mouth
Estonian: Pihustage RevitaCAM koerale suhu
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Estonian: Teised mittesteroidsed põletikuvastased ravimid, diureetikumid, antikoagulandid, aminoglükosiidantibiootikumid ja muud valkudega hästi seonduvad ained võivad seondumisel selle ravimiga konkureerida, tekitades toksilisi toimeid.
English: The mist should be directed to the back and towards the gums and/or inner cheek, mucosal surfaces.
Estonian: Pihustus suunatakse tahapoole ja igemetele ja/või põse sisepinnale, limaskestadele.
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Estonian: Meloksikaam seondub vereplasma valkudega ligikaudu 97% ulatuses.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja pudelil.
English: In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration.
Estonian: Mõnel koeral võib vahetult pärast ravimi manustamist täheldada aevastamist, köha/öökimist või ilastamist.
English: Maintenance dosage range meloxicam delivered (mg/kg)*
Estonian: Manustatava meloksikaami säilitava annuse vahemik (mg/kg)*
English: Shelf-life of the veterinary medicinal product as packaged for sale: 30 months Shelf-life after first opening the immediate packaging: 6 months
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 30 kuud Kõlblikkusaeg pärast vahetu pakendi esmast avamist: 6 kuud