FrancophonIA/ELRC3.0 huggingface dataset:
English: To limit the risk of side effects affecting the liver, several restrictions have already been introduced in the past, including restriction to second line treatment, the use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain.
Estonian: Maksaga seotud kõrvalnähtude tekkeriski vähendamiseks on ravimi kasutamisele juba varem seatud mitmeid piiranguid, sealhulgas nõue kasutada nimesuliidi ainult teise valiku ravimina, soovitus kasutada väikseimat efektiivset annust lühima võimaliku aja vältel ja ägeda valu ravi maksimaalne kestus.
English: • primary dysmenorrhoea (period pains).
Estonian: • primaarne düsmenorröa (valulik menstruatsioon).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of nimesulide used systemically continue to outweigh its risks but that its use should be restricted to the treatment of acute pain and primary dysmenorrhoea.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et süsteemselt kasutatava nimesuliidi kasulikkus on endiselt suurem kui sellega kaasnevad riskid, aga selle kasutamine peab piirduma üksnes ägeda valu ja primaarse düsmenorröa raviga.
English: The CHMP also concluded that a fuller review of nimesulide was needed, that would look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original review.
Estonian: Samuti järeldas inimravimite komitee, et nimesuliidi teave vajab põhjalikumat läbivaatamist, mis käsitleks kõiki ravimi võimalikke riske, eriti mao ja soolega seotud kõrvalnähte, mida ei käsitletud esialgsel läbivaatamisel.
English: • Prescribers should review treatment of patients being treated for painful osteoarthritis with a view to choosing an appropriate alternative treatment.
Estonian: • Arstid peavad üle vaatama nende patsientide ravi, kes kasutavad praegu nimesuliidi osteoartroosist tingitud valu raviks, et määrata neile sobiv muu ravi.
English: To this effect the Committee recommended that treatment duration should be limited to a maximum of 15 days (packs were also limited to a two-week supply), that nimesulide should be restricted to second line treatment, and that doctors should be clearly informed of the risk.
Estonian: Selleks soovitas inimravimite komitee piirata ravi maksimaalse kestuse 15 päevaga (samuti vähendati pakendi suurust, et ravimit jätkuks ainult kahenädalaseks raviks), kasutada nimesuliidi üksnes teise valiku
English: The Committee considered that the use of systemic nimesulide for the treatment of painful osteoarthritis, which is a chronic condition, will increase the risk of the medicines being used for long-term treatment with a consequent increase in the risk of liver injury.
Estonian: Komitee leidis, et süsteemse nimesuliidi kasutamine osteoartroosist (krooniline haigusseisund) tingitud valu raviks suurendab ravimi pikaajalise kasutamise riski.
English: • Prescribers should no longer prescribe systemic nimesulide for treating painful osteoarthritis.
Estonian: • Arstid ei tohi enam määrata süsteemset nimesuliidi osteoartroosist tingitud valu raviks.
English: The review procedure was triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, due to new information regarding cases of fulminant hepatic failure requiring liver transplantation.1 The Committee concluded that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Estonian: Läbivaatamismenetluse põhjuseks oli Iirimaa ravimiameti 2007. aasta mai otsus peatada nimesuliidi sisaldavate süsteemsete ravimite müügiload tingituna uutest andmetest fulminantse (ülikiire kuluga) ja maksasiirdamist vajanud maksapuudulikkuse juhtude kohta1.
English: The CHMP is now recommending, as a further restriction, that systemic nimesulide should no longer be used for treating painful osteoarthritis.
Estonian: Komitee soovitab nüüd lisapiiranguna, et nimesuliidi ei tohi enam kasutada osteoartroosist tingitud valu raviks.
English: In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs.
Estonian: Ohutuse osas märkis inimravimite komitee, et nimesuliidi kasutamisel on mao- ja sooleprobleemide tekke risk sama suur kui teiste NSAID-ravimite kasutamisel.
English: The CHMP concluded that nimesulide was associated with an increased risk of liver toxicity compared with other anti-inflammatory treatments.
Estonian: Inimravimite komitee järeldas, et nimesuliidi kasutamine on teiste põletikuvastaste ravimitega võrreldes seotud maksatoksilisuse suurema riskiga.
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Estonian: Nimesuliid on mitteselektiivne mittesteroidne põletikuvastane ravim (NSAID-ravim), mida kasutatakse järgmiste seisundite raviks:
English: • painful osteoarthritis (swelling in the joints) ,
Estonian: • osteoartroosist (liigesepaistetus) tingitud valu;
English: It issued a recommendation that it should no longer be used for the treatment of painful osteoarthritis.
Estonian: Komitee soovitas, et nimesuliidi ei tohi enam kasutada osteoartroosist tingitud valu raviks.
English: • Patient currently receiving systemic nimesulide for painful osteoarthritis should consult their doctor in order to arrange alternative treatment.
Estonian: • Patsiendid, kes praegu kasutavad süsteemset nimesuliidi osteoartroosist tingitud valu raviks,
English: A summary of the recommended changes will be published on the EMA website.
Estonian: Soovitatud muudatuste kokkuvõte avaldatakse EMA veebilehel.
English: Metamizole-containing medicines are available in Austria, Belgium, Bulgaria, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Estonian: Metamisooli sisaldavaid ravimeid turustatakse Austrias, Belgias, Bulgaarias, Hispaanias, Horvaatias, Itaalias, Leedus, Luksemburgis, Lätis, Madalmaades, Poolas, Portugalis, Rumeenias, Saksamaal, Slovakkias, Sloveenias, Soomes, Tšehhi Vabariigis, Ungaris.
English: They are marketed under a variety of names including Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin and Tempimet.
Estonian: Neid ravimeid turustatakse eri nimetuste all, sealhulgas Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin ja Tempimet.
English: The review of metamizole was initiated on 31 May 2018 at the request of Poland, under Article 31 of Directive 2001/83/EC.
Estonian: Metamisooli läbivaatamismenetlus algatati 31. mail 2018 Poola taotlusel vastavalt direktiivi 2001/83/EÜ artiklile 31.
English: Treatment should start at the lowest recommended dose and only be increased if needed.
Estonian: Ravi tuleks alustada väikseimast soovitatavast annusest, mida tuleks suurendada üksnes vajaduse korral.
English: 20 March 2019 EMA/191666/2019
Estonian: 20. märts 2019 EMA/191666/2019
English: • Updated summaries of product characteristics (information for healthcare professionals) and package leaflets for patients which contain the new recommendations will be available nationally following the final legal decision issued by the European Commission.
Estonian: • Ravimi omaduste ajakohastatud kokkuvõtted (teave tervishoiutöötajatele) ja uusi soovitusi sisaldavad pakendi infolehed patsientidele tehakse riikides kättesaadavaks pärast Euroopa Komisjoni lõplikku õiguslikult siduvat otsust.
English: • Patients who have any concerns about their medication should consult their doctor or pharmacist.
Estonian: • Ravimiga seotud küsimuste korral peaksid patsiendid pidama nõu oma arsti või apteekriga.
English: E M A /191666/2019
Estonian: EMA/191666/2019
English: EMA's recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age.
Estonian: EMA soovitab muu hulgas kehtestada maksimaalne ühekordne suukaudne annus 1000 mg kuni 4 korda ööpäevas (maksimaalne ööpäevane annus 4000 mg) vähemalt 15-aastastel patsientidel.
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Estonian: Läbivaatamise teostas inimravimite komitee, kes vastutab inimravimitega seotud küsimuste eest ja kes võttis vastu Euroopa Ravimiameti arvamuse.
English: Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce.
Estonian: Ehkki metamisool on olnud turul peaaegu sajandi, on vähe tõendeid selle mõju kohta raseduse ja imetamise ajal.
English: Metamizole (also known as dipyrone) is an analgesic medicine (painkiller) that can also relieve fever and muscle spasm.
Estonian: Metamisool (teise nimetusega dipüroon) on analgeetikum (valuvaigisti), mis võib leevendada ka palavikku ja lihasespasme.
English: The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
Estonian: Amet vaatas läbi olemasoleva teabe selle kohta, kuidas ravim organismis jaotub ja toimib, ning piiratud andmed selle mõju kohta lootele või rinnaga toidetavatele imikutele.
English: The review was carried out by EMA's human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.
Estonian: Läbivaatamismenetluse teostas EMA inimravimikomitee Poola taotlusel, kes pidas probleemseks olulisi erinevusi metamisooli kasutamise soovitustes ELi eri riikides, arvestades, et on teada, et see ravim võib mõnikord põhjustada raskeid kõrvalnähte, näiteks toime verele.
English: EMA's recommendations were forwarded to the European Commission, which issued a final legally binding decision valid across the EU on 20 March 2019.
Estonian: EMA soovitused saadeti Euroopa Komisjonile, kes võttis 20. märtsil 2019 vastu kogu ELi territooriumil kehtiva õiguslikult siduva lõpliku otsuse.
English: As a precaution, metamizole should not be used during breastfeeding because the infant may receive high amounts of the medicine in the milk relative to the infant's weight.
Estonian: Ettevaatusabinõuna ei tohi metamisooli kasutada imetamise ajal, sest imik võib oma kehamassi suhtes saada piimaga suure koguse ravimit.
English: The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used.
Estonian: Läbivaatamisel ei leitud kindlaid tõendeid probleemidest raseduse varases etapis ning ühekordsed annused võivad esimese 6 kuu jooksul olla lubatud, kui ei ole võimalik kasutada muid valuvaigisteid.
English: However, there was some evidence of effects on the kidneys and circulation of the fetus if the medicine were used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period.
Estonian: Leiti siiski mõned tõendid, et ravim mõjutas loote neerusid ja vereringet, kui ravimit kasutati raseduse viimases trimestris, ning seetõttu ei tohi ravimit sel perioodil kasutada.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20 March 2019.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile, kes tegi 20. märtsil 2019 lõpliku õiguslikult siduva otsuse, mida kohaldatakse kõigis Euroopa Liidu liikmesriikides.
English: • EMA has recommended changes to the product information of metamizole, to ensure that advice on the maximum daily doses and warnings not to use the medicine during the last 3 months of pregnancy or during breastfeeding are consistent across the EU.
Estonian: • EMA soovitas muuta metamisooli ravimiteavet, et tagada kogu ELis ühtsed nõuanded maksimaalsete ööpäevaste annuste kohta ja hoiatused mitte kasutada ravimit raseduse viimase trimestri või imetamise ajal.
English: The recommendation addressed inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.
Estonian: Soovituses käsitleti ravimiteabe vastuolusid metamisooli sisaldavate ravimite korral, mida turustatakse paljudes ELi liikmesriikides, et ravida tugevat valu ja palavikku, mis ei allu muule ravile.
English: It has been used for many decades in the EU by mouth, as suppositories or by injection, to treat severe pain and fever that cannot be controlled with other treatments.
Estonian: Seda on ELis aastakümneid kasutatud kas suukaudselt, suposiidi või süstina, et ravida tugevat valu ja palavikku, mis ei allu muule ravile.
English: On 13 December 2018, following a review of medicines containing the painkiller metamizole, EMA recommended that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the EU market.
Estonian: Pärast valuvaigistit metamisooli sisaldavate ravimite läbivaatamismenetlust soovitas Euroopa Ravimiamet (EMA) 13. detsembril 2018 ühtlustada kõikide ELi turul olevate metamisooli sisaldavate ravimite maksimaalsed ööpäevased annused ja nende kasutamise vastunäidustused raseduse või imetamise ajal.
English: If given by injection the total daily dose should not exceed 5,000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.
Estonian: Nooremate patsientide annused peaksid põhinema nende kehamassil, ent mõned ravimid võivad olla tugeva toime tõttu ebasobivad.
English: • EMA has completed a review of the painkiller metamizole, used in many EU countries to treat severe pain and fever that cannot be controlled with other treatments.
Estonian: Seda kasutatakse paljudes ELi riikides, et ravida tugevat valu ja palavikku, mis ei allu muule ravile.
English: Ristempa pegfilgrastim
Estonian: Ristempa pegfilgrastiim
English: This summary was last updated in 04-2015.
Estonian: Kokkuvõtte viimane uuendus: 04-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristempa on 13 April 2015.
Estonian: Euroopa Komisjon andis Ristempa müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. aprillil 2015.
English: What measures are being taken to ensure the safe and effective use of Ristempa?
Estonian: Mis meetmed võetakse, et tagada Ristempa ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Ristempa is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Ristempa võimalikult ohutu kasutamine.
English: What is Ristempa and what is it used for?
Estonian: Mis on Ristempa ja milleks seda kasutatakse?
English: The full EPAR and risk management plan summary for Ristempa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Ristempa kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Ristempa approved?
Estonian: Miks Ristempa heaks kiideti?
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Estonian: Filgrastiimi on Euroopa Liidus muude ravimite koostisainena turustatud mitmeid aastaid.
English: This medicine is the same as Neulasta, which is already authorised in the European Union (EU).
Estonian: See ravim on samane Neulastaga, millel juba on Euroopa Liidus müügiluba.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What are the risks associated with Ristempa?
Estonian: Mis riskid Ristempaga kaasnevad?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ristempa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Ristempa kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It is not intended to provide practical advice on how to use Ristempa.
Estonian: Hindamisaruandes ei anta Ristempa kasutamise praktilisi nõuandeid.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Estonian: Efektiivsuse põhinäitaja oli raske neutropeenia kestus esimese keemiaravitsükli jooksul.
English: It is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Estonian: Seda manustatakse 6 mg ühekordse nahaaluse süstena ligikaudu 24 tundi pärast iga keemiaravitsükli lõppu.
English: The company that makes Neulasta has agreed that its scientific data can be used for Ristempa (‘informed consent').
Estonian: Neulasta tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Ristempa toetuseks (teabel põhinev nõusolek).
English: Other information about Ristempa
Estonian: Muu teave Ristempa kohta
English: Patients can inject themselves if they have been trained appropriately.
Estonian: Kui patsiendid on saanud asjakohast õpetust, võivad nad end ise süstida.
English: Ristempa has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Estonian: Ristempat uuriti kahes põhiuuringus, milles osales 467 rinnavähiga patsienti, kes said tsütotoksilist keemiaravi.
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when neither medicine is used.
Estonian: Mõlemas uuringus kestis patsientidel raske neutropeenia esimese keemiaravitsükli jooksul 1,7 päeva, kumbagi ravimit kasutamata kestis see 5-7 päeva.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristempa, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Ristempa omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The most common side effects with Ristempa (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick).
Estonian: Ristempa kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on luu- ja lihasvalu, peavalu ja iiveldus.
English: Ristempa is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Estonian: Ristempat kasutatakse neutropeenia kestuse ja febriilse neutropeenia (palavikuga neutropeenia) esinemissageduse vähendamiseks.
English: Ristempa is a medicine used in cancer patients to help with some of the side effects of their treatment.
Estonian: Ristempat kasutatakse vähktõvega patsientidel, et anda abi nende ravi teatud kõrvalnähtude vastu.
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Estonian: Et filgrastiim on pegfilgrastiimis pegüleeritud, väljub ravim organismist aeglasemalt ja seda võib anda harvemini.
English: How is Ristempa used?
Estonian: Kuidas Ristempat kasutatakse?
English: Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia.
Estonian: Ristempa oli raske neutropeenia kestuse vähendamisel sama efektiivne kui filgrastiim.
English: Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections.
Estonian: Tsütotoksiline (rakke hävitav) keemiaravi (vähktõve ravi) hävitab ka vere valgeliblesid, mis võib põhjustada neutropeeniat (valgeliblede neutrofiilide vähesus; neutrofiilid võitlevad nakkuste vastu) ja nakkuste teket.
English: Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg pegfilgrastim.
Estonian: Ristempat turustatakse süstelahusena eeltäidetud süstaldes, mis sisaldavad 6 mg pegfilgrastiimi.
English: The active substance in Ristempa, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF), that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Estonian: Ristempa toimeaine pegfilgrastiim koosneb filgrastiimist - inimvalgu granulotsüütide kolooniat stimuleeriva faktori (G-CSF) koopiast -, mis on pegüleeritud (kaetud polüetüleenglükooliga (PEG)).
English: It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).
Estonian: Samuti ei saa seda kasutada müelodüsplastiliste sündroomidega (haigus, mille korral valgeliblesid tekib liiga palju, mis võib areneda leukeemiaks) patsientidel.
English: For practical information about using Ristempa, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Ristempa kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Ristempa.
Estonian: See on ravimi Ristempa Euroopa avaliku hindamisaruande kokkuvõte.
English: In both studies, a single injection of Ristempa was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Estonian: Mõlemas uuringus võrreldi Ristempa ühekordse süste ja ööpäevas mitu korda tehtud filgrastiimi süste efektiivsust kõigi nelja keemiaravitsükli ajal.
English: Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Estonian: Filgrastiim ergutab luuüdi tootma rohkem valgeliblesid, see suurendab valgeliblede hulka ja ravib neutropeeniat.
English: Ristempa cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells).
Estonian: Ristempat ei saa kasutada patsientidel, kellel on krooniline müeloidleukeemia (valgeliblede vähk).
English: What benefits of Ristempa have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ristempa kasulikkus?