FrancophonIA/ELRC3.0 huggingface dataset:
English: CHMP, the contraindication for the use of topiramate for migraine prophylaxis in pregnancy or women of child bearing potential without adequate contraception has been included by the MAH for the indication migraine prophylaxis.
Estonian: Vastavalt inimravimite komitee soovitusele lisas müügiloa hoidja ravimi omaduste kokkuvõttesse vastunäidustuse topiramaadi kasutamiseks migreeni profülaktikas raseduse ajal ja tõhusaid rasestumisvastaseid vahendeid mittekasutavate viljastumisvõimeliste naiste korral.
English: • Hoarseness of the voice
Estonian: • Hääle kähedus
English: Joint swelling*, musculoskeletal stiffness, flank pain, muscle fatigue
Estonian: Liigeste tursed*, skeletilihaste kangus, küljevalu, lihasväsimus
English: Nephrolithiasis
Estonian: Pioglitasoon
English: DATE OF REVISION OF THE TEXT
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV [Täidetakse riiklikult]
English: 20 October 2015 EMA/490629/2015
Estonian: oktoober 2015 EMA/490629/2015
English: Their frequency has not been established.
Estonian: Nende esinemissagedus on määramata.
English: Although possible beneficial effects were observed, the data were insufficient to be used as evidence, particularly because in these studies matricaria flower was not compared with any other treatment.
Estonian: Kuigi täheldati võimalikku kasulikku toimet, ei piisanud nendest andmetest tõenditena kasutamiseks, eelkõige seetõttu, et nendes uuringutes ei võrreldud kummeliõit ühegi muu ravimeetodiga.
English: Matricaria flower medicines are usually for use in adults and adolescents (above 12 years of age).
Estonian: Kummeliõit sisaldavaid ravimeid kasutatakse tavaliselt täiskasvanutel ja noorukitel (üle 12aastastel).
English: • relieving the symptoms of common cold;
Estonian: • külmetuse sümptomite leevendamine;
English: (furuncles).
Estonian: Kummeliõis
English: Matricaria flower medicines must not be used in patients allergic to matricaria flowers or other plants of the Asteraceae (Compositae) family.
Estonian: Kummeliõit sisaldavaid ravimeid ei tohi kasutada patsiendid, kes on allergilised kummeliõite või teiste Asteraceae (Compositae) sugukonna taimede vastu.
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol).
Estonian: Ekstrakte valmistatakse taimeosadest ühendite ekstraheerimise teel, lahustades need lahustis (nt etanoolis).
English: Further information on the risks associated with matricaria flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave kummeliõit sisaldava ravimiga kaasnevate riskide, sh selle ohutu kasutamise ettevaatusabinõude kohta, on ravimtaime monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of matricaria flower medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave kummeliõit sisaldava ravimi hinnangu kohta, sh komitee kokkuvõtte detailne kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: • as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a doctor;
Estonian: • naha- ning päraku- ja suguelundipiirkonna ärrituste ravi lisaravim, kui arst on välistanud raskemad haigused;
English: Patients with severe heart and circulation problems should not have full baths with matricaria flowers.
Estonian: Raskete südame- ja vereringeprobleemidega patsientidele ei tohi teha kummeliõie täisvanni.
English: The HMPC conclusions on the use of matricaria flower medicines for the above-mentioned indications are based on their ‘traditional use' in these conditions.
Estonian: Taimsete ravimite komitee järeldused kummeliõit sisaldavate ravimite kasutamise kohta eespool nimetatud näidustustel põhinevad nende traditsioonilisel kasutamisel selliste seisundite korral.
English: Herbal medicines containing matricaria flower preparations are available as herbal teas to be drunk or their steam inhaled; as infusions to be applied onto the skin or lining of the mouth; as liquid forms to be taken by mouth, used for steam inhalation, for rinsing the mouth or applied on the skin, or used as bath additives; and as semi-solid forms (such as ointments) to be applied onto the skin.
Estonian: Kummeliõie valmistisi sisaldavaid taimseid ravimeid turustatakse tavaliselt joodavate või auruna inhaleeritavate taimeteedena; nahale või suu limaskestale kantavate leotistena; suukaudsete, auruna inhaleeritavate, suuloputus-, nahale kantavate või vannilisandina kasutatavate vedelikena ning nahale kantavate pooltahkete ainetena (nt salvid).
English: In its assessment, the HMPC also considered several clinical studies with matricaria flower used for different conditions.
Estonian: Hindamise käigus vaatas taimsete ravimite komitee läbi ka mitu kliinilist uuringut kummeliõie kasutamisest erinevate seisundite korral.
English: The HMPC concluded that, on the basis of its long-standing use, matricaria flower medicines can be used for the following:
Estonian: Taimsete ravimite komitee järeldas, et lähtudes taime pikaajalisest kasutamisest tohib kummeliõit sisaldavaid ravimeid kasutada järgmistel juhtudel:
English: Any applications for the licensing of medicines containing matricaria flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Kummeliõit sisaldava ravimi müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimse ravimi müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslike järelduste kokkuvõtet.
English: Only some matricaria flower preparations are recommended for use in children below 12 years.
Estonian: Alla 12-aastastel lastel soovitatakse kasutada üksnes teatud kummeliõie valmistisi.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing matricaria flower.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad kummeliõit sisaldavate taimsete ravimite müügilubade taotlusi.
English: Matricaria flower can also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis esineb kummeliõit ka kombinatsioonis teiste taimsete ainetega.
English: What is matricaria flower?
Estonian: Mis on kummeliõis?
English: What evidence supports the use of matricaria flower medicines?
Estonian: Millised tõendid toetavad kummeliõit sisaldava ravimi kasutamist?
English: Other information about matricaria flower medicines
Estonian: Muu teave kummeliõit sisaldava ravimi kohta
English: How are matricaria flower medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus kummeliõit sisaldavale ravimile müügiluba?
English: Patients with open wounds, extensive skin damage or acute (short-term) skin disease, high fever and severe infections should not have full or partial baths with matricaria flowers.
Estonian: Kummeliõie täis- või osalist vanni ei tohi teha patsientidele, kellel on lahtised haavad, ulatuslikud nahakahjustused, äge (lühiajaline) nahahaigus, kõrge palavik ja rasked infektsioonid.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of matricaria flower.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb kummeliõie meditsiinilisi kasutusviise.
English: Matricaria flower is the common name for the flower heads of the plant Matricaria recutita L. (also known as chamomile).
Estonian: Kummeliõis on taime Matricaria recutita L. (tuntud ka kui kummel) õisikute üldnimetus.
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than one week during treatment.
Estonian: Kui ravi ajal püsivad sümptomid üle ühe nädala, tuleb pöörduda arsti või pädeva tervishoiutöötaja poole.
English: What are the risks associated with matricaria flower medicines?
Estonian: Mis riskid kaasnevad kummeliõit sisaldava ravimiga?
English: For practical information about using matricaria flower medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate kummeliõit sisaldava ravimi kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For dry extracts the solvent is then evaporated to obtain the extract.
Estonian: Kuivekstrakti saamiseks lahusti seejärel aurustatakse.
English: Matricaria flower preparations are obtained by comminuting (reducing into tiny pieces) the flower, or as dry or liquid extracts.
Estonian: Kummeliõie valmistisi saadakse kuivatatud õisi peenestades (väikesteks tükkideks lõigates) või kuivvõi vedelekstraktist.
English: For more information about treatment with matricaria flower medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate lisateavet kummeliõit sisaldava ravimi kasutamise kohta, lugege palun pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The flowers for medicinal use are obtained either from plants that have been cultivated or found in the wild.
Estonian: Meditsiiniliselt kasutatavad õied saadakse kasvatatud või loodusest leitud taimedelt.
English: Therefore, the HMPC conclusions on the use of matricaria flower medicines are based on their long-standing use.
Estonian: Seetõttu põhinevad taimsete ravimite komitee järeldused kummeliõit sisaldavate ravimite kasutamise kohta nende pikaajalisel kasutamisel.
English: Detailed instructions on how to take matricaria flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Kummeliõit sisaldavate ravimite võtmise ja näidustuse üksikasjalik teave on ravimi pakendi infolehel.
English: Allergic reactions, sometimes severe, have been reported following contact of liquid chamomile preparations with internal moist surfaces such as the lining of the mouth.
Estonian: Vedelate kummeliõie valmististe kokkupuutumisel limaskestaga, nt suu limaskestaga, on teatatud allergilistest ja mõnikord rasketest allergilistest reaktsioonidest.
English: • treating minor inflammation of the skin (sunburn) and superficial wounds and small boils
Estonian: • kergete nahapõletike (päikesepõletus), pindmiste haavade ja väikeste paisete (furunklid) ravi.
English: Information on the use and licensing of matricaria flower medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab teavet kummeliõit sisaldava ravimi kasutamise ja müügiloa kohta riiklikult ravimiametilt.
English: • treating the symptoms of minor gastro-intestinal (stomach and gut) complaints such as bloating and minor spasms;
Estonian: • seedetrakti (mao ja soole) kergemate sümptomite, nagu kõhupuhituse ja nõrkade spasmide ravi;
English: This summary is not intended to provide practical advice on how to use medicines containing matricaria flower.
Estonian: Kokkuvõttes ei anta kummeliõit sisaldava ravimi kasutamise kohta praktilisi nõuandeid.
English: • treating minor ulcers (open sores) and inflammations of the mouth and throat;
Estonian: • suu ja kurgu väikeste haavandite (lahtised haavad) ja põletike ravi;
English: EMEA/H/C/000549
Estonian: EMA/741008/2015 EMEA/H/C/000549
English: Each injection lasts 15 minutes.
Estonian: Iga süste peab kestma 15 minutit.
English: Pedea ibuprofen
Estonian: Pedea ibuprofeen
English: The European Commission granted a marketing authorisation valid throughout the European Union to Orphan Europe SARL on 29 July 2004.
Estonian: Euroopa Komisjon andis Pedea müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Orphan Europe SARL 29. juulil 2004.
English: The full EPAR for Pedea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Pedea kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Pedea
Estonian: Muu teave Pedea kohta
English: The first injection is given when the baby is at least six hours old.
Estonian: Esimene süst tehakse imikule, kes on vähemalt kuus tundi vana.
English: Because ibuprofen has been in use for a long time, the company presented information from the published literature.
Estonian: Et ibuprofeeni on kasutatud kaua, esitas ettevõte avaldatud kirjandusest pärinevaid andmeid.
English: This is a summary of the European public assessment report (EPAR) for Pedea.
Estonian: See on ravimi Pedea Euroopa avaliku hindamisaruande kokkuvõte.
English: The main measure of effectiveness was the number of babies whose ductus arteriosus closed without the need for surgery.
Estonian: Efektiivsuse põhinäitaja oli vastsündinute arv, kelle arterioosjuha sulgus ilma kirurgilise sekkumiseta.
English: The CHMP decided that Pedea's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Pedea kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: The active substance in Pedea, ibuprofen, has been used since the 1960s as a painkiller and an anti inflammatory medicine.
Estonian: Pedea toimeainet ibuprofeeni on kasutatud alates 1960. aastatest valuvaigisti ja põletikuleevendina.
English: It also presented the results of studies, including one study looking at different doses of Pedea in 40 newborn premature babies.
Estonian: Ettevõte esitas ka uuringutulemused, sealhulgas sellise uuringu tulemused, kus vaadeldi Pedea eri annuste toimet 40 enneaegsele vastsündinule.
English: What is Pedea?
Estonian: Mis on Pedea?
English: For more information about treatment with Pedea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 11-2015.
Estonian: Kui vajate Pedeaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.Kokkuvõtte viimane uuendus: 11-2015.
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 Pedea.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Pedea is given as three injections into a vein at 24-hour intervals.
Estonian: Pedeat manustatakse 24-tunniste intervallidega kolme veenisüstina.
English: In the study looking at the treatment of patent ductus arteriosus, the approved dose of Pedea led to a closure rate of 75% in babies born 11 to 13 weeks premature (six out of eight) and 33% in babies born 14 to 16 weeks premature (two out of six).
Estonian: Avatud arterioosjuha ravimise uuringus oli vastsündinuist neid, kellel Pedea heakskiidetud annuse korral arterioosjuha sulgus, 11-13 nädala võrra enneaegsetest vastsündinutest 75% (6 vastsündinut 8st) ja 14-16 nädala võrra enneaegsetest vastsündinutest 33% (2 vastsündinut 6st).
English: However, the study had to be stopped early because of side effects (kidney and lung problems).
Estonian: Uuring tuli ilmnenud kõrvalnähtude (neeru- ja kopsuprobleemid) tõttu siiski katkestada.
English: Why has Pedea been approved?
Estonian: Miks Pedea heaks kiideti?
English: What is the risk associated with Pedea?
Estonian: Mis riskid Pedeaga kaasnevad?
English: If the condition is unchanged after the second course of therapy, surgery may be necessary.
Estonian: Kui haigusseisund püsib ka teise ravikuuri järel, võib olla vaja sekkuda kirurgiliselt.
English: The most common side effects seen in babies receiving the medicine (seen in more than 1 baby in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely), increased blood creatinine levels (a marker of kidney function) and decreased blood sodium levels.
Estonian: Pedeat saanud vastsündinute kõige sagedamad kõrvalnähud (esinenud enam kui 1 vastsündinul 10st) on trombotsütopeenia (vereliistakute vähesus), neutropeenia (vere teatud valgeliblede neutrofiilide vähesus), bronhopulmonaalne düsplaasia (ebanormaalne kopsukude, mis esineb tavaliselt enneaegsetel vastsündinutel), vere suurenenud kreatiniinisisaldus (neeruprobleemide marker) ja vere vähenenud naatriumisisaldus.
English: Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).
Estonian: Ravi Pedeaga peab toimuma üksnes vastsündinute intensiivravi osakonnas ja kogenud neonatoloogi (vastsündinutele spetsialiseerunud arst) järelevalve all.
English: This causes heart and lung problems in the baby.
Estonian: See põhjustab vastsündinul kopsuprobleeme.
English: In study looking at the use of Pedea before there was proof that the babies had patent ductus arteriosus, Pedea seemed to be more effective than placebo at preventing surgery.
Estonian: Uuringus, kus uuriti Pedea kasutamist enne vastsündinute avatud arterioosjuha leiu kinnitamist, näis Pedea olevat kirurgilise operatsiooni ennetamisel efektiivsem kui platseebo.
English: Pedea is a solution for injection that contains the active substance ibuprofen.
Estonian: Pedea on süstelahus, mis sisaldab toimeainena ibuprofeeni.
English: Pedea must not be used in babies who have a life-threatening infection, bleeding, blood clotting problems or significant kidney problems.
Estonian: Ravimit ei tohi kasutada vastsündinutel, kellel on eluohtlik nakkus, verejooks, hüübimishäired või rasked neeruprobleemid.
English: If the ductus arteriosus has not closed by 48 hours after the final injection, or if it re-opens, a second course of three doses of Pedea may be given.
Estonian: Kui viimasest süstist on möödunud 48 tundi, aga arterioosjuha ei ole ikka sulgunud, või kui arterioosjuha taasavaneb, tohib manustada teise Pedea 3-annuselise ravikuuri.
English: A further study compared the effects of Pedea and placebo (a dummy treatment) in 131 newborns who were treated before there was proof that they had patent ductus arteriosus.
Estonian: Lisauuringus võrreldi Pedea ja platseebo (näiva ravimi) toimet 131 vastsündinul, keda raviti enne avatud arterioosjuha leiu kinnitamist.
English: It must also not be used in babies with congenital heart disease where an open ductus arteriosus is needed for the blood to flow, or in babies with necrotising enterocolitis (a severe bacterial infection causing death of tissue in the gut).
Estonian: Ravimit ei tohi kasutada ka kaasasündinud südamehaigusega vastsündinutel, kellel on avatud arterioosjuha vaja vereringe säilitamiseks, või vastsündinutel, kellel on nekrotiseeriv enterokoliit (raske bakteriaalnakkus, mis põhjustab soolekoe laigutist kärbumist).
English: As prostaglandins are also involved in keeping the ductus arteriosus open after birth, Pedea is thought to work by reducing the levels of prostaglandins, allowing this blood vessel to close.
Estonian: Et prostaglandiinid on seotud ka arterioosjuha avatuna püsimisega pärast sündi, seisneb Pedea toime eeldatavalt selles, et ravim vähendab prostaglandiini sisaldust, mille tulemusel juha sulgub.
English: For the full list of all side effects reported with Pedea, see the package leaflet.
Estonian: Pedea kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefit has Pedea shown during the studies?
Estonian: Milles seisneb uuringute põhjal Pedea kasulikkus?
English: Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby's lungs before birth) fails to close after birth.
Estonian: Avatud arterioosjuha on haigusseisund, kus arterioosjuha (juha, mis suunab loote vere kopsudest mööda) on jäänud pärast sündi avatuks.
English: The cause of any side effects seen in babies receiving Pedea is difficult to assess because they may be related to the patent ductus arteriosus or to Pedea itself.
Estonian: Pedeat saanud vastsündinute kõrvalnähtude põhjuse selgitamine on keerukas, sest kõrvalnähud võivad olla tingitud avatud arterioosjuhast või Pedeast.
English: Pedea should not be used before there is proof that the baby has patent ductus arteriosus.
Estonian: Pedeat ei tohi kasutada, enne kui vastsündinu avatud arterioosjuha leid on kinnitatud.
English: Pedea is used to treat ‘patent ductus arteriosus' in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age).
Estonian: Pedeat kasutatakse avatud arterioosjuha ravimiseks vähemalt kuus nädalat enne õiget aega (enne 34. rasedusnädalat) sündinud enneaegsetel vastsündinutel.
English: How has Pedea been studied?
Estonian: Kuidas Pedeat uuriti?
English: How is Pedea used?
Estonian: Kuidas Pedeat kasutatakse?
English: How does Pedea work?
Estonian: Kuidas Pedea toimib?
English: It works by reducing the level of chemical messengers called prostaglandins within cells.
Estonian: Ibuprofeen toimel väheneb rakkudes keemiliste virgatsainete prostaglandiinide sisaldus.
English: What is Pedea used for?
Estonian: Milleks Pedeat kasutatakse?
English: For the full list of restrictions see the see the package leaflet.
Estonian: Pedea piirangute täielik loetelu on pakendi infolehel.
English: The medicine can only be obtained with a prescription.
Estonian: Pedea on retseptiravim.
English: What measures are being taken to ensure the safe and effective use of Kevzara?
Estonian: Mis meetmed võetakse, et tagada Kevzara ohutu ja efektiivne kasutamine?
English: The full EPAR for Kevzara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Kevzara kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kevzara
Estonian: Muu teave Kevzara kohta
English: The safety profile of Kevzara was considered acceptable and in line with that of other similar medicines.
Estonian: Kevzara ohutusprofiili peeti vastuvõetavaks ning vastavaks teiste sarnaste ravimite omale.
English: It is used with methotrexate (a DMARD) but can also be used alone if the patient cannot take methotrexate.
Estonian: Seda kasutatakse koos metotreksaadiga (DMARD-ravim), kuid seda tohib manustada ka ainuravimina, kui patsient metotreksaati võtta ei saa.
English: Why is Kevzara approved?
Estonian: Miks Kevzara heaks kiideti?
English: What is Kevzara and what is it used for?
Estonian: Mis on Kevzara ja milleks seda kasutatakse?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kevzara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Kevzara kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Kevzara is available as a solution for injection in pre-filled pens and pre-filled syringes (150 mg and 200 mg).
Estonian: Kevzarat turustatakse süstelahusena eeltäidetud pensüstaldes ja eeltäidetud süstaldes (150 mg ja 200 mg).