FrancophonIA/ELRC3.0 huggingface dataset:
English: − Actos 15 mg tablets are white to off-white, round, convex tablets marked ‘15' on one face and
Estonian: Kuidas Actos välja näeb ja pakendi sisu - Actos 15 mg tabletid on valged või kahvatuvalged ümmargused kumerad ning ühel küljel on märgistus „15“ ja teisel küljel „ACTOS“.
English: Investigations weight increased6
Estonian: 6 FARMATSEUTILISED ANDMED
English: Bladder cancer
Estonian: KLIINILISED ANDMED
English: General disorders and administration site conditions
Estonian: Üldised häired ja manustamiskoha reaktsioonid tursed5
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Estonian: Pioglitasooni kasutamisel koos insuliiniga või kui pioglitasooni kasutati südamepuudulikkuse anamneesiga patsientidel, on turustamise järgselt teatatud südamepuudulikkuse juhtudest.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Estonian: Ravimite nimetuste, ravimivormide, tugevuste, manustamisviiside, taotlejate loetelu liikmesriikides
English: Dexamed 5 mg comprimidos 5 mg
Estonian: Dexamed 5 mg comprimidos
English: Actavis Nordic A/S
Estonian: Actavis Nordic A/S Spasmalgon
English: Teva Gyógyszergyár Zrt Optalgin
Estonian: Teva Gyógyszergyár Zrt
English: Capsule
Estonian: Kapsel
English: Sc Centrofarm Sa
Estonian: Sc Centrofarm Sa Centralgin
English: Sidefarma - Sociedade Industrial De Expansão Farmacêutica, S.A.
Estonian: SidefarmaSociedade Industrial De Expansão Farmacêutica, S.A.
English: Meditop Pharmaceutical Co. Ltd.
Estonian: Pharmaceutical Co. Ltd.
English: S C Biofarm S A
Estonian: S C Biofarm S A Algoblock
English: Berlin-Chemie Ag
Estonian: Berlin-Chemie Ag Berlosin
English: Solution For Injection/Infusion
Estonian: Süstelahus/ infusioonilahus
English: Noraminophenazoni Fonovii.
Estonian: Parma Produkt Kft Noraminophenazoni Fonovii.
English: Stada Arzneimittel Ag Metamistad
Estonian: Stada Arzneimittel Ag
English: Metamizol-Natrium 1 H2o 1a-Pharma
Estonian: 1 A Pharma Gmbh Metamizol-Natrium 1 H2o 1a-Pharma
English: Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg
Estonian: Chemax Pharma Ltd Диалгин Джуниор Naatriummetamisoolmonohüdraat 250 mg kotike
English: Sanofi Belgium Novalgin
Estonian: Luksemburg Sanofi Belgium Novalgin
English: Aramis Pharma Kft
Estonian: Aramis Pharma Kft Metarapid
English: Sandoz Pharmaceuticals D.D.
Estonian: Pharmaceuticals D.D.
English: Goodwill Pharma Ltd Metapyrin
Estonian: Goodwill Pharma Ltd
English: Novaminsulfon 1 A Pharma
Estonian: 1 A Pharma Gmbh Novaminsulfon 1 A Pharma
English: Sanofi-Aventis Zrt
Estonian: Sanofi-Aventis Zrt Algopyrin
English: Metamizole 500mg/ml
Estonian: Metamisool 500 mg/ml
English: Codeine Phosphate Sesquihydrate 0.03g in form of Codeine Phosphate Hemihydrate 0.02873g, Metamizole Sodium 0.9g, Caffeine And Sodium Benzoate 0.1g / suppository
Estonian: Kodeiinfosfaatseskvihüdraat 0,03 g kodeiinfosfaathemihüdraadina 0,02873 g, Naatriummetamisool 0,9 g, Kofeiin ja Naatriumbensoaat 0,1 g / rektaalsuposiit
English: Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Estonian: Naatriummetamisool 0,9 g rektaalsuposiit, Kofeiin 0,05 g rektaalsuposiit, Kodeiinfosfaathemihüdraat 0,03 g rektaalsuposiit
English: Hydrochloride 10mg, Metamizole Sodium 1g
Estonian: Pitofenoonvesinikkloriid 10 mg, Naatriummetamisool 1 g
English: Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Estonian: Naatriummetamisool 450 mg tablett, Kofeiin 50 mg tablett
English: Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Estonian: Naatriummetamisool 300 mg tablett, Paratsetamool 200 mg tablett, Kofeiin 30 mg tablett, Kodeiinfosfaat 20 mg tablett
English: Metamizol Normon Metamizole Magnesium 2g/5ml
Estonian: Metamizol Normon Magneesiummetamisool 2 g/5 ml
English: Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Estonian: Naatriummetamisool 150 mg tablett, Paratsetamool 300 mg tablett, Fenobarbitaal 15 mg tablett, Kofeiin 50 mg tablett, Kodeiinfosfaathemihüdraat 10 mg tablett
English: Metamizol Normon Metamizole Magnesium 575mg Capsule
Estonian: Metamizol Normon Magneesiummetamisool 575 mg kapsel
English: Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Estonian: Naatriummetamisool 500 mg tablett, Triatsetonamiintosülaat 20 mg tablett
English: Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Estonian: Drotaveriinvesinikkloriid 40 mg tablett, Naatriummetamisool 400 mg tablett, Kofeiin 60 mg tablett
English: Tabletta Analgetica Fono Vii
Estonian: Parma Produkt Kft Tabletta Analgetica Fono Vii
English: Metamizole Magnesium 500mg Capsule
Estonian: Magneesiummetamisool 500 mg kapsel
English: Labormed Pharma S.A. Algozone
Estonian: Labormed Pharma S.A.
English: Intramuscular Use | Intravenous Use
Estonian: Intramuskulaarne | Intravenoosne | Parenteraalne
English: Suppositorium Analgeticum Fono Vii
Estonian: Parma Produkt Kft Suppositorium Analgeticum Fono Vii
English: Heumann Pharma Gmbh & Co. Generica Kg
Estonian: Heumann Pharma Gmbh & Co.
English: Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml, Metamizole Sodium 500mg/ml
Estonian: Pitofenoonvesinikkloriid 2 mg/ml, Fenpiveriinbromiid 0,02 mg/ml, Naatriummetamisool 500 mg/ml
English: Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Estonian: Tiamiinvesinikkloriid 38,75 mg tablett, Naatriummetamisool 500 mg tablett, Kofeiin 50 mg tablett
English: Metamizole Sodium Monohydrate 0.525g/ml
Estonian: Naatriummetamisoolmonohüdraat 0,525 g/ml
English: Effervescent Tablet
Estonian: Sulav tablett
English: Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Estonian: Tsüanokobalamiin 0.5 mg tablett, Naatriummetamisool 500 mg tablett, Tiamiinnitraat 75 mg tablett, Püridoksiinvesinikkloriid 50 mg tablett
English: Melting Tablets
Estonian: Kihisev tablett
English: Metamizole Sodium 1g/2ml
Estonian: Naatriummetamisool 1 g/2 ml
English: Berlosin Injekt
Estonian: Berlin-Chemie Ag Berlosin Injekt
English: Metamizole Magnesium 2000mg /5ml
Estonian: Magneesiummetamisool 2000 mg/5 ml
English: Metamizole Sodium 200mg Suppository
Estonian: Naatriummetamisool 200 mg rektaalsuposiit
English: Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Estonian: Naatriummetamisoolmonohüdraat 527 mg tablett, Pitofenoonvesinikkloriid 5,25 mg tablett, Fenpiveriinbromiid 0,1 mg tablett
English: Metamizol Sintocalmin Metamizole 500mg Tablet
Estonian: Metamizol Heumann Naatriummetamisoolmonohüdraat 500 mg tablett
English: Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Estonian: Pitofenoonvesinikkloriid 5 mg, Naatriummetamisool 500 mg
English: Metamizole 575mg Capsule
Estonian: Metamisool 575 mg kapsel
English: Sanofi-Aventis Sro
Estonian: Sanofi-Aventis Sro Novalgin
English: Metarapid
Estonian: Metapyrin
English: Pannonpharma Kft.
Estonian: Pannonpharma Kft. Panalgorin
English: Metamizole Magnesium 575mg Tablet
Estonian: Metamizol Tarbis Magneesiummetamisool 575 mg tablett
English: Metamizol Heumann Metamizole Sodium Monohydrate 500mg/ml
Estonian: Metamizol Heumann Naatriummetamisoolmonohüdraat 500 mg/ml
English: Metamizole Sodium 1g Suppository
Estonian: Naatriummetamisool 1 g rektaalsuposiit
English: Metamizole Sodium 100mg Suppository
Estonian: Naatriummetamisool 100 mg rektaalsuposiit
English: Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository
Estonian: Naatriummetamisool 0,5 g rektaalsuposiit, Kofeiin ja Naatriumbensoaat 0,1 g rektaalsuposiit
English: Metamizole Sodium 500mg
Estonian: Naatriummetamisool 500 mg
English: Ratiopharm Gmbh
Estonian: Ratiopharm Gmbh Novaminsulfon
English: Metamizole Magnesium 1000mg Suppository
Estonian: Naatriummetamisool 1000 mg kotike
English: Metamizole Magnesium 575mg Capsule
Estonian: Magneesiummetamisool 575 mg kapsel
English: Metamizole Sodium Monohydrate 2,5 g/5 ml
Estonian: Naatriummetamisoolmonohüdraat 2,5 g/5 ml
English: Hydrochloride 2mg/ml, Metamizole Sodium 500mg/ml
Estonian: Pitofenoonvesinikkloriid 2 mg/ml, Naatriummetamisool 500 mg/ml
English: Metamizole Sodium Monohydrate 500mg/ml, Pitofenone Hydrochloride 5mg/ml
Estonian: Naatriummetamisoolmonohüdraat 500 mg/ml, Pitofenoonvesinikkloriid 5 mg/ml
English: Metamizole Magnesium 575mgg
Estonian: Magneesiummetamisool 575 mg
English: Metamizole Magnesium 2g/5ml
Estonian: Magneesiummetamisool 2 g/5 ml
English: Hydrochloride 5mg/ml, Metamizole Sodium 500mg/ml
Estonian: Pitofenoonvesinikkloriid 5 mg/ml, Naatriummetamisool 500 mg/ml
English: Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg
Estonian: Naatriummetamisool 250 mg tablett, Hüostsiinbutüülbromiid 10 mg tablett
English: Hydrochloride 2mg/ml, Fenpiverinium Bromide 0.02mg/ml
Estonian: Naatriummetamisoolmonohüdraat 0,5 g/ml, Pitofenoonvesinikkloriid 2 mg/ml, Fenpiveriinbromiid 0,02 mg/ml
English: Metamizole Sodium 300mg Suppository
Estonian: Naatriummetamisool 300 mg rektaalsuposiit
English: Sanofi-Aventis, S.A.
Estonian: Sanofi-Aventis, S.A. Buscapina Compositum
English: 1 A Pharma Gmbh
Estonian: 1 A Pharma Gmbh Novaminsulfon
English: Metamizole Magnesium Hexahydrate 575mg Capsule
Estonian: Magneesiummetamisoolheksahüdraat 575 mg kapsel
English: Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Estonian: Pitofenoonvesinikkloriid 10 mg/5 ml, Fenpiveriinbromiid 0,1 mg/5 ml, Naatriummetamisool 2500 mg/5 ml
English: Laboratorios Cinfa, S.A. Metamizol Cinfa
Estonian: Laboratorios Cinfa, S.A.
English: Metamizole Sodium 500g/ml
Estonian: Naatriummetamisool 500 g/ml
English: Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Estonian: Naatriummetamisoolmonohüdraat 500 mg tablett, Pitofenoonvesinikkloriid 5 mg tablett, Fenpiveriinbromiid 0,1 mg tablett
English: Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Estonian: Pitofenoonvesinikkloriid 5 mg tablett, Naatriummetamisool 500 mg tablett, Fenpipramiidbromometülaat 0,1 mg tablett
English: Metamizol Kalceks
Estonian: Metamizol Sintocalmin
English: Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Estonian: Pitofenoonvesinikkloriid 5 mg tablett, Fenpiveriinbromiid 0,1 mg tablett, Naatriummetamisool 500 mg tablett
English: Metamizole Kalceks
Estonian: Naatriummetamisool Kalceks
English: NovaminsulfonRatiopharm
Estonian: Ratiopharm Gmbh NovaminsulfonRatiopharm
English: Laboratorios Alter, S.A. Metamizol Alter
Estonian: Laboratorios Alter, S.A.
English: Metamizole Sodium Monohydrate 1000mg Suppository
Estonian: Naatriummetamisoolmonohüdraat 1000 mg rektaalsuposiit
English: Metamizole Magnesium 500mg Sachet
Estonian: Pyralgina Gorączka Magneesiummetamisool 500 mg kotike
English: Pyralgina Gorączka
Estonian: Kihisev pulber
English: The majority of EU patients have been treated in Germany.
Estonian: Enamik ELi patsiente on ravi saanud Saksamaal.
English: EMA will complete its in-depth review and make public the final outcome.
Estonian: EMA lõpetab oma põhjaliku läbivaatamise ja avaldab lõpptulemused.
English: Three of the cases were fatal.
Estonian: Kolm nendest juhtumitest lõppes surmaga.
English: Please tell us what you think about this information by answering a few questions - it will only take a couple of minutes of your time:
Estonian: Palume teilt selle teabe kohta tagasisidet - küsimustele vastamine võtab vaid paar minutit.
English: 8 March 2018 EMA/155367/2018
Estonian: 7. märts 2018 EMA/134289/2018
English: The review of Zinbryta was initiated following a request from the European Commission on 26 February 2018, under Article 20 of Regulation (EC) No 726/2004.
Estonian: Zinbryta läbivaatamine algatati 26. veebruaril 2018 Euroopa Komisjoni taotlusel kooskõlas määruse (EÜ) nr 726/2004 artikliga 20.
English: Most cases occurred within 8 months of starting treatment.
Estonian: Enamik juhtumitest tekkis 8 kuu jooksul ravi alustamisest.
English: To date over 8,000 patients have been treated with Zinbryta worldwide.
Estonian: Seni on Zinbrytaga üle maailma ravitud enam kui 8000 patsienti.
English: Evidence indicates risk of serious inflammatory brain disorders
Estonian: Tõendid viitavad raskete põletikuliste ajuhäirete riskile
English: Consider alternative treatments as appropriate.
Estonian: Kaalutlege vastavalt vajadusele ravialternatiive.
English: Patients stopping treatment must be followed up for at least 6 months (see more details below).
Estonian: Ravi lõpetanud patsiente tuleb vähemalt 6 kuu jooksul jälgida (vt lisateave allpool).
English: Start the survey
Estonian: Alustage küsitluse täitmist
English: • Zinbryta will be recalled from pharmacies and hospitals across the EU.
Estonian: • Zinbryta võetakse ELi apteekidest ja haiglatest tagasi.
English: A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Estonian: Kättesaadavate tõendite esialgse läbivaatamise kohaselt võivad teatatud juhtumite korral täheldatud immuunreaktsioonid olla seotud Zinbryta kasutamisega.
English: Zinbryta may also be linked to severe immune reactions affecting several other organs.
Estonian: Zinbryta võib olla seotud ka mitut muud elundit kahjustavate raskete immuunreaktsioonidega.
English: Available evidence also indicates that Zinbryta could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis.
Estonian: Kättesaadavate tõendite järgi võib Zinbrytat seostada ka muude immuunvahendatud häiretega, näiteks vere düskraasiad, türeoidiit või glomerulonefriit.
English: These could be signs of a reaction to Zinbryta.
Estonian: Need võivad olla Zinbrytale tekkinud reaktsiooni nähud.
English: Zinbryta was authorised in 2016 for treating relapsing forms of multiple sclerosis.
Estonian: Zinbryta müügiluba anti 2016. aastal hulgiskleroosi relapseeruvate vormide raviks.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Estonian: Esialgse läbivaatamise teeb inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee, kes koostab soovitused.
English: • Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
Estonian: • Öelge oma arstile otsekohe, kui teil on esinenud või tekivad sellised sümptomid nagu püsivalt kõrge kehatemperatuur, tugev peavalu, iiveldus, väsimus, naha või silmavalgete kollasus ja oksendamine.
English: The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Estonian: Zinbryta turustaja Biogen Idec Ltd on juba vabatahtlikult taotlenud ravimi müügiloa tühistamist ning teavitanud ravimiametit kavatsusest katkestada kliinilised uuringud.
English: These reactions can occur for 6 months after treatment has been stopped.
Estonian: Need reaktsioonid võivad tekkida kuni 6 kuu jooksul alates ravi lõpetamisest.
English: Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Estonian: 2017. aastal tehtud läbivaatamisel uuriti ravimi toimet maksale ning menetluse tulemusena piirati ravimi kasutamine patsientidega, keda on ravitud vähemalt kahe teise haigust modifitseeriva ravimiga ning kes ei saa kasutada ühtki muud hulgiskleroosi ravimit.
English: Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives.
Estonian: Tervishoiutöötajad peavad otsekohe kontakteeruma Zinbryta-ravi saavate patsientidega, nende ravi lõpetama ja kaaluma ravialternatiive.
English: • Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting.
Estonian: • Paluge patsientidel teatada otsekohe maksakahjustuse sümptomitest, näiteks pikaajaline palavik, tugev peavalu, väsimus, kollatõbi, iiveldus või oksendamine.
English: • Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
Estonian: • Arst teeb teile korrapäraselt vereanalüüse kuni 6 kuu jooksul alates ravi lõpetamisest, et jälgida teid kõrvalnähtude suhtes.
English: To date EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed 12 cases of immune-mediated inflammatory disorders, including encephalitis.
Estonian: Praeguseks on EMA ravimiohutuse riskihindamise komitee läbi vaadanud 12 juhtumit, mille korral patsientidel tuvastati immuunvahendatud põletikuline häire (sh entsefaliit).
English: A previous PRAC review in 2017 found that unpredictable and potentially fatal immune-mediated liver injury can occur with Zinbryta for up to 6 months after stopping treatment and concluded that patients stopping treatment should be followed up.
Estonian: Ravimiohutuse riskihindamise komitee varasema, 2017. aastal tehtud läbivaatamise tulemusena leiti, et Zinbrytaga võivad kuni 6 kuu jooksul alates ravi lõpetamisest tekkida ettenägematud ja potentsiaalselt fataalsed immuunvahendatud maksakahjustused, ning järeldati, et ravi lõpetanud patsiente tuleb jälgida.
English: • Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment.
Estonian: • Võtke võimalikult kiiresti ühendust patsientidega, kellel on Zinbryta-ravi pooleli, ning lõpetage ravi.
English: To protect patients' health, the marketing authorisation in the EU of Zinbryta is now suspended and batches are to be recalled from pharmacies and hospitals.
Estonian: Patsientide tervise kaitseks soovitab EMA ravimi müügiloa ELis viivitamata peatada ning võtta ravimipartiid apteekidest ja haiglatest tagasi.
English: • Do not take another injection of Zinbryta.
Estonian: • Ärge manustage enam ühtki Zinbryta süsti.
English: • Patients stopping treatment should be monitored at least monthly and more frequently as clinically indicated for up to 6 months after the last dose of Zinbryta.
Estonian: • Ravi lõpetanud patsiente tuleb kuni 6 kuu jooksul alates Zinbryta viimasest annusest kontrollida vähemalt kord kuus või sagedamini, kui see on kliiniliselt näidustatud.
English: • If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Estonian: • Kui osalete Zinbryta kliinilises uuringus, võtke ühendust uuringus osaleva arstiga, kes teile ravi määras.
English: • If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
Estonian: • Kui teid ravitakse Zinbrytaga, pöörduge ravi arutamiseks oma arsti poole.
English: On 6 March 2018, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.
Estonian: Euroopa Ravimiamet (EMA) soovitas viivitamata peatada hulgiskleroosi ravimi Zinbryta (beetadaklisumaab) müügiloa ja võtta ravim turult tagasi, sest ravimiga seoses on üle maailma teatatud 12 juhtumist, mille korral patsiendil on tekkinud raske põletikuline ajuhäire, sealhulgas entsefaliidi ja meningoentsefaliidi juhtumid.
English: No new patients should start treatment with Zinbryta.
Estonian: Zinbryta-ravi ei tohi alustada uutel patsientidel.
English: The PRAC's recommendation to suspend Zinbryta and recall the product was sent to the European Commission, which issued a legally binding decision on 8 March 2018.
Estonian: EMA soovitus Zinbryta müügiloa peatamise ja ravimi turult tagasivõtmise kohta saadetakse Euroopa Komisjonile, kes teeb õiguslikult siduva otsuse.
English: • Do not start any new patients on Zinbryta.
Estonian: • Zinbryta-ravi ei tohi alustada ühelgi uuel patsiendil.
English: 19 January 2015
Estonian: 19. jaanuar 2015
English: The amended information to doctors and patients is available here.
Estonian: Parandatud teave arstidele ja patsientidele on siin.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 19 January 2015.
Estonian: Euroopa Komisjon tegi nende muudatuste rakendamiseks kogu Euroopa Liidus õiguslikult siduva otsuse 19. jaanuaril 2015.
English: Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Estonian: Nasonexi ja sarnaseid nimetusi turustatakse praegu järgmistes Euroopa Liidu liikmesriikides: Austrias, Belgias, Bulgaarias, Eestis, Hispaanias, Horvaatias, Iirimaal, Itaalias, Kreekas, Küprosel1, Leedus, Luksemburgis, Lätis, Madalmaades, Maltas, Poolas, Portugalis, Prantsusmaal, Rootsis, Rumeenias, Saksamaal, Slovakkias, Sloveenias, Soomes, Taanis, Tšehhi Vabariigis, Ungaris ja Ühendkuningriigis ning ka Islandil ja Norras.
English: What is Nasonex?
Estonian: Mis on Nasonex?
English: The areas harmonised include:
Estonian: Ühtlustamist vajavad valdkonnad on järgmised.
English: Why was Nasonex reviewed?
Estonian: Miks Nasonexi taotlus uuesti üle vaadati?
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Estonian: Inimravimite komitee ühtlustas ka ravimi omaduste kokkuvõtte muud lõigud, sh lõigud 4.4 (erihoiatused ja ettevaatusabinõud kasutamisel), 4.6 (fertiilsus, rasedus ja imetamine), 4.8 (kõrvaltoimed) ning 5.1 (farmakodünaamilised omadused).
English: 1 Nasonex is marketed in Cyprus under Art.126a of Directive 27/2004 EC, which allows a country to place a product in the market for justified public health reasons for a limited number of years.
Estonian: 1 Küprosel turustatakse Nasonexi direktiivi 27/2004/EÜ artikli 126a alusel, mille kohaselt on riigil lubatud rahvatervisega seonduvatel õigustatud põhjustel turustada teatud ravimit piiratud arv aastaid.
English: The company that markets these medicines is Merck Sharp & Dohme.
Estonian: Ravimeid turustab Merck Sharp & Dohme.
English: Nasonex and associated names have been authorised in EU Member States through national procedures since
Estonian: Nasonex ja sarnased nimetused on olnud Euroopa Liidu liikmesriikides riiklike menetluste kaudu heaks kiidetud aastast 1997.
English: Nasonex contains the active substance mometasone furoate.
Estonian: Nasonex sisaldab toimeainena mometasoonfuroaati.
English: The Committee also agreed that Nasonex should no longer be recommended to treat acute sinusitis, which was authorised in some Member States, because the available data to support this use were considered limited.
Estonian: Lisaks nõustus komitee, et Nasonexi ei tohi enam soovitada mõnes liikmesriigis heakskiidetud ägeda sinusiidi ravi näidustuse korral, sest seda toetavaid andmeid peeti piiratuks.