FrancophonIA/ELRC3.0 huggingface dataset:
English: What Eucreas looks like and contents of the pack Eucreas 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Estonian: Eucreas 50 mg/850 mg õhukese polümeerikattega tabletid on kollased, ovaalsed tabletid, mille ühel küljel on kiri „NVR” ja teisel „SEH”.
English: - For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Estonian: Patsiendid, kellel kaksikkombinatsioon insuliini ja maksimaalse talutava metformiini annusega ei taga adekvaatset kontrolli: Eucreas'e annus peaks vastama vildagliptiini annusele 50 mg kaks korda päevas (kokku 100 mg ööpäevas) ja metformiini annusele, mis on sarnane juba võetavaga.
English: How to store Eucreas
Estonian: Kuidas Eucreas't säilitada
English: Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Estonian: Eucreas õhukese polümeerikattega tablette on pakendis 10, 30, 60, 120, 180 või 360 tk ja mitmikpakendis 120 (2x60), 180 (3x60) või 360 (6x60) õhukese polümeerikattega tabletti.
English: • Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Estonian: • Esinemissagedus teadmata (ei saa hinnata olemasolevate andmete alusel): sügelus, lööve,
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Eucreas.
Estonian: Samuti soovitatakse Eucreas'e võtmise ajal pöörata erilist tähelepanu villide või haavandite esmakordsele tekkimisele.
English: Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Estonian: Eucreas 50 mg/1000 mg õhukese polümeerikattega tabletid Vildagliptinum/Metformini hydrochloridum
English: Eucreas 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Estonian: Eucreas 50 mg/850 mg õhukese polümeerikattega tabletid Vildagliptinum/Metformini hydrochloridum
English: The amount of Eucreas that people have to take varies depending on their condition.
Estonian: Eucreas'e annus sõltub haiguse raskusest.
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets
Estonian: Eucreas 50 mg/850 mg õhukese polümeerikattega tabletid Eucreas 50 mg/1000 mg õhukese polümeerikattega tabletid
English: Eucreas 50 mg/850 mg film-coated tablets
Estonian: Eucreas 50 mg/850 mg õhukese polümeerikattega tabletid
English: Eucreas 50 mg/1000 mg film-coated tablets
Estonian: Eucreas 50 mg/1000 mg õhukese polümeerikattega tabletid
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Eucreas should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Estonian: Normaalse neerufunktsiooniga täiskasvanud patsiendid (GFR ≥ 90 ml/min) Eucreas'e annus hüperglükeemiavastases ravis tuleb määrata individuaalselt sõltuvalt patsiendi praegusest raviskeemist, efektiivsusest ja talutavusest ning see ei tohi ületada soovitatavat ööpäevast vildagliptiini annust 100 mg. Eucreas-ravi võib alustada kas 50 mg/850 mg või 50 mg/1000 mg tabletitugevusega kaks korda päevas, üks tablett hommikul ja teine õhtul.
English: Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Eucreas therapy is recommended.
Estonian: Kui püsib ASAT või ALAT aktiivsuse suurenemine kolm või enam korda üle
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Estonian: Eucreas 50 mg/850 mg õhukese polümeerikattega tabletid Eucreas 50 mg/1000 mg õhukese polümeerikattega tabletid vildagliptiin/metformiinvesinikkloriid (Vildagliptinum/Metformini hydrochloridum)
English: EU/1/07/425/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/030 360 film-coated tablets (PCTFE/PVC/Alu)
Estonian: EU/1/07/425/007 10 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/008 30 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/009 60 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/010 120 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/011 180 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/012 360 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/025 10 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/026 30 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/027 60 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/028 120 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/029 180 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/030 360 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu)
English: EU/1/07/425/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/036 360 film-coated tablets (PCTFE/PVC/Alu)
Estonian: EU/1/07/425/016 120 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/017 180 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/018 360 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/034 120 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/035 180 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/036 360 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu)
English: Eucreas combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Estonian: Eucreas sisaldab kahte antihüperglükeemilise toimega ravimit, millel on teineteist täiendav toimemehhanism veresuhkru taseme langetamisel II tüüpi diabeediga patsientidel.
English: EU/1/07/425/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/024 360 film-coated tablets (PCTFE/PVC/Alu)
Estonian: EU/1/07/425/001 10 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/002 30 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/003 60 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/004 120 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/005 180 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/006 360 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/019 10 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/020 30 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/021 60 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/022 120 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/023 180 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/024 360 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu)
English: EU/1/07/425/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/033 360 film-coated tablets (PCTFE/PVC/Alu)
Estonian: EU/1/07/425/013 120 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/014 180 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/015 360 õhukese polümeerikattega tabletti (PA/Alu/PVC/Alu) EU/1/07/425/031 120 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/032 180 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu) EU/1/07/425/033 360 õhukese polümeerikattega tabletti (PCTFE/PVC/Alu)
English: - Each Eucreas 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Estonian: - Iga Eucreas 50 mg/850 mg õhukese polümeerikattega tablett sisaldab 50 mg vildagliptiini ja
English: The marketing authorisation was renewed on 13 March 2002 and on 13 March 2007.
Estonian: Müügiluba pikendati 13. märtsil 2002 ja 13. märtsil 2007.
English: The marketing authorisation holder is Celgene Europe Ltd.
Estonian: Müügiloa hoidja on Celgene Europe Ltd.
English: The recommended dose is 0.4 mg per kilogram body weight as a single injection into a vein, followed by a continuous infusion at a dose of 0.15 mg/kg per hour for two to 10 days, or longer if needed.
Estonian: Soovitatav annus on 0,4 mg kehakaalu kilogrammi kohta ühe süstena veeni, millele järgneb veenisisene pidevinfusioon annuses 0,15 mg kehakaalu kilogrammi kohta tunnis, mida tehakse 2-10 päeva või vajaduse korral kauem.
English: Bleeding leading to death occurs in around 1 patient in 100.
Estonian: Surmaga lõppev veritsemine esineb ligikaudu ühel patsiendil sajast.
English: Some patients can have a serious allergic shock when they receive Refludan for a second time.
Estonian: Mõnel patsiendil võib Refludani teistkordsel manustamisel tekkida raske allergiline šokk.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Refludan on 13 March 1997.
Estonian: Euroopa Komisjon andis Refludani müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. märtsil 1997.
English: During the study period, 9% of the patients died (11 out of 125), 6% had amputations (7 out of 125) and 10% had new thromboembolic complications (12 out of 125).
Estonian: Uuringu ajal 9% patsientidest suri (11 patsienti 125-st), 6%-l oli amputatsioon (7 patsiendil 125-st) ja 10%-l oli uusi trombemboolilisi tüsistusi (12 patsiendil 125-st).
English: The Committee recommended that Refludan be given marketing authorisation.
Estonian: Komitee soovitas anda Refludanile müügiloa.
English: Other information about Refludan:
Estonian: Muu teave Refludani kohta
English: As the disease is very severe and there are no other effective treatments approved, the Committee for Medicinal Products for Human Use (CHMP) decided that Refludan's benefits are greater than its risks for the treatment of patients with HIT and thromboembolic disease.
Estonian: Et see haigus on väga raske ja muud heakskiidetud efektiivsed ravimid puuduvad, otsustas inimravimite komitee, et hepariinist tingitud trombotsütopeeniat ja trombembooliat põdevate patsientide ravis ületab Refludani kasulikkus ravimiga kaasnevaid riske.
English: The studies did not compare Refludan with any other treatments, so the results were judged against historical controls (the results expected in untreated patients, based on past studies).
Estonian: Uuringutes ei võrreldud Refludani muude ravimitega, vaid tulemusi kõrvutati varasemate andmetega (ravimata patsientide tulemustega, mis ilmnesid varem toimunud uuringutes).
English: Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and thromboembolic disease.
Estonian: Refludani uuriti kahes põhiuuringus, milles osales 198 patsienti, neist 125 patsiendil oli hepariinist tingitud trombotsütopeenia koos trombembooliaga.
English: What is the risk associated with Refludan?
Estonian: Mis riskid kaasnevad Refludaniga?
English: The doses need to be reduced in patients with kidney problems.
Estonian: Neeruprobleemidega patsientidel tuleb annuseid vähendada.
English: Its use is not advisable in patients who are bleeding or are at risk of bleeding because of a recent biopsy, stroke or major surgery, or because they are over the age of 65 years, among other reasons.
Estonian: Refludani ei soovitata kasutada patsientidel, kellel on veritsus või veritsusrisk muu hulgas hiljutise biopsia, insuldi või suure operatsiooni järel või selle tõttu, et nad on vanemad kui 65 aastat.
English: By blocking thrombin, Refludan greatly reduces the risk of blood clots forming, preventing subsequent damage.
Estonian: Trombiini blokeerides vähendab Refludan oluliselt trombide tekkimise ohtu, ennetades seega kahjustusi.
English: As with other antithrombotic drugs, the most common side effect with Refludan (seen in more than 1 patient in 10) is bleeding.
Estonian: Nagu muudelgi tromboosiravimitel, on Refludani kõige tavalisem kõrvalnäht veritsemine (esinenud enam kui ühel patsiendil kümnest).
English: What is Refludan?
Estonian: Mis on Refludan?
English: The studies looked at the numbers of patients who died, had an amputation, and had new thromboembolic (clotting) complications.
Estonian: Uuringus jälgiti nende patsientide arvu, kes surid, kellele tehti amputatsioon või kellel tekkisid uued trombemboolilised (hüübimis-) tüsistused.
English: Why has Refludan been approved?
Estonian: Miks Refludan heaks kiideti?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REFLUDAN EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE REFLUDAN Kokkuvõte üldsusele
English: It contains the active substance lepirudin.
Estonian: Ravim sisaldab toimeainena lepirudiini.
English: It must not be used in patients who are pregnant or breast-feeding.
Estonian: Rasedad või imetavad patsiendid Refludani kasutada ei tohi.
English: Refludan should not be used in people who may be hypersensitive (allergic) to lepirudin, any other hirudin derivative, or any of the other ingredients.
Estonian: Refludani ei tohi kasutada patsiendid, kes võivad olla lepirudiini, hirudiini mis tahes muu derivaadi või selle ravimi mis tahes muu koostisosa suhtes ülitundlikud (allergilised).
English: The diagnosis must be confirmed using specific tests, such as the heparin-induced platelet aggregation assay (HIPAA) test.
Estonian: Diagnoosi peavad kinnitama spetsiifilised katsed, näiteks HIPAA-test (trombotsüütide agregratsioon hepariini toimel).
English: Lepirudin specifically blocks a substance called thrombin, which is central for the complete process of blood clotting.
Estonian: Lepirudiin blokeerib spetsiifiliselt trombiini, mis on üks vere hüübimisel osalevatest ainetest.
English: It is used in adults with heparin-induced thrombocytopenia (HIT, a type of allergy to heparin that causes a lack of platelets in the blood or clots in the blood vessels) and who have thromboembolic disease (abnormal development of blood clots) that needs injected anti-clotting treatment, usually heparin.
Estonian: Refludani kasutatakse verehüübimise takistamiseks täiskasvanud patsientidel, kellel on hepariinist tingitud trombotsütopeenia (HIT, teatavat tüüpi allergia hepariini suhtes, mis põhjustab trombotsüütide (vereliistakute) vähesuse ja/või trombide tekke veresoontes) ja kellel on trombemboolia (trombide ehk soonesiseste verehüüvete ebanormaalne teke), mida on vaja ravida tromboosivastaste süstidega, tavaliselt hepariiniga.
English: Lepirudin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce lepirudin.
Estonian: Lepirudiini valmistatakse rekombinant-DNA-tehnika abil: lepirudiini toodab bakter, millele on lisatud lepirudiini teket võimaldav geen (DNA).
English: See the Package Leaflet for the full list of restrictions.
Estonian: Piirangute täieliku loetelu on pakendi infolehel.
English: For the full list of all side effects reported with Refludan, see the Package Leaflet.
Estonian: Refludani kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Refludan is a powder that is dissolved to make up a solution for injection or infusion (drip into a vein).
Estonian: Refludan on pulber, millest valmistatakse süste- või infusioonilahus (veeni tilgutatav lahus).
English: In the comparison with historical controls, the two trials taken together showed a significant benefit of Refludan on the rate of new thromboembolic complications and a trend towards increased survival.
Estonian: Mõlema uuringu koondtulemustest selgus, et varasemate andmetega võrreldes vähendas Refludan märkimisväärselt uute trombembooliliste tüsistuste teket ja suurendas ka elulemust.
English: Doctors should be very careful when re-exposing a patient to the medicine.
Estonian: Ravimi korduval manustamisel peab arst olema väga ettevaatlik.
English: What benefit has Refludan shown during the studies?
Estonian: Milles seisneb uuringute põhjal Refludani kasulikkus?
English: How is Refludan used?
Estonian: Kuidas Refludani kasutatakse?
English: The full EPAR for Refludan is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Refludani kohta leiate siit.
English: The active substance in Refludan, lepirudin, is nearly identical to hirudin, the anti-clotting substance produced by leeches.
Estonian: Refludani toimeaine lepirudiin on peaaegu identne kaanide eritatava antikoagulandi (hüübimist takistava aine) hirudiiniga.
English: Treatment with Refludan should be started by a doctor who has experience in the treatment of coagulation (clotting) disorders.
Estonian: Ravi Refludaniga peab alustama hüübimishäirete ravis kogenud arst.
English: What is Refludan used for?
Estonian: Milleks Refludani kasutatakse?
English: How has Refludan been studied?
Estonian: Kuidas Refludani uuriti?
English: How does Refludan work?
Estonian: Kuidas Refludan toimib?
English: Refludan is an antithrombotic medicine (a medicine that prevents the blood from clotting).
Estonian: Refludan on tromboosiravim (ravim, mis takistab vere hüübimist ja trombide ehk soonesiseste verehüüvete teket).
English: EU/1/99/097/001 Beromun
Estonian: EU/1/99/097/001
English: vial (glass)
Estonian: viaal (klaas)
English: Isolated limb perfusion (intra-arterial use)
Estonian: Infusioonilahuse pulber isoleeritud jäseme perfusioon (intraarteriaalne)
English: Content
Estonian: Beromun
English: MA (EU) number Invented name Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Manustamistee
English: Allergic reactions have been reported with these medicines.
Estonian: Nende ravimite kasutamisel on teatatud allergilistest reaktsioonidest.
English: Primula veris L. and/or Primula elatior (L.) Hill, flos
Estonian: Primula veris L. ja/või Primula elatior (L.) Hill, flos
English: Primula flower EMA/423706/2016EMA/423706/2016
Estonian: september 2016 EMA/423706/2016
English: If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified
Estonian: Kui sümptomid püsivad üle 1 nädala või ravimi kasutamise ajal süvenevad, peab konsulteerima arsti
English: Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Estonian: Nurmenukuõit sisaldavaid ravimeid tohivad kasutada üksnes täiskasvanud ja üle 12-aastased noorukid.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/423706/2016
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: What is primula flower?
Estonian: Mis on nurmenukuõis?
English: Further information on the risks associated with these primula 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 nende nurmenukuõit sisaldavate ravimitega kaasnevate riskide, sh nende ohutu kasutamise ettevaatusabinõude kohta, on taimse aine monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: No clinical studies have been carried out with primula flower.
Estonian: Nurmenukuõiega ei ole toimunud ühtki kliinilist uuringut.
English: Detailed instructions on how to take primula flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Üksikasjalik teave, kuidas võtta nurmenukuõit sisaldavaid ravimeid ja kes neid tohib kasutada, on ravimi pakendi infolehel.
English: Further information on the HMPC assessment of primula 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 nurmenukuõit sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing primula 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: Nurmenukuõit sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
English: Primula flower medicines must not be used in patients who are allergic to primula flower or to other plants of the primula species.
Estonian: Nurmenukuõit sisaldavaid ravimeid ei tohi kasutada patsiendid, kes on allergilised nurmenukuõie või nurmenuku perekonna teiste taimede suhtes.
English: Other information about primula flower medicines
Estonian: Muu teave nurmenukuõit sisaldavate ravimite kohta
English: What evidence supports the use of primula flower medicines?
Estonian: Mis tõendid toetavad nurmenukuõit sisaldavate ravimite kasutamist?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula flower.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad nurmenukuõit sisaldavate taimsete ravimite müügilubade taotlusi.
English: Information on the use and licensing of primula flower medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab nurmenukuõit sisaldavate ravimite kasutamise ja müügilubade teavet asjakohastelt riiklikelt ravimiametitelt.
English: healthcare practitioner should be consulted.
Estonian: või pädeva tervishoiutöötajaga.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb nurmenukuõie meditsiinilisi kasutusviise.
English: The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Estonian: Taimsete ravimite komitee järeldused käsitlevad üksnes nurmenukuõie valmistisi, mis saadakse õite peenestamisel või taimeosadel asetamisel lahustisse (nt etanooli), et ekstraheerida ühendid ja saada vedelekstrakt.