FrancophonIA/ELRC3.0 huggingface dataset:
English: · Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the
Estonian: • Kadcyla 160 mg: steriilse süstlaga süstida aeglaselt 160 mg trastuzumabemtansiini viaali 8 ml steriilset süstevett.
English: One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Estonian: Üks infusioonilahuse kontsentraadi pulbri viaal sisaldab 160 mg trastuzumabemtansiini.
English: 2,% [95% CI] Disease-Free Survival (DFS)3 Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Distant recurrence-free interval (DRFI) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Estonian: 3 aasta juhtumivaba määr2,% [95% CI] Kaugmetastaaside vaba periood (DRFI) Haiguse progressiooniga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseerimata)
English: Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Estonian: Trastuzumabemtansiini kasutamisel täheldatud teadaoleva hepatotoksilisuse tõttu peab maksakahjustusega patsientide ravimisel olema ettevaatlik (vt lõigud 4.4 ja 5.2).
English: Diarrhoea, Vomiting, Nausea,
Estonian: Stomatiit, kõhulahtisus, oksendamine, iiveldus, kõhukinnisus, suukuivus, kõhuvalu
English: Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla (trastuzumab emtansine) to patients.
Estonian: Kadcyla (trastuzumabemtansiin) väljakirjutamisel, infusioonilahuse valmistamisel ja ravimi manustamisel patsientidele tuleb kasutada nii väljamõeldud nimetust (Kadcyla) kui ka täispikka mittekaubanduslikku nimetust (trastuzumabemtansiin) ning need kinnitada.
English: (> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
Estonian: 2. raskusaste (> 3,0...≤ 5 × ULN ettenähtud ravipäeval)
English: There have been no studies performed with other routes of administration.
Estonian: Muid manustamisteid ei ole uuritud.
English: Serious hepatobiliary disorders, including nodular regenerative hyperplasia (NRH) of the liver and some with a fatal outcome due to drug-induced liver injury have been observed in patients treated with trastuzumab emtansine.
Estonian: Trastuzumabemtansiiniga ravitud patsientidel on täheldatud tõsiseid maksa ja sapiteede häireid, kaasa arvatud maksa nodulaarset regeneratiivset hüperplaasiat (NRH) ning mõningaid surmaga lõppenud juhtusid ravimist tingitud maksakahjustuse tõttu.
English: It is not known whether trastuzumab emtansine is excreted in human milk.
Estonian: Ei ole teada, kas trastuzumabemtansiin eritub rinnapiima.
English: Cases of haemorrhagic events, including central nervous system, respiratory and gastrointestinal haemorrhage, have been reported with trastuzumab emtansine treatment.
Estonian: Trastuzumabemtansiini kasutamisel on teatatud verejooksudest, sealhulgas kesknärvisüsteemi, hingamisteede ja seedetrakti hemorraagiast.
English: No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Estonian: Trastuzumabemtansiiniga ei ole reproduktsiooni- ja arengutoksilisuse uuringuid läbi viidud.
English: Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Estonian: Haiguse progressiooniga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseerimata)
English: The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm.
Estonian: Üldise elulemuse kirjeldava jätkuanalüüsi ajal oli kokku 27,4% lapatiniibi pluss kapetsitabiini rühma patsientidest üle läinud trastuzumabemtansiini rühma.
English: Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Estonian: Trombotsütopeenia 2.-3. raskusaste ettenähtud ravipäeval (25 000...< 75 000/mm3)
English: Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Estonian: Kadcyla 100 mg infusioonilahuse kontsentraadi pulber Üks infusioonilahuse kontsentraadi pulbri viaal sisaldab 100 mg trastuzumabemtansiini.
English: Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Estonian: Kadcyla 160 mg infusioonilahuse kontsentraadi pulber Üks infusioonilahuse kontsentraadi pulbri viaal sisaldab 160 mg trastuzumabemtansiini.
English: Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Estonian: Kadcyla 100 mg infusioonilahuse kontsentraadi pulber Kadcyla 160 mg infusioonilahuse kontsentraadi pulber trastuzumabemtansiin
English: Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are linked together: · trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2).
Estonian: • trastuzumab - monoklonaalne antikeha, mis valikuliselt seondub antigeeniga (märklaudvalk), mille nimetus on inimese epidermaalne kasvufaktori retseptor 2 (HER2).
English: Grade 4 (> 10´ the ULN)
Estonian: 4. raskusaste (> 10 × ULN)
English: In order to prevent medicinal product errors it is important to check the vial labels to ensure that the medicinal product being prepared is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Estonian: Ravimpreparaadi kasutusvigade vältimiseks on tähtis kontrollida viaali etiketilt, et valmistatav ravimpreparaat on Kadcyla (trastuzumabemtansiin), mitte Herceptin (trastuzumab).
English: Grade 4 (> 20´ the ULN)
Estonian: 4. raskusaste (> 20 × ULN)
English: LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Estonian: LVEF 40%...≤ 45% ja langus on < 10% punkti algväärtusest
English: AST recovers to Grade ≤ 1, and then reduce one dose level
Estonian: ASAT tõus taandub raskusastmeni ≤ 1,
English: Kadcyla 160 mg powder for concentrate for solution for infusion.
Estonian: Kadcyla 160 mg infusioonilahuse kontsentraadi pulber.
English: peripheral neuropathy until resolution to ≤ Grade 2.
Estonian: Mitte manustada trastuzumabemtansiini, kuni on taandunud raskusastmeni ≤ 2
English: Continue treatment with trastuzumab emtansine
Estonian: Jätkata ravi trastuzumabemtansiiniga
English: Trastuzumab emtansine must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion.
Estonian: Tervishoiutöötaja peab trastuzumabemtansiini lahustama ja lahjendama ning manustama veeniinfusiooni teel.
English: What Kadcyla looks like and contents of the pack · Kadcyla is a white to off-white lyophilised powder for concentrate for solution for infusion supplied in glass vials.
Estonian: • Kadcyla on klaasviaalidesse pakendatud valge või valkjas lüofiliseeritud pulber infusioonilahuse kontsentraadi valmistamiseks.
English: In order to prevent medicinal product errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Estonian: Ravimpreparaadi kasutusvigade vältimiseks on tähtis kontrollida viaali etiketilt, et valmistatav ja manustatav ravimpreparaat on Kadcyla (trastuzumabemtansiin), mitte Herceptin (trastuzumab).
English: Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine.
Estonian: Trastuzumabemtansiini kliinilistes uuringutes on täheldatud raskekujulisi anafülaktilisi reaktsioone.
English: The population PK analysis showed that age did not affect the PK of trastuzumab emtansine.
Estonian: Populatsiooni farmakokineetiline analüüs näitas, et vanus ei mõjutanud trastuzumabemtansiini farmakokineetikat.
English: Events of LVEF drop of >10% from baseline and/or CHF were observed in an observational study (BO39807) of MBC patients with baseline LVEF of 40-49% in a real world setting.
Estonian: Vaatlusuuringus (BO39807) täheldati LVEF languse juhtusid > 10% algväärtusest ja/või südame paispuudulikkuse teket metastaatilise rinnanäärmevähiga patsientidel, kellel oli tavapraktika tingimustes ravieelne LVEF 40...49%.
English: Invasive Disease-Free Survival (IDFS) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Secondary Endpoints
Estonian: Esmane tulemusnäitaja Invasiivse haiguse vaba elulemus (IDFS)3 Haiguse progressiooniga patsientide arv (%) HR [95% CI] p-väärtus (logaritmiline astaktest, stratifitseerimata)
English: Kadcyla 100 mg powder for concentrate for solution for infusion.
Estonian: Kadcyla 100 mg infusioonilahuse kontsentraadi pulber.
English: (> 5 to ≤ 20´ ULN on day of scheduled treatment)
Estonian: 3. raskusaste (> 5...≤ 20 × ULN ettenähtud ravipäeval)
English: Patients with dyspnoea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary events.
Estonian: Pulmonaalsete kõrvaltoimete tekkerisk võib olla suurem patsientidel, kellel esineb kaugelearenenud pahaloomulise kasvaja tüsistustest, kaasuvatest haigustest ja samaaegsest kopsu kiiritusravist tingitud rahuoleku hingeldus.
English: Hyperbilirubinemia TBILI
Estonian: Hüperbilirubineemia Üldbilirubiin (TBILI) > 1,0...≤ 2,0 × ULN ettenähtud ravipäeval
English: The liver is a primary organ for eliminating DM1 and DM1-containing catabolites.
Estonian: DM1 ja DM1 sisaldavate kataboliitide eliminatsioon toimub peamiselt maksa kaudu.
English: How you are given Kadcyla
Estonian: Kuidas Kadcyla't manustatakse
English: Kadcyla will be given to you by a doctor or nurse in a hospital or clinic: · It is given by a drip into a vein (intravenous infusion).
Estonian: Kadcyla't manustab teile arst või meditsiiniõde haiglas või kliinikus.
English: Instructions for reconstitution · Kadcyla 100mg: using a sterile syringe, slowly inject 5 mL of sterile water for injection into the
Estonian: • Kadcyla 100 mg: steriilse süstlaga süstida aeglaselt 100 mg trastuzumabemtansiini viaali 5 ml steriilset süstevett.
English: Instructions for reconstitution · 100 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 5 mL of sterile water for injection into the vial.
Estonian: • 100 mg trastuzumabemtansiini viaal: steriilse süstlaga süstida aeglaselt viaali 5 ml steriilset süstevett.
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Estonian: RAVIMPREPARAADI NIMETUS Kadcyla 100 mg infusioonilahuse kontsentraadi pulber trastuzumabemtansiin
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Estonian: RAVIMPREPARAADI NIMETUS Kadcyla 160 mg infusioonilahuse kontsentraadi pulber trastuzumabemtansiin
English: For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Estonian: Annuse muutmise juhised ülitundlikkusreaktsioonide korral vt lõigud 4.2 ja 4.4.
English: Early Breast Cancer (EBC)
Estonian: Haigusvaba elulemus (DFS)3
English: What you need to know before you are given Kadcyla 3.
Estonian: 1. Mis ravim on Kadcyla ja milleks seda kasutatakse 2. Mida on vaja teada enne Kadcyla manustamist 3.
English: Fatigue, Pyrexia, Asthenia
Estonian: Väsimus, palavik, asteenia
English: Gastrointestinal disorders Stomatitis,
Estonian: Infusioonilahuse kontsentraadi pulber.
English: Left Ventricular Dysfunction
Estonian: Vaskulaarsed häired Hemorraagia
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then reduce one dose level
Estonian: Mitte manustada trastuzumabemtansiini, kuni trombotsüütide arvu langus on taandunud raskusastmeni ≤ 1 (≥ 75 000/mm3), seejärel vähendada annust ühe taseme võrra
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kadcyla 160 mg infusioonilahuse kontsentraadi pulber trastuzumabemtansiin
English: Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1 and then reduce one dose level.
Estonian: Mitte manustada trastuzumabemtansiini, kuni üldbilirubiini tõus taandub raskusastmeni ≤ 1,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kadcyla 100 mg infusioonilahuse kontsentraadi pulber trastuzumabemtansiin
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then treat at the same dose level
Estonian: Mitte manustada trastuzumabemtansiini, kuni trombotsüütide arvu langus on taandunud raskusastmeni ≤ 1 (≥ 75 000/mm3), seejärel jätkata ravi sama annusega
English: Succinic acid Sodium hydroxide Sucrose
Estonian: Merevaikhape Naatriumhüdroksiid Sahharoos Polüsorbaat 20
English: The use of 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Estonian: Kui infusioonilahuse kontsentraat lahjendatakse naatriumkloriidi 9 mg/ml (0,9%) infusioonilahusega, peab infusiooni ajal kasutama 0,20- või 0,22-mikronilist süsteemisisest polüeetersulfoon (PES)filtrit.
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then reduce one dose level.
Estonian: Mitte manustada trastuzumabemtansiini, kuni trombotsüütide arvu langus on taandunud raskusastmeni ≤ 1 (≥ 75 000/mm3), seejärel vähendada annust ühe taseme võrra.
English: What Kadcyla contains · The active substance is trastuzumab emtansine.
Estonian: Mis ravim on Kadcyla Kadcyla sisaldab toimeainena trastuzumabemtansiini, mis koosneb kahest omavahelt seotud osast:
English: Do not administer trastuzumab emtansine until platelet count recovers to £ Grade 1 (≥ 75,000/mm3), and then treat at the same dose level.
Estonian: Mitte manustada trastuzumabemtansiini, kuni trombotsüütide arvu langus on taandunud raskusastmeni ≤ 1 (≥ 75 000/mm3), seejärel jätkata ravi sama annusega.
English: Injection site extravasation
Estonian: Süstekoha ekstravasatsioon
English: Permanently discontinue trastuzumab emtansine
Estonian: Lõpetada alaliselt ravi trastuzumabemtansiiniga
English: Very common (may affect more than 1 in 10 people): · Kadcyla may cause inflammation or damage to cells in the liver, resulting in elevated liver enzymes in blood tests.
Estonian: • Kadcyla võib põhjustada maksarakkude põletikku või kahjustust, mille tagajärjel suureneb maksaensüümide tase vereanalüüsides.
English: A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
Estonian: Trastuzumabemtansiini või lapatiniibi pluss kapetsitabiini saama randomiseeriti kokku 991 patsienti järgmiselt:
English: Paediatric population
Estonian: Haiguse progressiooniga patsientide arv
English: 6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used.
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Estonian: Üks infusioonilahuse kontsentraadi pulbri viaal sisaldab 100 mg trastuzumabemtansiini.
English: It is essentially ‘sodium- free'.
Estonian: Ravim on praktiliselt naatriumivaba.
English: Grade ≥ 2.
Estonian: Võimalikud kõrvaltoimed 5.
English: Transaminases increased
Estonian: • vererõhu tõus
English: No formal PK study has been conducted in patients with renal impairment.
Estonian: Neerukahjustusega patsientidel ei ole farmakokineetika uuringut läbi viidud.
English: The Mutual Recognition Procedure started on 28 February 2008.
Estonian: Vastastikuse tunnustamise menetlus algas 28. veebruaril 2008.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, Poland, Portugal and Spain.
Estonian: Taotlus esitati muudetud direktiivi 2001/82/EÜ artikli 32 kohaselt; viiteliikmesriik oli Ühendkuningriik ning asjaomased liikmesriigid Austria, Belgia, Hispaania, Iirimaa, Itaalia, Madalmaad, Poola, Portugal Prantsusmaa ja Saksamaa.
English: The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Estonian: Ettekandja ja kaasettekandja olid vastavalt Dr Bruno Urbain ja Dr Michael Holzhauser-Alberti.
English: Ref.EMEA/313849/2009
Estonian: 3. august 2009 Viide EMEA/519974/2009
English: The referral procedure started on 16 September 2008.
Estonian: Esildise menetlemine algas 16. septembril 2008.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Estonian: ARVAMUS PÄRAST ARTIKLI 33 LÕIKE 41 KOHAST ESILDIST, MIS KÄSITLEB RAVIMIT FENFLOR 300 MG/ML SÜSTELAHUS VEISTELE Rahvusvaheline mittekaubanduslik nimetus (INN): florfenikool
English: The Marketing Authorisation Holder, Gosmore Ltd, submitted an application via mutual recognition for Fenflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Estonian: Müügiloa hoidja, Gosmore Ltd, esitas Fenflor 300 mg/ml süstelahus veistele müügiloa taotluse vastastikuse tunnustamise menetluse kaudu, võttes aluseks Ühendkuningriigis väljastatud müügiloa.
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Fenflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Estonian: 31. juulil 2008 tegi Ühendkuningriik Euroopa Ravimiametile direktiivi 2001/82/EÜ artikli 33 lõike 4 kohase esildise Saksamaa ja Madalmaade tõstatatud probleemi tõttu, et Fenflor 300 mg/ml süstelahus veistele võib olla keskkonnale ohtlik.
English: Moreover, the intended uses do not require medical supervision.
Estonian: Lisaks ei nõua nende kasutusviis meditsiinilist järelevalvet.
English: Agrimony should only be used in adults and children over the age of 12 years.
Estonian: Maarjalepaürti tohib kasutada ainult täiskasvanutel ja üle 12-aastastel lastel.
English: Agrimony
Estonian: Maarjalepaürt
English: These may also be used to prepare liquid extracts with water and alcohol.
Estonian: Neid saab kasutada ka vedelekstraktide valmistamiseks vee ja alkoholiga.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom pöörduda arsti või pädeva tervishoiutöötaja poole.
English: What is agrimony?
Estonian: Mis on maarjalepaürt?
English: Agrimony EMA/HMPC/332849/2015
Estonian: Maarjalepaürt EMA/HMPC/332849/2015
English: The HMPC noted the lack of clinical studies with agrimony, but took into account the well documented use of this herbal medicine for the above uses.
Estonian: Taimsete ravimite komitee märkis, et puuduvad maarjalepaürti käsitlevad kliinilised uuringud, kuid arvestas selle taimse ravimi hästi dokumenteeritud kasutust eespool nimetatud näidustuste korral.
English: It can also be applied to the skin for relief of minor inflammation and small superficial wounds.
Estonian: Samuti tohib seda kasutada nahal kerge põletiku ja väikeste pindmiste haavade leevendamiseks.
English: Further information on the risks associated with agrimony 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 maarjalepaürti 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: The HMPC conclusions on the use of agrimony medicines for the relief of mild diarrhoea, mild inflammation of the mouth and throat, skin inflammation and wounds are based on their ‘traditional use' in these conditions.
Estonian: Taimsete ravimite komitee järeldused maarjalepaürti sisaldavate ravimite kasutamise kohta kerge kõhulahtisuse, suu ja kurgu kerge põletiku, nahapõletiku ja haavade leevendamiseks põhinevad nende traditsioonilisel kasutamisel selliste seisundite korral.
English: Further information on the HMPC assessment of agrimony 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 maarjalepaürti 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: What evidence supports the use of agrimony medicines?
Estonian: Millised tõendid toetavad maarjalepaürti sisaldava ravimi kasutamist?
English: Other information about agrimony medicines
Estonian: Muu teave maarjalepaürti sisaldava ravimi kohta
English: treatment, or if mouth, throat or skin symptoms persist for more than a week during treatment.
Estonian: Kui kõhulahtisus kestab ravi ajal üle 3 päeva või kui suu-, kurgu- või nahasümptomid püsivad ravi ajal üle nädala, tuleb
English: Agrimony can also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis esineb maarjalepaürt ka kombinatsioonis teiste taimsete ainetega.
English: The HMPC concluded that, on the basis of its long-standing use, agrimony can be taken by mouth for the relief of mild diarrhoea, or used as a gargle to relieve mild inflammation of the mouth and throat.
Estonian: Taimsete ravimite komitee järeldas, et lähtudes selle pikaajalisest kasutamisest, tohib maarjalepaürti võtta suu kaudu kerge kõhulahtisuse leevendamiseks või kasutada seda kuristamiseks suu ja kurgu kerge põletiku leevendamiseks.
English: Any applications for the licensing of medicines containing agrimony 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: Maarjalepaürti sisaldava ravimi müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimse ravimi müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslike järelduste kokkuvõtet.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing agrimony.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad maarjalepaürti sisaldavate taimsete ravimite müügilubade taotlusi.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of agrimony.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb maarjalepaürdi meditsiinilisi kasutusviise.
English: What are the risks associated with agrimony medicines?
Estonian: Mis riskid kaasnevad maarjalepaürti sisaldava ravimiga?