FrancophonIA/ELRC3.0 huggingface dataset:
English: Priligy can make you faint or make your blood pressure drop when you stand up.
Estonian: Priligy võib põhjustada vererõhu järsku langust või minestamist püstitõusmisel.
English: • Spinning sensation
Estonian: • Hägune nägemine
English: • Diarrhoea, constipation or having wind
Estonian: • Kõhuvalu, kõhupuhitus või oksendamine
English: • You have a history of fainting
Estonian: • kui teil on varem esinenud minestamist
English: • You have fits (seizures)
Estonian: • teil on krambid (krambihood)
English: • Urgency of bowel action.
Estonian: • Äkiline uinumine • Järsk soole tühjendamise vajadus.
English: • Stomach pain, bloating or being sick
Estonian: • Väsimustunne või unisus, haigutamine
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Estonian: MANUSTAMISVIIS JA -TEE Suukaudne
English: • Tell your doctor if you faint when taking this medicine.
Estonian: • Kui olete selle ravimi võtmisel minestanud, rääkige sellest oma arstile.
English: - You have an illness where you have a high temperature, diarrhoea or being sick.
Estonian: See võib juhtuda, kui o Te ei ole viimase 4 kuni 6 tunni jooksul midagi joonud o Te olete pikaajaliselt higistanud o Teil on haigus, mille korral teil on kõrge palavik, kõhulahtisus või oksendamine.
English: The effects of treatment were greatest in the first year.
Estonian: Ravitoime oli suurim esimesel aastal.
English: Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015.
Estonian: Jinarc on saanud müügiloa, mis kehtib kogu ELis, 27. mail 2015.
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Jinarci kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jinarc (tolvaptan)
Estonian: Jinarc (tolvaptaan)
English: What measures are being taken to ensure the safe and effective use of Jinarc?
Estonian: Mis meetmed võetakse, et tagada Jinarci ohutu ja efektiivne kasutamine?
English: Jinarc is available as tablets (15, 30, 45, 60 and 90 mg).
Estonian: Jinarci turustatakse tablettidena (15, 30, 45, 60 ja 90 mg).
English: Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects.
Estonian: Ravi alguses tuleb võtta 45 mg annus hommikul ja 15 mg õhtul (45 + 15 mg) ning seejärel tuleb annust suurendada annuseni 60 + 30 mg või 90 + 30 mg olenevalt ravimi kõrvalnähtudest.
English: The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity.
Estonian: Samuti korraldab turustaja uuringu, et täiendavalt uurida ravimi ohutust, sealhulgas maksatoksilisuse riski.
English: Doses may need to be reduced in patients taking certain other medicines.
Estonian: Teatud muid ravimeid kasutavatel patsientidel võib olla vaja annust vähendada.
English: The European Medicines Agency decided that Jinarc's benefits are greater than its risks and that it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Jinarci kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Jinarc are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Jinarci kasutamise kohta pidevat järelevalvet.
English: Jinarc must also not be used in pregnant and breastfeeding women.
Estonian: Jinarci ei tohi kasutada ka rasedad ega imetavad naised.
English: What is Jinarc and what is it used for?
Estonian: Mis on Jinarc ja milleks seda kasutatakse?
English: Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment.
Estonian: Ravi ajal tuleb patsiente jälgida ka maksakahjustuse sümptomite suhtes (nt isutus, iiveldus ja oksendamine, kihelus, väsimus ja valu paremal pool ülakõhus).
English: Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter.
Estonian: Enne ravi alustamist tuleb teha patsiendi maksafunktsiooni kontrolliks vereanalüüsid ning korrata neid 18 kuu jooksul igal kuul ja seejärel iga 3 kuu tagant.
English: Side effects reported with Jinarc are carefully evaluated and any necessary action taken to protect patients.
Estonian: Jinarci kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Estonian: Blokeerides neerude vasopressiini retseptorid, võib Jinarc aeglustada tsüstide teket.
English: For more information about using Jinarc, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Jinarci kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems).
Estonian: Jinarc võib suurendada vere teatud maksaensüümide sisaldust (võimalike maksaprobleemide sümptom).
English: What are the risks associated with Jinarc?
Estonian: Mis riskid Jinarciga kaasnevad?
English: The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy during treatment.
Estonian: Jinarci turustaja annab ravimit eeldatavasti kasutavatele patsientidele ja arstidele teabematerjalid maksatoksilisuse riski ning ravi ajal raseduse vältimise tähtsuse kohta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jinarc have also been included in the summary of product characteristics and the package leaflet.
Estonian: Jinarci ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Other information about Jinarc
Estonian: Muu teave Jinarci kohta
English: Vasopressin controls the amount of water and sodium that the kidneys remove.
Estonian: Vasopressiin reguleerib neerude väljutatava vee ja naatriumi kogust.
English: How does Jinarc work?
Estonian: Kuidas Jinarc toimib?
English: While the most common side effects are manageable, the Agency identified liver toxicity as the most important risk with Jinarc, which was addressed by putting in place several measures (see below).
Estonian: Kuigi kõige sagedamad kõrvalnähud on hallatavad, tuvastas amet Jinarci kõige olulisema riskina maksatoksilisuse, mida lahendati mitme riskivähendusmeetmega (vt allpool).
English: This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail.
Estonian: See on pärilik haigusseisund, mille korral tekib neerus palju vedelikuga täitunud tsüste, mis aegamööda vähendavad neerutalitlust ja võivad põhjustada neerupuudulikkust.
English: The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment.
Estonian: Esimeses uuringus osales 1445 patsienti, kellel oli normaalne neerutalitlus või neerutalitluse mõõdukas halvenemine, ning selles hinnati neerude suuruse muutust 3 raviaasta järel.
English: The second study included 1,370 patients with moderately to severely reduced kidney function.
Estonian: Teises uuringus osales 1370 patsienti, kellel oli neerutalitluse mõõdukas kuni raske halvenemine.
English: The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food.
Estonian: Hommikune annus tuleb võtta vähemalt 30 minutit enne hommikusööki.
English: The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin.
Estonian: Jinarci toimeaine tolvaptaan on vasopressiini V2-retseptori antagonist: see blokeerib neerudes hormooni vasopressiini retseptorid.
English: Jinarc contains the active substance tolvaptan.
Estonian: Jinarc sisaldab toimeainena tolvaptaani.
English: Subsequent supportive results confirmed that increase in kidney size over 5 years was slower with Jinarc.
Estonian: Edasised toetavad andmed kinnitasid, et 5 aasta kestel suurenesid Jinarci kasutanud patsientidel neerud aeglasemalt.
English: The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition.
Estonian: Amet märkis, et autosoom-dominantse polütsüstilise neeruhaiguse ravivajadus on täitmata, ning oli arvamusel, et Jinarc on efektiivne selle haigusseisundiga patsientidel tsüstide tekke ja neerutalitluse halvenemise aeglustamisel.
English: Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease.
Estonian: Jinarc on ravim, mida kasutatakse autosoom-dominantse polütsüstilise neeruhaigusega täiskasvanute raviks.
English: Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.
Estonian: Jinarci efektiivsust tsüstide tekke aeglustamisel võrreldes platseeboga (näiv ravim) tõendati kahes põhiuuringus, milles osalesid kiiresti progresseeruva autosoom-dominantse polütsüstilise neeruhaigusega täiskasvanud.
English: For the full list of side effects reported with Jinarc, see the package leaflet.
Estonian: Jinarci kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: In autosomal dominant polycystic kidney disease, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts.
Estonian: Arvatakse, et autosoom-dominantse polütsüstilise neeruhaiguse korral ei reageeri neerurakud vasopressiinile normaalselt ja see põhjustab vedelikuga täitunud tsüstide teket.
English: Jinarc must not be used in patients who are anuric (cannot pass urine or have difficulty in passing it), volume depleted (have reduced amounts of fluids in the body) and in patients who cannot perceive or respond to thirst.
Estonian: Jinarci ei tohi kasutada patsiendid, kellel on anuuria (kusetus või urineerimisraskus), hüpovoleemia (vähenenud vedelikumaht organismis) või kes ei taju janu või ei reageeri sellele.
English: It must not be used in patients with hypernatraemia (increased sodium levels in the blood) and in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives.
Estonian: Samuti ei tohi Jinarci kasutada hüpernatreemiaga (vere liigne naatriumisisaldus) patsiendid ja patsiendid, kes on allergilised tolvaptaani või sellega sarnaste ravimite, nn bensasepiinide ja nende derivaatide suhtes.
English: Kidney size increases with disease severity due to swelling caused by cyst formation.
Estonian: Haiguse raskusastme süvenemisel suurenevad neerud tsüstide tekkest põhjustatud turse tõttu.
English: Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.
Estonian: Ravi ajal peavad patsiendid jooma rohkelt vett või muid vedelikke (v.a greibimahl).
English: Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment.
Estonian: Tulemustest nähtus, et Jinarciga ravitud patsientidel oli neerutalitlus 1 raviaasta järel halvenenud 35% vähem kui platseebot kasutanud patsientidel.
English: Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.
Estonian: Jinarc-ravi tohib alustada kiiresti progresseeruva haigusega patsientidel, kellel on normaalne kuni raskelt halvenenud neerufunktsioon.
English: Jinarc must not be started in certain patients with increased blood levels of liver enzymes or with signs or symptoms of liver injury.
Estonian: Ravi Jinarciga ei tohi alustada teatud patsientidel, kelle maksaensüümide sisaldus veres on suurenenud või kellel on maksakahjustuse nähte või sümptomeid.
English: In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%.
Estonian: Platseeborühma patsientide neerud suurenesid kokku 19% ja Jinarci uuringurühma patsientidel 10% võrra.
English: An overview of Jinarc and why it is authorised in the EU
Estonian: Ülevaade ravimist Jinarc ja ELis müügiloa väljastamise põhjendus
English: The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day).
Estonian: Jinarci kõige sagedamad kõrvalnähud (võivad esineda enam kui 2 patsiendil 10st) on janu, polüuuria (liigkusesus), nüktuuria (öiskusesus) ja pollakisuuria (sagekusesus).
English: In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.
Estonian: Neerutalitluse raske halvenemisega 262 patsiendi seas oli neerutalitlus Jinarci rühma patsientidel pärast 1 raviaastat võrreldes platseeborühma patsientidega halvenenud 17% vähem.
English: Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.
Estonian: Ravi tohib alustada ainult autosoom-dominantse polütsüstilise neeruhaiguse ravis kogenud arst, kes teab Jinarciga kaasnevaid riske, ning ravi peab toimuma tema järelevalve all.
English: How is Jinarc used?
Estonian: Kuidas Jinarci kasutatakse?
English: What benefits of Jinarc have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Jinarci kasulikkus?
English: The Reference Member State was Denmark and the Concerned Member States were: Czech Republic, Hungary, Poland, Slovakia, and United Kingdom.
Estonian: Viiteliikmesriik oli Taani ja asjassepuutuvad liikmesriigid Tšehhi Vabariik, Ungari, Poola, Slovakkia ja Ühendkuningriik.
English: The Mutual Recognition Procedure started on 25 May 2005.
Estonian: Vastastikuse tunnustamise menetlust alustati 25. mail 2005.
English: Pharmcom OY submitted applications for mutual recognition of Cardoreg 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Estonian: Ettevõte Pharmcom OY esitas Cardoreg 4 mg toimeainet prolongeeritult vabastavate tablettide ja sarnaste nimetuste vastastikuse tunnustamise taotlused müügiloa alusel, mis oli väljastatud Taanile 30. septembril 2002.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Cardoreg 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Estonian: Kõigi esitatud andmete põhjal ja komitees toimunud teadusliku arutelu käigus jõudis inimtervishoius kasutatavate ravimite komitee oma juunis 2006 peetud koosolekul arvamusele, et Cardoreg 4 mg toimeainet prolongeeritult vabastavate tablettide ja sarnaste nimetuste kasu ja riski vahekord on soodne ning tõstatatud vastulaused ei tohiks takistada müügiloa andmist, samuti tuleks viiteliikmesriigil muuta ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Cardoreg 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Estonian: INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 29 LÕIKE 21 JÄRGSET ESILDIST Cardoreg 4 mg toimeainet prolongeeritult vabastavate tablettide ja sarnaste nimetuste kohta Rahvusvaheline mittekaubanduslik nimetus (INN): doksasosiin
English: The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Estonian: Esildise eesmärgiks oli leppida kokku, kas Cardoreg 4 mg toimeainet prolongeeritult vabastavad tabletid erinevad toimeaine vabastamise profiili poolest oluliselt originaalravimist, nii et see võiks suurendada selliste kõrvalnähtude sagedust nagu peapööritus ja hüpertensioon; kas ühe annuse uuringutes 5208 ja 1995 kasutatud partiide toimes oli märkimisväärseid erinevusi; ning kas taotleja on eiranud inimtervishoius kasutatavate ravimite komitee bioekvivalentsuse uuringute ülesehituse suuniseid, eelkõige koostoimes toiduga.
English: Cardoreg 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Estonian: Cardoreg 4 mg toimeainet prolongeeritult vabastavad tabletid ja sarnased nimetused (doksasosiin) sisaldavad alfaretseptori blokaatorit, mida kasutatakse patsientide essentsiaalse hüpertensiooni raviks ja eesnäärme healoomulise suurenemise sümptomaatiliseks raviks.
English: 4 December 2015
Estonian: 4. detsember 2015
English: These medicines should only be used in adults and should not be taken for longer than 10 days.
Estonian: Neid ravimeid tohivad kasutada ainult täiskasvanud ja neid ei tohi kasutada kauem kui 10 päeva.
English: EMA/HMPC/333915/2015 Corr.1
Estonian: EMA/HMPC/333915/2015
English: However, the amount of pyrrolizidine alkaloids has to be specified in each comfrey root medicine and patients should not be exposed to more than 0.35 microgram of pyrrolizidine alkaloids per day.
Estonian: Samas tuleb märkida pürrolisidiinialkaloidide kogus igas varemerohujuurt sisaldavas ravimis ja patsiendid ei tohi kokku puutuda rohkem kui 0,35 mikrogrammi pürrolisidiinialkaloidididega ööpäevas.
English: Comfrey root EMA/HMPC/333915/2015
Estonian: Varemerohujuur EMA/HMPC/333915/2015
English: However, since the exact composition of the herbal preparation used in these studies is not known, these data were not taken into account and the HMPC conclusions on the use of comfrey root medicines are based on their long-standing use.
Estonian: Et aga nendes uuringutes kasutatud taimse preparaadi täpne koostis ei ole teada, ei arvestatud neid andmeid ja taimsete ravimite komitee järeldused varemerohujuurt sisaldavate ravimite kasutamise kohta põhinevad nende pikaaegsel kasutamisel.
English: These studies suggested a reduction in swelling and pain in patients using this herbal preparation for sprains and bruises.
Estonian: Nendes uuringutes täheldati, et turse ja valu vähenesid patsientidel, kes kasutasid seda taimset preparaati venituste ja verevalumite korral.
English: Further information on the risks associated with comfrey root 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 varemerohujuurt 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 comfrey root 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 varemerohujuurt 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: The HMPC also noted 4 clinical studies carried out with a different comfrey preparation (not covered by this summary).
Estonian: Lisaks võttis taimsete ravimite komitee teadmiseks 4 kliinilist uuringut varemerohujuure teistsuguse preparaadi kohta, mida ei käsitleta käesolevas kokkuvõttes.
English: Any applications for the licensing of medicines containing comfrey root 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: Varemerohujuurt 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 comfrey root.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad varemerohujuurt sisaldavate taimsete ravimite müügilubade taotlusi.
English: Comfrey root contains substances known as pyrrolizidine alkaloids, which have toxic effects on the liver when taken by mouth.
Estonian: Varemerohujuur sisaldab pürrolisidiinialkaloide, millel on suukaudse manustamise korral toksiline toime maksale.
English: What evidence supports the use of comfrey root medicines?
Estonian: Millised tõendid toetavad varemerohujuurt sisaldava ravimi kasutamist?
English: Other information about comfrey root medicines
Estonian: Muu teave varemerohujuurt sisaldava ravimi kohta
English: What is comfrey root?
Estonian: Mis on varemerohujuur?
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of comfrey root.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb varemerohujuure meditsiinilisi kasutusviise.
English: The HMPC conclusions on the use of comfrey root medicines for the relief of symptoms of minor sprains and bruises are based on their ‘traditional use' in these conditions.
Estonian: Taimsete ravimite komitee järeldused varemerohujuurt sisaldavate ravimite kasutamise kohta kergete venituste ja verevalumite sümptomite leevendamiseks põhinevad nende traditsioonilisel kasutamisel
English: What are the risks associated with comfrey root medicines?
Estonian: Mis riskid kaasnevad varemerohujuurt sisaldava ravimiga?
English: Herbal medicines containing this comfrey root preparation are available in semi-solid forms (such as creams or ointments) to be applied to the skin.
Estonian: Varemerohujuure preparaati sisaldavaid taimseid ravimeid turustatakse nahale kantavate pooltahkete ainetena (nt kreemide või salvidena).
English: Comfrey root is the common name for the root of the plant Symphytum officinale L. This summary covers Comfrey root medicines containing a specific herbal preparation, which is obtained by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in alcohol).
Estonian: See kokkuvõte käsitleb varemerohujuurt sisaldavaid ravimeid, milles sisalduv spetsiifiline taimepreparaat on saadud etanoolekstraheerimisega (meetod, millega eraldatakse taimeosadest ühendid neid alkoholis lahustades).