FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose of Zalasta depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Estonian: Zalasta soovituslik algannus sõltub ravitavast haigusest: skisofreenia korral ja maaniaepisoodide ennetamiseks manustatakse 10 mg päevas ning maaniaepisoodide raviks 15 mg päevas, välja arvatud kasutamisel koos teiste ravimitega - sellisel juhul võib algannus olla 10 mg päevas.
English: Orodispersible tablets are tablets that dissolve in the mouth.
Estonian: Dispergeeruvad tabletid on suus lahustuvad tabletid.
English: Other information about Zalasta:
Estonian: Muu teave Zalasta kohta
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZALASTA EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE ZALASTA Kokkuvõte üldsusele
English: The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Estonian: Suus dispergeeruvad tabletid, mida võib kasutada tavaliste tablettide asemel, asetatakse keelele, kus need süljes kiiresti lagunevad, või segatakse need enne neelamist veega.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Estonian: Seda võib kasutada ka episoodide kordumise (sümptomite taastekkimise) ennetamiseks bipolaarse meeleoluhäirega (vaimuhaigus, kus vahelduvad meeleolu liigne tõus ja langus) täiskasvanud patsientidel, kellel on tekkinud esialgne ravivastus.
English: Zalasta is used to treat adults with schizophrenia.
Estonian: Zalastat kasutatakse täiskasvanud patsientidel skisofreenia ravimiseks.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Estonian: Zalasta täpne toimemehhanism ei ole teada, kuid ravim seondub aju närvirakkude pinnal oleva mitme retseptoriga.
English: Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i.e. that the medicines produce the same levels of the active substance in the body).
Estonian: Et Zalasta on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Zalasta bioekvivalentsust võrdlusravimitega (st need ravimid tekitavad organismis toimeainet samal määral).
English: What are the benefit and risk of Zalasta?
Estonian: Milles seisneb Zalasta kasulikkus ja mis riskid Zalastaga kaasnevad?
English: What is Zalasta?
Estonian: Mis on Zalasta?
English: Why has Zalasta been approved?
Estonian: Miks Zalasta heaks kiideti?
English: Because Zalasta is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Estonian: Et Zalasta on geneeriline ravim ja võrdlusravimitega bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimitel.
English: Zalasta is a medicine containing the active substance olanzapine.
Estonian: Zalasta on ravim, mis sisaldab toimeainena olansapiini.
English: Zalasta is a ‘generic medicine'.
Estonian: Zalasta on geneeriline ravim.
English: Zalasta is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Estonian: Zalastat saab kasutada ka esialgse ravivastusega patsientide paranemistulemuse efektiivseks säilitamiseks.
English: Zalasta is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Estonian: Samuti kasutatakse Zalastat mõõdukate või raskete maaniaepisoodide (meeleolu äärmuslik tõus) raviks täiskasvanutel.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Estonian: See häirib neurotransmitterite See häirib neurotransmitterite (keemilised ained, mille abil toimub närvirakkudevaheline signaalivahetus) vahendatavaid närviimpulsse.
English: The full EPARs for the reference medicines can also be found on the EMEA's website.
Estonian: Euroopa avaliku hindamisaruande täisteksti võrdlusravimit kohta leiate samuti Euroopa Ravimiameti veebilehelt.
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Zyprexa ja Zyprexa Velotabi korral, ületab Zalasta kasulikkus ravimiga kaasnenud riskid.
English: The active substance in Zalasta, olanzapine, is an antipsychotic medicine.
Estonian: Zalasta toimeaine olansapiin on antipsühhootikum.
English: The full EPAR for Zalasta can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Zalasta kohta leiate siit.
English: This means that Zalasta is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Estonian: See tähendab, et Zalasta on sarnane võrdlusravimitega Zyprexa ja Zyprexa Velotab, millel juba on Euroopa Liidus müügiluba.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zalasta has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Estonian: Inimravimite komitee otsustas, et vastavalt Zalasta võrdväärne kvaliteet ja bioekvivalentsus ravimitega Zyprexa ja Zyprexa Velotab on Euroopa Liidu nõuetele tõendatud.
English: How is Zalasta used?
Estonian: Kuidas Zalastat kasutatakse?
English: What is Zalasta used for?
Estonian: Milleks Zalastat kasutatakse?
English: How does Zalasta work?
Estonian: Kuidas Zalasta toimib?
English: How has Zalasta been studied?
Estonian: Kuidas Zalastat uuriti?
English: It is given six to nine times a day.
Estonian: Ventavist võetakse 6-9 korda ööpäevas.
English: What measures are being taken to ensure the safe and effective use of Ventavis?
Estonian: Mis meetmed võetakse, et tagada Ventavise ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Ventavis is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Ventavise võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis on 16 September 2003.
Estonian: Euroopa Komisjon andis Ventavise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. septembril 2003.
English: The full EPAR for Ventavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ventavise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel tekkis 12 nädala jooksul ravivastus.
English: The recommended dose is 2.5 or 5 micrograms.
Estonian: Soovitatav annus on 2,5 µg või 5,0 µg.
English: Ventavis was originally authorised under ‘exceptional circumstances' because, as the disease is rare, limited information was available at the time of approval.
Estonian: Esialgu kiideti Ventavis heaks erandkorras, sest haigus esineb harva ja ravimi heakskiitmise ajal ei olnud piisavalt teavet.
English: Other information about Ventavis
Estonian: Muu teave Ventavise kohta
English: The CHMP decided that Ventavis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Ventavise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.
Estonian: Nende veresoonte laienemisel vererõhk alaneb ning sümptomid leevenevad.
English: If the patient has liver or kidney problems, the time between doses should be at least three to four hours.
Estonian: Maksa- või neeruprobleemide korral peab annuste vahele jätma vähemalt 3-4 tundi.
English: This is a summary of the European public assessment report (EPAR) for Ventavis.
Estonian: See on ravimi Ventavis Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Ventavis (seen in more than 1 patient in 10) are headache, vasodilation (blood vessels becoming wider causing flushing or reddening of the face), bleeding episodes, chest pain and discomfort, peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), pain in the jaw and contraction of the jaw muscles, and cough.
Estonian: Ventavise kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on peavalu, vasodilatatsioon (veresoonte laienemine, mis põhjustab näopunetust), verejooksud, valu ja ebamugavustunne rindkeres, perifeerne turse (eriti pahkluupiirkonna ja jalgade turse), iiveldus, lõualuuvalu ja lõualihaste kokkutõmbumine ning köha.
English: What is Ventavis?
Estonian: Mis on Ventavis?
English: Ventavis must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein.
Estonian: Ventavist ei tohi kasutada patsiendid, kellel on verejooksu risk, teatud südameprobleemid, kellel on hiljuti olnud insult või kelle pulmonaalhüpertensiooni põhjustab ummistunud või ahenenud veen.
English: For more information about treatment with Ventavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ventavisega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ventavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Ventavise omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: As the company had supplied the additional information requested at the time of authorisation, the ‘exceptional circumstances' ended on 26 August
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 26. augustil 2013.
English: Ventavis is a medicine that contains the active substance iloprost.
Estonian: Ventavis on ravim, mis sisaldab toimeainena iloprosti.
English: Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Estonian: Ventavist kasutatakse nende täiskasvanud patsientide raviks, kellel on III klassi primaarne pulmonaalne hüpertensioon (PAH), et parandada nende koormustaluvust (füüsilist suutlikkust) ja leevendada sümptomeid.
English: ‘Primary' means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘class' reflects the severity of the symptoms caused by the disease: ‘class III' involves marked limitation of physical activity.
Estonian: Primaarne tähendab, et kõrgenenud vererõhk ei ole põhjustatud ühestki teisest südame- ega kopsuhaigusest, ning klass väljendab tõve raskusastet: „III klass“ tähendab märkimisväärselt piiratud kehalist aktiivsust.
English: Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adults with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Estonian: Ventavist võrreldi platseeboga (näiva ravimiga) ühes uuringus, milles osales 203 stabiilse III või IV klassi pulmonaalse hüpertensiooniga patsienti, kelle haigus oli kas primaarne või põhjustatud muust seisundist.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ventavis.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs.
Estonian: Pulmonaalne hüpertensioon on kopsuarterite ebanormaalselt kõrge vererõhk.
English: A ‘response' was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient's condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
Estonian: Ravivastuseks peeti patsiendi koormustaluvuse suurenemist 10% võrra (koormustaluvust mõõdeti kaugusega, mida patsient suutis kõndida 6 minuti jooksul) ja seisundi paranemist (haiguse raskus vähenes vähemalt ühe klassi võrra), kui pulmonaalne hüpertensioon ei süvenenud ja patsient hindamishetkel elas.
English: Patients should start with the low dose of 2.5 micrograms for the first inhalation, and if the first dose is well tolerated, the second and consecutive doses should be 5 micrograms.
Estonian: Esimene sissehingatav annus peab olema väike, 2,5 µg, ning kui patsient talub seda hästi, tohib teine annus ja järgmised olla 5,0 µg.
English: For the full list of all side effects reported with Ventavis, see the package leaflet.
Estonian: Ventavise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.
Estonian: Samas ilmnes Ventavise asjakohane kasulikkus uuringus osalenud eri patsiendirühmadest ainult nendel patsientidel, kellel oli III klassi primaarne pulmonaalne hüpertensioon.
English: Ventavis was significantly more effective than placebo: 17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
Estonian: Ravile reageeris Ventavist saanud patsientidest 17% (17 patsienti 101st) ja platseeborühmast 5% (5 patsienti 102st).
English: What is the risk associated with Ventavis?
Estonian: Mis riskid Ventavisega kaasnevad?
English: Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs that causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Estonian: Pulmonaalne hüpertensioon on kurnav haigus, mille korral kopsude veresooned ahenevad tugevasti, põhjustades kõrget vererõhku paremast südamepoolest kopsu viivates veresoontes.
English: Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Estonian: Ventavist hingatakse sisse nebulisaatori abil (nebulisaator on spetsiaalne seade, mis pihustab lahuse sissehingatavaks aerosooliks).
English: Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Estonian: Iloprost on aine, mis on väga sarnane prostatsükliinilelooduslikule molekulile, mis põhjustab veresoonte laienemist.
English: How does Ventavis work?
Estonian: Kuidas Ventavis toimib?
English: Why has Ventavis been approved?
Estonian: Miks Ventavis heaks kiideti?
English: What benefit has Ventavis shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ventavise kasulikkus?
English: Treatment with Ventavis should be started and monitored by a doctor experienced in the treatment of pulmonary hypertension.
Estonian: Ravi Ventavisega peab alustama pulmonaalse hüpertensiooni ravis kogenud arst ja ravi peab toimuma tema järelevalve all.
English: It is available as a solution for inhalation using a nebuliser.
Estonian: Seda turustatakse nebulisaatori abil manustatava inhaleerimislahusena (sissehingamislahusena).
English: How has Ventavis been studied?
Estonian: Kuidas Ventavist uuriti?
English: The dose should be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Estonian: Kui patsient ei talu suuremat annust, tuleb annust vähendada 2,5 µg-ni.
English: What is Ventavis used for?
Estonian: Milleks Ventavist kasutatakse?
English: How is Ventavis used?
Estonian: Kuidas Ventavist kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Ravimit tuleb manustada dosimeetrilise nebulisaatoriga,
English: Date of first authorisation: 03 May 1996 Date of latest renewal: 29 May 2006
Estonian: Müügiloa esmase väljastamise kuupäev: 3. mai 1996 Müügiloa viimase uuendamise kuupäev: 29. mai 2006
English: Puregon is usually not effective in such cases.
Estonian: Sel juhul pole Puregon tavaliselt efektiivne.
English: Important information about some of the ingredients of Puregon
Estonian: Oluline teave mõningate Puregon'i koostisainete suhtes
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Estonian: Üldine kogemus IVF-il näitab, et ravi edukuse määr jääb stabiilseks 4 esimese katse puhul ja alaneb seejärel järk-järgult.
English: You should not use Puregon if you are already pregnant, or think you might be pregnant.
Estonian: Te ei tohi Puregon'i kasutada, kui te olete juba rase või arvate end olevat rase.
English: Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).
Estonian: Hõlmab indutseeritud ovulatsiooniga naisi (Puregon, n = 76; u-FSH, n = 42).
English: Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Estonian: Vähenenud verevarustusest tingitud munasarja kahjustust saab vähendada varase diagnoosimise ja kohese detorsiooniga.
English: Other medicines and Puregon
Estonian: Muud ravimid ja Puregon
English: Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Estonian: Kõrge endogeenne FSH tase meestel näitab primaarset testikulaarpuudulikkust.
English: It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Estonian: On näidatud, et pensüsteliga manustatakse keskmiselt 18% suurem hulk FSHi võrreldes tavalise süstlaga.
English: What Puregon looks like and contents of the pack
Estonian: Kuidas Puregon välja näeb ja pakendi sisu
English: The use of Puregon during pregnancy is not indicated.
Estonian: Puregon ei ole raseduse ajal näidustatud.
English: Start again with Step 1 using a new syringe, new needles and a new vial of Puregon.
Estonian: Alustage uuesti kogu protseduuri 1. sammust, kasutades uut süstalt, uusi nõelasid ning uut Puregon'i viaali.
English: If you are breast-feeding, tell your doctor before using Puregon.
Estonian: Kui te toidate last rinnaga, öelge seda oma arstile enne Puregon'i kasutamist.
English: When there are 30 or more follicles in total it is advised to withhold hCG administration.
Estonian: Kui folliikuleid on kokku 30 või rohkem, on soovitatav hCG manustamine ära jätta.
English: Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Estonian: Mitmikrasedus suurendab tervisekahjustuste riski sünnituse ajal nii emale kui ka lastele.
English: The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.
Estonian: Subkutaanselt manustatud Puregon´i absoluutne biosaadavus on umbes 77%.
English: Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Estonian: Ravi Puregon'i ja hCG-ga tuleb jätkata vähemalt 3…4 kuud, enne kui on oodata spermatogeneesi paranemist.
English: Median duration of treatment (days)
Estonian: Keskmine koguannus (RÜ) Keskmine raviperioodi kestus (päevades)
English: What Puregon contains
Estonian: Mida Puregon sisaldab
English: Puregon can thus be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function.
Estonian: Puregon'i saab seega kasutada follikulaarse arengu ja steroidide tootmise stimuleerimiseks, juhtudel kui gonaadide funktsioon on häiritud.
English: What Puregon is and what it is used for
Estonian: Mis ravim on Puregon ja milleks seda kasutatakse
English: Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'.
Estonian: Ärge kasutage Puregon'i pärast kõlblikkusaega, mis on märgitud sildil 'EXP' ja karbil pärast 'Kõlblik kuni:'.
English: Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).
Estonian: Õhumullid tuleb kolbampullist enne süstimist eemaldada (vaata juhendit pensüsteli kasutamise kohta).
English: Based on the results of comparative clinical studies, it is considered appropriate to give a lower total dosage of Puregon over a shorter treatment period than generally used for urinary FSH, not only in order to optimise follicular development but also to reduce the risk of unwanted ovarian hyperstimulation (see section 5.1).
Estonian: Tuginedes võrdlevate kliiniliste uuringute tulemustele, oleks õige kasutada Puregon'i väiksemas koguannuses ning lühema raviperioodi jooksul kui urofollitropiini, mitte ainult optimaalse folliikulite arengu saavutamiseks, vaid ka munasarjade soovimatu hüperstimulatsiooni riski vähendamiseks (vt lõik 5.1).
English: Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Estonian: Tingituna suhteliselt pikast poolväärtusajast viib sama annuse korduv manustamine FSH plasmakontsentratsiooni umbes 1,5…2,5 korda kõrgemaks, kui see on pärast üksikannuse manustamist.
English: The first injection with Puregon should be performed under direct medical supervision.
Estonian: Puregon'i esimene süst tuleb teha otsese meditsiinilise järelevalve all.
English: The active substance is follitropin beta.
Estonian: Toimeaine on follitropiin beeta.
English: Treatment with Puregon is generally followed by administration of hCG to induce the final phase of follicle maturation, resumption of meiosis and rupture of the follicle.
Estonian: Puregon'i ravile järgneb tavaliselt hCG manustamine, et indutseerida folliikulite küpsemise lõppfaasi, taaskäivitada meioosi ja soodustada folliikuli ruptureerumist.
English: For use only with the Puregon Pen.
Estonian: Kasutamiseks ainult koos Puregon Pen'iga.
English: These side effects are not considered to be related to the use of Puregon, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Estonian: Neid kõrvaltoimeid ei seostata Puregon'i kasutamisega, vaid kunstliku viljastamise ja/või järgneva rasedusega.
English: Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Estonian: Seejärel hoidke süstalt nii, et nõel oleks suunatud üles ning koputage õrnalt vastu süstla külge, et õhumullid liiguksid üles; siis suruge kogu õhk süstlast välja nii, et süstlasse jääks ainult Puregon'i lahus (d).
English: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations:
Estonian: Täiskasvanud naistel: Puregon on näidustatud infertiilsuse raviks naistel järgnevatel kliinilistel tingimustel: