FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘3' on either side of the breakline on one side and breakline on the other side.
Estonian: Tabletid on valged kuni valkjad, ümmargused lameda pinna ja kaldservadega, ühel küljel poolitusjoonest ühel pool on sissepressitud märgis „I“ ja teisel pool „3“ ning teisel küljel on poolitusjoon.
English: • Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
Estonian: Väga sage: - Düskineesia (st ebanormaalsed ja kontrollimatud jäsemete liigutused) - Unisus - Pearinglus - Iiveldus (“süda on paha”)
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘2' on either side of the breakline on one side and breakline on the other side.
Estonian: Tabletid on valged kuni valkjad, ümmargused lameda pinna ja kaldservadega, ühel küljel poolitusjoonest ühel pool on sissepressitud märgis „I“ ja teisel pool „2“ ning teisel küljel on poolitusjoon.
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Estonian: Antidiureetilise hormooni liigne sekretsioon* Düskineesia (nt jäsemete ebanormaalsed, kontrollimatud liigutused) Hüperkineesia (liigutusterohkus ja võimetus paigal püsida)* Paranoia (nt liigne hirm omaenese heaolu pärast)* Tundepete (delusioon)*
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Estonian: Iga tablett sisaldab 0,125 mg pramipeksooldivesinikkloriidi monohüdraati, mis on samaväärne 0,088 mg pramipeksooliga.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/007-008 (30/100 tablets in alu/alu blister)
Estonian: EU/1/11/728/007-008 (30/100 tabletti alu / alu blistrid)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/005-006 (30/100 tablets in alu/alu blister)
Estonian: EU/1/11/728/005-006 (30/100 tabletti alu / alu blistrid)
English: The effect of Pramipexole Accord on the unborn child is not known.
Estonian: Pole teada, kas Pramipexole Accord võib kahjustada loodet.
English: 2 Pramipexole Accord tablets 0.18 mg three times a day
Estonian: Üks Pramipexole Accord 0,35 mg tablett kolm korda ööpäevas VÕI Kaks Pramipexole Accord 0,18 mg tabletti kolm korda
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/003-004 (30/100 tablets in alu/alu blister)
Estonian: EU/1/11/728/003-004 (30/100 tabletti alu / alu blistrid)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg pramipexole.
Estonian: Iga tablett sisaldab 1,5 mg pramipeksooldivesinikkloriidi monohüdraati, mis on samaväärne 1,1 mg pramipeksooliga.
English: 1 dose (0.5 ml) contains approximately: Human Papillomavirusa Type 6 L1 proteinb,c aHuman Papillomavirus = HPV bL1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Estonian: b L1-valgud viiruste moodi osakestena, mis on toodetud pärmirakkudes (Saccharomyces cerevisiae CANADE 3C-5 (tüvi 1895)) kasutades rekombinantset DNA tehnoloogiat c adsorbeerituna vaktsiinide abiainele amorfsele alumiiniumhüdroksüfosfaatsulfaadile (225 mikrogrammi alumiiniumi).
English: Content (concentratio n)
Estonian: Pakendi sisu (kontsentratsioon)
English: There were no differences between the two dose frequencies.
Estonian: Kahe annuse vahel esinemissageduses erinevusi ei olnud.
English: The marketing authorisation was renewed on 18 September 2003 and on 18 September 2008.
Estonian: Müügiluba pikendati 18. septembril 2003 ja 18. septembril 2008.
English: This summary was last updated in 09-2008.
Estonian: Kokkuvõtte viimane uuendus: 09-2008.
English: The marketing authorisation holder is Meda AB.
Estonian: Müügiloa hoidja on Meda AB.
English: It is available as 250 mg sachets, each containing 12.5 mg imiquimod (5%).
Estonian: Seda turustatakse 250 mg kotikestena, mis sisaldavad 12,5 mg imikvimoodi (5%).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aldara on 18 September 1998.
Estonian: Euroopa Komisjon andis Aldara müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 18. septembril 1998.
English: The Committee recommended that Aldara be given marketing authorisation.
Estonian: Komitee soovitas anda Aldarale müügiloa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ALDARA EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE ALDARA Kokkuvõte üldsusele
English: Aldara is used in adults to treat the following skin diseases:
Estonian: Aldarat kasutatakse järgmiste nahahaiguste ravimiseks täiskasvanutel:
English: • small basal cell carcinomas (slow-growing types of skin cancer);
Estonian: • pindmised basaalrakulised kartsinoomid (aeglaselt kasvav nahavähivorm);
English: What is Aldara?
Estonian: Mis on Aldara?
English: The cream is applied in a thin layer to the affected areas of skin before sleeping, so that it remains on the skin for a suitable length of time (about eight hours) before being washed off. For further information, see the Package Leaflet.
Estonian: Kreemi manustatakse õhukese kihina kahjustatud nahapiirkonnale enne magamaminekut, et see jääks nahale piisavalt kauaks (ligikaudu kaheksaks tunniks), enne kui see maha pestakse.
English: The number of times Aldara is applied and the duration of treatment depend on the condition being treated:
Estonian: Aldara manustamiskordade arv ja ravi kestus sõltuvad ravitavast seisundist:
English: When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon.
Estonian: Imikvimoodi kandmisel nahale avaldab see immuunsüsteemile paikset toimet, vallandades tsütokiinide, sealhulgas interferooni vabanemise.
English: In all studies, Aldara was compared with placebo (the same cream but without the active substance).
Estonian: Aldarat võrreldi kõikides uuringutes platseeboga (sama kreem ilma toimeaineta).
English: Why has Aldara been approved?
Estonian: Miks Aldara heaks kiideti?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara's benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Estonian: Inimravimite komitee jõudis otsusele, et Aldara kasulikkus välissuguorganite ja anaalpiirkonna teravikuliste tüügaskasvajate (condylomata acuminata), pindmiste basaalrakuliste kartsinoomide ja mittehüperkeratootiliste, mittehüpertroofiliste aktiinkeratooside raviks immunokompetentsetel täiskasvanud patsientidel, juhul kui teised paiksed ravivõimalused on vastunäidustatud või vähem sobivad, on suurem kui sellega kaasnevad riskid.
English: The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching).
Estonian: Aldara kõige sagedam kõrvalnäht (esinenud enam kui ühel patsiendil kümnest) on reaktsioon kreemi manustamiskohal (punetus või sügelus).
English: • Aldara has also been studied in 724 patients with small basal cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day.
Estonian: • Aldara kasutamist uuriti ka 724 pindmise basaalrakulise kartsinoomiga patsiendil kahes uuringus, milles patsiente raviti kuus kuud ning Aldarat või platseebot kasutati kas viis korda nädalas või iga päev.
English: These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.
Estonian: Need ained aitavad hävitada viirusi, mis põhjustavad tüügaste või ebanormaalsete nahavähiks või keratoosideks arenevate rakkude tekkimist.
English: • Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks.
Estonian: • Aldara kasutamist 923 suguelundite tüügastega patsiendil uuriti neljas põhiuuringus, mille kestus oli 16 nädalat.
English: Aldara should not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.
Estonian: Aldarat ei tohi kasutada patsiendid, kes võivad olla imikvimoodi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: • Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients.
Estonian: • Aldara kasutamist uuriti ka aktiinkeratoosiga patsientidel kahes uuringus, milles osales kokku 505 patsienti.
English: Aldara is a cream containing the active substance imiquimod.
Estonian: Aldara on kreem, mis sisaldab toimeainena imikvimoodi.
English: • For genital warts, Aldara is applied three times a week for up to 16 weeks.
Estonian: • suguelundite tüügaste korral manustatakse Aldarat kolm korda nädalas kuni 16 nädalat;
English: Other information about Aldara:
Estonian: Muu teave Aldara kohta
English: What is the risk associated with Aldara?
Estonian: Mis riskid Aldaraga kaasnevad?
English: • For small basal cell carcinomas, the cream is applied five times a week for six weeks.
Estonian: • pindmiste basaalrakuliste kartsinoomide korral manustatakse kreemi viis korda nädalas kuus nädalat;
English: How does Aldara work?
Estonian: Kuidas Aldara toimib?
English: In all studies, Aldara was more effective than placebo.
Estonian: Aldara oli kõikides uuringutes platseebost efektiivsem.
English: For the full list of all side effects reported with Aldara, see the Package Leaflet.
Estonian: Aldara kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: This means that it uses the immune system, the body's natural defences, to bring about its effect.
Estonian: See tähendab, et see toimib immuunsüsteemi (ogranismi loomulike kaitsemehhanismide) abil.
English: • warts on the genitals and around the anus;
Estonian: • välissuguelundite ja pärakuümbruse tüükad;
English: The main measure of effectiveness was the number of patients whose keratoses had cleared after one or two four-week courses of treatment.
Estonian: Efektiivsust mõõdeti põhiliselt nende patsientide arvu järgi, kellel haigus pärast ühe- või kahenädalast ravikuuri kadus.
English: The main measure of effectiveness was the number of patients with total clearance of the tumours after 12 weeks.
Estonian: Efektiivsust mõõdeti põhiliselt nende patsientide arvu järgi, kellel 12 nädala pärast kadus kasvaja täielikult.
English: • When the results of the two studies in basal cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group.
Estonian: • Kahe pindmise basaalrakulise kartsinoomi uuringu tulemuste kokkuvõttes kadus haigus täielikult 66-80%-l Aldaraga ravitud patsientidest, võrreldes 0-3%-ga platseeborühmas.
English: • In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients.
Estonian: • Suguelundite tüügaste ravi neljas põhiuuringus kadusid nähud täielikult 15-52%-l Aldaraga ravitud patsientidest, võrreldes 3-18%-ga platseeboga ravitud patsientidest.
English: What benefit has Aldara shown during the studies?
Estonian: Milles seisneb uuringute põhjal Aldara kasulikkus?
English: • For actinic keratoses, it is applied three times a week, for one or two four-week courses, with four weeks between courses.
Estonian: • aktiinkeratooside korral manustatakse ravimit kolm korda nädalas ühe või kahe neljanädalase kuurina, jättes kuuride vahele neljanädalase intervalli.
English: The main measure of effectiveness was the number of patients with total clearance of treated warts.
Estonian: Efektiivsust mõõdeti põhiliselt nende patsientide arvu järgi, kellel tüükad ravi tulemusel kadusid täielikult.
English: • actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally.
Estonian: • näo ja peanaha aktiinkeratoosid (vähieelne ebanormaalne nahapaksenemus, mis tekib pärast liigset päikese käes viibimist) normaalselt toimiva immuunsüsteemiga patsientidel; ravimit kasutatakse sel juhul, kui muid raviviise, nt krüoteraapiat (külmaravi) ei saa kasutada.
English: The active substance in Aldara cream, imiquimod, is an immune response modifier.
Estonian: Aldaras toimeainena sisalduv imikvimood on immuunvastuse modulaator.
English: What is Aldara used for?
Estonian: Milleks Aldarat kasutatakse?
English: How has Aldara been studied?
Estonian: Kuidas Aldarat uuriti?
English: How is Aldara used?
Estonian: Kuidas Aldarat kasutatakse?
English: • In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.
Estonian: • Mõlemas aktiinkeratoosi uuringus kadus haigus täielikult 54-55%-l Aldaraga ravitud patsientidest, võrreldes 15-2%-ga platseeboga ravitud patsientidest.
English: The full EPAR for Aldara is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Aldara kohta leiate siit.
English: The recommended dose is 0.5 mg per kg body weight which the patient should take once.
Estonian: Soovitatav annus on 0,5 mg kehamassi kilogrammi kohta, mida patsient peab võtma üks kord.
English: Overall, the side effects were mostly mild and short-lasting, with no need for a specific treatment.
Estonian: Üldiselt olid kõrvalnähud enamasti kerged ja lühiajalised ega vajanud eriravi.
English: However this risk is considered small as patients take only one dose of the medicine and are supervised by their doctor.
Estonian: Seda riski peetakse siiski väikseks, sest patsiendid manustavad ainult ühe ravimiannuse arsti järelevalve all.
English: It is not used to treat patients with the condition.
Estonian: Seda ei kasutata selle seisundiga patsientide raviks.
English: The doctor then takes blood samples 45, 60 and 90 minutes later to see how much growth hormone the body has produced.
Estonian: Arst võtab seejärel vereproovid pärast 45, 60 ja 90 minutit, et määrata, kui palju kasvuhormooni on tekkinud organismis.
English: This means that, although Macimorelin Aeterna Zentaris might not diagnose all cases of disease, it can help to confirm presence of the disease.
Estonian: See tähendab, et kuigi Macimorelin Aeterna Zentarisega ei pruugi diagnoosida kõiki haigusjuhtumeid, võib see aidata kinnitada haiguse olemasolu.
English: The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency.
Estonian: Uuringus osales 166 täiskasvanut, kellel oli kasvuhormooni vaeguse esinemise suur, mõõdukas või väike tõenäosus või kellel oli kinnitatud kasvuhormooni vaeguse puudumine.
English: Further information on Macimorelin Aeterna Zentaris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
Estonian: Lisateave Macimorelin Aeterna Zentarise kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
English: In terms of safety, the main concern was that the medicine may change heart rhythm.
Estonian: Ohutuse aspektist on põhiprobleem, et ravim võib mõjutada südamerütmi.
English: It is used by doctors to diagnose growth hormone deficiency, a condition where the patient does not have enough growth hormone.
Estonian: Seda kasutavad arstid, et diagnoosida kasvuhormooni vaegust, mis on seisund, kui patsiendi organismis ei ole piisavalt kasvuhormooni.
English: EMA considered that it is a priority to avoid over-diagnosis of adult growth hormone deficiency and that Macimorelin Aeterna Zentaris helps confirm positive diagnosis and so avoid unnecessary treatment of patients with a false positive test result.
Estonian: EMA pidas prioriteetseks vältida kasvuhormooni vaeguse ülediagnoosimist täiskasvanutel ning märkis, et Macimorelin Aeterna Zentaris aitab kinnitada positiivset diagnoosi ning vältida seega valepositiivsete testitulemustega patsientide tarbetut ravi.
English: What measures are being taken to ensure the safe and effective use of Macimorelin Aeterna Zentaris?
Estonian: Mis meetmed võetakse, et tagada Macimorelin Aeterna Zentarise ohutu ja efektiivne kasutamine?
English: The level of growth hormone in the blood is then measured and indicates whether or not the body is able to produce growth hormone.
Estonian: Seejärel mõõdetakse hormooni sisaldust veres ning tuvastatakse, kas organism suudab kasvuhormooni toota.
English: Side effects reported with Macimorelin Aeterna Zentaris are carefully evaluated and any necessary action taken to protect patients.
Estonian: Macimorelin Aeterna Zentarise kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: EMA therefore decided that Macimorelin Aeterna Zentaris's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Macimorelin Aeterna Zentarise kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: For more information about using Macimorelin Aeterna Zentaris, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Macimorelin Aeterna Zentarise kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm.
Estonian: Macimorelin Aeterna Zentarise kõige sagedamad kõrvalnähud (esinevad enam kui 1 patsiendil 10st) on mõru või metallimaitse suus, väsimus, peavalu, iiveldus, peapööritus, kõhulahtisus ja kuumahood.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Macimorelin Aeterna Zentaris have been included in the summary of product characteristics and the package leaflet.
Estonian: Macimorelin Aeterna Zentarise ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Macimorelin Aeterna Zentaris (macimorelin)
Estonian: Macimorelin Aeterna Zentaris (matsimoreliin)
English: Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone.
Estonian: Macimorelin Aeterna Zentaris on ravim, mida kasutatakse, et testida organismi võimet toota kasvuhormooni.
English: Macimorelin Aeterna Zentaris is available as granules that are dissolved in water and taken by mouth.
Estonian: Macimorelin Aeterna Zentarist turustatakse graanulitena, mis lahustatakse vees ja võetakse suu kaudu.
English: As for all medicines, data on the use of Macimorelin Aeterna Zentaris are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Macimorelin Aeterna Zentarise kasutamise kohta pidevat järelevalvet.
English: What is Macimorelin Aeterna Zentaris and what is it used for?
Estonian: Mis on Macimorelin Aeterna Zentaris ja milleks seda kasutatakse?
English: Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator.
Estonian: Macimorelin Aeterna Zentarisega saadi sarnane arv negatiivseid testitulemusi kasvuhormooni vaeguse esinemise suhtes kui võrdlustestiga, kuid positiivsete tulemuste arv oli väiksem kui võrdlustestis.
English: For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.
Estonian: Macimorelin Aeterna Zentarise kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.
Estonian: Macimorelin Aeterna Zentarisel on kokku vähem kõrvalnähte kui võrdlustestil, mis ajutiselt vähendab vere glükoosisisaldust.
English: Other information about Macimorelin Aeterna Zentaris
Estonian: Muu teave Macimorelin Aeterna Zentarise kohta
English: The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain.
Estonian: Macimorelin Aeterna Zentarise toimeaine matsimoreliin stimuleerib kasvuhormooni vabanemist verre, aktiveerides toime sihtmärgina retseptorid, mida leidub ajupõhimiku piirkonnas paikneva näärme, hüpofüüsi rakkudel.
English: Macimorelin Aeterna Zentaris can only be obtained with a prescription and its use must be supervised by a healthcare professional experienced in diagnosing growth hormone deficiency.
Estonian: Macimorelin Aeterna Zentaris on retseptiravim ja selle kasutamine peab toimuma kasvuhormooni vaeguse diagnoosimises kogenud tervishoiutöötaja järelevalve all.
English: Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
Estonian: Macimorelin Aeterna Zentarist võrreldi põhiuuringus kasvuhormooni vaeguse diagnoosimiseks tavaliselt kasutatava testi, insuliini tolerantsuse testiga (ITT).
English: Macimorelin Aeterna Zentaris contains the active substance macimorelin.
Estonian: Macimorelin Aeterna Zentaris sisaldab toimeainena matsimoreliini.
English: Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.
Estonian: Neist 140 osalejat testiti Macimorelin Aeterna Zentarisega ning ka insuliini tolerantsuse testiga.
English: Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris.
Estonian: Kõigist isikuist, kelle insuliini tolerantsuse testi tulemused olid kasvuhormooni vaeguse suhtes negatiivsed, oli 94% neid, kelle tulemus oli negatiivne ka Macimorelin Aeterna Zentarisega tehtud testis.
English: An overview of Macimorelin Aeterna Zentaris and why it is authorised in the EU
Estonian: Ülevaade ravimist Macimorelin Aeterna Zentaris ja ELis müügiloa väljastamise põhjendus
English: What are the risks associated with Macimorelin Aeterna Zentaris?
Estonian: Mis riskid Macimorelin Aeterna Zentarisega kaasnevad?
English: How is Macimorelin Aeterna Zentaris used?
Estonian: Kuidas Macimorelin Aeterna Zentarist kasutatakse?
English: What benefits of Macimorelin Aeterna Zentaris have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Macimorelin Aeterna Zentarise kasulikkus?
English: How does Macimorelin Aeterna Zentaris work?
Estonian: Kuidas Macimorelin Aeterna Zentaris toimib?
English: Macimorelin Aeterna Zentaris received a marketing authorisation valid throughout the EU on 11 January 2019.
Estonian: Macimorelin Aeterna Zentaris (matsimoreliin) EMA/820056/2018
English: This may vary depending on whether you are an adult or a child.
Estonian: See võib varieeruda sõltuvalt sellest, kas olete täiskasvanu või laps.
English: Please discuss this with your doctor.
Estonian: Palun arutage seda oma arstiga.
English: It is important to tell your doctor if you:
Estonian: Tähtis on öelda arstile, kui te:
English: The healthcare professional's educational material should contain the following key elements:
Estonian: Tervishoiutöötaja teabematerjal peab sisaldama järgmisi põhielemente:
English: This will make the injection more comfortable.
Estonian: See muudab süstimise mugavamaks.
English: At the final analysis, 1,653 deaths were reported.
Estonian: Lõppanalüüsi tulemusel teatati 1653-st surmajuhust.
English: Your injection could take about 15 seconds.
Estonian: Teie süstimiseks kulub ligikaudu 15 sekundit.