FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga õhukese polümeerikattega tablett sisaldab 150 mg aliskireeni (hemifumaraadina).
English: What Tekturna looks like and contents of the pack Tekturna 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Estonian: Tekturna 300 mg õhukese polümeerikattega tabletid on helepunased, kaksikkumerad, ovaalsed tabletid, mille ühel poolel on märge „IU” ja teisel „NVR”.
English: Tekturna 150 mg film-coated tablets Aliskiren
Estonian: Tekturna 150 mg õhukese polümeerikattega tabletid Aliskireen
English: What Tekturna looks like and contents of the pack Tekturna 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Estonian: Tekturna 150 mg õhukese polümeerikattega tabletid on heleroosad, kaksikkumerad ümmargused tabletid, mille ühel poolel on märge „IL” ja teisel „NVR”.
English: Therefore as with any agent acting on the RAS system, routine monitoring of electrolytes and renal function is indicated in patients with diabetes mellitus, kidney disease, or heart failure.
Estonian: Seetõttu tuleb kõigi RAS süsteemi mõjutavate ravimite kasutamisel neeruhaigusi, südamepuudulikkust või diabetes mellitus't põdevatel patsientidel jälgida elektrolüütide sisaldust ja neerufunktsiooni.
English: Tekturna 300 mg film-coated tablets Aliskiren
Estonian: Tekturna 300 mg õhukese polümeerikattega tabletid Aliskireen
English: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),
Estonian: Mida Tekturna sisaldab - Toimeaine on aliskireen (hemifumaraadina) 300 mg - Abiained on krospovidoon, hüpromelloos, magneesiumstearaat, makrogool, mikrokristalne tselluloos, povidoon, kolloidne veevaba ränidioksiid, talk, titaandioksiid (E 171), must raudoksiid (E 172), punane raudoksiid (E 172).
English: However, in one study where Tekturna was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Estonian: Seerumi kaaliumisisalduse suurenemist esines aga sagedamini (5,5%) uuringus, kus Tekturna't kasutati kombinatsioonis AKE inhibiitoriga suhkurtõve patsientidel.
English: The change in plasma levels of aliskiren in the presence of ketoconazole is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Estonian: Kontrollitud kliinilistes uuringutes on aliskireeni kuni 600 mg annused (600 mg on kaks korda suurem suurimast soovitatavast raviannusest) olnud hästi talutavad.
English: NAME OF THE MEDICINAL PRODUCT Tekturna 150 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Tekturna 150 mg õhukese polümeerikattega tabletid
English: Pharmacovigilance system
Estonian: Ohutusalane süsteem
English: Film-coated tablet Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side.
Estonian: Helepunane, kaksikkumer, ovaalne tablett, mille ühel poolel on märge „IU” ja teisel „NVR”.
English: NAME OF THE MEDICINAL PRODUCT Tekturna 300 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Tekturna 300 mg õhukese polümeerikattega tabletid
English: Film-coated tablet Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Estonian: Heleroosa, kaksikkumer, ümmargune tablett, mille ühel poolel on märge „IL” ja teisel „NVR”.
English: Tekturna induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Estonian: Hüdroklorotiasiidile ja ramipriilile lisamisel kutsus Tekturna esile aditiivse vererõhku langetava toime.
English: NAME OF THE MEDICINAL PRODUCT Tekturna 150 mg film-coated tablets Aliskiren
Estonian: RAVIMPREPARAADI NIMETUS Tekturna 150 mg õhukese polümeerikattega tabletid Aliskireen
English: NAME OF THE MEDICINAL PRODUCT Tekturna 300 mg film-coated tablets Aliskiren
Estonian: RAVIMPREPARAADI NIMETUS Tekturna 300 mg õhukese polümeerikattega tabletid Aliskireen
English: As for other agents acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
Estonian: Nagu teiste reniin-angiotensiin süsteemi mõjutavate ravimitega, tuleb ka aliskireeni manustamisega olla ettevaatlik, kui samaaegselt esinevad neerutalitluse häireid soodustavad tegurid, nagu hüpovoleemia (tuleneb nt vere kaotusest, ägedast või pikaajalisest diarröast, pikaajalisest oksendamisest jms), südamehaigus, maksahaigus või neeruhaigus.
English: Potassium and potassium-sparing diuretics
Estonian: Kaalium ja kaaliumisäästvad diureetikumid
English: What Tekturna contains - The active substance is aliskiren (as hemifumarate) 150 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Estonian: Mida Tekturna sisaldab - Toimeaine on aliskireen (hemifumaraadina) 150 mg - Abiained on krospovidoon, hüpromelloos, magneesiumstearaat, makrogool, mikrokristalne tselluloos, povidoon, kolloidne veevaba ränidioksiid, talk, titaandioksiid (E 171), must raudoksiid (E 172), punane raudoksiid (E 172).
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Estonian: • MÜÜGILOA HOIDJALE ESITATUD HANKE- JA KASUTUSTINGIMUSED JA Retseptiravim.
English: In addition, an updated RMP should be submitted
Estonian: Lisaks tuleb riski juhtimise plaan esitada
English: One tablet is taken daily by mouth with water.
Estonian: Ööpäevas tuleb võtta sisse üks tablett koos veega.
English: Both are antihypertensive medicines that have been available separately in the European Union (EU) since the mid1990s.
Estonian: Mõlemad on vererõhku alandava toimega ravimid, mida on Euroopa Liidus eraldi turustatud alates 1990. aastate keskpaigast.
English: Amlodipine is a calcium channel blocker.
Estonian: Amlodipiin on kaltsiumikanali blokaator.
English: Amlodipine/Valsartan Mylan is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Estonian: Amlodipine/Valsartan Mylani turustatakse tablettidena (5 mg amlodipiini ja 80 mg valsartaani; 5 mg amlodipiini ja 160 mg valsartaani; 10 mg amlodipiini ja 160 mg valsartaani).
English: The full EPAR for Amlodipine/Valsartan Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Amlodipine/Valsartan Mylani kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet.
Estonian: On soovitatav, et patsient võtaks amlodipiini ja valsartaani eraldi tablettide või kapslitena enne üleminekut kombineeritud tabletile.
English: It blocks special channels on the surface of cells through which calcium normally enters the cells.
Estonian: See blokeerib rakupinnal olevaid spetsiaalseid kanaleid, mille kaudu kaltsium tavaliselt rakku siseneb.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Estonian: Vererõhu alanemisel vähenevad kõrge vererõhuga seotud riskid, näiteks insuldirisk.
English: A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Amlodipine/Valsartan Mylani võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?
Estonian: Mis meetmed võetakse, et tagada Amlodipine/Valsartan Mylani ohutu ja efektiivne kasutamine?
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Estonian: Valsartaan on angiotensiin II retseptori antagonist, mis blokeerib organismi hormooni angiotensiin II toime.
English: The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.
Estonian: Komitee soovitas Amlodipine/Valsartan Mylani kasutamise Euroopa Liidus heaks kiita.
English: Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Estonian: Amlodipine/Valsartan Mylani kasutatakse essentsiaalse hüpertensiooniga (kõrgvererõhutõvega) patsientidel, kelle vererõhku ei saa ainult amlodipiini või valsartaaniga piisavalt reguleerida.
English: Therefore, the CHMP's view was that, as for Exforge, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Exforge korral, on ravimi kasulikkus suurem kui sellega kaasnevad riskid.
English: When calcium enters the cells in the muscles of blood vessel walls, this causes contraction.
Estonian: Kui kaltsium siseneb veresoonte seinte lihaste rakkudesse, tõmbuvad rakud kokku.
English: Amlodipine/Valsartan Mylan amlodipine / valsartan
Estonian: Amlodipine/Valsartan Mylan amlodipiin/valsartaan
English: Because Amlodipine/Valsartan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Amlodipine/Valsartan Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks nagu võrdlusravimil.
English: This means that Amlodipine/Valsartan Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exforge.
Estonian: See tähendab, et Amlodipine/Valsartan Mylan on sarnane võrdlusravimiga Exforge, millel juba on Euroopa Liidus müügiluba.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge.
Estonian: Inimravimite komitee järeldas, et Euroopa Liidu nõuete kohaselt on tõendatud ravimi Amlodipine/Valsartan Mylan võrreldav kvaliteet ja bioekvivalentsus/võrreldavus ravimiga Exforge.
English: This is a summary of the European public assessment report (EPAR) for Amlodipine/Valsartan Mylan.
Estonian: See on ravimi Amlodipine/Valsartan Mylan Euroopa avaliku hindamisaruande kokkuvõte.
English: The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Estonian: Kasutatava tableti tugevus sõltub patsiendi varasemast amlodipiini või valsartaani annusest.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine/Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Amlodipine/Valsartan Mylani omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan.
Estonian: Amlodipine/Valsartan Mylan sisaldab kaht toimeainet, amlodipiini ja valsartaani.
English: For practical information about using Amlodipine/Valsartan Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Amlodipine/Valsartan Mylani kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What is Amlodipine/Valsartan Mylan and what is it used for?
Estonian: Mis on Amlodipine/Valsartan Mylan ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Amlodipine/Valsartan Mylan.
Estonian: Hindamisaruandes ei anta Amlodipine/Valsartan Mylani kasutamise praktilisi nõuandeid.
English: For more information about treatment with Amlodipine/Valsartan Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Amlodipine/Valsartan Mylaniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Because Amlodipine/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge.
Estonian: Et Amlodipine/Valsartan Mylan on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi Amlodipine/Valsartan Mylani bioekvivalentsust võrdlusravimiga Exforge.
English: Other information about Amlodipine/Valsartan Mylan
Estonian: Muu teave Amlodipine/Valsartan Mylani kohta
English: Why is Amlodipine/Valsartan Mylan approved?
Estonian: Miks Amlodipine/Valsartan Mylan heaks kiideti?
English: How is Amlodipine/Valsartan Mylan used?
Estonian: Kuidas Amlodipine/Valsartan Mylani kasutatakse?
English: How has Amlodipine/Valsartan Mylan been studied?
Estonian: Kuidas Amlodipine/Valsartan Mylani uuriti?
English: How does Amlodipine/Valsartan Mylan work?
Estonian: Kuidas Amlodipine/Valsartan Mylan toimib?
English: What are the benefits and risks of Amlodipine/Valsartan Mylan?
Estonian: Milles seisneb Amlodipine/Valsartan Mylani kasulikkus ja mis riskid ravimiga kaasnevad?
English: Horses were examined at days 14, 35 and 63.
Estonian: Hobuseid uuriti 14, 35 ja 63 päeval.
English: Substantial improvement occurs in the next 48 hours with complete resolution in the following two weeks.
Estonian: Järgmise 48 tunni jooksul paranevad sümptomid oluliselt ning lahenevad järgmise 2 nädala jooksul täielikult.
English: Further information on HorStem can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Estonian: Lisateave HorStemi kohta on ameti veebilehel: ema.europa.eu/medicines/veterinary/EPAR/horstem.
English: Hands should be washed after handling the medicine.
Estonian: Pärast ravimi käsitsemist tuleb pesta käsi.
English: The European Medicines Agency decided that HorStem's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et HorStemi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise saab ELis heaks kiita.
English: Other information about HorStem
Estonian: Muu teave HorStemi kohta
English: What is HorStem and what is it used for?
Estonian: Mis on Horstem ja milleks seda kasutatakse?
English: HorStem received a marketing authorisation valid throughout the EU on 19 June 2019.
Estonian: HorStemi müügiluba, mis kehtib kogu Euroopa Liidus, anti 19/06/2019.
English: In case of severe inflammation, treatment with an anti-inflammatory medicine (NSAID) might be necessary.
Estonian: Raske põletiku korral võib olla vaja kasutada ravi mittesteroidsete põletikuvastaste ravimitega (NSAID).
English: It is not clear exactly how HorStem works in horses with osteoarthritis.
Estonian: Ei ole täpselt teada, kuidas HorStem toimib osteoartriidiga hobuse organismis.
English: Care should be taken to avoid accidental self-injection.
Estonian: Hoolikalt tuleb vältida juhuslikku enesesüstimist.
English: Stem cells can develop into other types of cells.
Estonian: Tüvirakkudest arenevad muud tüüpi rakud.
English: These are stem cells taken from the umbilical cord of donor horses when a foal is born and grown in a laboratory to increase their numbers.
Estonian: Need tüvirakud eraldatakse doonorhobuste nabaväädist pärast varsa sündi ja neid kasvatatakse laboris, et suurendada rakkude arvu.
English: Mesenchymal stem cells can have effects on the immune system as well as anti-inflammatory effects and can possess tissue regenerative properties.
Estonian: Mesenhümaalsed tüvirakud võivad mõjutada immuunsüsteemi ning neil võib olla põletikuvastaseid toimeid ja koeregeneratiivseid omadusi.
English: The withdrawal period for meat from horses treated with HorStem is ‘zero' days, which means that there is no mandatory waiting time.
Estonian: HorStemiga ravitud hobuste liha keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: Twelve HorStem treated horses were successfully treated (success rate 75%) at day 63 compared to only 4 of the control group (success rate 25%).
Estonian: HorStemiga ravitud hobuste seas oli 12 hobust, kelle ravi oli 63. päeval edukas (ravi edukus 75%), kontrollrühmas oli paranenuid ainult 4 (ravi edukus 25%).
English: What are the risks associated with HorStem?
Estonian: Mis riskid HorStemiga kaasnevad?
English: For more information about using HorStem, see the package leaflet or contact your veterinarian or pharmacist.
Estonian: Kui vajate HorStemiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte või pöörduge oma veterinaararsti või apteekri poole.
English: HorStem is a veterinary medicine used to treat lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Estonian: HorStem on veterinaarravim, mida kasutatakse kergest kuni mõõdukast degeneratiivsest liigesehaigusest (osteoartriidist) põhjustatud lonkamise raviks hobustel.
English: How is HorStem used?
Estonian: Kuidas HorStemi kasutatakse?
English: An overview of HorStem and why it is authorised in the EU
Estonian: Ravimi HorStem ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: Treatment success was a reduction in lameness to a grade of 1 or less, using an accepted scale for equine lameness measurement (scale from 0 to 5, where 0 is nonlame, and 5 is severely lame).
Estonian: Hobuste lonkamise mõõtmiseks kasutati aktsepteeritavat skaalat (skaala 0-5, kus 0 tähendab lonkamise puudumist ja 5 tugevat lonkamist).
English: How does HorStem work?
Estonian: Kuidas HorStem toimib?
English: This overview was last updated in February 2019.
Estonian: Kokkuvõtte viimane uuendus: 02-2019.
English: The most common side effect with HorStem (which may affect more than 1 in 10 horses) is short-lived synovitis (inflammation of the joint lining) with severe lameness, joint effusion (increased fluid in the joint) and pain on palpation 24 hours after injection.
Estonian: HorStemi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 hobusel 10st) on lühiajaline sünoviit (sünoviaalmembraani põletik) koos raske lonkamisega, liigeseefusioon (liigesevedeliku koguse
English: These properties are expected to play a role in the effect of HorStem.
Estonian: Eeldatakse, et HorStemi toime on seotud nende omadustega.
English: What benefits of HorStem have been shown in studies?
Estonian: Milles seisneb uuringute põhjal HorStemi kasulikkus?
English: In a field study of horses with mild to moderate osteoarthritis, 16 horses received an injection of HorStem into the affected joint and 17 horses received a placebo (dummy) injection.
Estonian: Väliuuringus, milles uuriti kerge kuni mõõduka osteoartriidiga hobuseid, manustati 16 hobusele haigesse liigesesse ühe süstena HorStemi ja 17 hobusele platseebot (näiv ravim).
English: HorStem (equine umbilical cord mesenchymal stem cells) EMA/162149/2019
Estonian: HorStem (hobuse nabaväädi mesenhümaalsed tüvirakud) EMA/336346/2019
English: HorStem (equine umbilical cord mesenchymal stem cells)
Estonian: HorStem (hobuse nabaväädi mesenhümaalsed tüvirakud)
English: HorStem is given only by a veterinarian as a single injection into the affected joint.
Estonian: HorStemi manustab veterinaararst ühe süstena haigestunud liigesse.
English: It contains the active substance equine umbilical cord mesenchymal stem cells.
Estonian: Ravim sisaldab toimeainena hobuse nabaväädi mesenhümaalseid tüvirakke.
English: The medicine can only be obtained with a prescription.
Estonian: HorStem on retseptiravim.
English: Why is HorStem authorised in the EU?
Estonian: HorStemi Euroopa Liidus heakskiitmise põhjused
English: This summary was last updated in 05-2016.
Estonian: Kokkuvõtte viimane uuendus: 05-2016.
English: These materials have been inactivated where necessary so that they do not cause any disease.
Estonian: Materjal on vajadusel inaktiveeritud, et see ei põhjustaks haigust.
English: Although no data are available in children older than 2 years, there is no indication that older children would respond differently.
Estonian: Üle 2-aastaste laste kohta puuduvad andmed, kuid puuduvad tõendid, et vanemad lapsed reageeriksid erinevalt.
English: What measures are being taken to ensure the safe and effective use of Hexacima?
Estonian: Mis meetmed võetakse, et tagada Hexacima ohutu ja efektiivne kasutamine?
English: Vaccination with Hexacima should be carried out according to official recommendations.
Estonian: Vaktsineerimine Hexacimaga peab toimuma vastavalt ametlikele soovitustele.
English: Other information about Hexacima
Estonian: Muu teave Hexacima kohta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexacima on 17 April 2013.
Estonian: Euroopa Komisjon andis Hexacima müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 17. aprillil
English: This means that some of the active substances are fixed onto aluminium compounds, to stimulate a better response.
Estonian: See tähendab, et mõned toimeained on parema immuunvastuse tekitamiseks kinnitatud alumiiniumiühenditele.
English: Reactions may be more likely after the first dose than later doses.
Estonian: Reaktsioonid tekivad suurema tõenäosusega pärast esmase annuse manustamist kui hilisemate annuste korral.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexacima's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Hexacima kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Estonian: Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi looduslikke kaitsemehhanisme) ennast haiguse eest kaitsma.
English: What is Hexacima and what is it used for?
Estonian: Mis on Hexacima ja milleks seda kasutatakse?
English: The vaccine is ‘adsorbed'.
Estonian: Vaktsiin on adsorbeeritud.
English: Hexacima is a vaccine.
Estonian: Hexacima on vaktsiin.
English: Hexacima contains small amounts of materials derived from the bacteria and viruses it protects against.
Estonian: Hexacima sisaldab väheses koguses materjali, mis pärineb bakteritelt ja viirustelt, mille vastu see kaitseb.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy, unless the condition has stabilised with treatment and the benefit clearly outweighs the risk.
Estonian: Samuti ei tohi seda kasutada lastel, kellel on ravile allumatu või raske aju- või närvisüsteemi haigus, näiteks ravile allumatu epilepsia, välja arvatud juhul, kui lapse seisund on sobiva raviga stabiliseerunud ja vaktsineerimise kasulikkus on selgelt suurem kui selle riskid.
English: It is not intended to provide practical advice on how to use Hexacima.
Estonian: Hindamisaruandes ei anta Hexacima kasutamise praktilisi nõuandeid.
English: Why is Hexacima approved?
Estonian: Miks Hexacima heaks kiideti?
English: Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Estonian: Hexacimat on mitmes riigis kogu maailmas uuritud 12 põhiuuringus, milles osales üle 3400 lapse vanuses 6 nädalat kuni 2 aastat, kellele manustati kohalike vaktsineerimisskeemide järgi esimese kuue elukuu vältel kolm vaktsiiniannust.
English: This is a summary of the European public assessment report (EPAR) for Hexacima.
Estonian: See on vaktsiini Hexacima Euroopa avaliku hindamisaruande kokkuvõte.