FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Suliqua?
Estonian: Mis riskid Suliquaga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also been included in the summary of product characteristics and the package leaflet.
Estonian: Suliqua ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The CHMP concluded that combination treatments with a long-acting insulin and a GLP-1 agonist such as Suliqua are an important treatment option for patients who are eligible for insulin or who need intensive insulin therapy.
Estonian: Inimravimite komitee järeldas, et kombinatsioonravi pikatoimelise insuliini ja GLP-1 agonistiga nagu Suliqua on insuliinravi alustamise kriteeriumidele vastavatele või intensiivset insuliinravi vajavatele patsientidele oluline ravivõimalus.
English: One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood.
Estonian: Suliqua üks toimeaineid glargiininsuliin on asendusinsuliin, mis toimib samal viisil kui organismis tekkiv insuliin, aidates glükoosil siseneda verest rakkudesse ning seeläbi reguleerida vere glükoosisisaldust.
English: It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Estonian: See toimib sarnaselt sooles tekkiva hormooni GLP-1ga, suurendades insuliini kogust, mida kõhunääre eritab toidu mõjul.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Estonian: Vere glükoosisisalduse reguleerimisega vähenevad diabeedi sümptomid ja tüsistuste risk on väiksem.
English: Results showed that Suliqua is more effective at controlling blood glucose levels than either components: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.
Estonian: Tulemused näitasid, et Suliqua on vere glükoosisisalduse reguleerimisel efektiivsem kui kumbki toimeaine eraldi: uuringu alustamisel oli keskmine HbA1c sisaldus 8,1%, mis pärast 30 ravinädalat oli Suliquat saanud patsientidel langenud 6,5%-le, glargiininsuliini saanud patsientidel 6,8%-le ja liksisenatiidi saanud patsientidel 7,3%-le.
English: In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain.
Estonian: Sellistel patsientidel oli Suliqua vere glükoosisisalduse reguleerimisel efektiivne ja vähendas intensiivse insuliinraviga seostatavate probleemide, näiteks hüpoglükeemia ja kaalutõusu riski.
English: The other active substance in Suliqua, lixisenatide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Estonian: Suliqua teine toimeaine liksisenatiid kuulub diabeediravimite GLP-1 agonistide rühma.
English: The active substances in Suliqua are insulin glargine and lixisenatide.
Estonian: Suliqua toimeained on glargiininsuliin ja liksisenatiid.
English: For practical information about using Suliqua, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Suliqua kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Suliqua, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Suliquaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine.
Estonian: Patsientide keskmine HbA1c sisaldus enne Suliqua või glargiininsuliini ravi alustamist oli 8,1%.
English: Patients who entered the study, had to stop all medicines given by mouth except metformin and were then given either Suliqua or insulin glargine.
Estonian: Uuringusse kaasatud patsiendid pidid katkestama ravi kõikide suukaudsete ravimitega peale metformiini ning neile anti kas Suliquat või glargiininsuliini.
English: For the full list of all side effects and restrictions with Suliqua, see the package leaflet.
Estonian: Suliqua kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: After 30 weeks of treatment average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.
Estonian: 30 ravinädala järel oli HbA1c sisaldus Suliquat saanud patsientide seas langenud 6,9%-le ja glargiininsuliini saanud patsientide seas 7,5%-le.
English: How does Suliqua work?
Estonian: Kuidas Suliqua toimib?
English: What benefits of Suliqua have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Suliqua kasulikkus?
English: Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription.
Estonian: Suliquat turustatakse eeltäidetud ühekordsetes pensüstaldes, kahes eri tugevusea.
English: The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth.
Estonian: Teises uuringus osales 736 patsienti, kelle vere glükoosisisaldus ei olnud pikatoimelise insuliini (nagu glargiininsuliini) monoravi või pikatoimelise insuliini ja ühe või kahe teise suukaudse diabeediravimi kombinatsioonraviga piisavalt reguleeritud.
English: The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth.
Estonian: Esimeses uuringus osales 1170 patsienti, kelle vere glükoosisisaldus ei olnud metformiini monoravi või metformiini ja teise suukaudse diabeediravimi kombinatsioonraviga piisavalt reguleeritud.
English: Before Suliqua is started the patient's insulin and diabetes medicines other than metformin must be stopped.
Estonian: Enne Suliqua ravi alustamist tuleb katkestada insuliinravi ja ravi muude diabeediravimitega kui metformiin.
English: In both studies, the main measure of effectiveness was the change after 30 weeks of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja glükohemoglobiini (HbA1c) sisalduse muutus veres 30 ravinädala järel; glükohemoglobiini sisaldus näitab vere glükoosisisalduse reguleeritust.
English: It is given as an injection under the skin of the belly, the thigh or the upper arm. Suliqua is given once a day, preferably at the same time each day.
Estonian: Suliquat manustatakse üks kord ööpäevas, eelistatavalt iga päev samal kellaajal.
English: How is Suliqua used?
Estonian: Kuidas Suliquat kasutatakse?
English: In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.
Estonian: Suliquas sisalduvate glargiininsuliini ja liksisenatiidi kombinatsioon ei tekitanud võrreldes koostisainete eraldi kasutamisega uusi ohutusprobleeme.
English: Upon entering the study, all patients had to stop their other diabetes medicines and were given Suliqua or insulin glargine or lixisenatide, all with metformin.
Estonian: Uuringu alustamisel pidid kõik patsiendid katkestama ravi teiste diabeediravimitega ning neile anti metformiini koos Suliqua, glargiininsuliini või liksisenatiidiga.
English: It is used when blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or by a combination of metformin and another medicine (either another glucose-lowering medicine taken by mouth or a long-acting insulin).
Estonian: See on näidustatud, kui monoravi metformiiniga või kombinatsioonravi metformiini ja mõne teise ravimiga (vere glükoosisisaldust vähendava suukaudse ravimi või pikatoimelise insuliiniga) ei ole aidanud piisavalt reguleerida vere glükoosisisaldust.
English: The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick).
Estonian: Suliqua kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on hüpoglükeemia
English: Suliqua has been shown to be effective at controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes.
Estonian: Kahes põhiuuringus, milles osales 1906 2. tüüpi diabeediga patsienti, tõendati Suliqua efektiivsust vere glükoosisisalduse reguleerimisel.
English: 6 bottles Not applicable
Estonian: 6 pudelit Ei ole kohaldatav
English: EU (MA) Number
Estonian: EL (ML) number Väljamõeld ud nimetus
English: 1 bottle Not applicable
Estonian: Ei ole kohaldatav
English: This will help to protect against the diseases caused by these viruses.
Estonian: See aitab kaitsta haiguste eest, mida need viirused põhjustavad.
English: It must also not be used in a pregnant woman.
Estonian: Samuti ei tohi ravimit kasutada raseduse ajal.
English: The full EPAR for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ProQuadi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Because ProQuad contains well known weakened viruses, which are already used in other vaccines, the company presented data from vaccines that are already on the market.
Estonian: Et ProQuad sisaldab hästi tuntud nõrgestatud viirusi, mida kasutatakse ka teistes vaktsiinides, esitas ettevõte juba turustatavate vaktsiinide andmeid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.
Estonian: Euroopa Komisjon andis ProQuadi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 6. aprillil
English: This study looked at the ability of the vaccine to trigger immune responses in these age groups.
Estonian: Selles uuringus vaadeldi vaktsiini omadust tekitada immuunvastust nendes vanuserühmades.
English: It must not be used in children who have severely weakened immune systems.
Estonian: Seda ei tohi kasutada oluliselt nõrgenenud immuunsüsteemiga lastel.
English: Other information about ProQuad
Estonian: Muu teave ProQuadi kohta
English: The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months).
Estonian: Põhiuuringutes vaadeldi vaktsiini ühe või kahe annuse võimet tekitada immuunvastust 5446 tervel 12-23 kuu vanusel lapsel.
English: Another study also looked at the responses one year after vaccination in 2,108 children.
Estonian: Ühes uuringus vaadeldi ka 2108 lapse ravivastuseid ühe aasta möödumisel vaktsineerimisest.
English: ProQuad is a vaccine.
Estonian: ProQuad on vaktsiin.
English: ProQuad is used according to official recommendations, including the number of doses and the interval between them.
Estonian: ProQuadi kasutatakse vastavalt ametlikele soovitustele, sealhulgas annuste arvu ja sageduse osas.
English: For more information about treatment with ProQuad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ProQuadiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults.
Estonian: Vaktsiini süstitakse kas lihasesse või naha alla, väikelastel eelistatult reielihasesse ning suurematel lastel ja täiskasvanutel õlalihasesse.
English: This is a summary of the European public assessment report (EPAR) for ProQuad.
Estonian: See on vaktsiini ProQuad Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection.
Estonian: ProQuadi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on palavik ja valu ning süstekoha erüteem (punetus).
English: The CHMP decided that ProQuad's benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.
Estonian: Inimravimite komitee otsustas, et ProQuadi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa kasutamiseks üle 12-kuustel lastel, märkides, et täieliku kaitse tagamiseks tuulerõugete vastu tuleb teha teine tuulerõugete vastane vaktsineerimine.
English: A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later.
Estonian: Ühes uuringus osales 1620 last, kellele manustati ProQuadi esimene annus 9, 11 ja 12 kuu vanuselt ning teine annus 3 kuud hiljem.
English: It is only given under the skin in patients with low levels of platelets in the blood or other bleeding disorders, as they may experience bleeding if the vaccine is injected into a muscle.
Estonian: Vaktsiini süstitakse naha alla ainult patsientidel, kellel on vereliistakute vähesus või muud hüübimishäired, sest vaktsiini lihasesse süstimisel võib neil tekkida veritsus.
English: The active substances are attenuated (weakened) viruses for the diseases.
Estonian: Toimeained on nende haiguste nõrgestatud viirused.
English: The Committee also recommended that the vaccine be authorised in children from nine to 12 months of age only in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Estonian: Komitee soovitas ka anda loa vaktsiini manustamiseks 9-12-kuustel lastel üksnes teatud olukordades, nt riikliku vaktsineerimisprogrammi raames, haiguspuhangu ajal või kui reisitakse piirkonda, kus leetrid on levinud.
English: After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.
Estonian: Pärast teist annust olid ligikaudsed määrad leetrite suhtes 99%, mumpsi suhtes 100%, punetiste suhtes 98% ja tuulerõugete suhtes 99%.
English: The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox.
Estonian: Üle 12-kuustel lastel oli reageerimismäär järgmine (see näitab, kuidas immuunsüsteem viirustele reageeris): leetrite suhtes 98%, mumpsi suhtes 96-99%, punetiste suhtes 96% ja tuulerõugete suhtes 91%.
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 ProQuad.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: What is ProQuad?
Estonian: Mis on ProQuad?
English: For the full list of all side effects reported with ProQuad, see the package leaflet.
Estonian: ProQuadi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes defences against them.
Estonian: Kui patsient saab vaktsiini, peab immuunsüsteem nõrgestatud viirusi organismile võõraks ja tekitab nende vastu antikehi.
English: ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox.
Estonian: ProQuadi antakse lastele alates 12 kuu vanusest, et kaitsta neid nelja haiguse eest: leetrid, mumps, punetised ja tuulerõuged.
English: ProQuad may also be given to children from nine months of age in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Estonian: ProQuadi tohib manustada lastele ka alates 9 kuu vanusest teatud olukordades, nt riikliku vaktsineerimisprogrammi raames, haiguspuhangu ajal või kui reisitakse piirkonda, kus leetrid on levinud.
English: Children between nine and 12 months of age should receive a second dose at least three months after the first dose to ensure that they are adequately protected against measles and chickenpox.
Estonian: 9-12-kuustele lastele tuleb manustada teine annus vähemalt 3 kuud pärast esimest annust, et tagada piisav kaitse leetrite ja tuulerõugete eest.
English: To protect against chickenpox, a second injection is needed, given one to three months after the first one; this can be done either by giving a second dose of ProQuad, or by giving a dose of another vaccine that only protects against chickenpox.
Estonian: Teist annust on vaja kaitseks tuulerõugete vastu ja see manustatakse üks kuni kolm kuud pärast esimest; seda võib teha, manustades teise annuse ProQuadi või manustades annuse vaktsiini, mis kaitseb ainult tuulerõugete vastu.
English: Why has ProQuad been approved?
Estonian: Miks ProQuad heaks kiideti?
English: ProQuad must not be used in children who are hypersensitive (allergic) to any chickenpox vaccine or measles, mumps or rubella vaccine, to any of the other ingredients, or to neomycin.
Estonian: ProQuadi ei tohi kasutada lapsed, kes on tuulerõugete, leetrite, mumpsi või punetiste mis tahes vaktsiini või selle mis tahes koostisaine või neomütsiini suhtes ülitundlikud (allergilised).
English: However, children who received the first dose at nine months of age had a lower immune response against measles.
Estonian: 9-kuuselt esimese annuse saanud lastel oli aga väiksem immuunvastus leetrite suhtes.
English: What is the risk associated with ProQuad?
Estonian: Mis riskid ProQuadiga kaasnevad?
English: For children above 12 months of age, one ProQuad injection is sufficient to provide optimal protection against measles, mumps and rubella.
Estonian: Üle 12-kuustele lastele piisab ühest ProQuadi süstist optimaalse kaitse tagamiseks leetrite, mumpsi ja punetiste vastu.
English: In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again.
Estonian: Kui immuunsüsteem puutub viirustega hiljem uuesti kokku, tekivad antikehad kiiremini.
English: The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age.
Estonian: 9-12-kuustel lastel läbiviidud uuringu tulemused näitasid, et teise annuse manustamise järel oli 9kuuselt ProQuadi esimese annuse saanud lastel immuunvastus mumpsi, punetiste ja tuulerõugete vastu võrreldav 12-kuuselt esimese annuse saanud laste immuunvastusega.
English: ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox.
Estonian: ProQuad sisaldab leetreid, mumpsi, punetisi ja tuulerõugeid tekitavate viiruste nõrgestatud vorme.
English: ProQuad is available as a powder and solvent that are made up into a suspension for injection.
Estonian: ProQuadi turustatakse pulbri ja lahustina, millest valmistatakse süstesuspensioon.
English: What benefit has ProQuad shown during the studies?
Estonian: Milles seisneb uuringute põhjal ProQuadi kasulikkus?
English: How does ProQuad work?
Estonian: Kuidas ProQuad toimib?
English: How is ProQuad used?
Estonian: Kuidas ProQuadi kasutatakse?
English: ProQuad was compared with its ‘component vaccines', a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox.
Estonian: ProQuadi võrreldi selle komponentvaktsiinidega - mumpsi, leetrite ja punetiste vastase kolmikvaktsiiniga ning tuulerõugevaktsiiniga.
English: What is ProQuad used for?
Estonian: Milleks ProQuadi kasutatakse?
English: Measles, mumps, rubella and varicella vaccine (live)
Estonian: ProQuad leetrite, mumpsi, punetiste ja tuulerõugete (elus)vaktsiin
English: How has ProQuad been studied?
Estonian: Kuidas ProQuadi uuriti?
English: ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
Estonian: ProQuad on leetrite, mumpsi, punetiste ja tuulerõugete vaktsiin.
English: 3 tablets
Estonian: 3 tabletti
English: 1 tablet
Estonian: 1 tablett
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes l t o r
Estonian: 1/1 R
English: EU Number
Estonian: l n a
English: 18 weeks.
Estonian: 18 nädalat.
English: This product contains genetically modified organisms (GMOs).
Estonian: See ravim sisaldab geneetiliselt muundatud organisme (GMO).
English: Some side effects may be serious
Estonian: Mõned kõrvaltoimed võivad olla tõsised
English: Not all pack sizes may be available in your country.
Estonian: Kõik pakendi suurused ei pruugi teie riigis saadaval olla.
English: • if the child is less than 24 months of age.
Estonian: • kui laps on noorem kui 24 kuu vanune.
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 20 November 2018
Estonian: Müügiloa esmase väljastamise kuupäev: 4. detsember 2013 Müügiloa viimase uuendamise kuupäev: 20. november 2018
English: Y=years.
Estonian: a = aastad.
English: Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
Estonian: Vaktsiin on igal aastal suunatud gripi nelja tüve vastu, järgides Maailma Terviseorganisatsiooni igaaastaseid soovitusi.
English: If the vaccine has not been used after this 12 hour period, it should be discarded.
Estonian: Kui vaktsiini ei ole selle 12 tunni möödudes ära kasutatud, tuleb see ära visata.
English: Since 1985, two distinct lineages of influenza B viruses (Victoria and Yamagata) have circulated worldwide.
Estonian: Alates 1985, aastast on kogu maailmas ringelnud kaks B-gripiviiruse alltüüpi (Victoria ja Yamagata).
English: fewer cases than injectable fewer cases than injectable
Estonian: vähem juhtumeid kui süstitavaga vähem juhtumeid kui süstitavaga
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Estonian: Kui inimene saab vaktsiini, loob immuunsüsteem (keha loomulik kaitsesüsteem) endale kaitse gripiviiruse vastu.
English: Number of study participants for year 1 efficacy analysis.
Estonian: a k = kuud 1. aasta efektiivsuse analüüsis osalejate arv.
English: • reduced appetite
Estonian: • vähenenud isu
English: None of the ingredients in the vaccine can cause the flu.
Estonian: Ükski vaktsiini koostisosadest ei suuda põhjustada grippi.
English: Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C.
Estonian: Enne kasutamist võib vaktsiini ühe korra võtta välja külmikust ja hoida seda maksimaaalselt kuni 12 tundi temperatuuril kuni 25 °C.
English: Four placebo-controlled studies included second season revaccination.
Estonian: Neli platseeboga kontrollitud uuringut hõlmasid teise hooaja kordusvaktsineerimist.
English: Small white particles may be present.
Estonian: Võib sisaldada väikseid valgeid osakesi.
English: Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Estonian: Enamiku hospitaliseerimiste põhjuseks olid seedetrakti ja hingamisteede infektsioonid, mis esinesid rohkem kui 6 nädalat pärast vaktsineerimist.