FrancophonIA/ELRC3.0 huggingface dataset:
English: Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment.
Estonian: Xolairi uuriti ka kolmes põhiuuringus, milles osales kokku 978 kroonilise spontaanse urtikaariaga patsienti, kellel ei tekkinud antihistamiinipõhise raviga ravivastust.
English: The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).
Estonian: Efektiivsuse põhinäitaja oli sügeluse tugevuse muutus pärast 12-nädalast ravi, mõõdetuna 0 (sügelus puudub) kuni 21 (maksimaalne sügelustugevus) punkti skaalal.
English: Other information about Xolair:
Estonian: Muu teave Xolairi kohta
English: In the treatment of asthma, Xolair is intended for long-term use.
Estonian: Astma ravis on Xolair ette nähtud pikaajaliseks kasutamiseks.
English: Patients with low IgE levels are less likely to benefit from the medicine.
Estonian: Väikese IgE-sisaldusega patsientidel on ravimi eeldatav kasulikkus väiksem.
English: Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab has been shown to improve the symptoms of this condition.
Estonian: Ehkki IgE osatähtsus kroonilise spontaanse urtikaaria vallandamises on veel ebaselge, on tõestatud, et IgE-sisalduse vähendamine omalisumaabiga leevendab selle haiguse sümptomeid.
English: • they must have had many severe ‘exacerbations' of asthma (where asthma gets worse, requiring rescue treatment with other medicines) despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.
Estonian: • on esinenud mitmeid raske astma ägenemisi (astma süveneb ja on vaja päästvat ravi muude ravimitega) hoolimata suurtes annustes inhaleeritavate kortikosteroidide kasutamisest koos pikatoimelise inhaleeritava β2-agonistiga.
English: For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Xolairiga 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 Xolair, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Xolairi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.
Estonian: Efektiivsuse põhinäitajad olid astma ägenemiste arv, ägenemistega patsientide arv, patsientide elukvaliteet (hinnati standardküsimustike järgi) ja astma leevendamiseks inhaleeritava kortikosteroidi kasutamise vajaduse vähenemine.
English: What is Xolair?
Estonian: Mis on Xolair?
English: Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen.
Estonian: Omalisumaab seondub inimese IgE-ga, mida tekib allergiapatsientidel suures koguses ja mis vallandab allergeenile reageerides allergiareaktsiooni.
English: It is used as an addon to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.
Estonian: Seda kasutatakse lisaravimina vähemalt 12-aastastel patsientidel, kelle ravi antihistamiinidega ei anna tulemusi.
English: Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash).
Estonian: Xolairi kasutatakse ka kroonilise (pikaajalise) spontaanse urtikaaria (sügeleva lööbe) raviks.
English: • they must have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;
Estonian: • õhuallergeeni (sissehingamisel allergiat tekitava aine, nt kodutolmulestade eritiste, õietolmu või hallituse) positiivne nahatest;
English: Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group.
Estonian: Esimeses kolmes uuringus oli ravi esimese 28 või 52 nädala jooksul Xolairi ravirühmas ligikaudu 0,5 ägenemist aastas ja platseeborühmas ligikaudu üks ägenemine aastas.
English: In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo.
Estonian: Kroonilise spontaanse urtikaariaga patsientide uuringutes parandas annuses 300 mg manustatud Xolair 12-nädalase ravi järel sügelussümptome 4,5-5,8 punkti võrra rohkem kui platseebo.
English: Xolair is a medicine that contains the active substance omalizumab.
Estonian: Xolair on ravim, mis sisaldab toimeainena omalisumaabi.
English: For the full list of all side effects and restrictions with Xolair, see the package leaflet.
Estonian: Xolairi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection.
Estonian: Seda turustatakse kahel kujul: viaalis oleva pulbri ja lahustina, millest segatakse kokku süstelahus, ning eeltäidetud süstlas oleva süstelahusena.
English: The effects were maintained after 6 months of treatment.
Estonian: Tulemus säilis 6 ravikuu järel.
English: The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients' existing treatment, but noted that study data on long-term use beyond 6 months are limited.
Estonian: Komitee järeldas ka, et Xolairi lisamine annuses 300 mg patsiendi senisele ravile leevendab oluliselt kroonilise spontaanse urtikaaria sümptomeid, kuid märkis, et puuduvad uuringuandmed pikaajalise (rohkem kui 6 kuud kestva) kasutamise kohta.
English: Why has Xolair been approved?
Estonian: Miks Xolair heaks kiideti?
English: In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.
Estonian: Raske allergilise astmaga patsientide uuringus oli Xolairi ja platseeboga ravitud patsientidel astma ägenemiste arv sama, kuid Xolair vähendas ägenemiste arvu sarnasel viisil kui eelmainitud uuringutes.
English: Before giving Xolair to patients with asthma, the doctor must measure the level of IgE in the patient's blood.
Estonian: Enne Xolairi manustamist astmapatsientidele määrab arst patsiendi vere IgEsisalduse.
English: The effects of Xolair were greater in patients with severe asthma.
Estonian: Xolairi toime oli tugevam raske astmaga patsientidel.
English: The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma.
Estonian: Inimravimite komitee järeldas, et Xolairiga tehtud astmauuringud näitasid üldiselt ravimi efektiivsust raske allergilise astma ravis.
English: In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).
Estonian: Kroonilise spontaanse urtikaariaga patsientidel on Xolairi kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) sinusiit (põskkoopapõletik), peavalu, artralgia (liigesevalu), süstekoha reaktsioonid ja ülemiste hingamisteede nakkus (külmetus).
English: What is the risk associated with Xolair?
Estonian: Mis riskid Xolairiga kaasnevad?
English: For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks.
Estonian: Astma korral manustab tervishoiutöötaja Xolairi nahaaluse süstina õlga või reide üks kord iga kahe või nelja nädala järel.
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 Xolair.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments.
Estonian: Xolairi uuriti viies põhiuuringus, milles osales üle 2000 allergilise astmaga patsiendi vanuses vähemalt 12 aastat, kusjuures ühes uuringus osales 482 patsienti, kelle raske allergiline astma tavapärasele ravile ei allunud.
English: Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).
Estonian: Ravi Xolairiga tohib kaaluda vaid patsientidel, kelle astma on põhjustatud antikehast E-immunoglobuliinist (IgE).
English: This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
Estonian: Selle tulemusel on allergeeniga kokku puutudes organismis allergilise reaktsiooni vallandamiseks vajalikku IgE-d vähem.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Estonian: Xolairi toimeaine omalisumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära teatud antigeeni (organismis leiduva spetsiifilise valgu) ja seondub sellega.
English: Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.
Estonian: 235 lapsel, keda uuringu alguses raviti suures annuses inhaleeritavate kortikosteroididega koos pikatoimelise β2agonistiga, oli esimese 24 ravinädala jooksul Xolairiga ravitutel keskmiselt 0,4 ägenemist ja platseebot võtnutel keskmiselt 0,6 ägenemist.
English: It is used as an add-on to existing asthma treatment in patients aged six years or over.
Estonian: Seda kasutatakse astmaravis täiendava ravina vähemalt 6-aastastel patsientidel.
English: In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients' existing treatment.
Estonian: Kõigis uuringutes võrreldi Xolairi platseeboga (näiva ravimiga), lisades neid patsiendi senisele ravile.
English: For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks.
Estonian: Kroonilise spontaanse urtikaaria korral manustab tervishoiutöötaja Xolairi nahaaluse süstina õlga või reide annuses 300 mg üks kord iga nelja nädala järel.
English: All patients receiving Xolair must meet the following criteria:
Estonian: Xolairi tohib manustada üksnes patsientidele, kellel on järgmised näidustused:
English: In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching.
Estonian: Vähemalt 12-aastastel allergilise astmaga patsientidel on Xolairi kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) peavalu ja süstekoha reaktsioonid, sealhulgas turse, punetus, valu ja sügelus.
English: Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria.
Estonian: Ravi Xolairiga peab alustama raske püsiva astma või kroonilise spontaanse urtikaaria ravis kogenud arst.
English: In the study in children with allergic asthma aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair.
Estonian: 6-12-aastaste allergilise astmaga laste uuringus oli Xolairi rühmas ägenemiste arv väiksem.
English: The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight.
Estonian: Xolairi annus ja annustamissagedus sõltuvad vere IgE-sisaldusest ja patsiendi kehakaalust.
English: In all of the studies, Xolair was compared with placebo, when they were added to the patients' existing treatment.
Estonian: Kõigis uuringutes võrreldi Xolairi toimet platseeboga (näiv ravim), lisades neid patsiendi senisele ravile.
English: What benefit has Xolair shown during the studies?
Estonian: Milles seisneb uuringute põhjal Xolairi kasulikkus?
English: By attaching to IgE, omalizumab ‘mops up' the free IgE circulating in the blood.
Estonian: IgE-ga seondudes kõrvaldab omalisumaab verest vaba IgE.
English: In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever).
Estonian: 6-12-aastastel lastel on kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) peavalu ja palavik.
English: In the studies in patients with allergic asthma aged 12 years or over, Xolair reduced the number of exacerbations by around half.
Estonian: Vähemalt 12-aastaste allergilise astmaga patsientide uuringutes vähendas Xolair ägenemiste arvu ligikaudu kaks korda.
English: In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo.
Estonian: Xolairi võtnud patsientide seas oli ägenemistega patsiente vähem kui platseebot võtnute seas.
English: What is Xolair used for?
Estonian: Milleks Xolairi kasutatakse?
English: How has Xolair been studied?
Estonian: Kuidas Xolairi uuriti?
English: How is Xolair used?
Estonian: Kuidas Xolairi kasutatakse?
English: Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Estonian: Xolairi kasutatakse raske püsiva allergilise astma ravimiseks.
English: How does Xolair work?
Estonian: Kuidas Xolair toimib?
English: This summary was last updated on 25 January 2008.
Estonian: Kokkuvõtte viimane uuendus: 25. jaanuar 2008.
English: They included young and adult cats of various breeds, but not young kittens.
Estonian: Nendes osalesid noored ja täiskasvanud eri tõugudest kassid, kuid mitte väikesed kassipojad.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Estonian: Selles selgitatakse, kuidas veterinaarravimite komitee hinnangu alusel, mis tugineb esitatud dokumentidele, koostati soovitused ravimi kasutustingimuste kohta.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Estonian: Kui soovite ravitava looma haigusseisundi või ravi kohta rohkem teavet, võtke palun ühendust oma loomaarstiga.
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 (keha loomulikke kaitsemehhanisme) ennast haiguse eest kaitsma.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet veterinaarravimite komitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
English: The vaccine helps to reduce the symptoms of the diseases.
Estonian: Vaktsiin aitab nende haiguste sümptomeid leevendada.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Estonian: Euroopa Komisjon väljastas Purevax RCCh müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele MERIAL 23. veebruaril 2005.
English: The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Estonian: Antikehad aitavad kaitsta haiguste eest, mida need viirused või bakterid esile kutsuvad.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis.
Estonian: Kassi tuleb revaktsineerida kõikide komponentide vastu ühe aasta möödumisel esimesest vaktsineerimiskuurist ning seejärel rinotrahheiidi, kalitsiviroosi ja klamüdioosi vastu igal aastal.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Estonian: Milliseid ettevaatusmeetmeid peab loomale ravimit andev või loomaga kokku puutuv inimene võtma?
English: • attenuated Chlamydophila felis (905 strain).
Estonian: • nõrgestatud Chlamydophila felis (905 tüvi).
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Estonian: • inaktiveeritud (hävitatud) kalitsiviroosi antigeenid (FCV 431 ja G1 tüvi);
English: The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later.
Estonian: Kasse süstitakse esmakordselt vähemalt kaheksa nädala vanuses ja teine süst tehakse kolm kuni neli nädalat hiljem.
English: It also helps to reduce viral excretion in case of calicivirus infection.
Estonian: See aitab vähendada ka viiruse eritumist kalitsiviiruse nakkuse korral.
English: Purevax RCCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.
Estonian: Purevax RCCh sisaldab vähesel hulgal nõrgestatud või hävitatud viirusi ja baktereid, mis põhjustavad eespool loetletud haigusi.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCCH EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE PUREVAX RCCH Kokkuvõte üldsusele
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Estonian: Kassidel tekib vahetevahel ajutine apaatia (huvi kadumine ümbritseva vastu) ja anoreksia (isutus), samuti hüpertermia (kehatemperatuuri tõus), mis kestab üks või kaks päeva.
English: If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Estonian: Emalt päritud antikehade kõrgete tasemete korral tuleks kassi vaktsineerimise põhiskeem edasi lükata 12 nädala vanuseni.
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Estonian: Nende viirustega hiljem elu jooksul kokku puutudes kass kas ei nakatu või on haigus nakatumise korral palju kergem.
English: In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Estonian: Juhusliku iseenesele süstimise korral pöörduda kohe arsti poole ja näidata ravimi pakendi infolehte või etiketti.
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Estonian: C. felis'e vastaste antikehade taseme tõusu ei olnud võimalik kindlaks määrata, kuna kasside antikehade tase oli uuringu algul kõrge.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Estonian: Kui kassile antakse vaktsiini, peab immuunsüsteem nõrgestatud või hävitatud viirusi ja nõrgestatud baktereid võõraks ja toodab nende vastu antikehi.
English: Purevax RCCh should not be used in pregnant cats.
Estonian: Purevax RCCh-d ei tohi kasutada tiinetel kassidel.
English: After Purevax RCCh has been made up, 1 ml is injected under the skin.
Estonian: Pärast Purevax RCCh valmistamist süstitakse seda 1 ml naha alla.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Purevax RCCh soodne toime selle kasutamisel 8-nädalaste või vanemate kasside aktiivseks immuniseerimiseks eespool nimetatud haiguste vastu on suurem kui sellega kaasnevad ohud, ning soovitas anda Purevax RCCh-le müügiloa.
English: The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis.
Estonian: Purevax RCCh efektiivsust uuriti mitmes laboratoorses uuringus, mille käigus kasse vaktsineeriti ja nakatati virulentse herpesviiruse, kalitsiviiruse või C. felis'ega.
English: In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Estonian: Purevax RCCh väliuuringutes vaadeldi põhivaktsineerimisskeemi (kaks süsti 3-4-nädalaste intervallidega) ja revaktsineerimist (ainult üks süst).
English: Purevax RCCh is a vaccine containing the following active substances:
Estonian: Purevax RCCh on vaktsiin, mis sisaldab järgmisi toimeaineid:
English: In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above.
Estonian: Laboratoorsetes tingimustes tõestati, et Purevax RCCh kaitseb eespool nimetatud haiguste vastu.
English: Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Estonian: Purevax RCCh-d kasutatakse 8-nädalaste ja vanemate kasside vaktsineerimiseks järgmiste haiguste vastu:
English: There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Estonian: Süstekohal võib tekkida paikne reaktsioon, millega kaasneb vähene valu puudutamisel, kihelus või turse, mis ühe või kahe nädalaga kaob.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Estonian: Efektiivsust mõõdeti põhiliselt vaktsiinis sisalduvate viiruste ja bakterite vastaste antikehade taseme järgi veres.
English: Purevax RCCh is a vaccine.
Estonian: Purevax RCCh on vaktsiin.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Estonian: Ravimi kasulikkuse ja riski suhte leiate käesoleva Euroopa avaliku hindamisaruande 6. jaotisest.
English: For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet.
Estonian: Purevax RCCh kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Estonian: • kasside nõrgestatud rinotrahheiit-herpesviirus (FHV F2 tüvi);
English: If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Estonian: Juhuslikul iseenesele süstimisel peavad need inimesed arstile ütlema, et nad on süstinud endale klamüüdia elusvaktsiini.
English: Other information about Purevax RCCh:
Estonian: Muu teave Purevax RCCh kohta