FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in oncophage, vitespen, is made up of proteins (‘heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells.
Estonian: Oncophage toimeaine vitespen koosneb valkudest (kuumašoki valgu-peptiidi kompleks 96 e heat shock protein-peptide complex-96, HSPPC-96), mis on ekstraheeritud patsiendi vähirakkudest.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Oncophage?
Estonian: Kuidas mõjutab tagasivõtmine praegu Oncophage kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Oncophage for use as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee küsimustele, oli komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse, milles soovitas keelduda müügiloa andmisest Oncophagele, mida kavatseti kasutada lokaalse neerurakk-kartsinoomi lisaravimina patsientidel, kellel on operatsiooni järel kasvaja suur taastekke risk.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Oncophage did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et Oncophage kasulikkus ei ole suurem kui kaasnevad riskid.
English: The main measure of effectiveness was how long the patients lived without the cancer coming back.
Estonian: Efektiivsuse põhinäitaja oli aeg, mille kestel vähk ei taastunud.
English: When Oncophage is given to the patient, the body's defence system (immune system) learns to recognize the proteins in vitespen as foreign and triggers an immune response.
Estonian: Kui patsiendile antakse Oncophaget, peab organismi immuunsüsteem vitespenis sisalduvaid valke võõraks ja tekitab immuunvastuse.
English: The study compared the patients who were given Oncophage with those who were not.
Estonian: patsiente nendega, kes seda ravimit ei saanud.
English: The effects of Oncophage were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Oncophage toimet muude katsetega.
English: On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Estonian: 23. novembril 2009 teatas ettevõte Antigenics Therapeutics Limited ametlikult inimravimite komiteele oma soovist võtta tagasi Oncophage müügiloa taotlus.
English: How was Oncophage expected to work?
Estonian: Milline on Oncophage eeldatav toime?
English: Oncophage was designated as an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2005 for renal cell carcinoma.
Estonian: Oncophage nimetati 11. aprillil 2005 neerurakk-kartsinoomi ravi harvikravimiks.
English: It was to be used when there is a high risk of the cancer coming back after the patient has had surgery to remove the tumour.
Estonian: Seda kavatseti kasutada patsientidel, kellel on kasvaja eemaldamise operatsiooni järel vähi taastekke suur risk.
English: What was Oncophage expected to be used for?
Estonian: Milleks kavatseti Oncophaget kasutada?
English: Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: EU-number
Estonian: Müügiloa nr Euroopa Liidus
English: Prolia (denosumab)
Estonian: Prolia (denosumaab)
English: What measures are being taken to ensure the safe and effective use of Prolia?
Estonian: Mis meetmed võetakse, et tagada Prolia ohutu ja efektiivne kasutamine?
English: Further information on Prolia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Lisateave Prolia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Prolia received a marketing authorisation valid throughout the EU on 26 May 2010.
Estonian: Prolia on saanud müügiloa, mis kehtib kogu ELis, 26. mail 2010.
English: Other information about Prolia
Estonian: Muu teave Prolia kohta
English: What is Prolia and what is it used for?
Estonian: Mis on Prolia ja milleks seda kasutatakse?
English: The European Medicines Agency decided that Prolia's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Prolia kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Prolia are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Prolia kasutamise kohta pidevat järelevalvet.
English: The medicine contains the active substance denosumab.
Estonian: Ravim sisaldab toimeainena denosumaabi.
English: Side effects reported with Prolia are carefully evaluated and any necessary action taken to protect patients.
Estonian: Prolia kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prolia have also been included in the summary of product characteristics and the package leaflet.
Estonian: Prolia ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Prolia is a medicine used to treat the following conditions:
Estonian: Prolia on ravim, mida kasutatakse järgmiste haigusseisundite raviks.
English: The active substance in Prolia, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL.
Estonian: Prolia toimeaine denosumaab on monoklonaalne antikeha (teatud valk), mis on kavandatud ära tundma organismi teatud struktuuri (RANKL) ja sellega seonduma.
English: For more information about using Prolia, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Prolia kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Osteoporosis in women
Estonian: Osteoporoos naistel
English: Osteoporosis in men
Estonian: Osteoporoos meestel
English: Prolia was also more effective at reducing the number of women who had fractures elsewhere in the body, including in the hip.
Estonian: Prolia vähendas efektiivsemalt ka nende naiste arvu, kellel esines muid luumurde, sealhulgas puusapiirkonnas.
English: Uncommon or rare cases of cellulitis (inflammation of deep skin tissue), hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone have been seen in patients taking Prolia.
Estonian: Proliat kasutavatel patsientidel on täheldatud ebaharilikke või harvu tselluliidijuhte (nahaaluse koe põletik), hüpokaltseemiat (vere liiga väike kaltsiumisisaldus), ülitundlikkust (allergia), lõualuu osteonekroosi (lõualuude kahjustus, mis võib põhjustada valu, suuhaavandeid või hammaste logisemist) ja ebatavalisi reieluumurde.
English: The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs, and bone, joint and muscle pain.
Estonian: Prolia kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on käsivarte või jalgade valu ning luu-, liigese- ja lihasevalu.
English: Prolia has been compared with placebo in one main study involving 242 men with osteoporosis.
Estonian: Proliat võrreldi platseeboga ühes põhiuuringus, milles osales 242 osteoporoosiga meest.
English: The company that markets Prolia will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Estonian: Turustaja varustab Prolia patsiendid teabekaardiga, milles neid teavitatakse lõualuu osteonekroosi riskist ning soovitatakse neil sümptomite tekkimisel pöörduda arsti poole.
English: How does Prolia work?
Estonian: Kuidas Prolia toimib?
English: Prolia must not be used in people with hypocalcaemia (low blood calcium levels).
Estonian: Proliat ei tohi kasutada patsiendid, kellel on hüpokaltseemia (vere liiga väike kaltsiumisisaldus).
English: For the full list of side effects and restrictions with Prolia, see the package leaflet.
Estonian: Prolia kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Estonian: RANKL osaleb osteoklastide ehk luukoe lagundamises osalevate rakkude aktiveerimises organismis.
English: What benefits of Prolia have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Prolia kasulikkus?
English: What are the risks associated with Prolia?
Estonian: Mis riskid Proliaga kaasnevad?
English: This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
Estonian: See vähendab luukoe hävimist, säilitab luutugevust ja vähendab luumurruriski.
English: Prolia is available as a solution for injection in prefilled syringes, each containing 60 mg denosumab.
Estonian: Proliat turustatakse eeltäidetud süstaldes süstelahusena (iga süstal sisaldab 60 mg denosumaabi).
English: In the second study, the women were receiving treatment for breast cancer and were considered to be at high risk of fracture.
Estonian: Teises uuringus osalesid suure murruriskiga naised, kellel raviti rinnavähki.
English: Prolia can be given by someone who has been trained in how to give injections appropriately.
Estonian: Proliat tohib manustada isik, keda on õpetatud õigesti süstima.
English: • bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
Estonian: • Luukoe hävimine suurenenud luumurruriskiga täiskasvanutel, kes saavad pikaajalist ravi suukaudsete või süstitavate kortikosteroididega.
English: Bone loss in adults receiving long-term corticosteroid therapy
Estonian: Luukoe hävimine pikaajalist kortikosteroidravi saavatel täiskasvanutel
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Estonian: Denosumaab vähendab RANKLiga seondudes ja blokeerides seda osteoklastide teket ja aktiivsust.
English: • bone loss in men receiving treatment for prostate cancer that increases their risk of fracture.
Estonian: • Luukoe hävimine meestel, kes saavad eesnäärmevähi ravi, mis suurendab luumurruriski.
English: In addition, after 3 years the risk of new spine fractures was lower in patients who received Prolia.
Estonian: Lisaks oli 3 aasta pärast Proliat kasutanud patsientidel uute lülisambamurdude risk väiksem.
English: An overview of Prolia and why it is authorised in the EU
Estonian: Ülevaade ravimist Prolia ja ELis müügiloa väljastamise põhjendus
English: • osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones).
Estonian: • Osteoporoos (luu-urbnemus) menopausijärgses eas naistel ja suurenenud luumurruriskiga meestel.
English: Prolia reduces the risk of fractures in the spine;
Estonian: Prolia vähendab lülisambamurru riski.
English: Bone loss in men receiving treatment for prostate cancer
Estonian: Luukoe hävimine eesnäärmevähi ravi saavatel meestel
English: In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
Estonian: Esimeses nendest uuringutest oli pärast 3 raviaastat uue lülisambamurruga naisi 2% Proliat kasutanud naistest ja 7% platseebot kasutanud naistest.
English: In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
Estonian: Menopausijärgses eas naistel vähendab Prolia lülisambamurru ja muude luumurdude, sealhulgas puusamurdude riski.
English: In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Estonian: Patsientide seas, keda oli enne uuringut kuni 3 kuud ravitud kortikosteroididega, oli luutihedus lülisamba nimmeosas Proliat kasutanud patsientidel 1 raviaasta järel suurenenud 3,1% võrra ja risedronaati kasutanud patsientidel 0,8% võrra.
English: In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Estonian: Patsientide seas, kes oli enne uuringut üle 3 kuu ravitud kortikosteroidega, oli luutihedus lülisamba nimmeosas Proliat kasutanud patsientidel 1 raviaasta järel suurenenud 3,6% võrra ja risedronaati kasutanud patsientidel 2,0% võrra.
English: After 2 years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo.
Estonian: Pärast 2 aastat oli Proliat kasutanud meestel luutihedus lülisamba nimmeosas 7% suurem kui platseebot kasutanud meestel.
English: Women who took Prolia had higher bone density (a measure of how strong the bones are) in the lumbar (lower) spine after 1 year of treatment than women on placebo.
Estonian: Proliat kasutanud naistel oli luutihedus (luutugevuse näitaja) lülisamba nimmeosas pärast 1 raviaastat suurem kui platseebot kasutanud naistel.
English: In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Estonian: Meestel suurenes 1 raviaasta järel luutihedus Prolia rühmas 5,7% võrra ja platseeborühmas 0,9% võrra.
English: How is Prolia used?
Estonian: Kuidas Proliat kasutatakse?
English: Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Estonian: Ühes põhiuuringus, milles osales 795 kortikosteroidravimeid kasutanud täiskasvanut, oli Prolia luutiheduse suurendamisel efektiivsem kui risedronaat (teatav bisfosfonaatravim).
English: Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Estonian: Proliat manustatakse iga 6 kuu järel 60 mg subkutaanse süstina reide, kõhupiirkonda või õlavarre väliskülge.
English: The medicine can only be obtained with a prescription.
Estonian: Prolia on retseptiravim.
English: Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Estonian: Ühes põhiuuringus, milles osales 1468 eesnäärmevähi ravi saavat ja suurenenud luumurruriskiga meest, oli Prolia luukoe hävimise ravis efektiivsem kui platseebo.
English: Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
Estonian: Kahes põhiuuringus, milles osales kokku üle 8000 osteoporoosiga menopausijärgses eas naist, vähendas Prolia luumurdude arvu efektiivsemalt kui platseebo (näiv ravim).
English: None
Estonian: Puuduvad.
English: The local reactions lasted up to 25 days.
Estonian: Lokaalsed reaktsioonid kestsid kuni 25 päeva.
English: The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
Estonian: Vaktsiinis kasutatav serotüüp valitakse enne tootmist sõltuvalt sellest, mis tüüp parajasti levib ja haigust põhjustab.
English: Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Estonian: Lisateave Zulvac BTV kohta on ameti veebilehel: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
English: They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Estonian: Naha all võib tunda ka kuni 60 cm2 suurusi sõlmi, mis aja jooksul vähenevad, kuid võivad püsida kuni 50 päeva.
English: The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Zulvac BTV kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Estonian: Zulvac BTV müügiluba, mis kehtib kogu Euroopa Liidus, anti 25. aprillil 2017.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Estonian: Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi looduslikud kaitsemehhanismid) kaitsma organismi haiguse eest.
English: A booster is required after 12 months.
Estonian: 12 kuu pärast on vaja teha korduvvaktsineerimine.
English: The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Estonian: Ravimi nimetus muudeti 21. veebruaril 2019 Zulvac BTV-ks.
English: In most cases the reactions are diffuse swellings at the injection site which last no longer than one week.
Estonian: Enamikul juhtudest on reaktsioon süstekoha difuusne turse, mis ei kesta kauem kui üks nädal.
English: The withdrawal period for meat and milk from sheep and cattle treated with Zulvac BTV is ‘zero' days, which means there is no mandatory waiting time.
Estonian: Zulvac BTV-ga ravitud lammaste ja veiste liha ja piima keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: This summary was last updated in December 2018.
Estonian: Kokkuvõtte viimane uuendus: 12-2018.
English: The vaccine contains inactivated (killed) bluetongue virus.
Estonian: Vaktsiin sisaldab lammaste katarraalse palaviku inaktiveeritud (surmatud) viirust.
English: The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Estonian: Vaktsiiniga saab ennetada serotüüpide 1 ja 8 esinemist veres ning vähendada serotüübi 4 sisaldust.
English: The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Estonian: Esimene süst tehakse lammastele 6 nädala vanuselt ja veistele 12 nädala vanuselt ning teine süst tehakse 3 nädalat hiljem.
English: Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
Estonian: Arvesse võeti ka andmeid lammaste katarraalse palaviku viiruse üksikserotüüpe või kahe serotüübi kombinatsiooni sisaldavate muude vaktsiinide efektiivsuse kohta välitingimustes.
English: For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Estonian: Kui vajate vaktsiiniga Zulvac BTV toimuva ravi kohta lisateavet, lugege palun pakendi infolehte või pöörduge oma veterinaararsti või apteekri poole.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Estonian: Samuti sisaldab vaktsiin immuunvastuse tugevdamiseks adjuvante (immunsüsteemi reaktsiooni tugevdavaid aineid) alumiiniumhüdroksiidi ja Quil-A-d.
English: The vaccine is given as two injections under the skin for sheep and in the muscle for cattle.
Estonian: Vaktsiini manustatakse lammastele kahe süstiga naha alla ja veistele kahe süstiga lihasesse.
English: Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Estonian: Zulvac BTV sisaldab lammaste katarraalse palaviku viirust, mis on inaktiveeritud ega saa seetõttu haigust tekitada.
English: Zulvac BTV (inactivated bluetongue vaccine containing either serotype 1, 4 or 8)1
Estonian: Zulvac BTV (lammaste katarraalse palaviku inaktiveeritud vaktsiin, mis sisaldab serotüüpi 1, 4 või 8)1
English: What is Zulvac BTV and what is it used for?
Estonian: Mis on Zulvac BTV ja milleks seda kasutatakse?
English: A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Estonian: Serotüübiga 4 vaktsineeritud lammaste laboriuuring näitas, et vaktsiin vähendas serotüübi 4 sisaldust veres vähemalt 12 kuuks, samas kui serotüübi 1 ja 8 uuringud näitasid vastavate serotüüpide puudumist ühe aasta pärast.
English: Zulvac BTV is a vaccine.
Estonian: Zulvac BTV on vaktsiin.
English: The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Estonian: Zulvac BTV kõige sagedamad kõrvalnähud lammastel (võivad esineda enam kui 1 loomal 10st) on mööduv kehatemperatuuri tõus kuni 1,6 °C kahe päeva jooksul pärast vaktsineerimist ja lokaalsed reaktsioonid süstekohas.
English: For sheep protection starts 3 weeks after the initial course of two injections and lasts for one year.
Estonian: Lammastel tekib kaitse 3 nädalat pärast kaht esmast vaktsineerimist ning kestab 1 aasta.
English: 1 Previously known as Zulvac BTV Ovis.
Estonian: 1 Varasem nimetus Zulvac BTV Ovis.
English: When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Estonian: Lammaste vaktsiin sisaldab üht järgmisest kolmest vaktsiinitüvest: BTV serotüüp 1, BTV serotüüp 4 ja BTV serotüüp 8.
English: The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Estonian: Zulvac BTV kõige sagedamad kõrvalnähud veistel (võivad esineda enam kui 1 loomal 10st) on mööduv kehatemperatuuri tõus kuni 2,7 °C kahe päeva jooksul pärast vaktsineerimist ja lokaalsed reaktsioonid süstekohas.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Estonian: Vaktsiini turustatakse süstesuspensioonina ja see on retseptiravim.
English: Further laboratory studies showed protection lasts for one year for each serotype.
Estonian: Edasised laboriuuringud tõendasid, et iga serotüübi vastane kaitse kestab 1 aasta.
English: Other information about Zulvac BTV?
Estonian: Muu teave Zulvac BTV kohta
English: An overview of Zulvac BTV and why it is authorised in the EU
Estonian: Zulvac BTV ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: Further laboratory studies showed protection lasts for one year for the respective serotypes.
Estonian: Edasised laboriuuringud tõendasid, et vastavate serotüüpide vastane kaitse kestab 1 aasta.
English: How does Zulvac BTV work?
Estonian: Kuidas Zulvac BTV toimib?