FrancophonIA/ELRC3.0 huggingface dataset:
English: Glutamyltransferase
Estonian: Gamma glutamüültransferaasi tõus10
English: There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
Estonian: ZYPREXA VELOTAB`i kasutamise ajal võite end uimasena tunda.
English: What ZYPREXA VELOTAB contains
Estonian: Mida ZYPREXA VELOTAB sisaldab:
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Estonian: Olansapiinravi järsul katkestamisel on harva ( ≥0,01% ja < 0,1%) registreeritud ägedaid sümptomeid nagu higistamine, unetus, treemor, ärevus, iiveldus või oksendamine.
English: Excipients with known effect: Each orodispersible tablet contains 1.20 mg aspartame,
Estonian: Teadaolevat toimet omavad abiained: Iga suus dispergeeruv tablett sisaldab 1,20 mg aspartaami,
English: How to store ZYPREXA VELOTAB
Estonian: Kuidas ZYPREXA VELOTAB`i säilitada
English: Each orodispersible tablet contains 20 mg olanzapine.
Estonian: Iga suus dispergeeruv tablett sisaldab 20 mg olansapiini.
English: Excipients with known effect: Each orodispersible tablet contains 0.80 mg aspartame,
Estonian: Teadaolevat toimet omavad abiained: Iga suus dispergeeruv tablett sisaldab 0,80 mg aspartaami,
English: ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Estonian: ZYPREXA VELOTAB sisaldab aspartaami, mannitooli ja naatriummetüülparahüdroksübensoaati ning naatriumpropüülparahüdroksübensoaati.
English: Excipients with known effect: Each orodispersible tablet contains 1.60 mg aspartame,
Estonian: Teadaolevat toimet omavad abiained: Iga suus dispergeeruv tablett sisaldab 1,60 mg aspartaami,
English: 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Estonian: 0,30 mg naatrium-metüülparahüdroksübensoaati, 0,10 mg naatriumpropüülparahüdroksübensoaati.
English: Discontinuation symptoms7, 12
Estonian: Maliigne neuroleptikumisündroom (vt lõik 4.4) 12 Ravi katkestamise sümptomid7, 12
English: 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Estonian: 0,15 mg naatrium-metüülparahüdroksübensoaati, 0,05 mg naatriumpropüülparahüdroksübensoaati.
English: Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame,
Estonian: Teadaolevat toimet omavad abiained: Iga suus dispergeeruv tablett sisaldab 0,60 mg aspartaami,
English: Each orodispersible tablet contains 5 mg olanzapine.
Estonian: Iga suus dispergeeruv tablett sisaldab 5 mg olansapiini.
English: However, the incidence of death was higher in olanzapine-treated than in placebotreated patients independent of these risk factors.
Estonian: Siiski vaatamata riskifaktoritele oli suremus olansapiinravi saanud patsientidel suurem kui platseebo rühmas.
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) ZYPREXA VELOTAB 5 mg
English: If you take more ZYPREXA VELOTAB than you should Patients who have taken more ZYPREXA VELOTAB than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech,
Estonian: Patsientidel, kes on võtnud ZYPREXA VELOTAB´i rohkem kui ette nähtud, on esinenud järgmisi sümptomeid: kiired südamelöögid, ärevus/agressiivsus, kõnehäired, ebaharilikud liigutused (eriti näo või keele) ja vähenenud teadlikkuse tase.
English: Each orodispersible tablet contains 15 mg olanzapine.
Estonian: Iga suus dispergeeruv tablett sisaldab 15 mg olansapiini.
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) ZYPREXA VELOTAB 15 mg
English: (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Estonian: Trombemboolia (sh kopsuarteri emboolia ja süvaveenide tromboos) (vt lõik
English: Eli Lilly Nederland B.V. Tel: + 31(0)30 6025800
Estonian: Tel: + 31(0)30 6025800
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) ZYPREXA VELOTAB 10 mg
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section
Estonian: Triglütseriidide sisalduse tõus 2,5 Glükosuuria Söögiisu suurenemine ägenemine või tekkimine, millega on mõnikord kaasnenud ketoatsidoos või kooma, sh mõned letaalse lõppega juhud (vt lõik 4.4) 11
English: Dystonia (including oculogyration) 11
Estonian: Düstoonia (sh okulogüratsioon)11 Tardiivdüskineesia11
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP ZYPREXA VELOTAB 20 mg SUUS DISPERGEERUVATELE TABLETTIDELE
English: Each orodispersible tablet contains 10 mg olanzapine.
Estonian: Iga suus dispergeeruv tablett sisaldab 10 mg olansapiini.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l)
Estonian: Esialgse piiripealse tühja kõhu glükoositaseme (≥ 5,56...< 7 mmol/l) muutumine kõrgeks (≥ 7 mmol/l) oli väga sage.
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA VELOTAB 20 mg suus dispergeeruvad tabletid Olansapiin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine
Estonian: TOIMEAINE(TE) SISALDUS Iga suus dispergeeruv tablett sisaldab 10 mg olansapiini
English: Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
Estonian: ZYPREXA VELOTAB`i ööpäevane annus on 5 mg ja 20 mg. Sümptomite taastumisel konsulteerige arstiga, kuid ärge katkestage ZYPREXA VELOTAB`i kasutamist ilma arsti korralduseta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA VELOTAB 20 mg SUUS DISPERGEERUVAD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine
Estonian: TOIMEAINE(TE) SISALDUS Iga suus dispergeeruv tablett sisaldab 15 mg olansapiini
English: An updated RMP should be submitted: • At the request of the European Medicines Agency
Estonian: Ajakohastatud riskijuhtimiskava tuleb esitada:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine
Estonian: TOIMEAINE(TE) SISALDUS Iga suus dispergeeruv tablett sisaldab 5 mg olansapiini
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA VELOTAB 15 mg suus dispergeeruvad tabletid Olansapiin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP ZYPREXA VELOTAB 5 mg SUUS DISPERGEERUVATELE TABLETTIDELE
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA VELOTAB 5 mg suus dispergeeruvad tabletid Olansapiin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP ZYPREXA VELOTAB 15 mg SUUS DISPERGEERUVATELE TABLETTIDELE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA VELOTAB 5 mg SUUS DISPERGEERUVAD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Estonian: EU/1/99/125/00328 suus dispergeeruvat tabletti EU/1/99/125/011 35 suus dispergeeruvat tabletti EU/1/99/125/007 56 suus dispergeeruvat tabletti EU/1/99/125/015 70 suus dispergeeruvat tabletti EU/1/99/125/019 98 suus dispergeeruvat tabletti
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA VELOTAB 10 mg SUUS DISPERGEERUVAD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA VELOTAB 15 mg SUUS DISPERGEERUVAD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Estonian: Naatriumpropüülparahüdroksübensoaat (E217)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP ZYPREXA VELOTAB 10 mg SUUS DISPERGEERUVATELE TABLETTIDELE
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Estonian: EU/1/99/125/00228 suus dispergeeruvat tabletti EU/1/99/125/010 35 suus dispergeeruvat tabletti EU/1/99/125/006 56 suus dispergeeruvat tabletti EU/1/99/125/014 70 suus dispergeeruvat tabletti EU/1/99/125/018 98 suus dispergeeruvat tabletti
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA VELOTAB 10 mg suus dispergeeruvad tabletid Olansapiin
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Estonian: EU/1/99/125/00428 suus dispergeeruvat tabletti EU/1/99/125/012 35 suus dispergeeruvat tabletti EU/1/99/125/008 56 suus dispergeeruvat tabletti EU/1/99/125/016 70 suus dispergeeruvat tabletti EU/1/99/125/020 98 suus dispergeeruvat tabletti
English: Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Estonian: Naatrium-metüülparahüdroksübensoaat ja naatriumpropüülparahüdroksübensoaat Olansapiini suus dispergeeruv tablett sisaldab naatrium-metüülparahüdroksübensoaati ja naatriumpropüülparahüdroksübensoaati.
English: Phadisco Ltd
Estonian: Lilly Portugal Produtos Farmacêuticos, Lda
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Estonian: EU/1/99/125/00128 suus dispergeeruvat tabletti EU/1/99/125/009 35 suus dispergeeruvat tabletti EU/1/99/125/005 56 suus dispergeeruvat tabletti EU/1/99/125/013 70 suus dispergeeruvat tabletti EU/1/99/125/017 98 suus dispergeeruvat tabletti
English: Elevated triglyceride levels2,5
Estonian: Teadmata tõus 2,3
English: High uric acid 10
Estonian: Kõrge kusihappe tase10
English: Talk to your doctor or pharmacist before you take ZYPREXA VELOTAB
Estonian: Enne ZYPREXA VELOTAB võtmist pidage nõu oma arsti või apteekriga.
English: CLINICAL PARTICULARS
Estonian: Patsientide erirühmad
English: Hypersensitivity11
Estonian: Uriinijoa nõrkus11
English: The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst UpCardi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.
Estonian: UpCard on retseptiravim ja seda turustatakse tablettidena (0,75 mg, 3 mg, 7,5 mg ja 18 mg).
English: UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect.
Estonian: UpCardi manustatakse üks kord ööpäevas koos toiduga või ilma ning annust kohandatakse soovitud tulemuse saavutamiseks.
English: Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given.
Estonian: Kui kongestiivse südamepuudulikkuse nähud on kontrolli all, tuleb pikaajalise ravi vajaduse korral manustada väikseim efektiivne annus.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et UpCardi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.
Estonian: Inimesed, kes on torasemiidi või teiste sulfoonamiidide suhtes teadaolevalt ülitundlikud (allergilised), peavad käsitsema seda ravimit ettevaatlikult.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Estonian: See omakorda vähendab üldist vere ruumala, mistõttu südame koormus vere pumpamisel väheneb ja südametalitlus paraneb.
English: Other information about UpCard
Estonian: Muu teave UpCardi kohta
English: This is a summary of the European public assessment report (EPAR) for UpCard.
Estonian: See on ravimi UpCard Euroopa avaliku hindamisaruande kokkuvõte.
English: What is UpCard and what is it used for?
Estonian: Mis on UpCard ja milleks seda kasutatakse?
English: UpCard contains the active substance torasemide.
Estonian: UpCard sisaldab toimeainena torasemiidi.
English: This summary was last updated in June 2015.
Estonian: Kokkuvõtte viimane uuendus: 06-2015.
English: For the full list of restrictions and side effects reported with UpCard, see the package leaflet.
Estonian: UpCardi kohta teatatud piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs.
Estonian: UpCard on veterinaarravim, mida kasutatakse kongestiivse südamepuudulikkuse nähtude raviks koertel.
English: It is not intended to provide practical advice on how to use UpCard.
Estonian: Hindamisaruandes ei anta UpCardi kasutamise praktilisi nõuandeid.
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton.
Estonian: Kuni manustamiseni tuleb tablette hoida blisterpakendis ja blisterpakendit välispakendis.
English: What are the risks associated with UpCard?
Estonian: Mis riskid UpCardiga kaasnevad?
English: The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen.
Estonian: Efektiivsuse põhinäitaja oli ravivastuse teke pärast ligikaudu 3 kuud kestnud ravi, jälgides hingamisraskuste, köhimissageduse, füüsilise koormuse talumatuse ja kõhuturse tugevust.
English: Why is UpCard approved?
Estonian: Miks UpCard heaks kiideti?
English: In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide.
Estonian: 251 kongestiivse südamepuudulikkusega koeral toimunud väliuuringus võrreldi UpCardi ravi standardraviga, milles kasutati diureetikumi furosemiidi.
English: Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Estonian: Kongestiivne südamepuudulikkus on tavaliselt eakate koerte haigus, mille korral südamepuudulikkus tekitab kliinilisi nähte, näiteks füüsilise koormuse talumatust, hingamisraskusi ja vedelikupeetust.
English: The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.
Estonian: Uuringus tõendati, et UpCard oli kongestiivse südamepuudulikkuse nähtude ravis vähemalt sama efektiivne kui furosemiid.
English: In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Juhusliku allaneelamise korral (eriti kui ravimit on neelanud laps) tuleb pöörduda kohe arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: It works by increasing the elimination of salt and water in the urine.
Estonian: Torasemiid on diureetikum, mis suurendab soola ja vee eritumist uriiniga.
English: This product may increase urination and gastrointestinal disturbances if ingested.
Estonian: Ravim võib allaneelamisel põhjustada sagenenud urineerimist ja seedetrakti häireid.
English: The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.
Estonian: UpCardi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 koeral 10st) on neeruprobleemid ning janu, joodava vee ja uriini koguse suurenemine.
English: Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati UpCardi ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
English: How does UpCard work?
Estonian: Kuidas UpCard toimib?
English: For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad UpCardi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: UpCard
Estonian: UpCard torasemiid
English: What benefits of UpCard have been shown in studies?
Estonian: Milles seisneb uuringute põhjal UpCardi kasulikkus?
English: The European Commission granted a marketing authorisation valid throughout the EU for UpCard on
Estonian: Euroopa Komisjon andis UpCardi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 31/07/2015.
English: How is UpCard used?
Estonian: Kuidas UpCardi kasutatakse?
English: Temozolomide Sun should be taken without food.
Estonian: Temozolomide Suni tuleb võtta ilma toiduta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011.
Estonian: Euroopa Komisjon andis Temozolomide Suni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. juulil 2011.
English: The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Temozolomide Suni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Estonian: • täiskasvanud ja üle kolmeaastased lapsed, kellel on pahaloomuline glioom, näiteks multiformne glioblastoom või anaplastiline astrotsütoom, kui kasvaja on tavapärase ravi järel taastunud või süvenenud.
English: The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Estonian: Temozolomide Suni annus oleneb kehapindalast (arvutatakse patsiendi pikkuse ja kehamassi järgi) ning on 75-200 mg/m2 ööpäevas.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Sun is being used alone or with other treatments, and how the patient responds to treatment.
Estonian: Annus ja annuste arv sõltuvad ravitava kasvaja liigist, varasemast ravist, sellest, kas Temozolomide Suni kasutatakse ainsa raviviisina või koos teistega, ja patsiendi ravivastusest.
English: For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Temozolomide Suniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Other information about Temozolomide Sun
Estonian: Muu teave ravimi Temozolomide Sun kohta
English: Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Temodali korral, ületab Temozolomide Suni kasulikkus sellega kaasnevad riskid.
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 Temozolomide Sun.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Temozolomide Sun is used first with radiotherapy and then on its own;
Estonian: Temozolomide Suni kasutatakse esialgu koos kiiritusraviga ja seejärel iseseisva raviviisina;
English: Because Temozolomide Sun 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 Temozolomide Sun on geneeriline ravim ja bioekvivalentne võrdlusravimitega, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This means that Temozolomide Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Estonian: See tähendab, et Temozolomide Sun on sarnane võrdlusravimiga Temodal, millele juba on Euroopa Liidus müügiluba.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun has been shown to have comparable quality and to be bioequivalent to Temodal.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Temozolomide Sun võrdväärne kvaliteet ja bioekvivalentsus ravimiga Temodal.
English: The Committee recommended that Temozolomide Sun be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Sun.
Estonian: Käesolev dokument on ravimi Temozolomide Sun Euroopa avaliku hindamisaruande kokkuvõte.
English: Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Estonian: Et Temozolomide Sun on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Temozolomide Suni bioekvivalentsust võrdlusravimiga Temodal.
English: Why has Temozolomide Sun been approved?
Estonian: Miks Temozolomide Sun heaks kiideti?
English: What is Temozolomide Sun?
Estonian: Mis on Temozolomide Sun?
English: Treatment with Temozolomide Sun should be prescribed by a doctor with experience in the treatment of brain tumours.
Estonian: Ravi Temozolomide Suniga võib määrata vaid ajukasvajate ravis kogenud arst.
English: Temozolomide Sun is a ‘generic medicine'.
Estonian: Temozolomide Sun on geneeriline ravim.
English: Temozolomide Sun is a medicine that contains the active substance temozolomide.
Estonian: Temozolomide Sun on ravim, mis sisaldab toimeainena temosolomiidi.
English: The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Estonian: Temozolomide Sun toimeaine temosolomiid kuulub alküleerivateks aineteks nimetatavate vähiravimite rühma.