FrancophonIA/ELRC3.0 huggingface dataset:
English: However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.
Estonian: Et 5-aminolevuliinhape on looduslik aine, mida juba kasutatakse mõne teise seisundi korral, esitas ettevõte siiski ka kirjanduses avaldatud andmed.
English: Which measures are being taken to ensure the safe use of Gliolan?
Estonian: Milliseid meetmed võetakse, et tagada Gliolani kasutamise ohutus?
English: The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
Estonian: Ajupilte analüüsis ekspert, kes ei teadnud, kas patsient oli saanud Gliolani või mitte.
English: The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Estonian: Gliolani soovitatav annus on 20 mg kehakaalu kilogrammi kohta, mis võetakse sisse kaks kuni neli tundi enne patsiendi viimist anesteesiasse.
English: It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Estonian: Toimeaine imendub organismi rakkudes, kus see muutub ensüümide toimel fluorestseerivateks kemikaalideks, eelkõige ühendiks protoporfüriin IX (PPIX).
English: If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui soovite oma haigusseisundi või ravi osas asjakohast lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või võtke ühendust oma arsti või apteekriga.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE GLIOLAN Kokkuvõte üldsusele
English: It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
Estonian: Ravimit ei tohi kasutada ka patsientidel, kellel on porfüüria (võimetus lagundada porfüriine) või kes on rasedad.
English: It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
Estonian: Gliolan sisaldab toimeainena 5aminolevuliinhappe hüdrokloriidi (30 mg/ml).
English: The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Estonian: Kõige sagedamad kõrvalnähud (mida on esinenud rohkem kui ühel patsiendil kümnest) on aneemia (punaliblede vähesus), trombotsütopeenia (vereliistakute vähesus), leukotsütoos (valgeliblede rohkus) ning maksaensüümide (bilirubiini, alaniini aminotransferaasi, aspartaadi aminotransferaasi, gammaglutamüültransferaasi ja amülaasi) suurenenud kontsentratsioon veres.
English: It recommended that Gliolan be given marketing authorisation.
Estonian: Komitee soovitas anda Gliolanile müügiloa.
English: When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue.
Estonian: Teatud lainepikkusega sinise valgusega valgustamisel helendab kasvajakoes olev PPIX intensiivse punase värvusega, samas kui normaalne ajukude näib olevat sinine.
English: Before the medicine is launched, the company that makes Gliolan will set up training courses in all Member States for brain surgeons to inform them about how to use the medicine safely and effectively during surgery.
Estonian: Enne ravimi müügile laskmist korraldab Gliolani tootja koolitused kõikide liikmesriikide ajukirurgidele, et selgitada neile selle ravimi ohutut ja tõhusat kasutamist lõikuse ajal.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet inimtervishoius kasutatavate ravimite komitee soovituste aluse kohta, lugege palun teaduslikku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
English: After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Estonian: Kuue kuu pärast oli ilma kasvaja progresseerumiseta elus 20,5% Gliolani saanud patsientidest ja 11,0% neist, kes ravimit ei saanud.
English: The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light).
Estonian: Võrreldi lõikuse tulemust Gliolani saanud patsientidel (opereeriti sinises valguses) ja neil, kes ei võtnud kasvaja eristamise parandamiseks ühtegi ravimit (opereeriti tavalises valges valguses).
English: The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour.
Estonian: Gliolani kõige sagedamad kõrvalnähud on tingitud ravimi, anesteesia ja kasvaja eemaldamise kombinatsioonist.
English: Because the number of patients with malignant glioma is low, the disease is considered ‘rare', and Gliolan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 November
Estonian: Et pahaloomulise glioomiga patsientide arv on väike ja haigus esineb harva, nimetati Gliolan 13. novembril 2002 harva kasutatavaks ravimiks.
English: The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger (‘progressing').
Estonian: Peamised tõhususe näitajad olid nende patsientide osakaal, kellel puudus nähtav kasvaja 72 tundi pärast lõikust tehtud aju-tomograafiauuringul, ning nende patsientide osakaal, kes elasid kuus kuud ilma ajukasvaja retsidiivi (taasilmumise) või progressioonita (suurenemiseta).
English: Removal of the brain tumour during surgery was more complete when Gliolan was used.
Estonian: Ajukasvaja eemaldamine lõikusel oli Gliolani kasutamisel täielikum.
English: What is Gliolan?
Estonian: Mis on Gliolan?
English: The Committee for Medicinal Products for Human Use (CHMP) noted that surgical treatment for malignant glioma should aim to remove as much of the tumour as possible while sparing healthy brain tissue.
Estonian: Inimtervishoius kasutatavate ravimite komitee märkis, et pahaloomulise glioomi kirurgilise ravi eesmärgiks on eemaldada võimalikult suur osa kasvajast, säästes samal ajal tervet ajukude.
English: Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Estonian: Gliolani ei tohi kasutada patsientidel, kes võivad olla ülitundlikud (allergilised) 5-aminolevuliinhappe hüdrokloriidi või porfüriinide suhtes.
English: Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.
Estonian: Gliolani võivad kasutada vaid kogenud ajukirurgid, kes oskavad läbi viia pahaloomulise glioomi kirurgilist ravi, tunnevad väga hästi aju anatoomiat ning on läbinud fluorestsentsiga juhitava lõikuse koolituse.
English: Other information about Gliolan:
Estonian: Muu teave Gliolani kohta
English: Since glioma cells take up more of the active substance and convert it more rapidly into PPIX, higher levels of PPIX accumulate in the cancer cells than in normal tissue.
Estonian: Et glioomirakkudes imendub toimeainet rohkem ja see muundub PPIX-ks kiiremini, koguneb pahaloomulise kasvaja rakkudesse suurem PPIX-i kontsentratsioon kui normaalsetesse kudedesse.
English: At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
Estonian: 72 tundi pärast lõikust puudus aju-uuringul nähtav kasvaja 63,6%-l Gliolani saanud patsientidest ja 37,6%-l neist, kes Gliolani ei saanud.
English: Why has Gliolan been approved?
Estonian: Miks Gliolan heaks kiideti?
English: What is the risk associated with Gliolan?
Estonian: Millised on Gliolaniga kaasnevad riskid?
English: It concluded that Gliolan increases the ability of the tumour to be distinguished from healthy brain tissue during surgery, and that it increases the proportion of patients whose tumours are completely removed and extends the time that patients survive without progression.
Estonian: Komitee järeldas, et Gliolan parandab kasvaja eristamisvõimet tervest ajukoest lõikuse ajal ja suurendab nende patsientide osakaalu, kellel eemaldatakse kasvaja täielikult, ning pikendab patsientide kasvajaretsidiivita elulemust.
English: Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour.
Estonian: Gliolani on uuritud ühes suures uuringus, kuhu oli kaasatud 415 pahaloomulise glioomiga patsienti, kellel oli kavas kasvajat eemaldav ajulõikus.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Estonian: Harva kasutatavate ravimite komitee arvamuse kokkuvõtte Gliolani kohta leiate siit.
English: Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Estonian: Gliolani kasutatakse pahaloomulise glioomiga (teatud liiki ajukasvaja) täiskasvanud patsientidel.
English: For the full list of all side effects reported with Gliolan, see the Package Leaflet.
Estonian: Gliolani kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The active substance in Gliolan, 5-aminolevulinic acid, is a ‘sensitiser used in photodynamic therapy'.
Estonian: Gliolani toimeaine 5-aminolevuliinhape on fotodünaamilises ravis kasutatav sensitiseeriv (tundlikuks muutev) ühend.
English: The effects of Gliolan were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Gliolani toimet muude katsetega.
English: Gliolan is a powder to be made up into a solution to be taken by mouth.
Estonian: Gliolan on pulber, millest valmistatakse suukaudne lahus.
English: The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Estonian: Komitee otsustas, et Gliolani kasulikkus ületab ravimi riske, kui ravimit kasutatakse pahaloomulise glioomi operatiivse ravi ajal kasvajakoe visualiseerimiseks.
English: This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.
Estonian: See võimaldab kirurgil lõikuse ajal eristada ja eemaldada kasvajakude täpsemini, säästes tervet ajukude.
English: How does Gliolan work?
Estonian: Kuidas Gliolan toimib?
English: Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
Estonian: Enne kui patsient lahuse ära joob, peab õde või farmatseut lahustama Gliolani pulbri 50 ml kraanivees.
English: What is Gliolan used for?
Estonian: Milleks Gliolani kasutatakse?
English: The full EPAR for Gliolan can be found here.
Estonian: Gliolani Euroopa avaliku hindamisaruande täisteksti leiate siit.
English: Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.
Estonian: Gliolan aitab lõikuse ajal kasvajat ajukoest paremini eristada, et kirurgil oleks seda kergem eemaldada.
English: How is Gliolan used?
Estonian: Kuidas Gliolani kasutatakse?
English: Gliolan should be used with caution in patients who have problems with their liver or kidneys.
Estonian: Maksa- või neeruprobleemidega patsientidel tuleb Gliolani kasutamisel olla ettevaatlik.
English: What benefit has Gliolan shown during the studies?
Estonian: Milles seisneb uuringute põhjal Gliolani kasulikkus?
English: How has Gliolan been studied?
Estonian: Kuidas Gliolani uuriti?
English: Treatment is continued for up to two weeks after the infection has been cured.
Estonian: Ravi jätkatakse kuni kahe nädala jooksul pärast infektsiooni paranemist.
English: What measures are being taken to ensure the safe and effective use of Cancidas?
Estonian: Mis meetmed võetakse, et tagada Cancidase ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Estonian: Euroopa Komisjon andis Caspofungin MSD müügiloa, mis kehtib kogu Euroopa Liidus, 24. oktoobril 2001.
English: It is given once a day by infusion lasting about one hour.
Estonian: Ravimit manustatakse üks kord ööpäevas ligikaudu üks tund kestva infusioonina.
English: The full EPAR for Cancidas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Cancidase kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The name of the medicine was changed to Cancidas on 9 April
Estonian: Ravimi nimetus muudeti 9. aprillil 2003 Cancidaseks.
English: Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group.
Estonian: Cancidase kasutamisel alla 12-kuustel lastel peab olema ettevaatlik, sest selles vanuserühmas ei ole ravimit piisavalt uuritud.
English: Other information about Cancidas
Estonian: Muu teave Cancidase kohta
English: Cancidas caspofungin
Estonian: Cancidas kaspofungiin
English: The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
Estonian: Cancidase kõige sagedamad kõrvalnähud täiskasvanutel (võivad esineda kuni 1 patsiendil 100st) on hemoglobiini või vere punaliblede vähesus, leukotsüütide (vere valgeliblede) vähesus, vere väike kaaliumisisaldus, peavalu, veenipõletik, raskendatud hingamine, iiveldus, kõhulahtisus, oksendamine, maksaensüümide ja bilirubiini suurenenud sisaldus (võib osutada maksaprobleemidele), lööve, sügelus, nahapunetus, liigne higistamine, liigesevalu, palavik, külmavärinad, süstekoha sügelus ning albumiini (teatud valgu) väike sisaldus veres.
English: What is Cancidas and what is it used for?
Estonian: Mis on Cancidas ja milleks seda kasutatakse?
English: In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight.
Estonian: 12-kuuste kuni 17-aastaste patsientide annus arvutatakse pikkuse ja kehamassi järgi.
English: ‘Invasive' means that the infection has spread into the blood;
Estonian: Invasiivne tähendab, et seen on levinud vereringesse.
English: Why is Cancidas approved?
Estonian: Miks Cancidas heaks kiideti?
English: This is known as ‘empirical treatment', which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection.
Estonian: Ravimit kasutatakse empiiriliseks raviks: ravi alustatakse patsiendi läbivaatuse põhjal, enne kui infektsiooni olemasolu on kinnitatud.
English: This is a summary of the European public assessment report (EPAR) for Cancidas.
Estonian: See on ravimi Cancidas Euroopa avaliku hindamisaruande kokkuvõte.
English: It is not intended to provide practical advice on how to use Cancidas.
Estonian: Hindamisaruandes ei anta Cancidase kasutamise praktilisi nõuandeid.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts.
Estonian: • Seeninfektsiooni kahtlus (näiteks seente Candida või Aspergillus põhjustatud infektsiooni kahtlus), kui patsiendil on palavik ja leukotsüütide (vere valgeliblede) vähesus.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cancidas have been included in the summary of product characteristics and the package leaflet.
Estonian: Cancidase ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What are the risks associated with Cancidas?
Estonian: Mis riskid Cancidasega kaasnevad?
English: The Committee therefore recommended that Cancidas be given marketing authorisation.
Estonian: Komitee soovitas seepärast anda ravimi müügiloa.
English: How does Cancidas work?
Estonian: Kuidas Cancidas toimib?
English: In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.
Estonian: Täiskasvanute ravi alustatakse 70 mg algannusega ning jätkatakse annusega 50 mg või 70 mg ööpäevas (patsientidel kehamassiga üle 80 kg).
English: • invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Estonian: • Invasiivne aspergilloos (seene Aspergillus põhjustatud teatud seeninfektsioon), kui amfoteritsiin-B või itrakonasool (samuti seeneravimid) on patsiendil ebaefektiivsed või patsient neid ei talu.
English: For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Cancidasega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: • invasive candidiasis (an infection caused by Candida).
Estonian: • Invasiivne kandidoos (seene Candida põhjustatud teatud seeninfektsioon (nakkus)).
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to continue living and growing.
Estonian: Selle toime seisneb seene eluks ja kasvamiseks vajaliku rakuseinakomponendi glükaanpolüsahhariidi tekke takistamises.
English: Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow.
Estonian: Cancidas kahjustab seene rakuseinu, nii et need muutuvad hapraks ega suuda kasvada.
English: Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
Estonian: Sarnased tulemused saadi uuringus, kus osalesid 49 invasiivse kandidoosiga või invasiivse aspergilloosiga last ja noorukit: Cancidasele tekkis ravivastus 50%-l (5 patsiendil 10st) invasiivse kandidoosiga ja 81%-l (30 patsiendil 37st) invasiivse aspergilloosiga patsientidest.
English: What benefits of Cancidas have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Cancidase kasulikkus?
English: For practical information about using Cancidas, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Cancidase kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Cancidas in adults and children, see the Package Leaflet.
Estonian: Cancidase kohta täiskasvanutel ja lastel teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Estonian: Patsientidest, kes ei talunud ravi muude ravimitega, tekkis Cancidast kasutanutest ravivastus 70%-l (7 patsiendil 10st).
English: Studies show that Cancidas treatment can lead to favourable responses in patients with fungal infections, including improvement of symptoms and the clearing of fungus from patient's body.
Estonian: Uuringute kohaselt saavutatakse seeninfektsiooniga patsientidel Cancidasega soodne ravivastussümptomid paranevad ning seen eemaldatakse patsiendi organismist.
English: The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children.
Estonian: Inimravimite komitee otsustas, et Cancidase kasulikkus invasiivse kandidoosi ja aspergilloosi ning kahtlustatavate seeninfektsioonide empiirilises ravis täiskasvanutel ja lastel on suurem kui sellega kaasnevad riskid.
English: The most common side effect in children is fever and this occurs in more than 1 patient in 10.
Estonian: Cancidase kõige sagedam kõrvalnäht lastel (täheldatud enam kui 1 patsiendil 10st) on palavik.
English: Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Estonian: Ravi Cancidasega peab alustama invasiivsete seeninfektsioonide ravis kogenud arst.
English: In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Estonian: Invasiivse kandidoosiga 239 täiskasvanu uuringus oli soodsa ravivastusega täiskasvanud patsiente Cancidasega ravitutest 73% (80 patsienti 109st) ja amfoteritsiin-B-ga ravitutest 62% (71 patsienti 115st).
English: Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Estonian: Täiskasvanud patsientidest, kelle ravi muude ravimitega ei andnud tulemusi, tekkis Cancidast kasutanutest ravivastus 36%-l (19 patsiendil 53st).
English: Cancidas is a powder that is made up into a solution for infusion (drip) into a vein.
Estonian: Cancidas on infusioonilahuse (veeni tilgutatava lahuse) pulber.
English: In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63).
Estonian: Invasiivse aspergilloosiga 69 täiskasvanu uuringu lõpuks tekkis Cancidasele soodne ravivastus 41%-l patsientidest (26 patsiendil 63st).
English: How is Cancidas used?
Estonian: Kuidas Cancidast kasutatakse?
English: The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Estonian: Cancidase suhtes tundlike seente loetelu on ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
English: Cancidas contains the active substance caspofungin
Estonian: Cancidas sisaldab toimeainena kaspofungiini.
English: Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
Estonian: Cancidas on seeneravim, millega ravitakse täiskasvanuid, noorukeid ja lapsi, kellel on järgmised seisundid.
English: The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Estonian: Cancidase toimeaine kaspofungiin kuulub seeneravimite ehhinokandiinide rühma.
English: Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years.
Estonian: Kahes uuringus, kus osalesid seeninfektsiooni kahtlusega patsiendid, keda raviti empriiriliselt, osutus Cancidas sama efektiivseks kui amfoteritsiin-B.