FrancophonIA/ELRC3.0 huggingface dataset:
English: Emgality was shown to be effective at reducing the number of days patients suffer migraines in 3 main studies.
Slovenian: V treh glavnih študijah je bilo dokazano, da je zdravilo Emgality učinkovito pri zmanjševanju števila migrenskih dni pri bolnikih.
English: This summary was last updated in 07-2007.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gliolan to m e d a c Gesellschaft für klinische Spezialpräparate mbH on 7 September 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Gliolan, veljavno po vsej Evropski uniji, odobrila družbi m e d a c Gesellschaft für klinische Spezialpräparate mbH dne 7. september 2007.
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.
Slovenian: Ker pa je 5-aminolevulinska kislina snov, ki se naravno pojavlja, ter se že uporablja pri nekaterih drugih stanjih, je podjetje predstavilo tudi podatke iz objavljene literature.
English: Other information about Gliolan:
Slovenian: Druge informacije o zdravilu Gliolan:
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.
Slovenian: Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Which measures are being taken to ensure the safe use of Gliolan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Gliolan?
English: The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
Slovenian: Slike možganov je analiziral strokovnjak, ki ni vedel, ali so bolniki prejeli zdravilo Gliolan ali ne.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Gliolan je na voljo tukaj.
English: It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
Slovenian: Vsebuje zdravilno učinkovino hidroklorid 5-aminolevulinske kisline (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).
Slovenian: Najpogostejši neželeni stranski učinki (opaženi pri več kot 1 od 10 bolnikov) so slabokrvnost (nizka koncentracija rdečih krvničk), trombocitopenija (nizka koncentracija krvnih ploščic), levkocitoza (visoka koncentracija levkocitov, vrste belih krvničk) ter povišane ravni jetrnih encimov v krvi (bilirubina, alanin-aminotransferaze, aspartataminotransferaze, gamaglutamil-transferaze in amilaze).
English: It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
Slovenian: V telesu ga absorbirajo celice, v le-teh pa ga encimi pretvorijo v fluorescentne kemikalije, zlasti protoporfirin IX (PPIX).
English: The effects of Gliolan were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Gliolan so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) GLIOLAN Povzetek EPAR za javnost
English: It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
Slovenian: Prav tako ga ne smejo uporabljati bolniki s porfirijo (nezmožnostjo razgradnje porfirinov) ali nosečnice.
English: The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Slovenian: Priporočeni odmerek zdravila Gliolan je 20 mg na kilogram telesne mase, ki ga bolnik prejme dve do štiri ure pred prejemom anestezije.
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
Slovenian: Ker je število bolnikov z malignim gliomom majhno, velja ta bolezen za redko, zato je bilo zdravilo Gliolan 13. novembra 2002 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
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.
Slovenian: Po šestih mesecih je bilo še živih brez napredovanja bolezni 20,5 % bolnikov, ki so prejeli zdravilo Gliolan, v primerjavi z 11 % bolnikov, ki zdravila niso prejeli.
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.
Slovenian: Ob osvetlitvi z modro svetlobo z določeno valovno dolžino PPIX v tumorju žari intenzivno rdeče, medtem ko je normalno možgansko tkivo videti modro.
English: What benefit has Gliolan shown during the studies?
Slovenian: Kakšne koristi je zdravilo Gliolan izkazalo med raziskavami?
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.
Slovenian: Pred pričetkom trženja zdravila bo podjetje, ki proizvaja zdravilo Gliolan, pripravilo izobraževalne tečaje za nevrokirurge v vseh državah članicah, katerih namen bo posredovanje informacij o varni in učinkoviti uporabi zdravila med operacijo.
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.
Slovenian: Najpogostejši neželeni učinki, opaženi pri uporabi zdravila Gliolan, so posledica kombinacije zdravila samega, kakor tudi anestezije in odstranitve tumorja.
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.
Slovenian: 72 ur po operaciji 63,6 % bolnikov, ki so prejeli zdravilo Gliolan, ni imelo vidnega tumorja na sliki možganov, v primerjavi s 37,6 % med bolniki, ki niso prejeli zdravila Gliolan.
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).
Slovenian: Primerjali so rezultate operacij pri bolnikih, ki so prejeli zdravilo Gliolan (operirani pod modro svetlobo), z rezultati operacij pri bolnikih, ki niso prejeli nikakršnega sredstva za izboljšanje vidnosti tumorja (operirani pod normalno belo svetlobo).
English: Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Slovenian: Zdravila Mimpara ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) hidroklorid 5-aminolevulinske kisline ali porfirine.
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.
Slovenian: Ker celice glioma absorbirajo več učinkovine in jo hitreje pretvorijo v PPIX, pride v rakavih celicah do višje koncentracije PPIX kot v normalnem tkivu.
English: Gliolan should be used with caution in patients who have problems with their liver or kidneys.
Slovenian: Zdravilo Gliolan je treba pri bolnikih, ki imajo težave z jetri ali ledvicami, uporabljati previdno.
English: It recommended that Gliolan be given marketing authorisation.
Slovenian: Priporočil je odobritev dovoljenja za promet z zdravilom Gliolan.
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.
Slovenian: Sklenil je, da zdravilo Gliolan poveča možnost razlikovanja med tumorjem in zdravim možganskim tkivom med operacijo ter da povečuje delež bolnikov, katerih tumorji so odstranjeni v celoti, kakor tudi podaljša čas preživetja bolnikov brez napredovanja bolezni.
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').
Slovenian: Glavno merilo učinkovitosti sta bila delež bolnikov, ki na sliki možganov, posneti 72 ur po operaciji, ni imel vidnega tumorja, ter delež bolnikov, ki je 6 mesecev preživel brez ponovnega pojava tumorja ali njegove rasti (napredovanja).
English: Why has Gliolan been approved?
Slovenian: Zakaj je bilo zdravilo Gliolan odobreno?
English: For the full list of all side effects reported with Gliolan, see the Package Leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Gliolan, glejte Navodilo za uporabo.
English: What is the risk associated with Gliolan?
Slovenian: Kakšna tveganja so povezana z zdravilom Gliolan?
English: Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Slovenian: Zdravilo Gliolan se uporablja pri odraslih bolnikih z malignim gliomom (vrsto možganskega tumorja).
English: Removal of the brain tumour during surgery was more complete when Gliolan was used.
Slovenian: Odstranitev možganskega tumorja med operacijo je bila ob uporabi zdravila Gliolan popolnejša.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je poudaril, da bi naj kirurško zdravljenje malignega glioma stremelo k odstranitvi kar se da velikega dela tumorja, vendar brez nepotrebnega odstranjevanja zdravega možganskega tkiva.
English: Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
Slovenian: Prašek Gliolan mora medicinska sestra ali farmacevt raztopiti v 50 ml pitne vode, tako dobljeno raztopino pa bolnik popije.
English: The active substance in Gliolan, 5-aminolevulinic acid, is a ‘sensitiser used in photodynamic therapy'.
Slovenian: Zdravilna učinkovina v zdravilu Gliolan, 5-aminolevulinska kislina, je pripravek, namenjen uporabi pri fotodinamični terapiji.
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.
Slovenian: Zdravilo Gliolan so preučevali v okviru ene glavne študije, ki je vključevala 415 bolnikov z malignim gliomom, pri katerih bi naj izvedli operacijo možganov z namenom odstranitve tumorja.
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.
Slovenian: Zdravilo smejo uporabljati samo nevrokirurgi z izkušnjami pri operacijah malignih gliomov in s poglobljenim znanjem anatomije možganov, ki so zaključili tečaj iz opravljanja kirurških posegov, vodenih s fluorescenco.
English: The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Slovenian: Odbor je sklenil, da so koristi zdravila Gliolan za vizualizacijo malignega tkiva med operacijo malignega glioma večje od z njim povezanih tveganj.
English: This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.
Slovenian: To zagotavlja kirurgu med operacijo boljšo vidnost tumorja in s tem njegovo natančnejšo odstranitev, brez nepotrebnega odstranjevanja zdravega možganskega tkiva.
English: What is Gliolan used for?
Slovenian: Za kaj se zdravilo Gliolan uporablja?
English: How has Gliolan been studied?
Slovenian: Kako je bilo zdravilo Gliolan raziskano?
English: Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.
Slovenian: Zdravilo Gliolan omogoča kirurgom med operacijo boljšo vidnost tumorja in s tem njegovo odstranitev iz možganov.
English: How does Gliolan work?
Slovenian: Kako zdravilo Gliolan deluje?
English: What is Gliolan?
Slovenian: Kaj je zdravilo Gliolan?
English: Gliolan is a powder to be made up into a solution to be taken by mouth.
Slovenian: Zdravilo Gliolan je prašek, namenjen za pripravo peroralne raztopine (ki se daje skozi usta).
English: How is Gliolan used?
Slovenian: Kako se zdravilo Gliolan uporablja?
English: The full EPAR for Gliolan can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gliolan je na voljo tukaj.
English: ‘Invasive' means that the infection has spread into the blood;
Slovenian: „Invazivna“ pomeni, da se je okužba razširila v kri;
English: Cancidas caspofungin
Slovenian: Cancidas kaspofungin
English: It is given once a day by infusion lasting about one hour.
Slovenian: Zdravilo se daje enkrat dnevno v obliki počasne infuzije, ki traja približno eno uro.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Caspofungin MSD, veljavno po vsej Evropski uniji, izdala 24. oktobra 2001.
English: What measures are being taken to ensure the safe and effective use of Cancidas?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cancidas?
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.
Slovenian: Temu pravimo „empirično zdravljenje“, kar pomeni, da se zdravljenje začne na podlagi opazovanja bolnika, preden lahko zdravnik potrdi, da je bolnik okužen.
English: The name of the medicine was changed to Cancidas on 9 April
Slovenian: Ime zdravila je bilo 9. aprila 2003 spremenjeno v Cancidas.
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cancidas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Slovenian: Zdravilo Cancidas je treba pri otrocih, mlajših od 12 mesecev, uporabljati previdno, saj zdravilo v tej starostni skupini ni bilo zadostno raziskano.
English: Other information about Cancidas
Slovenian: Druge informacije o zdravilu Cancidas
English: This is a summary of the European public assessment report (EPAR) for Cancidas.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cancidas.
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.
Slovenian: Najpogostejši neželeni učinki zdravila Cancidas pri odraslih (ki lahko prizadenejo največ 1 osebo od 10) so zmanjšana raven hemoglobina ali rdečih krvnih celic, zmanjšano število belih krvnih celic, nizka raven kalija v krvi, glavobol, vnetje ven, težave pri dihanju, navzeja, driska, bruhanje, povišane ravni jetrnih encimov in bilirubina (kar lahko kaže na težave z jetri), izpuščaj, srbenje, pordelost kože, čezmerno znojenje, bolečina v sklepih, povišana telesna temperatura, mrzlica, srbenje na mestu injiciranja in zmanjšane ravni albumina (beljakovine v krvi).
English: In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight.
Slovenian: Pri bolnikih, starih od 12 mesecev do 17 let, se odmerek izračuna na podlagi otrokove višine in telesne mase.
English: It is not intended to provide practical advice on how to use Cancidas.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow.
Slovenian: Celice gliv, ki so izpostavljene zdravilu Cancidas, imajo nepopolne ali okvarjene celične stene, zaradi česar so občutljive in ne morejo rasti.
English: Treatment is continued for up to two weeks after the infection has been cured.
Slovenian: Ko je okužba pozdravljena, se zdravljenje nadaljuje še do dva tedna.
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.
Slovenian: Deluje tako, da posega v tvorbo ene od sestavin celične stene glive, ki se imenuje glukan polisaharid in je nujna, da bi lahko gliva živela in rasla.
English: What benefits of Cancidas have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cancidas izkazalo v študijah?
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);
Slovenian: • invazivno aspergilozo (drugo vrsto glivne okužbe, ki jo povzroča Aspergillus), če se bolnik ne odziva na amfotericin B ali itrakonazol (drugi protiglivni zdravili) ali ju ne prenaša;
English: Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
Slovenian: Cancidas je protiglivno zdravilo, ki se uporablja za zdravljenje naslednjih glivnih okužb pri odraslih in otrocih:
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.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cancidas upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts.
Slovenian: • domnevnimi glivnimi okužbami (npr. zaradi Candide or Aspergillusa), če je bolnik febrilen in mu primanjkuje belih krvničk.
English: • invasive candidiasis (an infection caused by Candida).
Slovenian: • invazivne kandidioze (vrste glivne okužbe, ki jo povzroča Candida).
English: What is Cancidas and what is it used for?
Slovenian: Kaj je zdravilo Cancidas in za kaj se uporablja?
English: What are the risks associated with Cancidas?
Slovenian: Kakšna tveganja so povezana z zdravilom Cancidas?
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.
Slovenian: Študije so pokazale, da se bolniki z glivno okužbo lahko pozitivno odzovejo na zdravljenje z zdravilom Cancidas, tudi z izboljšanjem simptomov in odstranitvijo glive iz bolnikovega telesa.
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.
Slovenian: Podobne odzive je pokazala študija pri 49 otrokih in mladostnikih z invazivno kandidiazo ali invazivno aspergilozo: 50 % (5 od 10) tistih z invazivno kandidiazo in 81 % (30 od 37) tistih z invazivno asperigilozo se je odzvalo na zdravilo Cancidas.
English: Why is Cancidas approved?
Slovenian: Zakaj je bilo zdravilo Cancidas odobreno?
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.
Slovenian: Pri odraslih se zdravljenje začne s 70-miligramskim uvajalnim odmerkom, ki mu sledi dnevni odmerek 50 mg oziroma 70 mg, če bolnik tehta več kot 80 kg.
English: The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Slovenian: Zdravilna učinkovina v zdravilu Cancidas, kaspofungin, sodi v skupino protiglivnih zdravil, znanih kot ehinokandini.
English: For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cancidas preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with Cancidas in adults and children, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cancidas pri odraslih in otrocih, glejte navodilo za uporabo.
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.
Slovenian: Poleg tega je bilo zdravilo Cancidas v dveh študijah pri bolnikih z domnevno glivno okužbo, ki so bili zdravljeni empirično, enako učinkovito kot amfotericin B. V eni od študij pri približno 1 000 odraslih se je 34 % bolnikov ugodno odzvalo na Cancidas ali amfotericin B. Podobne rezultate je pokazala druga študija, v katero je bilo vključenih 82 otrok, starih od 2 do 17 let.
English: For practical information about using Cancidas, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cancidas naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The most common side effect in children is fever and this occurs in more than 1 patient in 10.
Slovenian: Najpogostejši neželeni učinek pri otrocih (opažen pri več kot 1 od 10 bolnikov) je povišana telesna temperatura.
English: Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Slovenian: Zdravljenje z zdravilom Cancidas mora uvesti zdravnik z izkušnjami z zdravljenjem invazivnih glivnih okužb.
English: Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Slovenian: Od odraslih, ki se niso odzvali na drugo zdravljenje, se jih je 36 % (19 od 53) odzvalo na zdravilo Cancidas.
English: The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Za seznam gliv, proti katerim deluje zdravilo Cancidas, glejte povzetek glavnih značilnosti zdravila (ki je prav tako sestavni del EPAR).