FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, in the main study comparing the use of Kantos Master for MART versus maintenance treatment with Kantos Master plus a short-acting bronchodilator given for relief, there were concerns that the comparison group might not have been receiving adequate maintenance treatment, which could have made the results in the MART group look better than they really were.
Slovenian: Razlogi za napotitev so bili zadržki Švedske, da podatki o zdravilu Kantos Master, predloženi v vlogi, ne zadostujejo za dokaz učinkovitosti zdravila za shemo MART. Zadržke, da primerjalna skupina morda ni prejemala ustreznega vzdrževalnega zdravljenja, kar je morda povzročilo navidezno boljše rezultate skupine MART, kot bi dejansko bili, so izrazili predvsem v glavni študiji, v kateri je bila primerjana uporaba zdravila Kantos Master za shemo MART z vzdrževalnim zdravljenjem z zdravilom Kantos Master skupaj z bronhodilatatorjem s kratkim delovanjem za lajšanje simptomov.
English: The company wanted the authorisation to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania,
Slovenian: Pri podjetju so želeli, da se dovoljenje prizna v naslednjih državah članicah: Avstriji, Belgiji,
English: This four-week period is one ‘cycle'.
Slovenian: To štiritedensko obdobje je en cikel.
English: Vidaza azacitidine
Slovenian: Vidaza azacitidin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vidaza on 17 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vidaza, veljavno po vsej Evropski uniji, izdala 17. decembra 2008.
English: The effect of Vidaza was similar in all three diseases.
Slovenian: Učinek zdravila Vidaza je bil podoben pri vseh treh boleznih.
English: What measures are being taken to ensure the safe and effective use of Vidaza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vidaza?
English: The main measure of effectiveness was how long the patients survived.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja bolnikov.
English: Treatment continues for at least six cycles and then for as long as it benefits the patient.
Slovenian: Zdravljenje traja vsaj šest ciklov, nato pa dokler koristi bolniku.
English: Vidaza has been studied in two main studies.
Slovenian: Zdravilo Vidaza so proučevali v dveh glavnih študijah.
English: Both studies compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient's condition).
Slovenian: V obeh študijah so zdravilo Vidaza primerjali z običajno oskrbo (zdravljenjem, ki je za vsakega bolnika izbrano na podlagi lokalne prakse in njegovega zdravstvenega stanja).
English: The full EPAR for Vidaza 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 Vidaza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vidaza have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Vidaza, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What benefit has Vidaza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Vidaza izkazalo med študijami?
English: Other information about Vidaza
Slovenian: Druge informacije o zdravilu Vidaza
English: The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Slovenian: Priporočeni odmerek zdravila Vidaza je 75 mg na kvadratni meter površine telesa (izračunano na podlagi bolnikove telesne mase in višine).
English: Vidaza treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Slovenian: Zdravljenje z zdravilom Vidaza mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: The CHMP decided that Vidaza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Vidaza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.
Slovenian: Če število določenih celic v krvi preveč pade ali če se pri bolniku pojavijo ledvične težave, je treba naslednji cikel zdravljenja prestaviti ali uporabiti manjši odmerek.
English: It is available as a powder to be made up into a suspension for injection.
Slovenian: Na voljo je v obliki praška za pripravo suspenzije za injiciranje.
English: It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment.
Slovenian: Zdravilo se daje kot injekcija pod kožo nadlahti, stegna ali trebuha vsak dan en teden, temu pa sledijo trije tedni brez zdravljenja.
English: For more information about treatment with Vidaza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vidaza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Vidaza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vidaza.
English: Vidaza was more effective than conventional care in extending survival.
Slovenian: Zdravilo Vidaza je bilo pri podaljševanju preživetja učinkovitejše od običajne oskrbe.
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 Vidaza.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What is the risk associated with Vidaza?
Slovenian: Kakšna tveganja so povezana z zdravilom Vidaza?
English: It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Slovenian: Predvideva se, da deluje s spreminjanjem načina, kako celica vklaplja in izklaplja gene, ter z motenjem proizvodnje nove RNK in DNK.
English: Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA).
Slovenian: Azacitidin je analog citidina, kar pomeni, da se vgradi v dedni material celic (RNK in DNK).
English: Vidaza must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Slovenian: Zdravila Vidaza ne smejo uporabljati bolniki z napredovalim rakom jeter ali ženske, ki dojijo.
English: Because the number of patients with these diseases is low, the diseases are considered ‘rare', and Vidaza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML.
Slovenian: Ker je bolnikov s temi boleznimi malo, veljajo te za redke, zato je bilo zdravilo Vidaza 6. februarja 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za mielodisplastične sindrome, 29. novembra 2007 pa še za akutno mieloično levkemijo.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Vidaza can be found on the Agency's website: here (myelodysplastic syndromes) and here (AML).
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Vidaza je na voljo na spletni strani agencije: tukaj (mielodisplastični sindromi) in tukaj (akutna mieloična levkemija).
English: The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Vidaza, ki so jih opazili pri več kot 60 % bolnikov z mielodisplastičnimi sindromi, kronično mielomonocitno levkemijo ali akutno mieloično levkemijo (pri katerih je bilo od 20 do 30 % celic nenormalnih), so krvne reakcije, ki vključujejo trombocitopenijo (nizko število trombocitov), nevtropenijo (nizko število nevtrofilcev, vrste belih krvničk) in levkopenijo (nizko število belih krvnih celic), neželeni učinki v želodcu in črevesju, ki vključujejo navzejo (slabost) in bruhanje, ter reakcije na mestu injiciranja.
English: In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Slovenian: V prvi študiji so bolniki, ki so prejeli zdravilo Vidaza, v povprečju preživeli 24,5 meseca v primerjavi s 15,0 meseca pri bolnikih, ki so bili deležni običajne oskrbe.
English: Vidaza is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Slovenian: Zdravilo Vidaza se uporablja za zdravljenje odraslih z naslednjimi boleznimi, če jim ni mogoče presaditi hematopoetskih (krvotvornih) matičnih celic (pri čemer bolnik prejme matične celice, ki pomagajo obnoviti sposobnost kostnega mozga, da proizvaja zdrave krvne celice):
English: The liver, kidneys and blood should be checked before each cycle.
Slovenian: Pred vsakim ciklom je treba opraviti preiskave jeter, ledvic in krvi.
English: Why has Vidaza been approved?
Slovenian: Zakaj je bilo zdravilo Vidaza odobreno?
English: Vidaza is a medicine that contains the active substance azacitidine.
Slovenian: Vidaza je zdravilo, ki vsebuje zdravilno učinkovino azacitidin.
English: The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation.
Slovenian: V drugo študijo je bilo vključenih 488 bolnikov z akutno mieloično levkemijo, ki so bili starejši od 65 let in jim niso mogli presaditi hematopoetskih matičnih celic.
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Slovenian: • s kronično mielomonocitno levkemijo (KMML, rakom, ki prizadene bele krvničke, imenovane monociti).
English: These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Slovenian: Verjetno je, da take reakcije odpravljajo težave, ki se pojavijo pri zorenju in rasti mladih krvnih celic v kostnem mozgu, kar povzroča mielodisplastične motnje, ter uničujejo rakave celice pri levkemiji.
English: Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Slovenian: Zdravilo Vidaza se uporablja, kadar je od 10 do 29 % celic kostnega mozga nenormalnih, kostni mozeg pa ne proizvaja zadostnega števila belih krvničk;
English: Patients should receive medicines to prevent nausea (feeling sick) and vomiting before giving Vidaza.
Slovenian: Bolniki morajo pred zdravljenjem z zdravilom Vidaza prejeti zdravila za preprečevanje navzeje (slabosti) in bruhanja.
English: In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).
Slovenian: V nekaterih primerih lahko mielodisplastični sindromi povzročijo akutno mieloično levkemijo (AML, raka, ki prizadene bele krvničke, imenovane mieloične celice).
English: In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Slovenian: V drugi študiji z bolniki, starejšimi od 65 let, so tisti, ki so prejemali zdravilo Vidaza, v povprečju preživeli 10,4 meseca v primerjavi s 6,5 meseca pri bolnikih, ki so bili deležni običajne oskrbe.
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Slovenian: • z akutno mieloično levkemijo, ki se je razvila iz mielodisplastičnega sindroma in kostni mozeg tvori 20 do 30 % nenormalnih celic;
English: At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.
Slovenian: V času določitve zdravila kot zdravilo sirota je bila kronična mielomonocitna levkemija razvrščena kot ena od vrst mielodisplastičnega sindroma.
English: Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;
Slovenian: Zdravilo Vidaza se uporablja pri bolnikih s srednjo in visoko stopnjo tveganja za napredovanje bolezni do akutne mieloične levkemije ali smrti;
English: For the full list of all side effects reported with Vidaza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vidaza, glejte navodilo za uporabo.
English: The active substance in Vidaza, azacitidine, belongs to the group ‘anti-metabolites'.
Slovenian: Zdravilna učinkovina v zdravilu Vidaza, azacitidin, je zdravilo, ki spada v skupino antimetabolitov.
English: The patients' bone marrow contained up to 30% abnormal cells.
Slovenian: Kostni mozeg bolnikov je vseboval do 30 % nenormalnih celic.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Slovenian: • z mielodisplastičnimi sindromi, tj. skupino obolenj, pri katerih kostni mozeg ne ustvarja dovolj velikega števila krvnih celic.
English: Their bone marrow contained more than 30% abnormal cells.
Slovenian: Njihov kostni mozeg je vseboval več kot 30 % nenormalnih celic.
English: What is Vidaza used for?
Slovenian: Za kaj se zdravilo Vidaza uporablja?
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant.
Slovenian: V prvo študijo je bilo vključenih 358 odraslih z mielodisplastičnimi sindromi s srednjo in visoko stopnjo tveganja, kronično mielomonocitno levkemijo ali akutno mieloično levkemijo, pri katerih je zelo majhna verjetnost presaditve matičnih celic.
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Slovenian: Neželeni učinki so bili podobni pri bolnikih z akutno mieloično levkemijo z več kot 30 % nenormalnih celic.
English: How has Vidaza been studied?
Slovenian: Kako je bilo zdravilo Vidaza raziskano?
English: • AML, when the bone marrow has more than 30% abnormal cells.
Slovenian: • z akutno mieloično levkemijo, ko kostni mozeg vsebuje več kot 30 % nenormalnih celic.
English: How does Vidaza work?
Slovenian: Kako zdravilo Vidaza deluje?
English: How is Vidaza used?
Slovenian: Kako se zdravilo Vidaza uporablja?
English: What is Vidaza?
Slovenian: Kaj je zdravilo Vidaza?
English: However, knowledge on the long-term effects of the medicine is still awaited.
Slovenian: Informacije o dolgoročnih učinkih zdravila se še pričakujejo.
English: It must also not be used in patients infected with hepatitis B, C and/or HIV virus.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, okuženih z virusom hepatitisa B, C in/ali HIV.
English: The company will also continue the first study to obtain more information about the long-term safety and effectiveness of Spherox.
Slovenian: Družba bo prav tako nadaljevala izvajanje prve študije, da bo pridobila več informacij o dolgoročni varnosti in učinkovitosti zdravila Spherox.
English: It is used where the affected area is no larger than 10 cm².
Slovenian: Uporablja se, kadar prizadeti predel ni večji od 10 cm2.
English: The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility.
Slovenian: Zdravilo se pripravi za vsakega bolnika posebej, dajati pa ga mora usposobljen zdravnik v zdravstveni ustanovi.
English: The safety profile was considered acceptable; most side effects expected can be due to the surgery.
Slovenian: Varnostni profil velja za sprejemljivega, večina pričakovanih neželenih učinkov pa je posledica kirurškega posega.
English: The full EPAR for Spherox 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 Spherox je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Slovenian: Gre za skupino zdravil, ki vsebujejo celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za obnovitev, regeneracijo ali nadomeščanje tkiva.
English: Cartilage in the knee can be damaged because of an accident, such as a fall or a sport injury.
Slovenian: Hrustanec v kolenu se lahko poškoduje zaradi nezgode, kot sta padec ali športna poškodba.
English: What measures are being taken to ensure the safe and effective use of Spherox?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Spherox?
English: This is a summary of the European public assessment report (EPAR) for Spherox.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Spherox.
English: The European Medicines Agency therefore decided that Spherox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je tako sklenila, da so koristi zdravila Spherox večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: The KOOS was self-measured by patients rating the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.
Slovenian: Bolniki so sami izpolnjevali vprašalnik KOOS in ocenjevali resnost svojih simptomov, kot so bolečina, vpliv na vsakodnevno življenje, šport in rekreacijo ter kakovost življenja.
English: In addition, two other studies will be carried out on the manufacture of Spherox, which will look, among other things, at the consistency of the finished product.
Slovenian: Poleg tega bo izvedla še dve dodatni študiji o izdelavi zdravila Spherox, v katerih bodo med drugim preučevali doslednost končnega zdravila.
English: In this study, patients' outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment.
Slovenian: V tej študiji so se izidi bolnikov ob zdravljenju z zdravilom Spherox v prvem letu izboljšali za 16 točk, v do triletnem zdravljenju pa je prišlo še do dodatnih izboljšanj.
English: Other information about Spherox
Slovenian: Druge informacije o zdravilu Spherox
English: All these patients received treatment with Spherox, as microfracture is not recommended to repair large defects.
Slovenian: Vsi ti bolniki so se zdravili z zdravilom Spherox, saj mikrofraktura za popravilo večjih poškodb ni priporočljiva.
English: Preliminary data from this study after one year show that Spherox improved by 22 points the outcome score and was as effective as microfracture.
Slovenian: Predhodni podatki te študije po enem letu kažejo, da je zdravilo Spherox za 22 točk izboljšalo izid in je bilo enako učinkovito kot mikrofraktura.
English: The chondrocyte spheroids attach to the cartilage within 20 minutes.
Slovenian: Hondrocitni sferoidi se v 20 minutah pripojijo na hrustanec.
English: The second study looked at 73 patients with large cartilage defects of the knee from 4 to 10 cm².
Slovenian: V drugi študiji so preučevali 73 bolnikov z večjimi poškodbami kolenskega hrustanca, velikimi od 4 do 10 cm².
English: The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale of 0 to 100 (where 0 means severest symptoms and 100 means no symptoms).
Slovenian: Glavno merilo učinkovitosti je bil rezultat po vprašalniku KOOS (Knee Injury and Osteoarthritis Outcome Score - vprašalnik o izidih poškodb kolena in osteoartritisa), ki se ocenjuje z lestvico od 0 do 100 (pri čemer 0 pomeni najhujše simptome, 100 pa odsotnost simptomov).
English: In the first study involving 102 patients, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage).
Slovenian: V prvi študiji, ki je vključevala 102 bolnika, so zdravilo Spherox primerjali z mikrofrakturo (vrsto kirurškega posega, ki se uporablja za popravilo poškodb hrustanca).
English: The company that markets Spherox will ensure that all surgeons and other healthcare professionals handling or using the medicine receive training materials on how to use and store it.
Slovenian: Družba, ki trži zdravilo Spherox, bo zagotovila, da bodo vsi kirurgi in drugi zdravstveni delavci, ki rokujejo z zdravilom ali ga uporabljajo, prejeli gradivo za usposabljanje v zvezi z njegovo uporabo in shranjevanjem.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zdravilom Spherox, morajo izvajati poseben rehabilitacijski program, vključno s fizioterapijo.
English: Using chondrocyte spheroids that attach to the knee cartilage allows for a less invasive surgery (i.e. arthroscopy).
Slovenian: Uporaba hondrocitnih sferoidov, ki se pripojijo na kolenski hrustanec, omogoča manj invaziven kirurški poseg (tj. artroskopijo).
English: The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids.
Slovenian: Celice hrustanca nato gojijo v laboratoriju in iz njih pripravijo suspenzijo hondrocitnih sferoidov.
English: Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing symptoms (such as pain and problems moving the knee).
Slovenian: Spherox je zdravilo, ki se uporablja za popravilo poškodb hrustanca v kolenu pri odraslih s simptomi (kot so bolečina in težave pri premikanju kolena).
English: For more information about treatment with Spherox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Spherox preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Spherox have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Spherox izkazalo v študijah?
English: Spherox is a type of advanced therapy medicine called a ‘tissue engineered product'.
Slovenian: Zdravilo Spherox spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženirstvom“.
English: What is Spherox and what is it used for?
Slovenian: Kaj je zdravilo Spherox in za kaj se uporablja?
English: Spherox is available as a suspension for implantation into the knee joint.
Slovenian: Zdravilo Spherox je na voljo kot suspenzija za implantacijo v kolenski sklep.
English: What are the risks associated with Spherox?
Slovenian: Kakšna tveganja so povezana z zdravilom Spherox?
English: The knee cartilage defects were between 1 and 4 cm2 in size.
Slovenian: Poškodbe kolenskega hrustanca so bile velike od 1 do 4 cm2.