FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the study included a limited number of patients and more data are needed to confirm the results, the European Medicines Agency considered that Polivy meets an unmet medical need.
Slovenian: Čeprav je študija vključevala omejeno število bolnikov in je za potrditev rezultatov potrebnih več podatkov, je Evropska agencija za zdravila ocenila, da zdravilo Polivy izpolnjuje neizpolnjeno medicinsko potrebo.
English: As for all medicines, data on the use of Polivy are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Polivy stalno spremljajo.
English: If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Slovenian: Če se pri bolniku pojavi z infuzijo povezana reakcija, je treba infundiranje upočasniti ali prekiniti.
English: Why is Polivy authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Polivy odobreno v EU?
English: Polivy has been given a ‘conditional authorisation'.
Slovenian: Zdravilo Polivy je pridobilo „pogojno dovoljenje za promet“.
English: Polivy can affect the production of blood cells.
Slovenian: Zdravilo Polivy lahko vpliva na nastajanje krvnih celic.
English: MMAE then stops the B cells from dividing and causes them to die.
Slovenian: MMAE nato prepreči delitev celic B in povzroči njihovo odmrtje.
English: An overview of Polivy and why it is authorised in the EU
Slovenian: Pregled zdravila Polivy in zakaj je odobreno v EU
English: The dose of Polivy depends on the patient's bodyweight and is given for 6 cycles.
Slovenian: Odmerek zdravila Polivy je odvisen od bolnikove telesne mase in se daje šest ciklov.
English: What is Polivy and what is it used for?
Slovenian: Kaj je zdravilo Polivy in za kaj se uporablja?
English: Polivy is for infusion (drip) into a vein over 90 minutes.
Slovenian: Zdravilo Polivy je namenjeno infundiranju (kapalni infuziji) v veno v trajanju 90 minut.
English: What are the risks associated with Polivy?
Slovenian: Kakšna tveganja so povezana z zdravilom Polivy?
English: What benefits of Polivy have been shown in studies?
Slovenian: Kakšne koristi zdravila Polivy so se pokazale v študijah?
English: The main study showed that Polivy is effective at treating patients whose disease was not responding to previous treatment or had returned and who could not have a transplant.
Slovenian: Glavna študija je pokazala, da je zdravilo Polivy učinkovito pri zdravljenju bolnikov, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je ponovila in pri katerih presaditev ni mogoča.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Polivy have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Polivy upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Polivy are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Polivy, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: It is used in combination with two other medicines, bendamustine and rituximab.
Slovenian: Uporablja se v kombinaciji z dvema drugima zdraviloma, bendamustinom in rituksimabom.
English: It is given in 21-day cycles with rituximab and bendamustine.
Slovenian: Daje se v 21dnevnih ciklih skupaj z rituksimabom in bendamustinom.
English: For more information about using Polivy, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Polivy glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What information is still awaited for Polivy?
Slovenian: Katere informacije o zdravilu Polivy še pričakujemo?
English: Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Slovenian: Ker je zdravilo Polivy prejelo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo dodatne podatke o njegovih učinkih, da bi potrdili učinkovitost in varnost zdravila Polivy, kadar se pri bolnikih z difuznim velikoceličnim limfomom B uporablja v kombinaciji z drugimi zdravili proti raku.
English: Polivy can only be obtained with a prescription, and treatment must be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila Polivy je le na recept, zdravljenje z njim pa se mora izvajati pod nadzorom zdravnika, ki ima izkušnje z diagnostiko in zdravljenjem raka.
English: After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Slovenian: Po šestih do osmih tednih zdravljenja znakov raka ni bilo več (popolni odziv) pri 40 % bolnikov, ki so prejemali zdravilo Polivy v kombinaciji z rituksimabom in bendamustinom, in pri 18 % bolnikov, ki so prejemali samo rituksimab in bendamustin.
English: The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Slovenian: Monoklonsko protitelo se veže na beljakovino CD79b, prisotno na celicah B, vključno z rakavimi celicami B, pri tem pa vanje sprosti MMAE.
English: Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Slovenian: Resni neželeni učinki (ki se lahko pojavijo pri največ 1 od 10 bolnikov) vključujejo febrilno nevtropenijo (nizko raven belih krvnih celic s povišano telesno temperaturo), povišano telesno temperaturo in pljučnico (okužbo pljuč).
English: The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Slovenian: Učinkovina v zdravilu Polivy, polatuzumab vedotin, je sestavljena iz monoklonskega protitelesa (vrste beljakovine) v kombinaciji s snovjo, imenovano monometil avristatin E (MMAE).
English: DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Slovenian: Difuzni velikocelični limfom B je redka bolezen, zato je bilo zdravilo Polivy 16. aprila 2018 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Slovenian: Polivy je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z difuznim velikoceličnim limfomom B, pri katerih se je rak ponovil ali se je prenehal odzivati na druga zdravljenja in pri katerih ni mogoče opraviti presaditve kostnega mozga.
English: Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Slovenian: Nadaljnje informacije za zdravilo Polivy so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/polivy.
English: For the full list of side effects and restrictions of Polivy, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Polivy glejte navodilo za uporabo.
English: The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Slovenian: Najpogostejši neželeni učinki zdravila Polivy v kombinaciji z bendamustinom in rituksimabom (ki se lahko pojavijo pri več kot 3 od 10 bolnikov) so bili anemija (nizka raven rdečih krvnih celic), trombocitopenija (nizka raven trombocitov), nevtropenija (nizka raven belih krvnih celic), utrujenost, driska, navzeja (siljenje na bruhanje) in povišana telesna temperatura.
English: How does Polivy work?
Slovenian: Kako zdravilo Polivy deluje?
English: Patients with DLBCL have cancerous B cells, which are a type of white blood cell.
Slovenian: Pri bolnikih z difuznim velikoceličnim limfomom B so celice B, tj. vrsta belih krvnih celic, rakave.
English: How is Polivy used?
Slovenian: Kako se zdravilo Polivy uporablja?
English: Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Slovenian: Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, bolniki pred zdravljenjem z zdravilom Polivy prejmejo paracetamol in antihistaminik.
English: Half of the patients received Polivy added to the standard regimen of bendamustine plus rituximab whereas the other half received bendamustine plus rituximab alone.
Slovenian: Zdravilo Polivy so preučevali v študiji, ki je vključevala 80 bolnikov z difuznim velikoceličnim limfomom B. Polovica bolnikov je prejemala zdravilo Polivy, dodano standardnemu režimu z bendamustinom in rituksimabom, druga polovica pa je prejemala samo bendamustin in rituksimab.
English: The doctor may reduce or stop the dose of Polivy if the patient develops side effects affecting blood cells.
Slovenian: Če se pri bolniku pojavijo neželeni učinki, ki vplivajo na krvne celice, lahko zdravnik zmanjša odmerek zdravila Polivy ali prekine zdravljenje.
English: Polivy contains the active substance polatuzumab vedotin.
Slovenian: Zdravilo Polivy vsebuje učinkovino polatuzumab vedotin.
English: This was confirmed in the fourth study.
Slovenian: To je potrdila tudi četrta študija.
English: This summary was last updated in 03-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 03-2009.
English: The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 14. februarja 2001 in 14. februarja 2006.
English: It is available as white, round tablets (60 mg).
Slovenian: Na voljo je v obliki belih okroglih tablet (60 mg).
English: The marketing authorisation holder is Orion Corporation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Orion Corporation.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Slovenian: Beseda „metastatski“ pomeni, da se je rak že razširil na druge dele telesa.
English: The recommended dose of Fareston is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Fareston je ena tableta enkrat dnevno.
English: Other information about Fareston:
Slovenian: Druge informacije o zdravilu Fareston:
English: The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.
Slovenian: Glavna merila učinkovitosti so bila stopnja odziva (število bolnic, pri katerih so se tumorji odzvali na zdravljenje), čas do napredovanja bolezni (čas do poslabšanja bolezni) in preživetje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fareston, veljavno po vsej Evropski uniji, odobrila dne 14. februarja 1996.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FARESTON EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FARESTON Povzetek EPAR za javnost
English: The effects of Fareston were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Fareston so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Fareston must not be used in patients with ‘QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Slovenian: Zdravilo Fareston se ne sme uporabljati pri bolnicah, s podaljšanim intervalom QT (motnja električne aktivnosti srca), motnjami elektrolitov (spremenjenimi ravnmi soli v krvi), zlasti hipokaliemijo (nizkimi ravnimi kalija), bradikardijo (zelo počasnim bitjem srca), srčnim popuščanjem (nezmožnostjo srca črpati dovolj krvi po telesu) ali anamnezo simptomatske aritmije (nepravilnimi srčnimi ritmi) ali pri bolnicah, ki jemljejo tudi druga zdravila, ki povzročajo podaljšanje intervala QT. Za celoten seznam teh zdravil glejte navodilo za uporabo.
English: It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone.
Slovenian: Veže se na estrogenske receptorje na površini celic, kjer je njegova glavna naloga zaviranje učinkov hormona.
English: As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
Slovenian: Posledica tega je, da estrogen ne spodbuja rasti tumorskih celic, rast tumorja pa se upočasni.
English: What benefit has Fareston shown during the studies?
Slovenian: Kakšne koristi je zdravilo Fareston izkazalo med študijami?
English: What is the risk associated with Fareston?
Slovenian: Kakšna tveganja so povezana z zdravilom Fareston?
English: The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
Slovenian: Najpogostejši neželeni učinki zdravila Fareston (opaženi pri več kot 1 bolnici od 10) so navali vročine in potenje.
English: Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients.
Slovenian: Zdravila Fareston ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) toremifen ali katero koli drugo sestavino zdravila.
English: The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
Slovenian: Učinke zdravila Fareston so primerjali z učinki tamoksifena (drugega antiestrogena, ki se uporablja za zdravljenje raka dojk).
English: Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen.
Slovenian: Primerjava rezultatov treh največjih glavnih študij kaže, da so imele bolnice, ki so jemale zdravilo Fareston, podobno stopnjo odziva, čas do napredovanja bolezni in stopnjo preživetja kot bolnice, ki so jemale tamoksifen.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi in tveganja zdravila Fareston pri ženskah s tumorji, ki so pozitivni za estrogenske receptorje, primerljivi s koristmi in tveganji tamoksifena.
English: For the full list of all side effects reported with Fareston, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fareston, glejte navodilo za uporabo.
English: Fareston is a medicine that contains the active substance toremifene.
Slovenian: Fareston je zdravilo, ki vsebuje zdravilno učinkovino toremifen.
English: Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Slovenian: Zdravilo Fareston so proučevali v štirih glavnih študijah s 1 869 ženskami po menopavzi, ki so imele metastatski rak dojk.
English: The active substance in Fareston, toremifene, is an anti-oestrogen.
Slovenian: Zdravilna učinkovina v zdravilu Fareston, toremifen, je antiestrogen.
English: Most types of breast cancer grow in response to the hormone oestrogen.
Slovenian: Rast večine vrst raka dojk je odvisna od hormona estrogena.
English: Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Slovenian: Zdravilo Fareston ni priporočljivo pri bolnicah s tumorji brez estrogenskih receptorjev (z rakavimi celicami, ki na površini nimajo receptorjev za hormon estrogen).
English: Why has Fareston been approved?
Slovenian: Zakaj je bilo zdravilo Fareston odobreno?
English: Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause.
Slovenian: Zdravilo Fareston se uporablja za zdravljenje hormonsko odvisnega metastatskega raka dojk pri bolnicah po menopavzi.
English: It should be used with caution in patients who have problems with their liver.
Slovenian: Pri bolnicah, ki imajo težave z jetri, je treba zdravilo uporabljati previdno.
English: The effectiveness of Fareston and tamoxifen were equivalent.
Slovenian: Učinkovitost zdravila Fareston je bila enakovredna učinkovitosti tamoksifena.
English: It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems.
Slovenian: Bolnice, ki imajo hiperplazijo endometrija (zadebeljeno maternično sluznico) ali huda obolenja jeter, zdravila ne smejo uporabljati dolgotrajno.
English: The full EPAR for Fareston can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fareston je na voljo tukaj.
English: What is Fareston used for?
Slovenian: Za kaj se zdravilo Fareston uporablja?
English: Therefore, the Committee decided that Fareston's benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Slovenian: Odbor je zato sklenil, da so koristi zdravila Fareston pri hormonskem zdravljenju prve izbire hormonsko odvisnega metastatskega raka dojk pri bolnicah po menopavzi večje od z njim povezanih tveganj Odbor je priporočil, da se za zdravilo Fareston odobri dovoljenje za promet.
English: How has Fareston been studied?
Slovenian: Kako je bilo zdravilo Fareston raziskano?
English: How does Fareston work?
Slovenian: Kako zdravilo Fareston deluje?
English: What is Fareston?
Slovenian: Kaj je zdravilo Fareston?
English: How is Fareston used?
Slovenian: Kako se zdravilo Fareston uporablja?
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v program sočutne uporabe zdravila in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: In addition, no long-term safety data were provided, although treatment with Egrifta was expected to be long term.
Slovenian: Poleg tega niso bili predloženi nobeni dolgoročni podatki o varnosti, kljub temu da naj bi bilo zdravljenje z zdravilom Egrifta dolgoročno.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki mu jo je družba predložila, in oblikoval sezname vprašanj.
English: The company presented the results from two main studies involving 816 HIV patients with excessive accumulation of abdominal fat.
Slovenian: Družba je predložila rezultate dveh glavnih študij, ki sta zajeli 816 bolnikov, okuženih z virusom HIV, pri katerih se je pojavilo prekomerno kopičenje maščobnega tkiva na trebuhu.
English: Withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Egrifta (tesamorelin)
English: Egrifta is a medicine that contains the active substance tesamorelin.
Slovenian: Egrifta je zdravilo, ki vsebuje zdravilno učinkovino tesamorelin.
English: The relevance of the results was also questioned because the patients in the main studies were not representative of European HIV patients, who have a lower average body mass index (BMI) and smaller amounts of abdominal fats than the patients in the studies.
Slovenian: Odbor je podvomil tudi v relevantnost rezultatov, saj v glavni študiji niso bili vključeni bolniki, ki bi bili reprezentativni za bolnike, okužene z virusom HIV, iz Evrope, ki imajo nižji povprečni indeks telesne mase (ITM) in manjše količine maščobnega tkiva na trebuhu kot bolniki, zajeti v študijah.
English: The company informed the CHMP that there are no consequences for patients currently included in compassionate use programmes using Egrifta.
Slovenian: Družba je obvestila Odbor CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v programih sočutne uporabe zdravila Egrifta.
English: High levels of IGF-1 may be associated with an increased risk of cancer and a potential worsening of diabetic eye disease, and the Committee considered this to be a major safety concern.
Slovenian: Visoka raven IGF-1 je lahko vzrok za povečano tveganje za pojav rakavih obolenj in za morebitno poslabšanje diabetične očesne bolezni, zato je odbor ocenil, da zdravilo predstavlja znatno tveganje za varnost bolnikov.
English: The studies compared Egrifta with placebo (a dummy treatment), and the main measure of effectiveness was the change in abdominal fat after 26 weeks of treatment.
Slovenian: V študijah so zdravilo Egrifta primerjali s placebom (z zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba maščobnega tkiva na trebuhu po 26 tednih zdravljenja.
English: It was to be available as a powder to be made up into a solution for injection.
Slovenian: Na voljo naj bi bilo v obliki praška za pripravo raztopine za injiciranje.
English: In addition, although the main studies showed a reduction in abdominal fat with Egrifta, the reduction has not been shown to be clinically meaningful in terms of actual health benefits to patients.
Slovenian: Poleg tega sta glavni študiji sicer pokazali, da je zdravilo Egrifta pripomoglo k zmanjšanju maščobnega tkiva na trebuhu, vendar ni dokazov, da bi bilo zmanjšanje klinično pomembno v smislu dejanske koristi za zdravje bolnikov.
English: What is Egrifta?
Slovenian: Kaj je zdravilo Egrifta?
English: Growth hormone has been shown to play a role in regulating the formation and breakdown of fat tissue.
Slovenian: Rastni hormon dokazano pomaga uravnavati tvorbo in razgradnjo maščobnega tkiva.
English: On 21 June 2012, Ferrer Internacional, S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egrifta, for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Slovenian: Družba Ferrer Internacional, S. A. je dne 21. 6. 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Egrifta, namenjenim zdravljenju prekomerne trebušne maščobe pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija.
English: The CHMP considered a suggestion by the company to restrict the medicine to patients with abdominal fat above a certain amount (defined as greater than 130 cm2), but the evidence supporting the cut-off point was not considered to be sufficient.
Slovenian: Odbor CHMP je proučil predlog družbe, da naj se uporabo zdravila omeji samo za bolnike, katerih maščobno tkivo na trebuhu presega določeno vrednost (več kot 130 cm2), vendar je ocenil, da ni bilo zadostnih dokazov, ki bi podprli omenjeno vrednostno mejo.