FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the orphan designations can be found on the European Medicines Agency's website (Hodgkin's lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila (Hodgkinov limfom: 15. januarja 2009; sistemski anaplastični velikocelični limfom: 15. januarja 2009; kutani T-celični limfom: 11. januarja 2012).
English: Therefore, the Agency decided that the benefits of Adcetris are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Zato je zaključila, da so koristi zdravila Adcetris večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Adcetris received a conditional marketing authorisation valid throughout the EU on 25 October 2012.
Slovenian: Za zdravilo Adcetris je bilo 25. oktobra 2012 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: Treatment should continue for up to 6 months when used with other cancer medicines or up to 1 year when used alone.
Slovenian: Zdravljenje mora trajati do šest mesecev, če se uporablja skupaj z drugimi zdravili za zdravljenje raka, ali do enega leta, kadar se uporablja samostojno.
English: Adcetris (brentuximab vedotin)
Slovenian: Adcetris (brentuksimab vedotin)
English: As for all medicines, data on the use of Adcetris are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Adcetris stalno spremljajo.
English: The most common side effects of Adcetris given alone (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat), peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia, rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain.
Slovenian: Najpogostejši neželeni učinki zdravila Adcetris, ki se daje samostojno, (ki lahko prizadenejo več kot 1 osebo od 10), so okužbe (tudi nosu in grla), senzorična ali motorična nevropatija (poškodbe živcev, ki prizadenejo občutenje ali nadzor in usklajenost mišic), utrujenost, navzeja (siljenje na bruhanje), driska, povišana telesna temperatura, nevtropenija (nizko število belih krvnih telesc), izpuščaj, kašelj, bruhanje, bolečine v sklepih, reakcije, povezane z injiciranjem, srbenje, zaprtje, dispneja (težave z dihanjem), izguba telesne mase, bolečine v mišicah in trebuhu.
English: After 2 years, 82% of patients given Adcetris survived without their disease getting worse, compared with 77% of patients given bleomycin.
Slovenian: Po dveh letih je 82 % bolnikov, ki so prejemali zdravilo Adcetris, preživelo brez poslabšanja bolezni v primerjavi s 77 % bolnikov, ki so prejemali bleomicin.
English: The Agency further noted that the overall safety profile of Adcetris was acceptable given the serious conditions for which it is used.
Slovenian: Agencija je ugotovila tudi, da je skupni varnostni profil zdravila Adcetris sprejemljiv glede na resnost bolezni, za katere se uporablja.
English: An overview of Adcetris and why it is authorised in the EU
Slovenian: Pregled zdravila Adcetris in zakaj je odobreno v EU
English: Every year, the Agency will review any new information that may become available and this overview will be updated as necessary.
Slovenian: Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris 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 Adcetris, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Why is Adcetris authorised in the EU?
Slovenian: Zakaj je zdravilo Adcetris odobreno v EU?
English: Adcetris has been given ‘conditional approval'.
Slovenian: Zdravilo Adcetris je pridobilo „pogojno dovoljenje za promet“.
English: When given with other cancer medicines, patients may also be given a medicine to help prevent neutropenia (low white blood cell count).
Slovenian: Če se daje z drugimi zdravili za zdravljenje raka, lahko bolniki dobijo tudi zdravilo za preprečevanje nevtropenije (nizkega števila belih krvnih celic).
English: A complete response was observed in 33% of patients (34 out of 102).
Slovenian: Popolni odziv so zabeležili pri 33 % (34 od 102) bolnikov.
English: In this study, the average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those given placebo.
Slovenian: V tej študiji je bil povprečni čas preživetja, preden se je bolezen poslabšala, pri tistih, ki so prejemali zdravilo Adcetris, okoli 43 mesecev v primerjavi s 24 meseci pri tistih, ki so prejemali placebo.
English: For more information about using Adcetris, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Adcentris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Adcetris and what is it used for?
Slovenian: Kaj je zdravilo Adcetris in za kaj se uporablja?
English: These diseases are rare, and Adcetris was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Slovenian: Te bolezni so redke, zato je bilo zdravilo Adcetris večkrat določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Response to treatment was assessed using body scans and patients' clinical data.
Slovenian: Odziv na zdravljenje so ocenili na podlagi slikanja telesa bolnika in njegovih kliničnih podatkov.
English: Adcetris is also used to treat adults with two other lymphomas:
Slovenian: Zdravilo Adcetris se uporablja tudi za zdravljenje odraslih z dvema drugima vrstama limfoma:
English: Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs.
Slovenian: Zdravilo Adcetris se ne sme uporabljati skupaj z bleomicinom (drugim zdravilom za zdravljenje raka), ker njuna kombinacija poškoduje pljuča.
English: • when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);
Slovenian: • če se je rak ponovil ali se ni odzval na avtologno presaditev matičnih celic (presaditev bolnikovih lastnih krvotvornih celic);
English: What are the risks associated with Adcetris?
Slovenian: Kakšna tveganja so povezana z zdravilom Adcetris?
English: In this study, 75% of patients (76 out of 102) responded partially or completely to treatment.
Slovenian: V tej študiji se je 75 % (76 od 102) bolnikov deloma ali popolnoma odzvalo na zdravljenje.
English: Side effects reported with Adcetris are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Adcetris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments.
Slovenian: Pri teh bolnikih, pri katerih je prognoza večinoma neugodna in za katere ni primernih zdravljenj, lahko zdravilo Adcetris vodi do ozdravitve ali jim omogoči morebitno kurativno zdravljenje.
English: • when patients have had an autologous stem cell transplant but are considered to be at increased risk of the cancer coming back or not responding;
Slovenian: • če je bila opravljena avtologna presaditev matičnih celic, a se šteje, da je bolnik izpostavljen povečanemu tveganju, da se rak ponovi ali ne odzove;
English: The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).
Slovenian: Delež bolnikov, ki so se vsaj štiri mesece odzivali na zdravljenje, je bil 56 % (36 od 64 bolnikov) med tistimi, ki so prejemali zdravilo Adcetris, in 13 % (8 od 64 bolnikov) med tistimi, ki so prejemali druga zdravljenja.
English: What information is still awaited for Adcetris?
Slovenian: Katere informacije o zdravilu Adcetris še pričakujemo?
English: The data on these patients showed that 55% of patients (22 out of 40) responded to treatment.
Slovenian: Podatki o teh bolnikih so pokazali, da se je na zdravljenje odzvalo 55 % (22 od 40) bolnikov.
English: What benefits of Adcetris have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Adcetris izkazalo v študijah?
English: The study compared treatment with Adcetris and treatment with another appropriate medicine (methotrexate or bexarotene).
Slovenian: V študiji so zdravilo Adcetris primerjali z zdravljenjem z drugim ustreznim zdravilom (metotreksatom ali beksarotenom).
English: For 23% of these patients (9 out of 40) a complete response was observed.
Slovenian: Pri 23 % (9 od 40) bolnikov so poročali o popolnem odzivu.
English: The recommended dose depends on body weight and whether Adcetris is given with other cancer medicines.
Slovenian: Priporočeni odmerek je odvisen od telesne mase in tega, ali se zdravilo Adcetris daje skupaj z drugimi zdravili za zdravljenje raka.
English: Adcetris is a cancer medicine used to treat adults with Hodgkin's lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system).
Slovenian: Adcetris je zdravilo za zdravljenje raka, ki se uporablja pri odraslih s Hodgkinovim limfomom (vrsto raka, ki izhaja iz krvnih celic limfnega sistema, tj. dela imunskega sistema).
English: For the full list of all side effects with Adcetris, including side effects when used with doxorubicin, vinblastine and dacarbazine, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Adcetris, vključno z neželenimi učinki, kadar se uporablja skupaj z doksorubicinom, vinblastinom in dakarbazinom, glejte navodilo za uporabo.
English: • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) that has not been treated before;
Slovenian: • skupaj z doksorubicinom, vinblastinom in dakarbazinom (drugimi zdravili za zdravljenje raka) pri bolnikih s Hodgkinovim limfomom, katerih bolezen je v IV. stadiju (napredovali rak, ki se je razširil na druge dele telesa), ki še niso bili zdravljeni;
English: In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit.
Slovenian: Poleg tega je dajanje zdravila Adcetris bolnikom, ki so jim presadili avtologne matične celice in za katere se šteje, da so izpostavljeni tveganju za napredovanje ali ponovni pojav raka, izkazalo jasno klinično korist.
English: • when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used.
Slovenian: • če se je rak ponovil ali se ni odzval na vsaj dve drugi zdravljenji in če avtologne presaditve matičnih celic ali kemoterapije z več zdravili (kombinacijo zdravil za zdravljenje raka) ni mogoče opraviti.
English: Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts (tests of the number of blood cells) before every dose of Adcetris.
Slovenian: Bolnike je treba med infundiranjem in po njem spremljati glede pojava določenih neželenih učinkov, pred vsakim odmerkom zdravila Adcetris pa je treba pridobiti popolno krvno sliko bolnika.
English: Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:
Slovenian: Uporablja se, kadar so tumorske celice pozitivne na CD30 (na površini vsebujejo beljakovino, imenovano CD30), in se daje:
English: The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30).
Slovenian: Učinkovina v zdravilu Adcetris, brentuksimab vedotin, je narejena iz monoklonskega protitelesa CD30 (vrste beljakovine, ki se veže na CD30).
English: The company that markets the medicine will carry out a study on the benefits of the medicine in sALCL patients and a safety study in a larger population of HL and sALCL patients.
Slovenian: Podjetje, ki trži zdravilo, bo izvedlo študijo o koristih zdravila pri bolnikih s sistemskim anaplastičnim velikoceličnim limfomom in varnostno študijo na večji populaciji bolnikov s Hodgkinovim limfomom ter sistemskim anaplastičnim velikoceličnim limfomom.
English: In a main study of 1334 patients with CD30-positive HL who had not received previous treatment, Adcetris was compared with bleomycin (another HL medicine) when each was given with other cancer medicines (doxorubicin, vinblastine and dacarbazine).
Slovenian: V glavni študiji s 1 334 bolniki s Hodgkinovim limfomom, pozitivnim na CD30, ki niso prejemali predhodnega zdravljenja, so zdravilo Adcetris primerjali z bleomicinom (drugim zdravilom za zdravljenje te bolezni), kadar se je posamezno zdravilo dajalo skupaj z drugim zdravilom za zdravljenje raka (doksorubicinom, vinblastinom in dakarbazinom).
English: • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;
Slovenian: • sistemskega anaplastičnega velikoceličnega limfoma (sALCL, tj. raka belih krvnih celic, imenovanih limfociti T, pozitivnega na CD30), če je se rak ponovil ali se ni odzval na druga zdravljenja;
English: For the full list of all restrictions with Adcetris, see the package leaflet.
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes that initially affects the skin, in patients who have received at least one previous treatment.
Slovenian: • kutanega T-celičnega limfoma, pozitivnega na CD30 (CTCL), tj. limfoma limfocitov T, ki prvotno prizadene kožo, pri bolnikih, ki so prejeli vsaj eno predhodno zdravljenje.
English: Adcetris can only be obtained with a prescription, and it should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Slovenian: Predpisovanje in izdaja zdravila Adcetris je le na recept, dajati pa se sme samo pod nadzorom zdravnika z izkušnjami z zdravljenjem raka.
English: In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).
Slovenian: V študiji z bolniki s sistemskim anaplastičnim velikoceličnim limfomom se je 86 % (50 od 58) bolnikov deloma ali popolnoma odzvalo na zdravljenje, pri 59 % (34 od 58) bolnikov pa je bil odziv popoln.
English: In patients with CTCL, a clinically significant benefit was seen over treatment with bexarotene or methotrexate.
Slovenian: Pri bolnikih s sistemskim anaplastičnim limfomom velikih celic je bilo opaziti klinično pomembno korist v primerjavi z zdravljenjem z beksarotenom ali metotreksatom.
English: The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, and the cancer cells eventually die.
Slovenian: Monoklonsko protitelo prenese monometil avristatin E do rakavih celic, pozitivnih na CD30, ko pa enkrat dospe v rakave celice, prepreči njihovo delitev, zaradi česar rakave celice sčasoma odmrejo.
English: The European Medicines Agency noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy.
Slovenian: Evropska agencija za zdravila je zaključila, da je kljub omejenim podatkom in dejstvu, da v študijah zdravila Adcetris niso primerjali s kontrolnim zdravljenjem, to zdravilo koristno za bolnike s Hodgkinovim limfomom in sistemskim anaplastičnim limfomom velikih celic, pri katerih se je rak ponovil ali se na zdravljenje niso odzvali.
English: How is Adcetris used?
Slovenian: Kako se zdravilo Adcetris uporablja?
English: How does Adcetris work?
Slovenian: Kako zdravilo Adcetris deluje?
English: In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least 2 prior therapies and who were not eligible for autologous stem cell transplant or multi-agent chemotherapy.
Slovenian: Poleg tega je podjetje zagotovilo podatke raziskav pri 40 bolnikih s Hodgkinovim limfomom, pozitivnim na CD30, pri katerih se je rak ponovil ali se niso odzvali na vsaj dve predhodni zdravljenji oziroma niso bili primerni za avtologno presaditev matičnih celic ali kemoterapijo z več zdravili.
English: The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule.
Slovenian: Monoklonsko protitelo se veže na monometil avristatin E, tj. citotoksično molekulo (molekulo, ki uničuje celice).
English: Previously untreated patients with advanced HL also benefited from Adcetris used in combination with other cancer medicines.
Slovenian: Korist zdravila Adcetris je bila izkazana tudi pri predhodno nezdravljenih bolnikih z napredovalim Hodgkinovim limfomom, kadar se to uporablja v kombinaciji z drugimi zdravili za zdravljenje raka.
English: In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.
Slovenian: V še eni glavni študiji so zdravilo Adcetris primerjali s placebom (zdravilom brez učinkovine) pri 329 bolnikih s Hodgkinovim limfomom, pozitivnim na CD30, pri katerih je bila opravljena presaditev avtolognih matičnih celic in ki so izpostavljeni povečanemu tveganju za napredovanje ali ponoven pojav raka.
English: Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment.
Slovenian: Zdravilo Adcetris so proučevali pri 58 bolnikih s sistemskim anaplastičnim velikoceličnim limfomom, pri katerih se je rak ponovil ali se na zdravljenje ni odzval.
English: Adcetris contains the active substance brentuximab vedotin.
Slovenian: Zdravilo Adcetris vsebuje učinkovino brentuksimab vedotin.
English: Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment.
Slovenian: Zdravilo Adcetris se je izkazalo za učinkovito pri zdravljenju kutanega T-celičnega limfoma, pozitivnega na CD30, v glavni študiji s 128 bolniki, ki so imeli to bolezen in so prejeli vsaj eno predhodno zdravljenje.
English: In another main study, Adcetris was used in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment.
Slovenian: V drugi glavni študiji so zdravilo Adcetris proučevali pri 102 bolnikih s Hodgkinovim limfomom, pozitivnim na CD30, ki so predhodno že prejeli zdravljenje z avtologno presaditvijo matičnih celic, vendar se je rak ponovil ali se na prejšnje zdravljenje ni odzval.
English: Cutaneous T-cell lymphoma
Slovenian: Kutani T-celični lifmom
English: Strength Pharmaceutical form
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: EU number
Slovenian: Številka (EU) dovoljenja za promet
English: The virus has first been inactivated (killed) so that it does not cause any disease.
Slovenian: Virus je bil najprej inaktiviran (uničen), tako da ne povzroča bolezni.
English: This will help to protect against the disease caused by the virus.
Slovenian: To lahko prispeva k obrambi pred boleznijo, ki jo ta virus povzroča.
English: Pandemrix was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Slovenian: Zdravilo Pandemrix je prvotno pridobilo dovoljenje v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemrix on 20 May 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pandemrix, veljavno po vsej Evropski uniji, izdala 20. maja 2008.
English: Side effects are similar in children.
Slovenian: Pri otrocih prihaja do podobnih neželenih učinkov.
English: The full EPAR for Pandemrix 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 Pandemrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains parts of influenza (flu) viruses that have been inactivated.
Slovenian: Vsebuje delce virusov influence (gripe), ki so bili inaktivirani.
English: The resulting ‘emulsion' is then injected.
Slovenian: Tako dobljena „emulzija“ se nato injicira.
English: What measures are being taken to ensure the safe and effective use of Pandemrix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pandemrix?
English: In all of the studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
Slovenian: V vseh študijah je bilo dokazano, da cepivo povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil odbor CHMP.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Vehikel vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
English: Six main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response in the following groups (the numbers given are for those who received Pandemrix in the studies):
Slovenian: Izvedenih je bilo šest glavnih študij, v katerih so proučevali sposobnost cepiva, da po shemi dveh odmerkov sproži imunski odziv pri naslednjih skupinah (navedene številke veljajo za tiste osebe, ki so v študijah prejele zdravilo Pandemrix):
English: The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults (including the elderly), adolescents and children from 10 years of age.
Slovenian: Ta je poudaril, da je enojni odmerek sprožil imunost na zadovoljivi ravni pri odraslih (vključno s starostniki), mladostnikih in otrocih, starejših od 10 let.
English: Vaccination should be postponed in subjects with severe fever or an acute (short-lived) infection.
Slovenian: Cepljenje je treba prestaviti pri osebah z močno povišano telesno temperaturo ali akutno (kratkotrajno) okužbo.
English: For more information about treatment with Pandemrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pandemrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This document is a summary of the European Public Assessment Report (EPAR) for Pandemrix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pandemrix.