FrancophonIA/ELRC3.0 huggingface dataset:
English: On 14 November 2016, Erytech Pharma SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia.
Slovenian: Družba Erytech Pharma SA je 14. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Graspa, namenjenim zdravljenju akutne limfoblastne levkemije.
English: Because asparaginase is a protein,
Slovenian: Ker je asparaginaza beljakovina, lahko
English: The company provided data on Graspa, including the results of a main study involving 80 patients with ALL whose disease had come back after initial treatment or who had not responded to initial treatment, some of whom had an allergy to other products containing asparaginase.
Slovenian: Družba je predložila podatke o zdravilu Graspa, vključno z rezultati glavne študije, ki je vključevala 80 bolnikov z ALL, pri katerih se je bolezen po začetnem zdravljenju ponovila ali ki se niso odzvali na začetno zdravljenje, med njimi pa so imeli nekateri alergijo na druga zdravila, ki vsebujejo asparaginazo.
English: The CHMP was concerned about the way the effectiveness of the medicine had been measured in the main study, and whether the results of this study could be extended to patients taking other combinations of cancer medicines.
Slovenian: Odbor CHMP je izrazil zaskrbljenost zaradi načina merjenja učinkovitosti zdravila v glavni študiji in vprašanja, ali se rezultati te študije lahko uporabijo tudi pri bolnikih, ki uporabljajo druge kombinacije zdravil za zdravljenje raka.
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells.
Slovenian: Zdravilo Graspa naj bi se uporabljalo v kombinaciji z drugimi zdravili za zdravljenje raka, in sicer za zdravljenje odraslih in otrok, starejših od enega leta, ki imajo akutno limfoblastno levkemijo (ALL), vrsto raka belih krvnih celic.
English: Withdrawal of the marketing authorisation application for Graspa (eryaspase)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (eriaspaza)
English: The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment.
Slovenian: Uporabljalo naj bi se pri bolnikih, pri katerih je rak negativen za kromosom Philadelphia in ki se niso odzvali na začetno zdravljenje oziroma so se po zdravljenju vrnili.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Graspa.
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL.
Slovenian: Zdravilo Graspa je bilo 26. oktobra 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje ALL.
English: Cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
Slovenian: Rakave celice to aminokislino potrebujejo za rast in razmnoževanje, zato upad njene ravni v krvi povzroči odmrtje teh celic.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker dodatnih podatkov, ki so po mnenju odbora CHMP potrebni za podporo vlogi, ne more pridobiti v razpoložljivem času.
English: Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group).
Slovenian: Graspa je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino eriaspazo (različico encima asparaginaze, vključeno v rdeče krvne celice, ki so združljive z bolnikovo krvno skupino).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Graspa.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Graspa.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Graspa ni mogoče odobriti za zdravljenje ALL.
English: The asparaginase in Graspa is enclosed in red blood cells with the intention of helping protect the enzyme from being broken down in the body.
Slovenian: Asparaginaza v zdravilu Graspa je vključena v rdeče krvničke, ki encim ščitijo pred razgradnjo v telesu.
English: The asparaginase in Graspa works by breaking up and reducing the blood levels of the amino acid asparagine.
Slovenian: Asparaginaza v zdravilu Graspa deluje tako, da razgrajuje aminokislino asparagin in zmanjšuje njeno koncentracijo v krvi.
English: * efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
Slovenian: * efavirenz / emtricitabin / tenofovirdizoproksil (v obliki fumarata)
English: 600 mg/200 mg/245 mg * 600 mg/200 mg/245 mg *
Slovenian: 600 mg/200 mg/245 mg * Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE/alu) 30 filmsko obloženih tablet
English: Atripla Atripla
Slovenian: Ovojnina
English: 3 x 30 film-coated tablets
Slovenian: 600 mg/200 mg/245 mg * Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE/alu) 3 x 30 filmsko obloženih tablet
English: The full EPAR for Docetaxel Accord 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 Docetaxel Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Docetaxel Accord is given as a one-hour infusion every three weeks.
Slovenian: Zdravilo Docetaxel Accord se daje kot enourna infuzija vsake tri tedne.
English: For more information on generic medicines, see the question-and-answer document here.
Slovenian: Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
English: Docetaxel Accord is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Slovenian: Zdravilo Docetaxel Accord se uporablja le, kadar je število nevtrofilcev (raven vrste belih krvnih celic) normalno (vsaj 1 500 celic/mm3).
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Accord.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Slovenian: • raka prostate, kadar se ta ne odziva na hormonsko zdravljenje.
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Slovenian: Dokler je ogrodje postavljeno, se celice ne morejo deliti in sčasoma odmrejo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Accord, veljavno po vsej Evropski uniji, odobrila dne 22. maja 2012.
English: This means that Docetaxel Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
English: Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Docetaxel Accord generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Accord primerljivo z zdravilom Taxotere.
English: Docetaxel Accord docetaxel
Slovenian: Docetaxel Accord docetaksel
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Slovenian: • raka glave in vratu pri bolnikih, pri katerih je rak lokalno napredoval (rakava tvorba je zrasla, vendar se še ni razširila po telesu).
English: For more information about treatment with Docetaxel Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Docetaxel Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Docetaxel Accord.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Docetaxel Accord, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Docetaxel Accord is used to treat the following types of cancer:
Slovenian: Zdravilo Docetaxel Accord se uporablja za zdravljenje naslednjih vrst raka:
English: What are the benefits and risks of Docetaxel Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Accord?
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion.
Slovenian: Bolniku je treba dati tudi protivnetno zdravilo, kot je na primer deksametazon, in sicer dan pred infuzijo zdravila Docetaxel Accord.
English: Docetaxel Accord can be used on its own after other treatments have failed.
Slovenian: Zdravilo Docetaxel Accord se lahko uporablja kot samostojno zdravilo, kadar druge oblike zdravljenja niso bile uspešne.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Slovenian: Prav tako se lahko uporablja sočasno z drugimi zdravili proti raku (doksorubicinom, ciklofosfamidom, trastuzumabom ali kapecitabinom) pri bolnikih, ki se še niso zdravili proti raku ali pri katerih so bile druge oblike zdravljenja neuspešne, odvisno od vrste in stadija raka dojke, ki se zdravi;
English: The Committee recommended that Docetaxel Accord be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Docetaxel Accord odobri dovoljenje za promet.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil.
Slovenian: Zdravilo Docetaxel Accord se uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: Docetaxel Accord should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Slovenian: Zdravilo Docetaxel Accord se sme uporabljati samo na specializiranih oddelkihza kemoterapijo (uporabo zdravil za zdravljenje raka) in le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije.
English: Other information about Docetaxel Accord
Slovenian: Druge informacije o zdravilu Docetaxel Accord
English: Docetaxel Accord is a ‘generic medicine'.
Slovenian: Zdravilo Docetaxel Accord je „generično zdravilo“.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Slovenian: • adenokarcinoma želodca (vrste raka na želodcu) pri bolnikih, ki se zaradi raka še niso zdravili.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Slovenian: Docetaksel učinkuje tudi na nerakave celice, kot sokrvne celice, kar lahko povzroči neželene učinke.
English: The active substance in Docetaxel Accord, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Slovenian: Zdravilna učinkovina v zdravilu Docetaxel Accord, docetaksel, spada v skupino zdravil proti raku, imenovani taksani.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Slovenian: Zdravilo Docetaxel Accord se uporablja v kombinaciji s cisplatinom in 5-fluorouracilom (drugima zdraviloma za zdravljenje raka);
English: Docetaxel Accord is a medicine that contains the active substance docetaxel.
Slovenian: Docetaxel Accord je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
English: The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere.
Slovenian: Poleg tega je predstavila tudi dokaze o tem, da je kakovost raztopine za infundiranje Docetaxel Accord primerljiva z zdravilom Taxotere.
English: Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines);
Slovenian: Zdravilo Docetaxel Accord se uporablja sočasno s prednizonom ali prednizolonom (protivnetnima zdraviloma);
English: Why has Docetaxel Accord been approved?
Slovenian: Zakaj je bilo zdravilo Docetaxel Accord odobreno?
English: No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Slovenian: Ker je zdravilo Docetaxel Accord generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile potrebne nobene dodatne študije.
English: How has Docetaxel Accord been studied?
Slovenian: Kako je bilo zdravilo Docetaxel Accord raziskano?
English: What is Docetaxel Accord?
Slovenian: Kaj je zdravilo Docetaxel Accord?
English: How does Docetaxel Accord work?
Slovenian: Kako zdravilo Docetaxel Accord deluje?
English: What is Docetaxel Accord used for?
Slovenian: Za kaj se zdravilo Docetaxel Accord uporablja?
English: How is Docetaxel Accord used?
Slovenian: Kako se zdravilo Docetaxel Accord uporablja?
English: Annually within the annual reassessment
Slovenian: Letno v okviru letne ponovne ocene
English: One, five, ten vials
Slovenian: ena, pet, deset vial
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015
Slovenian: Datum prve odobritve: 11. november 2015
English: Your doctor will also check if the bleeding is adequately controlled.
Slovenian: Preveril bo tudi, ali je krvavitev zadostno obvladovana.
English: Before starting reconstitution you will need the following:
Slovenian: Preden začnete rekonstitucijo, morate pripraviti naslednje:
English: The length of treatment depends on clinical judgement.
Slovenian: Trajanje zdravljenja je odvisno od klinične presoje.
English: The educational programme is aimed to minimize the risk of dose dispensing errors.
Slovenian: Cilj izobraževalnega programa je zmanjšati tveganja za napake pri izdajanju odmerkov.
English: Initial Phase
Slovenian: Začetna faza
English: Those with pre-existing cardiovascular disease and the elderly are at particular risk.
Slovenian: Še posebej so ogroženi bolniki z obstoječim kardiovaskularnimi boleznimi in starejše osebe.
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka je treba upoštevati standardno medicinsko zdravljenje šoka.
English: Use in children and adolescents
Slovenian: Otroci in mladostniki
English: 500 U
Slovenian: 500 e.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so bile ocenjene v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The maximum blood FVIII activity must not exceed 200%.
Slovenian: Največja aktivnost faktorja VIII v krvi ne sme preseči 200 %.
English: EU/1/15/1035/002
Slovenian: EU/1/15/1035/001 EU/1/15/1035/002 EU/1/15/1035/003
English: A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
Slovenian: Pozitiven odziv so po 8 urah ugotovili pri 95 % (19/20) preiskovancih, po 16 urah pa pri 100 % (18/18).
English: • Health care professional brochure including a detailed calculation of number of vials for a patient weighing for example 70 kg
Slovenian: • Brošuro za zdravstvene delavce, vključno s podrobnim izračunom števila vial za bolnike, ki tehtajo na primer 70 kg.
English: The healthcare professionals training material shall contain the following key elements:
Slovenian: Izobraževalno gradivo za usposabljanje zdravstvenih delavcev mora vsebovati naslednje ključne elemente:
English: It is a glycoprotein.
Slovenian: Je glikoprotein.
English: The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H2O.
Slovenian: Osmolalnost pufra formulacije je v razponu od 59 in 65 10 % mOsm/kg H2O.
English: If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered.
Slovenian: Če je potreben venski kateter, je treba upoštevati tveganje zapletov, povezanih s katetrom, kot je na primer tromboza na mestu katetra.
English: <This leaflet is available in all EU/EEA languages on the European Medicines Agency website.>
Slovenian: <To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.>
English: If any of these symptoms occur, the injection should be stopped.
Slovenian: Če opazite katerega koli izmed teh simptomov, je treba prekiniti injiciranja.
English: If severe and sudden allergic reactions occur, the injection must be stopped immediately.
Slovenian: Če se pojavi huda in nenadna alergijska reakcija, nemudoma prekinite injiciranje zdravila.
English: Efficacy and safety data in patients with acquired haemophilia are limited (see section 5.1).
Slovenian: Podatki o učinkovitost in varnosti za bolnike s pridobljeno hemofilijo so omejeni (glejte poglavje 5.1).
English: Initial Dose (Units per kg)
Slovenian: Začetni odmerek (enot na kg)
English: Severe symptoms, including difficulty in breathing and (near) fainting, require emergency treatment.
Slovenian: Hudi simptomi, med katere sodijo težave z dihanjem in (grozečo) izgubo zavesti, zahtevajo nujno medicinsko zdravljenje.
English: For intravenous injection only!
Slovenian: Samo za intravensko injiciranje!
English: Frequency and Duration of Subsequent Dosing
Slovenian: Pogostnost in trajanje naslednjih odmerkov
English: A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with Factor VIII activity above a pre-specified target.
Slovenian: Pozitiven odziv je bil opredeljen z ustavitvijo ali zmanjšanjem krvavitve s kliničnim izboljšanjem ali aktivnostjo faktorja VIII nad vnaprej določeno ciljno vrednostjo.
English: Extensive cutaneous purpura do not necessarily require treatment.
Slovenian: Za obsežno kožno purpuro zdravljenje običajno ni potrebno.
English: Activated Factor VIII acts as a co-factor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X, which ultimately converts prothrombin into thrombin.
Slovenian: Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospeši pretvorbo faktorja X v aktivirani faktor X, ta pa pretvarja protrombin v trombin.
English: • The healthcare professionals training material
Slovenian: • Izobraževalno gradivo za usposabljanje zdravstvenih delavcev
English: The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials.
Slovenian: Postopek izdelave ne vključuje humanega seruma, produktov iz humanih beljakovin in drugih snovi, pridobljenih iz živali.
English: Dose every 4 to 12 hours, frequency may be adjusted based on clinical response and measured Factor VIII activity
Slovenian: Odmerjanje vsakih 4 do 12 ur, pogostnost se lahko prilagodi glede na klinični odziv in meritve aktivnosti faktorja VIII
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodnja preglednica je pripravljena v skladu s klasifikacijo organskih sistemov MedDRA (SOC in prednostni termini).
English: Baxalta US, Inc 27 Maple Street Milford
Slovenian: Baxalta US, Inc Baxter Milford 27 Maple Street Milford
English: The Factor VIII/von Willebrand factor complex consists of two molecules (Factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja je sestavljen iz dveh molekul (faktorja VIII in von Willebrandovega faktorja), ki imata različne fiziološke funkcije.
English: Healing phase
Slovenian: Faza zdravljenja
English: The dose and frequency of administration should be based on results of Factor VIII activity (to be maintained within recommended limits) and on the clinical response achieved.
Slovenian: Odmerek in pogostnost uporabe določite glede na rezultate aktivnosti faktorja VIII (da se ta ohrani v priporočenih mejah) in na doseženi klinični odziv.
English: OBIZUR is indicated in adults.
Slovenian: Zdravilo OBIZUR je indicirano za odrasle.
English: Major moderate to severe intramuscular, retroperitoneal, gastrointestinal, intracranial bleeding
Slovenian: Poglavitna zmerna do resna intramuskularna, retroperitonealna, gastrointestinalna, intrakranialna krvavitev
English: Positive test for inhibitory antibodies against porcine Factor VIII (see section 4.4)
Slovenian: Preiskave pozitiven rezultat testa za inhibitorna protitelesa proti prašičjemu faktorju VIII (glejte poglavje 4.4)
English: Use in children and adolescents below 18 years with congenital or in rare cases of acquired haemophilia is currently not approved.
Slovenian: Uporaba pri otrocih in mladostnikih, mlajših od 18 let, s prirojeno hemofilijo ali v redkih primerih pridobljeno hemofilijo trenutno ni odobrena.
English: Your doctor will calculate your dose of OBIZUR (in units or U) depending on your condition and body weight.
Slovenian: Zdravnik bo izračunal vaš odmerek zdravila OBIZUR (v enotah ali e.), pri čemer bo upošteval vaše stanje in telesno maso.
English: In addition to response to treatment, the overall treatment success was determined by the investigator based on his/her ability to discontinue or reduce the dose and/or dosing frequency of OBIZUR.
Slovenian: Poleg odziva na zdravljenje so raziskovalci ugotavljali skupno uspešnost zdravljenja na osnovi možnosti prekinitve ali zmanjšanja odmerka in/ali pogostnosti odmerjanja zdravila OBIZUR.