FrancophonIA/ELRC3.0 huggingface dataset:
English: PecFent must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Croatian: PecFent se ne smije primjenjivati u bolesnika koji već ne uzimaju opioide za održavanje kontrole nad bolovima, koji pate od teške respiratorne depresije (inhibicije disanja) ili koji imaju kronične opstruktivne bolesti pluća (bolesti koje ozbiljno ometaju disanje).
English: PecFent is a medicine used to treat breakthrough pain in adult patients with cancer.
Croatian: PecFent je lijek koji se koristi za liječenje probijajuće boli u odraslih bolesnika s rakom.
English: While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.
Croatian: Dok se referentni lijekovi Effentora (bukalne tablete) i Actiq (pastile) uzimaju peroralno, PecFent se primjenjuje kao sprej za nos.
English: Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Croatian: Kod primjene lijeka PecFent mogu se očekivati tipične nuspojave liječenja opiodima; ove nuspojave često prestaju ili postaju blaže kod kontinuirane primjene lijeka.
English: An additional study measured the ‘acceptability' of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use.
Croatian: Dodatnim ispitivanjem izmjerena je „prihvatljivost” lijeka PecFent od strane bolesnika, koji su ocijenili koliko su zadovoljni lijekom PecFent te smatraju li primjenu jednostavnom i praktičnom.
English: PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Croatian: PecFent se primjenjuje u bolesnika koji već uzimaju opioide (skupinu analgetika koja obuhvaća morfin i fentanil) za kontrolu dugotrajne boli povezane s rakom.
English: Treatment with PecFent should be started by and remain under the supervision of a doctor who has experience in managing opioid treatment in cancer patients.
Croatian: Liječenje lijekom PecFent trebao bi započeti i nadzirati liječnik s iskustvom u upravljanju liječenjem opioidima u bolesnika s rakom.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Croatian: Nakon što uđe u krvotok, fentanil djeluje na receptore u mozgu i leđnoj moždini u svrhu ublažavanja boli.
English: What benefits of PecFent have been shown in studies?
Croatian: Koje su koristi od lijeka PecFent utvrđene u ispitivanjima?
English: PecFent contains the active substance fentanyl.
Croatian: PecFent sadrži djelatnu tvar fentanil.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Croatian: Probijajuća bol je dodatna, nagla bol koja se javlja unatoč tome što se bolesnik već liječi analgeticima.
English: In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids.
Croatian: U jednom glavnom ispitivanju provedenom na 83 odrasle osobe liječene opiodima pokazalo se da je PecFent učinkovitiji od placeba (prividnog liječenja) u liječenju probijajuće boli uzrokovane rakom.
English: How does PecFent work?
Croatian: Kako djeluje PecFent?
English: The active substance in PecFent, fentanyl, is an opioid.
Croatian: Fentanil, djelatna tvar u lijeku PecFent, je opioid.
English: How is PecFent used?
Croatian: Kako se PecFent primjenjuje?
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja vezanih za primjenu potražite u uputi o lijeku.
English: For the full list of side effects reported with PecFent, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka PecFent potražite u uputi o lijeku.
English: Patients should be closely monitored for these side effects.
Croatian: Bolesnike valja motriti zbog mogućnosti nuspojava.
English: This is expected to reduce the number and
Croatian: Očekuje se da će se time smanjiti broj i
English: What is Begedina?
Croatian: Što je Begedina?
English: In addition, the safety profile and the way the medicine is expected to work in the body had not been sufficiently characterised.
Croatian: Nadalje, sigurnosni profil i očekivano djelovanje lijeka u organizmu nisu opisani u dostatnoj mjeri.
English: There were also deficiencies identified in the manufacturing process of the medicine.
Croatian: Također su utvrđeni nedostaci u postupku proizvodnje lijeka.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it acknowledges the need to obtain additional data from a confirmatory study.
Croatian: U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je potvrdila da postoji potreba za podnošenjem dodatnih podataka iz potvrdnog ispitivanja.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Begedina (begelomab)
English: The medicine was for use in patients whose disease did not respond to treatment with steroids.
Croatian: Lijek se trebao primjenjivati u bolesnika čija bolest nije reagirala na liječenje steroidima.
English: In the studies, Begedina was not compared with any other treatment.
Croatian: U tim ispitivanjima lijek Begedina nije uspoređen niti s jednom drugom terapijom.
English: Begedina was expected to be used for the treatment of acute graft-versus-host disease (a condition in which transplanted cells attack the patient's body) in adults who have had haematopoietic progenitor cell transplantation (transplant of cells that can develop into different types of blood cells) from a donor.
Croatian: Lijek Begedina trebao se koristiti za liječenje akutne reakcije presatka protiv primatelja (stanja u kojem presađene stanice napadaju bolesnikovo tijelo) u odraslih primatelja transplantacije matičnih krvotvornih stanica (transplantacije stanica koje se mogu razviti u različite vrste krvnih stanica) od darivatelja.
English: Begedina is a medicine that contains the active substance begelomab.
Croatian: Begedina je lijek koji sadrži djelatnu tvar begelomab.
English: The company presented the results of two studies with Begedina involving a total of 29 adults with acute graft-versus-host disease that did not respond to steroid treatment.
Croatian: Tvrtka je dostavila rezultate dvaju ispitivanja lijeka Begedina u kojima je sudjelovalo ukupno 29 odraslih osoba s akutnom reakcijom presatka protiv primatelja koja nije reagirala na liječenje steroidima.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. srpnja 2016. EMA/579451/2016 EMEA/H/C/004144
English: The active substance in Begedina, begelomab, is a monoclonal antibody (a type of protein) that has been designed to attach itself to a receptor called CD26, which is present on T cells.
Croatian: Djelatna tvar u lijeku Begedina, begelomab, monoklonsko je protutijelo (vrsta proteina) namijenjeno tomu da se veže na receptor CD26 koji se nalazi u T-stanicama.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Begedina.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Begedina.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Croatian: Lijek je trebao biti dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
English: The CHMP considered that the data provided were insufficient to demonstrate a beneficial effect of Begedina.
Croatian: CHMP je smatrao da dostavljeni podaci nisu bili dostatni kako bi se dokazao povoljan učinak lijeka Begedina.
English: activity of T cells from the transplant that attack the patient's organs, thereby helping to control graftversus-host disease.
Croatian: aktivnost T-stanica iz transplantata koje napadaju organe bolesnika, čime se pridonosi kontroli reakciji presatka protiv primatelja.
English: EMA/579473/2016 EMEA/H/C/004144
Croatian: (begelomab) EMA/579451/2016
English: Begedina was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 November 2010 for treatment of graft-versus-host disease.
Croatian: Lijek Begedina bio je označen kao lijek za liječenje rijetkih bolesti 26. studenoga 2010. za liječenje reakcije presatka protiv primatelja.
English: Based on the review of the available data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Begedina could not have been approved for the treatment of acute graft-versus-host disease that did not respond to steroid treatment.
Croatian: Na temelju pregleda podataka u trenutku povlačenja, CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Begedina za liječenje akutne reakcije presatka protiv primatelja koja nije reagirala na liječenje steroidima.
English: By attaching to CD26, this medicine is expected to reduce the rate at which the T cells multiply.
Croatian: Očekuje se da će ovaj lijek vezivanjem na receptor CD26 smanjiti brzinu umnožavanja T-stanica.
English: What was Begedina expected to be used for?
Croatian: Za što se lijek Begedina trebao koristiti?
English: How was Begedina expected to work?
Croatian: Kako je lijek Begedina trebao djelovati?
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 Begedina.
Croatian: Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao da tvrtka nije dostavila dostatne podatke koji bi poduprli zahtjev za lijek Begedina.
English: These are a type of white blood cells that play a role in graft-versus-host disease.
Croatian: T-stanice vrsta su bijelih krvnih stanica koje imaju ulogu u reakciji presatka protiv primatelja.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.
Croatian: Dana 4. srpnja 2016., društvo Adienne S.r.l. S.U. službeno je obavijestilo Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Begedina za liječenje reakcije presatka protiv primatelja.
English: --1 Inactivated Coxiella burnetii, strain Nine Mile: ≥72 QF Units*/ml.
Croatian: --1 Inaktivirana Coxiella burnetii, soj Nine Mile: ≥72 QF jedinica*/ml.
English: * QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Croatian: *QF (Q groznica) jedinica: relativna potencija faze I antigena izmjerenog ELISA testom u usporedbi s referentnom vrijednošću
English: The average duration of response to treatment was 17.5 months.
Croatian: Prosječno trajanje reakcije na liječenje bilo je 17,5 mjeseci.
English: Further information on Imbruvica can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/imbruvica .
Croatian: Više informacija o lijeku Imbruvica nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/imbruvica.
English: This overview was last updated in 09-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 09. 2019.
English: Imbruvica is available as capsules (140 mg) and tablets (140, 280, 420 and 560 mg).
Croatian: Lijek Imbruvica dostupan je u obliku kapsula (140 mg) i tableta (140, 280, 420 i 560 mg).
English: The side effects of the medicine were considered acceptable.
Croatian: Nuspojave lijeka smatrale su se prihvatljivima.
English: What is Imbruvica and what is it used for?
Croatian: Što je Imbruvica i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Imbruvica?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imbruvica?
English: Other information about Imbruvica
Croatian: Ostale informacije o lijeku Imbruvica
English: Imbruvica received a marketing authorisation valid throughout the EU on 21 October 2014.
Croatian: Lijek Imbruvica dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 21. listopada 2014.
English: What are the risks associated with Imbruvica?
Croatian: Koji su rizici povezani s lijekom Imbruvica?
English: If the patient is taking other medicines that may interact with Imbruvica, or gets severe side effects, the dose may be lowered or treatment interrupted.
Croatian: Ako bolesnik uzima druge lijekove koji mogu utjecati na djelovanje lijeka Imbruvica ili ako se razviju ozbiljne nuspojave, doza se može smanjiti ili se liječenje može privremeno prekinuti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imbruvica have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Imbruvica također se nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency decided that Imbruvica's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Imbruvica nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Treatment with Imbruvica should continue for as long as the disease improves or remains stable and the side effects are tolerable.
Croatian: Terapija lijekom Imbruvica može se nastaviti sve dok se stanje poboljšava ili ostaje stabilno, a nuspojave su podnošljive.
English: Chronic lymphocytic leukaemia
Croatian: Kronična limfocitna leukemija
English: Side effects reported with Imbruvica are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Imbruvica pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Imbruvica can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in using cancer medicines.
Croatian: Imbruvica se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: An overview of Imbruvica and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Imbruvica i zašto je odobren u EU-u
English: These diseases are rare, and Imbruvica was designated an ‘orphan medicine' (a medicine used in rare diseases) for chronic lymphocytic leukaemia on 26 April 2012, mantle cell lymphoma on 12 March 2013 and Waldenström's macroglobulinaemia on 29 April 2014.
Croatian: Ove su bolesti rijetke, a lijek Imbruvica dobio je status „lijeka za rijetku bolest” za kroničnu lifmocitnu leukemiju 26. travnja 2012., limfom plaštenih stanica 12. ožujka 2013. i Waldenströmovu makroglobulinemiju 29. travnja 2014.
English: The most serious side effects are neutropenia, pneumonia (lung infection) and thrombocytopenia.
Croatian: Najozbiljnije nuspojave su neutropenija, upala pluća (pneumonija) i trombocitopenija.
English: The most common side effects with Imbruvica (which may affect more than 1 in 5 people) are diarrhoea, neutropenia (low levels of neutrophils, a type of white blood cell), pain in muscles and bones, haemorrhage (bleeding), bruising, rash, feeling sick and thrombocytopenia (low blood platelet counts).
Croatian: Najčešće nuspojave lijeka Imbruvica (koje se mogu javiti u više od 1 na 5 osoba) jesu proljev, neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica), bol u mišićima i kostima, hemoragija (krvarenje), modrice, osip, mučnina (slabost), vrućica i trombocitopenija (niska razine trombocita).
English: Why is Imbruvica authorised in the EU?
Croatian: Zašto je lijek Imbruvica odobren u EU-u?
English: St. John's wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica.
Croatian: Gospina trava (biljni lijek koji se koristi za liječenje depresije i anksioznosti) ne smije se koristiti u bolesnika koji primaju lijek Imbruvica.
English: For patients with mantle cell lymphoma the dose is 560 mg once a day, for patients with chronic lymphocytic leukaemia or Waldenström's macroglobulinaemia the usual dose of Imbruvica is 420 mg once a day.
Croatian: Za bolesnike s limfomom plaštenih stanica doza iznosi 560 mg jednom dnevno, dok za bolesnike s kroničnom limfocitnom leukemijom ili Waldenströmovom makroglobulinemijom uobičajena doza lijeka Imbruvica iznosi 420 mg jednom dnevno.
English: As for all medicines, data on the use of Imbruvica are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Imbruvica kontinuirano se prate.
English: It does this by blocking an enzyme called Bruton's tyrosine kinase (Btk), which promotes survival of B lymphocytes and their migration to the organs where these cells normally divide.
Croatian: Djeluje blokiranjem enzima naziva Brutonove tirozin kinaze (Btk), čime se potiče preživljenje B-limfocita i njihova migracija do organa u kojima uobičajeno nastupa dioba ovih stanica.
English: The active substance in Imbruvica, ibrutinib, works against cancerous B lymphocytes, a type of white blood cells.
Croatian: Djelatna tvar lijeka Imbruvica, ibrutinib, djeluje protiv kanceroznih B-limfocita, vrste bijelih krvnih stanica.
English: • mantle cell lymphoma in patients whose disease does not respond to or has come back after previous treatment;
Croatian: • limfoma plaštenih stanica u bolesnika čija bolest nije reagirala na liječenje ili se vratila nakon prethodnog liječenja;
English: In addition Imbruvica was shown to be effective in patients with Waldenström's macroglobulinaemia..
Croatian: Nadalje se lijek Imbruvica pokazao učinkovitim u bolesnika s Waldenströmovom makroglobulinemijom.
English: • chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
Croatian: • kronične limfocitne leukemije (KLL) u prethodno liječenih i neliječenih bolesnika;
English: The company that markets Imbruvica needs to provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients.
Croatian: Tvrtka koja lijek Imbruvica stavlja u promet treba dostaviti dodatne podatke o koristima od lijeka Imbruvica u liječenju kronične limfocitne leukemije iz kontrola prethodno liječenih bolesnika.
English: For more information about using Imbruvica, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Imbruvica pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Imbruvica is a medicine for treating adult patients with the following blood cancers:
Croatian: Imbruvica je lijek za liječenje sljedećih vrsta raka krvi u odraslih bolesnika:
English: Waldenström's macroglobulinaemia
Croatian: Waldenströmova makroglobulinemija
English: By blocking Btk, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.
Croatian: Inhibirajući Btk, ibrutinib smanjuje preživljenje i migraciju B-limfocita te na taj način odgađa napredovanje raka.
English: The average time before patients died or the disease got worse was 15 months with Imbruvica versus 6 months with temsirolimus.
Croatian: Prosječno vrijeme u kojem su bolesnici preminuli ili u kojem se bolest pogoršala iznosilo je 15 mjeseci u bolesnika liječenih lijekom Imbruvica, u odnosu na 6 mjeseci u bolesnika liječenih temsirolimusom.
English: In addition, Imbruvica was effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group of patients with poor prognosis and few other treatment options.
Croatian: Nadalje, lijek Imbruvica također je bio učinkovit u bolesnika s limfomom plaštenih stanica koji nisu reagirali na terapiju ili kod kojih se rak vratio nakon prethodne terapije, te u skupini bolesnika sa lošom prognozom i malim brojem drugih mogućnosti za terapiju.
English: A second study in 280 such patients compared Imbruvica with another cancer medicine, temsirolimus.
Croatian: U drugom ispitivanju kojim je obuhvaćeno 280 bolesnika lijek Imbruvica uspoređen je s drugim lijekom protiv raka, temsirolimusom.
English: Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in untreated patients and in those who had received treatment previously.
Croatian: Lijek Imbruvica pokazao se učinkovitim u usporavanju napredovanja kronične limfocitne leukemije u bolesnika koji prethodno nisu liječeni, kao i u prethodno liječenih bolesnika.
English: What benefits of Imbruvica have been shown in studies?
Croatian: Koje su koristi od lijeka Imbruvica utvrđene u ispitivanjima?
English: In a study in 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, 21% of patients taking Imbruvica had complete response (i.e. disappearance of all signs of cancer) and 47% had partial response (i.e. the patient improved but some signs of the disease remained).
Croatian: U ispitivanju na 111 bolesnika s limfomom plaštenih stanica koji nisu reagirali na prethodno liječenje ili kod kojih se rak vratio nakon prethodnog liječenja, 21 % bolesnika koji su primali lijek Imbruvica u potpunosti je reagiralo (tj. nestali su svi znakovi raka), a 47 % djelomično je reagiralo (tj. došlo je do poboljšanja, ali su neki znakovi bolesti ostali).
English: In one main study involving 63 patients who had previously received another treatment for Waldenström's macroglobulinaemia, the disease responded to treatment with Imbruvica in 87% of patients.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 63 bolesnika koji su prethodno primili drugu terapiju za Waldenströmovu makroglobulinemiju, 87 % bolesnika reagiralo je na terapiju lijekom Imbruvica.
English: Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström's disease.
Croatian: Reakcija na liječenje mjerena je smanjenjem razine bjelančevine IgM u krvi, čije su visoke razine prisutne u krvi kod bolesnika oboljelih od Waldenströmove makroglobulinemije.
English: Imbruvica contains the active substance ibrutinib.
Croatian: Imbruvica sadržava djelatnu tvar ibrutinib.
English: How does Imbruvica work?
Croatian: Kako djeluje Imbruvica?
English: In a study in 578 patients whose disease had not responded to or had come back after previous treatment, death or signs that the cancer was progressing occurred in 19% of patients (56 of 289) who took Imbruvica together with the cancer medicines bendamustine and rituximab compared with 63% (183 of 289) in those who took bendamustine and rituximab without Imbruvica.
Croatian: U ispitivanju provedenom na 578 bolesnika čija bolest nije reagirala na terapiju ili se ponovno pojavila nakon terapije, smrtni slučajevi ili znakovi napredovanja raka nastupili su u 19 % bolesnika (56 od 289) koji su primali lijek Imbruvica zajedno s lijekovima protiv raka bendamustinom i rituksimabom, u usporedbi sa 63 % (183 od 289) bolesnika koji su primali bendamustin i rituksimab bez lijeka Imbruvica.