FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the significance of the findings of the ERA 223 clinical trial, it was considered that they should be thoroughly reviewed in the context of all available data related to radium-223 dichloride (including evidence from non-authorised use that might impact the authorised use) in order to assess their potential impact on the benefit-risk balance of Xofigo in the authorised indication of the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Croatian: S obzirom na značaj rezultata kliničkog ispitivanja ERA 223, smatralo se da ih je potrebno temeljito pregledati u kontekstu svih dostupnih podataka vezanih uz radij-223 diklorid (uključujući dokaze iz neodobrene primjene koji mogu imati učinak na odobrenu primjenu) kako bi se procijenio njihov potencijalni učinak na omjer koristi i rizika lijeka Xofiga u odobrenoj indikaciji liječenja odraslih s rakom prostate otpornim na kastraciju, sa simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza.
English: The PRAC also considered other available data, including further data from the ALSYMPCA clinical trial submitted in support of the initial marketing authorisation, in relation to the potential impact of results of Study ERA 223 on the benefit-risk balance of radium Ra223 dichloride in its authorised indication.
Croatian: PRAC je također razmotrio ostale dostupne podatke, uključujući dodatne podatke iz kliničkog ispitivanja ALSYMPCA, dostavljene radi podupiranja inicijalnog odobrenja za stavljanje u promet, a povezane s potencijalnim učinkom rezultata ispitivanja ERA 223 o omjeru koristi i rizika radija RA-223 diklorida u njegovim odobrenim indikacijama.
English: In view of the seriousness of these results, the fact that they were observed in a patient population with earlier disease characteristics but partly overlapping with that described in the authorised indication, and considering that the mechanism behind the events observed remain largely unexplained at this stage, the PRAC considered that, as a provisional measure, the use of radium-223 in combination with abiraterone acetate and prednisone/prednisolone should be contraindicated.
Croatian: S obzirom na ozbiljnost tih rezultata, kao i činjenicu da su opaženi kod bolesnika sa svojstvima bolesti u ranijoj fazi, ali da se djelomično preklapaju s onima opisanima u odobrenoj indikaciji, te uzimajući u obzir činjenicu da je mehanizam u pozadini opaženih događaja u ovoj fazi i dalje uglavnom neobjašnjen, PRAC je smatrao da, kao privremena mjera, primjena radija-223 u kombinaciji s abirateronacetatom i prednizonom/prednizolonom treba biti kontraindicirana.
English: On 30 November 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Xofigo and to issue a recommendation on whether the marketing authorisation of this product should be maintained, varied, suspended or revoked.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji, te je od PRAC-a zatražila procjenu učinka prethodno navedenih razloga za zabrinutost na omjer koristi i rizika lijeka Xofigo i davanje preporuke o tome treba li odgovarajuće odobrenje za stavljanje u promet biti zadržano, izmijenjeno, privremeno obustavljeno ili ukinuto.
English: • In addition, in the absence of definite evidence that the results observed were specific to the combination with abiraterone acetate and prednisone/prednisolone, the PRAC considered that healthcare professionals and patients should be warned that the safety and efficacy of radium Ra223 dichloride in combination with second-generation androgen receptor antagonists including enzalutamide have not been established.
Croatian: • Pored toga, u nedostatku definitivnog dokaza da su opaženi rezultati karakteristični za kombinaciju s abirateronaceatatom i prednizonom/prednizolonom, PRAC je smatrao da je zdravstvene radnike i bolesnike potrebno upozoriti da sigurnost i učinkovitost radija Ra-223 diklorida u kombinaciji s antagonistima androgenih receptora druge generacije, uključujući enzalutamid, još nisu utvrđene.
English: Xofigo (radium Ra223 dichloride, also radium-223 herein) is a centrally authorised product indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Croatian: Xofigo (radij Ra223 diklorid, ovdje također radij-2239) centralno je odobren lijek indiciran za liječenje odraslih s rakom prostate otpornim na kastraciju, sa simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza.
English: • The PRAC reviewed the preliminary data analyses of Study ERA 223 that suggested an increased risk of fracture and mortality when radium Ra223 dichloride treatment, compared to placebo, is initiated concurrently with abiraterone acetate and prednisone/prednisolone treatment.
Croatian: • PRAC je pregledao analize preliminarnih podataka ispitivanja ERA 223 koji su upućivali na povećani rizik od prijeloma i smrtnost kada liječenje radijem Ra-223 dikloridom, u usporedbi s placebom, započinje istodobno s liječenjem abirateronacetatom i prednizonom/prednizolonom.
English: In view of the above, the Committee considers that the benefit-risk balance of Xofigo (radium Ra223 dichloride) remains favourable subject to the agreed provisional amendments to the product information.
Croatian: S obzirom na prethodno navedeno, Odbor smatra da omjer koristi i rizika za lijek Xofigo (radij Ra223 diklorid) ostaje povoljan uz uvjet dogovorenih privremenih izmjena informacija o lijeku.
English: The PRAC considered preliminary data analyses from a randomized, placebo-controlled multicentre phase III study (15396/ERA-223) in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases (CRPC).
Croatian: PRAC je razmotrio analize preliminarnih podataka iz randomiziranog, placebom kontroliranog multicentričnog ispitivanja faze III. (15396(ERA-223) kod pacijenata s rakom prostate otpornim na kastraciju (CRPC), sa koštanim metastazama, bez simptoma ili s blagim simptomima, koji nisu bili liječeni kemoterapijom.
English: Considering current therapeutic options available for patients with symptomatic castration resistant prostate cancer with bone metastases, the PRAC considered that as a provisional measure, a warning that the safety and efficacy of Xofigo in combination with second-generation androgen receptor antagonists such as enzalutamide have not been established, should be included in the product information.
Croatian: Uzimajući u obzir postojeće terapijske opcije dostupne za bolesnike s rakom prostate otpornim na kastraciju sa koštanim metastazama, PRAC je smatrao da je kao preventivnu mjeru u informacije o lijeku potrebno dodati upozorenje da sigurna primjena i učinkovitost lijeka Xofigo u kombinaciji s antagonistima androgenih receptora druge generacije nisu još utvrđene.
English: Therefore and in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to contraindicate the use of radium Ra223 dichloride in combination with abiraterone acetate and prednisone/prednisolone and inform on the results of Study ERA 223.
Croatian: Zbog toga i s obzirom na ozbiljnost opaženih događaja, PRAC je preporučio privremene izmjene informacija o lijeku, tj. dodavanje kontraindikacije uporabe radija Ra-223 diklorida u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom te informacije o rezultatima ispitivanja ERA 223.
English: Healthcare professionals should be informed of the increased incidence of fractures and deaths among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone in Study ERA-223, and of the reduced incidence of fractures observed in both treatment arms with concurrent use of bisphosphonates or denosumab bone health agents.
Croatian: Zdravstvene radnike treba informirati o povećanoj incidenciji prijeloma i smrtnih slučajeva među bolesnicima koji primaju Xofigo u kombinaciji s abirateronacetatom i prednizonom/prednizolonom u usporedbi s bolesnicima koji primaju placebo u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom u ispitivanju ERA-223 te o smanjenoj incidenciji prijeloma opaženih u obje skupine koje su primale lijek uz istodobnu uporabu bisfosfonata ili denosumaba, tvari za zdravlje kostiju.
English: These measures will be further reviewed as part of the ongoing Article 20 procedure.
Croatian: Navedene mjere dodatno će se preispitati kao dio postupka koji je u tijeku temeljem članaka
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Croatian: Ova preporuka ne dovodi u pitanje konačne zaključke postupka koji je u tijeku temeljem članka 20.
English: Based on the available data, Study 15396 shows that in chemotherapy-naïve asymptomatic or mildly symptomatic patients with CRPC, radium-223 in combination with concurrent abiraterone acetate and prednisolone/prednisone decreases overall survival and increases the risk of fractures compared to placebo in combination with abiraterone acetate and prednisone/prednisolone.
Croatian: Na temelju dostupnih podataka, ispitivanje 15396 pokazuje da kod pacijenata s CRPC-om bez simptoma ili s blagim simptomima, koji nisu bili liječeni kemoterapijom, radij-223 u kombinaciji istodobno s abirateronacetatom i prednizonom/prednizolonom smanjuje ukupno preživljenje i povećava rizik od prijeloma u usporedbi s placebom u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom.
English: Analyses of uncleaned preliminary data of a clinical trial evaluating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in a patient population with asymptomatic or mildly symptomatic prostate cancer (ERA 223), found that the incidences of treatment emergent fractures and deaths were increased in the treatment arm (radium-223 dichloride plus abiraterone acetate and prednisone/prednisolone) compared to the control arm (placebo plus abiraterone acetate and prednisone/prednisolone).
Croatian: Analize neobrađenih preliminarnih podataka kliničkog ispitivanja u kojem je ocijenjen lijek Xofigo u kombinaciji s abirateronacetatom i prednizonom/prednizolonom kod bolesnika s karcinomom prostate bez simptoma ili s blagim simptomima (ERA 223) pokazale su povećanu incidenciju smrtnih slučajeva i prijeloma u skupini koja je primala lijek (radij-223 diklorid u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom) u usporedbi s kontrolnom skupinom (placebo u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom).
English: Abasaglar is given once a day at the same time each day.
Croatian: Abasaglar se daje jednom na dan u isto vrijeme.
English: This summary was last updated in 01-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran 1. 2015. godine.
English: The full EPAR and risk management plan summary for Abasaglar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Abasaglarnalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Croatian: Drugačiji znači da ga tijelo apsorbira sporije i redovito nakon injekcija i da ima dugotrajno djelovanje.
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Croatian: Mjesto injekcije treba mijenjati sa svakom injekcijom kako bi se izbjegle promjene na koži (poput zadebljanja) koje čine da inzulin djeluje slabije od očekivanog.
English: It is used in adults and children over the age of two for the treatment of diabetes.
Croatian: Koristi se kod djece u odraslih starijih od dvoje godine za liječenje dijabetesa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Abasria na snazi u Europskoj uniji od 09. rujna 2014.
English: Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.
Croatian: Reakcije na mjestu injekcije (crvenilo, bol, svrbež i oticanje) te kožne reakcije (osip) uočavaju se češće kod djece nego kod odraslih.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and effectiveness to Lantus.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je u skladu sa zahtjevima EU-a za bioslične lijekove dokazano da lijek Abasaglar posjeduje usporedivu razinu kvalitete, sigurnosti i djelotvornosti kao i lijek Lantus.
English: This means that Abasaglar is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, lijek Abasaglar je sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: The dose is adjusted individually, and the patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Croatian: Doza se prilagođava individualno a bolesnikovu razinu glukoze (šećera) treba redovito testirati kako bi se otkrila najniža djelotvorna doza.
English: What is Abasaglar and what is it used for?
Croatian: Što je Abasaglar i za što se koristi?
English: The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Croatian: Najčešća nuspojava lijeka Abasaglar (koja može zahvatiti više od 1 na 10 osoba) je hipoglikemija (niska razina glukoze u krvi).
English: Patients can inject themselves with Abasaglar if they have been trained appropriately.
Croatian: Bolesnici mogu sami sebi injektirati lijek Abasaglar ako su pravilno obučeni.
English: Abasaglar is a ‘biosimilar medicine'.
Croatian: Abasaglar je „biosličan lijek”.
English: It is not intended to provide practical advice on how to use Abasaglar.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Abasaglar.
English: This is a summary of the European public assessment report (EPAR) for Abasaglar.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Abasaglar.
English: In both studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Croatian: U oba ispitivanja glavna mjera djelotvornosti bila je promjena nakon 6 mjeseci liječenja u razini glikoliziranog hemoglobina u krvi (HbA1c) što je indikacija kontrole glukoze u krvi.
English: What measures are being taken to ensure the safe and effective use of Abasaglar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Abasaglar?
English: Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively.
Croatian: Prosječna početna razina HbA1c iznosila je 8,3%, te je pala na ispod 7% kod 48,8% bolesnika koji su primali lijek Abasaglar te 52,5% onih koji su primali Lantus, s prosječnom točkom pada u postotcima od 1,29 odnosno 1,34.
English: Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained with a prescription.
Croatian: Abasaglar je dostupna u obliku uložaka i napunjenih brizgalica za jednokratnu uporabu (KwikPen) i može se dobiti samo na recept.
English: A risk management plan has been developed to ensure that Abasaglar is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Abasaglar.
English: The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce insulin glargine.
Croatian: Djelatna tvar u lijeku Abasaglar proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”; nastaje u bakterijama u koje se uvodi gen (DNK), što ih čini sposobnim za proizvodnju inzulina glargina.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Croatian: Dijabetes je bolest u kojoj organizam ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi.
English: Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target of 7%.
Croatian: Njihova prosječna razina HbA1c prije terapije iznosila je 7,8%, a prosječni pad nakon 6 mjeseci bio je sličan (0,35% u skupini koja je primala lijek Abasaglar te 0,46% u skupini koja je primala lijek Lantus); 34,5% od ispitanika koji su primali lijek Abasaglar i 32,2% onih koji su primali Lantus imali su vrijednost HbA1c ispod ciljne vrijednosti od
English: Insulin glargine is slightly different from human insulin.
Croatian: Inzulin glargin je nešto drugačiji od humanog inzulina.
English: Why is Abasaglar approved?
Croatian: Zašto je lijek Abasaglar odobren?
English: Other information about Abasaglar
Croatian: Ostale informacije o lijeku Abasaglar
English: Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Lantus koristi nadmašuju utvrđene rizike.
English: What are the risks associated with Abasaglar?
Croatian: Koji su rizici povezani s lijekom Abasaglar?
English: The Committee recommended that Abasaglar be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Abasaglar.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abasaglar, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Abasaglar nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (upper arm).
Croatian: Daje se injekcijom pod kožu na trbuhu, bedru ili deltoidnoj regiji (nadlaktica).
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Croatian: Zamjenski inzulin pomaže na isti način kao i prirodni inzulin i pomaže ulasku glukoze iz krvi u stanice.
English: For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Abasaglar pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Abasaglar is a replacement insulin that is very similar to the insulin made by the body.
Croatian: Abasaglar je zamjenski inzulin koji je vrlo sličan inzulinu koje proizvodi ljudski organizam.
English: Abasaglar is a medicine that contains the active substance insulin glargine.
Croatian: Abasaglar je lijek koji sadrži djelatnu tvar inzulin glargin.
English: How is Abasaglar used?
Croatian: Kako se Abasaglar koristi?
English: • In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes.
Croatian: • U jednom ispitivanju Abasaglar je uspoređena s lijekom Lantus kad se dodavala kratkodjelujućem inzulinu u 536 bolesnika s dijabetesom tipa 1.
English: What benefits of Abasaglar have been shown in studies?
Croatian: Koje su koristi lijeka Abasaglar dokazane u ispitivanjima?
English: insulin glargine
Croatian: Abasaglar inzulin glargin
English: • In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, as an addition to diabetes medicines taken by mouth.
Croatian: • U drugom ispitivanju terapija lijekom Abasaglar ili Lantus uspoređena je u 759 bolesnika s dijabetesom tipa 2 kao dodatak peroralnim antidijabeticima.
English: Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts on blood glucose were similar to Lantus.
Croatian: Provedena su ispitivanja kako bi se dokazalo da se način apsorpcije lijeka Abasaglar u tijelo i način na koji djeluje slični kao i kod lijeka Lantus.
English: In addition, treatment with once-daily Abasaglar has been shown to be comparable to the reference medicine, Lantus, in two supportive studies involving a total of 1,295 adults with diabetes.
Croatian: Osim toga liječenje lijekom Abasaglar jednom na dan pokazalo usporedivo s referentnim lijekom Lantus u dva suportivna ispitivanja koja su uključivala ukupno 1295 odraslih ispitanika s dijabetesom.
English: Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes.
Croatian: Abasaglar se također može davati skupa s peroralnim antidijabeticima u bolesnika koji imaju dijabetes tipa 2.
English: For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Abasaglar pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects and restrictions with Abasaglar, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Abasaglar, potražite u uputi o lijeku.
English: Abasaglar1
Croatian: Lantus.
English: The reference medicine for Abasaglar is Lantus.
Croatian: Referentni lijek za Abasaglar je lijek
English: How does Abasaglar work?
Croatian: Kako djeluje Abasaglar?
English: This can lead to weakness or even paralysis.
Croatian: To može dovesti do slabosti pa čak i paralize.
English: Overall Population (n=237)
Croatian: Cjelokupna populacija (n=237)
English: Date when taken out of the refrigerator:______
Croatian: Datum vađenja iz hladnjaka: ______
English: Effect of Food
Croatian: Učinak hrane
English: The safety and efficacy of Veltassa in children aged under 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Veltassa u djece u dobi manjoj od 18 godina nisu još ustanovljene.
English: It should not be taken in its dry form.
Croatian: Ne smije se uzimati u suhom obliku.
English: ATC code: V03AE09
Croatian: ATK oznaka: V03AE09
English: Carcinogenicity studies have not been performed.
Croatian: Nisu provedena ispitivanja karcinogenosti.
English: If powder remains in the glass after drinking,
Croatian: Ako u čaši ostane praška nakon ispijanja,
English: Study Visit (week)
Croatian: Posjet tijekom ispitivanja (tjedni)
English: add more water, stir and drink immediately.
Croatian: dodajte još vode, promiješajte i odmah popijte.
English: Veltassa may affect certain medicines if they are taken by mouth and at the same time, such as:
Croatian: Veltassa može utjecati na određene lijekove ako se uzimaju kroz usta i u isto vrijeme, kao što su: