FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, having considered all the data submitted, in view of the above, the PRAC concluded that the benefit-risk balance of the bove listed products remains positive, but considered that changes to the product information of all authorised SGLT2 inhibitors adding information on the risk of lower limb amputations, as well as additional pharmacovigilance activities to be reflected in the RMP, are warranted.
Croatian: Stoga, uzevši u obzir sve dostavljene podatke i imajući u vidu ono što je navedeno u prethodnu tekstu, PRAC je zaključio da je omjer koristi i rizika prethodno navedenih lijekova i dalje povoljan, ali je također smatrao da je potrebno izmijeniti informacije o lijeku za sve odobrene SGLT2 inhibitore na način da se dodaju informacije o riziku od amputacija donjih udova te da je nužno da se u planu upravljanja rizikom predvide dodatne farmakovigilancijske aktivnosti.
English: • The PRAC was of the view that it is currently not possible to identify an underlying cause for the observed imbalances in amputation risk that would be specifically attributable to canagliflozin-containing medicines and not to the other products of the class;
Croatian: • PRAC je smatrao da trenutačno nije moguće utvrditi glavni uzrok uočenih razlika u riziku od amputacija koji bi se konkretno mogao pripisati lijekovima koji sadržavaju kanagliflozin, a ne ostalim lijekovima u tom razredu;
English: The PRAC was also of the view that it is currently not possible to identify an underlying cause for the observed imbalances in amputation risk that would be specifically attributable to canagliflozincontaining medicines and not to the other products of the class.
Croatian: PRAC je također smatrao da trenutačno nije moguće utvrditi glavni uzrok uočenih razlika u riziku od amputacija koji bi se konkretno mogao pripisati lijekovima koji sadržavaju kanagliflozin, a ne ostalim lijekovima u tom razredu.
English: The warning for canagliflozin also includes information that, in patients developing amputation preceding events, consideration may be given to discontinue treatment.
Croatian: Upozorenje za kanagliflozin također sadržava informacije o tome da bi se trebala razmotriti mogućnost prestanka davanja tog lijeka bolesnicima sa simptomima koji upućuju na potrebu za amputacijom.
English: The communication also asked healthcare professionals to consider treatment discontinuation in patients who develop amputation preceding events.
Croatian: U pismu se od zdravstvenih radnika također tražilo da razmotre mogućnost prekida primjene tog lijeka u bolesnika sa simptomima koji upućuju na potrebu za amputacijom.
English: In addition, an analysis of the ongoing renal study CANVAS-R with a similar population as CANVAS showed a numerical imbalance with regards to amputation events.
Croatian: Osim toga, analizom u okviru trenutačnog kliničkog ispitivanja utjecaja kanagliflozina na bubrežne funkcije CANVAS-R, u koje je uključena populacija koja je slična populaciji uključenoj u ispitivanje CANVAS, uočena je razlika u rezultatima u odnosu na broj slučajeva amputacija.
English: • The PRAC noted that data on amputation events from clinical trials and post-marketing surveillance for dapagliflozin and empagliflozin-containing medicines are either not available to the same extent as for canagliflozin-containing medicines or there were some limitations in the data collection of these events;
Croatian: • PRAC je napomenuo da podaci o slučajevima amputacija dobiveni u kliničkim ispitivanjima lijekova koji sadržavaju dapagliflozin i empagliflozin te tijekom nadzora nakon stavljanja tih lijekova u promet nisu dostupni u jednakoj mjeri kao podaci za lijekove koji sadržavaju kanagliflozin ili su postajala neka ograničenja u prikupljanju podataka o tim slučajevima;
English: The PRAC also considered that data on amputation events from clinical trials and postmarketing surveillance for dapagliflozin and empagliflozin-containing medicines are either not available to the same extent as for canagliflozin-containing medicines or here were some limitations in the data collection.
Croatian: PRAC je također zaključio da podaci o slučajevima amputacija dobiveni u kliničkim ispitivanjima lijekova koji sadržavaju dapagliflozin i empagliflozin te tijekom nadzora nakon stavljanja tih lijekova u promet nisu dostupni u jednakoj mjeri kao podaci za lijekove koji sadržavaju kanagliflozin ili su postajala neka ograničenja u prikupljanju podataka.
English: In March 2016 the EMA was informed by the Marketing authorization holder (MAH) of canagliflozin about an approximately 2-fold increase of lower limb amputations in canagliflozin-treated subjects compared to placebo in the MAH sponsored ongoing cardiovascular (CV) event study CANVAS.
Croatian: U ožujku 2016. nositelj odobrenja za stavljanje kanagliflozina u promet obavijestio je Europsku agenciju za lijekove o gotovo dvostrukom povećanju amputacija donjih udova u ispitanika liječenih kanagliflozinom u odnosu na bolesnike koji su uzimali placebo, što je ustanovljeno u kliničkom ispitivanju kanagliflozina s obzirom na rizik od kardiovaskularnih događaja CANVAS, koje je trenutačno u tijeku i koje sponzorira nositelj odobrenja.
English: A Direct Healthcare Professional Communication (DHPC) was circulated on 2 May 2016 to inform healthcare professionals that a two-fold higher incidence of lower limb amputation (primarily of the toe) had been seen in a clinical trial with canagliflozin; in addition, the need to counsel patients about the importance of routine preventative foot care was highlighted.
Croatian: Dana 2. svibnja 2016. poslano je pismo zdravstvenim radnicima kako bi ih se obavijestilo o tome da je tijekom kliničkog ispitivanja kanagliflozina zamijećena dvostruko veća incidencija amputacija donjih udova (ponajprije nožnih prstiju).
English: Having considered all available data, the PRAC was of the view that the growing data on amputation in the CANVAS and CANVAS-R trial confirm an increased amputation risk for canagliflozin; it is unlikely that the difference in amputation risk seen with canagliflozin compared to placebo is a finding by chance.
Croatian: Uzimajući u obzir sve dostupne podatke, PRAC je smatrao da se rastućim brojem amputacija u ispitivanjima CANVAS i CANVAS-R potvrđuje povećan rizik od amputacija pri uporabi kanagliflozina.
English: Annex IV Scientific conclusions
Croatian: Prilog IV.
English: For canagliflozin, lower limb amputations (mainly of the toe) have been also included, as an adverse drug reaction, in the product information;
Croatian: Što se tiče kanagliflozina, u informacijama o lijeku također se navodi da je moguća nuspojava lijeka mogućnost amputacija donjih udova (ponajprije nožnih prstiju);
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the SGLT2 inhibitor containing products identified in Annex A remains favourable, subject to the agreed amendments to the product information and additional pharmacovigilance activities to be reflected in the RMP.
Croatian: Slijedom navedenoga, PRAC je zaključio da je omjer koristi i rizika lijekova koji sadržavaju SGLT2 inhibitore i koji su navedeni u Prilogu
English: It is given by infusion (drip) into a vein over 2 hours 4 times a day.
Croatian: Primjenjuje se intravenskom infuzijom (ukapavanjem) u trajanju od 2 sata 4 puta dnevno.
English: Defitelio has been authorised under ‘exceptional circumstances'.
Croatian: Defitelio je odobren u „iznimnim okolnostima”.
English: This overview was last updated in 10-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 10. 2019.
English: The dose depends on the patient's bodyweight.
Croatian: Doza ovisi o tjelesnoj težini bolesnika.
English: Treatment should last for at least 3 weeks and continue until the patient no longer has symptoms.
Croatian: Liječenje treba trajati najmanje 3 tjedna i nastaviti se sve dok se simptomi u bolesnika ne povuku.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Agencija procjenjuje sve nove dostupne podatke te se ovaj sažetak po potrebi ažurira.
English: Defitelio is used in adults and in children from one month of age.
Croatian: Defitelio se primjenjuje u odraslih i djece u dobi od mjesec dana i starijih.
English: Defitelio (defibrotide)
Croatian: Defitelio (defibrotid)
English: Severe VOD has a high mortality rate of 75% or higher.
Croatian: Teška vensko-okluzivna bolest ima visoku stopu smrtnosti od 75 % ili više.
English: What measures are being taken to ensure the safe and effective use of Defitelio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Defitelio?
English: What is Defitelio and what is it used for?
Croatian: Što je Defitelio i za što se koristi?
English: Further information on Defitelio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Defitelio dostupno je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival.
Croatian: Iako nije bilo moguće provesti ispitivanje u kojem bi se lijek Defitelio izravno usporedio s placebom (prividno liječenje), tvrtka je dostavila dovoljno podataka koji pokazuju da su se u bolesnika liječenih ovim lijekom poboljšali izgledi za preživljenje.
English: The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio.
Croatian: Smatra se da se primijećene nuspojave, kao što je krvarenje, mogu kontrolirati, a nije bilo moguće sa sigurnošću odrediti jesu li one bile prouzročene lijekom Defitelio.
English: Benefits of Defitelio were also seen in data from a United States patient registry (information about patients collected in a standard way), where patients with severe VOD after blood stem cell transplantation who received Defitelio plus standard care had better outcomes than those given standard care alone, including a higher 100-day survival rate (39% versus 31%) and a higher proportion of patients whose VOD resolved (51% versus 29%).
Croatian: Koristi od lijeka Defitelio opažene su i na temelju podataka iz registra bolesnika u SAD-u (informacije o bolesnicima prikupljene na uobičajeni način) u kojima su bolesnici s teškom vensko-okluzivnom bolešću, koji su nakon transplantacije krvotvornih matičnih stanica primali lijek Defitelio uz standardnu skrb, imali bolje rezultate od bolesnika koji su primali samo standardnu skrb, uključujući višu 100dnevnu stopu preživljenja (39 % u odnosu na 31 %) i veći udio bolesnika u kojih se vensko-okluzivna bolest povukla (51 % u odnosu na 29 %).
English: Side effects reported with Defitelio are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Defitelio pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Defitelio lowered the mortality rate to 62% at 100 days after transplantation, and 24% of patients had no symptoms of severe VOD after 100 days.
Croatian: Defitelio je 100 dana nakon transplantacije smanjio stopu smrtnosti na 62 %, dok 24 % bolesnika nisu imali simptome teške vensko-okluzivne bolesti nakon 100 dana.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Defitelio have 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 Defitelio nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: This is because it has not been possible to obtain complete information about Defitelio due to the rarity of the disease.
Croatian: Razlog tome je nemogućnost dobivanja potpunih podataka o lijeku Defitelio zbog male učestalosti bolesti.
English: The most common side effects with Defitelio are hypotension (low blood pressure) and bleeding.
Croatian: Najčešće nuspojave lijeka Defitelio bile su hipotenzija (nizak krvni tlak) i krvarenje.
English: Defitelio must not be used together with other medicines that break down blood clots.
Croatian: Defitelio se ne smije primjenjivati zajedno s drugim lijekovima koji razgrađuju krvne ugruške.
English: Defitelio received a marketing authorisation valid throughout the European Union on 18 October 2013.
Croatian: Lijek Defitelio dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. listopada 2013.
English: An overview of Defitelio and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Defitelio i zašto je odobren u EU-u
English: The European Medicines Agency decided that Defitelio'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 Defitelio nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Since Defitelio has been authorised under exceptional circumstances, the company that markets the medicine is required to provide results of an ongoing study on safety of the medicine when used for prevention of VOD in adults and children undergoing hematopoietic stem cell transplantation.
Croatian: Budući da je lijek Defitelio odobren u iznimnim okolnostima, tvrtka koja lijek stavlja na tržište obvezna je omogućiti rezultate ispitivanja koje se trenutačno provodi o sigurnosti lijeka kad se primjenjuje za sprječavanje vensko-okluzivne bolesti u odraslih i djece koji će ići na transplantaciju hematopoetskih matičnih stanica.
English: Why is Defitelio authorised in the EU?
Croatian: Zašto je lijek Defitelio odobren u EU-u?
English: What are the risks associated with Defitelio?
Croatian: Koji su rizici povezani s lijekom Defitelio?
English: For more information about using Defitelio, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Defitelio pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: VOD is rare, and Defitelio was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 July 2004.
Croatian: Vensko-okluzivna bolest je rijetka bolest, a lijek Defitelio dobio je status „lijeka za rijetku bolest” 29. srpnja 2004.
English: As for all medicines, data on the use of Defitelio are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Defitelio kontinuirano se prate.
English: The company will also analyse data on transplant outcomes in VOD patients who have and have not been treated with Defitelio.
Croatian: Tvrtka će također pregledati podatke o analizi ishoda transplantacije u bolesnika s vensko-okluzivnom bolesti koji su liječeni i koji nisu liječeni lijekom Defitelio.
English: The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood.
Croatian: Djelatna tvar u lijeku Defitelio, defibrotid, djeluje tako što povećava razgradnju ugrušaka u krvi.
English: In one main study involving 102 patients with severe VOD following blood stem cell transplantation, Defitelio was compared with past records of patients who had received standard supportive care.
Croatian: U jednom glavnom ispitivanju u kojem su sudjelovala 102 bolesnika s teškom vensko-okluzivnom bolešću nakon transplantacije krvotvornih matičnih stanica, Defitelio je uspoređen s prethodnim rezultatima bolesnika koji su liječeni standardnom potpornom skrbi.
English: The medicines used for this treatment can damage the lining of the blood vessels in the liver, leading to the formation of clots and obstruction of the vessels seen in VOD.
Croatian: Lijekovi koji se primjenjuju u tom liječenju mogu oštetiti unutarnju prevlaku krvnih žila u jetri, što dovodi do stvaranja ugrušaka i opstrukcije krvnih žila kakva se opaža kod venskookluzivne bolesti.
English: VOD is usually a complication resulting from a treatment known as ‘myeloablative chemotherapy' given before blood stem cell transplantation.
Croatian: Vensko-okluzivna bolest obično je komplikacija povezana s liječenjem poznatim kao „mijeloablativna kemoterapija” koja se daje prije transplantacije krvotvornih matičnih stanica.
English: Other information about Defitelio
Croatian: Ostale informacije o lijeku Defitelio
English: Defitelio can only be obtained with a prescription and it must be prescribed and given by a doctor experienced in the management of complications of blood stem cell transplantation.
Croatian: Defitelio se izdaje samo na recept te ga mora propisati i davati liječnik s iskustvom u liječenju komplikacija povezanih s transplantacijom krvotvornih matičnih stanica.
English: In addition, defibrotide may protect the cells that line blood vessels.
Croatian: Uz to, defibrotid može zaštititi stanice u unutarnjoj prevlaci krvnih žila.
English: Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation.
Croatian: Lijek Defitelio upotrebljava se za liječenje teške vensko-okluzivne bolesti u bolesnika koji će ići na transplantaciju hematopoetskih (krvotvornih) matičnih stanica.
English: Myeloablative chemotherapy is used to clear the patient's bone marrow of cells before receiving healthy stem cells.
Croatian: Mijeloablativna kemoterapija primjenjuje se kako bi se iz koštane srži bolesnika uklonile stanice prije primanja zdravih matičnih stanica.
English: Defitelio contains the active substance defibrotide.
Croatian: Defitelio sadržava djelatnu tvar defibrotid.
English: How does Defitelio work?
Croatian: Kako djeluje Defitelio?
English: What benefits of Defitelio have been shown in studies?
Croatian: Koje su koristi od lijeka Defitelio utvrđene u ispitivanjima?
English: What information is still awaited for Defitelio?
Croatian: Koji se još podatci očekuju o lijeku Defitelio?
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku.
English: How is Defitelio used?
Croatian: Kako se Defitelio primjenjuje?
English: VOD is a condition in which the veins in the liver become blocked and stop the liver working properly.
Croatian: Vensko-okluzivna bolest je stanje začepljenja vena u jetri, uslijed čega jetra ne radi pravilno.
English: Defitelio had been shown to improve survival in patients with severe VOD.
Croatian: Utvrđeno je da se lijekom Defitelio poboljšava preživljenje bolesnika s teškom vensko-okluzivnom bolešću.
English: For the full list of side effects of Defitelio, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Defitelio potražite u uputi o lijeku.
English: Keep the bottle tightly closed.
Croatian: Bocu čuvati čvrsto zatvorenu.
English: The tmax was delayed by two hours.
Croatian: Tmax bio je odgođen za dva sata.
English: What it is used for
Croatian: Za što se koristi
English: • Take care not to infect other people.
Croatian: • Vodite računa da ne zarazite druge osobe.
English: Clinical efficacy and safety:
Croatian: Klinička djelotvornost i sigurnost:
English: As data becomes available
Croatian: Čim podaci postanu dostupni
English: It is important not to miss a dose.
Croatian: Važno je da ne propustite dozu.
English: Wait and take the next dose at the regular time.
Croatian: Pričekajte i uzmite sljedeću dozu u redovno vrijeme.
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: You must continue to take precautions to avoid this.
Croatian: Morate biti i dalje oprezni kako biste izbjegli tu situaciju.
English: You may need blood tests for several months after treatment.
Croatian: Možda ćete trebati raditi krvne pretrage nekoliko mjeseci nakon liječenja.
English: County Cork, T45 DP77 Ireland
Croatian: County Cork, T45 DP77 Irska
English: • If you are over 65 years of age your doctor may monitor your health more closely.
Croatian: • Ako ste stariji od 65 godina, liječnik može pomnije nadzirati Vaše zdravlje.
English: The optimum duration of treatment is unknown.
Croatian: Optimalno trajanje liječenja nije poznato.
English: Tablet.
Croatian: Tableta.
English: A risk to the newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: • Do not use Hepsera in children or adolescents under 18 years of age.
Croatian: • Ne upotrebljavajte Hepseru u djece ili adolescenata mlađih od 18 godina.
English: Hepsera with food and drink
Croatian: Hepsera s hranom i pićem
English: • Tell your doctor immediately if you are pregnant or planning to become pregnant.
Croatian: • Odmah obavijestite svog liječnika ako ste trudni ili planirate trudnoću.
English: Do not take a double dose (two doses close together).
Croatian: Nemojte uzeti dvostruku dozu (dvije doze u kratkom vremenskom razmaku).
English: If you do get any of them, it is unlikely to be serious, but you need to check.
Croatian: Ako osjetite ijedan od ovih simptoma, najvjerojatnije nije ništa ozbiljno, ali svejedno morate provjeriti.
English: • If you are HIV positive this medicine will not control your HIV infection.
Croatian: • Ako ste HIV pozitivni, ovaj lijek neće držati pod kontrolom HIV infekciju.
English: Elderly: The clinical experience in patients > 65 years of age is very limited.
Croatian: Starije osobe: Kliničko iskustvo u pacijenata starijih od 65 godina vrlo je ograničeno.
English: • pentamidine, for other types of infection.
Croatian: • pentamidin za druge vrste infekcija.
English: These patients should be followed closely.
Croatian: Ove pacijente treba pomno pratiti.
English: Hepsera belongs to a group of medicines called antiviral medicines.
Croatian: Hepsera pripada skupini lijekova koji se zovu antivirusni lijekovi.
English: 90 (3 bottles of 30) tablets.
Croatian: 90 (3 boce od 30) tableta.
English: Other medicines and Hepsera
Croatian: Drugi lijekovi i Hepsera
English: Treatment discontinuation may be considered as follows:
Croatian: Prekid liječenja se može uzeti u obzir u sljedećim slučajevima:
English: Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage.
Croatian: Hepsera smanjuje količinu virusa u Vašem tijelu te se pokazalo da smanjuje oštećenje jetre.
English: Some patients have experienced:
Croatian: Neki su pacijenti razvili:
English: Do not store above 30ºC.
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: If you take more Hepsera than you should
Croatian: Ako uzmete više Hepsere nego što ste trebali
English: This is to make sure that your medicine is fully effective and to reduce the development of resistance to the treatment.
Croatian: Na taj se način osigurava puna djelotvornost Vašeg lijeka i smanjuje razvoj rezistencije na liječenje.
English: • If it is nearly time for your next dose, skip the missed dose.
Croatian: • Ako je uskoro vrijeme za Vašu sljedeću dozu, preskočite propuštenu dozu.
English: • Do not take Hepsera if you are taking any medicines containing tenofovir.
Croatian: • Ne uzimajte Hepseru ako uzimate bilo koje druge lijekove koji sadrže tenofovir.
English: Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008
Croatian: Datum posljednje obnove: 06.ožujka 2008
English: However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible influence on these abilities.
Croatian: Međutim, na temelju sigurnosnog profila i mehanizma djelovanja adefovirdipivoksila očekuje se nikakav ili zanemariv utjecaj na ove sposobnosti.
English: Excipient(s) with known effect:
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: