FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects and restrictions with Iblias, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Iblias potražite u uputi o lijeku.
English: Further information on Zydelig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zydelig.
Croatian: Više informacija o lijeku Zydelig dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zydelig.
English: This overview was last updated in 12-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 12. 2019.
English: What is Zydelig and what is it used for?
Croatian: Što je Zydelig i za što se koristi?
English: Zydelig received a marketing authorisation valid throughout the EU on 18 September 2014.
Croatian: Lijek Zydelig dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. rujna 2014.
English: Other information about Zydelig
Croatian: Ostale informacije o lijeku Zydelig
English: If the patient has severe side effects, treatment must be stopped and can be restarted at a lower dose of 100 mg twice a day.
Croatian: Ako bolesnik ima ozbiljne nuspojave, liječenje se mora obustaviti i može se ponovno započeti s manjom dozom od 100 mg dvaput dnevno.
English: In addition, the safety of the medicine was considered acceptable.
Croatian: Zaključeno je da je sigurnosni profil lijeka prihvatljiv.
English: The Agency therefore concluded that Zydelig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Zydelig nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u EU-u.
English: Zydelig is available as 100 mg and 150 mg tablets.
Croatian: Lijek Zydelig dostupan je u obliku tableta od 100 i 150 mg.
English: What measures are being taken to ensure the safe and effective use of Zydelig?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zydelig?
English: The recommended dose is 150 mg twice a day, and treatment should be continued for as long as the patient improves or remains stable and the side effects are tolerable.
Croatian: Preporučena doza je 150 mg dvaput dnevno i terapiju treba nastaviti sve dok se stanje bolesnika ne poboljša ili ostane stabilno, a nuspojave se može kontrolirati.
English: This enzyme plays a role in the growth, migration and survival of white blood cells but is overactive in blood cancers, where it enables the survival of the cancer cells.
Croatian: Taj je enzim važan za rast, migraciju i preživljavanje bijelih krvnih zrnaca, ali je preaktivan kada je riječ o vrstama raka krvi kod kojih omogućuje preživljavanje stanica raka.
English: By targeting this enzyme and blocking its effects, idelalisib causes death of the cancer cells, thereby delaying or stopping the progression of the cancer.
Croatian: Djelovanjem na taj enzim i inhibiranjem njegova učinka idelalisib uništava stanice raka i na taj način odgađa ili zaustavlja napredovanje raka.
English: Zydelig should not be started in patients with any generalised infection (infection that has spread with symptoms affecting the whole body, such as fever and chills).
Croatian: Zydelig se ne smije primjenjivati u bolesnika s bilo kojom vrstom generalizirane infekcije (infekcije čiji su se simptomi proširili po čitavom tijelu, poput vrućice i zimice).
English: Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zydelig pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Zydelig?
Croatian: Koji su rizici povezani s lijekom Zydelig?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zydelig 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 Zydelig nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment.
Croatian: Zydelig je bio učinkovit pri čemu je 54 % bolesnika s folikularnim limfomom imalo potpun ili djelomičan odgovor na terapiju.
English: Zydelig contains the active substance idelalisib.
Croatian: Zydelig sadrži djelatnu tvar idelalisib.
English: Zydelig can only be obtained with a prescription and it should be prescribed by a doctor experienced in using cancer medicines.
Croatian: Zydelig se izdaje samo na recept koji treba propisati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Patients should also be monitored for infection and have regular blood tests to measure the level of white blood cells.
Croatian: Bolesnici trebaju biti pod nadzorom radi utvrđivanja moguće infekcije i redovito raditi krvne pretrage radi praćenja razine bijelih krvnih stanica u krvi.
English: An overview of Zydelig and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zydelig i zašto je odobren u EU-u
English: Zydelig with ofatumumab was more effective than ofatumumab alone in the treatment of CLL.
Croatian: Zydelig je u kombinaciji s ofatumumabom bio učinkovitiji od samog ofatumumaba u liječenju KLL-a.
English: For more information about using Zydelig, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Zydelig pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: As for all medicines, data on the use of Zydelig are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zydelig kontinuirano se prate.
English: The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections (including lung infection caused by Pneumocystis jirovecii, and cytomegalovirus infections), neutropenia (low levels of neutrophils, a type of white blood cell), lymphocytosis (increased levels of lymphocytes, another type of white blood cell), diarrhoea, blood tests showing changes in the liver, rash, fever and increased blood fat levels.
Croatian: Najčešće nuspojave povezane s lijekom Zydelig (koje se mogu javiti u više od 1 na 10 osoba) jesu infekcije (uključujući upalu pluća izazvanu uzročnikom Pneumocystis jirovecii i infekcije citomegalovirusom), neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica), limfocitoza (povišene razine limfocita, druge vrste bijelih krvnih stanica), proljev, rezultati krvnih pretraga koji upućuju na promjene u jetri, osip, vrućica i povišene razine masnoća u krvi.
English: The European Medicines Agency noted that data from the main studies showed high response rates with Zydelig in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Croatian: Europska agencija za lijekove napomenula je da je na temelju podataka iz glavnih ispitivanja utvrđena visoka stopa odgovora na Zydelig u bolesnika s kroničnom limfocitnom leukemijom i folikularnim limfomom.
English: Why is Zydelig authorised in the EU?
Croatian: Zašto je lijek Zydelig odobren u EU-u?
English: All patients treated with Zydelig should also be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia, and this should be continued for up to 6 months after stopping treatment with Zydelig.
Croatian: Svi bolesnici na terapiji lijekom Zydelig trebaju preventivno primati lijekove protiv upale pluća izazvane uzročnikom Pneumocystis jiroveci, što treba nastaviti do šest mjeseci nakon prestanka terapije lijekom Zydelig.
English: Zydelig was also more effective than placebo in patients who had a specific genetic mutation in their cancer cells that makes them unsuitable for certain other therapies.
Croatian: Zydelig je bio učinkovitiji od placeba i u bolesnika koji su imali specifičnu genetsku mutaciju u njihovim stanicama raka zbog koje nisu prikladni za druge terapije.
English: The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta.
Croatian: Aktivna tvar u lijeku Zydelig, idelalisib, inhibira učinke enzima naziva PI3K-delta.
English: In a main study of 220 patients with previously treated CLL, Zydelig was more effective at treating the cancer than placebo (a dummy treatment) when both were given in combination with rituximab: 75% of patients taking Zydelig had an improvement in their disease compared with 15% of patients receiving placebo.
Croatian: U glavnom ispitivanju na 220 bolesnika s prethodno liječenim KLL-om, Zydelig je bio u liječenju raka učinkovitiji od placeba (prividnog liječenja) kada su oba primjenjivana u kombinaciji s rituksimabom: u 75 % bolesnika koji su primali Zydelig došlo je do poboljšanja bolesti u usporedbi s 15 % bolesnika koji su primali placebo.
English: What benefits of Zydelig have been shown in studies?
Croatian: Koje su koristi od lijeka Zydelig utvrđene u ispitivanjima?
English: In a study of 261 previously treated CLL patients, it took over 16 months on average before the disease got worse in patients treated with Zydelig plus ofatumumab, compared with 8 months in those treated with ofatumumab alone.
Croatian: U ispitivanju na 261 bolesniku koji su prethodno liječeni od KLL-a, utvrđeno je da je u prosjeku bilo potrebno više od 16 mjeseci da se bolest pogorša u bolesnika koji su Zydelig primali zajedno s ofatumumabom u usporedbi s osam mjeseci u bolesnika koji su liječeni samo ofatumumabom.
English: How does Zydelig work?
Croatian: Kako djeluje Zydelig?
English: In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
Croatian: Za liječenje KLL-a Zidelig se primjenjuje u kombinaciji s drugim lijekom (rituksimabom ili ofatumumabom) u bolesnika koji su primili najmanje jednu prethodnu terapiju i u bolesnika čije stanice raka imaju genetske mutacije (promjene) naziva delecija 17p ili mutacija TP53 i koji se ne mogu liječiti drugim terapijama.
English: Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
Croatian: Zidelig je lijek protiv raka koji se koristi za liječenje kronične limfocitne leukemije (KLL, vrste raka bijelih krvnih stanica naziva B limfociti) i folikularnog limfoma (druge vrste raka koja zahvaća bijele krvne stanice).
English: Zydelig was also effective in chronic lymphocytic leukaemia patients whose cancer cells have the 17p deletion or TP53 mutation, who usually have a poor outcome.
Croatian: Zydelig je bio učinkovit i u bolesnika s kroničnom limfocitnom leukemijom čije stanice raka imaju delaciju 17p ili mutaciju TP53 i kod kojih su učinci terapija slabi.
English: In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments.
Croatian: Za liječenje folikularnog limfoma Zydelig se primjenjuje kao monoterapija u bolesnika čije se stanje nije poboljšalo usprkos dvama prethodnim terapijama.
English: Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments.
Croatian: U drugom glavnom ispitivanju lijek Zydelig ocjenjivao se u bolesnika s različitim limfomima, uključujući 72 bolesnika s folikularnim limfomom koji nisu reagirali na prethodna dva liječenja.
English: For the full list of side effects and restrictions of Zydelig, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Zydelig potražite u uputi o lijeku.
English: How is Zydelig used?
Croatian: Kako se Zydelig primjenjuje?
English: Wash your hands.
Croatian: Operite ruke.
English: Then start the rotation again.
Croatian: Zatim ponovno započnite rotaciju.
English: Please read the instructions carefully and follow them step by step.
Croatian: Molimo Vas da pozorno pročitate upute i slijedite ih korak po korak.
English: 2 years.
Croatian: 2 godine.
English: This makes it easier to remember it.
Croatian: Tako ćete se i lakše sjetiti.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji put revidirana u
English: It is important to have your hands and the items you use as clean as possible.
Croatian: Važno je da ruke i predmeti koje koristite budu što čišći.
English: The dose will depend on your condition.
Croatian: Doza će ovisiti o Vašem stanju.
English: 1 ml contains:
Croatian: 1 ml sadrži:
English: Lay out everything you need in advance.
Croatian: Sve što Vam je potrebno pripremite unaprijed.
English: This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: No fertility studies have been performed (see section 5.3).
Croatian: Nisu provedena ispitivanja plodnosti (vidjeti dio 5.3).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA /DATUM OBNOVE ODOBRENJA
English: SN: {number} [serial number]
Croatian: SN: {broj} [serijalizacijski broj]
English: Let the skin air-dry.
Croatian: Neka se koža osuši na zraku.
English: 22578 1522 ΛΕΥΚΩΣΙΑ Κ Υ Π Ρ Ο Σ
Croatian: Τ. Θ. 22578 1522 ΛΕΥΚΩΣΙΑ Κ Υ Π Ρ Ο Σ
English: Find a clean place where you can spread out all the items you are going to use:
Croatian: Pronađite čisto mjesto na kojem možete rasporediti predmete koje ćete koristiti:
English: Try to take the injection at the same time of day.
Croatian: Pokušajte si davati injekciju u isto vrijeme tijekom dana.
English: There is no data about efficacy in post-exposure prophylaxis.
Croatian: Nema podataka o djelotvornosti u postekspozicijskoj profilaksi.
English: IgG and IgG-complexes are broken down in the reticuloendothelial system.
Croatian: IgG i IgG-kompleksi se razgrađuju u retikuloendotelnom sustavu.
English: This is likely to be the easiest place to inject if you are doing it yourself.
Croatian: Ovo je vjerojatno najjednostavnije mjesto za injiciranje ako to obavljate sami.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
English: True hypersensitivity reactions are rare.
Croatian: Prave reakcije preosjetljivosti su rijetke.
English: The doctor or his/her assistant will teach you the process of administration.
Croatian: Liječnik ili njegov/njezin pomoćnik podučit će Vas postupku primjene.
English: Do not take a double dose to make up for a forgotten injection.
Croatian: Nemojte uzeti dvostruku dozu da biste nadoknadili zaboravljenu injekciju.
English: Before the injection:
Croatian: Prije injiciranja:
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratorij ili laboratorij određen za tu svrhu.
English: The individual treatment duration per patient was planned to be up to 24 weeks after transplantation.
Croatian: Planirano je da pojedinačno trajanje liječenja po bolesniku traje najviše 24 tjedna nakon transplantacije.
English: All patients used antiviral medicine.
Croatian: Svi bolesnici primali su antivirusni lijek.
English: The contents of one syringe are intended for use once only.
Croatian: Sadržaj jedne štrcaljke namijenjen je samo za jednokratnu uporabu.
English: Do not inject into a blood vessel.
Croatian: Nemojte ubrizgavati u krvnu žilu.
English: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA content ≤ 6,000 micrograms/ml
Croatian: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA sadržaj ≤ 6000 mikrograma/ml
English: Zutectra contains a small quantity of IgA.
Croatian: Zutectra sadrži malu količinu IgA.
English: This medicine must not be mixed with other medicines.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima.
English: Self-administration was feasible for most patients.
Croatian: Samostalno davanje lijeka bilo je prihvatljivo za većinu bolesnika.
English: Always double-check the dose.
Croatian: Uvijek dva puta provjerite dozu koju primjenjujete.
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Croatian: NN: {broj} [nacionalni broj s liste lijekova ili drugi nacionalni broj za identifikaciju lijeka]
English: Zutectra might affect the results of certain blood tests (serological tests).
Croatian: Zutectra može utjecati na rezultate određenih krvnih pretraga (serološke pretrage).
English: C/Frederic Mompou, 5 - 6° 3a A
Croatian: C/ Frederic Mompou, 5 - 6º 3ª A
English: What is in this leaflet:
Croatian: Što se nalazi u ovoj uputi
English: No other non-clinical trials have been carried out.
Croatian: Nisu provedena druga neklinička ispitivanja.
English: All patients included in this study had to run through a training period of at least 29 days and home self-administration could start on day 36 at the earliest.
Croatian: Svi ispitanici uključeni u ovo ispitivanje morali su proći razdoblje uvježbavanja od najmanje 29 dana i samostalna primjena kod kuće mogla je započeti najranije 36. dan.
English: Patients should be HBsAg negative before treatment start.
Croatian: Bolesnici moraju biti HBsAg negativni prije početka liječenja.
English: For your own safety you will be monitored for antibody levels regularly.
Croatian: Radi vlastite sigurnosti redovito će vam se kontrolirati razine antitijela.
English: For safety information with respect to transmissible agents, see section 4.4.
Croatian: Informacije o sigurnosti koje se odnose na prenosive uzročnike vidjeti u dijelu 4.4.
English: Paediatric population There is no relevant indication for use of Zutectra in children under the age of 18.
Croatian: Pedijatrijska populacija Nema relevantnih indikacija za primjenu lijeka Zutectra u djece mlađe od 18 godina.
English: Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili zdravstvenog djelatnika ako uzimate, nedavno ste uzeli ili biste mogli uzimati bilo koje druge lijekove.
English: It's important to change (rotate) the injection sites.
Croatian: Važno je mijenjati (rotirati) mjesta injiciranja.
English: No patient prematurely discontinued the study due to lack of feasibility of home self-treatment.
Croatian: Nijedan bolesnik nije prerano prekinuo ispitivanje zbog nemogućnosti samostalne primjene kod kuće.
English: Rotating sites means starting at one site and using all other sites before going back to the first site you used.
Croatian: Mijenjanje mjesta injiciranja znači početi na jednom mjestu i iskoristiti sva ostala mjesta prije povratka na početno mjesto.
English: In most cases you will be given the injection by your doctor or nurse.
Croatian: U većini slučajeva injekciju će Vam dati liječnik ili medicinska sestra.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili zdravstvenom djelatniku za savjet prije nego uzmete ovaj lijek.
English: This can be an allergic reaction or a serious allergic reaction (anaphylactic shock).
Croatian: To može biti alergijska reakcija ili ozbiljna alergijska reakcija (anafilaktički šok).
English: Zutectra has a half-life of about 3-4 weeks.
Croatian: Poluvijek lijeka Zutectra je oko 3 - 4 tjedna.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka treba primijeniti standardni postupak liječenja.
English: Inject beneath the skin as you have been shown by the doctor or nurse.
Croatian: Ubrizgajte lijek ispod kože kako su Vam pokazali liječnik ili sestra.
English: With the exception of 6 patients who withdrew prior to day 36, all patients achieved complete hospital and home self-administration.
Croatian: S iznimkom 6 bolesnika koji su se povukli iz ispitivanja prije 36. dana, svi su bolesnici postigli potpunu samostalnu primjenu u bolnici i kod kuće.
English: The effects were grouped by system organ classes under relevant medical headings.
Croatian: Učinci su grupirani prema klasama organskih sustava pod relevantnim medicinskim naslovima.
English: PC: {number} [product code]
Croatian: PC: {broj} [oznaka lijeka]
English: Abdomen (stomach): Do not use the area within one inch around the navel.
Croatian: Abdomen (trbuh): ne koristite područje unutar 2,5
English: Your doctor will explain you how to use it.
Croatian: Liječnik će Vam pokazati kako ga treba koristiti.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Arms: The back of the upper arm should be used.
Croatian: Ruke: treba upotrijebiti stražnju stranu nadlaktice.
English: This is very rare and may result in allergic reactions.
Croatian: To stanje je vrlo rijetko i može prouzročiti alergijske reakcije.
English: This half-life may vary from patient to patient.
Croatian: Taj poluvijek može biti različit u različitih bolesnika.
English: ATC code: J06BB04
Croatian: ATK oznaka: J06BB04
English: - Take the syringe out of the pack.
Croatian: - Izvadite štrcaljku iz pakiranja.
English: Other medicines and Zutectra
Croatian: Drugi lijekovi i Zutectra
English: All other patients should be observed for at least 20 minutes after administration.
Croatian: Svi ostali bolesnici moraju biti pod nadzorom najmanje 20 minuta nakon primjene lijeka.
English: Possible interference with blood tests
Croatian: Mogući utjecaj na krvne pretrage
English: The administration in thighs is shown as an example in the following pictures:
Croatian: Davanje lijeka u bedro prikazano je kao primjer na sljedećim slikama:
English: Consequences of an overdose are not known.
Croatian: Posljedice predoziranja nisu poznate.
English: Allow yourself enough time to inject the whole of the solution until the syringe is empty.
Croatian: Ostavite dovoljno vremena za ubrizgavanje cijele količine otopine, sve dok se štrcaljka ne isprazni.
English: Carefully push the plunger in until the air bubbles have disappeared.
Croatian: Pažljivo gurajte klip dok ne nestanu svi mjehurići zraka.
English: Then pull the needle out immediately and let go of the pinched skin.
Croatian: Zatim odmah izvucite iglu i pustite pritisnutu kožu.
English: What Zutectra looks like and the contents of the pack
Croatian: Kako Zutectra izgleda i sadržaj pakiranja
English: Do not use Zutectra - if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati lijek Zutectra - ako ste alergični na ljudski imunoglobulin ili bilo koji drugi sastojak lijeka Zutectra (naveden u dijelu 6).
English: Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection.
Croatian: Ne pokušavajte sami injicirati lijek Zutectra dok niste sigurni da ste razumjeli kako pripremiti otopinu injekcije i dati injekciju.
English: Talk to the doctor or healthcare professional about these or any other unusual conditions you may find.
Croatian: Razgovarajte s liječnikom ili zdravstvenim djelatnikom o ovim ili drugim neuobičajenim stanjima kože koje ste primijetili.