natgillin/translations-raw huggingface dataset:
Immediate packaging Pack size blister (PVC/PE/PVDC/alu) 294 (3x98) tablets (multipack)
Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja blister (PVC/PE/PVDC/alu) 294 (3x98) tableta (višestruko pakiranje)
Strength Pharmaceutical form Route of administration
(Zaštićeno) ime Doza
The recommended starting dose is 45 mg once per day.
Preporučena početna doza je 45 mg jednom na dan.
Iclusig is available as tablets (15 mg, 30 mg and 45 mg).
Iclusig je dostupan u obliku tableta (15 mg, 30 mg i 45 mg).
This overview was last updated in 07-2018.
Sažetak je posljednji put ažuriran u 07. 2018.
What is Iclusig and what is it used for?
Što je Iclusig i za što se primjenjuje?
Further information on Iclusig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Iclusig nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Treatment is continued for as long as the patient benefits.
Liječenje se nastavlja sve dok bolesnik ostvaruje koristi od liječenja.
What measures are being taken to ensure the safe and effective use of Iclusig?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Iclusig?
• chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
• kronične mijeloične leukemije (KML) u njezinim različitim stadijima koji su poznati kao kronična, ubrzana i blastična faza;
It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Primjenjuje se za liječenje odraslih osoba sa sljedećim vrstama leukemije (raka bijelih krvnih stanica):
The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
Rezultati ispitivanja pokazali su da je liječenje lijekom Iclusig uzrokovalo klinički značajne odgovore u svim skupinama bolesnika:
Further information on the orphan designations can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
Više informacija o statusu lijeka za rijetku bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Ako bolesnik razvije određene ozbiljne nuspojave, liječnik može odlučiti smanjiti sljedeće doze, odnosno odgoditi ili prekinuti liječenje.
The doctor should consider stopping treatment if the level of white cells in the blood does not return to normal within three months.
Liječnik treba razmotriti prekid terapije ako u roku od tri mjeseca nije postignut povratak na normalan broj leukocita u krvi.
Other information about Iclusig
Ostale informacije o lijeku Iclusig
• acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
• akutne limfoblastične leukemije (ALL) u bolesnika koji su „pozitivni na Philadelphia-kromosom” (Ph+).
The company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Tvrtka koja stavlja lijek Iclusig u promet osigurat će edukacijski materijal svim liječnicima za koje se očekuje da će propisivati ovaj lijek, a u tim će materijalima biti naglašeni važni rizici za koje se preporučuje praćenje i prilagođavanje doziranja.
These diseases are rare, and Iclusig was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 February 2010.
Te bolesti su rijetke, a Iclusig dobio je status „lijeka za rijetku bolest” 2. veljače 2010.
By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Blokirajući Bcr-Abl, lijek Iclusig pomaže u kontroli rasta i širenja leukemijskih stanica.
What are the risks associated with Iclusig?
Koji su rizici povezani s lijekom Iclusig?
This enzyme is found on the surface of leukaemia cells where it is involved in stimulating the cells to divide uncontrollably.
Taj se enzim nalazi na površini leukemijskih stanica kod kojih sudjeluje u stimulaciji nekontrolirane diobe stanica.
Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia.
Ph+ znači da su se neki od gena bolesnika prerasporedili i stvorili poseban kromosom zvan Philadelphia-kromosom koji uzrokuje razvoj leukemije.
For more information about using Iclusig, see the package leaflet or contact your doctor or pharmacist.
Za više informacija o primjeni lijeka Iclusig, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
The most common serious side effects with Iclusig (which may affect more than 2 in 100 people) are pneumonia (infection of the lungs), pancreatitis (inflammation of the pancreas), pyrexia (fever), abdominal pain (stomach ache), myocardial infarction (heart attack), atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), peripheral arterial occlusive disease (problem with blood flow in the arteries), anaemia (low red blood cell counts), angina pectoris (pains to the chest, jaw and back due to problems with blood flow to the heart), decreased blood levels of platelets (components that help the blood to clot), febrile neutropenia (low white blood cell counts with fever), hypertension (high blood pressure), coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), cardiac failure (when the heart does not work as well as it should), cerebrovascular accident (stroke), sepsis (blood poisoning), cellulitis (inflammation of the deep skin tissue), acute kidney injury (kidney damage), urinary tract infection (infection of the structures that carry urine) and increased levels of lipase (an enzyme).
Najčešće ozbiljne nuspojave lijeka Iclusig (koje se mogu javiti kod više od 2 na 100 osoba) jesu upala pluća (infekcija pluća), pankreatitis (upala gušterače), pireksija (vrućica), abdominalna bol (bol u trbuhu), infarkt miokarda (srčani udar), arterijska fibrilacija (nepravilne brze kontrakcije gornjih srčanih klijetki), periferna arterijska okluzivna bolest (problem s protokom krvi u arterijama), anemija (niska razina eritrocita), angina pectoris (bol u prsima, čeljusti i leđima zbog problema s protokom krvi prema srcu), smanjena razina trombocita (tjelešaca koja pomažu pri zgrušavanju krvi), febrilna neutropenija (niska razina leukocita praćena vrućicom), hipertenzija (visoki krvni tlak), bolest koronarnih arterija (bolest srca uzrokovana začepljenjem krvnih žila koje opskrbljuju srčani mišić), zatajenje srca (kada srce ne radi kako bi trebalo), cerebrovaskularni incident (moždani udar), sepsa
Also, the company will conduct a study in order to determine the best starting dose of Iclusig and to assess the safety and effectiveness of Iclusig following dose reduction in patients with chronic phase CML who achieve major cytogenetic response.
Ta će tvrtka također provesti ispitivanje kako bi se utvrdila najbolja početna doza lijeka Iclusig te procijenila sigurnost i učinkovitost primjene lijeka Iclusig nakon smanjenja doze u bolesnika s KML-om u kroničnoj fazi kod kojih se postiže snažan citogenetski odgovor.
Side effects reported with Iclusig are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Iclusig pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Iclusig received a marketing authorisation valid throughout the EU on 1 July 2013.
Lijek Iclusig dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 1. srpnja 2013.
The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response' (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response' (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
Odgovor na liječenje procijenjen je mjerenjem udjela bolesnika koji su imali „značajan hematološki odgovor” (kad se broj leukocita vrati na normalnu razinu ili kada nema dokaza leukemije) ili „značajan citogenetski odgovor” (kada udio leukocita s Philadelphia-kromosomom padne ispod 35 %).
An overview of Iclusig and why it is authorised in the EU
Pregled informacija o lijeku Iclusig i zašto je odobren u EU-u
Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
U pogledu sigurnosti, nuspojave lijeka Iclusig bile su uglavnom slične nuspojavama ostalih inhibitora tirozin kinaze i uglavnom su se mogle kontrolirati smanjenjem doze ili odgađanjem primjene doze.
Iclusig can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.
Iclusig se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju leukemije.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iclusig have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Iclusig nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Ponatinib djeluje blokirajući tirozin kinazu zvanu Bcr-Abl.
Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Arterijski okluzivni štetni događaj (ugrušci ili začepljenja u arterijama) pojavio se u 25 % bolesnika, pri čemu su se ozbiljni štetni događaji pojavili u 20 % bolesnika.
It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Također se primjenjuje u bolesnika koji imaju genetsku mutaciju zvanu „T315I” koja ih čini rezistentnima na liječenje imatinibom, dasatinibom ili nilotinibom.
Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Venske tromboembolijske reakcije (problemi zbog krvnih ugrušaka u venama) pojavili su se u 6 % bolesnika.
The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Philadelphia-kromosom prisutan je kod nekih bolesnika s ALL-om te je prisutan u većine bolesnika s KML-om.
As for all medicines, data on the use of Iclusig are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Iclusig kontinuirano se prate.
The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
Rizik od problema (uključujući srčane i moždane udare) koji su rezultat krvnog ugruška ili začepljenja u arterijama ili venama može se smanjiti provjerom ili liječenjem čimbenika koji doprinose tom stanju poput visokog krvnog tlaka i povišenog kolesterola prije i tijekom liječenja.
Why is Iclusig authorised in the EU?
Zašto je lijek Iclusig odobren u EU-u?
The dose may need to be reduced or interrupted if the patient experiences certain side effects; it should be interrupted immediately if a blockage develops in an artery or vein.
Dozu je možda potrebno smanjiti ili privremeno prekinuti liječenje ako se kod bolesnika razviju određene nuspojave; liječenje se mora odmah prekinuti ako dođe do začepljenja u arteriji ili veni.
In the study, Iclusig was not compared with another treatment.
Iclusig u ispitivanju nije uspoređivan ni s jednom drugom terapijom.
The European Medicines Agency decided that Iclusig's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi lijeka Iclusig nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate.
Iclusig se koristi u bolesnika koji ne podnose ili ne reagiraju na liječenje dasatinibom (za bolesnike s KML-om ili ALL-om) ili nilotinibom, koji su drugi lijekovi istog razreda protiv raka i kod kojih se naknadno liječenje imatinibom (trećim takvim lijekom) ne smatra odgovarajućim.
The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Djelatna tvar u lijeku Iclusig, ponatinib, pripada skupini lijekova zvanih „inhibitori tirozin kinaze”.
Iclusig is a cancer medicine that contains the active substance ponatinib.
Iclusig je lijek protiv karcinoma koji sadrži djelatnu tvar ponatinib.
How does Iclusig work?
Kako djeluje Iclusig?
Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Pokazalo se da Iclusig predstavlja djelotvorno liječenje za one bolesnike s KML-om ili ALL-om Ph+ kojima su mogućnosti liječenja ograničene.
These compounds act by blocking enzymes known as tyrosine kinases.
Te tvari djeluju blokirajući enzime zvane tirozin kinaze.
What benefits of Iclusig have been shown in studies?
Koje su koristi od lijeka Iclusig utvrđene u ispitivanjima?
Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Iclusig je ispitivan u jednom glavnom ispitivanju koje je uključivalo 449 bolesnika s KML-om ili ALL-om Ph+ koji nisu podnosili liječenje ili nisu reagirali na liječenje dasatinibom, odnosno nilotinibom ili su imali mutaciju T315I.
Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Ozbiljni venski okluzivni štetni događaj (ugrušci ili začepljenja u venama) pojavili su se u 5 % bolesnika.
Iclusig can lead to clots or blockages in arteries and veins and patients should have the condition of their heart and circulation considered before starting and during treatment, and be treated appropriately for any problems.
Iclusig može uzrokovati ugruške ili začepljenja u arterijama i venama te je prije početka i tijekom liječenja potrebno provjeriti status srca i krvotoka bolesnika te ga liječiti na odgovarajući način ako je potrebno.
• among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
• među bolesnicima s ALL-om Ph+ otprilike 41 % (13 od 32 bolesnika) imalo je značajan hematološki odgovor.
• among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
• među bolesnicima s KML-om u kroničnoj fazi otprilike 54 % (144 od 267 bolesnika) imalo je značajan citogenetski odgovor;
• among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
• među bolesnicima s KML-om u ubrzanoj fazi otprilike 58 % (48 od 83 bolesnika) imalo je značajan hematološki odgovor;
• among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
• među bolesnicima s KML-om u blastičnoj fazi otprilike 31 % (19 od 62 bolesnika) imalo je značajan hematološki odgovor;
For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Iclusig potražite u uputi o lijeku.
The usual dose is one infusion of 4 mg over at least 15 minutes.
Uobičajena doza lijeka je jedna infuzija od 4 mg tijekom najmanje 15 minuta.
This reduces bone loss.
Time se smanjuje gubitak kosti.
Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Više informacija o lijeku Zoledronatna kiselina Accord možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Patients with tumours can have high levels of calcium in their blood, released from the bones.
Bolesnici s tumorima mogu imati visoku razinu kalcija u krvi koja se otpušta iz kostiju.
This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
To znači da Zoledronatna kiselina Accord sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Zometa.
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
To uključuje prijelome (lomove u kostima), kompresiju kralježaka (kada kost pritišće kralježničnu moždinu), koštane poremećaje koji zahtijevaju radioterapiju (liječenje zračenjem) ili kirurški zahvat, te hiperkalcemiju (visoku razinu kalcija u krvi).
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Zometa i stoga ih nije potrebno ponavljati za lijek Zoledronatna kiselina Accord.
Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Budući da je Zoledronatna kiselina Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Ona zaustavlja djelovanje osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Zoledronatna kiselina Accord na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
It is not recommended for patients with severely reduced kidney function.
Primjena lijeka ne preporučuje se u bolesnika s iznimno smanjenom funkcijom bubrega.
By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.
Sprečavanjem razgradnje kostiju lijek Zoledronatna kiselina Accord pridonosi i smanjenju količine kalcija koja se otpušta u krv.
Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Osteonekroza čeljusti bolest je koja zahvaća kosti čeljusti, što može dovesti do boli, rana u ustima i gubitka zuba.
Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Zoledronatna kiselina Accord pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoledronic Acid Accord have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zoledronatna kiselina Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Therefore, the Agency's view was that, as for Zometa, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Stoga je stav Agencije da korist od lijeka, kao i kod lijeka Zometa, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
The medicine is given as an infusion (drip) into a vein.
Lijek se daje intravenskom infuzijom (ukapavanje).
The company that markets Zoledronic Acid Accord will provide a card to inform patients receiving Zoledronic Acid Accord about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Tvrtka koja stavlja lijek Zoledronatna kiselina Accord u promet bolesnicima će osigurati informativnu karticu o riziku od osteonekroze čeljusti te ih uputiti da se obrate liječniku ako osjete navedene simptome.
Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Zoledronatna kiselina Accord može se primjenjivati i za liječenje hiperkalcemije uzrokovane tumorima.
The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno je da lijek Zoledronatna kiselina Accord posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Zometa.
Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Zoledronatna kiselina Accord izdaje se samo na liječnički recept i mora ga propisivati i davati zdravstveni radnik s iskustvom u intravenskoj primjeni ove vrste lijeka.
Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Lijek Zoledronatna kiselina Accord dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. siječnja 2014.
What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zoledronatna kiselina Accord?
An overview of Zoledronic Acid Accord and why it is authorised in the EU
Pregled informacija o lijeku Zoledronatna kiselina Accord i zašto je odobren u EU-u
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Smanjenje gubitka kosti pridonosi smanjenju lomljivosti kostiju, što pomaže u sprečavanju prijeloma u bolesnika oboljelih od raka i s metastazama kostiju.
For more information about using Zoledronic Acid Accord, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Zoledronatna kiselina Accord pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zoledronatna kiselina Accord lijek je za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom koji zahvaća kost.
Zoledronic Acid Accord (zoledronic acid)
Zoledronatna kiselina Accord (zoledronatna kiselina)
As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanju kakvoće lijeka Zoledronatna kiselina Accord.
This is because Zoledronic Acid Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Razlog tome je činjenica da se Zoledronatna kiselina Accord daje intravenskom infuzijom i stoga djelatna tvar odmah ulazi u krvotok.
Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Lijek Zoledronatna kiselina Accord sadrži djelatnu tvar zoledronatnu kiselinu te je „generički lijek”.