FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Velcade?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Velcade?
English: Velcade must not be used in people who are hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients.
Croatian: Velcade se ne smije upotrebljavati kod osoba koje su preosjetljive (alergične) na bortezomib, boron ili na bilo koju drugu tvar.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velcade.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Velcade.
English: When Velcade is used with other medicines the restrictions for those medicines must also be taken into account, including the requirements for pregnancy testing and prevention with thalidomide.
Croatian: Ako se Velcade koristi s drugim lijekovima, u obzir se moraju uzeti i ograničenja povezana s tim lijekovima, uključujući i zahtjeve za provođenje testa na trudnoću i prevenciju talidomidom.
English: Velcade is used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Croatian: Velcade se koristi za liječenje multipla mijeloma, raka krvi u sljedećih grupa bolesnika:
English: The main measures of effectiveness in these studies were the number of patients who responded to treatment and how long the patients lived without their disease getting worse.
Croatian: Glavna mjera djelotvornosti u ovim ispitivanjima bio je broj bolesnika koji su odgovorili na terapiju i duljina preživljenja bolesnika bez pogoršanja bolesti.
English: The main measure of effectiveness was how long the patients lived without their disease getting worse.
Croatian: Glavna mjera djelotvornosti bila je duljina preživljenja bez pogoršanja bolesti.
English: This document is a summary of the European public assessment report (EPAR) for Velcade.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni dokumentacije (EPAR) o lijeku Velcade.
English: Velcade 1 mg must only be given by injection into a vein, while Velcade 3.5 mg is only given either by injection into a vein or under the skin.
Croatian: Velcade od 1 mg smije se davati samo injekcijom u venu, dok se Velcade od 3,5 mg daje injekcijom u venu ili pod kožu.
English: In addition, the company that markets Velcade will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Croatian: Nadalje, tvrtka koja stavlja lijek Velcade u promet osigurat će da zdravstveni djelatnici zaprime edukacijske materijale koji objašnjavaju način izračunavanja doze i pripreme te primjene lijeka.
English: • Around 34% of the patients responded partially or completely to treatment with Velcade (in a study in which Velcade was not compared with any other medicine)
Croatian: • Otprilike 34% bolesnika odgovorilo je djelomično ili u potpunosti na liječenje lijekom Velcade (u ispitivanju u kojem Velcade nije uspoređen s bilo kojim drugim lijekom).
English: It is available in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection.
Croatian: Dostupan je u bočicama (1 i 3,5 mg) kao prašak za otopinu za injekciju.
English: Velcade is a cancer medicine that contains the active substance bortezomib.
Croatian: Velcade je lijek protiv karcinoma koji sadrži djelatnu tvar bortezomib.
English: A risk management plan has been developed to ensure that Velcade is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Velcade.
English: The most serious adverse reactions include heart failure, tumour lysis syndrome (complications due to breakdown of cancer cells), pulmonary hypertension (high blood pressure in the arteries of the lungs), posterior reversible encephalopathy syndrome (a reversible brain disorder), acute diffuse infiltrative pulmonary disease (a severe lung problem), and autonomic neuropathy (damage to nerves controlling organs such as the bladder, eyes, gut, heart and blood vessels).
Croatian: Najozbiljnije nuspojave uključuju zatajenje srca, sindrom lize tumora (komplikacije povezane s razgradnjom tumorskih stanica), pulmonalnu hipertenziju (visoki krvni tlak u arterijama pluća), posterioran reverzibilan sindrom encefalopatije (reverzibilan poremećaj mozga), akutni difuzni infiltrativni plućni poremećaj (ozbiljan problem s plućima) i autonomnu neuropatiju (oštećenje živaca koji kontroliraju organe poput mjehura, očiju, crijeva, srca i krvnih žila).
English: What is the risk associated with Velcade?
Croatian: Koji su rizici povezani s lijekom Velcade?
English: For more information about treatment with Velcade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Velcade pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Treatment with Velcade should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Croatian: Liječenje lijekom Velcade treba započeti i nadzirati liječnik s iskustvom u primjeni kemoterapije za liječenje karcinoma.
English: Doses of Velcade are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Velcade is given alone or in combination with other medicines.
Croatian: Doze lijeka Velcade daju se u razmacima s razdobljima odmora između dvije doze, i to u ciklusima liječenja od tri do šest tjedna ovisno o tome primjenjuje li se Velcade kao monoterapija ili u kombinaciji s drugim lijekovima.
English: When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Croatian: Nakon što se daje u venu, otopina se daje kao injekcija od tri do pet sekundi kroz kateter (tanku sterilnu cijev).
English: Why has Velcade been approved?
Croatian: Zašto je Velcade odobren?
English: • The study that compared Velcade given under the skin with Velcade given into a vein showed that the percentage of patients who responded partially or completely to treatment was the same (42%) when using either route of administration.
Croatian: • Ispitivanje koje je usporedilo Velcade primijenjen supkutano s lijekom Velcade primijenjen intravenozno dokazalo je da je postotak bolesnika koji su odgovorili djelomično ili u potpunosti na liječenje bio isti (42%) bez obzira na to koji je put primjene korišten.
English: The most commonly reported side effects during treatment with Velcade are nausea (feeling sick), diarrhoea, constipation, vomiting, fatigue (tiredness), pyrexia (fever), thrombocytopenia (low blood platelets count), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), peripheral neuropathy (nerve damage in the hands and feet), headache, paraesthesia (unusual sensations like pins and needles), decreased appetite, dyspnoea (difficulty breathing), rash, herpes zoster (shingles) and myalgia (muscle pain).
Croatian: Najčešće zabilježene nuspojave tijekom liječenja lijekom Velcade su mučnina (osjećaj slabosti), proljev, zatvor, povraćanje, iscrpljenost (umor), pireksija (groznica), trombocitopenija (mali broj trombocita), anemija (mali broj crvenih krvnih stanica), neutropenija (niske razine neutrofila, tipa bijelih krvnih stanica koje se bore protiv infekcije), periferna neuropatija (oštećenje živaca u rukama i nogama), glavobolja, parastezija (neobični osjećaji poput trnaca i iglica), smanjenje apetita, dispneja (otežano disanje), osip, herpes zoster (pasac) i mialgija (bol u mišićima).
English: The CHMP decided that Velcade's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Velcade nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velcade, 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 Velcade nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: • Around 15% of patients who were candidates for high-dose chemotherapy and a blood stem-cell transplant responded to treatment with Velcade plus dexamethasone, compared with 6% of those given standard combinations.
Croatian: • Otprilike 15% bolesnika koji su kandidati za kemoterapiju velike doze s transplantacijom hematopoetskih matičnih stanica odgovorilo je na terapiju Velcade i deksametazon u usporedbi sa 6% onih koji su primili standardne kombinacije.
English: What is Velcade?
Croatian: Što je Velcade?
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
Croatian: • odraslih osoba čija se bolest pogoršava inakon najmanje jednogliječenja i koji su već podvrgnuti, ili se ne mogu podvrgnuti, transplantaciji hematopoetskih matičnih stanica.
English: In multiple myeloma, Velcade has been evaluated in 10 main studies involving over 4,339 adults, which evaluated the benefits of Velcade alone or in combination with other treatments.
Croatian: U slučaju multipla mijeloma, Velcade je ispitan u 10 glavnih ispitivanja koja su obuhvatila 4339 odraslih osoba koje su ocijenile korist lijeka Velcade kada se primjenjivao kao monoterapija ili u kombinaciji s drugim terapijama.
English: In addition, 49% of these patients responded to Velcade plus thalidomide and dexamethasone, compared with about 26% who responded to treatment containing Velcade plus other anticancer drugs, and 17% who responded to thalidomide and dexamethasone alone.
Croatian: Nadalje, 49% ovih bolesnika odgovorilo je na Velcade i talidomid te deksametazon u usporedbi s otprilike 26% za liječenje koje je sadržavalo Velcade plus druge protutumorske lijekove, a 17% onih koji su primili samo monoterapiju talidomidom i deksametazonom.
English: Velcade is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Croatian: Velcade se također koristi za liječenje limfoma stanica rubne zone, drugog raka krvi, u neliječenih odraslih osoba koje ne mogu primiti transplantaciju hematopoetskih matičnih stanica.
English: In mantle cell lymphoma, Velcade was evaluated in a main study involving 487 previously untreated adults who were not considered suitable for blood stem-cell transplantation.
Croatian: U slučaju limfoma stanica rubne zone, Velcade je ocijenjen u glavnom ispitivanju koje je obuhvatilo 487 prethodno ne liječenih odraslih osoba koji nisu bili prikladni za transplantaciju hematopoetskih matičnih stanica.
English: In mantle cell lymphoma, patients treated with a combination of Velcade plus rituximab, cyclophosphamide, doxorubicin and prednisone lived longer without their disease getting worse (24.7 months) than those given the same combination but with vincristine in place of Velcade (14.4 months).
Croatian: U slučaju limfoma stanica rubne zone, bolesnici liječeni kombinacijom Velcade plus rituksimab, ciklofosfamid, doksorubicin i prednizon živjeli su dulje bez progresije (24,7 mjeseci) u odnosu na one s istom kombinacijom, no uz primjenu vinkristina umjesto lijeka Velcade (14,4 mjeseci).
English: • Among patients with worsening disease that had come back or failed to respond to at least one other treatment, around 70% responded to treatment with the Velcade-dexamethasone combination.
Croatian: • U bolesnika s pogoršanjem bolesti koja se vratila ili koji nisu odgovorili na najmanje jednu terapiju, pri čemu je 70% bolesnika odgovorilo na liječenje kombinacijom lijekova Velcade i deksametazona.
English: For more information on the use of Velcade, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o korištwnju lijeka Velcade pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Studies in multiple myeloma showed Velcade and combinations containing Velcade to be beneficial in several patient groups.
Croatian: Ispitivanja provedena u multipla mijeloma utvrdila su korist lijeka Velcade i kombinacija koje sadrže Velcade za nekoliko grupa bolesnika.
English: In this study, Velcade together with rituximab, cyclophosphamide, doxorubicin and prednisone was compared with the same combination containing another medicine, vincristine, in place of Velcade.
Croatian: U ovom ispitivanju, Velcade zajedno s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom uspoređen je s istom kombinacijom koja je sadržavala drugi lijek, vinkristin, umjesto lijeka Velcade.
English: In these patients, Velcade is used in combination with melphalan and prednisone;
Croatian: U ovih bolesnika, Velcade se koristi u kombinaciji s melfalanom i prednisonom;
English: • previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant.
Croatian: • bolesnika koji nisu prethodno liječeni i koji će primiti kemoterapiju u visokim dozama nakon čega slijedi transplantacija hematopoetskih matičnih stanica.
English: • patients given Velcade with pegylated liposomal doxorubicin whose disease was getting worse after having failed to respond to at least one other treatment, lived for 9.3 months without their disease getting worse compared to 6.5 months for patients receiving Velcade alone.
Croatian: • Bolesnici koji su primali Velcade s pegiliranim liposomalnim doksorubicinom, a čija se bolest pogoršavala nakon što nisu uspješno odgovorili na najmanje jedno drugo liječenje, imali su prosječno razdoblje do pogoršanja bolesti od 9,3 mjeseca u usporedbi sa 6,5 mjeseci za bolesnike koji su primali monoterapiju lijekom Velcade.
English: What is Velcade used for?
Croatian: Za što se Velcade koristi?
English: • Previously patients receiving Velcade lived for an average of 6.2 months without their disease getting worse, compared with 3.5 months in those receiving dexamethasone.
Croatian: • Bolesnici koji su prethodno primali lijek Velcade živjeli su prosječno 6,2 mjeseca bez da se njihova bolest pogoršavala, u usporedbi s 3,5 mjeseci u bolesnika koji su primali deksametazon.
English: What benefit has Velcade shown during the studies?
Croatian: Koje su koristi lijeka Velcade utvrđene u ispitivanjima?
English: In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Croatian: U ovoj grupi bolesnika, Velcade se koristi u kombinaciji s deksametazonom ili s deksametazonom plus talidomid;
English: • previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
Croatian: • odraslih osobakoje nisu prethodno liječene i za koje nije prikladna kemoterapija u visokim dozama s transplantacijom hematopoetskih matičnih stanica.
English: For mantle cell lymphoma, Velcade is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: Za potrebe liječenja limfoma stanica rubne zone, Velcade se koristi u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: For the full list of all side effects reported with Velcade, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Velcade potražite u uputi o lijeku.
English: Velcade is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Croatian: Velcade se koristi kao monoterapija u ovih bolesnika ili u kombinaciji s pegiliranim liposomalnim doksorubicinom ili deksametazonom.
English: Velcade was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Croatian: Velcade je odobren u „iznimnim okolnostima”.
English: It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Croatian: Djelatna tvar u lijeku Velcade, bortezomib, je inhibitor proteazoma Inhibira proteazom, koji je sustav unutar stanica koje razgrađuju protein ako se isti više nisu potrebni.
English: • Previously untreated patients lived for an average of 20.7 months without their disease getting worse when they received Velcade together with melphalan and prednisone, compared with 15.0 months in the patients receiving only melphalan and prednisone.
Croatian: • Bolesnici koji prethodno nisu liječeni živjeli su prosječno 20,7 mjeseci bez da se njihova bolest pogoršala nakon što su primili Velcade zajedno s melfalanom i prednisonom.
English: How has Velcade been studied?
Croatian: Kako je Velcade ispitivan?
English: How is Velcade used?
Croatian: Kako se Velcade koristi?
English: How does Velcade work?
Croatian: Kako djeluje Velcade?
English: Patients should be monitored for signs and symptoms and managed as recommended in section 4.2.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma te liječiti u skladu s preporukama navedenim u dijelu 4.2.
English: Corticosteroid treatment unless otherwise specified
Croatian: Liječenje kortikosteroidima, osim ako nije drugačije navedeno
English: • Inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Croatian: • upalu ili probleme s mišićima: simptomi mogu uključivati bol u mišićima, ili slabost ili brzo umaranje mišića;
English: Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
Croatian: Razmotriti primjenu prednizona u početnoj dozi od 1 - 4 mg/kg na dan ili ekvivalenta, koja se zatim postupno smanjuje
English: Durvalumab - Myasthenia gravis (EPITT no 19451)
Croatian: Durvalumab - mijastenija gravis (EPITT br. 19451)
English: Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:
Croatian: Liječnik će možda odgoditi primjenu sljedeće doze lijeka IMFINZI ili obustaviti liječenje lijekom IMFINZI, ako imate:
English: Adopted at the 30 September-3 October 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a održanoj od 30. rujna do 3. listopada 2019.
English: Permanently discontinue d d) For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Croatian: Trajno prekinuti liječenjed d) Kod mijastenije gravis, ako postoje znakovi mišićne slabosti ili respiratorne insuficijencije, liječenje lijekom IMFINZI treba trajno prekinuti.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/532016/2019
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/556427/2019
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Croatian: S obzirom na mehanizam djelovanja lijeka IMFINZI, mogu se javiti i druge potencijalne imunološki uzrokovane nuspojave.
English: treated with IMFINZI monotherapy in clinical trials (n = 1889): myasthenia gravis, myocarditis, myositis, polymyositis.
Croatian: Sljedeće imunološki uzrokovane nuspojave zabilježene su u manje od 1 % bolesnika liječenih monoterapijom lijekom IMFINZI u kliničkim ispitivanjima (n = 1889): mijastenija gravis, miokarditis, miozitis, polimiozitis.
English: Undesirable effects Nervous system disorders Rare: Myasthenia gravis
Croatian: Nuspojave Poremećaji živčanog sustava Rijetko: Mijastenija gravis
English: IMFINZI treatment modification
Croatian: Prilagodba liječenja lijekom IMFINZI
English: Other immunemediated adverse reactions
Croatian: Ostale imunološki uzrokovane nuspojave
English: Withhold dose
Croatian: Odgoditi primjenu doze
English: Rare: a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Croatian: Moguće nuspojave Rijetko: stanje u kojem mišići postaju slabi i dolazi do brzog umora mišića (mijastenija gravis).
English: Frequency not known: eruption of the skin or mucous membranes (lichenoid drug reaction)
Croatian: Učestalost nepoznata: izbijanje promjena na koži ili sluznici (lihenoidna reakcija na lijek)
English: Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: lichenoid drug reaction
Croatian: Poremećaji kože i potkožnog tkiva Učestalost nepoznata: lihenoidna reakcija na lijek
English: Special warnings and precautions for use
Croatian: Posebna upozorenja i mjere opreza pri uporabi Ostale imunološki uzrokovane nuspojave
English: Summary of product characteristics 4.2.
Croatian: Sažetak opisa svojstava lijeka 4.2. Doziranje i način primjene
English: Lithium - Drug-induced lichenoid reaction (EPITT no
Croatian: Litij - lihenoidna reakcija uzrokovana lijekom (EPITT br. 19389)
English: The binding is about 90%.
Croatian: Vezanje je oko 90%.
English: • Difficulty sleeping
Croatian: • teškoće sa spavanjem
English: If you have forgotten to take your tablet in the morning, take it as soon as possible thereafter.
Croatian: Ako ste zaboravili uzeti tabletu ujutro, uzmite je čim je moguće poslije toga.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekova koje više ne koristite.
English: • You should preferably be in an upright position.
Croatian: • Poželjno je da budete u uspravnom položaju.
English: No antidote is available.
Croatian: Nema antidota.
English: Risks may be higher when high doses are given.
Croatian: Rizici su veći kada se daju više doze.
English: The need for additional doses of Plenadren
Croatian: Potreba za dodatnim dozama Plenadrena
English: Do not stop taking it without consulting your doctor.
Croatian: Nemojte ga prestati uzimati a da se niste posavjetovali s liječnikom.
English: Side effects of this medicine are:
Croatian: Nuspojave ovog lijeka su:
English: B - 1000 Brussels Belgium
Croatian: B-1000 Brussels
English: The safety and efficacy of Plenadren in children/adolescents aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Plenadrena u djece/adolescenata u dobi ispod 18 godina nisu još ustanovljene.
English: Other medicines and Plenadren
Croatian: Drugi lijekovi i Plenadren
English: • Mood changes such as feelings of overexcitement or losing touch with reality
Croatian: • promjene raspoloženja kao što je osjećaj prevelike uzbuđenosti ili gubitka dodira sa stvarnošću
English: The effect of corticosteroids may be reduced for 3-4 days after treatment with mifepristone.
Croatian: Učinak kortikosteroida može biti smanjen 3 do 4 dana nakon liječenja mifepristonom.
English: Please discuss this with your doctor and follow the instructions on how to act in these situations.
Croatian: Molimo porazgovarajte o tome sa svojim liječnikom i pridržavajte se uputa o tome kako postupati u takvim situacijama.
English: They will normally disappear with time, if not contact your doctor.
Croatian: One obično s vremenom nestanu, a ako ne, obratite se liječniku.
English: Stopping Plenadren may be life threatening.
Croatian: Prestanak uzimanja Plenadrena može biti opasan za život.
English: In which case, symptomatic treatment should be instituted as necessary.
Croatian: U tom slučaju treba uvesti simptomatsko liječenje prema potrebi.
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Croatian: Upotrebljavaju se također zbog svojih snažnih protuupalnih učinaka u poremećajima mnogih organskih sustava.
English: The lowest possible maintenance dosage should be used.
Croatian: Primjenjivati valja najnižu moguću dozu održavanja.