FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding its safety, the CHMP noted that Provenge was generally well tolerated.
Croatian: Što se tiče njegove sigurnosti, CHMP je uočio da se Provenge općenito dobro podnosi.
English: Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
Croatian: Provenge autologne mononuklearne stanice periferne krvi aktivirane s PAP-GM-CSF (sipuleucel-T)
English: It is used when the cancer is metastatic (has spread to other parts of the body), and when medical or surgical castration (stopping the production of male hormones) has not worked or no longer works but treatment with chemotherapy (medicines that kill fast-growing cells like cancer cells) is not yet considered appropriate.
Croatian: Koristi se kad je karcinom metastatski (proširio se na druge dijelove tijela) i kada medicinska ili kirurška kastracija (prekid proizvodnje muških hormona) nije bila djelotvorna ili više ne djeluje ali liječenje kemoterapijom (lijekovima koji ubijaju brzo rastuće stanice poput stanica karcinoma) se još uvijek ne smatra odgovarajućim.
English: What are the risks associated with Provenge?
Croatian: Koji su rizici povezani s lijekom Provenge?
English: It contains immune cells that are extracted from the patient's blood.
Croatian: Sadrži stanice imunološkog sustava koje su ekstrahirane iz bolesnikove krvi.
English: Once prepared, the medicine is given as an infusion lasting around 1 hour.
Croatian: Nakon pripreme lijek se daje u obliku infuzije koja traje približno sat vremena.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease.
Croatian: Riječ je o vrsti lijeka koja sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za liječenje, dijagnostiku ili sprječavanje bolesti.
English: Around half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce infusion-related reactions with Provenge.
Croatian: Oko pola sata prije svake infuzije bolesnik treba uzeti paracetamol i antihistaminik za redukciju reakcija povezanih s infuzijom lijeka Provenge.
English: The company will also set up an EUbased registry of patients treated with Provenge in order to monitor overall survival and side effects reported (particularly stroke and heart attack), and will provide data from a US-based registry.
Croatian: Tvrtka će također uspostaviti EU registar bolesnika liječenih lijekom Provenge kako bi se nadziralo ukupno preživljavanje i prijavljene nuspojave (posebice moždani i srčani udar) te će osigurati podatke iz američkog registra.
English: In addition, the company that markets Provenge will provide educational materials for doctors and patients on how to use the medicine and the leukapheresis procedure.
Croatian: Osim toga, tvrtka koja stavlja Provenge na tržište osigurati će edukacijske materijale za liječnike i bolesnike o tome kako koristiti lijek i kako provoditi postupak leukafereze.
English: It will also supply cards for patients to record the scheduled leukapheresis and infusion dates.
Croatian: Također će osigurati kartice za bolesnike kako bi mogli upisivati raspored leukafereze i datume infuzije.
English: The main risks included acute infusion reactions, toxicities associated with the leukapheresis procedure and infections, but the CHMP considered that these were manageable and adequately addressed by risk minimisation measures for this medicine.
Croatian: Glavni rizici povezani su s akutnim infuzijskim reakcijama, toksičnosti povezanom s postupkom leukafereze i infekcijama, ali je CHMP smatrao da se te reakcije mogu liječiti i kontrolirati na odgovarajući način planom upravljanja rizicima za ovaj lijek.
English: Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge.
Croatian: Također će se provesti daljnja ispitivanja kako bi se dobili dodatni podaci koji potkrepljuju djelotvornost lijeka Provenge.
English: Provenge is available as a liquid dispersion for infusion (drip) into a vein.
Croatian: Provenge je dostupan kao tekuća disperzija za infuziju (drip) u venu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Provenge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Provenge nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji.
English: The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients.
Croatian: CHMP je zaključio da je poboljšavanje u ukupnom preživljavanju uočeno kod lijeka Provenge važno za bolesnike.
English: Serious side effects with Provenge include severe acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteraemia), heart attack and cerebrovascular events (related to the blood supply to the brain).
Croatian: Ozbiljne nuspojave povezane s lijekom Provenge uključuju teške akutne infuzijske reakcije, tešku infekciju (katetersku sepsu i stafilokoknu bakterijemiju), srčani udar i cerebrovaskularne događaje (povezane s opskrbom mozga krvlju).
English: Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Croatian: Provenge je vrsta lijeka za naprednu terapiju koji se naziva „lijek za terapiju somatskim stanicama”.
English: These cells are then mixed outside the patient's body with a ‘fusion protein', which is taken up by the cells.
Croatian: Te se stanice zatim miješaju izvan bolesnikova tijela s „proteinom fuzije” koji stanice apsorbiraju.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Provenge, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju ovog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka i uputu o lijeku za Provenge uključujući i odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Provenge is a cancer medicine that is prepared specifically for each patient using their own immune cells (cells that form part of the body's natural defences).
Croatian: Provenge je lijek protiv karcinoma koji se priprema specifično za svakog bolesnika upotrebom stanica njegovog vlastitog imunološkog sustava (stanica koje su dio prirodnog obrambenog sustava tijela).
English: The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells.
Croatian: Protein fuzije sastoji se od fosfataze prostatične kiseline (PAP), molekule koja se nalazi u većini stanica karcinoma prostate, pričvršćena faktor koji stimulira koloniju granulocita-makrofaga (GM-CSF), molekule koja aktivira imunološki sustav.
English: Provenge is used to treat adult men with cancer of the prostate (a gland of the male reproductive system) who have few or no symptoms.
Croatian: Provenge se koristi za liječenje odraslih muškaraca s karcinomom prostate (žlijezda muškog spolnog sustava) koji imaju nekoliko ili nimalo simptoma.
English: Three days before the infusion, a procedure called leukapheresis is performed to collect immune cells from the patient's blood, and these are then sent to a manufacturing facility to prepare the medicine.
Croatian: Tri dana prije infuzije provodi se postupak zvan leukafereza kako bi se prikupile stanice imunološkog sustava iz bolesnikove krvi i potom se iste šalju u proizvodni pogon da bi se pripremio lijek.
English: When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP.
Croatian: Kad se stanice imunološkog sustava infundiraju natrag u bolesnika, iste stimuliraju odgovor na PAP što potiče imunološki sustav da napadne i ubije stanice karcinoma prostate jer sadrže PAP.
English: The most common side effects with Provenge (which may affect more than 1 in 10 people) include chills, fatigue (tiredness), pyrexia (fever), nausea (feeling sick), arthralgia (joint pain), headache and vomiting.
Croatian: Najčešće nuspojave lijeka Provenge (koje se mogu javiti u više od 1 na 10 osoba) uključuju trnce, umor (zamor), pireksiju (vrućicu), mučninu, artralgiju (bol u zglobovima), glavobolju i povraćanje.
English: Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells.
Croatian: Provenge je imunoterapija, lijek koji stimulira imunološki sustav da ubija stanice karcinoma.
English: Provenge was shown to improve overall survival (the average length of time the patients lived) of patients with castration-resistant metastatic prostate cancer, compared with placebo (a dummy treatment).
Croatian: Dokazano je da Provenge poboljšava ukupno preživljavanje (prosječna duljina vremena života bolesnika) bolesnika s karcinomom prostate otpornim na kastraciju, u usporedbi s placebom (slijepo liječenje).
English: What benefits of Provenge have been shown in studies?
Croatian: Koje koristi lijeka Provenge su dokazane u ispitivanjima?
English: For more information about treatment with Provenge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Provenge pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For practical information about using Provenge, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Provenge bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: This type of prostate cancer is called castration-resistant matastatic prostate cancer.
Croatian: Ova vrsta karcinoma prostate naziva se metastatski karcinom prostate otporan na kastraciju.
English: How does Provenge work?
Croatian: Kako Provenge djeluje?
English: For the full list of all side effects reported with Provenge, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Provenge potražite u uputi o lijeku.
English: Provenge can only be obtained with a prescription.
Croatian: Umnažanje je dopušteno samo uz citiranje izvora.
English: Further information on Bexsero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Bexsero možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The second main study involved 1,631 adolescents aged between 11 and 17.
Croatian: U drugom glavnom ispitivanju sudjelovao je 1631 adolescent u dobi od 11 do 17 godina.
English: Bexsero should be used according to official recommendations.
Croatian: Bexsero treba primjenjivati u skladu sa službenim preporukama.
English: The number of injections given, and the interval between them, varies depending on the age of the patient.
Croatian: Broj primijenjenih injekcija i razdoblje između njihove primjene razlikuje se ovisno o dobi bolesnika.
English: This means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response.
Croatian: To znači da su proteini fiksirani u jedan spoj koji sadrži aluminij radi stimulacije boljeg imunosnog odgovora.
English: Young children are most at risk, followed by adolescents.
Croatian: Najugroženija skupina su mala djeca i adolescenti.
English: Although group B meningococcal disease is relatively uncommon in Europe, it is more common in certain regions of Europe.
Croatian: Iako je meningokokna bolest relativno rijetka u Europi, učestalija je u određenim europskim regijama.
English: It is given by deep injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in children under two years old.
Croatian: Primjenjuje se injektiranjem duboko u mišić, po mogućnosti u rameni mišić, a u djece mlađe od dvije godine u bedreni mišić.
English: Other information about Bexsero
Croatian: Ostale informacije o lijeku Bexsero
English: The first main study involved 2,627 children who were two months old when the study started.
Croatian: Prvo glavno ispitivanje obuhvatilo je 2627 djece koja su na početku ispitivanja imala dva mjeseca.
English: What is Bexsero and what is it used for?
Croatian: Što je Bexsero i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Bexsero?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bexsero?
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Croatian: Invazivna bolest nastupa kad se bakterija proširi tijelom uzrokujući ozbiljne infekcije poput meningitisa (infekcije membrana koje okružuju mozak i kralježnicu) i sepse (infekcije krvi).
English: Why is Bexsero authorised in the EU?
Croatian: Zašto je Bexsero odobren u EU-u?
English: Bexsero received a marketing authorisation valid throughout the EU on 14 January 2013.
Croatian: Lijek Bexsero dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 14. veljače 2013.
English: For more information about using Bexsero, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni cjepiva Bexsero pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Bexsero are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Bexsero pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Bexsero are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Bexsero kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bexsero 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 Bexsero nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: A smaller supportive study was also carried out in adults and similar results were seen in this study.
Croatian: Provedeno je i manje pomoćno ispitivanje u kojem su sudjelovali odrasli.
English: An overview of Bexsero and why it is authorised in the EU
Croatian: Pregled cjepiva Bexsero i zašto je odobreno u EU-u
English: The European Medicines Agency decided that Bexsero'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 Bexsero nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What are the risks associated with Bexsero?
Croatian: Koji su rizici povezani s lijekom Bexsero?
English: The effects of giving one, two or three doses of Bexsero (at intervals of at least one month) were compared with giving placebo (a dummy treatment).
Croatian: Učinak primjene jedne, dvije ili triju doza cjepiva Bexsero (u intervalima od barem mjesec dana) uspoređen je s učinkom placeba (prividnog lijeka).
English: Bexsero is available as a suspension for injection in a pre-filled syringe and can only be obtained with a prescription.
Croatian: Bexsero je dostupan kao otopina za injekciju u napunjenoj štrcaljki, a izdaje se samo na liječnički recept.
English: The most common side effects with Bexsero in children up to 10 years of age (seen in more than 1 patient in 10) are eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia (joint pain), fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site.
Croatian: Najčešće nuspojave cjepiva Bexsero u djece u dobi do 10 godina (zabilježene u više od 1 na 10 bolesnika) su poremećaji u prehrani, pospanost, neuobičajeni plač, glavobolja, proljev, povraćanje, osip, artralgija (bol u zglobovima), vrućica i razdražljivost kao i osjetljivost, oticanje, tvrdoća i crvenilo kože na mjestu primjene injekcije.
English: Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B).
Croatian: Bexsero je cjepivo koje se primjenjuje za zaštitu osoba u dobi od dva mjeseca i starijih od invazivne meningokokne bolesti uzrokovane jednom grupom bakterija Neisseria meningitidis (grupa B).
English: Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed])
Croatian: Cjepivo Bexsero (protiv meningokoka grupe B [rDNK, komponentno, adsorbirano])
English: The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Croatian: Najčešće nuspojave cjepiva Bexsero u adolescenata u dobi od 11 godina i odraslih (zabilježene u više od 1 na 10 bolesnika) su glavobolja, mučnina i slabost, mialgija (bol u mišićima) i artralgija (bol u zglobovima), vrućica i razdražljivost kao i osjetljivost, oticanje, tvrdoća i crvenilo kože na mjestu primjene injekcije.
English: How is Bexsero used?
Croatian: Kako se Bexsero koristi?
English: How does Bexsero work?
Croatian: Kako djeluje Bexsero?
English: This study was extended to look at the effects of giving a booster dose of Bexsero at or after 12 months of age to children who had already received Bexsero in early infancy, compared with giving two ‘catch-up' doses to those who had not.
Croatian: Ispitivanje je produženo da bi se istražila primjena dodatne doze cjepiva Bexsero u djece u dobi od 12 mjeseci ili starije koja su već primila Bexsero u ranoj dojenačkoj dobi u usporedbi s primjenom dvije „naknadne” doze u djece koja ga nisu primila u ranoj dobi.
English: The effects of giving three doses of Bexsero at two-month intervals together with other routine infant vaccinations were compared with giving the routine vaccinations alone.
Croatian: Učinak primjene triju doza cjepiva Bexsero svaka dva mjeseca zajedno s drugim standardnim cjepivima za dojenčad uspoređen je s učinkom standardnih cjepiva primijenjenih samostalno.
English: Bexsero contains four proteins which are found on the surfaces of cells of the N. meningitidis group B bacterium.
Croatian: Bexsero sadrži četiri proteina koji se nalaze na površini stanica bakterije N. meningitidis grupe B.
English: What benefits of Bexsero have been shown in studies?
Croatian: Koje su koristi od cjepiva Bexsero utvrđene u ispitivanjima?
English: Bexsero has been shown to produce a robust immune response to N. meningitidis group B and the risks are acceptable.
Croatian: Dokazano je da Bexsero proizvodi snažan imunosni odgovor na bakteriju N. meningitidis grupe B te da su rizici prihvatljivi.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B and that two doses were needed to produce an adequate immune response.
Croatian: Ispitivanje je pokazalo da je Bexsero učinkovito stimulirao imunosni odgovor na bakteriju N. meningitidis grupe B te da je potrebno primijeniti dvije doze da bi se stvorio odgovarajući imunosni odgovor.
English: For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Bexsero potražite u uputi o lijeku.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Croatian: Osim toga, jedna dodatna doza cjepiva Bexsero primijenjena u dobi od 12 mjeseci proizvela je jači imunosni odgovor u djece koja su već primila Bexsero u odnosu na prvu od dvije „naknadne” doze u djece iste dobi koja ga nisu primila.
English: Bexsero contains parts of the bacteria N. meningitidis group B.
Croatian: Neisseria meningitidis (N. meningitidis) grupe B.
English: Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. The studies measured the production of protective antibodies which are able to kill the bacteria.
Croatian: U dva glavna ispitivanja utvrđeno je da Bexsero učinkovito stimulira imunosni odgovor na bakteriju N. meningitidis grupe B.
English: Xagrid was originally authorised under ‘exceptional circumstances'.
Croatian: Xagrid je odobren u „iznimnim okolnostima”.
English: Further information on Xagrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Xagrid nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients were treated with Xagrid for up to five years.
Croatian: Bolesnici su liječeni lijekom Xagrid do najviše pet godina.
English: Xagrid was not compared with any other medicines.
Croatian: Xagrid nije uspoređen ni s jednim drugim lijekom.
English: Xagrid is available as capsules (0.5 mg).
Croatian: Dostupan je u obliku kapsula (0,5 mg).
English: In the largest study, 67% of the patients with essential thrombocythaemia (628 out of 934), and 66% of those who could not tolerate other treatments or whose condition did not respond to them (480 out of 725) had a complete response to Xagrid.
Croatian: U najvećem ispitivanju kod 67 % bolesnika s esencijalnom trombocitemijom (628 od 934) i 66 % onih koji nisu podnosili druge lijekove ili kod kojih je zabilježen izostanak odgovora na liječenje drugim lijekovima (480 od 725) zabilježen je potpuno uspješan odgovor na liječenje lijekom Xagrid.
English: The recommended starting dose is 1 capsule twice a day.
Croatian: Preporučena početna doza lijeka Xagrid je jedna kapsula dvaput dnevno.
English: What is Xagrid and what is it used for?
Croatian: Što je Xagrid i za što se koristi?
English: Most patients had previously received other medicines but could not continue with them.
Croatian: Većina bolesnika prethodno je uzimala druge lijekove, ali im je bila potrebna promjena terapije.
English: The dose can then be increased every week by 1 capsule a day, until the patient's platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the usual level in healthy people).
Croatian: Nakon jednog tjedna, doza se svakog tjedna povećava za jednu kapsulu dnevno sve dok broj trombocita u bolesnika ne bude manji od 600 milijuna trombocita po mililitru, pri čemu bi bilo idealno da taj broj bude između 150 i 400 milijuna/ml (razina koja je obično prisutna u zdravih osoba).
English: This summary was last updated in 06-2018.
Croatian: Ovaj sažetak je posljednji put ažuriran u 01. 2017.
English: The maximum recommended dose of Xagrid is 5 capsules at a time.
Croatian: Najviša preporučena doza lijeka Xagrid jest pet kapsula odjedanput.
English: The main measure of effectiveness was the number of patients who had a ‘complete response', when platelet counts fell either by at least 50% from the start of treatment or to below 600 million/ml.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kod kojih je zabilježen „potpuno uspješan odgovor na lijek”, što je bilo definirano kao smanjenje broja trombocita za najmanje 50 % od početka liječenja ili smanjenje na razinu ispod 600 milijuna/ml.
English: Other information about Xagrid
Croatian: Ostale informacije o lijeku Xagrid