FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Travatan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Travatan.
English: Travatan is used to reduce intraocular pressure (pressure inside the eye).
Croatian: Travatan se koristi za snižavanje intraokularnog tlaka (tlaka unutar oka).
English: For more information about treatment with Travatan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Travatan pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball.
Croatian: U oku, prostaglandini povećavaju drenažu vodene tekućine (vodenog humora) iz očne jabučice.
English: What is the risk associated with Travatan?
Croatian: Koji su rizici povezani s lijekom Travatan?
English: All three studies compared travoprost with timolol, which is the standard treatment for glaucoma.
Croatian: Sva tri ispitivanja usporedila su travoprost s timololom, koji je standardna terapija za liječenje glaukoma.
English: The combined treatment with Travatan plus timolol produced an additional decrease of intraocular pressure in patients who were not controlled with timolol alone.
Croatian: Kombinirano liječenje lijekom Travatan i timololom rezultiralo je dodatnim smanjivanjem intraokularnog tlaka u bolesnika koji nisu bilo kontrolirani monoterapijom timolola.
English: Other information about Travatan
Croatian: Ostale informacije o lijeku Travatan
English: The CHMP decided that Travatan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP odlučilo je da koristi od lijeka Travatan nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: It is used in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Croatian: Koristi se u odraslih osoba koje imaju glaukomom otvorenog kuta (bolesti u slučaju koje se tlak u oku povisuje uslijed nemogućnosti drenaže tekućine iz oka) te u odraslih osoba s okularnom hipertenzijom (u slučaju kada je tlak u oku viši od normalnog).
English: The active substance in Travatan, travoprost, is a prostaglandin analogue (a man-made copy of a prostaglandin, one of a group of substances naturally found in the body).
Croatian: Djelatna tvar lijeka Travatan, travoprost, je analog prostaglandina (umjetno proizvedene kopije prostaglandina, jedne od grupe tvari koje su prirodno prisutne u tijelu).
English: One of the three trials also included a comparison with latanoprost (another prostaglandin analogue used for glaucoma).
Croatian: Jedno od tri ispitivanja uključilo je također usporedbu s latanoprostom (drugim analogom prostaglandina koji se koristi za liječenje glaukoma).
English: Why has Travatan been approved?
Croatian: Zašto je Travatan odobren?
English: When intraocular pressure is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Croatian: Prilikom povišenja intraokularnog tlaka, isti uzrokuje oštećenje šarenice (membrane osjetljive na svjetlo u stražnjem dijelu oka) i optičkog živca tako što šalje signale iz oka u mozak.
English: What is Travatan?
Croatian: Što je Travatan?
English: For the full list of all side effects and restrictions with Travatan, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja s lijekom Travatan, potražite u uputi o lijeku.
English: The most common side effects when using Travatan (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness) and iris hyperpigmentation (darkening of the colour of the iris).
Croatian: Najčešće nuspojave lijeka Travatan (mogu se javiti u više od 1 na 10 osoba) su okularna hiperemija (povišena isporuka krvi u oko, što rezultira nadraženošću i crvenilom oka) kao i hiperpigmentacija rožnice (tamnjenje rožnice).
English: Travatan is a clear eye drop solution that contains the active substance travoprost.
Croatian: Travatan je bistra otopina za kapi za oko koja sadrži djelatnu tvar travoprost.
English: What is Travatan used for?
Croatian: Za što se Travatan koristi?
English: What benefit has Travatan shown during the studies?
Croatian: Koje su koristi lijeka Travatan utvrđene u ispitivanjima?
English: Travatan acts in the same way and increases the flow of fluid out of the eye.
Croatian: Travatan djeluje na isti način i može povećati protok tekućine iz oka.
English: How is Travatan used?
Croatian: Kako se Travatan koristi?
English: How has Travatan been studied?
Croatian: Kako je Travatan ispitan?
English: 50 mg Powder for concentrate for solution for injection / infusion
Croatian: 50 mg Prašak za koncentrat za otopinu za injekciju/infuziju
English: EU Number
Croatian: Broj EU odobrenja
English: Intravenous use Vial (glass)
Croatian: Za primjenu u venu Bočica (staklo)
English: It is used:
Croatian: Primjenjuje se:
English: The remaining 16 patients did not fall into either group.
Croatian: Preostalih 16 bolesnika nije pripadalo ni jednoj od tih skupina.
English: This summary was last updated in 08-2017.
Croatian: Sažetak je posljednji put ažuriran u 08. 2017.
English: It is given using an infusion pump.
Croatian: Daje se infuzijskom pumpom.
English: This was switched to a full marketing authorisation on 24 April 2015.
Croatian: To je odobrenje pretvoreno u potpuno odobrenje za stavljanje u promet 24. travnja 2015.
English: To reduce the risk of these reactions, infusions are started slowly (particularly when first starting treatment) and then speeded up every 30 minutes if no reactions occur.
Croatian: Kako bi se smanjio rizik od tih reakcija, infuzije se počinju davati polako (osobito na samom početku liječenja), a zatim se ubrzavaju svakih 30 minuta ako se ne pojave reakcije.
English: What measures are being taken to ensure the safe and effective use of Arzerra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Arzerra?
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Arzerra on 19 April 2010.
Croatian: Europska komisija izdala je uvjetno odobrenje za stavljanje u promet lijeka Arzerra koje je na snazi u Europskoj uniji od 19. travnja 2010.
English: Arzerra was originally given ‘conditional approval', because there was more evidence to come about the medicine.
Croatian: Za lijek Arzerra prvotno je izdano „uvjetno odobrenje” jer su se očekivali dodatni podatci o lijeku.
English: What is Arzerra and what is it used for?
Croatian: Što je Arzerra i za što se koristi?
English: The dosing schedule depends on whether the patient has been treated before and whether the patient's disease has come back.
Croatian: Raspored doziranja ovisi o tome je li bolesnik prethodno liječen i je li se bolesnikova bolest ponovo pojavila.
English: Other information about Arzerra
Croatian: Ostale informacije o lijeku Arzerra
English: The full EPAR for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Arzerra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European Public Assessment Report (EPAR) for Arzerra.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Arzerra.
English: If reactions occur, treatment is interrupted and may be restarted at a slower rate when the patient has recovered or stopped permanently if a serious allergic reaction occurs.
Croatian: Ako se reakcije pojave, liječenje se prekida i može se ponovo započeti manjom brzinom kad se bolesnik oporavi ili potpuno prekinuti ako se pojavi teška alergijska reakcija.
English: The European Medicines Agency decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Arzerra can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in treating cancer and in a place where facilities for resuscitating patients are readily available.
Croatian: Arzerra se izdaje samo na liječnički recept, a treba ga davati pod nadzorom liječnika koji ima iskustva u liječenju raka i u ustanovi gdje je oprema za reanimaciju bolesnika odmah dostupna.
English: Because the number of patients with CLL is low, the disease is considered ‘rare', and Arzerra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Croatian: Budući da je broj bolesnika s KLL-om nizak, dotična se bolest smatra „rijetkom” te je lijek Arzerra dobio status „lijeka za liječenje rijetkih bolesti” 7. studenoga 2008.
English: The Agency also noted that patients with CLL who had not responded to previous treatment have limited treatment options.
Croatian: Agencija je također napomenula da bolesnici s KLL-om kod kojih nije zabilježen odgovor na prethodnu terapiju imaju ograničene mogućnosti liječenja.
English: By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Croatian: Vezivanjem na CD20 ofatumumab stimulira imunosni sustav tijela na napadanje stanica raka, čime pomaže u kontroliranju bolesti.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kod kojih je zabilježen odgovor na liječenje.
English: Refractory CLL
Croatian: Refraktorni KLL
English: Before each infusion, the patient receives medicines, such as a corticosteroid, an antihistamine and paracetamol, to help to prevent infusion reactions (such as rash, fever, allergic reactions and difficulty breathing).
Croatian: Prije svake infuzije bolesnik prima lijekove, kao što je kortikosteroid, antihistaminik i paracetamol, koji će pomoći u sprječavanju reakcija na infuziju (kao što su osip, vrućica, alergijske reakcije i otežano disanje).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Arzerra can also be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Arzerra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: What are the risks associated with Arzerra?
Croatian: Koji su rizici povezani s lijekom Arzerra?
English: In patients whose previous treatment with both fludarabine and alemtuzumab had failed, 49% (47 out of 95) responded to treatment with Arzerra.
Croatian: U bolesnika čije prethodno liječenje fludarabinom i alemtuzumabom nije uspjelo, 49 % (47 od 95) reagiralo je na liječenje lijekom Arzerra.
English: It is not intended to provide practical advice on how to use of Arzerra.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Arzerra.
English: • in previously untreated patients who cannot be treated with fludarabine; in these patients it is used together with chlorambucil or bendamustine (other cancer medicines);
Croatian: • u prethodno neliječenih bolesnika koje nije moguće liječiti fludarabinom; u tih bolesnika on se primjenjuje zajedno s klorambucilom ili bendamustinom (drugim lijekovima protiv raka);
English: In these patients Arzerra is used together with fludarabine and cyclophosphamide.
Croatian: U tih bolesnika Arzerra se upotrebljava zajedno s fludarabinom i ciklofosfamidom.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Croatian: Monoklonsko protutijelo je protutijelo (vrsta proteina) namijenjeno prepoznavanju određene strukture (nazvane antigen) koja se nalazi u određenim stanicama u tijelu i vezivanju na nju.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arzerra 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 Arzerra nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The most common side effects with Arzerra (seen in more than 1 patient in 10) are lower respiratory tract infection (infection of the lungs such as pneumonia), upper respiratory tract infection (nose and throat infection), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), nausea (feeling sick), fever, rash, dyspnoea (difficulty breathing), cough, diarrhoea and tiredness.
Croatian: Najčešće nuspojave lijeka Arzerra (uočene u više od 1 na 10 osoba) jesu infekcije donjeg respiratornog trakta (infekcija pluća kao što je upala pluća), infekcije gornjeg respiratornog trakta (infekcije nosa i grla), neutropenija (niska razina neutrofila, vrste bijelih krvnih stanica), anemija (niska razina crvenih krvnih stanica), mučnina (slabost), vrućica, osip, dispneja (otežano disanje), kašalj, proljev i umor.
English: • in patients whose disease has come back after previous treatment (known as relapsed disease).
Croatian: • u bolesnika čija se bolest ponovo pojavila nakon prethodnog liječenja (poznato kao recidiv bolesti).
English: Why is Arzerra approved?
Croatian: Zašto je lijek Arzerra odobren?
English: In 95 of these patients, the disease had not responded to both fludarabine and alemtuzumab, and in 112, treatment with fludarabine had failed but the patients had not been treated with alemtuzumab because this medicine was not suitable for them.
Croatian: U 95 od tih bolesnika bolest nije odgovorila ni na fludarabin ni na alemtuzumab, a u 112 bolesnika liječenje fludarabinom nije uspjelo, ali bolesnici nisu bili liječeni alemtuzumabom jer taj lijek za njih nije bio prikladan.
English: Relapsed CLL
Croatian: Relapsni KLL
English: The response rate was slightly lower in patients whose treatment with fludarabine had failed but who were not suitable for treatment with alemtuzumab (43%).
Croatian: Stopa odgovora bila je nešto niža u bolesnika čije liječenje fludarabinom nije uspjelo, ali za koje liječenje alemtuzumabom nije bilo prikladno (43 %).
English: For practical information about using Arzerra, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Arzerra bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Arzerra has been investigated in one main study involving 223 patients with CLL whose disease had not responded to previous treatment.
Croatian: Lijek Arzerra ispitan je u jednom glavnom ispitivanju koje je obuhvatilo 223 bolesnika s KLL-om čija bolest nije odgovorila na prethodno liječenje.
English: • in patients whose disease has not responded to previous treatment (known as refractory disease)
Croatian: • u bolesnika čija bolest ne odgovara na prethodno liječenje (poznata kao refraktorna bolest)
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Croatian: Arzerra je lijek za liječenje odraslih bolesnika s kroničnom limfocitnom leukemijom (KLL), vrstom raka bijelih krvnih stanica koje se nazivaju limfociti.
English: The response to treatment was assessed by looking at the patients' symptoms, the number of lymphocytes in their blood, results of blood and bone marrow tests and the size of their lymph nodes, liver and spleen.
Croatian: Odgovor na liječenje procijenjen je promatranjem simptoma bolesnika, broja limfocita u njihovoj krvi, rezultata krvnih pretraga i pretraga koštane srži te veličine njihovih limfnih čvorova, jetre i slezene.
English: Arzerra is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Arzerra dostupan je kao koncentrat za otopinu za infuziju (drip) u venu.
English: Ofatumumab has been designed to attach to a protein called CD20 that is found on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Croatian: Ofatumumab je namijenjen vezivanju na protein naziva CD20 koji se nalazi na površini limfocita, uključujući i tumorske limfocite prisutne kod KLL-a.
English: Arzerra plus fludarabine and cyclophosphamide was effective at increasing progression-free survival, with patients living on average for 28.9 months without their disease getting worse, compared with 18.8 months in patients given fludarabine and cyclophosphamide alone.
Croatian: Lijek Arzerra plus fludarabin i ciklofosfamid bio je djelotvoran u povećavanju preživljenja bez napredovanja bolesti, pri čemu su bolesnici živjeli u prosjeku 28,9 mjeseci bez pogoršanja bolesti, u usporedbi s 18,8 mjeseci u bolesnika koji su dobivali samo fludarabin i ciklofosfamid.
English: Arzerra was not compared with any other treatments in this study.
Croatian: Lijek Arzerra u tom ispitivanju nije uspoređen ni s jednim drugim liječenjem.
English: The Agency noted that Arzerra was shown to be effective at treating patients with CLL (previously untreated patients, patients who had not responded to previous treatment with fludarabine and alemtuzumab and patients whose cancer had come back after previous treatment).
Croatian: Agencija je napomenula da se lijek Arzerra pokazao djelotvornim u liječenju bolesnika s KLL-om (bolesnika koji nisu prethodno liječeni i bolesnika kod kojih nije zabilježen odgovor na prethodnu terapiju fludarabinom i alemtuzumabom te bolesnika čiji se karcinom vratio nakon prethodne terapije).
English: One main study involving 447 previously untreated patients who could not be treated with fludarabinebased therapy compared a combination of Arzerra plus chlorambucil with chlorambucil given alone.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 447 prethodno neliječenih bolesnika koje nije bilo moguće liječiti terapijom na bazi fludarabina uspoređena je kombinacija lijeka Arzerra i klorambucila s davanjem samo klorambucila.
English: Arzerra plus chlorambucil was effective at increasing progression-free survival (how long the patients lived without their disease getting worse), with patients living on average for 22.4 months without their disease getting worse, compared with 13.1 months in patients given chlorambucil alone.
Croatian: Lijek Arzerra i klorambucil bili su djelotvorni u povećanju preživljenja bez progresije (koliko su dugo bolesnici živjeli bez pogoršanja bolesti), pri čemu su bolesnici živjeli u prosjeku 22,4 mjeseca bez pogoršanja bolesti, u usporedbi s 13,1 mjeseci u bolesnika koji su dobivali samo klorambucil.
English: Previously untreated CLL
Croatian: KLL koji nije prethodno liječen
English: How is Arzerra used?
Croatian: Kako se Arzerra koristi?
English: with fludarabine and a medicine called alemtuzumab;
Croatian: fludarabinom i lijekom naziva alemtuzumab;
English: What benefits of Arzerra have been shown in studies?
Croatian: Koje su koristi lijeka Arzerra utvrđene u ispitivanjima?
English: How does Arzerra work?
Croatian: Kako djeluje Arzerra?
English: For more information about treatment with Arzerra, read the Package Leaflet (also part of the EPAR).
Croatian: Više informacija o liječenju lijekom Arzerra pročitajte u uputi o lijeku (također dio EPAR-a).
English: One main study involving 365 patients whose cancer had come back compared the combination of Arzerra plus fludarabine and cyclophosphamide with fludarabine and cyclophosphamide used alone.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 365 bolesnika čiji se rak ponovo pojavio uspoređena je kombinacija lijeka Arzerra primijenjenog uz fludarabin i ciklofosfamid s liječenjem samo fludarabinom i ciklofosfamidom.
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody.
Croatian: Djelatna tvar lijeka Arzerra, ofatumumab, monoklonsko je protutijelo.
English: For the full list of side effects and restrictions with Arzerra, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja lijeka Arzerra potražite u uputi o lijeku.
English: For more information on how Arzerra is used, see the summary of product characteristics (also part of the EPAR).
Croatian: Više informacija o načinu primjene lijeka Arzerra pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: The symptoms were completely reversible.
Croatian: Simptomi su bili u potpunosti reverzibilni.
English: The tablets can be divided into equal halves.
Croatian: . Tablete se mogu podijeliti na jednake polovice.
English: Incompatibilities: None known.
Croatian: Inkompatibilnosti: Nisu poznate.
English: For example: Overnight fasting if the dog is to be treated in the morning.
Croatian: Na primjer : Post preko noći ako će se pas tretirati ujutro.
English: The potential clinical consequences of such interactions have not been investigated.
Croatian: Potencijalne kliničke posljedice takvih interakcija nisu ispitane.
English: Do not administer orally or parenterally.
Croatian: Ne smije se primijeniti peroralno ili parenteralno.
English: Keep children away from treated animals during that time.
Croatian: Kroz to vrijeme djecu treba držati podalje od tretiranih životinja.
English: ATCvet code: QP52AA51.
Croatian: ATCvet kod: QP52AA51.
English: Do not smoke, eat or drink during application.
Croatian: Za vrijeme primjene ne smije se jesti, piti i pušiti.
English: The excretion of emodepside has not been investigated in dogs.
Croatian: Izlučivanje emodepsida nije ispitano kod pasa.
English: Maximum concentrations were reached 2 hours after treatment for both active substances.
Croatian: Maksimalne koncentracije postignute su 2 sata nakon primjene za obje djelatne tvari.
English: Echinococcosis represents a hazard for humans.
Croatian: Ehinokokoza predstavlja opasnost za čovjeka.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo da kontaktirate lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
English: Avoid the treated cat or other cats in the household licking the site of application while it is wet.
Croatian: Spriječite da tretirana mačka ili druge mačke u kućanstvu, ližu mjesto aplikacije dok je mokro.
English: Date of first authorisation: 27/07/2005.
Croatian: Datum prvog odobrenja: 27/07/2005.
English: Remove screw cap (2).
Croatian: Uklonite navojni čep (2).
English: Appropriate combination of volumes
Croatian: Prikladna kombinacija volumena
English: No food should be given until 4 hours after treatment.
Croatian: Nikakva hrana ne smije se davati unutar 4 sata nakon tretiranja.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na posljednji dan u mjesecu.
English: Highest concentration levels are found in the fat.
Croatian: Najviše koncentracije izmjerene su u masti.
English: Unused half tablets must not be stored for future use and should be disposed of in accordance with local requirements.
Croatian: Neupotrebljene polovice tableta ne smiju se čuvati za daljnju upotrebu i moraju se ukloniti u skladu s lokalnim propisima.
English: Treated animals therefore should not be bathed until the solution has dried.
Croatian: Tretirane životinje se stoga ne smiju kupati dok se otopina ne osuši.