FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment.
Croatian: U ispitivanjima je Ganfort uspoređen s bimatoprostom, timololom ili bimatoprostom i timololom koji su davani istovremeno nakon tri tjedna do četiri mjeseca terapije.
English: In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye.
Croatian: Kod glaukoma otvorenog kuta, visoki tlak nastaje zbog nemogućnosti istjecanja tekućine iz oka.
English: Other information about Ganfort
Croatian: Ostale informacije o lijeku Ganfort:
English: The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Ganfort nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Raised pressure in the eye 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: Povišeni tlak u oku oštećuje mrežnicu (membranu osjetljivu na svjetlost smještenu na stražnjem dijelu očne jabučice) kao i očni živac kojim se iz oka šalju signali prema mozgu.
English: What is Ganfort?
Croatian: Što je Ganfort?
English: The most common side effect (seen in more than 1 patient in 10) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye).
Croatian: Najčešća nuspojava (zabilježena u više od 1 na 10 bolesnika) je konjunktivalna hiperemija (povećan dotok krvi u oko što dovodi do crvenila oka).
English: Overall, the studies showed that Ganfort is effective in lowering eye pressure.
Croatian: Općenito su ispitivanja pokazala da je Ganfort djelotvoran u snižavanju očnog tlaka.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Croatian: Kombinacija tih dviju djelatnih tvari ima kumulativno djelovanje, snižavajući krvni tlak više nego samo jedan lijek samostalno.
English: By lowering the pressure, Ganfort reduces the risk of damage.
Croatian: Snižavanjem tlaka lijek Ganfort smanjuje rizik od oštećenja.
English: What benefit has Ganfort shown during the studies?
Croatian: Koje su koristi lijeka Ganfort dokazane u ispitivanjima?
English: In addition, Ganfort was shown to be as effective as bimatoprost and timolol given at the same time.
Croatian: Osim toga, pokazalo se da je Ganfort jednako djelotvoran kao bimatoprost i timolol kad ih se daje zajedno.
English: Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s.
Croatian: Timolol se uobičajeno koristi za liječenje glaukoma od 1970-tih.
English: Ganfort was more effective than timolol on its own and was as effective as bimatoprost.
Croatian: Lijek Ganfort pokazao se djelotvornijim od timolola kada se zasebno uzima i jednako djelotvornim kao i bimatoprost.
English: For the full list of all side effects reported with Ganfort, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Ganfort potražite u uputi o lijeku.
English: Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan.
Croatian: Bimatoprost je analogan prostaglandinu (kopija prirodne tvari prostaglandina) koji djeluje povećanim izlučivanjem tekućine iz oka.
English: Why has Ganfort been approved?
Croatian: Zašto je lijek Ganfort odobren?
English: How is Ganfort used?
Croatian: Kako se Ganfort koristi?
English: What is Ganfort used for?
Croatian: Za što se Ganfort koristi?
English: How has Ganfort been studied?
Croatian: Kako je Ganfort ispitivan?
English: How does Ganfort work?
Croatian: Kako djeluje Ganfort?
English: This may be because of manufacturing issues.
Croatian: Do toga može doći zbog problema u proizvodnji.
English: Common (≥ 1/100 to < 1/10)
Croatian: (≥1/100 do < 1/10)
English: Some of these side effects may be serious and may lead to hospitalization.
Croatian: Neke od ovih nuspojava mogu biti ozbiljne i mogu dovesti do hospitalizacije.
English: What to check before infusion
Croatian: Što provjeriti prije infuzije
English: March 2021
Croatian: ožujak 2021.
English: Your doctor will closely supervise the treatment therapy.
Croatian: Vaš liječnik će pozorno nadzirati terapiju.
English: • You have not received the Certificate of Analysis.
Croatian: • Niste primili certifikat o analizi.
English: It is unlikely that you will be given too much.
Croatian: Nije vjerojatno da ćete primiti previše lijeka.
English: Studies in animals have not been performed.
Croatian: Ispitivanja na životinjama nisu provedena.
English: Please inform your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Molimo Vas da obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The safety and efficacy in children and adolescents (less than 18 years) have not been established.
Croatian: Sigurnost i djelotvornost u djece i adolescenata (mlađih od 18 godina) nisu ustanovljene.
English: This will ensure that the cells can be eliminated before they can cause damage to the patient's cells.
Croatian: To će osigurati da stanice budu eliminirane prije nego uzrokuju štetu stanicama bolesnika.
English: There were no GvHD-related deaths or long-term complications.
Croatian: Nije bilo slučajeva smrti niti dugoročnih komplikacija povezanih s GvHD-om.
English: The clinical study report should be submitted by March 2021.
Croatian: Izvješće o kliničkom ispitivanju treba podnijeti do ožujka 2021.
English: Acute GvHD (33% of patients)
Croatian: Akutni GvHD (33 % bolesnika)
English: Progress updates should be submitted yearly with the annual renewal.
Croatian: Nadopune o napretku treba podnijeti jednom godišnje s godišnjom obnovom.
English: Non clinical safety data obtained in two different immunedeficient animal models for GvHD did not indicate special hazards for humans, but allowed only a very limited safety assessment.
Croatian: Neklinički podaci o sigurnosti primjene dobiveni u dva različita imunodeficijentna životinjska modela za GvHD nisu ukazali na posebne opasnosti za ljude, već su omogućili vrlo ograničenu ocjenu sigurnosti.
English: MARKETING AUTHORISATION NUMBER EU/1/16/1121/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1121/001
English: However, the risk of transmitting infectious viruses to healthcare professionals cannot be totally excluded.
Croatian: Ipak, rizik prenošenja infektivnih virusa na zdravstvene radnike ne može se u potpunosti isključiti.
English: As this medicine is prescribed by a doctor, each dose is prepared for you only and each preparation consists of a single dose.
Croatian: S obzirom da ovaj lijek propisuje liječnik, svaka doza pripremljena je isključivo za Vas i svaki pripravak čini jednu dozu.
English: The hospital staff are responsible for the correct storage of the product both before and during its use, as well as for correct disposal.
Croatian: Osoblje bolnice odgovorno je za pravilno čuvanje lijeka prije i tijekom korištenja, kao i za pravilno zbrinjavanje.
English: • The product integrity has been breached in anyway.
Croatian: • Integritet lijeka je narušen na bilo koji način.
English: In vitro evaluation of oncological potential indicate that the risk of malignant transformation is low.
Croatian: In vitro procjena onkološkog potencijala ukazuje na mali rizik od maligne transformacije.
English: Donor code:
Croatian: Oznaka donora:
English: • Put the bag into two plastic envelopes (double envelopment) to avoid direct contact with water.
Croatian: • Vrećicu stavite u dva plastična omota (dvostruki omot) kako bi se izbjegao njen direktni doticaj s vodom.
English: 20132 Milano Italy
Croatian: 20132 Milano Italija
English: • Proceed with the infusion as quickly as possible, avoiding keeping the bag in the water bath after thawing.
Croatian: • Krenite s infuzijom što je prije moguće, izbjegavajući držanje vrećice u vodenoj kupelji nakon odmrzavanja.
English: The amount of cells to be administered depends on your body weight.
Croatian: Količina stanica koju je potrebno primijeniti ovisi o Vašoj tjelesnoj težini.
English: • The expiry date has passed.
Croatian: • Rok valjanosti je prošao.
English: The cellular composition and the final cell number will vary according to the weight of the patient.
Croatian: Stanični sastav i konačan broj stanica varirat će ovisno o težini bolesnika.
English: CONTENTS OF THE PACK AND OTHER INFORMATION What Zalmoxis contains
Croatian: SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE Što Zalmoxis sadrži
English: Women of childbearing potential have to provide a negative pregnancy test (serum or urine) within 14 days prior to start the treatment.
Croatian: Žene reprodukcijske dobi moraju imati negativan test na trudnoću (iz seruma ili urina) unutar 14 dana prije početka liječenja.
English: This medicinal product contains genetically-modified cells.
Croatian: Ovaj lijek sadrži genetički modificirane stanice.
English: OTHER MolMed SpA
Croatian: DRUGO MolMed SpA
English: • The Certificate of Analysis is marked as rejected.
Croatian: • Certifikat o analizi nosi oznaku da je odbijen.
English: Additional infusions are given once a month, for up to 4 months.
Croatian: Dodatne infuzije daju se jednom mjesečno, najviše 4 mjeseca.
English: The recommended infusion time is around 20-60 minutes
Croatian: Preporučeno vrijeme infuzije je oko 20-60 minuta.
English: The bag is put in a second bag (intermediate container) and this one is placed in an aluminium box (outer container).
Croatian: Vrećica se nalazi u drugoj vrećici (intermedijarni spremnik), a ona se nalazi u aluminijskoj kutiji (vanjski spremnik).
English: This medicine is prescribed by a doctor and given in a hospital under strict survelliance and predetermined schedule so that you cannot forget your dose.
Croatian: Ovaj lijek propisuje liječnik te se daje u bolnici pod strogim nadzorom prema unaprijed utvrđenom rasporedu, tako da ne biste zaboravili sljedeću dozu.
English: Conventional toxicology, carcinogenicity, mutagenicity and reproductive toxicology studies have not been performed.
Croatian: Konvencionalna ispitivanja toksikologije, kancerogenosti, mutagenosti i reproduktivne toksičnosti nisu bila provedena.
English: Severity of acute GvHD was grade 1 in one case (3%), grade 2 in seven (23%), grade 3 in one (3%) and grade 4 in one (3%).
Croatian: Težina akutnog GvHD-a bila je 1. stupnja u jednom slučaju (3%), 2. stupnja u njih sedam (23%), 3. stupnja u jednom slučaju (3%) te 4. stupnja također u jednom slučaju (3%).
English: Donors are tested for transmissible infectious agents in line with applicable local requirements.
Croatian: Donori se testiraju na prenosive infektivne agense u skladu s primjenjivim lokalnim propisima.
English: This strategy allows the direct targeting of those T lymphocytes that are initiating the GvHD response.
Croatian: Ta strategija omogućava izravno ciljanje onih T-limfocita koji iniciraju GvHD reakciju.
English: The course of treatment is a maximum of four infusions at approximately one month intervals.
Croatian: Tijek liječenja čine maksimalno četiri infuzije u intervalima od približno jednog mjeseca.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene prema sve manjoj ozbiljnosti.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Croatian: Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: nije još dodijeljena Mehanizam djelovanja
English: If the bag appears to have clear breaks or to be non-intact, do not use the product.
Croatian: Ako na vrećici ima jasnih pukotina ili se ne čini netaknuta, nemojte koristiti lijek.
English: One patient with grade 1 acute GvHD did not receive any treatment.
Croatian: Jedan bolesnik s akutnim GvHD-om 1. stupnja nije primio nikakvo liječenje.
English: Do not irradiate.
Croatian: Nemojte ozračivati.
English: If GvHD occurs, GCV/VCV will be administered.
Croatian: U slučaju pojave GvHD-a, primijenit će se GCV/VCV.
English: The nature and the intended use of the product are such that conventional studies on pharmacokinetics including absorption, distribution, metabolism and excretion are not applicable.
Croatian: Priroda i namjena lijeka je takva da konvencionalna ispitivanja farmakokinetičkih svojstava poput apsorpcije, distribucije, metabolizma i izlučivanja nisu primjenjiva.
English: However, you should pay attention to your overall status when considering performing tasks that require judgment, motor or cognitive skills.
Croatian: Ipak, trebali biste obratiti pažnju na svoje cjelokupno stanje ukoliko biste željeli obavljati radnje koje zahtijevaju prosuđivanje te korištenje motoričkih ili kognitivnih vještina.
English: The identity of the patient must be matched with the essential unique donor information prior to infusion.
Croatian: Identitet bolesnika mora biti u skladu s ključnim jedinstvenim podacima o donoru prije infuzije.
English: The median interval time between the first and the subsequent infusions of Zalmoxis cells was 30 days.
Croatian: Medijan vremenskog intervala između prve i sljedeće infuzije stanica Zalmoxisa iznosio je 30 dana.
English: Both acute and chronic GvHD events developed only in patients who had achieved immune reconstitution.
Croatian: Akutni kao i kronični događaji GvHD-a razvili su se samo u bolesnika koji su postigli imunološku rekonstituciju.
English: The bag should be removed from the liquid nitrogen, put in a double bag container and thawed in a pre-warmed water bath at 37 °C.
Croatian: Vrećicu treba izvaditi iz tekućeg dušika, staviti u spremnik s dvostrukom vrećicom i odmrznuti u prethodno zagrijanoj vodenoj kupelji na 37 °C.
English: All acute GvHD events fully resolved after a median duration of 12 days.
Croatian: Svi akutni događaji GvHD-a u potpunosti su se povukli nakon medijana trajanja od 12 dana.
English: If you receive more Zalmoxis than you should
Croatian: Ako primite više lijeka Zalmoxis nego što ste trebali
English: There may be cases in which the treating physician may still consider preferable to give the treatment or select an alternative treatment.
Croatian: Mogu postojati slučajevi u kojima liječnik može smatrati da je ipak bolje primijeniti liječenje ili odabrati zamjensko liječenje.
English: Local biosafety guidelines applicable for such products should be followed for unused medicinal product or waste material.
Croatian: Lokalne smjernice o biosigurnosti primjenjive na takve lijekove moraju se slijediti za neiskorišteni lijek ili otpadni materijal.
English: • While holding the top of the envelope bag out of the water, put it in a 37±1°C water bath being careful not to allow water to penetrate the seal.
Croatian: • Pridržavajući gornju stranu vrećice s omotom izvan vode, stavite je u vodenu kupelj temperature 37 ± 1 °C, pritom pazeći da voda ne bi ulazila kroz zapečaćeni dio.
English: It has been shown that Zalmoxis cells may circulate for years after the last administration.
Croatian: Pokazalo se da stanice Zalmoxisa mogu ostati u cirkulaciji još godinama nakon posljednje primjene.
English: For the patients who achieved immune reconstitution, a nonrelapse mortality (NRM) of 17% was reported, with 35% of these patients being disease free at 5 years and 34% alive at 10 years.
Croatian: Za bolesnike koji su postigli imunološku rekonstituciju prijavljena je smrtnost bez relapsa od 17%, od čega je 35% bolesnika bilo bez znakova bolesti nakon 5 godina te 34% njih živih nakon 10 godina.
English: In this case, Zalmoxis may be administered after an adequate wash out period (the time necessary to remove a medicine from your body).
Croatian: U tom slučaju Zalmoxis je moguće primijeniti nakon odgovarajućeg vremena ispiranja (vrijeme potrebno za uklanjanje lijeka iz organizma).
English: • When completely thawed, remove the Zalmoxis bag out from the double envelopment, dry it off and disinfect the outside.
Croatian: • Nakon što se u potpunosti odmrzne, izvadite vrećicu Zalmoxisa iz dvostrukog omota, osušite je i dezinficirajte njen vanjski dio.
English: Practical information for medical or healthcare professionals on the handling and administration of Zalmoxis.
Croatian: Praktične informacije za medicinske ili zdravstvene radnike o rukovanju i primjeni Zalmoxisa.
English: No adverse reactions were reported for this patient.
Croatian: Nikakve nuspojave nisu bile prijavljene za tog bolesnika.
English: There was no significant difference regarding leukaemia free survival and the chance for relapse.
Croatian: Nije bilo značajne razlike u pogledu preživljenja bez leukemije i izgleda za pojavu relapsa.
English: Seven patients needed to add an immunosuppressive treatment consisting of steroids, mycophenolate and/or cyclosporine.
Croatian: U sedam bolesnika bilo je potrebno dodatno imunosupresivno liječenje koje se sastojalo od steroida, mikofenolata i/ili ciklosporina.
English: A Detailed step-by step description of Zalmoxis administration procedure, also focusing on:
Croatian: Detaljni opis postupka primjene lijeka Zalmoxis, korak po korak, koji je također usredotočen na:
English: Zalmoxis should be infused intravenously over a period of 20-60 minutes.
Croatian: Zalmoxis se treba infundirati intravenski tijekom razdoblja od 20-60 minuta.
English: Results from a matched-pair analyses that included 36 Zalmoxis patients (22 from TK007 trial and 14 from the ongoing phase III TK008 trial) and 127 control patients, showed that the Zalmoxis treated patients that had survived the first 3 weeks post-transplant without relapse benefited in terms of 1 year overall survival (OS) (40% vs 51% (p=0.03)) and 1-year NRM (42% vs 23% (p=0.04)).
Croatian: Rezultati analize podudarnih parova, koja je uključivala 36 bolesnika koji su primali Zalmoxis (22 iz ispitivanja TK007 i 14 iz tekućeg ispitivanja faze III TK008) i 127 kontrolnih bolesnika, pokazali su da su bolesnici liječeni lijekom Zalmoxis koji su preživjeli prva tri tjedna nakon transplantacije bez relapsa, imali koristi u smislu ukupnog preživljenja nakon godinu dana (OS, engl. overall survival) (40% naspram 51% (p=0,03)) i smrtnosti bez relapsa nakon godinu dana (42% naspram 23% (p=0,04)).
English: - If, before infusion, the value of CD3+ lymphocytes in your tests is equal to or more than 100 per μL.
Croatian: - ako je prije infuzije vrijednost limfocita CD3+ u vašim pretragama jednaka ili veća od 100 po μl.
English: Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per dose.
Croatian: Svaka vrećica sadrži približno 13,3 mmol (305,63 mg) natrija po dozi.
English: • Zalmoxis must be used be immediately after removal from the shipping container.
Croatian: • Zalmoxis se mora upotrijebiti odmah nakon što ga se izvadi iz spremnika za dostavu.
English: Cases in which Zalmoxis cannot be supplied / infused In some cases, the patient may be unable to receive Zalmoxis because of manufacturing issues.
Croatian: Slučajevi u kojima se Zalmoxis ne može dostaviti / primijeniti putem infuzije U nekim slučajevima bolesnik možda neće moći primiti Zalmoxis zbog problema proizvodnji.
English: - If you are taking medicines to suppress your immune system or you are taking G-CSF (that stimulates the bone marrow to produce blood cells) after receiving stem-cell transplantation .
Croatian: - ako uzimate lijekove za supresiju imunološkog sustava ili primjenjujete G-CSF (koji stimulira koštanu srž na proizvodnju krvnih stanica) nakon obavljene transplantacije matičnih stanica.
English: • Zalmoxis is shipped directly to the medical facility where the infusion will be administered.
Croatian: • Zalmoxis se isporučuje izravno medicinskoj ustanovi u kojoj će se primijeniti infuzija.
English: Zalmoxis can only be prescribed and administered in a hospital by a doctor or a nurse who is trained in administering this medicine.
Croatian: Zalmoxis se može propisati i primijeniti samo u bolnici od strane liječnika ili medicinske sestre koja je prošla obuku za primjenu ovog lijeka.
English: Currently, no data are available for these patients.
Croatian: Trenutno nema dostupnih podataka za ovu skupinu bolesnika.
English: Of 30 patients receiving Zalmoxis, 23 patients (77%) obtained immune reconstitution, with a median time of 31 days after the first infusion.
Croatian: Od 30 bolesnika koji su primali Zalmoxis, 23 bolesnika (77%) je postiglo imunološku rekonstituciju, s medijanom vremena od 31 dana nakon prve infuzije.
English: - If you have any further questions, ask your doctor, or a physician experienced in the medical treatment of blood cancer.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili liječniku s iskustvom u liječenju raka krvi.
English: No detrimental effects on such activities are predicted from the pharmacology of the medicinal product.
Croatian: Nikakvi štetni učinci na takve radnje nisu predviđeni s obzirom na farmakologiju lijeka.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: MOGUĆE NUSPOJAVE Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Post transplant lymphoproliferative disorder
Croatian: Post-transplantacijski limfoproliferativni poremećaj
English: Accordingly, healthcare professionals should take appropriate precautions (e.g. wearing gloves and glasses) when handling Zalmoxis.
Croatian: U skladu s time, zdravstveni radnici moraju poduzeti odgovarajuće mjere opreza (npr. nositi rukavice i zaštitne naočale) prilikom rukovanja Zalmoxisom.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately.
Croatian: U slučaju predoziranja, bolesnike je potrebno pažljivo pratiti radi znakova ili simptoma nuspojava te odmah započeti s odgovarajućim simptomatskim liječenjem.
English: Given the intended clinical use in the context of a haploidentical bone marrow transplantation, a need for treatment during pregnancy is not expected.
Croatian: S obzirom na namjeravanu kliničku primjenu u kontekstu haploidentične transplantacije koštane srži ne očekuje se potreba za liječenjem tijekom trudnoće.
English: Upon full cell dispersion thawing, the bag is dried, disinfected and ready to be infused at a rate prescribed by the physician.
Croatian: Nakon što se sva stanična disperzija odmrzne, vrećica se osuši, dezinficira te je spremna za infuziju brzinom propisanom od strane liječnika.
English: The primary mechanism of action of Zalmoxis relies on its ability to engraft and stimulate immunereconstitution.
Croatian: Primarni mehanizam djelovanja Zalmoxisa zasniva se na njegovoj sposobnosti usađivanja i stimuliranja imunološke rekonstitucije.
English: The dose corresponds to 1 ± 0.2 x 107 cells/kg.
Croatian: Doza odgovara 1 ± 0,2 x 107 stanica/kg.
English: Additional infusions are administered at approximately one month intervals for a maximum of four times, until a circulating T lymphocyte count is equal to or more than 100 per µL.
Croatian: Dodatne infuzije primjenjuju se u razmacima od približno mjesec dana, do najviše četiri puta, sve dok broj cirkulirajućih T-limfocita ne bude jednak ili veći od 100 po µl.
English: Symptoms of overdose are not known.
Croatian: 4.9 Predoziranje Simptomi predoziranja nisu poznati.
English: Immune cells are excreted in human milk in low amounts.
Croatian: Stanice imunološkog sustava izlučuju se u majčino mlijeko u ljudi u malim količinama.
English: Work surfaces and material which have potentially been in contact with Zalmoxis must be decontaminated with appropriate disinfectant.
Croatian: Radne površine i materijali koji su možda bili u doticaju s lijekom Zalmoxis moraju se dekontaminirati odgovarajućim dezinfekcijskim sredstvom.