FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano s neadjuviranim cjepivima tvrtke Merial (različite kombinacije komponenti protiv virusnog rinotraheitisa, kaliciviroze, panleukopenije i klamidioze mačaka) i/ili primijenjeno istog dana, ali ne pomiješano s adjuviranim cjepivom protiv bjesnoće tvrtke Merial.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I NOSITELJ(I) ODOBRENJA
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Croatian: U uvjetima na terenu samo je podgrupa A infektivna, te imunizacija protiv podgrupe
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and rabies components).
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istoga dana, ali ne pomiješano s adjuviranim cjepivima tvrtke Merial (različite kombinacije komponenti protiv virusnog rinotraheitisa, kaliciviroze, panleukopenije i bjesnoće mačaka).
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano i primijenjeno s paletom neadjuviranih cjepiva tvrtke Merial (različite kombinacije komponenti protiv virusnog rinotraheitisa, kaliciviroze, panleukopenije i klamidioze mačaka.
English: Read the package leaflet before use
Croatian: KOLIČINA DJELATNE(IH) TVARI Pročitati uputu o VMP prije primjene
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Croatian: 14. RIJEČI “ČUVATI IZVAN DOSEGA
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I NOSITELJ(I)
English: The recommended starting dose is one capsule three times a day.
Croatian: Preporučena početna doza lijeka Yargesa je jedna kapsula triput dnevno.
English: The full EPAR for Yargesa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Yargesa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari i stoga se očekuje da imaju isti učinak.
English: Yargesa is available as 100 mg capsules to be taken by mouth.
Croatian: Yargesa je dostupna u obliku kapsula od 100 mg koje se uzimaju kroz usta.
English: As for every medicine, the company provided studies on the quality of Yargesa.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Yargesa.
English: As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones.
Croatian: Kao posljedica toga glukozilceramid se nakuplja u različitim dijelovima tijela poput slezene, jetre i kostiju.
English: This is a summary of the European public assessment report (EPAR) for Yargesa.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Yargesa.
English: This means that it contains the same active substance (miglustat) and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zavesca.
Croatian: To znači da Yargesa sadržava istu djelatnu tvar (miglustat) i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Zavesca.
English: What measures are being taken to ensure the safe and effective use of Yargesa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Yargesa?
English: What is Yargesa and what is it used for?
Croatian: Što je Yargesa i za što se koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Yargesa has been shown to have comparable quality and to be bioequivalent to Zavesca.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Yargesa posjeduje usporedivu razinu kvalitete te je bioekvivalentan lijeku Zavesca.
English: Yargesa is used in patients who cannot receive enzyme-replacement therapy.
Croatian: Yargesa se koristi u bolesnika koji ne mogu primati enzimsko nadomjesno liječenje.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Yargesa.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari u odobrenoj uporabi već su provedena s referentnim lijekom Zavesca i ne treba ih ponavljati za lijek Yargesa.
English: Because Yargesa is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Yargesa generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Croatian: Lijek se izdaje samo na recept, a liječenje moraju nadzirati liječnici s iskustvom u kontroliranju Gaucherove bolesti.
English: Yargesa is a ‘generic medicine'.
Croatian: To je „generički lijek”.
English: Other information about Yargesa
Croatian: Ostale informacije o lijeku Yargesa
English: It is not intended to provide practical advice on how to use Yargesa.
Croatian: Svrha sažetka nije pružiti praktične savjete o primjeni lijeka Yargesa.
English: For more information on generic medicines, see the question-and-answer document here.
Croatian: Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorimaovdje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yargesa 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 Yargesa nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the benefits and risks of Yargesa?
Croatian: Koje su koristi i rizici lijeka Yargesa?
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Croatian: Sprječavanjem djelovanja enzima miglustat može smanjiti proizvodnju glukozilceramida u stanicama i pritom smanjiti simptome Gaucherove bolesti tipa 1.
English: Patients with this disease lack an enzyme that breaks down a type of fat called glucosylceramide.
Croatian: Bolesnicima koji boluju od ove bolesti nedostaje enzim koji razgrađuje određeni tip masnoća zvani glukozilceramid.
English: Therefore, the CHMP's view was that, as for Zavesca, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i u slučaju lijeka Zavesca, koristi nadmašuju utvrđene rizike.
English: For more information about treatment with Yargesa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Yargesa pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Yargesa is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.
Croatian: Yargesa je lijek za liječenje odraslih osoba s blagom do umjerenom Gaucherovom bolesti tipa 1.
English: Why is Yargesa approved?
Croatian: Zašto je lijek Yargesa odobren?
English: The Committee recommended that Yargesa be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Yargesa u Europskoj uniji.
English: For practical information about using Yargesa, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Yargesa bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: A lower dose should be used in patients with reduced kidney function and those who develop diarrhoea.
Croatian: Bolesnicima sa smanjenom funkcijom bubrega i onima kod kojih se javi proljev treba dati manju dozu.
English: How does Yargesa work?
Croatian: Kako djeluje Yargesa?
English: How is Yargesa used?
Croatian: Kako se Yargesa koristi?
English: The active substance in Yargesa, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Croatian: Djelatna tvar u lijeku Yargesa, miglustat, sprječava djelovanje enzima glukozilceramid sintaze.
English: For more information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti u uputi o lijeku.
English: How has Yargesa been studied?
Croatian: Kako je lijek Yargesa ispitivan?
English: What is Zaltrap and what is it used for?
Croatian: Što je Zaltrap i za što se koristi?
English: This cycle of treatment is repeated every two weeks, until the disease gets worse or the patient cannot tolerate the treatment.
Croatian: Taj ciklus liječenja ponavlja se svaka dva tjedna, dok se bolest ne pogorša ili bolesnik više ne podnosi liječenje.
English: The full EPAR for Zaltrap can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR lijeka Zaltrap nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the average length of time that patients survived after treatment.
Croatian: Glavna mjera djelotvornosti bila je prosječno vrijeme preživljavanja bolesnika nakon liječenja.
English: Zaltrap is given as an infusion (drip) into the vein over one hour, at a dose of 4 mg per kilogram body weight.
Croatian: Zaltrap se primjenjuje kao infuzija (drip) u venu tijekom jednog sata, u dozi od 4 mg po kilogramu tjelesne težine.
English: What measures are being taken to ensure the safe and effective use of Zaltrap?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zaltrap?
English: Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.
Croatian: Iako postoje lijekovi sa istom djelatnom tvari koji se mogu ubrizgavati u oko, Zaltrap se ne smije ubrizgavati u oko jer nije razvijen za takvu uporabu te može uzrokovati lokalno oštećenje.
English: What are the risks associated with Zaltrap?
Croatian: Koji su rizici povezani s lijekom Zaltrap?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zaltrap on 1 February 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Zaltrap u promet koje je na snazi u Europskoj uniji od 1. veljače 2013.
English: This is a summary of the European public assessment report (EPAR) for Zaltrap.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Zaltrap.
English: Other information about Zaltrap
Croatian: Ostale informacije o lijeku Zaltrap
English: It is not intended to provide practical advice on how to use Zaltrap.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Zaltrap.
English: This is then followed by the FOLFIRI treatment.
Croatian: Nakon toga primjenjuje se liječenje FOLFIRI.
English: Although Zaltrap is associated with significant side effects, which can be severe enough to force treatment to be stopped, the results of the large main study show that there is a small but clinically significant benefit in prolonging the life of treated patients in whom previous treatment failed.
Croatian: Iako je Zaltrap povezan sa značajnim nuspojavama koje mogu biti dovoljno ozbiljne za prekid liječenja, rezultati velikog glavnog ispitivanja pokazali su da postoji mala, ali klinički značajna korist u produljivanju preživljavanja liječenih bolesnika u kojih je prethodno liječenje bilo bezuspješno.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, so helping to slow down the growth of tumours.
Croatian: Kao rezultat toga tumorske stanice ne mogu razviti vlastitu opskrbu krvlju te su im uskraćeni kisik i hranjive tvari, što pomaže pri usporavanju rasta tumora.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zaltrap have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zaltrap nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Zaltrap approved?
Croatian: Zašto je lijek Zaltrap odobren?
English: Overall, the European Medicines Agency decided that Zaltrap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi od lijeka Zaltrap nadmašuju s njim povezane rizike i preporučila davanje odobrenja za njegovu primjenu u EU-u.
English: By binding to VEGF and PlGF, aflibercept stops them having an effect.
Croatian: Aflibercept vezanjem za VEGF i PIGF zaustavlja njihovo djelovanje.
English: How is Zaltrap used?
Croatian: Kako se Zaltrap koristi?
English: Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment.
Croatian: Zaltrap je ispitivan u jednom glavnom ispitivanju koje je obuhvatilo 1226 odraslih bolesnika s metastatskim rakom debelog crijeva koji nisu odgovorili na liječenje na bazi oksaliplatina.
English: Zaltrap can only be obtained with a prescription and treatment should be supervised by a doctor who is experienced in using cancer medicines.
Croatian: Zaltrap se izdaje samo na liječnički recept, a liječenje mora nadzirati liječnik s iskustvom primjene lijekova protiv raka.
English: The medicine contains the active substance aflibercept.
Croatian: Lijek sadrži djelatnu tvar afilibercept.
English: In this study, Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.
Croatian: Zaltrap je bio djelotvorniji od placeba u pogledu povećavanja stope preživljavanja bolesnika: bolesnici koji su liječeni lijekom Zaltrap u kombinaciji s protokolom FOLFIRI živjeli su prosječno 13,5 mjeseci, pri čemu su bolesnici koji su primali placebo u kombinaciji s lijekom FOLFIRI živjeli približno 12,1 mjesec.
English: Zaltrap is used with FOLFIRI, which is a treatment combining the medicines irinotecan, 5-fluorouracil, and folinic acid.
Croatian: Zaltrap se primjenjuje s protokolom FOLFIRI, liječenjem u kojem se kombiniraju lijekovi irinotekan, 5-fluorouracil i folna kiselina.
English: What benefits of Zaltrap have been shown in studies?
Croatian: Koje su koristi lijeka Zaltrap utvrđene u ispitivanjima?
English: The most common side effects with Zaltrap in combination with FOLFIRI (which may affect more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), tiredness, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache.
Croatian: Najčešće su nuspojave liječenja lijekom Zaltrap u kombinaciji s protokolom FOLFIRI (koje se mogu pojaviti u više od 20 od 100 bolesnika) leukopenija i neutropenija (niske razine bijelih krvnih stanica, uključujući vrstu stanica koje se bore protiv infekcija), proljev, proteinurija (protein u mokraći), povećana razina jetrenih enzima u krvi (aspartat i alanin transaminaze), stomatitis (upala usta), umor, trombocitopenija (smanjeni broj trombocita u krvi), hipertenzija (visoki krvni tlak), gubitak težine, smanjeni apetit, epistaksa (krvarenje iz nosa), bol u trbuhu, disfonija (poremećaj govora), povećanje kreatinina u krvi (znak bubrežnih problema) i glavobolja.
English: For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Zaltrap bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, tiredness, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).
Croatian: Najčešći uzroci koji su doveli do trajnog prekida liječenja bili su problemi s cirkulacijom, uključujući hipertenziju, infekcije, umor, proljev, dehidraciju, stomatitis, neutropenija, proteinurija i plućna embolija (krvni ugrušak u krvnoj žili koja opskrbljuje pluća).
English: Zaltrap was compared with placebo (a dummy treatment) when added to FOLFIRI.
Croatian: Zaltrap je uspoređivan s placebom (prividno liječenje) u kombinaciji s protokolom FOLFIRI.
English: For more information about treatment with Zaltrap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Zaltrap pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Zaltrap is a cancer medicine used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body) for whom treatment based on another medicine, oxaliplatin, has not worked or the cancer got worse.
Croatian: Zaltrap je lijek protiv raka koji se koristi za liječenje odraslih bolesnika s metastatskim rakom debelog crijeva (rak debelog crijeva proširio se na druge dijelove tijela) koji su bezuspješno primali drugi lijek oksaliplatin ili se rak pogoršao.
English: The active substance in Zaltrap, aflibercept, is a protein that attaches to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and make blood vessels grow.
Croatian: Djelatna tvar lijeka Zaltrap je aflibercept, protein koji se veže na vaskularni endotelni čimbenik rasta (VEGF) i placentarni čimbenik rasta (PIGF), tvari koje kruže u krvi i povećavaju krvne žile.
English: How does Zaltrap work?
Croatian: Kako djeluje Zaltrap?
English: Treatment should be discontinued, delayed, or the dose may have to be adjusted, in patients who develop certain side effects.
Croatian: U bolesnika koji razviju određene nuspojave liječenje treba prekinuti, odgoditi ili se doza treba prilagoditi.
English: For further details, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: For the full list of all side effects reported with Zaltrap, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Zaltrap potražite u uputi o lijeku.
English: (Invented) nameStrength Pharmaceutical Form Route of AdministrationImmediate PackagingPack size
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: Content (concentration)
Croatian: Put primjene Unutarnje pakovanje Sastav (koncentracija)
English: Rubraca (rucaparib)
Croatian: Rubraca (rukaparib)
English: The recommended dose of Rubraca is 600 mg twice a day.
Croatian: Preporučena doza lijeka Rubraca iznosi 600 mg dvaput na dan.
English: What is Rubraca and what is it used for?
Croatian: Što je Rubraca i za što se koristi?
English: Further information on Rubraca can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rubraca.
Croatian: Više informacija o lijeku Rubraca dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Rubraca.
English: This overview was last updated in 02-2019.
Croatian: Sažetak je posljednji put ažuriran u 02. 2019.
English: Rubraca is available as tablets of 200, 250 and 300 mg.
Croatian: Lijek Rubraca dostupan je u obliku tableta od 200, 250 i 300 mg.
English: Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
English: Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment.
Croatian: U pogledu sigurnosti, nuspojave su česte, ali uglavnom nisu ozbiljne i mogu se kontrolirati odgovarajućim liječenjem.
English: What measures are being taken to ensure the safe and effective use of Rubraca?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rubraca?
English: The company will also provide further data on maintenance treatment, including data on how long patients survived with Rubraca.
Croatian: Tvrtka će također dostaviti daljnje podatke o terapiji održavanja, uključujući i to koliko su dugo bolesnice preživjele uz lijek Rubraca.
English: Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.
Croatian: Žene ne smiju dojiti tijekom liječenja lijekom Rubraca i još najmanje dva tjedna nakon liječenja.
English: Why is Rubraca authorised in the EU?
Croatian: Zašto je lijek Rubraca odobren u EU-u?
English: The European Medicines Agency decided that although further study was needed to better understand the size of the benefit, Rubraca'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, iako je za bolje razumijevanje opsega koristi potrebno dodatno ispitivanje, koristi od lijeka Rubraca nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Of the 79 patients whose disease had responded in the past to platinumbased medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).
Croatian: Od 79 bolesnica u kojih je bolest prethodno reagirala na lijekove na bazi platine, u 65 % (51 bolesnica) zabilježen je odgovor na liječenje lijekom Rubraca koji je u prosjeku trajao 294 dana (otprilike 10 mjeseci).
English: Rubraca has been given ‘conditional authorisation'.
Croatian: Za lijek Rubraca izdano je „uvjetno odobrenje”.