FrancophonIA/ELRC3.0 huggingface dataset:
English: It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not dissiminate systemically at the recommended dose.
Croatian: Cjepni soj ne preživljava u sluznici oronazale šupljine niti se širi sistemski ako se koristi u preporučenoj dozi.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection
Croatian: Equilis StrepE liofilizat i otapalo za suspenziju za injekciju
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet: Intervet International BV
English: Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
Croatian: Liofilizat: bjelkasta do krem peleta.
English: 3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Croatian: adsorbirani na aluminijev fosfat (0,17 mg Al adsorbirani na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al 3 proizveden tehnologijom rekombinantne DNK u stanicama kvasca (Saccharomyces cerevisiae) 4 umnožen u Vero stanicama ili ekvivalentna količina antigena utvrđena odgovarajućom imunokemijskom metodom.
English: 50 (5x10) pre-filled syringes (multipack)
Croatian: 50 (5 x 10) napunjenih štrcaljki (višestruko pakiranje)
English: Poliovirus (Inactivated)4: Type 1 (Mahoney)
Croatian: Virus poliomijelitisa (inaktiviran) 4 Tip 1 (Mahoney)
English: --1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
Croatian: --1 Jedna doza (0,5 ml) sadrži: Toksoid difterije 1
English: Tetanus Toxoid1:
Croatian: Toksoid tetanusa 1
English: Hepatitis B surface antigen2,3:
Croatian: Površinski antigen virusa hepatitisa B 2,3
English: Bordetella pertussis antigens1: Pertussis Toxoid (PT)
Croatian: Antigene bakterije Bordetella pertussis1 Toksoid hripavca (PT)
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Croatian: Polisaharid bakterije Haemophilus influenzae tip b
English: Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN)
Croatian: Pertaktin (PRN)
English: All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion.
Croatian: Svi bolesnici nadziru se na bilo koje reakcije tijekom infuzije i tijekom najmanje jednog do dva sata nakon dovršetka infuzije.
English: What is Entyvio and what is it used for?
Croatian: Što je Entyvio i za što se koristi?
English: Further information can be found in the summary of the risk management plan.
Croatian: Više informacija možete naći u sažetku plana upravljanja rizicima.
English: A risk management plan has been developed to ensure that Entyvio is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Entyvio koristi što je sigurnije moguće.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Entyvio vrijedi na prostoru Europske unije od 22. svibnja 2014.
English: Entyvio is given as an infusion that lasts 30 minutes.
Croatian: Entyvio se daje u obliku infuzije koja traje najmanje 30 minuta.
English: The full EPAR and risk management plan summary for Entyvio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije za lijek Entyvio (EPAR), kao i plan upravljanja rizicima mogu se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.
Croatian: Preporučena doza je 300 mg na dan u nultom, drugom i šestom tjednu i potom svakih osam tjedana nakon toga u bolesnika koji odgovaraju na liječenje.
English: Other information about Entyvio
Croatian: Druge informacije o lijeku Entyvio
English: What measures are being taken to ensure the safe and effective use of Entyvio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Entyvio?
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) in the body.
Croatian: Monoklonsko protutijelo je protutijelo (vrsta proteina) koje je osmišljeno za prepoznavanje i vezivanje na specifičnu strukturu (zvanu antigen) u tijelu.
English: Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Croatian: Entyvio se također pokazao djelotvornijim od placeba u poboljšavanju simptoma Crohnove bolesti.
English: Why is Entyvio approved?
Croatian: Zašto je Entyvio odobren?
English: This is a summary of the European public assessment report (EPAR) for Entyvio.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Entyvio.
English: The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Croatian: Tvrtka će također osigurati edukacijske materijale za sve zdravstvene djelatnike za koje se očekuje da će propisivati Entyvio kako bi ih se podsjetilo na potrebu praćenja bolesnika na znakove neurološke bolesti ili PML-a, a posebice onih liječenih biološkim lijekovima koji mogu uzrokovati PML.
English: Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
Croatian: Entyvio se proizvodi metodom poznatom pod nazivom „tehnologija rekombinantne DNK”; nastaje u stanicama u koje se uvodi gen (DNK), što ih čini sposobnim za proizvodnju vedolizumaba.
English: It is not intended to provide practical advice on how to use Entyvio.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Entyvio.
English: Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo.
Croatian: Entyvio se pokazao znatno djelotvornijim od placeba: 47 % (106 od 225) bolesnika koji su primali Entyvio pokazalo je poboljšanje simptoma u usporedbi s 26 % (38 od 149) bolesnika koji su primali placebo.
English: Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut.
Croatian: Vedolizumab je osmišljen za vezivanje na „alfa-4-beta-7 integrin”, protein koji se uglavnom nalazi na površini leukocita u utrobi.
English: Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
Croatian: Bolesnici koji primaju Entyvio moraju dobiti posebnu karticu s upozorenjem koja sažima sigurnosne informacije o lijeku.
English: In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Croatian: Kod Crohnove bolesti CHMP je smatrao da iako vrijeme potrebno za poboljšavanje simptoma može biti dulje, a učinak ograničen u usporedbi s anti-TNF-alfa terapijom, lijek Entyvio još uvijek nudi koristi za bolesnike zbog svog različitog mehanizma djelovanja i sigurnosnog profila.
English: Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death).
Croatian: Entyvio se ne smije koristiti u osoba s aktivnim, ozbiljnim infekcijama poput tuberkuloze, sepse (infekcije krvi), listerioze (infekcije bakterijom zvanom Listeria) ili oportunističkim infekcijama (onim uočenim u bolesnika s oslabljenim imunološkim sustavom) poput progresivne multižarišne leukoencefalopatije (PML, rijetka infekcija mozga koja obično uzrokuje tešku onesposobljenost ili smrt).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka i u uputu o lijeku za Entyvio, uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni djelatnici i bolesnici.
English: By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.
Croatian: Blokadom alfa-4-beta-7 integrina vedolizumab smanjuje upalu u utrobi i simptome tih bolesti.
English: Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.
Croatian: Nadalje, unatoč nedostatku dugoročnih podataka o sigurnosti, rizici se smatraju prihvatljivima ako se bolesnici pridržavaju određenih preporuka.
English: Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment.
Croatian: Bolesnici su primili ili Entyvio ili placebo (slijepo liječenje), a glavna mjera djelotvornosti bio je omjer bolesnika čiji su se simptomi poboljšali nakon 6 tjedana liječenja.
English: The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain).
Croatian: Najčešće nuspojave lijeka Entyvio (koje mogu zahvatiti više od 1 na 10 osoba) bile su nazofaringitis (upala nosa i grla poput prehlade), glavobolja i artralgija (bol u zglobovima).
English: What are the risks associated with Entyvio?
Croatian: Koji su rizici povezani s lijekom Entyvio?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio'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 Entyvio nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn's disease.
Croatian: Entyvio se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik specijalist iskusan u dijagnozi i liječenju ulceroznog kolitisa ili Crohnove bolesti.
English: In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo.
Croatian: U jednom glavnom ispitivanju na odraslim bolesnicima s umjerenom do teškom aktivnom Crohnovom bolešću kod kojih standardna terapija ili antagonisti TNF-alfa nisu djelotvorni ili se nisu mogli podnositi, 15 % (32 od 220) bolesnika koji su primali lijek Entyvio pokazalo je poboljšanje u simptomima nakon 6 tjedana liječenja u usporedbi sa 7 % (10 od 148) bolesnika koji su bili na placebu.
English: In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut.
Croatian: Kod ulceroznog kolitisa i Crohnove bolesti te su stanice uključene u uzrokovanje upale u utrobi.
English: It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract).
Croatian: Koristi se za liječenje odraslih bolesnika s ulceroznim kolitisom (bolešću koja uzrokuje upale i ulceracije na sluznici crijeva) ili Crohnovom bolešću (bolešću koja uzrokuje upalu probavnog trakta).
English: In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo.
Croatian: Pored toga, ispitivanje je također pokazalo da je lijek Entyvio zadržao učinak do 52 tjedna djelotvornije nego placebo.
English: Similarly, in this study the maintenance of the effect up to 52 weeks with Entyvio was more effective than with placebo.
Croatian: Slično tome, u ovom ispitivanju održavanje učinka do 52. tjedna s lijekom Entyvio bilo je djelotvornije nego kod placeba.
English: Entyvio is a medicine that contains the active substance vedolizumab.
Croatian: Entyvio je lijek koji sadrži djelatnu tvar vedolizumab.
English: For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Entyvio pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: How does Entyvio work?
Croatian: Kako djeluje Entyvio?
English: Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Entyvio je dostupan kao prašak za pripravu otopine za infuziju (drip) u venu.
English: In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy.
Croatian: Kod ulceroznog kolitisa Povjerenstvo je smatralo da su koristi lijeka Entyvio jasno dokazane što je važno za bolesnike koji ne odgovaraju na terapiju TNF-alfa antagonistima.
English: Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.
Croatian: Vedolizumab se koristi za liječenje umjerene do teške aktivne bolesti kada standardna terapija ili lijekovi zvani antagonisti TNF-alfa nisu djelotvorni, kad su prestali biti djelotvorni ili kad ih bolesnik ne može podnijeti.
English: How is Entyvio used?
Croatian: Kako se Entyvio koristi?
English: What benefits of Entyvio have been shown in studies?
Croatian: Koje su koristi lijeka Entyvio dokazane u ispitivanjima?
English: In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated.
Croatian: Kod ulceroznog kolitisa Entyvio je ispitivan u glavnom ispitivanju u bolesnika s umjerenom do teškom aktivnom bolešću kod kojih standardna terapija ili antagonisti TNF-alfa nisu bili djelotvorni ili ih bolesnici nisu podnosili.
English: The active substance in Entyvio, vedolizumab, is a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Entyvio je vedolizumab, monoklonsko protutijelo.
English: For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Entyvio pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Entyvio, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Entyvio potražite u uputi o lijeku.
English: Marixino should be given once a day at the same time every day.
Croatian: Marixino se treba uzimati jedanput na dan u isto vrijeme svaki dan.
English: 1 Previously known as Maruxa.
Croatian: Prethodno poznat kao Maruxa.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Croatian: Neurotransmiteri su kemikalije u živčanom sustavu koje omogućuju živčanim stanicama međusobnu komunikaciju.
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Croatian: Liječenje mora započeti i nadzirati liječnik koji je iskusan u dijagnosticiranju i liječenju Alzheimerove bolesti.
English: The full EPAR for Marixino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Marixino može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The name of the medicine was changed to Marixino on 9 August 2013.
Croatian: Naziv proizvoda je promijenjen u Marixino dana 9. kolovoza 2013.
English: Marixino is a ‘generic medicine'.
Croatian: Marixino je „generički lijek”.
English: The company provided data on the medicine's solubility, composition and absorption in the body.
Croatian: Tvrtka je dostavila podatke o topljivosti, sastavu i apsorpciji lijeka u tijelu.
English: In addition, overstimulation of the NMDA receptors may result in cell damage or death.
Croatian: Nadalje, prekomjerna stimulacija NMDA receptora može rezultirati oštećenjem stanica ili smrću.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing
Croatian: Podnošljivost i doziranje treba ponovno procijeniti unutar tri mjeseca od početka liječenja, a od tada na dalje koristi kontinuiranog liječenja s
English: This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Croatian: To znači da je Marixino sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Ebixa.
English: Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Croatian: Marixino je lijek koji se koristi za liječenje bolesnika s umjerenom do teškom Alzheimerovom bolešću, tipom demencije (poremećaja funkcije mozga) koji postepeno utječe na pamćenje, intelektualnu sposobnost i ponašanje.
English: What measures are being taken to ensure the safe and effective use of Marixino?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Marixino?
English: It is not intended to provide practical advice on how to use Marixino.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Marixino.
English: What is Marixino and what is it used for?
Croatian: Što je Marixino i za što se koristi?
English: The cause of Alzheimer's disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.
Croatian: Uzrok Alzheimerove bolesti nije poznat, no vjeruje se da gubitak pamćenja uzrokovan ovom bolešću nastupa zbog poremećaja prijenosa signala u mozgu.
English: treatment with Marixino should be reassessed on a regular basis.
Croatian: lijekom Marixino trebaju se redovito ponovno procjenjivati.
English: The Committee recommended that Marixino be approved for use in the EU.
Croatian: Povjerenstvo preporučuje odobrenje lijeka Marixino za korištenje u EU.
English: It contains the active substance memantine hydrochloride.
Croatian: Sadrži djelatnu tvar memantin hidroklorid.
English: The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Croatian: Smanjenje doze može biti potrebno u bolesnika koji imaju umjereno ili teško oštećenje bubrega.
English: Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Croatian: Marixino je dostupan u obliku tableta od 10 mg i 20 mg i izdaje se samo na liječnički recept.
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Croatian: Blokiranjem NMDA receptora, memantin poboljšava prijenos signala u mozgu i smanjuje simptome Alzheimerove bolesti.
English: Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Croatian: Memantin djeluje tako što inhibira posebne tipove receptora poznatih pod nazivom NMDA receptori, na koje se normalno vezuje nerotransmiterski glutamat.
English: Other information about Marixino
Croatian: Druge informacije o lijeku Marixino
English: What are the benefits and risks of Marixino?
Croatian: Koje su koristi i rizici lijeka Marixino?
English: Why is Marixino approved?
Croatian: Zašto je Marixino odobren?
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Croatian: Promjene u načinu na koji glutamat prijenosi signale unutar mozga povezani su s gubitkom pamćenja uočenim u Alzheimerovoj bolesti.
English: This is a summary of the European public assessment report (EPAR) for Marixino.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Marixino.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.
Croatian: Liječenje se smije započeti samo ako su dostupni njegovatelji koji će redoviti nadzirati bolesnikovo uzimanje lijeka Marixino.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Sigurnosne informacije uključene su u sažetak opisa svojstava lijeka i uputu o lijeku za Marixino, uključujući odgovarajuće mjere opreza kojih se moraju pridržavati zdravstveni djelatnici i bolesnici.
English: The active substance in Marixino, memantine, is an antidementia medicine.
Croatian: Djelatna tvar u lijeku Marixino, memantin, jest lijek protiv demencije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Marixino vrijedi na prostoru Europske unije od 29. travnja 2013.
English: To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Croatian: Da bi se spriječile nuspojave, doza lijeka Marixino postepeno se povećava tijekom prva tri tjedna liječenja: tijekom prvog tjedna doza iznosi 5 mg.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Marixino posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Ebixa.