FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus.
Croatian: Cijepljene životinje mogu se razlikovati od životinja koje su zaražene terenskim sojem virusa na temelju uklanjanja markera (gE-) uz pomoć komercijalnih dijagnostičkih testova, osim ako su životinje prethodno bile cijepljene konvencionalnim cjepivom ili su bile zaražene terenskim sojem virusa.
English: Shelf life of the solvent as packaged for sale: 5 years.
Croatian: Rok valjanosti otapala kada je zapakirano za prodaju: 5 godine.
English: PACKAGE LEAFLET: HIPRABOVIS IBR MARKER LIVE
Croatian: UPUTA O VMP: HIPRABOVIS IBR MARKER LIVE
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Croatian: Ne miješaj s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s otapalom priloženim za primjenu s proizvodom.
English: The absence of the gene coding for the gE surface protein entails that the vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine).
Croatian: Odsustvo genskog kodiranja za površinski protein gE ima za posljedicu da cjepivo ne potiče stvaranje protutijela na glikoprotein E od virusa GHV-1 (marker-cjepivo).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 5 AND 25 DOSES
Croatian: PODACI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA: 5 I 25 DOZA
English: 17170 Amer (Girona) SPAIN
Croatian: 17170 Amer (Girona) ŠPANJOLSKA
English: Solvent: Colourless type I glass bottle (10 ml) or Type II glass bottle (50 ml or 100 ml containing 60 ml of solvent) or PET bottles (10, 50 or 100 ml containing 60 ml of solvent) closed with a bromobutyl rubber closure and an aluminium cap.
Croatian: 60 ml otapala) ili PET boca (10, 50 ili 100 ml koja sadrži 60 ml otapala) zatvorena čepom od bromobutilne gume i aluminijskim zatvaračem.
English: Lyophilisate: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Liofilizat: Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: Use only sterile needles and syringes for administration.
Croatian: Kod primjene koristi samo sterilne igle i šprice.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Croatian: Komisije (EU) br. 37/2010 naznačeno da se određivanje MRL ne zahtijeva ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: Suspension after reconstitution: transparent pinkish liquid.
Croatian: Suspenzija nakon otapanja: prozirna ružičasta tekućina.
English: The vaccine contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE surface protein and the tk enzyme.
Croatian: GHV-1 (soj CEDDEL) s dvostruko uklonjenim genom unutar gena koji kodiraju površinski protein gE i enzim tk.
English: Solvent of 30 doses: Do not store and transport above 25 ºC.
Croatian: Otapalo za 30 doza: Nemojte čuvati i prevoziti pri temperaturi iznad 25º C.
English: A slight increase in body temperature up to 1 °C is common within 4 days following vaccination.
Croatian: Do četiri dana nakon cijepljenja uobičajen je lagani porast tjelesne temperature do 1 °C.
English: Animals vaccinated with HIPRABOVIS IBR MARKER LIVE will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens.
Croatian: Životinje koje su bile cijepljene cjepivom HIPRABOVIS IBR MARKER LIVE pozitivne su na test (kao i goveda koja su zaražena terenskim sojem virusa GHV-1 ili cijepljena cjepivom GHV-1 bez markera), kada se uzorci analiziraju testom koji se temelji na identifikaciji protutijela na bilo koji drugi antigen GHV-1.
English: Shelf-life after reconstitution according to directions: 6 hours.
Croatian: Rok valjanosti poslije otapanja prema uputi: 6 sati.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNEIH TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE U PROMET
English: EXP {month/year} Once reconstituted, use by 6 hours.
Croatian: EXP {mjesec/godina} Otopljeno cjepivo iskoristite u roku od 6 sati.
English: Lyophilisate of 5, 25 and 30 doses: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Liofilizat za 5, 25 i 30 doza: Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle.
Croatian: Za poticanje aktivne imunosti goveda protiv goveđeg herpesvirusa tipa 1 (GHV-1).
English: Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose
Croatian: Kratice: gE-: uklonjen glikoprotein E; tk-: uklonjena timidin-kinaza; CCID: infektivna doza za staničnu kulturu
English: Solvent: Phosphate buffer solution.
Croatian: Otapalo: Otopina fosfatnog pufera.
English: Name and address of the manufacturer of the biological active substances Laboratorios Hipra, S.A.
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari
English: Common adverse reactions:
Croatian: Uobičajene nuspojave:
English: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride
Croatian: Otapalo: dinatrijev fosfat dodekahidrat kalijev dihidrogenfosfat natrijev klorid kalijev klorid voda za injekcije
English: Phosphate buffer solution.
Croatian: Otopina fosfatnog pufera.
English: Solvent of 5 and 25 doses: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Otapalo za 5 i 25 doza: Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.
Croatian: Za aktivnu imunizaciju goveda starijih od 3 mjeseca starosti protiv goveđeg herpesvirusa tipa 1 (GHV-1) kako bi se umanjili klinički znakovi zaraznog rinotraheitisa goveda (ZRG) i izlučivanje terenskog soja virusa.
English: Duration of immunity: 6 months after completion of the basic vaccination.
Croatian: Trajanje imunitetai: 6 mjeseci nakon dovršetka osnovnog cijepljenja.
English: For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion.
Croatian: Za aktivnu imunizaciju goveda starijih od 3 mjeseca protiv goveđeg herpesvirusa tipa 1 (GHV-1) kako bi se umanjili klinički znakovi zaraznog rinotraheitisa govedag (ZRG) i izlučivanje terenskog soja virusa.
English: Animals exposed to gE surface protein will test positive (i.e. cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (i.e. non-infected animals, including those vaccinated with HIPRABOVIS IBR MARKER LIVE).
Croatian: Životinje koje su bile izložene površinskom proteinu gE pozitivne su na test (tj. goveda zaražena terenskim sojem virusa GHV-1 ili cijepljena konvencionalnim cjepivom bez markera), ali su neizložene životinje negativne na test (tj.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE FOR THE LYOPHILISATE
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Reconstitute the lyophilisate with the entire contents of the supplied solvent to obtain a suspension for injection.
Croatian: Otopiti liofilizat s cijelom količinom isporučenog otapala kako bi se dobila suspenzija za injekciju.
English: A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination.
Croatian: Kod goveda unutar 72 sata nakon cijepljenja uobičajena je prolazna upala na mjestu cijepljenja.
English: Solvent for HIPRABOVIS IBR MARKER LIVE
Croatian: IBR MARKER LIVE
English: Onset of immunity: 21 days after completion of the basic vaccination scheme.
Croatian: Početak imuniteta: 21 dan nakon dovršetka osnovnog cijepljenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 30 DOSES LYOPHILISATE
Croatian: PODACI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA: 30 DOZA LIOFILIZATA
English: This enables discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines.
Croatian: To omogućuje razlikovanje između goveda cijepljenog ovim cjepivom i goveda koje je zaraženo terenskim sojem virusa GHV-1
English: lyophilisate and solvent for suspension for injection for cattle.
Croatian: liofilizat i otapalo za suspenziju za injekciju za goveda.
English: The injections should be preferably administered on the alternate sides of the neck.
Croatian: Kod cijepljenja poželjno je izmjenjivati strane vrata.
English: Do not store and transport above 25°C).
Croatian: 11. POSEBNI UVIJETI ČUVANJA Nemojte čuvati i prevoziti pri temperaturi iznad 25º C.
English: Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent.
Croatian: Kartonska kutija koja sadrži 1 bocu s liofilizatom za 25 doza i 1 bocu s 50 ml otapala.
English: Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent.
Croatian: Kartonska kutija koja sadrži 1 bocu s liofilizatom za 5 doza i 1 bocu s 10 ml otapala.
English: The solvent should be allowed to warm to a temperature between 15 ºC and 20 ºC before reconstitution of the lyophilisate.
Croatian: Prije otapanja liofilizata, potrebno je otapalo zagrijati na temperatur između 15 ºC i 20 ºC.
English: The method of administration is by intramuscular route, in the neck muscles.
Croatian: Način primjene je u vratni mišić.
English: Cardboard box containing 1 bottle with 60 ml of solvent.
Croatian: Kartonska kutija koja sadrži 1 bocu s 60 ml otapala.
English: Pharmacotherapeutic group: Live viral vaccines, bovine rhinotracheitis virus (IBR).
Croatian: Farmakoterapijska grupa: Živo virusno goveđe cjepivo, protiv virusnog rinotraheitisa goveda (VRG) ATCvet kod: QI02AD01.
English: The manufacture, import, possession, sale, supply and/or use of HIPRABOVIS IBR MARKER LIVE may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: je ili može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija sukladno nacionalnim propisima.
English: Each dose of 2 ml contains: Lyophilisate:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza od 2 ml sadrži:
English: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3
Croatian: Živi gE- tk dvostruko uklonjeni gen goveđeg herpes virusa tip 1 (GHV-1), , soj CEDDEL: 106.3 - 107.3
English: Avoid the introduction of contamination during reconstitution and use.
Croatian: Tijekom otapanja i primjene treba spriječiti kontaminaciju.
English: Cardboard box containing 1 bottle with 30 doses of lyophilisate.
Croatian: Kartonska kutija koja sadrži 1 bocu s liofilizatom za 30 doza.
English: No adverse reactions except those mentioned in section 6 “Adverse reactions” were observed after the administration of a 10-fold vaccine dose.
Croatian: Nakon primjene 10-terostruke doze cjepiva nisu zapažene nuspojave osim onih navedenih u dijelu 6.
English: Any person intending to manufacture, import, possess, sell, supply and/or use of HIPRABOVIS IBR MARKER LIVE must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Svaka osoba koja namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati HIPRABOVIS
English: Special precautions for use in animals
Croatian: 4.5 Posebne mjere opreza prilikom primjene Posebne mjere predostrožnost za primjenu na životinjama
English: Each dose of 2 ml: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Croatian: Jedna doza od 2 ml: Živi gE- tk- dvostruko uklonjeni gen goveđeg herpes virusa tip 1 (GHV-1), soj CEDDEL: 106.3 - 107.3 CCID50.
English: Each dose of 2 ml contains: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50.
Croatian: Jedna doza od 2 ml sadrži: Živi gE- tk- dvostruko uklonjeni gen goveđeg herpes virusa tip 1 (GHV-1) soj CEDDEL: 106.3 - 107.3 CCID50.
English: HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection for cattle.
Croatian: IBR MARKER LIVE liofilizat za suspenziju za injekciju za goveda.
English: HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection.
Croatian: IBR MARKER LIVE liofilizat za suspenziju za injekciju.
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a 10-fold vaccine dose.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene 10-terostruke doze cjepiva nisu zapažene nuspojave osim onih navedenih u dijelu 4.6. 4.11 Karencija(e)
English: BATCH NUMBER
Croatian: IBR MARKER
English: HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle.
Croatian: IBR MARKER LIVE liofilizat i otapalo za suspenziju za injekciju za goveda.
English: Avda la Selva, 135
Croatian: Laboratorios Hipra S.A. Avda. la Selva, 135
English: HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection.
Croatian: IBR MARKER LIVE liofilizat i otapalo za injekcijsku suspenziju.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
English: Monosodium glutamate Sodium chloride
Croatian: Liofilizat: dinatrijev fosfat dodekahidrat kalijev dihidrogenfosfat želatina povidon natrijev glutamat natrijev klorid kalijev klorid saharoza voda za injekcije
English: Name and address of the manufacturer responsible for batch release Laboratorios Hipra, S.A.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: Potassium chloride Sucrose
Croatian: Otapalo za HIPRABOVIS
English: The patients were followed up for an average of 14.5 months.
Croatian: Bolesnici su u prosjeku praćeni tijekom razdoblja do 14,5 mjeseci.
English: It is available as tablets (5 and 10 mg).
Croatian: Dostupan je u obliku tableta (5 i 10 mg).
English: Patients taking Efient should also take aspirin as prescribed by their doctors.
Croatian: Bolesnici koji uzimaju lijek Efient trebaju također uzimati i aspirin, kako im je propisao njihov liječnik.
English: This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Croatian: Nakon toga slijedi doza od 10 mg jednom na dan, osim u bolesnika koji imaju manje od 60 kg, koji bi trebali uzimati 5 mg jednom na dan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Efient on 25 February 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Efient na snazi u Europskoj uniji od 25. veljače 2009.
English: Other information about Efient
Croatian: Ostale informacije o lijeku Efient
English: It is recommended that treatment with Efient and aspirin continue for up to a year.
Croatian: Preporučuje se nastavak liječenja lijekom Efient s aspirinom u trajanju do jedne godine.
English: At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Croatian: Na kraju ispitivanja 9 % bolesnika koji su uzimali Efient umrlo je od kardiovaskularnih bolesti ili su pretrpjeli moždani ili srčani udar (643 od 6 813 bolesnika), naspram 11 % bolesnika koji su uzimali klopidogrel (781 od 6 795 bolesnika).
English: The use of Efient is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary.
Croatian: Korištenje lijeka Efient ne preporučuje se u bolesnika starijih od 75 godina osim ako liječnik nije pomno proučio njegove koristi i rizike te smatra da je liječenje tim lijekom nužno.
English: What measures are being taken to ensure the safe and effective use of Efient?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Efient?
English: What is Efient?
Croatian: Što je Efient?
English: This is a summary of the European public assessment report (EPAR) for Efient.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Efient.
English: The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.
Croatian: Ti će materijali uključivati informacije o sigurnoj primjeni lijeka kako bi se liječnike podsjetilo na to da se ovaj lijek ne preporučuje koristiti u bolesnika starijih od 75 godina.
English: In addition, the company that markets Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine.
Croatian: Nadalje, tvrtka koja lijek Efient stavlja u promet mora zajamčiti dostupnost edukacijskih materijala liječnicima koji će bolesnike liječiti tim lijekom u svim državama članicama.
English: Efient treatment starts with one 60-mg dose.
Croatian: Terapija lijekom Efient počinje jednom dozom od 60-mg.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Efient.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Efient.
English: What is the risk associated with Efient?
Croatian: Koji su rizici povezani s lijekom Efient?
English: A risk management plan has been developed to ensure that Efient is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Efient.
English: Why has Efient been approved?
Croatian: Zašto je Efient odobren?
English: The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention.
Croatian: Tim ispitivanjem obuhvaćeno je 14 000 odraslih osoba s akutnim koronarnim sindromom koje su trebale biti podvrgnute perkutanoj koronarnoj intervenciji.
English: In this case, the 5-mg daily dose should be used following a 60-mg starting dose.
Croatian: U tom slučaju dnevna doza od 5-mg treba se primjenjivati nakon početne doze od 60-mg.
English: In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘maintenance' doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
Croatian: U jednom glavnom ispitivanju Efient, davan u početnoj dozi od 60-mg i nakon toga u dozama održavanja od 10-mg, uspoređen je s klopidogrelom (još jednim inhibitorom nakupljanja trombocita), pri čemu su se oba lijeka uzimala u kombinaciji s aspirinom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Efient, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Efient nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The Committee recommended that Efient be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Efient.
English: The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising.
Croatian: Najčešće nuspojave zabilježene pri primjeni lijeka Efient (mogu se javiti u do 1 na 10 bolesnika na njih 100) su anemija (niske razine crvenih krvnih stanica), hematom (nakupljanje krvi ispod kože ili u mišiću), epistaksa (krvarenja iz nosa), gastrointestinalna krvarenja (krvarenja u želucu ili probavnom sustavu), osip, hematurija (krv u mokraći), krvarenje na mjestu primjene injekcije, hematom na mjestima uboda i nastanak modrica.
English: Efient is a medicine that contains the active substance prasugrel.
Croatian: Efient je lijek koji sadrži djelatnu tvar prasugrel.
English: The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje ukupnog broja smrtnih slučajeva uzrokovanih kardiovaskularnim bolestima (smrtnih slučajeva zbog problema sa srcem ili krvnim žilama) te slučajeva srčanih ili moždana udara.
English: Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes.
Croatian: Lijek Efient bio je djelotvorniji od klopidogrela u smanjivanju ukupnog broja smrtnih slučajeva uzrokovanih kardiovaskularnim bolestima, slučajeva srčanih ili moždanih udara.
English: Efient must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
Croatian: Lijek Efient ne smije se koristiti u bolesnika s poremećajem koji uzrokuje prekomjerno krvarenje, koji su pretrpjeli moždani udar ili tranzitorni ishemični napad (privremeno smanjenje opskrbe krvlju jednog dijela mozga) ili imaju ozbiljne probleme s jetrom.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.
Croatian: To sprječava „lijepljenje” trombocita, čime se smanjuje rizik od formiranja krvnih ugrušaka i pomaže pri sprječavanju nastanka srčanog ili moždanog udara.
English: The full EPAR for Efient can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Efient nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Efient pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: The CHMP decided that Efient's benefits are greater than its risks, when given together with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Efient nadmašuju s njim povezane rizike kada se primjenjuje s aspirinom radi sprečavanja aterotrombotskih događaja u bolesnika s akutnim korornarnim sindromom koji su podvrgnuti primarnoj ili odgođenoj perkutanoj koronarnoj intervenciji.