FrancophonIA/ELRC3.0 huggingface dataset:
English: - Transient local reactions may occur after the administration of one dose of vaccine.
Croatian: Česte nuspojave: - Nakon primjene jedne doze cjepiva mogu se pojaviti prolazne lokalne reakcije.
English: A. LABELLING
Croatian: ETIKETA
English: Pack sizes: - Cardboard box with 1 or 10 glass vials of 10 doses.
Croatian: 15. OSTALE INFORMACIJE Veličine pakovanja: - Kartonska kutija s 1 ili 10 staklenih bočica po 10 doza.
English: - Cardboard box with 1 or 10 PET bottles of 10 doses.
Croatian: - Kartonska kutija s 1 ili 10 plastičnih (PET) boca po 10 doza.
English: Name and address of the manufacturer
 responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: IM.
Croatian: C.
English: - Cardboard box with 1 PET bottle of 125 doses.
Croatian: - Kartonska kutija s 1 plastičnom (PET) bocom po 125 doza.
English: - Cardboard box with 1 PET bottle of 25 doses.
Croatian: - Kartonska kutija s 1 staklenom bočicom po 25 doza.
English: Excipient:
Croatian: Inkompatibilnosti:
English: - Cardboard box with 1 PET bottle of 50 doses.
Croatian: - Kartonska kutija s 1 staklenom bočicom po 50 doza.
English: Formaldehyde .................................................................................................................. 0.8 mg For the full list of excipients, see section 6.1.
Croatian: formaldehid ..................................................................................................................... 0,8 mg Bijela homogena suspenzija.
English: It was to be available as capsules.
Croatian: Trebao je biti dostupan u kapsulama.
English: The company that applied for authorisation is Portola Pharma UK Limited.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Portola Pharma UK Limited.
English: EMA/501901/2018EMA/501901/2018EMEA/H/C/004309
Croatian: EMA/501901/2018 EMEA/H/C/004309
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi u kliničkom ispitivanju.
English: The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness.
Croatian: Tvrtka je predstavila rezultate jednog glavnog ispitivanja u kojem je sudjelovalo više od 7 500 odraslih osoba koje su u bolnicu primljene radi nedavne bolesti.
English: What is Dexxience?
Croatian: Što je Dexxience?
English: After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 26 July 2018.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet 26. srpnja 2018.
English: Blood clots that start off in the veins can move to another part of the body such as the lungs and the brain where they can cause severe problems with breathing or stroke.
Croatian: Krvni ugrušci koji nastaju u venama mogu se pomaknuti u drugi dio organizma, kao što su pluća i mozak, gdje mogu prouzročiti ozbiljne poteškoće s disanjem ili moždani udar.
English: Thrombin is needed for blood to clot.
Croatian: Trombin je potreban za grušanje krvi.
English: It was to be used in adults admitted to hospital for the treatment of a recent medical illness.
Croatian: Trebao se primjenjivati u odraslih osoba hospitaliziranih radi liječenja nedavne bolesti.
English: This means that it blocks factor Xa, a protein which is involved in the production of thrombin.
Croatian: To znači da onemogućuje djelovanje faktora Xa, proteina koji sudjeluje u proizvodnji trombina.
English: Refusal of the marketing authorisation for Dexxience (betrixaban) EMA/501901/2018
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Dexxience (betriksaban) EMA/501901/2018
English: These patients may be at high risk of blood clots because of reduced mobility during their hospital treatment as well as other underlying conditions that increase the risk.
Croatian: Ti bolesnici mogu biti izloženi povećanom riziku od krvnih ugrušaka zbog smanjene pokretljivosti tijekom liječenja u bolnici kao i zbog drugih stanja osnovne bolesti koja povećavaju rizik.
English: What was Dexxience expected to be used for?
Croatian: Za što se Dexxience trebao koristiti?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Dexxience.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se primjenjuje lijek Dexxience.
English: The main measure of effectiveness was the occurrence of deep vein thrombosis (blood clot in a deep vein, usually in the leg), or of pulmonary embolism (blood clot in the lung), or death from a blood clot.
Croatian: Glavna mjera učinkovitosti bila je pojava duboke venske tromboze (krvnog ugruška u dubokoj veni, obično u nozi) ili plućne embolije (krvnog ugruška u plućima) ili smrt uslijed krvnog ugruška.
English: This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions for whom any episode of bleeding could have serious consequences, and Dexxience's long persistence in the body could complicate management of bleeding.
Croatian: To se smatralo vrlo važnom zabrinutošću uzimajući u obzir da se očekivalo da se lijek upotrebljava u bolesnika s ozbiljnom osnovnom bolesti u kojih svaka epizoda krvarenja može imati ozbiljne posljedice, a dugoročna perzistencija lijeka Dexxience u organizmu može dovesti do komplikacija u liječenju krvarenja.
English: The CHMP considered that the main study did not satisfactorily show Dexxience's effectiveness when used for preventing blood clots in patients admitted to hospital for recent medical illness.
Croatian: CHMP je smatrao da se glavnim ispitivanjem nije na zadovoljavajući način pokazala učinkovitost lijeka Dexxience kad se primjenjuje u sprječavanju krvnih ugrušaka u bolesnika primljenih u bolnicu zbog nedavne bolesti.
English: How does Dexxience work?
Croatian: Kako djeluje Dexxience?
English: The patients were at high risk of venous thromboembolism because of their age, presence of a protein indicating a blood clot, previous blood clots, cancer and lack of mobility during hospital treatment.
Croatian: Bolesnici su bili izloženi povećanom riziku od venske tromboembolije zbog svoje dobi, prisutnosti proteina koji su upućivali na krvni ugrušak, prethodnih krvnih ugrušaka, karcinoma i nedostatka pokretljivosti tijekom bolničkog liječenja.
English: Treatment with Dexxience was compared with enoxaparin, another medicine for preventing blood clots.
Croatian: Liječenje lijekom Dexxience bilo je uspoređeno s enoksaparinom, drugim lijekom za sprječavanje krvnih ugrušaka.
English: Also, patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine.
Croatian: Bolesnici liječeni lijekom Dexxience također su imali više epizoda krvarenja od bolesnika liječenih usporednim lijekom.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP tada smatrao da koristi od lijeka Dexxience ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje lijeka u promet.
English: By blocking factor Xa, the medicine reduces the levels of thrombin in the blood and this reduces the risk of blood clots forming in blood vessels.
Croatian: Onemogućavanjem djelovanja faktora Xa smanjuju se razine trombina u krvi, čime se smanjuje rizik od stvaranja krvnih ugrušaka u krvnim žilama.
English: Dexxience was expected to be used to prevent venous thromboembolism (formation of blood clots in veins).
Croatian: Dexxience se trebao primjenjivati za sprječavanje venske tromboembolije (stvaranje ugrušaka u venama).
English: Refusal of the marketing authorisation for Dexxience (betrixaban)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Dexxience (betriksaban)
English: Dexxience is a medicine that contains the active substance betrixaban.
Croatian: Dexxience je lijek koji sadrži djelatnu tvar betriksaban.
English: On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Dexxience, koji je namijenjen sprječavanju venske tromboembolije.
English: The active substance in Dexxience, betrixaban, is a ‘factor Xa inhibitor'.
Croatian: Djelatna tvar lijeka Dexxience, betriksaban, inhibitor je faktora Xa.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Croatian: Primjenjuje se jedanput svaka tri tjedna putem infuzije koja traje 10 minuta.
English: The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza jest 500 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
English: The full EPAR and risk management plan summary for Pemetrexed Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Pemetrexed Accord nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Do pretvaranja pemetrekseda u njegov djelatni oblik lakše dolazi u stanicama raka nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of cancer medicines.
Croatian: Ovaj se lijek izdaje samo na liječnički recept i smije se primjenjivati samo pod nadzorom liječnika koji je stručan u području primjene lijekova za liječenje raka.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Accord has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da je lijek Pemetrexed Accord usporediv s lijekom Alimta.
English: This means that Pemetrexed Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da je Pemetrexed Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Croatian: To rezultira smanjenim dijeljenjem stanica raka, dok je utjecaj na normalne stanice tek neznatan.
English: Pemetrexed Accord is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed Accord lijek je koji se koristi za liječenje dvaju tipova raka pluća:
English: Because Pemetrexed Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Pemetrexed Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Pemetrexed Accord is a ‘generic medicine'.
Croatian: Pemetrexed Accord je „generički lijek”.
English: A risk management plan has been developed to ensure that Pemetrexed Accord is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pemetrexed Accord.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: Pemetreksed se u tijelu pretvara u djelatni oblik koji blokira djelovanje enzima uključenih u proizvodnju „nukleotida” (stanica koje grade DNK i RNK, genetski materijal stanica).
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed Accord?
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Croatian: • malignog pleuralnog mezotelioma (raka ovojnice pluća koji je obično uzrokovan izlaganjem azbestu), pri čemu se koristi u kombinaciji s cisplatinom u bolesnika koji prethodno nisu primali kemoterapiju i kod kojih se rak ne može kirurški odstraniti;
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Croatian: Kao rezultat toga, djelatni oblik pemetrekseda usporava formiranje DNK-a i RNK-a te sprječava dijeljenje i umnožavanje stanica.
English: The company provided data from the published literature on pemetrexed.
Croatian: Tvrtka je osigurala podatke o pemetreksedu iz objavljene literature.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Pemetrexed Accord.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Accord.
Croatian: Kako bi se ublažile nuspojave, bolesnici trebaju uzimati kortikosteroid (vrstu lijeka koji ublažuje upalu) i folnu kiselinu (vrstu vitamina) te primati injekcije vitamina B12 tijekom liječenja lijekom Pemetrexed Accord.
English: What is Pemetrexed Accord and what is it used for?
Croatian: Što je Pemetrexed Accord i za što se koristi?
English: It is not intended to provide practical advice on how to use Pemetrexed Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pemetrexed Accord.
English: No additional studies were needed as Pemetrexed Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Dodatna ispitivanja nisu bila potrebna jer je Pemetrexed Accord generički lijek koji se daje putem infuzije i koji sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: For more information about treatment with Pemetrexed Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pemetrexed Accord pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Croatian: • uznapredovalog raka pluća nemalih stanica koje su poznate pod nazivom „neskvamozne stanice”, pri čemu se koristi ili u kombinaciji s cisplatinom u bolesnika koji prethodno nisu bili liječeni ili kao monoterapija u bolesnika koji su prethodno primili terapiju protiv raka.
English: When Pemetrexed Accord is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Pemetrexed Accord primjenjuje s cisplatinom, prije ili nakon davanja doze cisplatina bolesniku također treba dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprječavanje dehidracije).
English: The active substance in Pemetrexed Accord, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar lijeka Pemetrexed Accord, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice raka) koji se ubraja u grupu „antimetabolita”.
English: The Committee recommended that Pemetrexed Accord be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za primjenu lijeka Pemetrexed Accord u EU-u.
English: For practical information about using Pemetrexed Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pemetrexed Accord pročitajte u uputi o lijeku ili se obratite svojem liječniku ili ljekarniku.
English: Other information about Pemetrexed Accord
Croatian: Ostale informacije o lijeku Pemetrexed Accord
English: Pemetrexed Accord pemetrexed
Croatian: Pemetrexed Accord pemetreksed
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Croatian: U bolesnika čiji broj krvnih tjelešca nije normalan ili bolesnika koji imaju određene druge nuspojave liječenje treba odgoditi ili prekinuti ili treba smanjiti dozu.
English: What are the benefits and risks of Pemetrexed Accord?
Croatian: Koje su koristi i rizici od lijeka Pemetrexed Accord?
English: Pemetrexed Accord is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed Accord dostupan je kao prašak za pripremu otopine za intravensku infuziju (drip).
English: How is Pemetrexed Accord used?
Croatian: Kako se Pemetrexed Accord koristi?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Pemetrexed Accord nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Why is Pemetrexed Accord approved?
Croatian: Zašto je Pemetrexed Accord odobren?
English: Pemetrexed Accord contains the active substance pemetrexed.
Croatian: Pemetrexed Accord sadrži djelatnu tvar pemetreksed.
English: How has Pemetrexed Accord been studied?
Croatian: Kako je Pemetrexed Accord ispitivan?
English: Type (formulation)
Croatian: Vrsta (formulacija)
English: Commission decision date: 23/11/2017.
Croatian: Datum odluke Komisije: 23.11.2017.
English: • If you have any questions about your scan, speak to your doctor.
Croatian: • Imate li pitanja u pogledu snimanja, obratite se svojem liječniku.
English: The review of gadolinium contrast agents was initiated on 17 March 2016 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje gadolinijskih kontrastnih sredstava započeto je 17. ožujka 2016. na zahtjev Europske komisije, u skladu s člankom 31. Direktive 2001/83/EZ.
English: Following a request from companies concerned, the PRAC re-examined its initial recommendation.
Croatian: Nakon zaprimanja zahtjeva tvrtki obuhvaćenih postupkom, PRAC je ponovno razmotrio svoju prvotnu preporuku.
English: As a result of this interaction, the water molecules give a stronger signal, helping to obtain a brighter image.
Croatian: Kao posljedica ove interakcije molekule vode daju jači signal, što pomaže u dobivanju jasnijeg prikaza.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations in March 2017.
Croatian: Ocjenjivanje je prvotno proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja koja se odnose na lijekove za liječenje ljudi, koji je u ožujku 2017. donio niz preporuka.
English: • Healthcare professionals should always use the lowest dose that provides sufficient enhancement for diagnosis.
Croatian: • Zdravstveni radnici trebaju uvijek primjenjivati najnižu dozu koja omogućava dostatno pojačanje za postavljanje dijagnoze.
English: The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Croatian: Konačne preporuke poslane su Europskoj komisiji koja je donijela konačnu, pravno obvezujuću odluku koja se primjenjuje u svim državama članicama EU-a.
English: restrict use to liver scans
Croatian: ograničiti primjenu na snimanje jetre
English: These body scans rely on the magnetic fields produced by water molecules in the body.
Croatian: Takva snimanja tijela počivaju na magnetskim poljima koja proizvode molekule vode u tijelu.
English: • It is known that small amounts of gadolinium may remain in the brain after a scan with these agents, although there is currently no evidence that these small amounts cause any harm.
Croatian: • Poznato je da se male količine gadolinija mogu zadržati u mozgu nakon snimanja tim sredstvima, iako trenutačno nema dokaza da te male količine mogu imati štetne posljedice.
English: • As a precaution, doctors will stop using some contrast agents given into the vein while some others will only be used when other agents are not suitable (e.g. for liver scans).
Croatian: • Radi predostrožnosti, liječnici će prekinuti upotrebu nekih kontrastnih sredstava koja se primjenjuju u venu, a druga će primjenjivati samo kad druga sredstva nisu primjerena (npr. za snimanje jetre).
English: These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
Croatian: Ti se lijekovi mogu i dalje primjenjivati u njihovim postojećim indikacijama, ali u najnižim dozama koje dostatno pojačavaju prikaz te samo ako snimanje tijela bez pojačanja nije primjereno.
English: The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.
Croatian: Moguće je ukidanje obustava ili ograničenja primjene linearnih sredstava ako tvrtke obuhvaćene postupkom dostave dokaze o novim koristima u identificiranoj skupini bolesnika koje nadmašuju rizik od taloženja u mozgu ili ako mogu izmijeniti lijekove na način da ne otpuštaju gadolinij u znatnim količinama ili ne dovode do njegova zadržavanja u tkivima.
English: • Gadolinium deposition in the brain has been confirmed by mass spectrometry and increases in signal intensity in brain tissue.
Croatian: • Taloženje gadolinija u mozgu potvrđeno je masenom spektroskopijom i povećanjem intenziteta signala u tkivu mozga.
English: Product
Croatian: Lijek
English: OptiMARK (gadoversetamide) is the only gadolinium contrast agent that was authorised centrally via EMA in the EU.
Croatian: OptiMARK (gadoversetamid) jedino je gadolinijsko kontrastno sredstvo koje je putem EMA-e odobreno u EU-u centraliziranim postupkom.
English: • Healthcare professionals in the EU will be sent a letter with information about EMA's review of gadolinium contrast agents.
Croatian: • Zdravstveni radnici u EU-u primit će dopis s informacijama o ocjenjivanju gadolinijskih kontrastnih sredstava koje je provela EMA.