FrancophonIA/ELRC3.0 huggingface dataset:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležno tijelo države članice može, prema potrebi, naknadno ažurirati informacije o lijeku u suradnji s referentnom državom članicom, u skladu s postupcima utvrđenima u poglavlju 4. glave III.
English: The valid product information is the final version achieved during the Coordination group procedure.
Croatian: Važeće informacije o lijeku završna su verzija usuglašena tijekom postupka Koordinacijske grupe.
English: Annex III Product information
Croatian: Prilog III.
English: The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek HyQvia nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
Croatian: IgG se upotrebljava kao lijek od 1950.-ih godina i ima velik raspon djelovanja protiv organizama koji mogu uzrokovati infekciju.
English: This summary was last updated in 07-2016.
Croatian: Sažetak je posljednji put ažuriran: 07.2016.
English: The main measure of effectiveness was the number of serious bacterial infections that developed over one year of treatment.
Croatian: Glavno mjerilo djelotvornosti bio je broj ozbiljnih bakterijskih infekcija koje su se razvile tijekom jednogodišnjeg liječenja.
English: What is HyQvia and what is it used for?
Croatian: Što je HyQvia i za što se koristi?
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Croatian: Sadrži imunoglobulin G (IgG) koji je vrsta protutijela.
English: This study was extended to almost 4 years and confirmed the long-term benefits and safety of HyQvia.
Croatian: Ispitivanje je produljeno na gotovo četiri godine i njime su potvrđene dugotrajne koristi i sigurnost lijeka HyQvia.
English: HyQvia is used as ‘replacement therapy' to treat:
Croatian: Lijek HyQvia primjenjuje se kao „nadomjesna terapija” za liječenje:
English: Human normal immunoglobulin has been used to treat these diseases for many years.
Croatian: Normalni ljudski imunoglobulin upotrebljava se za liječenje tih bolesti niz godina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka HyQvia u promet koje vrijedi na prostoru Europske unije od 16. svibnja 2013.
English: The study showed that HyQvia was able to reduce this number to 0.03 per year.
Croatian: Ispitivanje je pokazalo da se primjenom lijeka HyQvia taj broj smanjio na 0,03 godišnje.
English: What measures are being taken to ensure the safe and effective use of HyQvia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka HyQvia?
English: These are patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Croatian: To su bolesnici čija krv ne sadrži dovoljno protutijela (proteina koji tijelu pomažu u borbi protiv infekcija i drugih bolesti), koja su također poznata pod nazivom imunoglobulini.
English: Other information about HyQvia
Croatian: Ostale informacije o lijeku HyQvia
English: This is a summary of the European public assessment report (EPAR) for HyQvia.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek HyQvia.
English: What are the risks associated with HyQvia?
Croatian: Koji su rizici povezani s lijekom HyQvia?
English: • primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
Croatian: • sindroma primarne imunodeficijencije (PID se javlja u bolesnika rođenih s nemogućnošću stvaranja dovoljno protutijela);
English: Why is HyQvia approved?
Croatian: Zašto je lijek HyQvia odobren?
English: In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Croatian: U skladu s trenutačnim smjernicama za te lijekove, lijek HyQvia ispitan je u jednom glavnom ispitivanju koje je trajalo godinu dana i obuhvatilo 89 bolesnika s PID-om koji su prethodno liječeni normalnim ljudskim imunoglobulinom barem tri mjeseca.
English: The dose and frequency of infusions (how often it is given) depend on the individual patient and may need to be adjusted depending on their response.
Croatian: Doziranje i učestalost infuzija ovise o pojedinom pacijentu, te ih je možda potrebno prilagoditi ovisno o njegovu odgovoru.
English: The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Croatian: Najčešće nuspojave lijeka HyQvia (mogu se javiti u više od 1 na 10 osoba) lokalne su reakcije na mjestu infuzije, poput oticanja i nelagode.
English: It is not intended to provide practical advice on how to use HyQvia.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka HyQvia.
English: HyQvia can only be obtained with a prescription and treatment should be started and monitored by a doctor or nurse experienced in treating immunodeficiency syndromes.
Croatian: HyQvia se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik ili medicinska sestra s iskustvom u liječenju sindroma imunodeficijencije.
English: HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Croatian: Lijek HyQvia ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na normalni ljudski imunoglobulin ili hijaluronidazu ili bilo koju drugu pomoćnu tvar, ni u bolesnika koji su alergični na druge vrste imunoglobulina, posebice ako imaju manjak (vrlo niske razine) imunoglobulina A (IgA) i protutijela protiv imunoglobulina A (IgA).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of HyQvia 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 HyQvia nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: • low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
Croatian: • niske razine protutijela u krvi bolesnika s kroničnom limfocitnom leukemijom ili mijelomom (dvjema vrstama raka koje zahvaćaju bijele krvne stanice) i bolesnika s učestalim infekcijama.
English: The possibility of patients or their carers giving the medicine themselves at home may also improve the convenience of the product.
Croatian: Bolesnici ili njihovi njegovatelji mogu sami primjenjivati lijek kod kuće, što također može pridonijeti praktičnosti proizvoda.
English: This was below the predefined number needed to show effectiveness (which is one infection per year), and was similar to that seen with other licensed human normal immunoglobulin products.
Croatian: To znači da je bio manji od unaprijed određenog broja potrebnog za dokazivanje djelotvornosti (jedna infekcija godišnje) te da je sličan broju koji je utvrđen za druge odobrene proizvode koji sadrže normalni ljudski imunoglobulin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Croatian: Odbor za lijekove za humanu uporabu (CHMO) pri Agenciji zaključio je da lijek HyQvia uzrokuje slično smanjenje broja ozbiljnih bakterijskih infekcija u usporedbi s ostalim proizvodima koji sadrže imunoglobulin te da primjena rekombinantne hijaluronidaze omogućuje davanje potkožnih infuzija u mnogo duljim razmacima, iako su lokalne reakcije neznatno učestalije.
English: HyQvia is used in patients with immunodeficiency syndromes.
Croatian: Lijek HyQvia primjenjuje se u bolesnika sa sindromima imunodeficijencije.
English: The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Odbor odlučio da koristi od lijeka HyQvia nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Croatian: Lijek HyQvia djeluje tako da omogućuje vraćanje abnormalno niske razine IgG-a u krvi na normalnu razinu.
English: What benefits of HyQvia have been shown in studies?
Croatian: Koje su koristi lijeka HyQvia dokazane u ispitivanjima?
English: For more information about treatment with HyQvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom HyQvia pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Croatian: Djelatna tvar u lijeku HyQvia, normalni ljudski imunoglobulin, iznimno je pročišćen protein izvađen iz krvi.
English: HyQvia is available as two solutions for infusion (drip) under the skin.
Croatian: Lijek HyQvia dostupan je u obliku dvije otopine za potkožnu infuziju (drip).
English: This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
Croatian: To je vrsta prirodnog ljudskog enzima, hijaluronidaze, koji razgrađuje tvar koja se naziva hijaluronska kiselina a koja se nalazi u sitnim međustaničnim prostorima tkiva, čime se privremeno smanjuje viskoznost tekućine u međustaničnom prostoru.
English: HyQvia also contains recombinant human hyaluronidase.
Croatian: Lijek HyQvia također sadrži rekombinantnu ljudsku hijaluronidazu.
English: The product also contains recombinant human hyaluronidase, which is an enzyme used to help deliver the human normal immunoglobulin under the skin and improve its absorption into the body.
Croatian: Proizvod također sadrži rekombinantnu ljudsku hijaluronidazu, tj. enzim koji pomaže u dostavljanju normalnog ljudskog imunoglobulina pod kožu i poboljšava njegovu apsorpciju u tijelu.
English: Human normal immunoglobulin
Croatian: HyQvia normalni ljudski imunoglobulin
English: A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Croatian: Prvo se primjenjuje otopina koja sadrži rekombinantnu ljudsku hijaluronidazu, a nakon toga se na istom mjestu primjenjuje otopina koja sadrži normalni ljudski imunoglobulin (100 mg/ml).
English: For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka HyQvia bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: When given under the skin before the normal human immunoglobulin, it helps to deliver the active substance under the skin, and assists its absorption into the body.
Croatian: Primjenjuje se pod kožu prije normalnog ljudskog imunoglobulina radi olakšavanja dostave djelatne tvari pod kožu i njezine apsorpciju u tijelu.
English: How is HyQvia used?
Croatian: Kako se HyQvia koristi?
English: Detailed information about using HyQvia is provided in the package leaflet.
Croatian: Detaljne informacije o primjeni lijeka HyQvia nalaze se u uputi o lijeku.
English: HyQvia contains the active substance human normal immunoglobulin.
Croatian: Lijek HyQvia sadrži djelatnu tvar normalni ljudski imunoglobulin.
English: How does HyQvia work?
Croatian: Kako djeluje HyQvia?
English: Although there had been concerns that antibodies that develop against recombinant hyaluronidase could cause side effects by affecting the natural version of the enzyme, the results of studies were reassuring.
Croatian: Rezultati ispitivanja odagnali su zabrinutosti da bi protutijela koja se razvijaju protiv rekombinantne hijaluronidaze mogla uzrokovati nuspojave djelujući na prirodnu inačicu enzima.
English: HyQvia must not be given into a blood vessel or a muscle.
Croatian: HyQvia se ne smije primjenjivati intravenski ili intramuskularno.
English: For the full list of all side effects reported with HyQvia, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka HyQvia potražite u uputi o lijeku.
English: Patients or their carers may be able to give HyQvia themselves once they have been trained appropriately.
Croatian: Nakon odgovarajućeg osposobljavanja, bolesnici ili njihovi njegovatelji mogu samostalno primjenjivati lijek HyQvia.
English: Further information on Prasugrel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Prasugrel Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 jedanput na dan, osim u bolesnika s tjelesnom težinom manjom od 60 kg, koji bi trebali uzimati dozu od 5 mg jedanput na dan.
English: Patients taking Prasugrel Mylan should also take aspirin as prescribed by their doctors.
Croatian: Bolesnici koji uzimaju Prasugrel Mylan trebaju također uzimati i aspirin, kako im je propisao njihov liječnik.
English: It includes unstable angina (a severe type of chest pain) and heart attack.
Croatian: Ta stanja uključuju nestabilnu anginu (snažan oblik boli u prsima) i srčani udar.
English: The materials will include information on how to prescribe the medicine safely and 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 te podsjetiti liječnike da se ovaj lijek ne preporučuje koristiti u bolesnika starijih od 75 godina.
English: Prasugrel Mylan is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Croatian: Prasugrel Mylan uzima se zajedno s aspirinom za sprečavanje aterotrombotskih poremećaja (problema prouzročenih krvnim ugrušcima i otvrdnućem arterija) u bolesnika s akutnim koronarnim sindromom koji se podvrgavaju perkutanoj koronarnoj intervenciji.
English: It is recommended that treatment with Prasugrel Mylan and aspirin continue for up to a year.
Croatian: Preporučuje se nastavak liječenja lijekom Prasugrel Mylan s aspirinom u trajanju do jedne godine.
English: In this case, the patient should take 5 mg daily following a 60-mg starting dose.
Croatian: U tom slučaju bolesnik bi trebao uzimati dnevnu dozu od 5 mg nakon početne doze od 60 mg.
English: This means that Prasugrel Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Efient.
Croatian: To znači da Prasugrel Mylan sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Efient.
English: Prasugrel Mylan is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Croatian: Prasugrel Mylan dostupan je u obliku tableta (5 i 10 mg) i izdaje se samo na liječnički recept.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanja koja su pokazala da je lijek „bioekvivalentan” referentnom lijeku.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Efient, and do not need to be repeated for Prasugrel Mylan.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Efient i stoga ih nije potrebno ponavljati za lijek Prasugrel Mylan.
English: What measures are being taken to ensure the safe and effective use of Prasugrel Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Prasugrel Mylan?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prasugrel Mylan have also 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 Prasugrel Mylan također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Side effects reported with Prasugrel Mylan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Prasugrel Mylan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The use of Prasugrel Mylan is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Prasugrel Mylan as necessary.
Croatian: Korištenje lijeka Prasugrel Mylan ne preporučuje se u bolesnika starijih od 75 godina, osim ako je liječnik pomno proučio njegove koristi i rizike te smatra da je liječenje tim lijekom nužno.
English: Prasugrel Mylan treatment starts with one 60-mg dose.
Croatian: Terapija lijekom Prasugrel Mylan počinje jednom dozom od 60 mg.
English: What is Prasugrel Mylan and what is it used for?
Croatian: Što je Prasugrel Mylan i za što se koristi?
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: Time se sprečava „lijepljenje” trombocita, čime se smanjuje rizik od nastanka krvnih ugrušaka i pomaže pri sprečavanju nastanka srčanog ili moždanog udara.
English: Because Prasugrel Mylan 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 Prasugrel Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Why is Prasugrel Mylan authorised in the EU?
Croatian: Zašto je lijek Prasugrel Mylan odobren u EU-u?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Prasugrel Mylan has been shown to have comparable quality and to be bioequivalent to Efient.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Prasugrel Mylan posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Efient.
English: What are the benefits and risks of Prasugrel Mylan?
Croatian: Koje su koristi i rizici lijeka Prasugrel Mylan?
English: For more information about using Prasugrel Mylan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Prasugrel Mylan pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: This means that it helps to prevent blood clots from forming.
Croatian: To znači da sprečava nastanak krvnih ugrušaka.
English: Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor (target) on their surface.
Croatian: Prasugrel sprečava nakupljanje trombocita tako što inhibira vezivanje tvari naziva ADP na posebne receptore (ciljeve) na njihovoj površini.
English: Acute coronary syndrome is a group of conditions in which blood supply in the vessels supplying the heart is interrupted so heart tissue cannot work properly or dies.
Croatian: Akutni koronarni sindrom skupina je stanja u kojima je ometen dotok krvi u krvne žile koje opskrbljuju srce krvlju, zbog čega srčano tkivo ne može dobro funkcionirati ili odumire.
English: The company that markets Prasugrel Mylan will make sure that educational materials are available for doctors who will treat patients with the medicine.
Croatian: Tvrtka koja stavlja lijek Prasugrel Mylan u promet mora zajamčiti dostupnost edukacijskih materijala liječnicima koji će bolesnike liječiti tim lijekom.
English: As for every medicine, the company provided studies on the quality of Prasugrel Mylan.
Croatian: Kao za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Prasugrel Mylan.
English: An overview of Prasugrel Mylan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Prasugrel Mylan i zašto je odobren u EU-u
English: Therefore, the Agency's view was that, as for Efient, the benefit of Prasugrel Mylan outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Prasugrel Mylan, kao i od lijeka Efient, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: As for all medicines, data on the use of Prasugrel Mylan are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Prasugrel Mylan kontinuirano se prate.
English: Other information about Prasugrel Mylan
Croatian: Ostale informacije o lijeku Prasugrel Mylan
English: Percutaneous coronary intervention is a procedure used to unblock the blood vessels supplying the heart.
Croatian: Perkutana koronarna intervencija postupak je kojim se ponovno uspostavlja neometana cirkulacija krvi u krvnim žilama koje srce opskrbljuju krvlju.
English: Blood clots are caused by special cells in the blood, the platelets, sticking together (aggregating).
Croatian: Krvni ugrušci nastaju zbog nakupljanja (povezivanja) posebnih stanica u krvi naziva trombociti.
English: Prasugrel Mylan contains the active substance prasugrel and is a ‘generic medicine'.
Croatian: Prasugrel Mylan sadrži djelatnu tvar prasugrel te je „generički lijek”.
English: The active substance in Prasugrel Mylan, prasugrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar lijeka Prasugrel Mylan, prasugrel, jest inhibitor nakupljanja trombocita.
English: How does Prasugrel Mylan work?
Croatian: Kako djeluje Prasugrel Mylan?
English: How is Prasugrel Mylan used?
Croatian: Kako se Prasugrel Mylan koristi?
English: How has Prasugrel Mylan been studied?
Croatian: Kako je Prasugrel Mylan ispitivan?
English: Prasugrel Mylan received a marketing authorisation valid throughout the EU on 16 May 2018.
Croatian: Prasugrel Mylan (prasugrel) EMA/203583/2018
English: Further information on Yervoy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Yervoy.
Croatian: Više informacija o lijeku Yervoy nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Yervoy.
English: Advanced melanoma
Croatian: Uznapredovali melanom
English: What measures are being taken to ensure the safe and effective use of Yervoy?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Yervoy?