FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Kogenate Bayer approved?
Croatian: Zašto je Kogenate Bayer odobren?
English: It is not intended to provide practical advice on how to use Kogenate Bayer.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Kogenate Bayer.
English: In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Kogenate Bayer into a vein.
Croatian: U prethodno liječenih bolesnika ukupno 95 % krvarenja zaustavljeno je nakon jedne ili dvije intravenske injekcije lijeka Kogenate Bayer.
English: What is Kogenate Bayer and what is it used for?
Croatian: Što je Kogenate Bayer i za što se koristi?
English: Kogenate Bayer is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Croatian: Lijek Kogenate Bayer dostupan je kao prašak i otapalo koji se miješaju kako bi se pripremila otopina za injekciju ili infuziju (drip) u venu.
English: Kogenate Bayer given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Croatian: Ispitivanje lijeka Kogenate Bayer, primijenjenog injekcijom u venu, provedeno je u 66 bolesnika koji su prethodno bili liječeni rekombinantnim ljudskim koagulacijskim faktorom VII i u 61 djeteta bez prethodnog liječenja.
English: The Agency concluded that Kogenate Bayer has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Croatian: Agencija je zaključila da se lijek Kogenate Bayer pokazao djelotvornim u liječenju i sprječavanju krvarenja u bolesnika s hemofilijom A te da ima prihvatljiv sigurnosni profil.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles and internal organs.
Croatian: Bolesnici s hemofilijom A nemaju dostatne razine faktora VIII, što uzrokuje probleme sa zgrušavanjem krvi, kao što su krvarenja u zglobovima, mišićima i unutarnjim organima.
English: Other information about Kogenate Bayer
Croatian: Ostale informacije lijeku Kogenate Bayer
English: For more information about treatment with Kogenate Bayer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Kogenate Bayer pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
Croatian: U bolesnika koji nisu bili prethodno liječeni oko 90 % krvarenja zaustavljeno je nakon jedne ili dvije intravenske injekcije.
English: Kogenate Bayer is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: Kogenate Bayer je lijek koji se koristi za liječenje i sprječavanje krvarenja u bolesnika svih dobi s hemofilijom A (nasljednim poremećajem krvarenja prouzročenim nedostatkom faktora VIII).
English: Kogenate Bayer can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.
Croatian: Kogenate Bayer izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju hemofilije.
English: Kogenate Bayer is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Croatian: Lijekom Kogenate Bayer nadomješćuje se nedostatak faktora VIII tako što se njime zamjenjuje faktor VIII koji nedostaje, čime se omogućuje privremena kontrola poremećaja krvarenja.
English: What are the risks associated with Kogenate Bayer?
Croatian: Koji su rizici povezani s lijekom Kogenate Bayer?
English: Kogenate Bayer given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Croatian: Ispitana je primjena velike doze lijeka Kogenate Bayer kako bi se utvrdilo je li on djelotvoran u uklanjanju protutijela za faktor VIII iz krvi (postupak poznat kao liječenje metodom inducirane imunotolerancije) tako da liječenje faktorom VIII ostane djelotvorno.
English: The active substance in Kogenate Bayer, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Croatian: Djelatna tvar u lijeku Kogenate Bayer, oktokog alfa (ljudski koagulacijski faktor VIII), pomaže u zgrušavanju krvi.
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Croatian: Pri primjeni lijekova koji sadržavaju faktor VIII zabilježene su reakcije preosjetljivosti (alergijske reakcije) koje u nekim slučajevima mogu postati ozbiljne.
English: Kogenate Bayer as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Croatian: Ispitivanje lijeka Kogenate Bayer, primijenjenog kontinuiranom infuzijom, provedeno je i u 15 bolesnika s hemofilijom A koji su bili podvrgnuti većem kirurškom zahvatu.
English: For practical information about using Kogenate Bayer, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Kogenate Bayer bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Patients or their carers may be able to administer Kogenate Bayer themselves at home once they have been trained appropriately.
Croatian: Nakon odgovarajuće obuke, bolesnici ili njihovi njegovatelji mogu samostalno primjenjivati lijek Kogenate Bayer kod kuće.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Croatian: U nekih bolesnika mogu se razviti inhibitori faktora VIII, odnosno protutijela (proteini) koja proizvodi imunosni sustav kako bi obranio organizam od faktora VIII, a koja mogu onemogućiti djelovanje lijeka i dovesti do gubitka kontrole nad krvarenjem.
English: For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Kogenate Bayer potražite u uputi o lijeku.
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Croatian: Kogenate Bayer sadržava djelatnu tvar oktokog alfa (ljudski koagulacijski faktor VIII).
English: How does Kogenate Bayer work?
Croatian: Kako djeluje Kogenate Bayer?
English: The data provided on immune tolerance induction in patients with inhibitors showed that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Croatian: Podatci o induciranoj imunotoleranciji u bolesnika s inhibitorima pokazuju da je u nekih bolesnika visoka doza bila djelotvorna te je inhibitor eliminiran.
English: How is Kogenate Bayer used?
Croatian: Kako se Kogenate Bayer koristi?
English: What benefits of Kogenate Bayer have been shown in studies?
Croatian: Koje su koristi lijeka Kogenate Bayer utvrđene u ispitivanjima?
English: The dose may need to be adjusted if Kogenate Bayer is to be given continuously as an infusion into a vein.
Croatian: Ako se Kogenate Bayer daje kontinuirano infuzijom u venu, možda će biti potrebno prilagoditi dozu.
English: The full EPAR for Competact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Competact nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pioglitazone / metformin hydrochloride
Croatian: Pioglitazon/metforminklorid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Competact on 28 July 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Competact na snazi u Europskoj uniji od 28. srpnja 2006.
English: The usual dose of Competact is one tablet taken twice a day.
Croatian: Uobičajena doza lijeka Competact jest jedna tableta dvaput na dan.
English: Other information about Competact
Croatian: Ostale informacije o lijeku Competact
English: The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination.
Croatian: Ta su ispitivanja trajala od četiri mjeseca do dvije godine i uključivala su 1305 bolesnika koji su uzimali tu kombinaciju lijekova.
English: Competact contains two active substances which each have a different mode of action.
Croatian: Lijek Competact sadrži dvije djelatne tvari, a svaka od njih djeluje na drugačiji način.
English: What measures are being taken to ensure the safe and effective use of Competact?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Competact?
English: This is a summary of the European public assessment report (EPAR) for Competact.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Competact.
English: Taking Competact with or just after food may reduce any stomach problems caused by metformin.
Croatian: Uzimanje lijeka Competact s hranom ili smjesta nakon obroka može smanjiti eventualne želučane probleme koje uzrokuje metformin.
English: Competact is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Croatian: Competact je lijek koji je dostupan u obliku tableta koje sadrže djelatne tvari pioglitazon (15 mg) i metforminklorid (850 mg).
English: For more information about treatment with Competact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Competact pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Patients changing from metformin only to Competact may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached.
Croatian: Bolesnici koji prelaze s metformina samo na Competact možda će se morati postupno privikavati na pioglitazon sve do dosezanja doze od 30 mg na dan.
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 Competact.
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 Competact.
English: A risk management plan has been developed to ensure that Competact is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Competact.
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Croatian: Kombiniranje pioglitazona u dozi od 30 mg s metforminom u svim je ispitivanjima dovelo do poboljšanja u kontroli glukoze u krvi, pri čemu su se razine tvari HbA1c dodatno smanjile za od 0,64 do 0,89 % u odnosu na razine u slučaju kada se metformin koristi kao monoterapija.
English: In addition, the company that markets Competact will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Croatian: Osim toga, tvrtka koja lijek Competact stavlja u promet osigurat će edukativne materijale za liječnike koji propisuju taj lijek koji će obuhvaćati informacije o mogućem riziku od srčanog zastoja i raka mjehura u primjeni terapija koje sadrže pioglitazon, kriterijima za odabir pacijenata te potrebi za redovitim procjenjivanjem učinaka terapije i prekidu liječenja u slučaju kada bolesnici više nemaju koristi od nje.
English: The Committee decided that Competact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Competact nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Croatian: CHMP je zaključio da je utvrđena djelotvornost pioglitazona i metformina u liječenju dijabetesa tipa 2 te da lijek Competact pojednostavljuje liječenje i poboljšava usklađenost kada je potrebna kombinacija tih dviju djelatnih tvari.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Croatian: Kao rezultat djelovanja obje djelatne tvari, smanjuje se razina glukoze u krvi što pomaže u kontroli dijabetesa tipa 2.
English: They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: U ispitivanjima se mjerila razina tvari (HbA1c) u krvi koja pokazuje koliko se uspješno kontrolira glukoza u krvi.
English: Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Croatian: Lijek Competact ne smije se primjenjivati u slučaju intoksikacije alkoholom i dijabetičke ketoacidoze (visokih razina ketona), stanja koja mogu utjecati na bubrege, te tijekom dojenja.
English: Treatment with Competact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Croatian: Nakon tri do šest mjeseci liječenja potrebno je procijeniti učinke terapije lijekom Competact i prekinuti liječenje u bolesnika kod kojih nisu vidljive dostatne koristi.
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Croatian: Pioglitazon, kao monoterapija, odobren je u EU-u pod nazivom Actos i može se koristiti s metforminom u bolesnika s dijabetesom tipa 2 koji ne mogu postići zadovoljavajuću kontrolu samo metforminom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, 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 lijek Competact nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Competact must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Croatian: Lijek Competact ne smije se primjenjivati u bolesnika koji imaju bolest koja uzrokuje manjak kisika u tkivu kao što je (nedavni) srčani udar ili šok.
English: It is possible to change to Competact directly from metformin if appropriate.
Croatian: Ako je potrebno, na lijek Competact može se izravno prijeći s metformina.
English: What is the risk associated with Competact?
Croatian: Koji su rizici povezani s lijekom Competact?
English: Competact must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Croatian: Lijek Competact ne smije se primjenjivati u bolesnika sa srčanim zastojem ili u bolesnika koji imaju probleme s jetrom ili bubrezima.
English: What is Competact?
Croatian: Što je Competact?
English: Why has Competact been approved?
Croatian: Zašto je lijek Competact odobren?
English: What benefit has Competact shown during the studies?
Croatian: Koje su koristi lijeka Competact utvrđene u ispitivanjima?
English: For the full list of side effects reported with Competact, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Competact potražite u uputi o lijeku.
English: How does Competact work?
Croatian: Kako djeluje Competact?
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
Croatian: Kako bi se dokazala korist od primjene lijeka Competact u istoj indikaciji, upotrebljena su tri ispitivanja lijeka Actos u kombinaciji s metforminom kao zasebnim tabletama.
English: What is Competact used for?
Croatian: Za što se Competact koristi?
English: Competact is used in adults (particularly those who are overweight) who have type 2 diabetes.
Croatian: Lijek Competact primjenjuje se u odraslih osoba (osobito onih s prekomjernom tjelesnom težinom) koje imaju dijabetes tipa 2. Lijek Competact primjenjuje se u bolesnika koji ne mogu postići zadovoljavajuću kontrolu samo metforminom (lijekom za liječenje dijabetesa) u najvišim podnošljivim dozama.
English: How is Competact used?
Croatian: Kako se Competact koristi?
English: How has Competact been studied?
Croatian: Kako je lijek Competact ispitivan?
English: EU number
Croatian: EMEA Broj
English: August 2015
Croatian: kolovoz 2015.
English: Adults, including the elderly
Croatian: Odrasli, uključujući i starije osobe
English: Allergic reactions:
Croatian: Alergijske reakcije:
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Croatian: U tom slučaju cijepljenje će obično biti odgođeno dok se ne budete osjećali bolje.
English: Clinical data suggest that a single dose may be sufficient.
Croatian: Klinički podaci ukazuju da bi jedna doza trebala biti dovoljna.
English: • if you have a severe infection with a high temperature (over 38°C).
Croatian: • ako imate tešku infekciju praćenu visokom temperaturom (preko 38°C).
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvorit će svoju vlastitu zaštitu (protutijela) protiv bolesti.
English: These side effects usually disappear within 1-2 days without treatment.
Croatian: Ove reakcije obično nestanu unutar jednog do dva dana bez terapije.
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Croatian: DRUGO Čuvati (2ºC-8ºC), ne zamrzavati, zaštiti od svjetlosti.
English: The vaccine contains an ‘adjuvant' AS03 to stimulate a better response.
Croatian: Cjepivo sadrži ‘adjuvans' AS03 kako bi se pospješio bolji odgovor.
English: NA= not available
Croatian: ND=nije dostupno
English: In addition, fever was very common in children aged 3-5 years.
Croatian: Dodatno, vrućica je bila vrlo česta u djece u dobi od 3-5 godina.
English: Adults aged 18 years and older:
Croatian: Odrasli u dobi od 18 godina i stariji:
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove ili ste nedavno primili bilo koje drugo cjepivo.
English: Prior to administration, the two components should be mixed.
Croatian: Prije primjene dvije navedene komponente trebaju se pomiješati.
English: The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the CHMP on 28 April 2016.
Croatian: Nositelj odobrenja je dostavio, gore navedene, tražene podatke, 5. kolovoza 2015, te je mišljenje od strane Povjerenstva za humane lijekove (CHMP) usvojeno 28. travnja 2016.
English: Risk Management Plan (RMP)
Croatian: PRIMJENU LIJEKA • Plan upravljanja rizikom (RMP)
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Croatian: • Alergijske reakcije koje uzrokuju opasan pad krvnog tlaka što, ako se ne liječi, može uzrokovati šok.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovo cjepivo.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Croatian: Liječnici znaju za tu mogućnost te imaju u pripremi terapiju za hitna stanja koja se primjenjuje u takvim slučajevima.
English: Tell the doctor requesting these tests that you have recently been given Pandemrix.
Croatian: Obavijestite liječnika koji je zatražio te pretrage da ste nedavno primili Pandemrix.
English: A minor infection such as a cold should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated with Pandemrix.
Croatian: Manja infekcija poput prehlade ne bi trebala predstavljati problem, no liječnik ili medicinska sestra će Vas savjetovati o tome možete li se unatoč tome cijepiti s Pandemrixom.
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Croatian: Ako Vaše dijete primi cjepivo, trebate znati da nuspojave mogu biti izraženije nakon druge doze, posebno temperatura povišena iznad 38°C.
English: Adverse reactions reported are listed per dose according to the following frequency: Very common (≥1/10)
Croatian: Prijavljene nuspojave navedene su prema sljedećim učestalostima: Vrlo često (≥1/10)
English: • Short-term sleepiness following vaccination
Croatian: • Kratkotrajna pospanost nakon cijepljenja
English: Other medicines and Pandemrix
Croatian: Drugi lijekovi i Pandemrix
English: They may also happen with Pandemrix.
Croatian: One se također mogu dogoditi s cjepivom Pandemrix.
English: The vaccine contains 5 micrograms thiomersal
Croatian: cjepivo sadrži 5 mikrograma tiomersala
English: 71-80 years
Croatian: 71-80 godina
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Croatian: Međutim, ako se to ne može izbjeći, cjepiva treba dati u različite udove.
English: Pandemrix should be used in accordance with Official Guidance.
Croatian: Pandemrix se mora primjenjivati u skladu sa službenim smjernicama.
English: Pandemrix has been administered to women in each trimester of pregnancy.
Croatian: Pandemrix se primjenjivao u trudnica u svakom trimestru trudnoće.
English: Febrile convulsions
Croatian: Febrilne konvulzije
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Croatian: 200 000 procijenjenih slučajeva žena koje su cijepljene tijekom trudnoće su trenutno ograničeni.
English: In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
Croatian: U prvih nekoliko tjedana nakon cijepljenja cjepivom Pandemrix rezultati takvih pretraga mogu biti netočni.
English: • if you have a bleeding problem or bruise easily.
Croatian: • ako imate problema s krvarenjem ili lako dobivate modrice.
English: The relationship between Pandemrix and narcolepsy is still under investigation.
Croatian: Povezanost između cjepiva Pandemrix i narkolepsije još se uvijek istražuje.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Croatian: Cjepivo će se ubrizgati u mišić (obično u nadlakticu).