FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as capsules (250 mg), tablets (500 mg), a powder to be made up into an oral suspension (1 g/5 ml) and a powder to be made up into a solution for infusion (drip) into a vein (500 mg).
Croatian: Dostupan je u kapsulama (250 mg), tabletama (500 mg), prašku koji se koristi za oralnu suspezniju (1 g/5 ml) i prašku koji se koristi kao otopina za infuziju (drip) u venu (500 mg).
English: Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.
Croatian: U dodatnim ispitivanjima dokazano je da su otopina za infuziju i oralna suspenzija dovele do sličnih razina djelatne tvari u krvi kao i kapsule.
English: CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Croatian: Lijek CellCept koristi se radi sprečavanja da tijelo odbaci transplantirani bubreg, srce ili jetru.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Croatian: Koristi se u kombinaciji s ciklosporinom i kortikosteroidima (drugim lijekovima koji se primjenjuju za sprečavanje odbacivanja organa).
English: In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.
Croatian: U svim ispitivanjima svi pacijenti također su primali ciklosporin i kortikosteroide, a glavna mjera učinkovitosti bio je udio bolesnika koji su nakon šest mjeseci odbacili novi organ.
English: The dose may need to be adjusted in patients with liver or kidney disease.
Croatian: Dozu će možda trebati prilagoditi u bolesnika s bolešću jetre ili bubrega.
English: Therefore, CellCept must not be used during pregnancy unless there is no suitable alternative to prevent rejection of the transplant.
Croatian: Lijek CellCept stoga se ne smije primjenjivati u trudnoći osim ako ne postoji nikakva prikladna alternativna terapija za sprečavanje odbacivanja organa nakon transplantacije.
English: Women able to have children should be tested before starting treatment to ensure that they are not pregnant.
Croatian: Žene u reproduktivnoj dobi potrebno je testirati prije početka liječenja kako bi se utvrdilo da nisu trudne.
English: CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant.
Croatian: Kapsule i tablete lijeka CellCept ispitivane su u trima ispitivanjima u kojima je sudjelovalo 1493 odraslih osoba nakon transplantacije bubrega, u jednom ispitivanju u kojem je sudjelovalo 650 odraslih osoba nakon transplantacije srca te u jednom ispitivanju u kojem je sudjelovalo 565 odraslih osoba nakon transplantacije jetre.
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 CellCept.
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 CellCept.
English: Women must not breastfeed while using CellCept and patients should not donate blood or sperm during treatment or for a period afterwards.
Croatian: Tijekom uzimanja lijeka CellCept žene ne smiju dojiti, a bolesnici ne smiju davati krv ili spermu tijekom ili određeno razdoblje nakon liječenja.
English: For more information about treatment with CellCept, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom CellCept pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
Croatian: U daljnjem ispitivanju ispitivan je učinak oralne suspenzije ljeka CellCept u 100 djece nakon transplantacije bubrega.
English: There will also be very close monitoring of the outcomes of any accidentally exposed pregnancies.
Croatian: Također, ishodi slučajno izloženih trudnoća bit će pozorno praćeni.
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Croatian: Na taj način limfociti postaju manje učinkoviti pri prepoznavanju i napadanju transplantiranog organa čime se smanjuje rizik od odbacivanja.
English: CellCept was as effective as azathioprine and more effective than placebo in preventing the rejection of transplanted kidneys after six months.
Croatian: Lijek CellCept bio je jednako učinkovit kao azatioprin te učinkovitiji u odnosu na placebo kad je riječ o sprečavanju odbacivanja transplantiranih bubrega nakon šest mjeseci.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Croatian: Riječ je o enzimu važnom za stvaranje DNK-a u stanicama, osobito u limfocitima (vrsta bijelih krvnih stanica koje sudjeluju u odbacivanju transplantiranog organa).
English: Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Croatian: Nakon transplantacije jetre 38 % odraslih bolesnika koji su uzimali CellCept odbacilo je novu jetru nakon šest mjeseci, u usporedbi s 48 % bolesnika koji su uzimali azatioprin, ali udio bolesnika koji su nakon godine dana izgubili novu jetru bio je sličan u obje skupine te je iznosio oko 4 %.
English: The way that CellCept should be given and the dose depend on the type of organ transplant and the patient's age and size.
Croatian: Način davanja i doza lijeka CellCept ovise o vrsti transplantiranoga organa te dobi i veličini pacijenta.
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Croatian: U slučaju transplantacije bubrega preporučena doza za odrasle osobe iznosi 1 g dvaput dnevno oralnim putem (kapsule, tablete ili oralna suspenzija) koja se počinje davati u roku od 72 sata nakon transplantacije.
English: The company that markets CellCept will provide educational materials for patients and healthcare professionals explaining the risk of harm to a developing baby and the precautions and measures to be taken to avoid pregnancy during treatment.
Croatian: Društvo koje stavlja lijek CellCept u promet omogućit će edukativne materijale za bolesnike i zdravstvene djelatnike u kojima će biti objašnjeni rizici štetnosti za plod te mjere opreza koje je potrebno poduzeti kako bi se spriječila trudnoća tijekom terapije.
English: In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Croatian: U djece kojoj su presađeni bubrezi stope odbacivanja bile su slične kao u odraslih koji su uzimali CellCept te manje u odnosu na bolesnike iz drugih ispitivanja djece koja nisu primala lijek CellCept.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 sata nakon transplantacije te u trajanju do 14 dana.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Croatian: U tijelu se pretvara u mikofenolnu kiselinu, koja blokira enzim inozin monofosfat dehidrogenazu.
English: The CHMP decided that CellCept's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka CellCept nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: CellCept mycophenolate mofetil
Croatian: CellCept mikofenolat mofetil
English: What is the risk associated with CellCept?
Croatian: Koji su rizici povezani s lijekom CellCept?
English: By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Croatian: Sprečavanjem nastajanja novog DNK-a lijek CellCept usporava razmnožavanje limfocita.
English: CellCept was compared with azathioprine (another anti-rejection medicine) in all studies except for one of the kidney transplant studies, in which it was compared with placebo (a dummy treatment).
Croatian: Lijek CellCept uspoređen je s azatioprinom (također lijekom za sprečavanje odbacivanja transplantiranih organa) u svim ispitivanjima osim u ispitivanju u kojem su sudjelovali bolesnici nakon transplantacije bubrega, u kojem je uspoređen s placebom (slijepo liječenje).
English: For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Croatian: U slučaju transplantacije srca preporučena doza za odrasle osobe iznosi 1,5 g dvaput dnevno, a lijek se počinje davati u roku od pet dana nakon transplantacije.
English: Why has CellCept been approved?
Croatian: Zašto je CellCept odobren?
English: For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Croatian: U slučaju transplantacije jetre lijek CellCept potrebno je davati kao infuziju od 1 g dvaput dnevno tijekom prva četiri dana nakon transplantacije, a prije promjene doze na 1,5 g dvaput dnevno oralnim putem čim bolesnik bude u mogućnosti podnositi lijek.
English: Safety information has also been included in the summary of product characteristics and the package leaflet for CellCept, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: U sažetku opisa svojstava lijeka CellCept kao i u uputi o lijeku CellCept nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: CellCept is a medicine containing the active substance mycophenolate mofetil.
Croatian: CellCept je lijek koji sadrži djelatnu tvar mikofenolat mofetil.
English: The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Croatian: Djelatna tvar u lijeku CellCept, mikofenolat mofetil, jest imunosupresiv.
English: In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
Croatian: U ispitivanju koje je uključivalo bolesnike s presađenim srcem oko 38 % odraslih bolesnika koji su uzimali lijek CellCept i bolesnika koji su uzimali azatioprin odbacilo je organe nakon šest mjeseci.
English: It can also be given as an infusion lasting two hours starting within 24 hours after the transplant, for up to 14 days.
Croatian: Lijek se može dati i u obliku infuzije koja traje dva sata, a terapija počinje u roku od
English: What is CellCept?
Croatian: Što je CellCept?
English: What benefit has CellCept shown during the studies?
Croatian: Koje su koristi lijeka CellCept utvrđene u ispitivanjima?
English: What is CellCept used for?
Croatian: Za što se koristi CellCept?
English: For full details of the restrictions with CellCept, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek CellCept potražite u uputi o lijeku.
English: For the full list of side effects reported with CellCept, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka CellCept potražite u uputi o lijeku.
English: How does CellCept work?
Croatian: Kako djeluje CellCept?
English: How is CellCept used?
Croatian: Kako se CellCept koristi?
English: It has been shown that there is a significant risk of harm to a developing baby and of miscarriage if CellCept is used in pregnancy.
Croatian: Ako se lijek CellCept koristi u trudnoći, dokazano je da postoji znatan rizik od oštećenja ploda i spontanog pobačaja.
English: How has CellCept been studied?
Croatian: Kako je lijek CellCept ispitivan?
English: EU (MA) Number
Croatian: EU (broj) odobrenja (Zaštićeno) ime Doza
English: This summary was last updated in 04-2014.
Croatian: Sažetak je posljednji put ažuriran u: 04.2014.
English: If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Croatian: Ako bolesnici moraju uzeti više od 8 inhalacija na dan, preporuča se da se obrate svojem liječniku kako bi se revidirala njihova terapija astme.
English: Formoterol is a long-acting beta-2 agonist.
Croatian: Formoterol je dugodjelujući agonist beta-2.
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Croatian: Koristi se za liječenje astme u odraslih osoba za koje se kombinirani lijek smatra prikladnim.
English: It can also be used for the treatment of COPD.
Croatian: Može se također koristiti za liječenje KOPB-a.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Croatian: Djeluje vezujući se na receptore poznate pod nazivom receptori beta-2 koji se nalaze u mišićima zračnih putova.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Croatian: Dostupan je kao prašak za inhalaciju u prijenosnom inhalatoru, a svaka inhalacija pruža određenu dozu lijeka.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Croatian: KOPB je dugoročna bolest u kojoj se zračni putovi i zračne vrećice u plućima oštećuju ili začepljuju, što rezultira poteškoćama u disanju.
English: The full EPAR and risk management plan summary for BiResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) kao i plan upravljanja rizikom lijeka BiResp Spiromax nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Croatian: BiResp Spiromax se također koristi za ublažavanje simptoma zbiljne kronične opstruktivne pulmonalne bolesti (KOPB-a) u odraslih osoba koji imaju eksacerbacije (pogoršanja) bolesti u prošlosti usprkos redovitom liječenju.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Croatian: Budezonid se ubraja u grupu protuupalnih lijekova poznatih pod nazivom kortikosteroidi.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Croatian: Može se koristiti u bolesnika čija se bolest ne može primjereno kontrolirati terapijom drugim lijekovima protiv astme naziva kortikosteroidi i inhalacijskim „kratkodjelujući agonisti beta-2” ili u bolesnika čija se bolest ne kontrolira na primjeren način terapijom kortikosteroidima i inhalacijskim „dugodjelujućim agonistima beta-2”.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: Ovo rezultira smanjenjem u otpuštanju tvari koje su uključene u upalni proces, poput histamina, te stoga pomaže u očuvanju zračnih putova čistima i omogućuje bolesniku da lakše diše.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Prilikom spajanja na ove receptore, uzrokuje opuštanje mišića, što održava zračne putove otvorenima i pomaže pri disanju bolesnika.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Croatian: Djeluje na sličan način kao hormoni kortikosteroida koji se prirodno pojavljuju u tijelu te smanjuje aktivnost imunosnog sustava tako što se vezuje na receptore u različitim tipovima imunosnih stanica.
English: The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari lijeka BiResp Spiromax su dobro poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme i KOPB-a, samostalno ili u kombinaciji s drugim lijekovima.
English: BiResp Spiromax budesonide / formoterol
Croatian: BiResp Spiromax budezonid / formoterol
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži istu djelatnu tvar, no BiResp Spiromax se primjenjuje pomoću drugog inhalatora.
English: For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Croatian: Za liječenje KOPB-a, preporučena doza iznosi 1 ili 2 inhalacije dva puta na dan, ovisno o jačini koja se koristi.
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Croatian: U slučaju primjene kao terapije za ublažavanje astme, bolesnici mogu uzeti dodatne 1 ili 2 inhalacije lijeka BiResp Spiromax od 160/4.5 mikrograma samo da ublaže svoje simptome.
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Croatian: Za redovno liječenje astme, preporučena doza iznosi 1 do 4 inhalacija dva puta na dan, ovisno o jačini koja se koristi i težini astme.
English: This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek BiResp Spiromax.
English: Because BiResp Spiromax is a hybrid 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 BiResp Spiromax hibridni lijek i bioekvivalent referentnog lijeka, smatra se da su njegove koristi i rizici isti kao referentnog lijeka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek BiResp Spiromax vrijedi na prostoru Europske unije od 28. travnja 2014.
English: The higher strength, BiResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Croatian: Lijek veće jačine, BiResp Spiromax od 320/9 mikrograma (320 mikrograma budezonida i 9 mikrograma formoterola), može se koristiti samo za redovno liječenje astme i za liječenje KOPB-a.
English: BiResp Spiromax is a ‘hybrid medicine'.
Croatian: BiResp Spiromax je „hibridni lijek”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek BiResp Spiromax uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is not intended to provide practical advice on how to use BiResp Spiromax.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka BiResp Spiromax.
English: What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka BiResp Spiromax?
English: What is BiResp Spiromax and what is it used for?
Croatian: Što je BiResp Spiromax i za što se koristi?
English: The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Croatian: Tvrtka je prvo primijenila i slabije jačine lijeka BiResp Spiromax, no bioekvivaletnost s referentnim lijekom nije utvrđena, te je primjena ove jačine povučena.
English: BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Croatian: BiResp Spiromax je lijek koji sadrži djelatne tvari budezonid i formoterol.
English: Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Croatian: Ispitivanja provedena na bolesnicima ograničena su na testiranja kako bi se utvrdilo je li BiResp Spiromax bioekvivalent referentnog lijeka, Symbicort Turbohaler.
English: A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka BiResp Spiromax.
English: Other information about BiResp Spiromax
Croatian: Ostale informacije o lijeku BiResp Spiromax
English: The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Croatian: Referentni lijek za BiResp Spiromax je Symbicort Turbohaler.
English: For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom BiResp Spiromax pročitajte u uputi lijeka (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu s preduvjetima EU-a, potvrđeno da BiResp Spiromax od 160/4.5 mikrograma i 320/9 mikrograma posjeduje usporedivu kvalitetu te je bioekvivalent s lijeka Symbicort Turbohaler odgovarajuće jačine.
English: What are the benefits and risks of BiResp Spiromax?
Croatian: Koje su koristi i rizici lijeka BiResp Spiromax?
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Croatian: Stoga je stav Povjerenstva kako koristi od lijeka Symbicort Turbohaler nadmašuju utvrđene rizike.
English: Why is BiResp Spiromax approved?
Croatian: Zašto je BiResp Spiromax odobren?
English: For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka BiResp Spiromax pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.