FrancophonIA/ELRC3.0 huggingface dataset:
English: For documents related to submission of authorised medicines data visit the Guidance document webpage.
Croatian: Za dokumente povezane s dostavljanjem podataka za odobrene lijekove posjetite internetsku stranicu s dokumentima koji sadrže smjernice.
English: MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
Croatian: Nositelji odobrenja također su dužni azurirati dostavljene informacije o lijeku i obavijestiti EMA-u o bilo kakvim novim odobrenim lijekovima ili izmjenama uvjeta odobrenja za stavljanje lijeka u promet primjenom formata XEVPRM.
English: • centrally authorised medicinal products;
Croatian: • lijekove odobrene centraliziranim postupkom;
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Croatian: Ovaj tip transplantata koristi se kod bolesnika koji trebaju zamjenu svojih krvotvornih stanica jer imaju poremećaj krvi (poput rijetkog tipa anemije) ili karcinom krvi.
English: This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
Croatian: To pomaže da se transplantirane stanice „presade” (kada počnu rasti i proizvoditi normalne krvne stanice).
English: The full EPAR and risk management plan summary for Busulfan Fresenius Kabi 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 Busulfan Fresenius Kabi nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These substances are ‘cytotoxic'.
Croatian: Te su tvari „citotoksične”.
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Croatian: Ciklofosfamid, melfalan ili fludarabin se potom koristi za supresiju imunosnog sustava tako da se smanjuju prirodne obrane tijela.
English: The company provided data from the published literature on busulfan.
Croatian: Tvrtka je dostavila podatke o busulfanu iz objavljenje literature.
English: It is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Croatian: Koristi se kod odraslih i djece kao dio „kondicioniranog” (preparativno) liječenja prije transplantacije krvotvornih progenitorskih stanica (stanica koje proizvode krvne stanice).
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing bloodmaking cells.
Croatian: Busulfan se koristi prije transplantacije za uništavanje nenormalnih stanica i postojećih krvotvornih stanica bolesnika.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (‘stem') cells (cells that make other types of cell).
Croatian: To znači da ubijaju stanice, posebice stanice koje se ubrzano razvijaju poput stanice karcinoma ili progenitorske („matične stanice”) stanice (stanice koje proizvode druge tipove stanica).
English: The medicine is available as a concentrate to be made up into a solution for central intravenous infusion (drip into a central vein in the chest).
Croatian: Lijek je dostupan u obliku koncentrata za otopinu za centralnu vensku infuziju (drip u središnju venu prsa).
English: This means that Busulfan Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Busilvex.
Croatian: To znači da je Busulfan Fresenius Kabi sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Busilvex.
English: Busulfan Fresenius Kabi can only be obtained with a prescription and should only be used by a doctor who has experience in treatments given before transplantation.
Croatian: Lijek Busulfan Fresenius Kabi može se dobiti samo na recept i smije ga koristiti samo liječnik koji ima iskustva u predtransplantacijskom liječenju.
English: Before receiving Busulfan Fresenius Kabi, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Croatian: Prije primanja lijeka Busulfan Fresenius Kabi bolesnicima se daju anti konvulzivni lijekovi (za sprječavanje napadaja) i antiemetici (za sprječavanje povraćanja).
English: This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Busulfan Fresenius Kabi.
English: When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Croatian: Kad se koristi u kombinaciji s fludarabinom preporučena doza lijeka Busulfan Fresenius Kabi iznosi 3,2 mg/kg jedanput dnevno kao trosatna infuzija odmah nakon uzimanja fludarabina, i to 2 ili 3 uzastopna dana.
English: Because Busulfan Fresenius Kabi is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da se Busulfan Fresenius Kabi daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek, njegove koristi i rizici isti su kao i oni kod referentnog lijeka.
English: For a conventional conditioning treatment, Busulfan Fresenius Kabi is given before treatment with a second medicine, cyclophosphamide in adults, and either cyclophosphamide or melphalan in children.
Croatian: Za uobičajno kondicionirano liječenje lijek Busulfan Fresenius Kabi se daje prije tretmana s drugim lijekom, ciklofosfamidom u odraslih tj. ciklofosfamidom ili melfalanom u djece.
English: Therefore, the CHMP's view was that, as for Busilvex, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Busilvex koristi nadmašuju utvrđene rizike.
English: Busulfan Fresenius Kabi is a ‘generic medicine'.
Croatian: Busulfan Fresenius Kabi je „generički lijek”.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busulfan Fresenius Kabi in adults is 0.8 mg per kilogram body weight.
Croatian: Kad se koristi u kombinaciji s ciklofosfamidom ili melfalanom, doza lijeka Busulfan Fresenius Kabi u odraslih iznosi 0,8 mg po kilogramu tjelesne težine.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Busulfan Fresenius Kabi has been shown to be comparable to Busilvex.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je u skladu s uvjetima EU-a za bioslične lijekove dokazano da lijek Busulfan Fresenius Kabi posjeduje usporedivu razinu kvalitete kao i Busilvex.
English: It is not intended to provide practical advice on how to use Busulfan Fresenius Kabi.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Busulfan Fresenius Kabi.
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busulfan Fresenius Kabi is given right after treatment with another medicine, fludarabine.
Croatian: U odraslih bolesnika podobnih za kondicionirano doziranje smanjenog intenziteta, lijek Busulfan Fresenius Kabi daje se odmah nakon liječenja drugim lijekom, fludarabinom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Busulfan Fresenius Kabi on 22 September 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Busulfan Fresenius Kabi na snazi u Europskoj uniji od 22. rujna 2014.
English: No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
Croatian: Nisu bila potrebna dodatna ispitivanja jer se Busulfan Fresenius Kabi daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek, Busilvex.
English: The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Croatian: Djelatna tvar u lijeku Busulfan Fresenius Kabi, busulfan pripada skupini lijekova zvanih „alkilirajući agensi”.
English: What measures are being taken to ensure the safe and effective use of Busulfan Fresenius Kabi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Busulfan Fresenius Kabi?
English: For more information about treatment with Busulfan Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Busulfan Fresenius Kabi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: A risk management plan has been developed to ensure that Busulfan Fresenius Kabi is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Busulfan Fresenius Kabi.
English: What is Busulfan Fresenius Kabi and what is it used for?
Croatian: Što je Busulfan Fresenius Kabi i za što se koristi?
English: Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan.
Croatian: Busulfan Fresenius Kabi je lijek koji sadrži djelatnu tvar busulfan.
English: What are the benefits and risks of Busulfan Fresenius Kabi?
Croatian: Koje su koristi i rizici povezani s lijekom Busulfan Fresenius Kabi?
English: Other information about Busulfan Fresenius Kabi
Croatian: Ostale informacije o lijeku Busulfan Fresenius Kabi
English: The Committee recommended that Busulfan Fresenius Kabi be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Busulfan Fresenius Kabi u EU-u.
English: For practical information about using Busulfan Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Busulfan Fresenius Kabi pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Why is Busulfan Fresenius Kabi approved?
Croatian: Zašto je Busulfan Fresenius Kabi odobren?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Fresenius Kabi nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In children up to 17 years of age, the recommended dose of Busulfan Fresenius Kabi varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Croatian: U djece starosti do 17 godina preporučena doza lijeka Busulfan Fresenius Kabi varira između 0,8 i 1,2 mg/kg ovisno o tjelesnoj težini djeteta.
English: How is Busulfan Fresenius Kabi used?
Croatian: Kako se Busulfan Fresenius Kabi koristi?
English: How has Busulfan Fresenius Kabi been studied?
Croatian: Kako je Busulfan Fresenius Kabi ispitivan?
English: How does Busulfan Fresenius Kabi work?
Croatian: Kako djeluje Busulfan Fresenius Kabi?
English: A response is usually seen in two to four weeks.
Croatian: Odgovor se najčešće vidi u roku dva do četiri tjedna.
English: • major depression;
Croatian: • teškom depresijom;
English: Most patients will need to take 60 mg per day.
Croatian: Većini bolesnika bit će potrebno 60 mg na dan.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Croatian: Neurotransmiteri su kemikalije ukoje omogućuju međusobnu komunikaciju živčanih stanica.
English: Since these neurotransmitters are involved in maintaining mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Croatian: Budući da su neurotransmiteri uključeni u održavanje dobrog raspoloženja i ublažavanje osjećaja boli, inhibiranjem njihove ponovne pohrane u živčane stanice mogu se poboljšati simptomi depresije, anksioznosti i neuropatične boli.
English: Patients who also have major depression should start with 60 mg once a day.
Croatian: Bolesnici koji imaju tešku depresiju također trebaju početi sa 60 mg jednom na dan.
English: This prevents the active substance being destroyed by the acid in the stomach.
Croatian: Na taj se način sprječava razgradnja djelatne tvari kiselinom u želucu.
English: The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.
Croatian: Dozu lijeka Duloxetine Zentiva treba postupno smanjivati prilikom prekida liječenja.
English: Duloxetine Zentiva is used to treat adults with the following diseases:
Croatian: Duloxetine Zentiva se koristi za liječenje odraslih osoba sa sljedećim bolestima:
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);
Croatian: • boli uslijed periferne dijabetičke neuropatije (oštećenja živaca u stopalima, šakama i rukama koje može nastupiti u bolesnika s dijabetesom);
English: Duloxetine Zentiva duloxetine
Croatian: Duloxetine Zentiva duloksetin
English: The Committee recommended that Duloxetine Zentiva be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Duloxetine Zentiva za korištenje u EU-u.
English: This means that Duloxetine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Croatian: To znači da je Duloxetine Sandoz sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Cymbalta.
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Croatian: Djeluje sprečavajući ponovnu pohranu neurotransmitera serotonina (5hidroksitriptamin) i noradrenalina u živčane stanice u mozgu i kralježničnoj moždini.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Zentiva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Duloxetine Zentiva.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Croatian: U slučaju generaliziranog anksioznog poremećaja, preporučena početna doza iznosi 30 mg jednom na dan, no doza se može povećati na 60, 90 ili 120 mg ovisno o odgovoru bolesnika.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Croatian: U bolesnika koji su odgovorili na Duloxetine Zentiva, terapiju treba nastaviti tijekom nekoliko mjeseci da bi se spriječio povratak bolesti ili dulje u bolesnika koji su imali ponovljena razdoblja depresije u prošlosti.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between nerve cells, increasing the level of communication between the cells.
Croatian: Inhibirajući njihovu ponovnu pohranu duloksetin povećava količinu ovih neurotransmitora u prostoru između živčanih stanica i na taj način povećava razinu komunikacije između stanica.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Duloxetine Zentiva posjeduje usporedivu kakvoću te je bioekvivalentan lijeku Cymbalta.
English: For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day.
Croatian: U slučaju teže depresije, preporučena doza lijeka Duloxetine Zentiva je 60 mg jednom na dan.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, 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 za lijek Duloxetine Zentiva nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day.
Croatian: U slučaju periferne dijabetičke neuropatije preporučena doza je 60 mg na dan, no pojedinim bolesnicima može biti potrebna veća doza do 120 mg na dan.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.
Croatian: U bolesnika koji su odgovorili na lijek Duloxetine Zentiva, terapiju treba nastaviti tijekom nekoliko mjeseci kako bi se spriječio povratak poremećaja.
English: It is not intended to provide practical advice on how to use Duloxetine Zentiva.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Duloxetine Zentiva.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Zentiva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Duloxetine Zentiva?
English: What is Duloxetine Zentiva and what is it used for?
Croatian: Što je Duloxetine Zentiva i za što se koristi?
English: A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Duloxetine Zentiva.
English: The full EPAR and risk management plan summary for Duloxetine Zentiva 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 Duloxetine Zentiva nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o liječenju lijekom Duloxetine Zentiva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Croatian: Djelatna tvar lijeka Duloxetine Zentiva, duloksetin, inhibitor je ponovne pohrane serotonin noradrenalina.
English: What are the benefits and risks of Duloxetine Zentiva?
Croatian: Koje su koristi i rizici lijeka Duloxetine Zentiva?
English: Duloxetine Zentiva contains the active substance duloxetine and is is a ‘generic medicine'.
Croatian: Duloxetine Zentiva sadrži djelatnu tvar duloksetin te je „generički lijek”.
English: For practical information about using Duloxetine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Duloxetine Zentiva pročitajte u uputi o lijeku ili se obratite svojem liječniku ili ljekarniku.
English: Because Duloxetine Zentiva 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 lijek Duloxetine Zentiva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Other information about Duloxetine Zentiva
Croatian: Ostale informacije o lijeku ADuloxetine Zentiva
English: Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Duloxetine Zentiva generički lijek, smatra se da su njegovi koristi i rizici isti kao i kod referentnog lijeka.
English: Why is Duloxetine Zentiva approved?
Croatian: Zašto je Duloxetine Zentiva odobren?
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Duloxetine Zentiva koristi nadmašuju utvrđene rizike.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Croatian: Duloxetin Zentiva dostupan je kao gastrorezistentne kapsule (30 i 60 mg). „Gastrorezistentno” znači da sadržaj kapsula prolazi kroz želudac bez razgradnje sve dok ne dođu u crijeva.
English: How is Duloxetine Zentiva used?
Croatian: Kako se koristi Duloxetine Zentiva?
English: How has Duloxetine Zentiva been studied?
Croatian: Kako je Duloxetine Zentiva ispitivan?
English: How does Duloxetine Zentiva work?
Croatian: Kako djeluje Duloxetine Zentiva?
English: Further information on Oncaspar can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR Oncaspar.
Croatian: Više informacija o lijeku Oncaspar nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR Oncaspar.
English: Oncaspar (pegaspargase)
Croatian: Oncaspar (pegaspargaza)
English: The healthcare professional should give the medicine in a hospital where resuscitation equipment is available.
Croatian: Zdravstveni radnici lijek moraju primjenjivati u bolnici gdje je dostupna oprema za oživljavanje.
English: This compares with 66% of those treated with another asparaginase.
Croatian: To se može usporediti sa 66 % bolesnika liječenih drugom vrstom asparaginaze.
English: Oncaspar is used in combination with other cancer medicines.
Croatian: Oncaspar se primjenjuje u kombinaciji s drugim lijekovima protiv raka.
English: However, the data in adult patients were limited and the company that markets the medicine is to provide further data of its benefit in this group of patients.
Croatian: Međutim, podatci u odraslih bolesnika bili su ograničeni i tvrtka koja lijek stavlja u promet treba pružiti dodatne podatke o njegovoj djelotvornosti u toj skupini bolesnika.
English: Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.
Croatian: Lijek Oncaspar dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 14. siječnja 2016.
English: What measures are being taken to ensure the safe and effective use of Oncaspar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Oncaspar?
English: The asparaginase enzyme in this medicine is linked to a chemical which slows down its removal from the body and can reduce the risk of allergic reactions.
Croatian: Enzim asparaginaza u ovom lijeku vezuje se na kemikaliju koja usporava njegovo izlučivanje iz organizma, što može smanjiti rizik od alergijske reakcije.
English: Oncaspar can only be obtained with a prescription and only healthcare professionals with experience of cancer treatments should prescribe and give the medicine.
Croatian: Oncaspar se izdaje samo na liječnički recept, a samo zdravstveni radnici s iskustvom u liječenju raka smiju propisivati i primjenjivati lijek.
English: The company that markets Oncaspar will complete two more studies on the safety and effectiveness of Oncaspar, which will help further clarify the benefits and risks of this medicine in adults and in newly diagnosed patients.
Croatian: Tvrtka koja lijek Oncaspar stavlja u promet provest će dva dodatna ispitivanja o sigurnosti i učinkovitosti ovog lijeka, što će dodatno razjasniti prednosti i rizike povezane s primjenom lijeka u odraslih i novodijagnosticiranih bolesnika.