FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Mozobil?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mozobil?
English: Further information on Mozobil can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/mozobil.
Croatian: Više informacija o lijeku Mozobil nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/mozobil.
English: Mozobil received a marketing authorisation valid throughout the EU on 31 July 2009.
Croatian: Lijek Mozobil dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 31. srpnja 2009.
English: What are the risks associated with Mozobil?
Croatian: Koji su rizici povezani s lijekom Mozobil?
English: Other information about Mozobil
Croatian: Ostale informacije o lijeku Mozobil
English: The medicine can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in treating cancer or blood disorders.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: • adults with lymphoma or multiple myeloma (types of blood cancer);
Croatian: • odraslim osobama oboljelim od multiplog mijeloma (vrsta raka krvi)
English: Because of this, treatment should be carried out in collaboration with a specialised centre that has experience with this type of procedure and can monitor the stem cells.
Croatian: Zbog toga liječenje treba provoditi u suradnji sa specijaliziranim centrom u kojem se obavlja ovakva vrsta postupka i gdje je moguće praćenje matičnih stanica.
English: Why is Mozobil authorised in the EU?
Croatian: Zašto je lijek Mozobil odobren u EU-u?
English: Side effects reported with Mozobil are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Mozobil pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The active substance in Mozobil, plerixafor, works by blocking the activity of a protein called the ‘CXCR4 chemokine receptor'.
Croatian: Djelatna tvar lijeka Mozobil, pleriksafor, djeluje blokiranjem aktivnosti bjelančevine pod nazivom „kemokinski receptor CXCR4”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mozobil 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 Mozobil nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What is Mozobil and what is it used for?
Croatian: Što je Mozobil i za što se primjenjuje?
English: As for all medicines, data on the use of Mozobil is continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Mozobil kontinuirano se prate.
English: The European Medicines Agency decided that Mozobil's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Mozobil nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Mozobil is given as an injection under the skin.
Croatian: Mozobil se daje injekcijom pod kožu.
English: The number of patients that need mobilisation and collection of haematopoietic stem cells for transplantation is low and Mozobil was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Croatian: Broj bolesnika kojima je potrebna mobilizacija i prikupljanje krvotvornih matičnih stanica u svrhu transplantacije nizak je, pa je lijek Mozobil dobio status „lijeka za rijetku bolest” 20. listopada 2004.
English: The most common side effects with Mozobil (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and reactions at the site of injection.
Croatian: Najčešće nuspojave lijeka Mozobil (koje se mogu javiti u više od 1 na 10 bolesnika) su proljev, mučnina i reakcije na mjestu injekcije.
English: An overview of Mozobil and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Mozobil i zašto je odobren u EU-u
English: Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.
Croatian: Mozobil se primjenjuje zajedno s hormonom koji se naziva čimbenik poticanja rasta granulocita (GCSF) i namijenjen je samo bolesnicima u kojih je prikupljanje matičnih stanica otežano.
English: Mozobil contains the active substance plerixafor.
Croatian: Mozobil sadržava djelatnu tvar pleriksafor.
English: Mozobil is given 6 to 11 hours before the patient's blood is taken and the stem cells are extracted.
Croatian: Mozobil sa daje 6 do 11 sati prije uzimanja krvi bolesnika i vađenja matičnih stanica.
English: For more information about using Mozobil, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Mozobil pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: How does Mozobil work?
Croatian: Kako djeluje Mozobil?
English: This protein normally helps to keep stem cells within the bone marrow.
Croatian: U normalnim okolnostima ta bjelančevina pomaže zadržati matične stanice unutar koštane srži.
English: In two main studies involving 298 adults with non-Hodgkin's lymphoma and 302 adults with multiple myeloma, more patients who received Mozobil achieved the target number of stem cells and had successful engraftment of stem cells (the cells started growing and producing normal blood cells after transplantation) than patients who received placebo (a dummy treatment).
Croatian: U dvama glavnim ispitivanjima kojima je bilo obuhvaćeno 298 odraslih osoba s ne-Hodgkinovim limfomom i 302 odrasle osobe s multiplim mijelomom, ciljni broj matičnih stanica i njihovo uspješno usađivanje (stanice su počele rasti i proizvoditi normalne krvne stanice nakon transplantacije) postiglo je više bolesnika koji su primili lijek Mozobil nego onih koji su primili placebo (prividno liječenje).
English: Mozobil is a medicine used to mobilise blood stem cells from a patient's bone marrow so that they can be collected and used later for transplantation in the same patient.
Croatian: Mozobil je lijek koji se primjenjuje za mobilizaciju krvotvornih matičnih stanica iz koštane srži bolesnika kako bi se mogle prikupiti i kasnije upotrijebiti za transplantaciju u istog bolesnika.
English: After the patient has been given Mozobil, the patient's stem cells are extracted from the blood and stored before transplantation.
Croatian: Nakon što bolesnik primi lijek Mozobil, matične stanice vade se iz krvi bolesnika i pohranjuju prije transplantacije.
English: What benefits of Mozobil have been shown in studies?
Croatian: Koje su koristi od lijeka Mozobil utvrđene u ispitivanjima?
English: Mozobil is used together with G-CSF.
Croatian: Mozobil se primjenjuje zajedno s hormonom G-CSF.
English: The patients who are given Mozobil are:
Croatian: Mozobil se daje sljedećim bolesnicima:
English: Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out of 154) of the patients receiving placebo.
Croatian: Među odraslim osobama s multiplim mijelomom, 72 % (106 od 148) onih koji su primali lijek Mozobil postiglo je ciljni broj matičnih stanica tijekom 4 dana prikupljanja, u odnosu na 34 % (53 od 154) bolesnika koji su primali placebo.
English: In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with 29% (4 out of 14) patients who received standard mobilisation treatment alone.
Croatian: U glavnom ispitivanju kojim je bilo obuhvaćeno 45 djece s limfomom ili solidnim tumorom, u 80 % (24 od 30) bolesnika koji su primali lijek Mozobil broj matičnih stanica u krvi barem se udvostručio, u usporedbi s 29 % (4 od 14) bolesnika koji su primali samo uobičajenu mobilizacijsku terapiju.
English: By blocking its activity, Mozobil allows the stem cells to be released into the blood, so that they can be collected.
Croatian: Blokiranjem njezine aktivnosti Mozobil omogućava otpuštanje matičnih stanica u krvotok i njihovo prikupljanje.
English: Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients receiving placebo.
Croatian: Među odraslim osobama s limfomom, 59 % (89 od 150) onih koji su primali lijek Mozobil postiglo je ciljni broj matičnih stanica tijekom 4 dana prikupljanja, u usporedbi s 20 % (29 od 148) bolesnika koji su primali placebo.
English: Mozobil is used to mobilise the stem cells from the bone marrow so they can be released into the blood.
Croatian: Mozobil se primjenjuje za mobilizaciju matičnih stanica iz koštane srži kako bi ih se moglo otpustiti u krvotok.
English: For the full list of side effects and restrictions with Mozobil, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Mozobil potražite u uputi o lijeku.
English: How is Mozobil used?
Croatian: Kako se Mozobil primjenjuje?
English: 20 November 2013
Croatian: 20. studenog 2013.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Croatian: Ishod postupka u skladu sa člankom 29.(4) Direktive 2001/83/EZ
English: What is Didanosine?
Croatian: Što je Didanozin?
English: The European Commission issued a decision on 20 November 2013.
Croatian: Europska je komisija usvojila odluku dana 20. studenog 2013.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Croatian: Dva lijeka su bioekvivalentna ako stvaraju iste koncentracije djelatne tvari u tijelu.
English: Aurobindo Pharma (Malta) Limited submitted Didanosine to the UK medicines regulatory agency for a decentralised procedure.
Croatian: Aurobindo Pharma (Malta) Limited dostavila je Didanozin regulatornoj agenciji za lijekove Ujedinjene Kraljevstve zbog provođenja decentraliziranog postupka.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 4 March 2013.
Croatian: No, države članice nisu bile u stanju postići dogovor, te je regulatorna agencija za lijekove Ujedinjene Kraljevine uputila predmet CHMP-u na arbitraciju dana 4. ožujka 2013. godine.
English: Why was Didanosine reviewed?
Croatian: Zašto je proveden pregled lijeka Didanozin?
English: On 19 September 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Didanosine.
Croatian: Dana 19. rujna 2013., Europska agencija za lijekove završila je arbitracijski postupak nastavno na neslaganje država članica Europske unije (EU) u vezi s odobrenjem za lijek Didanozin.
English: Didanosine does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Didanozin ne liječi zaraze HIV-om ili AIDS-om, no može odgoditi oštećenje imunosnog sustava, te razvijanje infekcija i bolesti povezanih s AIDS-om.
English: authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance France, Germany, Italy, Netherlands, Portugal, Romania and Spain).
Croatian: državama članicama („članicama sudionicama u postupku”, u ovom slučaju Francuskoj, Njemačkoj, Italiji, Nizozemskoj, Portugalu, Rumunjskoj i Španjolskoj).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Didanosine outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: France, Germany, Italy, the Netherlands, Portugal, Romania and Spain.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da koristi od Didanozina nadmašuju s njim povezane rizike, te se odobrenje za stavljanje lijeka u promet može dati u Ujedinjenoj Kraljevini i sljedećim državama članicama EU-a: Francuskoj, Njemačkoj, Italiji, Nizozemskoj, Portugalu, Rumunjskoj i Španjolskoj.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing
Croatian: Ovo je postupak u kojem jedna država članica („referenta država članica” u ovom slučaju Ujedinjena Kraljevina) procjenjuje lijek s obzirom na davanje odobrenja za stavljanje lijeka u promet koje će biti na snazi u toj državi kao i u drugim
English: This prevents the active substance from being destroyed by the acid in the stomach.
Croatian: Na ovaj se način sprječava razgradnja djelatne tvari kiselinom u želucu.
English: Didanosine is a hybrid medicine which means that it is similar to a ‘reference medicine' already authorised in the EU called Videx EC.
Croatian: Didanozin je hibridan lijek, što znači da je sličan „referentom lijeku” koji je već odobren u EU-u naziva Videx EC.
English: Didanosine is an antiviral medicine used in combination with other medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Didanozin je antivirusni lijek koji se koristi u kombinaciji s drugim lijekovima za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Croatian: Inhibira djelovanje reverzne transkriptaze, enzima kojeg proizvodi HIV-1, a koji mu omogućuje proizvodnju većeg broja virusa u stanicama koje su zaražene.
English: Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg)
Croatian: Pitanja i odgovori o lijeku Didanozin i srodnim nazivima (didanozin, želučanootporne kapsule, 200, 250 i 400 mg)
English: The CHMP therefore concluded that the benefits of Didanosine outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Croatian: Stoga je CHMP zaključio da koristi od lijeka Didanozin nadmašuju s njim povezane rizike i preporučio je davanje odobrenja za stavljanje lijeka u promet u članicama sudionicama u postupku.
English: Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs).
Croatian: Didanozin se ubraja u kategoriju lijekova naziva analozi nukleozida ili inhibitori reversne transkriptaze nukleozida (NRTI-ovi).
English: Although the Committee noted that the maximum concentrations of active substance in the blood when taken with food were somewhat higher after Didanosine than after the reference medicine, it considered that the difference was not clinically relevant since the medicine should be taken on an empty stomach, which produces much higher concentrations, and these small variations in the concentration of the active substance in the blood would therefore not increase the risks.
Croatian: Iako je Povjerenstvo napomenulo da su, ako se lijek uzima s hranom, maksimalne koncentracije djelatne tvari u krvi bile neznatno veće s lijekom Didanozin nakon uzimanja referentnog lijeka, Povjerenstvo smatra da razlika nije od kliničkog značaja s obzirom da se lijek treba uzimati na prazan želudac, pri čemu se stvaraju znatno veće koncentracije, pa ove male varijacije u koncentraciji djelatne tvari u krvi ne povećavaju rizike.
English: Although the presence of food in the stomach lowers the amount of active substance that can be absorbed and these medicines should therefore be taken on an empty stomach, as Didanosine is a gastro-resistant preparation bioequivalence in fed conditions must be shown to grant the marketing authorisation.
Croatian: Iako prisutnost hrane u želucu smanjuje količinu djelatne tvari koja se može apsorbirati, te se stoga ovi lijekovi trebaju uzimati na prazan želudac, budući da je Didanozin želučanootporan pripravak, bioekvivaletnosti u uvjetima kad su ispitanici smjeli jesti mora biti dokazana kako bi se izdalo odobrenje za stavljanje lijeka u promet.
English: The grounds for the referral were objections raised by France and the Netherlands that the bioequivalence study carried out under fed conditions did not show that Didanosine was bioequivalent to its reference medicine, Videx EC.
Croatian: Temelji za postupak upućivanja bili su prigovori iznijeti od strane Francuske i Nizozemske da ispitivanjem bioekvivaletnosti provedenim u uvjetima kad su ispitanici smjeli jesti nije dokazalo da je Didanozin bioekvivalent svojem referentom lijeku, lijeku Videx EC.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine has been shown when taken on an empty stomach, and under fed conditions when considering the overall exposure to the active substance (a measure known as AUC).
Croatian: Na temelju ocijene trenutno dostupnih podataka i znanstvene rasprave unutar Povjerenstva, CHMP je zaključio da je bioekvivaletnost s referentnim lijekom dokazana ako se lijek uzima na prazan želudac, te u uvjetima kad su ispitanici smjeli jesti ako se u obzir uzme cjelokupno izlaganje djelatnoj tvari (mjera koja je poznata pod nazivom AUC).
English: ‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
Croatian: Dostupan je u obliku želučanootpornih tableta. „Želučanootporno” znači da sadržaji tablete prolaze kroz želudac bez razgradnje sve dok ne dosegnu crijeva.
English: By blocking this enzyme, didanosine, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Inhibirajući ovaj enzim, lijek Didanozin smanjuje koncentraciju HIV-a u krvi i održava nisku razinu koncentracije virusa, ako se uzima u kombinaciji s drugim antivirusnim lijekovima.
English: 66 months.
Croatian: 66 mjeseci.
English: Day 7 or 8 or 9:
Croatian: 7., 8. ili 9. dan:
English: “+” indicates an ongoing response.
Croatian: "+" označava odgovor koji još traje.
English: Please ask your doctor how this may affect you, especially if you are planning on having children in the future.
Croatian: Molimo upitajte liječnika kako bi to moglo utjecati na Vas, osobito ako u budućnosti planirate imati djecu.
English: These usually decrease around two months after start of treatment.
Croatian: Oni se obično smanjuju otprilike dva mjeseca nakon početka liječenja.
English: Date of latest renewal: 16 January 2009
Croatian: Datum posljednje obnove: 16. siječnja 2009.
English: Zevalin contains 1 of each of the following:
Croatian: Zevalin sadrži po 1 od sljedećeg:
English: Tell your doctor immediately if you notice symptoms of any of the following:
Croatian: Odmah obavijestite liječnika ako primijetite simptome bilo kojeg od sljedećih poremećaja:
English: 1097 JB Amsterdam The Netherlands
Croatian: 1097 JB Amsterdam Nizozemska
English: Zevalin will only be used in special controlled areas.
Croatian: Zevalin će se primjenjivati samo u posebno kontroliranim prostorima.
English: Below limit of quantitation*
Croatian: Ispod granice kvantifikacije*
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Your doctor will immediately stop the treatment.
Croatian: Liječnik će odmah prekinuti liječenje.
English: Zevalin is indicated in adults.
Croatian: Zevalin je indiciran u odraslih.
English: • Additional testing that might be required for suitability assessment: Process-specific impurities:
Croatian: • Dodatna testiranja koja bi mogla biti potrebna radi procjene prikladnosti: Nečistoće specifične za proces:
English: You may, therefore, need to be tested for special antibodies.
Croatian: Stoga će Vas se možda morati testirati na posebna protutijela.
English: Date of first authorisation: 16 January 2004
Croatian: Datum prvog odobrenja: 16. siječnja 2004.
English: HCl concentration
Croatian: Koncentracija HCl
English: Individual metals*
Croatian: Pojedinačni metali*
English: Expected haematological toxicity was observed, including grade 3 or 4.
Croatian: Primijećena je očekivana hematološka toksičnost, uključujući i one 3. ili 4. stupnja.
English: Y]-Zevalin mGy/MBq Median
Croatian: Y]-Zevalin mGy/MBq Medijan
English: International Workshop Response Criteria (IWRC).
Croatian: International Workshop Response Criteria).
English: You will be given a total of 3 infusions in the course of two visits to a medical facility, 7 to 9 days apart.
Croatian: Primit ćete ukupno 3 infuzije tijekom dva posjeta zdravstvenoj ustanovi u razmaku od 7 do 9 dana.
English: * Needs to be included as release test or controlled through process validation if above limit of quantitation
Croatian: * Potrebno je uključiti kao test otpuštanja ili kontrolirati validacijom procesa ako se nalazi iznad granice kvantifikacije.
English: IWRC: International Workshop response criteria CRu: Unconfirmed complete response
Croatian: 1IWRC: kriteriji odgovora međunarodne radionice CRu: nepotvrđeni potpuni odgovor
English: Most radioactivity will decay within the body, but a small part will be eliminated through your urine.
Croatian: Većina radioaktivnosti će se raspasti u tijelu, ali će se manji dio eliminirati putem mokraće.
English: Y occurs in a radius of 5 mm around the isotope.
Croatian: događa se u polumjeru od 5 mm oko izotopa.
English: The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
Croatian: Obrazac vezanja vrlo je ograničen, bez križne reaktivnosti na druge leukocite ili druge vrste ljudskog tkiva.
English: System Organ Class (MedDRA)
Croatian: Klasifikacije organskih sustava (MedDRA)
English: Infections were very commonly observed.
Croatian: Infekcije su se primjećivale vrlo često.
English: - Pregnancy and lactation (see section 4.6).
Croatian: - Trudnoća i dojenje (vidjeti dio 4.6).
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Croatian: Vaš liječnik i liječnik nuklearne medicine smatraju da klinička korist koju ćete imati od postupka primjene radiofarmaceutika nadilazi rizik od izlaganja zračenju.
English: Refractory or relapsed NHL:
Croatian: Refraktorni ili recidivirajući NHL:
English: In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
Croatian: Ukupno, 87% bolesnika bilo je u CR(u), odnosno 76 % u CR, a 11 % u CRu.
English: Therefore, women must discontinue breast-feeding, as the potential for absorption and immunosuppression in the infant is unknown.
Croatian: Stoga žene moraju prekinuti s dojenjem jer potencijalna apsorpcija i imunosupresija u dojenčadi nije poznata.
English: Process residuals (e.g. ammonia, nitrate)
Croatian: Procesni ostaci (npr. amonijak, nitrat)
English: Y] in a total volume of 10 ml.
Croatian: Y] u ukupnom volumenu od 10 ml.
English: No interaction studies have been performed.
Croatian: Nisu provedena nikakva ispitivanja interakcija.
English: WHAT ZEVALIN IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE ZEVALIN I ZA ŠTO SE KORISTI
English: Estimated with observed range.
Croatian: Procijenjeno na temelju opaženog raspona.