FrancophonIA/ELRC3.0 huggingface dataset:
English: This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells.
Croatian: Ovo je obuhvatilo 109 ispitivanja koja su uključivala otprilike 6.000 odraslih bolesnika i 900 djece s krvnim bolestima ili solidnim tumorima, koji su bili podvrgnuti transplantaciji krvnih stanica.
English: The full EPAR for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tepadina nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 January 2007.
Croatian: Budući da je broj bolesnika u Europskoj uniji (EU) koji se podvrgavaju ovom tipu kondicioniranja i transplantacije nizak, Tepadina se označava kao lijek za liječenje rijetkih bolesti od 29 siječnja 2007.
English: The studies looked at the number of patients with successful transplantations, how long it took for the diseases to come back and how long the patients survived.
Croatian: Ispitivanja su istražila broj bolesnika s uspješnim transplantacijama, koliko je dugo trajalo da se bolest vrati te trajanje preživljenja bolesnika.
English: This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection.
Croatian: Ovo omogućuje novim stanicama da se transplantiraju, čime se stvara prostor za nove stanice i smanjuje se rizik od odbacivanja.
English: What is the risk associated with Tepadina?
Croatian: Koji su rizici povezani s lijekom Tepadina?
English: • as a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Croatian: • kao „kondicionirana“ (pripremna) terapija prije transplantacije hematopoetskih progenitorskih stanica (stanica koje proizvode krvne stanice).
English: Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation.
Croatian: Primjena lijeka Tepadina mora biti pod nadzorom liječnika s iskustvom u pripremnom liječenju prije transplantacije.
English: This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or ‘stem') cells (cells that can develop into different types of cell).
Croatian: To znači da ubijaju stanice koje se brzo umnožavaju, poput stanica raka ili progenitorskih (ili „matičnih“) stanica (stanica koje se mogu razviti u različite tipove stanica).
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 Tepadina.
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 i preporuke za uvjete uporabe lijeka Tepadina.
English: It helps to destroy the patient's existing blood-making cells, resulting in the successful transplantation of new cells, improved survival and a reduced risk of the diseases coming back.
Croatian: Pomaže pri uništavanju postojećih krvotvornih stanica bolesnika, što rezultira uspješnom transplantacijom novih stanica, poboljšanim preživljenjem i smanjenim rizikom od recidiva bolesti.
English: This is a summary of the European Public Assessment Report (EPAR) for Tepadina.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Tepadina.
English: A risk management plan has been developed to ensure that Tepadina is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tepadina.
English: Why has Tepadina been approved?
Croatian: Zašto je Tepadina odobren?
English: Tepadina is used with other medicines before transplantation to destroy the abnormal cells and the patient's existing blood-making cells.
Croatian: Tepadina se koristi zajedno s drugim lijekovima prije transplantacije kako bi se uništile abnormalne stanice i postojeće krvotvorne stanice bolesnika.
English: The published studies showed that thiotepa used in combination with other chemotherapy medicines is beneficial to adults and children being treated for blood diseases and solid tumours.
Croatian: U objavljenim ispitivanjima utvrđeno je da je tiotepa korištena u kombinaciji s drugim kemoterapijskim lijekovima od koristi u odraslih i djece koji se liječe protiv krvnih bolesti i solidnih tumora.
English: The most common side effects seen with Tepadina when used with other medicines are infections, cytopenia (low number of cells in the blood), graft-versus-host disease (when the transplanted cells attack the body), disorders of the gut, haemorrhagic cystitis (bleeding and inflammation in the bladder) and mucosal inflammation (inflammation of the moist body surfaces).
Croatian: Najčešće nuspojave koje se mogu javiti uslijed primjene lijeka Tepadina kada se lijek koristi s drugim lijekovima su infekcije, citopenija (mali broj stanica u krvi), bolest kada presadak napada domaćina (kada presađene stanice napadaju tijelo), poremećaji crijeva, hemoragijske ciste (krvarenje i upala mjehura) i upala sluznica (upala vlažnih tjelesnih površina).
English: Tepadina must not be used in women who are pregnant or breast-feeding.
Croatian: Tepadina se ne smije koristiti trudnica ili dojilja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tepadina on 15 March 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tepadina na snazi u Europskoj uniji od 15. ožujka 2010.
English: The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out.
Croatian: Doza lijeka Tepadina ovisi o tipu krvne bolesti ili solidnog tumora od kojeg bolesnik pati te tipu transplantacije koja će se provesti.
English: The Committee decided that, based on available published information, Tepadina's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je zaključio, na temelju dostupnih objavljenih informacija, da koristi od lijeka Tepadina nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: Tepadina can be used for transplantation of cells from a donor and for transplantation of cells derived from the patient's own body.
Croatian: Tepadina se može koristiti za transplantaciju stanica od donatora i za transplataciju stanica dobivenih iz tijela bolesnika.
English: Other information about Tepadina
Croatian: Ostale informacije o lijeku Tepadina
English: It contains the active substance thiotepa.
Croatian: Sadrži djelatnu tvar tiotepa.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tepadina, 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 Tepadina nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Tepadina?
Croatian: Što je Tepadina?
English: Tepadina is a powder that is made up into a solution for infusion (drip into a vein).
Croatian: Tepadina je prašak za koncentrat za otopinu za infuzij (drip u venu).
English: The active substance in Tepadina, thiotepa, belongs to a group of medicines called ‘alkylating agents'.
Croatian: Djelatna tvar u lijeku Tepadina, tiotepa, ubraja se u grupu lijekova naziva „alikirajuće tvari“.
English: What is Tepadina used for?
Croatian: Za što se Tepadina koristi?
English: The CHMP noted that the active substance in Tepadina, thiotepa, has a well established used.
Croatian: Mišljenje je CHMP da djelatna tvar lijeka Tepadina, tiotepa, ima dobro utvrđenu primjenu.
English: • during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.
Croatian: • kada je visoko-dozna kemoterapija, nakon transplantacije hematopoetskih progenitorskih stanica,
English: For the full list of all side effects reported with Tepadina in adults and children, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Tepadina u odraslih i djece, potražite u uputi o lijeku
English: What benefit has Tepadina shown during the studies?
Croatian: Koje su koristi lijeka Tepadina utvrđene u ispitivanjima?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija o terapiji lijekom Tepadina pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Tepadina dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: How is Tepadina used?
Croatian: Kako se Tepadina koristi?
English: This type of transplant is used in patients who need to replace their blood-making cells because they have a blood disease such as a cancer of the blood
Croatian: Ovaj tip presatka koristi se u bolesnika kojima je potrebna zamjena krvotvornih stanica budući da imaju bolest krvi poput raka krvi (uključujući i leukemiju) ili bolest koja uzrokuje mali broj crvenih krvnih stanica (uključujući talasemiju ili anemiju srpastih stanica);
English: How does Tepadina work?
Croatian: Kako djeluje Tepadina?
English: How has Tepadina been studied?
Croatian: Kako je lijek Tepadina ispitivan?
English: The full EPAR for Temozolomide Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Temozolomide Sandoz nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose of Temozolomide Sandoz depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Croatian: Doza Temozolomide Sandoz ovisi o tjelesnoj površini bolesnika (izračunava se pomoću visine i tjelesne težine bolesnika) u rasponu od 75 do 200 mg/m2 jednom na dan.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sandoz.
Croatian: Bolesnici će možda također trebati uzeti lijekove da bi spriječili povraćanje prije uzimanja lijeka Temozolomide Sandoz.
English: Temozolomide Sandoz should be taken without food.
Croatian: Temozolomide Sandoz treba uzimati bez hrane.
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 Temozolomide Sandoz.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Temozolomide Sandoz.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Sandoz is being used alone or with other treatments, and how the patient responds to treatment.
Croatian: Doza i broj doza ovise o tipu tumora koji se liječi, o činjenici je li bolesnik ranije primio terapiju, koristi li se Temozolomide Sandoz kao monoterapija ili u kombinaciji s drugom terapijom te kako bolesnik odgovara na terapiju.
English: For more information about treatment with Temozolomide Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Temozolomide Sandoz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Sandoz.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Temozolomide Sandoz.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sandoz on 15 March 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Temozolomide Sandoz na snazi u Europskoj uniji od 15. ožujka 2010.
English: This means that Temozolomide Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Croatian: To znači da je Temozolomide Sandoz sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Temodal.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sandoz has been shown to have comparable quality and to be bioequivalent to Temodal.
Croatian: CHMP je zaključio kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Temozolomide Sandoz posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Temodal.
English: Because Temozolomide Sandoz 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 Temozolomide Sandoz generički lijek i bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Temozolomide Sandoz is used first with radiotherapy and then on its own;
Croatian: Temozolomide Sandoz se prvo koristi istodobno s radioterapijom (RT), a zatim kao monoterapija;
English: Temozolomide Sandoz is a ‘generic medicine'.
Croatian: Temozolomide Sandoz je „generički lijek”.
English: Treatment with Temozolomide Sandoz should be prescribed by a doctor with experience in the treatment of brain tumours.
Croatian: Terapiju lijekom Temozolomide Sandoz smiju propisivati samo liječnici s iskustvom u liječenju tumora mozga.
English: The Committee recommended that Temozolomide Sandoz be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Temozolomide Sandoz.
English: Because Temozolomide Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Croatian: Budući da je Temozolomide Sandoz generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Temodal.
English: Temozolomide Sandoz temozolomide
Croatian: Temozolomide Sandoz temozolomid
English: Temozolomide Sandoz is used on its own in these patients.
Croatian: Temozolomide Sandoz se koristi kao monoterapija u ovih bolesnika.
English: Other information about Temozolomide Sandoz
Croatian: Ostale informacije o lijeku Temozolomide Sandoz
English: The active substance in Temozolomide Sandoz, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Croatian: Djelatna tvar lijeka Temozolomide Sandoz, temozolomid, ubraja se u grupu citostatika pod nazivom alkilirajući pripravci.
English: What are the benefit and risk of Temozolomide Sandoz?
Croatian: Koje su koristi i rizici lijeka Temozolomide Sandoz?
English: Temozolomide Sandoz is a medicine that contains the active substance temozolomide.
Croatian: Temozolomide Sandoz je lijek koji sadrži djelatnu tvar temozolomid.
English: What is Temozolomide Sandoz?
Croatian: Što je Temozolomide Sandoz?
English: Why has Temozolomide Sandoz been approved?
Croatian: Zašto je lijek Temozolomide Sandoz odobren?
English: What is Temozolomide Sandoz used for?
Croatian: Za što se Temozolomide Sandoz koristi?
English: How is Temozolomide Sandoz used?
Croatian: Kako se Temozolomide Sandoz koristi?
English: How has Temozolomide Sandoz been studied?
Croatian: Kako je Temozolomide Sandoz ispitivan?
English: How does Temozolomide Sandoz work?
Croatian: Kako djeluje Temozolomide Sandoz?
English: Ideal body weight can be determined using the following equations:
Croatian: Idealna tjelesna težina može se odrediti sljedećim jednadžbama:
English: • difficulty in sleeping
Croatian: • tegobe sa spavanjem
English: Your doctor may adjust the dose.
Croatian: Liječnik će možda prilagoditi dozu.
English: Tell your doctor:
Croatian: Obratite se svom liječniku:
English: The pharmacist will throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: Clinical data with this dose adjustment are limited.
Croatian: Klinički podaci o liječenju ovom prilagođenom dozom su ograničeni.
English: • low red blood cell count by laboratory test (anaemia in children)
Croatian: • nizak broj crvenih krvnih stanica u laboratorijskom testu (anemija u djece)
English: The clinical relevance of these findings is not known.
Croatian: Klinički značaj tih nalaza nije poznat.
English: In a few cases, enough stem cells may not be collected, and the collection attempt will be stopped.
Croatian: U nekim slučajevima možda neće biti moguće prikupiti dovoljno matičnih stanica pa će se postupak prikupljanja prekinuti.
English: When is Mozobil given for the first time?
Croatian: Kad se Mozobil daje prvi puta?
English: If you have moderate or severe kidney problems, your doctor will reduce the dose.
Croatian: Ako imate umjerene ili teške tegobe s bubrezima, liječnik će Vam smanjiti dozu.
English: • abnormal dreams, nightmares
Croatian: • abnormalni snovi, noćne more
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja prije primjene lijeka odgovornost su korisnika.
English: The safety profile in this paediatric study was consistent with what has been observed in adults.
Croatian: Sigurnosni profil u ovom pedijatrijskom ispitivanju bio je u skladu s onim što je primijećeno u odraslih.
English: No complications or clinical symptoms of leukostasis were observed.
Croatian: Nisu zabilježene komplikacije ni klinički simptomi leukostaze.
English: This teratogenic potential is likely due to its pharmacodynamic mechanism of action.
Croatian: Ovaj teratogeni potencijal vjerojatno je posljedica farmakodinamičkog mehanizma djelovanja.
English: Pharmacotherapeutic group: Other immunostimulants; ATC code: L03AX16
Croatian: Farmakoterapijska skupina: Ostali imunostimulatori, ATK oznaka: L03AX16
English: • if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na pleriksafor ili neki drugi drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Date of first authorisation: 31 July 2009 Date of latest renewal: 11 April 2014
Croatian: Datum posljednje obnove odobrenja: 11. travanj 2014.
English: SDF-1α and CXCR4 play major roles in embryo-foetal development.
Croatian: SDF-1α i CXCR4 igraju veliku ulogu u embriofetalnom razvoju.
English: female (kg):
Croatian: žene (kg):
English: What Mozobil is and what it is used for
Croatian: Što je Mozobil i za što se koristi
English: Each vial is intended for single use only.
Croatian: Svaka bočica namijenjena je isključivo za jednokratnu uporabu.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu faramakovigilancije ili minimizacije rizika).
English: What you need to know before you use Mozobil
Croatian: Što morate znati prije nego počnete primjenjivati Mozobil
English: Please inform your doctor immediately if you experience chest discomfort.
Croatian: Odmah obavijestite svoga liječnika ako osjetite nelagodu u prsima.
English: The elimination rate from tissues was slow.
Croatian: Brzina eliminacije iz tkiva bila je mala.
English: The recommended daily dose of plerixafor by subcutaneous injection (SC) is:
Croatian: Preporučena dnevna doza pleriksafora supkutanom injekcijom (s.c.) je:
English: From a microbiological point of view the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek se mora primijeniti odmah.
English: Mozobil should not be used during pregnancy unless the clinical condition of the woman requires treatment with plerixafor.
Croatian: Mozobil se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje pleriksaforom.
English: There are no adequate data on the use of plerixafor in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni pleriksafora u trudnica.
English: Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in approximately 30-60 minutes (tmax).
Croatian: Pleriksafor se nakon supkutane injekcije brzo apsorbira te doseže vršne koncentracije za približno 30-60 minuta (tmax).
English: Your medicine will be injected by a doctor or a nurse.
Croatian: Lijek će Vam injekcijom dati liječnik ili medicinska sestra.
English: Please tell your doctor immediately if
Croatian: Odmah obavijestite svog liječnika:
English: Studies in animals have shown teratogenicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da je lijek teratogen (vidjeti dio 5.3).
English: Plerixafor is moderately bound to human plasma proteins up to 58%.
Croatian: Distribucija Pleriksafor se umjereno veže za ljudske proteine u plazmi, do 58%.
English: Percents determined by Kaplan Meier method b n includes all patients who received at least one day of apheresis
Croatian: a postoci određeni Kaplan-Meierovom metodom b n uključuje sve bolesnike koji su imali barem jedan dan afereze
English: Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment.
Croatian: Žene reproduktivne dobi moraju tijekom liječenja primjenjivati učinkovitu kontracepciju.
English: Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
Croatian: Doza pleriksafora i liječenje bolesnika čija je težina iznosila više od 175% idealne tjelesne težine nisu ispitani.
English: Fertility The effects of plerixafor on male and female fertility are not known (see section 5.3).
Croatian: Učinak pleriksafora na plodnost muškaraca i žena nije poznata (vidjeti dio 5.3).
English: Your doctor may perform regular blood tests to monitor your blood cell count.
Croatian: Liječnik će možda provoditi redovite krvne pretrage kako bi pratio broj krvnih stanica.
English: • In children age 1 to less than 18 years of age with lymphoma or solid tumours.
Croatian: • u djece u dobi od navršene 1 do manje od 18 godina s limfomom ili solidnim tumorima
English: Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea (n = 1) or hypoxia (n = 1).
Croatian: Događaji su uključivali jedno ili više od navedenog: urtikariju (n = 2), periorbitalni edem (n = 2), dispneju (n = 1) ili hipoksiju (n = 1).
English: male (kg):
Croatian: muškarci (kg):
English: • anaphylactic reactions, including anaphylactic shock
Croatian: • anafilaktičke reakcije, uključujući anafilaktički šok