FrancophonIA/ELRC3.0 huggingface dataset:
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Croatian: Ako iskusite gubitak odgovora ili neuspjeh u održavanju odgovora kod liječenja filgrastimom, Vaš liječnik će ispitati razloge zbog čega se to dogodilo uključujući i da li ste razvili protutijela koja neutraliziraju aktivnost filgrastima.
English: Filgrastim for PBPC mobilisation when used alone:
Croatian: Filgrastim za mobilizaciju PBPC-ova kada je korišten sam:
English: It may harm them,
Croatian: (splenomegalija) ili puknuće (ruptura) slezene].
English: Take special care with other products that stimulate white blood cells.
Croatian: Budite posebno oprezni s drugim lijekovima koji stimuliraju bijele krvne stanice.
English: It is advisable to wait and see how you feel after taking Filgrastim HEXAL and before driving or operating machinery.
Croatian: Preporučuje se da pričekate kako biste vidjeli kako se osjećate nakon uzimanja lijeka Filgrastim HEXAL i prije upravljanja vozilom ili rada sa strojevima.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Croatian: Vrijeme za leukaferezu: često su dovoljne 1 ili 2 leukafereze 5. i 6. dana.
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: Rezultati analize broja CD34+ stanica protočnom citometrijom variraju ovisno o preciznoj metodologiji koja se koristi pa se preporuke za broj stanica temeljene na ispitivanjima u drugim laboratorijima trebaju tumačiti s oprezom.
English: If you think you have injected more than you should, contact your doctor as soon as possible.
Croatian: Ako mislite da ste injektirali više nego što ste trebali, odmah se javite svom liječniku.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Croatian: MDS i leukemije su prirodne komplikacije bolesti i nije sigurno u kakvom su odnosu s terapijom filgrastimom.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Croatian: Ljudski G-CSF je glikoprotein koji regulira proizvodnju i oslobađanje funkcionalnih neutrofila iz koštane srži.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju ako Vas liječnik ili medicinska sestra nisu tome posebno podučili.
English: Medicines (containing sorbitol/fructose) given intravenously may be lifethreatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Croatian: Lijekovi (koji sadrže sorbitol/fruktozu) koji se daju intravenski mogu biti opasni po život i moraju biti kontraindicirani u ovoj populaciji osim ako postoji velika klinička potreba te nema dostupnih zamjenskih lijekova.
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Croatian: Centrima za aferezu preporučuje se sustavno bilježenje i praćenje davatelja matičnih stanica tijekom najmanje 10 godina, kako bi se osiguralo dugoročno praćenje sigurnosti.
English: Filgrastim HEXAL is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Croatian: Filgrastim HEXAL se obično daje kao dnevna injekcija u tkivo neposredno ispod kože (poznata kao potkožna injekcija).
English: Subcutaneous or intravenous use.
Croatian: Za supkutanu ili intravensku primjenu.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Croatian: Podaci u tablicama ispod opisuju nuspojave prijavljene u kliničkim ispitivanjima i spontanim prijavljivanjem.
English: If you become pregnant during Filgrastim HEXAL treatment, please inform your doctor.
Croatian: Ako zatrudnite tijekom terapije lijekom Filgrastim HEXAL, obavijestite svog liječnika.
English: This should be considered when interpreting boneimaging results.
Croatian: To treba uzeti u obzir kod tumačenja rezultata slikovnih pretraga kostiju.
English: Your healthcare professional should always record the exact product you are using.
Croatian: Vaš liječnik uvijek treba zabilježiti točan naziv lijeka kojeg uzimate.
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Croatian: Međutim, primjena melfalana, karboplatine ili BCNU zajedno s filgrastimom pokazala se učinkovitom za mobilizaciju progenitorskih stanica.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Croatian: U bolesnika koji nisu primali opsežnu kemoterapiju često je dovoljna jedna leukafereza.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Croatian: Moguće interakcije s drugim hematopoetskim čimbenicima rasta i citokinima još nisu ispitane u kliničkim ispitivanjima.
English: There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Croatian: Postoji pozitivna linearna korelacija između doze i koncentracije filgrastima u serumu, bez obzira na to je li primijenjen intravenski ili supkutano.
English: Filgrastim dosing should be maintained until the last leukapheresis.
Croatian: Doziranje filgrastima treba održavati do posljednje leukafereze.
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Croatian: Preporučeni najmanji prinos od ≥ 2,0 x 106 CD34+ stanica/kg temelji se na objavljenim iskustvima koja su rezultirala odgovarajućim hematološkim oporavkom.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 72 hours (but not above 25°C).
Croatian: Štrcaljka se može izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi samo jednom i do najviše 72 sata (ali ne na temperaturi iznad 25 °C).
English: The efficacy of treatment was clear for this age-group, which included most patients with congenital neutropenia.
Croatian: Djelotvornost liječenja bila je jasna za tu dobnu skupinu, koja je uključivala bolesnike s kongenitalnom neutropenijom.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Croatian: Statistička analiza odnosa između broja ponovno infundiranih CD34+ stanica i brzine oporavka trombocita nakon visokih doza kemoterapije ukazuje na složen, ali kontinuirani odnos.
English: In other circumstances, additional leukaphereses are recommended.
Croatian: U drugim situacijama se preporučuju dodatne leukafereze.
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Croatian: Također se može dati i kao dnevna polagana injekcija u venu (poznata kao intravenska infuzija).
English: - The active substance is filgrastim.
Croatian: - Djelatna tvar je filgrastim.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Croatian: Učinci filgrastima na prenatalni razvoj proučavani su kod štakora i kunića.
English: • in patients with advanced HIV infection which will help reduce the risk of infections.
Croatian: • u bolesnika s uznapredovanom HIV-infekcijom, što će smanjiti rizik od infekcija.
English: How is Filgrastim HEXAL given and how much should I take?
Croatian: Kako se Filgrastim HEXAL daje i koju količinu trebam uzeti?
English: In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Croatian: U kliničkim je ispitivanjima > 90 % bolesnika imalo odgovor na ove doze i postiglo oporavak neutropenije u medijanu od 2 dana.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, lijek treba primijeniti odmah.
English: In patients with severe chronic neutropenia (SCN)
Croatian: Kod bolesnika s teškom kroničnom neutropenijom (SCN)
English: Filgrastim HEXAL is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Croatian: Filgrastim HEXAL je dostupan sa ili bez sigurnosne zaštite za iglu i liječnik ili medicinska sestra će Vam pokazati kako da ga koristite.
English: Then, if ANC remains > 1.0 x 109/l for 3 more consecutive days
Croatian: Zatim, ako ANC ostane > 1,0 x 109/l tijekom još 3 uzastopna dana
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Croatian: Ne postoje dokazi da bolesnici s HIV infekcijom liječeni filgrastimom pokazuju povećanu replikaciju HIV-a.
English: N Acute Grade II - IV GvHD
Croatian: Stupanj akutne GvHD II - IV
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Croatian: Nastaju i druge krvne promjene, uključujući anemiju i prolazna povećanja mijeloidnih progenitora, što zahtijeva pomno praćenje broja stanica.
English: - Mobilisation of peripheral blood progenitor cells (PBPCs).
Croatian: - Mobilizacija progenitorskih stanica iz periferne krvi (PBPC-ova, engl. peripheral blood progenitor cells).
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Croatian: Bolesnike koji razviju simptome sindroma povećane propusnosti kapilara mora se pažljivo nadzirati i liječiti standardnom simptomatskom terapijom, koja može uključivati i potrebu za intenzivnim liječenjem (vidjeti dio 4.8).
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Croatian: Raspored s bržim povećanjem doze može se razmotriti u bolesnika s teškim infekcijama.
English: Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Croatian: Nakon indukcijske i konsolidacijske faze liječenja akutne mijeloične leukemije, liječenje može trajati i znatno dulje (do 38 dana) ovisno o vrsti, dozi i rasporedu citotoksične kemoterapije koja se primjenjuje.
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-fluorouracil indicates that the severity of neutropenia may be exacerbated.
Croatian: Preliminarni dokazi na malom broju bolesnika istovremeno liječenih filgrastimom i 5-fluorouracilom ukazuju da se težina neutropenije može pogoršati.
English: If you are a stem cell donor, you must be aged between 16 and 60 years.
Croatian: Davatelji matičnih stanica smiju biti samo osobe između 16 i 60 godina starosti.
English: Rates of generation of antibodies against filgrastim is generally low.
Croatian: Stopa stvaranja protutijela na filgrastim općenito je niska.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Croatian: Kod procjene broja progenitorskih stanica prikupljenih u bolesnika liječenih filgrastimom osobitu pozornost treba posvetiti metodi kvantifikacije.
English: Each graduation ring corresponds to a volume of 0.1 ml.
Croatian: Svaka mjerna oznaka odgovara volumenu od 0,1 ml.
English: Inject the Filgrastim HEXAL solution as you have been shown by your doctor.
Croatian: Ubrizgajte otopinu Filgrastim HEXAL kako Vam je pokazao liječnik.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Croatian: G-CSF može poticati rast mijeloidnih stanica in vitro, a slični se učinci mogu primijetiti i na nekim nemijeloidnim stanicama in vitro.
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Croatian: Ukupne razlike u sigurnosti ili učinkovitosti nisu zabilježene u ispitanika starijih od 65 godina u usporedbi s mladim odraslim ispitanicima (> 18 godina starosti) koji su primali citotoksičnu kemoterapiju, a kliničko iskustvo nije utvrdilo razlike u odgovorima između starijih i mlađih odraslih bolesnika.
English: Risks associated with increased doses of chemotherapy
Croatian: Rizici povezani s povećanim dozama kemoterapije
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Croatian: Kao i drugi hematopoetski čimbenici rasta, G-CSF je pokazao in vitro stimulirajuće djelovanje na ljudske endotelne stanice.
English: Absolute neutrophil count (ANC) should be monitored closely, especially during the first few weeks of filgrastim therapy.
Croatian: Apsolutni broj neutrofila (ANC) treba pažljivo pratiti, osobito tijekom prvih nekoliko tjedana terapije filgrastimom.
English: Causes of transient neutropenia, such as viral infections should be excluded.
Croatian: Potrebno je isključiti uzroke prolazne neutropenije, kao što su virusne infekcije.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Croatian: Ipak, ne može se isključiti rizik poticanja zloćudnog mijeloidnog klona stanica.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Croatian: Nije jasno koja je klinička važnost ovog nalaza za primjenu višestrukih doza.
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Croatian: Filgrastim nije utjecao na reproduktivnu funkciju ili plodnost kod mužjaka ili ženki štakora (vidjeti dio 5.3).
English: If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni kako dati injekciju ili imate pitanja, zamolite liječnika ili medicinsku sestru za pomoć.
English: The dosing in children receiving chemotherapy is the same as for adults.
Croatian: Doziranje za djecu koja primaju kemoterapiju isto je kao i za odrasle.
English: What Filgrastim HEXAL is and what it is used for
Croatian: Što je Filgrastim HEXAL i za što se koristi
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Croatian: Filgrastim treba trajno obustaviti u bolesnika koji razviju ozbiljnu alergijsku reakciju.
English: Your doctor will tell you how long you will need to take Filgrastim HEXAL.
Croatian: Vaš liječnik će Vam reći koliko dugo ćete trebati uzimati Filgrastim HEXAL.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Filgrastim HEXAL therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Filgrastim HEXAL uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Contents of the pack and other information What Filgrastim HEXAL contains
Croatian: Sadržaj pakiranja i druge informacije Što Filgrastim HEXAL sadrži
English: How long will I have to take Filgrastim HEXAL?
Croatian: Koliko dugo trebam uzimati Filgrastim HEXAL?
English: The stem cells will then go back into the bone marrow and produce blood cells;
Croatian: Nakon toga će se matične stanice vratiti u koštanu srž i proizvoditi krvne stanice;
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Croatian: Nakon utvrđene kemoterapije zbog solidnog tumora, limfoma ili limfoidne leukemije, očekivano trajanje liječenja potrebnog da se ispune ti kriteriji iznosit će do 14 dana.
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Croatian: Međutim, s obzirom na moguće rizike povezane s teškom leukocitozom, određivanje broja leukocita treba raditi u redovitim intervalima za vrijeme terapije filgrastimom.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja pripremljenog lijeka prije primjene odgovornost su korisnika i obično ne bi smjeli iznositi više od 24 sata na temperaturi od 2 °C do 8 °C, osim ako se razrjeđenje nije provelo u kontroliranim i validiranim aseptičnim uvjetima.
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Croatian: Ako ste bolesnik s teškom kroničnom neutropenijom, može postojati rizik od razvoja zloćudne bolesti krvi (leukemije, mijelodisplastičnog sindroma [MDS]).
English: Filgrastim HEXAL is not recommended during pregnancy.
Croatian: Filgrastim HEXAL se ne preporučuje tijekom trudnoće.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Croatian: Preporučuje se obavljanje morfoloških i citogenetskih pretraga koštane srži kod bolesnika u redovitim vremenskim razmacima (približno svakih 12 mjeseci).
English: Filgrastim HEXAL is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Croatian: Filgrastim HEXAL je dostupan u pakiranjima s 1, 3, 5 ili 10 napunjenih štrcaljki s iglom za injekciju, sa ili bez sigurnosne zaštite za iglu.
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Croatian: Povišenja broja neutrofila ovise o dozi u rasponu preporučenih doza.
English: Filgrastim HEXAL containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Croatian: Filgrastim HEXAL sadrži r-metHuG-CSF (filgrastim) koji uzrokuje izrazito povećanje broja neutrofila u perifernoj krvi u roku od 24 sata, uz manje povećanje broja monocita.
English: Prior exposure to cytotoxic agents Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (≥ 2.0 x 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Croatian: U bolesnika koji su prethodno primali vrlo opsežnu mijelosupresivnu terapiju možda neće doći do dovoljne mobilizacije PBPC-ova kako bi se postigao preporučeni minimalni prinos (≥ 2,0 x 106 CD34+ stanica/kg) ili ubrzanje oporavka trombocita do istog stupnja.
English: Unless your doctor directs you otherwise, you must stop breast feeding if you use Filgrastim HEXAL.
Croatian: Osim ako Vas liječnik ne uputi drugačije, morate prestati dojiti ako uzimate Filgrastim HEXAL.
English: Only clear solutions without particles should be used.
Croatian: Smiju se koristiti samo bistre otopine bez čestica.
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Croatian: Potrebna je osobita pozornost kad se primjenjuje jedan ili kombinacija kemoterapeutika za koje se zna da uzrokuju tešku trombocitopeniju.
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Croatian: Čini se da prinosi veći od ovog koreliraju s bržim oporavkom, dok oni manji koreliraju sa sporijim oporavkom.
English: Your doctor will tell you how much Filgrastim HEXAL you should take.
Croatian: Vaš liječnik će Vam reći koju količinu lijeka Filgrastim HEXAL trebate uzeti.
English: As a result of the potential to receive higher doses or a greater number of these medicinal products with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Croatian: Kao rezultat mogućnosti primanja viših doza ili većeg broja tih lijekova uz terapiju filgrastimom, bolesnik može imati veći rizik od razvoja trombocitopenije i anemije.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku držati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Croatian: Šezdeset pet posto bolesnika ispitivanih u programu teške kronične neutropenije imalo je manje od 18 godina.
English: Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Croatian: Nakon toga doza se može individualno prilagođavati svakih 1 - 2 tjedna da bi se prosječni broj neutrofila održao na vrijednostima između 1,5 x 109/l i 10 x 109/l.
English: Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of filgrastim.
Croatian: Budući da litij potiče oslobađanje neutrofila, vjerojatno će pojačati učinak filgrastima.
English: If you use more Filgrastim HEXAL than you should
Croatian: Ako primijenite više lijeka Filgrastim HEXAL nego što ste trebali
English: The effects of filgrastim overdosage have not been established.
Croatian: Učinci predoziranja filgrastimom nisu utvrđeni.
English: Because of the potential of receiving higher doses of chemotherapy (e.g. full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
Croatian: Zbog mogućnosti primanja viših doza kemoterapije (npr. pune doze prema propisanom rasporedu), bolesnik može imati veći rizik od trombocitopenije i anemije.
English: Other medicines and Filgrastim HEXAL
Croatian: Drugi lijekovi i Filgrastim HEXAL
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Croatian: • visoka razina mokraćne kiseline u krvi, što može dovesti do gihta (hiperuricemija) (povišena mokraćna kiselina u krvi)
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici štrcaljke iza oznake „EXP“.
English: In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Croatian: S obzirom na osjetljivost mijeloidnih stanica koje se brzo dijele na mijelosupresivnu citotoksičnu kemoterapiju, ne preporučuje se primjenjivati filgrastim u razdoblju od 24 sata prije do 24 sata poslije kemoterapije.
English: Remove one syringe from the pack and remove the protective cap from the injection needle.
Croatian: Iz pakiranja izvadite jednu štrcaljku i skinite zaštitnu kapicu s igle za injekciju.