FrancophonIA/ELRC3.0 huggingface dataset:
English: Once Grastofil has been out at room temperature it should not be put back into the refrigerator.
Croatian: Nakon što je Grastofil bio na sobnoj temperaturi, ne smije ga se vratiti u hladnjak.
English: If you become pregnant during Grastofil treatment, please inform your doctor.
Croatian: Ako zatrudnite tijekom liječenja Grastofilom, obavijestite o tome svog liječnika.
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, trajanje i uvjeti čuvanja lijeka prije uporabe odgovornost su korisnika i oni obično ne bi smjeli iznositi više od 24 sata na temperaturi od 2 °C do 8 °C, osim ako razrijeđenje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Croatian: Leukaferezu je potrebno započeti 5. dana i, ako je potrebno, nastaviti do 6. dana kako bi se prikupilo 4 x 10
English: cells/kg) or acceleration of platelet recovery to the same degree.
Croatian: stanica/kg) ili ubrzao oporavak trombocita do istog stupnja.
English: If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.
Croatian: Ako razvijete ili postoji vjerojatnost da razvijete rak krvi, ne smijete primjenjivati Grastofil, osim ako to nije savjetovao liječnik.
English: • if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na filgrastim ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Croatian: Farmakoterapijska skupina: imunostimulansi, čimbenici poticanja rasta kolonija, ATK oznaka: L03AA02
English: • alcohol wipes or similar.
Croatian: • alkoholom natopljene vatice ili nešto slično tome.
English: Do not take a double dose to make up for a forgotten injection.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu injekciju.
English: If you are a stem cell donor, you must be aged between16 and 60 years.
Croatian: Ako ste darivatelj matičnih stanica, morate biti u dobi između 16 i 60 godina.
English: Clinical studies with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made.
Croatian: Klinička ispitivanja s filgrastimom uključivala su i mali broj starijih bolesnika, ali posebna ispitivanja nisu provedena u ovoj skupini bolesnika i stoga ne postoje posebne preporuke za doziranje.
English: The safety and efficacy of filgrastim has not been assessed in normal donors less than 16 years or greater than 60 years of age.
Croatian: Sigurnost i djelotvornost filgrastima nije procijenjena u zdravih darivatelja mlađih od 16 godina ili starijih od 60 godina.
English: In clinical studies, > 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Croatian: U kliničkim studijama, > 90% bolesnika je odgovorilo na te doze, postižući obrat neutropenije s medijanom od 2 dana.
English: If exposure has been greater than 24 hours or frozen more than once then Grastofil should not be used.
Croatian: Ako je izloženost Grastofila trajala dulje od 24 sata ili je bio zamrznut više od jedanput, ne smije se upotrijebiti.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Croatian: Ipak, rizik od poticanja zloćudnog mijeloičnog klona ne može se isključiti.
English: N Acute grade II - IV GvHD
Croatian: N Akutni stupanj II-IV GvHD
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Croatian: • pluća ne funkcioniraju kao što bi trebala, uzrokujući nedostatak zraka (respiratorno zatajenje)
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Croatian: Nema prospektivnih, randomiziranih usporedbi dvije preporučene metode mobilizacije (samo filgrastimom ili u kombinaciji s mijelosupresivnom kemoterapijom) u iste populacije bolesnika.
English: The degree of variation between individual patients and between laboratory assays of CD34
Croatian: Stupanj varijacije između pojedinih bolesnika i između laboratorijskih pretraga CD34
English: Overall, reports were more common after intravenous administration.
Croatian: Općenito su takvi slučajevi bili češći nakon intravenske primjene.
English: You can now use the pre-filled syringe.
Croatian: Sada možete uporabiti napunjenu štrcaljku.
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Croatian: Liječnik će Vas možda htjeti pažljivo pratiti, pogledajte dio 4 ove upute o lijeku.
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u: MM/GGGG
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Croatian: Stoga je potrebno pažljivo mjeriti veličinu slezene (npr., kliničkim pregledom, ultrazvukom).
English: Subcutaneous and intravenous use.
Croatian: Za supkutanu i intravensku primjenu.
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: Centru za aferezu preporučuje se sistematsko bilježenje i praćenje darivatelja matičnih stanica tijekom najmanje 10 godina kako bi se osigurao nadzor dugotrajne sigurnosti.
English: Diluted filgrastim may be adsorbed to glass and plastic materials.
Croatian: Razrijeđeni filgrastim može se adsorbirati na staklo i plastične materijale.
English: Statistical analysis of the relationship between the number of CD34
Croatian: Statistička analiza odnosa između broja CD34
English: Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day.
Croatian: Nakon što se broj bijelih krvnih stanica u krvi vrati u normalni raspon vrijednosti moguće je smanjiti doziranje na manje od jednom dnevno.
English: Your treatment with Grastofil will usually last for about 14 days.
Croatian: Vaše liječenje Grastofilom obično će trajati oko 14 dana.
English: Grastofil is injected into the tissue just under the skin.
Croatian: Grastofil se ubrizgava u tkivo neposredno ispod kože.
English: However, the administration of melphalan, carboplatin or carmustine (BCNU) together with filgrastim has been shown to be effective for progenitor mobilisation.
Croatian: Međutim, pokazalo se da je primjena melfalana, karboplatine ili karmustina (BCNU) zajedno s filgrastimom učinkovita za mobilizaciju progenitorskih stanica.
English: cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Croatian: stanica/kg temelji se na opisanom iskustvu koje je dovelo do odgovarajućeg hematološkog oporavka.
English: Leave the syringe at room temperature (15ºC to 25 ºC) for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Ostavite štrcaljku na sobnoj temperaturi (od 15ºC do 25°C) približno 30 minuta ili nježno držite napunjenu štrcaljku u ruci nekoliko minuta.
English: Contact your doctor to discuss when you should inject the next dose.
Croatian: Obratite se liječniku kako biste razjasnili kada morate primijeniti sljedeću dozu.
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Izbor puta primjene treba ovisiti o kliničkim okolnostima u pojedinom slučaju.
English: • osteoporosis (bone disease),
Croatian: • osteoporozu (bolest kostiju),
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 serumskih koncentracija filgrastima, bilo da je primijenjen intravenski ili supkutano.
English: Haematuria was common and proteinuria occurred in a small number of patients.
Croatian: Hematurija je bila česta, a proteinurija se javljala u malog broja bolesnika.
English: 9/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Croatian: 9/l) u bolesnika s uznapredovalom HIV-infekcijom, kako bi se smanjio rizik od bakterijskih infekcija kad druge mogućnosti liječenja neutropenije nisu prikladne.
English: Grastofil can be used:
Croatian: Grastofil se može primjenjivati:
English: What should I do before I give myself a subcutaneous injection of Grastofil?
Croatian: Što trebam učiniti prije nego što primijenim supkutanu injekciju Grastofila?
English: Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.
Croatian: Lagano potisnite klip do broja (oznake u ml) koji odgovara dozi Grastofila koju Vam je propisao liječnik.
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Croatian: Redovito će se provoditi krvne pretrage radi praćenja broja bijelih krvnih stanica u Vašem tijelu.
English: What Grastofil is and what it is used for
Croatian: Što je Grastofil i za što se koristi
English: The solution should be visually inspected prior to use.
Croatian: Otopinu treba vizualno pregledati prije uporabe.
English: This medicinal product contains 50 mg sorbitol.
Croatian: Ovaj lijek sadrži 50 mg sorbitola.
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: Pri procjeni broja progenitorskih stanica prikupljenih u bolesnika liječenih filgrastimom, posebnu pozornost treba posvetiti metodi kvantifikacije.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Croatian: Ako prinos nije odgovarajući, mjereno prema gore navedenim kriterijima, potrebno je razmotriti druge oblike liječenja za koje nije potrebna potpora progenitorskih stanica.
English: Neutropenia may be a long-standing condition where your body does not make enough neutrophils, or it may be caused by drugs used to treat cancer.
Croatian: Neutropenija može biti dugotrajno stanje u kojem tijelo ne stvara dovoljno neutrofila ili može biti uzrokovano lijekovima koji se primjenjuju za liječenje raka.
English: If someone else is injecting you, they can also use the back of your arms.
Croatian: Ako Vam netko drugi daje injekciju, može je dati i u stražnju stranu nadlaktica.
English: Grastofil is a biosimilar medicinal product.
Croatian: Grastofil je biosličan lijek.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Croatian: U nekim slučajevima, simptomi su se ponovno pojavili kod ponovnog izlaganja, što ukazuje na uzročno-posljedični odnos.
English: Do not put the cover back on used needles, as you may accidentally prick yourself.
Croatian: Nemojte vraćati poklopac na upotrijebljene igle, jer se možete nehotice ubosti.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih dodatnih pitanja o uporabi ovog lijeka, upitajte svog liječnika ili ljekarnika.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Croatian: MDS i leukemije prirodne su komplikacije ove bolesti i nije sigurno jesu li povezane s liječenjem filgrastimom.
English: Grastofil dosing should be maintained until the last leukapheresis.
Croatian: Grastofil je potrebno primjenjivati sve do posljednje leukafereze.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Croatian: Neki dokazi iz ispitivanja primjene jednokratne doze pokazuju da intravenska primjena može skratiti trajanje učinka.
English: Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Croatian: Budući da litij potiče oslobađanje neutrofila, vjerojatno će pojačati učinak filgrastima.
English: The incidence of fever and documented infections were not reduced in either setting.
Croatian: Incidencija vrućice i dokumentiranih infekcija nije bila smanjena u tim situacijama.
English: What Grastofil is and what it is used for What you need to know before you use Grastofil How to use Grastofil
Croatian: Što je Grastofil i za što se koristi Što morate znati prije nego počnete primjenjivati Grastofil Kako primjenjivati Grastofil
English: Instructions for injecting Grastofil
Croatian: Upute za ubrizgavanje Grastofila
English: This is known as a subcutaneuous injection.
Croatian: To se još zove supkutana injekcija.
English: The best places to inject are the top of the thighs and the abdomen.
Croatian: Najbolja mjesta za ubrizgavanje su gornji vanjski dio bedara i trbuh.
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Croatian: Brži raspored povećanja doze može se razmotriti u bolesnika koji imaju teške infekcije.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Croatian: Općenito, događaji glomerulonefritisa riješili su se nakon smanjenja doze ili prestanka primjene filgrastima i pegfilgrastima.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Croatian: Djelotvornost liječenja bila je očita za ovu dobnu skupinu, u kojoj je većina bolesnika imala kongenitalnu neutropeniju.
English: Grastofil is available in packs containing 1 and 5 pre-filled syringes.
Croatian: Grastofil je dostupan u pakiranjima koja sadrže 1 i 5 napunjenih štrcaljki.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 - 16 hours.
Croatian: Nakon supkutane primjene preporučenih doza, koncentracije u serumu bile su održane iznad 10 ng/ml tijekom 8-16 sati.
English: Long-term treatment with Grastofil is required for reduction in neutropenia.
Croatian: Dugotrajno liječenje Grastofilom je potrebno za smanjenje neutropenije.
English: Grastofil can be removed from the refrigerator and left at room temperature (not above 25℃) for a single period of up to 15 days that ends within the labelled expiry date.
Croatian: Grastofil se može izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi (ne višoj od 25°C) u jednokratnom razdoblju do 15 dana koje završava unutar označenog isteka roka valjanosti.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Croatian: Kao i kod drugih hematopoetskih čimbenika rasta, G-CSF in vitro iskazuje stimulirajuće djelovanje na ljudske endotelne stanice.
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 stvaranje i oslobađanje funkcionalnih neutrofila iz koštane srži.
English: 9/L, with the median dose frequency being 3 days per week.
Croatian: 9/l, uz medijan učestalosti doziranja od 3 dana tjedno.
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, možete biti pod rizikom od razvoja raka krvi (leukemije, mijelodisplastičnog sindroma (MDS)).
English: If you use more Grastofil than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako primijenite više Grastofila nego što ste trebali, obratite se svom liječniku ili ljekarniku što je prije moguće.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Croatian: Ako je potrebno više od jedne leukafereze, osobitu pozornost potrebno je posvetiti darivateljima s brojem trombocita < 100 x 10
English: cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Croatian: stanica/kg tjelesne težine primatelja u većine darivatelja nakon dvije leukafereze.
English: In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 μg/kg/day.
Croatian: U gravidnih štakorica nije zabilježena toksičnost za majku ili fetalna toksičnost kod doza do 575 μg/kg/dan.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Croatian: Učinci filgrastima na prenatalni razvoj bili su ispitivani u štakora i kunića.
English: • unusual change in the urine
Croatian: • neobične promjene u mokraći
English: 9/L) following filgrastim treatment and leukapheresis was observed in 35% of donors (see section 4.4).
Croatian: 9/l) nakon liječenja filgrastimom i leukafereze bila je opažena u 35% darivatelja (vidjeti dio 4.4).
English: Grastofil is a clear colourless solution for injection or infusion.
Croatian: Grastofil je bistra bezbojna otopina za injekciju ili infuziju.
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 u liječenju akutne mijeloične leukemije, trajanje liječenja može biti znatno dulje (do 38 dana) ovisno o vrsti, dozi i protokolu citotoksične kemoterapije koja se primjenjuje.
English: Rates of generation of antibodies against filgrastim is generally low.
Croatian: Stopa stvaranja protutijela protiv filgrastima je u pravilu niska.
English: If you forget to use Grastofil
Croatian: Ako ste zaboravili primijeniti Grastofil
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Croatian: S obzirom na ograničene podatke o sigurnosti i djelotvornosti u bolesnika sa sekundarnom AML, filgrastim je potrebno primjenjivati s oprezom.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Croatian: Malo povucite klip kako biste provjerili da niste uboli krvnu žilu.
English: The recommendation of a minimum yield of ≥ 2.0 x 10
Croatian: Preporučeni najmanji prinos od ≥ 2,0 x 10
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8; 21), t(15; 17), and inv(16)] have not been established.
Croatian: < 55 godina s dobrim citogenetskim nalazom [t (8; 21), t (15; 17), i inv (16)] nisu ustanovljene.
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Croatian: Nakon primjene standardne kemoterapije za liječenje solidnih tumora, limfoma i limfoidnih leukemija, očekuje se da će trajanje liječenja potrebno da se zadovolje ovi kriteriji iznositi najviše 14 dana.
English: Long term treatment with Grastofil may be required to maintain a normal number of white cells in your blood.
Croatian: Dugotrajno liječenje Grastofilom može biti potrebno za održavanje normalnog broja leukocita u Vašoj krvi.
English: It is recommended that the ANC is measured daily for the first 2 to 3 days of filgrastim administration.
Croatian: Preporučuje se svakodnevno mjeriti ABN tijekom prva 2 do 3 dana primjene filgrastima.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Croatian: • smanjena osjetljivost na dodir, osobito kože (hipoestezija)
English: Yields in excess of this minimum yield appear to correlate with more rapid recovery; those below with slower recovery.
Croatian: Čini se da prinosi veći od ovog najmanjeg prinosa koreliraju s bržim oporavkom, a oni manji sa sporijim oporavkom.
English: Grastofil is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Croatian: Grastofil se obično primjenjuje svakodnevno injekcijom u tkivo neposredno ispod kože (to se još naziva i supkutana injekcija).
English: Remember: if you have any problems, please ask your doctor or nurse for help and advice.
Croatian: Zapamtite: Ako imate ikakvih pitanja, obratite se svom liječniku ili medicinskoj sestri za pomoć i savjet.
English: Filgrastim should be discontinued and appropriate treatment given.
Croatian: Potrebno je prekinuti primjenu filgrastima i primijeniti odgovarajuće liječenje.
English: The data in the tables below describe adverse reactions reported from clinical studies and spontaneous reporting.
Croatian: Podaci u tablicama niže opisuju nuspojave zabilježene u kliničkim ispitivanjima i putem spontanih prijava.
English: World Trade Center Moll de Barcelona s/n, Edifici Est 6ª planta 08039 Barcelona Spain
Croatian: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Croatian: Sweetsov sindrom (akutna febrilna neutrofilna dermatoza)
English: Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Croatian: Polako potiskujte klip uz jednoličan pritisak, držeći cijelo vrijeme nabor kože između prstiju, sve dok se štrcaljka ne isprazni.
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 kod malog broja bolesnika liječenih istovremeno filgrastimom i 5-fluorouracilom pokazuju da to može pogoršati težinu neutropenije.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove Grastofil from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Croatian: Unutar roka valjanosti a u svrhu kućne primjene, bolesnik može izvaditi Grastofil iz hladnjaka i čuvati ga na sobnoj temperaturi (ne iznad 25°C) jednokratno u trajanju do 15 dana.
English: Filgrastim is not indicated for use in these conditions.
Croatian: Primjena filgrastima nije indicirana u tim stanjima.
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 u kojih se pojave simptomi stanja povećane kapilarne propusnosti potrebno je pomno pratiti i primijeniti standardno simptomatsko liječenje, što može uključivati i intenzivnu skrb (vidjeti dio 4.8).
English: Injecting the solution with the air bubble is harmless.
Croatian: Ubrizgavanje otopine sa mjehurićem zraka je bezopasno.
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 primjena filgrastima u razdoblju od 24 sata prije do 24 sata poslije kemoterapije.
English: Please tell your doctor before starting treatment if you have:
Croatian: Obavijestite svog liječnika prije početka liječenja ako imate:
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Croatian: Filgrastim nije utjecao ni na reproduktivnu sposobnost niti na plodnost u mužjaka i ženki štakora (vidjeti dio 5.3).
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Croatian: Povećanje broja neutrofila ovisi o dozi pri primjeni preporučenih doza.