FrancophonIA/ELRC3.0 huggingface dataset:
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Croatian: Ovo mogu biti simptomi stanja poznatog kao „sepsa” (ili „otrovanje krvi”), ozbiljne infekcije s upalnim odgovorom u cijelom tijelu koja može biti opasna po život i zahtijeva hitnu liječničku pomoć.
English: Glomerulonephritis Urine abnormality
Croatian: Glomerulonefritis Abnormalnosti u urinu
English: A common side effect of filgrastim use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Croatian: Česta nuspojava primjene filgrastima je bol u mišićima ili kostima (mišićno-koštana bol), koja se može olakšati uzimanjem standardnih lijekova za ublažavanje bolova (analgetika).
English: Filgrastim HEXAL is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines.
Croatian: Filgrastim HEXAL je čimbenik rasta bijelih krvnih stanica (čimbenik stimulacije granulocitnih kolonija) i pripada skupini proteina koji se zovu citokini.
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: Sigurnost i djelotvornost primjene filgrastima nije utvrđena u bolesnika mlađih od 55 godina s de novo akutnom mijeloičnom leukemijom i povoljnim citogenetskim obilježjima [t(8;21), t(15;17) i inv(16)].
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Croatian: Leukaferezu treba započeti 5. dana i nastaviti do 6. dana po potrebi, kako bi se prikupilo 4 x 106 CD34+ stanica/kg tjelesne težine primatelja.
English: An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Croatian: Povećana incidencija gubitka embrija uočena je kod kunića u višestrukim kliničkim izlaganjima te u prisutnosti maternalne toksičnosti (vidjeti dio 5.3).
English: In randomised clinical trials, a subcutaneous dose of 230 μg/m2/day (4.0 to 8.4 μg/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima primijenjena je supkutana doza od 230 μg/m2/dan (4,0 do 8,4 μg/kg/dan).
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C.
Croatian: Nakon razrjeđenja: dokazana kemijska i fizikalna stabilnost razrijeđene otopine za infuziju u primjeni je 24 sata na temperaturi od 2 °C do 8 °C.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Croatian: Zbog stupnja varijacije između pojedinih bolesnika i laboratorijskog određivanja broja CD34+ stanica teško je izravno usporediti različita ispitivanja.
English: You will need to take Filgrastim HEXAL until your white blood cell count is normal.
Croatian: Filgrastim HEXAL ćete trebati uzimati sve dok Vam se broj bijelih krvnih stanica ne vrati na normalu.
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 održale su se iznad 10 ng/ml tijekom 8 - 16 sati.
English: • if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Croatian: • ako se liječite zbog teške kronične neutropenije i imate krv u mokraći (hematurija).
English: In a separate retrospective international study in patients with acute and chronic myelogenous leukaemias, no effect on the risk of GvHD, TRM and mortality was seen.
Croatian: U posebnom retrospektivnom međunarodnom ispitivanju u bolesnika s akutnom i kroničnom mijeloičnom leukemijom, nije primijećen učinak na rizik od GvHD, TRM ili smrtnost.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/l.
Croatian: Ako je potrebno više od jedne leukafereze, osobitu pozornost treba posvetiti darivateljima s brojem trombocita < 100 x 109/l prije leukafereze; afereza se općenito ne smije provoditi ako je broj trombocita < 75 x 109/l.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities.
Croatian: Terapija filgrastimom smije se davati samo u suradnji s onkološkim centrom s iskustvom u liječenju G-CSF-om i hematologiji te s neophodnim dijagnostičkim mogućnostima.
English: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Ovo mogu biti simptomi stanja koje se naziva „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: In a small number of patients (< 10%), doses up to 1.0 MU/kg/day (10 μg/kg/day) were required to achieve reversal of neutropenia.
Croatian: U malog broja bolesnika (< 10 %) bile su potrebne doze do 1,0 MU/kg/dan (10 μg/kg/dan) da bi se postigao oporavak neutropenije.
English: The observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3 - 5 times the exposures observed in patients treated with the clinical dose.
Croatian: Razina uočenih štetnih učinaka za embriofetalnu toksičnost u ovom ispitivanju iznosila je 10 µg/kg/dan što je odgovaralo sistemskom izlaganju od približno 3 - 5 puta većem od izlaganja uočenog kod bolesnika liječenih kliničkom dozom.
English: Randomised, double-blind, single and multiple dose, crossover studies in 204 healthy volunteers showed that the pharmacokinetic profile of Filgrastim HEXAL was comparable to that of the reference product after subcutaneous and intravenous administration.
Croatian: Randomizirana, dvostruko slijepa ukrižena ispitivanja primjene jednokratne i višekratnih doza u 204 zdravih dobrovoljaca pokazala su da se farmakokinetički profil lijeka Filgrastim HEXAL može usporediti s profilom referentnog lijeka nakon supkutane i intravenske primjene.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Croatian: Sigurnost i djelotvornost filgrastima primijenjenog istog dana kao i mijelosupresivna citotoksična kemoterapija nisu u potpunosti utvrđene.
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Način primjene treba izabrati ovisno o kliničkoj situaciji pojedinog bolesnika.
English: How to store Filgrastim HEXAL Contents of the pack and other information
Croatian: Kako čuvati Filgrastim HEXAL Sadržaj pakiranja i druge informacije
English: Syringes are embossed with graduation rings in order to enable partial use if required.
Croatian: Štrcaljke imaju mjerne oznake kako bi se, prema potrebi, omogućila djelomična primjena.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim or pegfilgrastim.
Croatian: Slučajevi glomerulonefritisa obično bi se riješili nakon sniženja doze ili prestanka primjene filgrastima ili pegfilgrastima.
English: • unusual hair loss or thinning (alopecia)
Croatian: • neuobičajeno opadanje ili prorjeđivanje kose (alopecija)
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Croatian: Filgrastim je ispitivan u studijama toksičnost ponovljene doze do godine dana u trajanju koje je otkrilo promjene koje se mogu pripisati očekivanim farmakološkim akcijama uključujući poraste broja leukocita, mijeloidnu hiperplaziju u koštanoj srži, ekstramedularnu granulopoezu i uvećanje slezene.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious disease.
Croatian: Mobilizaciju progenitorskih stanica iz periferne krvi treba razmatrati samo u davatelja koji su prema normalnim kliničkim i laboratorijskim kriterijima pogodni za davanje matičnih stanica, uz posvećivanje posebne pozornosti hematološkim vrijednostima i infektivnoj bolesti.
English: If the ANC decreases to < 1.0 x 109/l during the treatment period, the dose of filgrastim should be re-escalated according to the above steps ANC = absolute neutrophil count
Croatian: Ako se ANC smanji na < 1,0 x 109/l tijekom razdoblja liječenja, dozu filgrastima treba ponovno povisiti u skladu s gore opisanim koracima.
English: Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis)
Croatian: Kožni vaskulitisa Sweetov sindrom (akutna febrilna neutrofilna dermatoza)
English: Dilution prior to administration (optional)
Croatian: Razrjeđenje prije primjene (po izboru)
English: For patients treated with filgrastim diluted to concentrations < 1.5 MU/ml (15 μg/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Croatian: Za bolesnike liječene filgrastimom razrijeđenim do koncentracije < 1,5 MU/ml (15 μg/ml), ljudski serumski albumin (HSA) treba se dodati do konačne koncentracije od 2 mg/ml.
English: In some SCN patients filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia already prior to treatment.
Croatian: U nekih bolesnika s teškom kroničnom neutropenijom filgrastim može izazvati i manje povećanje broja cirkulirajućih eozinofila i bazofila u odnosu na njihove početne vrijednosti; neki od tih bolesnika mogu pokazivati eozinofiliju ili bazofiliju već prije liječenja.
English: Decreased Appetitee Blood lactate dehydrogenase increased
Croatian: Smanjen apetite Povišena laktat dehidrogenaza u krvi
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Croatian: U kliničkim ispitivanjima bolesnika s malignom bolešću mišićno-koštana bol bila je blaga ili umjerena u 10 % bolesnika i teška u 3 % bolesnika.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Croatian: Davatelje koji primaju G-CSF zbog mobilizacije progenitorskih stanica iz periferne krvi treba pratiti sve dok se hematološki pokazatelji ne vrate na normalne vrijednosti.
English: Common (≥ 1/100 to
Croatian: Često (≥1/100 i
English: If you develop or are likely to develop cancers of the blood, you should not use Filgrastim HEXAL unless instructed by your doctor.
Croatian: U slučaju razvoja ili vjerojatnog razvoja zloćudne bolesti krvi, Filgrastim HEXAL ne smijete primjenjivati osim ako Vam tako ne odredi liječnik.
English: The solution should be visually inspected prior to use.
Croatian: Otopina se prije primjene treba vizualno pregledati.
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medication.
Croatian: Primjenom filgrastima u bolesnika s HIV infekcijom održava se normalni broj neutrofila kako bi se omogućilo doziranje antivirusnih i/ili drugih mijelosupresivnih lijekova prema rasporedu.
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Croatian: Broj trombocita treba pažljivo pratiti, osobito tijekom prvih nekoliko tjedana terapije filgrastimom.
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncologyhaematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Croatian: Postupci mobilizacije i afereze trebaju se provoditi u suradnji s onkološko-hematološkim centrom s prihvatljivim iskustvom u tim postupcima, u kojem se krvotvorne progenitorske stanice mogu pratiti na ispravan način.
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Croatian: • prije velikih doza kemoterapije kako bi koštana srž proizvodila više matičnih stanica koje se mogu prikupiti i vratiti
English: In patients with HIV infection
Croatian: Kod bolesnika s HIV infekcijom Doziranje
English: Filgrastim HEXAL can be used:
Croatian: Filgrastim HEXAL se može primjenjivati:
English: Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable elimination half-lives.
Croatian: Kontinuirana infuzija filgrastima tijekom razdoblja od 28 dana u bolesnika koji se oporavljaju od autologne transplantacije koštane srži nije pružila nikakve dokaze nakupljanja lijeka, a poluvremena eliminacije su bila usporediva.
English: The needle safety guard will rapidly move to cover the needle.
Croatian: Sigurnosna zaštita za iglu brzo će se pomaknuti i prekriti iglu.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Croatian: • promjena načina na koji tijelo regulira tekućine u tijelu, što može dovesti do natečenosti
English: Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Croatian: Potreban je poseban oprez kod liječenja bolesnika visokim dozama kemoterapije, jer se nije pokazalo da to poboljšava ishod tumorske bolesti, a povećane doze kemoterapeutika mogu dovesti do povećane toksičnosti, uključujući srčane, plućne, neurološke i dermatološke učinke (molimo pročitajte informacije o propisivanju konkretnih kemoterapeutika koji se koriste).
English: Excipients: glutamic acid, polysorbate 80, water for injections and sorbitol (E420).
Croatian: Pomoćne tvari: glutamatna kiselina, polisorbat 80, voda za injekcije i sorbitol (E420).
English: In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia (AML), filgrastim should be administered with caution.
Croatian: S obzirom na ograničene podatke o sigurnosti i djelotvornosti primjene u bolesnika sa sekundarnom akutnom mijeloičnom leukemijom, filgrastim treba primjenjivati s oprezom.
English: Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into the peripheral blood.
Croatian: Primjena filgrastima, bilo samog ili nakon kemoterapije, mobilizira krvotvorne progenitorske stanice u perifernu krv.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP-u), koji se nalazi u Modulu 1.8.2
English: If partial use of a syringe is required, remove unwanted solution before injection.
Croatian: U slučaju djelomične primjene sadržaja štrcaljke, uklonite nepotrebnu količinu otopine prije injekcije.
English: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Croatian: Kad se postigne oporavak neutropenije, potrebno je utvrditi najmanju učinkovitu dozu da bi se održao normalni broj neutrofila.
English: Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Croatian: Praćenje gustoće kosti može biti indicirano u bolesnika s osnovnom osteoporoznom bolešću kostiju koji primaju kontinuiranu terapiju filgrastimom dulje od 6 mjeseci.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Croatian: Filgrastim prvenstveno djeluje na prekursore neutrofila, pa se njegov učinak izražava preko povećanja broja neutrofila.
English: The median serum elimination half-life (t1/2) of filgrastim after single subcutaneous doses ranged from 2.7 hours (1.0 MU/kg, 10 µg/kg) to 5.7 hours (0.25 MU/kg, 2.5 µg/kg) and was prolonged after 7 days of dosing to 8.5 - 14 hours, respectively.
Croatian: Medijan poluvremena eliminacije filgrastima iz seruma (t½) nakon jednokratne supkutane doze kretao se u rasponu od 2,7 sati (1,0 MU/kg, 10 µg/kg) do 5,7 sati (0,25 MU/kg, 2,5 µg/kg) i bilo je produljeno nakon 7 dana doziranja na 8,5 - 14 sati.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Europske agencije za lijekove http://www.ema.europa.eu.
English: Filgrastim HEXAL contains sorbitol
Croatian: Filgrastim HEXAL sadrži sorbitol
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and foetal weight were observed.
Croatian: Intravenska (80 µg/kg/dan) primjena filgrastima kunićima tijekom razdoblja organogeneze bila je toksična za majku te je povećala stopu spontanih abortusa, gubitak nakon implantacije te je uočeno smanjenje prosječne veličine živog legla i težine fetusa.
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Croatian: Mobilizacija progenitorskih stanica iz periferne krvi nema izravnu kliničku korist za zdrave davatelje i treba je razmatrati samo u svrhu alogene transplantacije matičnih stanica.
English: Glutamic acid Sorbitol (E420) Polysorbate 80
Croatian: Glutamatna kiselina Sorbitol (E420) Polisorbat 80
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Croatian: U takvih se bolesnika osobita pozornost treba posvetiti broju mobiliziranih progenitorskih stanica prije primjene visoke doze kemoterapije.
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Croatian: Odmah se javite liječniku ako opazite natečenost lica ili gležnjeva, krv u mokraći ili smeđe obojanu mokraću ili primijetite da mokrite manje nego obično.
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Croatian: Mehanizam vaskulitisa kod bolesnika koji primaju filgrastim nije poznat.
English: When diluted in glucose 50 mg/ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Croatian: Kada se razrijedi u otopini glukoze od 50 mg/ml (5 %), filgrastim je kompatibilan sa staklom i različitim plastičnim materijalima uključujući polivinilklorid, poliolefin (kopolimer prolipropilena i polietilena) i polipropilen.
English: Neutropenia may be due to bone marrow-infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Croatian: Neutropenija može biti posljedica oportunističkih infekcija koje infiltriraju koštanu srž, kao što je Mycobacterium avium kompleks ili zloćudnih bolesti poput limfoma.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Croatian: Podmladak štakora kojima je primjenjivan filgrastim tijekom perinatalnog i laktacijskog razdoblja pokazao je kašnjenje u vanjskoj diferencijaciji i retardaciju rasta (≥20 µg/kg/dan) te blago smanjenu stopu preživljavanja (100 µg/kg/dan).
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy: Filgrastim should be given by subcutaneous injection.
Croatian: Filgrastim za mobilizaciju PBPC-ova nakon mijelosupresivne kemoterapije: Filgrastim treba davati supkutanom injekcijom.
English: Filgrastim may have a minor influence on the ability to drive and use machines.
Croatian: Filgrastim može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Croatian: Potrebno je razmotriti privremeni prekid primjene ili snižavanje doze filgrastima u bolesnika s teškom kroničnom neutropenijom koji razviju trombocitopeniju (broj trombocita < 100 x 109/l).
English: Example: In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 μg) should be given with 0.2 ml of human serum albumin 200 mg/ml (20%) solution Ph. Eur.
Croatian: Na primjer: U konačni volumen od 20 ml, ukupne doze filgrastima manje od 30 MU (300 μg) treba dati s 0,2 ml otopine ljudskog serumskog albumina od 200 mg/ml (20 %) Ph. Eur.
English: • if you experience kidney injury (glomerulonephritis).
Croatian: • ako razvijete oštećenje bubrega (glomerulonefritis).
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/l to > 5.0 x 109/l.
Croatian: Leukaferezu treba raditi u vrijeme kad se apsolutni broj neutrofila poveća s < 0,5 x 109/l na > 5,0 x 109/l.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 72 hours.
Croatian: Ako rok valjanosti nije istekao i za potrebe ambulantne primjene, bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne iznad 25 °C) samo jednom i u trajanju do 72 sata.
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: • ako počnete kašljati, dobijete vrućicu i počnete otežano disati (dispneja) jer to može biti znak sindroma akutnog respiratornog distresa (ARDS).
English: The onset of pulmonary signs, such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS).
Croatian: Pojava znakova zahvaćenosti pluća, kao što su kašalj, vrućica i dispneja, povezanih s radiološkim znakovima plućnih infiltrata i propadanja plućne funkcije mogu biti preliminarni znakovi sindroma akutnog respiratornog distresa (engl. acute respiratory distress syndrome, ARDS).
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Croatian: Postoje neki dokazi iz ispitivanja primjene jednokratne doze da učinak traje kraće kod intravenske primjene doze.
English: Patients having a bone marrow transplant after chemotherapy:
Croatian: Bolesnici koji su bili podvrgnuti transplantaciji koštane srži nakon kemoterapije: