FrancophonIA/ELRC3.0 huggingface dataset:
English: • liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
Croatian: • oštećenje jetre uzrokovano začepljenjem malih vena u jetri (venookluzivna bolest)
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 kemoterapijskih lijekova (npr. pune doze u propisanom protokolu) bolesnik može imati povećan rizik od trombocitopenije i anemije.
English: A diluted solution of Grastofil for infusion should be used within 24 hours when stored at 2 °C to 8 °C.
Croatian: Razrijeđenu otopinu Grastofila za infuziju treba primijeniti unutar 24 sata kad se čuva na temperaturi od 2°C do 8°C.
English: Solution for injection/infusion.
Croatian: Otopina za injekciju/infuziju
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Croatian: Filgrastim primarno djeluje na preteče neutrofila preko kojih iskazuje svoje učinke na povećanje broja neutrofila.
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 10
Croatian: Kad se primjenjuje za mobilizaciju progenitorskih stanica periferne krvi, potrebno je prekinuti primjenu ili smanjiti dozu filgrastima ako se broj leukocita poveća na > 70 x 10
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Croatian: Neki bolesnici mogu vrlo brzo odgovoriti i znatnim povećanjem broja neutrofila na početnu dozu filgrastima.
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Croatian: Kod podskupine od približno 12% bolesnika koji su imali normalne citogenetske nalaze na početku kasnije su se, na rutinskom ponavljanju pretrage, otkrile abnormalnosti, uključujući monosomiju
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: Sveukupne razlike u sigurnosti i djelotvornosti nisu uočene između ispitanika starijih od 65 godina u odnosu na mlađe odrasle (> 18 godina) ispitanike koji primaju citotoksičnu kemoterapije te kliničkim iskustvom nije identificirana razlika u odgovorima između starijih i mlađih odraslih bolesnika.
English: Pregnancy and breast-feeding Grastofil has not been tested in pregnant or breast-feeding women.
Croatian: Trudnoća i dojenje Grastofil nije ispitivan na trudnicama ili dojiljama.
English: Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
Croatian: Dezinficirajte kožu pomoću vatice natopljene alkoholom i uhvatite između palca i kažiprsta nabor kože (bez stiskanja).
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia.
Croatian: Potreban je poseban oprez kad se primjenjuje jedan kemoterapijski lijek ili kombinacija kemoterapijskih lijekova za koje se zna da uzrokuju tešku trombocitopeniju.
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 kad i mijelosupresivna citotoksična kemoterapija nije do kraja ustanovljena.
English: Dose adjustment: Grastofil should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 10
Croatian: Prilagodba doze: Grastofil je potrebno primjenjivati svakodnevno supkutanom injekcijom sve dok broj neutrofila ne poraste i održi se iznad vrijednosti od 1,5 x 10
English: ANC should be monitored closely, especially during the first few weeks of filgrastim therapy.
Croatian: ABN je potrebno pažljivo pratiti, osobito tijekom prvih nekoliko tjedana liječenja filgrastimom.
English: STADA Nordic ApS Telephone +45/44.85.99.99
Croatian: STADA Nordic ApS Tel:+45/44.85.99.99
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 plućnih znakova kao što su kašalj, vrućica i dispneja povezanih s radiološkim znakovima plućnih infiltrata i smanjenjem plućne funkcije mogu biti preliminarni znakovi akutnog respiratornog distres sindroma (ARDS).
English: Leukocytosis Leukocytosis (WBC > 50 x 10
Croatian: Leukocitoza Leukocitoza (leukociti > 50 x 10
English: The impact of filgrastim on human fertility is not known.
Croatian: Učinak filgrastima na plodnost u ljudi nije poznat.
English: Grastofil dose adjustment
Croatian: Prilagodba doze Grastofila
English: Based on reported data for another filgrastim product similar to Grastofil, comparable findings plus increased fetal malformations were observed at 100 μg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 μg/kg/day.
Croatian: Na temelju prijavljenih podataka za drugi lijek s filgrastimom koji je sličan lijeku Grastofil zabilježeni su usporedivi nalazi uz povećane fetalne malformacije pri dozi od 100 μg/kg/dan, toksičnoj dozi za majku koja odgovara sistemskoj izloženosti približno 50-90 puta većoj od izloženosti koja se bilježi u bolesnika liječenih kliničkom dozom od 5 μg/kg/dan.
English: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Croatian: Učinci filgrastima u bolesnika sa znatno smanjenim brojem mijeloičnih progenitorskih stanica nisu ispitani.
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 half-lives.
Croatian: Kontinuirana infuzija filgrastima tijekom razdoblja od najviše 28 dana u bolesnika koji su se oporavljali od transplantacije autologne koštane srži nije dovela do nakupljanja lijeka i poluvijek je bio usporediv.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Croatian: U literaturi se spominju slučajevi u kojima je zabilježen prolaz filgrastima kroz posteljicu u trudnica.
English: Regular urinalysis should be performed to monitor this event.
Croatian: Potrebno je redovito provoditi analizu mokraće zbog praćenja tog događaja.
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: Kod mladunčadi štakora koji su primali filgrastim tijekom perinatalnog razdoblja i razdoblja laktacije zabilježeno je kašnjenje u vanjskoj diferencijaciji i zaostajanje u rastu (≥ 20 μg/kg/dan) te blago smanjena stopa preživljenja (100 μg/kg/dan).
English: It is unknown whether filgrastim / metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se filgrastim/metaboliti u majčino mlijeko.
English: • notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).
Croatian: • primijetite neobično krvarenje ili modrice (to mogu biti simptomi smanjenog broja krvnih pločica (trombocitopenija), uz smanjenu sposobnost zgrušavanja krvi),
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: Zbog mogućnosti primanja viših doza ili većeg broja ovih lijekova tijekom liječenja filgrastimom, bolesnik može imati povećan rizik od razvoja trombocitopenije i anemije.
English: Long-term daily administration is required to maintain an adequate neutrophil count.
Croatian: Potrebna je dugotrajna svakodnevna primjena kako bi se održao odgovarajući broj neutrofila.
English: Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines.
Croatian: Grastofil je faktor rasta bijelih krvnih stanica (faktor stimulacije granulocitnih kolonija) te pripada skupini lijekova koji se nazivaju citokinima.
English: 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 10
Croatian: Bolesnici koji su prethodno primali mijelosupresivno liječenje visokim dozama možda neće postići dovoljnu mobilizaciju progenitorskih stanica periferne krvi kojom bi se postigao preporučeni minimalni prinos (2,0 x 10
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili u kućni otpad.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i na napunjenoj štrcaljki iza „Rok valjanosti“ / EXP.
English: During intermittent dosing with 30 MU (300 microgram)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Croatian: Tijekom isprekidane primjene filgrastima u dozi od 30 MU (300 mikrograma)/dan, mogu postojati velike fluktuacije ABN u bolesnika tijekom vremena.
English: Meta-Analysis a
Croatian: Metaanaliza a
English: There is insufficient data to evaluate filgrastim use in elderly subjects for other approved Grastofil indications.
Croatian: Ne postoji dovoljno podataka za procjenu primjene filgrastima u starijih ispitanika pri drugim odobrenim indikacijama za Grastofil.
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Croatian: Nema dokaza da je u bolesnika s HIV-infekcijom liječenih filgrastimom povećana replikacija HIV-a.
English: In randomised clinical studies, a subcutaneous dose of 230 micrograms/m2/day (4.0 to 8.4 micrograms/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima supkutano je primjenjivana doza od 230 mikrograma/m2/dan (od 4,0 do 8,4 mikrograma/kg/dan).
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Croatian: Potrebno je osobito pažljivo razlučiti dijagnozu blastične transformacije kronične mijeloične leukemije od akutne mijeloične leukemije.
English: Absolute neutrophil count (ANC)
Croatian: Apsolutni broj neutrofila (ABN)
English: The dosing in children and adolescents receiving chemotherapy is the same as for adults.
Croatian: Doziranje u djece i adolescenata koji primaju kemoterapiju isto je kao i u odraslih.
English: Period of study
Croatian: Razdoblje ispitivanja
English: Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 10
Croatian: Može biti potrebna daljnja prilagodba doze, što se određuje prema ABN bolesnika, za održavanje broja neutrofila na > 2,0 x 10
English: Telephone +44/1484-842.217
Croatian: Tel:+44/1484-842.217
English: In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10
Croatian: U bolesnika, bilo djece ili odraslih, s teškom kongenitalnom, cikličkom ili idiopatskom neutropenijom s apsolutnim brojem neutrofila (ABN) od ≤ 0,5 x 10
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Croatian: Mehanizam nastanka vaskulitisa u bolesnika koji primaju filgrastim nije poznat.
English: In a small number of patients (< 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
Croatian: Malom broju bolesnika (< 10%), bile su potrebne doze do 1,0 MU/kg/dan (10 mikrograma/kg/dan) kako bi se postigao obrat neutropenije.
English: • have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Croatian: • iznenada imate znakove alergije kao što su osip, svrbež ili koprivnjača na koži, oticanje lica, usana, jezika ili drugih dijelova tijela, nedostatak zraka, piskanje ili teškoće pri disanju, jer ovo mogu biti znakovi teške alergijske reakcije (preosjetljivosti),
English: Do not attempt to self-administer without this training.
Croatian: Nemojte pokušavati sami sebi primijeniti lijek bez njihovih uputa.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Croatian: Primjenu filgrastima potrebno je trajno prekinuti u bolesnika koji razviju ozbiljnu alergijsku reakciju.
English: You should not receive Grastofil in the 24 hours before and the 24 hours after receiving chemotherapy.
Croatian: Ne biste smjeli primiti Grastofil 24 sati prije i 24 sata nakon što ste primili kemoterapiju.
English: Use of filgrastim in patients undergoing cytotoxic chemotherapy leads to significant reductions in the incidence, severity and duration of neutropenia and febrile neutropenia.
Croatian: Primjena filgrastima u bolesnika na citotoksičnoj kemoterapiji dovodi do značajnog smanjenja incidencije, težine i trajanja neutropenije i febrilne neutropenije.
English: Special precautions in patients with HIV infection
Croatian: Posebne mjere opreza u bolesnika s HIV-infekcijom
English: Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 mL of 200 mg/mL (20%) human albumin solution added.
Croatian: Primjer: U konačnom volumenu injekcije od 20 ml, ukupnu dozu filgrastima manju od 30 MU (300 µg) treba dati s dodatkom 0,2 ml otopine ljudskog serumskog albumina od 200 mg/ml (20%).
English: Grastofil may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Croatian: Grastofil se može primijeniti putem 30-minutne ili 24-satne intravenske infuzije ili putem kontinuirane 24-satne supkutane infuzije.
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Croatian: Do smanjenja broja bijelih krvnih stanica (neutropenije) može doći iz više razloga, a to onda umanjuje sposobnost Vašeg tijela da se obrani od infekcije.
English: How do I give my injection?
Croatian: Kako primjenjujem injekciju?
English: Please tell your doctor immediately during treatment with Grastofil, if you:
Croatian: Odmah obavijestite svog liječnika tijekom liječenja Grastofilom ako:
English: • unusual hair loss or thinning (alopecia)
Croatian: • neuobičajen gubitak ili prorjeđivanje kose (alopecija)
English: Only clear solutions without particles should be used.
Croatian: Smiju se primijeniti samo bistre otopine koje ne sadrže čestice.
English: • low red blood cell count (anaemia)
Croatian: • sniženi broj crvenih krvnih stanica (anemija)
English: STADA Nordic ApS, Suomen sivuliike Telephone +358/207.416.888
Croatian: STADA Nordic ApS, Suomen sivuliike Puh/Tel: +358/207.416.888
English: Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Croatian: Stoga u bolesnika sa smanjenim brojem preteča odgovor neutrofila može biti smanjen (kao u onih liječenih visokim dozama radioterapije ili kemoterapijskih lijekova ili onih s malignom infiltracijom koštane srži).
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Croatian: Nema dovoljno podataka za daljnju procjenu primjene filgrastima u pedijatrijskih ispitanika.
English: Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Croatian: Leukafereza se ne smije provoditi u darivatelja koji uzimaju antikoagulacijske lijekove ili za koje se zna da imaju narušenu hemostazu.
English: If required, Grastofil may be diluted in 5% glucose solution for injection/infusion.
Croatian: Po potrebi, Grastofil se može razrijediti u 5%-tnoj otopini glukoze za injekciju/infuziju.
English: Analysis includes patients receiving BM transplant during this period
Croatian: Analiza uključuje bolesnike koji su primili transplantat koštane srži tijekom tog razdoblja.
English: Grastofil contains the active substance filgrastim.
Croatian: Grastofil sadrži djelatnu tvar filgrastim.
English: Dose reductions of filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Croatian: Zabilježeno je da sniženje doze filgrastima usporava ili zaustavlja progresiju povećanja slezene u bolesnika s teškom kroničnom neutropenijom, dok je u 3% bolesnika bila potrebna splenektomija.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Croatian: • promjena u načinu reguliranja tekućine u tijelu što može rezultirati podbuhlošću (poremećaji volumena tekućine)
English: Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Croatian: Primjena filgrastima u bolesnika, bilo djece ili odraslih, s teškom kroničnom neutropenijom (teška kongenitalna, ciklička i idiopatska neutropenija) izaziva trajno povećnje ABN u perifernoj krvi i smanjenje infekcija i s time povezanih događaja.
English: Long-term administration may be required to maintain the ANC > 2.0 x 10
Croatian: Može biti potrebna dugotrajna primjena kako bi se održao ABN > 2,0 x 10
English: One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Croatian: Jedno retrospektivno Europsko ispitivanje u kojem se procjenjivala primjena G-CSF nakon transplantacije alogene koštane srži u bolesnika s akutnim leukemijama ukazalo je na povećan rizik od GvHD-a, mortaliteta povezanog s liječenjem i mortaliteta kad se primjenjivao G-CSF.
English: • abnormal x-rays of the lungs (lung infiltration)
Croatian: • abnormalni rendgenski nalaz pluća (infiltracija pluća)
English: Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy.
Croatian: Broj trombocita potrebno je pažljivo mjeriti, osobito tijekom prvih nekoliko tjedana liječenja filgrastimom.
English: Grastofil pre-filled syringe contains dry natural rubber
Croatian: Grastofil napunjena štrcaljka sadrži suhu prirodnu gumu
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
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: Ispitivanjima toksičnosti ponovljenih doza u trajanju do 1 godine s filgrastimom otkrivene su promjene koje se pripisuju očekivanom farmakološkom djelovanju koje uključuje povećanje broja leukocita, mijeloidnu hiperplaziju u koštanoj srži, ekstramedularnu granulopoezu i povećanje slezene.
English: Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
Croatian: Primjena filgrastima, bilo samog ili nakon kemoterapije, mobilizira krvotvorne stanice preteče u perifernu krv.
English: It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Croatian: Trenutno nije jasno predisponira li dugotrajno liječenje bolesnike s teškom kroničnom neutropenijom za citogenetske abnormalnosti, MDS ili leukemijsku transformaciju.
English: Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Croatian: Mijelodisplastični sindrom ili kronična mijeloična leukemija Sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom nisu ustanovljene.
English: • sudden life-threatening allergic reaction (anaphylactic reaction)
Croatian: • iznenadna životno opasna alergijska reakcija (anafilaktička reakcija)
English: The needle cover of the pre-filled syringe contains dry natural rubber (latex, see section 4.4).
Croatian: Pokrov igle na napunjenoj štrcaljki sadrži suhu prirodnu gumu (lateks, vidjeti dio 4.4).
English: Take special care with other medicines that stimulate white blood cells Grastofil is one of a group of medicines that stimulate the production of white blood cells.
Croatian: Budite posebno oprezni s drugim lijekovima za stimulaciju bijelih krvnih stanica Grastofil pripada skupini lijekova koji potiču stvaranje bijelih krvnih stanica.
English: • you have a combination of any of the following symptoms: o fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Croatian: • imate bilo koju kombinaciju sljedećih simptoma: o vrućicu ili drhtavicu ili osjećaj jake hladnoće, ubrzan rad srca, smetenost ili dezorijentiranost, nedostatak zraka, krajnje jaku bol ili nelagodu i ljepljivu ili znojnu kožu.
English: cells/kg recipient bodyweight.
Croatian: stanica/kg tjelesne težine primatelja.
English: The recommended starting dose of Grastofil is 0.1 MU/kg/day (1 micrograms/kg/day) with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 10
Croatian: Preporučena početna doza Grastofila je 0,1 MU/kg/dan (1 mikrograma/kg/dan) uz titraciju do najviše 0,4 MU/kg/dan (4 mikrograma/kg/dan) dok se ne postigne normalan broj neutrofila koji je moguće održati (ABN > 2,0 x 10
English: 9/L after the expected nadir, filgrastim should be discontinued immediately.
Croatian: 9/l nakon očekivanog pada na najnižu vrijednost, potrebno je odmah prekinuti primjenu filgrastima.
English: The dose recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Croatian: Preporuke za doziranje u pedijatrijskih bolesnika iste su kao one za odrasle koji primaju mijelosupresivnu citotoksičnu kemoterapiju.
English: Reversal of neutropenia or maintaining normal neutrophil counts: Grastofil should be given by subcutaneous injection.
Croatian: Obrat nutropenije ili održavanje normalnog broja neutrofila: Grastofil se treba primijeniti putem supkutane injekcije.
English: Each mL of solution contains 50 mg of sorbitol (E420) (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedan ml otopine sadrži 50 mg sorbitola (E420) (vidjeti dio 4.4).