FrancophonIA/ELRC3.0 huggingface dataset:
English: When the response has been obtained the minimal effective dose to maintain this level should be established.
Croatian: Nakon što se postigne odgovor, treba odrediti minimalnu učinkovitu dozu za održavanje te razine neutrofila.
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), pri čemu može pomoći uzimanje standardnih lijekova za olakšavanje boli (analgetika).
English: 9/L after the expected nadir, filgrastim should be discontinued immediately.
Croatian: 9/l, filgrastim treba odmah obustaviti.
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 pokušate sami sebi dati injekciju ako Vas tome prethodno nisu podučili liječnik ili medicinska sestra.
English: Excipient with known effect 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).
English: Causes of transient neutropenia, such as viral infections should be excluded.
Croatian: Valja isključiti uzroke prolazne neutropenije, poput virusnih infekcija.
English: In normal donors, a 10 µg/kg/day dose administered subcutaneously for 4 to 5 consecutive days allows a collection of ≥ 4 x 10
Croatian: U zdravih davatelja doza od 10 g/kg/dan, primijenjena supkutano tijekom 4 do 5 uzastopnih dana omogućava prikupljanje 4 x 10
English: There are 1, 5, 8 or 10 syringes in each pack.
Croatian: Postoje pakiranja s 1, 5, 8 i 10 štrcaljki u pakiranju.
English: Remove the Nivestim syringe from the fridge and allow it to reach room temperature (approximately 25 C).
Croatian: Izvadite Nivestim štrcaljku iz hladnjaka i ostavite ga da se ugrije na sobnu temperaturu (otprilike 25C).
English: The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Croatian: Postupke mobilizacije i afereze treba obavljati u suradnji s onkološko-hematološkim centrom koji ima prihvatljivo iskustvo u tom području i u kojem se na pogodan način mogu pratiti krvotvorne matične stanice.
English: It is also important that you dispose of the syringe in a puncture-proof container.
Croatian: Također je važno da iskorištenu štrcaljku odložite u spremnik za oštre predmete.
English: cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Croatian: + stanica/kg temelji se na dosad objavljenim iskustvima u postizanju primjerene hematološke rekonstitucije.
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: U bolesnika koji su prethodno bili podvrgnuti opsežnoj mijelosupresivnoj terapiji mobilizacija KMSPK možda neće biti dovoljna za postizanje minimalnog prinosa (≥ 2,0 x 10
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: Njegova će primjena, nakon indukcijske i konsolidacijske kemoterapije akutne mijeloične leukemije, možda trajati znatno dulje (do 38 dana), ovisno o vrsti, dozi i shemi primijenjene citotoksične kemoterapije.
English: Special warning and precautions associated with co-morbidities
Croatian: Posebna upozorenja i mjere opreza povezane s komorbiditetima
English: Risks associated with increased doses of chemotherapy
Croatian: Rizici povezani s povišenim 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 stimulira ljudske endotelne stanice in vitro.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Croatian: • bol i oticanje zglobova, slično gihtu (pseudogiht)
English: Nivestim stimulates the bone marrow to produce new white cells quickly.
Croatian: Nivestim stimulira koštanu srž da brže proizvodi nove bijele stanice.
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: Primjena filgrastima u bolesnika s HIV infekcijom održava normalni broj neutrofila i omogućuje predviđeno doziranje antivirusnih i/ili drugih mijelosupresijskih lijekova.
English: • A new pre-filled syringe of Nivestim.
Croatian: • Nova napunjena štrcaljka Nivestima.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Croatian: Sigurnost i djelotvornost primjene u novorođenčadi i bolesnika s autoimunom neutropenijom nisu ustanovljene.
English: Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Croatian: Filgrastim je indiciran za mobilizaciju krvotvornih matičnih stanica periferne krvi (KMSPK-ova).
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Croatian: Nužan je poseban oprez pri primjeni jednog ili kombinacije kemoterapeutika za koje se zna da uzrokuju tešku trombocitopeniju.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Croatian: Bolesnici s plućnim infiltratima ili pneumonijom u nedavnoj anamnezi mogu biti izloženi većem riziku.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Croatian: Filgrastim se ne smije davati kako bi se povećala doza citotoksične kemoterapije iznad doza utvrđenih režima doziranja.
English: You will normally receive your first dose of Nivestim at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Croatian: Obično ćete primiti svoju prvu dozu Nivestima barem 24 sata nakon kemoterapije i barem 24 sata nakon primitka transplantata koštane srži.
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Croatian: 9/l ili veći uočen je u manje od 5% bolesnika oboljelih od raka koji su primali filgrastim u dozama većima od 0,3 MU/kg/dan (3 µg/kg/dan).
English: • changes in blood chemistry
Croatian: • biokemijske promjene krvi
English: This is known as a subcutaneous injection.
Croatian: Takva injekcija naziva se potkožna injekcija.
English: 4.8 Undesirable effects a.
Croatian: 4.8 Nuspojave a.
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/min/kg.
Croatian: Poluvrijeme eliminacije filgrastima iz seruma je približno 3,5 sata, uz stopu klirensa od otprilike 0,6 ml/min/kg.
English: The solution should be visually inspected prior to use.
Croatian: Prije uporabe otopinu treba vizualno pregledati.
English: Filgrastim had no observed effect on the fertility of male or female rats.
Croatian: Filgrastim nema uočenog učinka na plodnost mužjaka ili ženki štakora.
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 mijeloičnih stanica koje se brzo umnažaju na mijelosupresijsku citotoksičnu kemoterapiju, primjena filgrastima ne preporučuje se 24 sata prije ni 24 sata poslije kemoterapije.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Croatian: U pravilu, događaji glomerulonefritisa povukli su se nakon smanjenja doze ili prekida terapije filgrastimom ili pegfilgrastimom.
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 otopina ne upotrijebi odmah, vrijeme i uvjeti čuvanja su odgovornost korisnika i normalno ne bi trebali biti dulji od 24 sata na temperaturi od 2 °C do 8 °C, osim ako se razrjeđivanje provelo u kontroliranim i validiranim aseptičkim uvjetima.
English: Granulocyte colony-stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Croatian: Faktor stimulacije rasta granulocita može poticati rast mijeloičnih stanica in vitro, a mogući su slični učinci na neke nemijeloične stanice in vitro.
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Croatian: • bolest koja uzrokuje smanjenje gustoće kostiju, zbog čega su kosti slabije, krhkije i sklonije lomu (osteoporoza)
English: • worsening of rheumatoid arthritis
Croatian: • pogoršanje reumatoidnog artritisa
English: 9/L prior to leukapheresis; in general apheresis should not be performed if platelets
Croatian: 9/l prije leukafereze; aferezu općenito ne treba provoditi ako su trombociti <75
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 i posljedica infiltracije koštane srži uzročnicima oportunističkih infekcija poput Mycobacterium avium kompleksa ili zloćudnim bolestima poput limfoma.
English: • unusual hair loss or thinning (alopecia)
Croatian: • neuobičajeni gubitak ili stanjivanje kose (alopecija)
English: The effects of filgrastim overdosage have not been established.
Croatian: Nisu utvrđeni učinci predoziranja filgrastimom.
English: Do not choose an area which is tender, red, bruised or scarred.
Croatian: Nemojte primijeniti injekciju u područje koje je bolno, crveno ili gdje postoji modrica ili ožiljak.
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 da se primijene više doze kemoterapije (npr. pune doze prema propisanoj shemi), bolesnik može biti izložen većem riziku od trombocitopenije i anemije.
English: Agents such as melphalan, carmustine (BCNU), and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
Croatian: Lijekovi poput melfalana, karmustina (BCNU) i karboplatine, ako se daju tijekom duljeg vremenskog razdoblja prije pokušaja mobilizacije, mogu smanjiti prinos matičnih stanica.
English: If leucocyte counts exceed 50 x 10
Croatian: Ako je broj leukocita nakon očekivanih najnižih vrijednosti veći od 50 x 10
English: When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leucocyte counts rise to > 70 x 10
Croatian: Kada se daje radi mobilizacije krvotvornih matičnih stanica periferne krvi, filgrastim treba obustaviti ili njegovu dozu smanjiti ako broj leukocita dosegne vrijednost >70 x 10
English: The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Croatian: Sigurnost i djelotvornost filgrastima u bolesnika s mijelodisplastičnim sindromom ili s kroničnom mijeloičnom leukemijom nisu ustanovljene.
English: The stem cells will then go back into the bone marrow and produce blood cells; - to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections; - in patients with advanced HIV infection which will help reduce the risk of infections.
Croatian: Matične stanice potom se vraćaju u koštanu srž i proizvode krvne stanice; - Za povećanje broja bijelih krvnih stanica ako patite od teške kronične neutropenije, kako bi se pomoglo u borbi protiv infekcija; - U bolesnika s uznapredovalom HIV infekcijom, što će pomoći smanjiti rizik od infekcija.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Croatian: U nekim slučajevima simptomi su se ponavljali pri ponovnom uvođenju lijeka, što je upućivalo na uzročno posljedičnu povezanost.
English: Ensure the needle guard covers the needle according to the instructions for active needle guard or passive needle guard below.
Croatian: 12. Pazite da štitnik za iglu pokriva iglu u skladu s uputama za aktivno i pasivno osiguranje igle kako je prikazano u nastavku.
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: • imate iznenadne znakove alergije poput osipa, svrbeža ili koprivnjače na koži, oticanja lica, usana, jezika ili drugih dijelova tijela, nedostatak zraka, piskanje ili poteškoće u disanju jer to mogu biti znakovi teške alergijske reakcije (preosjetljivost).
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Croatian: Postojeći podaci pokazuju da imunološke interakcije između presađenih alogenih KMSPK i primatelja mogu biti povezane s većim rizikom od akutne i kronične bolesti GvHD u usporedbi s presađivanjem koštane srži.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Croatian: Razrijeđeni filgrastim se može adsorbirati na staklo ili plastične materijale, osim kada je razrijeđen kako je niže opisano.
English: Nivestim is one of a group of products that stimulate the production of white blood cells.
Croatian: Nivestim je jedan iz skupine lijekova koji stimuliraju stvaranje bijelih krvnih stanica.
English: If required, Nivestim may be diluted in 5% glucose solution.
Croatian: Po potrebi, Nivestim se može razrijediti u 5%-tnoj otopini glukoze.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Croatian: Unatoč tome, ne može se isključiti rizik poticanja rasta klona zloćudnih mijeloičnih stanica.
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Croatian: Filgrastim se ne smije davati bolesnicima s teškom kongenitalnom neutropenijom u kojih se razvila leukemija ili u kojih postoji dokaz razvoja leukemije.
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: • uočite neobično krvarenje ili nastanak modrica (to mogu simptomi pada broja krvnih pločica) (trombocitopenija) sa smanjenom mogućnošću Vaše krvi da se zgruša).
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se filgrastim/metaboliti u majčino mlijeko.
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 15 days.
Croatian: Unutar roka valjanosti i u svrhu kućne primjene, bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne iznad 25°C) jednokratno u trajanju do 15 dana.
English: • low red blood cell count (anaemia)
Croatian: • nizak broj crvenih krvnih stanica (anemija)
English: Special warning and precautions across indications
Croatian: Posebna upozorenja i mjere opreza u svim indikacijama
English: cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Croatian: + stanica primijenjenih reinfuzijom i brzine oporavka broja trombocita nakon visokodozne kemoterapije pokazuje da je taj odnos složen, ali neprekidan.
English: In normal stem cell donors, an increase in white blood cells (leucocytosis) and a decrease of platelets may be seen.
Croatian: U zdravih davatelja matičnih stanica može se uočiti porast bijelih krvnih stanica (leukocitoza) i smanjenje broja trombocita.
English: • abnormal x-rays of the lungs (lung infiltration)
Croatian: • abnormalne rendgenske slike pluća (infiltracija pluća)
English: • enlargement of the liver (hepatomegaly)
Croatian: • uvećanje jetre (hepatomegalija)
English: Nivestim has not been tested in pregnant or breast-feeding women.
Croatian: Nivestim nije ispitivan na trudnicama ili dojiljama.
English: Based on reported data for another filgrastim product similar to the originator, comparable findings plus increased foetal 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 filgrastim koji je sličan izvornom, uočeni su slični rezultati uz povećanu malformaciju fetusa pri dozi od 100 g/kg/dan, toksičnu dozu za majku koja je odgovarala sistemskoj izloženosti od oko 50 - 90 puta izloženosti zabilježene u bolesnika liječenih s kliničkom dozom od 5 g/kg/dan.
English: Urinalysis monitoring is recommended.
Croatian: Preporučuje se praćenje analizom urina.
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 leucocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Croatian: Filgrastim je proučavan u ispitivanjima toksičnosti ponovljenih doza koja su trajale do godinu dana i koja su pokazala promjene koje se mogu pripisati očekivanim farmakološkim djelovanjima uključujući povećanje broja leukocita, mijeloičnu hiperplaziju koštane srži, ekstramedularnu granulopoezu i povećanje slezene.
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient abnormal bone scans.
Croatian: Pojačana krvotvorna aktivnost koštane srži kao odgovor na terapiju faktorom rasta povezana je s prolaznim abnormalnim skenovima kosti.
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Croatian: U tih bolesnika osobitu pozornost valja posvetiti broju mobiliziranih matičnih stanica prije primjene visokodozne kemoterapije.
English: Filgrastim is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti filgrastim tijekom trudnoće.
English: Infusion of PBPC accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Croatian: Infuzijom KMSPK ubrzava se hematopoetski oporavak, skraćuje se trajanje rizika od hemoragijskih komplikacija i smanjuje potreba za transfuzijama trombocita.
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Croatian: Krvožilni poremećaji, uključujući venookluzivnu bolest i poremećaje volumena tekućine prijavljeni su povremeno u bolesnika koji se podvrgavaju visokoj dozi kemoterapije nakon čega slijedi transplantacija.
English: Nivestim is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Croatian: Nivestim se koristi u liječenju djece koja primaju kemoterapiju ili koja boluju od opsežnog smanjenja broja bijelih krvnih stanica (neutropenija).
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne smiju primiti ovaj lijek, osim ako je to zaista neophodno.
English: Period of Study
Croatian: Razdoblje ispitivanja
English: Analysis includes patients receiving BM transplant during this period.
Croatian: Analiza uključuje bolesnike kojima je presađena koštana srž u tom periodu.
English: Sweets syndrome
Croatian: Sweetov sindrom
English: It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Croatian: Za sada nije jasno može li dugotrajna primjena u bolesnika sa SCN-om stvoriti predispoziciju za citogenetske poremećaje, MDS ili leukemijsku pretvorbu.
English: Nivestim does not contain any preservative.
Croatian: Nivestim ne sadrži konzervans.
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, djece ili odraslih s teškom kongenitalnom, cikličkom ili idiopatskom neutropenijom s apsolutnim brojem neutrofila (ABN)  0,5 × 10
English: Filgrastim dose adjustment
Croatian: Prilagođavanje doze filgrastima
English: • allergic reaction (hypersensitivity)
Croatian: • alergijska reakcija (preosjetljivost)
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 pozovite svog liječnika ako osjetite podbuhlost lica ili gležnjeva, krv u mokraći ili smeđe obojenje mokraće ili ako uočite da mokrite manje nego inače.
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, poput kašlja, vrućice i dispneje, zajedno s radiološkim znakovima plućnih infiltrata i pogoršanjem funkcije pluća, mogu biti prvi znaci sindroma akutnog respiratornog distresa (ARDS).
English: Do not use the Nivestim syringe if the liquid has particles floating in it or any of the liquid has leaked out of the syringe.
Croatian: Nemojte koristiti Nivestim štrcaljku ako u otopini plutaju čestice ili je sadržaj iscurio iz štrcaljke.
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy:
Croatian: Filgrastim za mobilizaciju KMSPK-ova nakon mijelosupresivne kemoterapije:
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Croatian: Osobito je nužan oprez pri dijagnostičkom razlučivanju blastične transformacije kronične mijeloične leukemije od akutne mijeloične leukemije.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 15 days (but not above 25°C).
Croatian: Štrcaljku smijete izvaditi iz hladnjaka i ostaviti na sobnoj temperaturi (ne višoj od 25°C) jednokratno do najviše 15 dana.
English: cells mean that direct comparison between different studies is difficult.
Croatian: + stanica pokazuje da je izravna usporedba između metoda teška.
English: Nivestim must not be diluted with sodium chloride solution.
Croatian: Nivestim se ne smije razrjeđivati s otopinom natrijevog klorida.
English: • tingling or numbness of the hands or feet (paraesthesia)
Croatian: • trnci ili utrnulost šaka ili stopala (parestezija)
English: Osteoporosis
Croatian: Osteoporoza
English: Special precautions in patients with HIV infection
Croatian: Posebne mjere opreza u bolesnika s HIV infekcijom
English: Dose adjustment is not required in these circumstances.
Croatian: U tih bolesnika nije potrebna prilagodba doze.