FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on reported data for another filgrastim product similar to the reference filgrastim product, 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 lijek koji sadrži filgrastim sličan referentnom lijeku koji sadrži filgrastimu, uočeni su usporedivi nalazi te povećane malformacije pri dozi od 100 µg/kg/dan, dozi toksičnoj za majku koja odgovara sistemskom izlaganju od približno 50 do 90 puta većem od izlaganja uočenog kod bolesnika liječenih kliničkom dozom od 5 µg/kg/dan.
English: Filgrastim HEXAL may have a minor influence on your ability to drive and use machines.
Croatian: Filgrastim HEXAL može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Croatian: Potreban je osobit oprez pri dijagnostičkom razlučivanju blastične transformacije kronične mijeloične leukemije od akutne mijeloične leukemije.
English: Filgrastim HEXAL is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Croatian: Filgrastim HEXAL se primjenjuje za liječenje djece koja primaju kemoterapiju ili boluju od teškog oblika sniženja broja bijelih krvnih stanica (neutropenije).
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 davatelja koji primaju antikoagulanse ili koji imaju dokazane poremećaje hemostaze.
English: Always keeping your skin pinched, depress the plunger slowly and evenly.
Croatian: Uvijek držite nabor kože između prstiju i potiskujte klip polako i jednolično.
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, povremeno su zabilježeni u bolesnika koji su primali visoke doze kemoterapije nakon transplantacije.
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 ispitivani.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Croatian: U nekim slučajevima simptomi su se ponavljali kod ponovnog izlaganja lijeku (rechallenge a), što ukazuje na uzročno-posljedični odnos.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Croatian: Liječnik Vam može redovito vršiti pretrage mokraće ako primijetite tu nuspojavu ili ako se u Vašoj mokraći pronađu bjelančevine (proteinurija).
English: White blood cell counts of 100 x 109/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: Broj leukocita od 100 x 109/l ili veći primijećen je u manje od 5 % bolesnika koji su primali filgrastim u dozama većima od 0,3 MU/kg/dan (3 μg/kg/dan).
English: Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution.
Croatian: Napunjena štrcaljka (staklo tipa I) s injekcijskom iglom (nehrđajući čelik), sa ili bez sigurnosne zaštite za iglu, koja sadrži 0,5 ml otopine.
English: • to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;
Croatian: • za povećanje broja bijelih krvnih stanica ako bolujete od teške kronične neutropenije kako bi se spriječile infekcije;
English: Reduce to 0.5 MU/kg/day (5 μg/kg/day)
Croatian: Smanjiti na 0,5 MU/kg/dan (5 μg/kg/dan)
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 koji primaju citotoksičnu kemoterapiju dovodi do značajnog smanjenja incidencije, težine i trajanja neutropenije i febrilne neutropenije.
English: What Filgrastim HEXAL looks like and contents of the pack
Croatian: Kako Filgrastim HEXAL izgleda i sadržaj pakiranja
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post marketing experience.
Croatian: Reakcije preosjetljivosti, uključujući anafilaksiju, osip, urtikariju, angioedem, dispneju i hipotenziju, koje su se javile tijekom početnog ili nastavnog liječenja primijećene su u kliničkim ispitivanjima i u razdoblju nakon stavljanja lijeka u promet.
English: A single subcutaneous dose of 0.5 MU/kg (5 µg/kg) resulted in maximum serum concentrations after a tmax of 4.5 ± 0.9 hours (mean ± SD).
Croatian: Jednokratna supkutana doza od 0,5 MU/kg (5 µg/kg) rezultirala je najvišom koncentracijom u serumu nakon tmax od 4,5 ± 0,9 sati (prosječna vrijednost ± SD).
English: Put the used syringe in the disposal container.
Croatian: Stavite iskorištenu štrcaljku u spremnik za odlaganje potrošenih štrcaljki.
English: Overall, reports were more common after IV administration.
Croatian: Općenito su takvi slučajevi bili češći nakon intravenske primjene.
English: • increase in white blood cells (leukocytosis)
Croatian: • povećan broj bijelih krvnih stanica (leukocitoza)
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 odgovor neutrofila može biti slabiji u bolesnika sa smanjenim brojem prekursora (kao što je u onih liječenih opsežnom radioterapijom ili kemoterapijom, ili bolesnika u kojih je tumor infiltrirao koštanu srž).
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Croatian: Sigurnost i djelotvornost primjene filgrastima nisu ocjenjivane u zdravih davatelja mlađih od 16 godina ili starijih od 60 godina.
English: Relative Risk (95% CI) of GvHD and TRM Following treatment with G-CSF after bone marrow transplantation Publication
Croatian: Relativni rizik (95 % CI) od reakcije presatka protiv primatelja (GvHD) i smrtnosti povezane s liječenjem (TRM) Nakon liječenja s G-CSF poslije presađivanja koštane srži
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Croatian: Za mobilizaciju PBPC-ova kod bolesnika koji se podvrgavaju mijelosupresivnoj ili mijeloablativnoj terapiji nakon koje slijedi transplantacija autolognim PBPC-ovima
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Croatian: Nakon prekida liječenja filgrastimom, broj cirkulirajućih neutrofila smanjuje se za 50 % u roku od 1 - 2 dana, a na normalne vrijednosti u roku od 1 - 7 dana.
English: Pulmonary oedemaa Pulmonary haemorrhage Interstitial lung diseasea Lung infiltrationa Hypoxia
Croatian: Plućni edema Plućna hemoragija Intersticijska bolest plućaa Plućna infiltracijaa Hipoksija
English: Filgrastim HEXAL contains sorbitol (E420).
Croatian: Filgrastim HEXAL sadrži sorbitol (E420).
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Croatian: Neka citotoksična sredstva pokazuju osobitu toksičnost prema progenitorskim krvotvornim stanicama i mogu štetno utjecati na mobilizaciju progenitorskih stanica.
English: Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless to slightly yellowish liquid.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite promjenu boje, zamućenost ili čestice; lijek treba biti bistra do blago žućkasta tekućina.
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Croatian: • ako dobijete alergijsku reakciju, uključujući slabost, pad krvnog tlaka, otežano disanje, oticanje lica (anafilaksija), kožni osip, osip sa svrbežom (urtikarija), oticanje lica, usana, usta, jezika ili grla (angioedem) i nedostatak zraka (dispneja).
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: Sredstva kao što su melfalan, karmustin (BCNU) i karboplatina mogu smanjiti prinos progenitorskih stanica kad se primjenjuju tijekom produljenog razdoblja prije pokušaja mobilizacije progenitorskih stanica.
English: • sudden life-threatening allergic reaction (anaphylactic reaction)
Croatian: • iznenadna alergijska reakcija koja ugrožava život (anafilaktička reakcija)
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: Sadašnji podaci pokazuju da imunološke interakcije između presađenih alogenih progenitorskih stanica iz periferne krvi i primatelja mogu biti povezane s povećanim rizikom od akutne i kronične reakcije presatka protiv primatelja (GvHD) u usporedbi s onim nakon presađivanja koštane srži.
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC Code: L03AA02
Croatian: Farmakoterapijska skupina: Imunostimulatori, čimbenici stimulacije kolonija, ATK oznaka: L03AA02 Filgrastim HEXAL je biosličan lijek.
English: 1 pre-filled syringe without needle safety guard 3 pre-filled syringes without needle safety guard 5 pre-filled syringes without needle safety guard 10 pre-filled syringes without needle safety guard
Croatian: 1 napunjena štrcaljka bez sigurnosne zaštite za iglu 3 napunjene štrcaljke bez sigurnosne zaštite za iglu 5 napunjenih štrcaljki bez sigurnosne zaštite za iglu 10 napunjenih štrcaljki bez sigurnosne zaštite za iglu
English: Using the pre-filled syringe without a needle safety guard Administer the dose as per standard protocol.
Croatian: Uporaba napunjene štrcaljke bez sigurnosne zaštite za iglu Primijenite dozu prema standardnom protokolu.
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain.
Croatian: Moguću dijagnozu rupture slezene treba uzeti u obzir u davatelja i/ili bolesnika koji se žale na bol u lijevom gornjem dijelu abdomena ili vrhu ramena.
English: Very commonly seen in normal stem cell donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.
Croatian: Vrlo česta nuspojava u zdravih davatelja matičnih stanica je povećanje broja bijelih krvnih stanica (leukocitoza) i smanjenje broja trombocita što smanjuje mogućnost zgrušavanja krvi (trombocitopenija); te vrijednosti će pratiti Vaš liječnik.
English: 10 6336 Langkampfen Austria
Croatian: Sandoz GmbH Biochemiestr. 10 6336 Langkampfen Austrija
English: It is recommended that the ANC is measured daily for the first 2 - 3 days of filgrastim administration.
Croatian: Preporučuje se svakodnevno mjeriti apsolutni broj neutrofila tijekom prva 2 - 3 dana primjene filgrastima.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Croatian: U tom slučaju treba prekinuti davanje filgrastima i primijeniti odgovarajuće liječenje.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Croatian: Sigurnost i djelotvornost primjene nije utvrđena u novorođenčadi i bolesnika s autoimunom neutropenijom.
English: After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Croatian: Nakon ubrizgavanja tekućine, izvadite iglu zadržavajući pritisak na klip i pustite nabor kože.
English: The needle safety guard covers the needle after injection to prevent needle stick injury.
Croatian: Sigurnosna zaštita za iglu pokriva iglu nakon davanja injekcije kako bi se spriječila ozljeda ubodom igle.
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Croatian: U literaturi su zabilježeni slučajevi u kojih se pokazalo da filgrastim u trudnica prolazi kroz placentu.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment has been reported in patients treated with filgrastim.
Croatian: Preosjetljivost, uključujući anafilaktičke reakcije, koje se javljaju kod početnog ili nastavnog liječenja prijavljene su kod bolesnika liječenih filgrastimom.
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: Primijećeno je da smanjenje doze filgrastima usporava ili zaustavlja progresiju povećanja slezene kod bolesnika s teškom kroničnom neutropenijom, a u 3 %
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaj kože i potkožnog tkiva
English: For reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MU/kg/day (1 μg/kg/day), with titration up to a maximum of 0.4 MU/kg/day (4 μg/kg/day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/l).
Croatian: Preporučena početna doza filgrastima je 0,1 MU/kg/dan (1 μg/kg/dan) uz postupno povećanje do najviše 0,4 MU/kg/dan (4 μg/kg/dan) sve dok se ne postigne normalni broj neutrofila koji se može i održati (ANC > 2,0 x 109/l).
English: When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Croatian: Kada se predviđa presađivanje progenitorskih stanica iz periferne krvi, savjetuje se planirati postupak mobilizacije matičnih stanica u ranoj fazi liječenja bolesnika.
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Croatian: Podaci nisu dostatni za dodatnu procjenu primjene filgrastima u pedijatrijskih ispitanika. e.
English: • lack of absorption of oxygen in the lung (hypoxia)
Croatian: • izostanak apsorpcije kisika u plućima (hipoksija)
English: Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Croatian: Ispitivanja filgrastima u bolesnika s teškim oštećenjem funkcije bubrega ili jetre pokazuju da filgrastim ima farmakokinetički i farmakodinamički profil sličan onom kakav se opaža u zdravih osoba.
English: Aspartate aminotransferase increased Gammaglutamyl transferase increased
Croatian: Povišena aspartat aminotransferaza Povišena gamaglutamiltransferaza
English: Accidental exposure to freezing temperatures does not adversely affect the stability of filgrastim.
Croatian: Slučajno izlaganje temperaturama zamrzavanja neće štetno utjecati na stabilnost filgrastima.
English: Injection site reaction
Croatian: Reakcija na mjestu primjene injekcije
English: • if you have a combination of any of the following symptoms: 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: • ako imate bilo koju kombinaciju sljedećih simptoma: vrućica ili drhtanje, osjećaj velike hladnoće, visok puls, smetenost ili dezorijentiranost,
English: Filgrastim HEXAL contains no preservative: In view of the possible risk of microbial contamination, Filgrastim HEXAL syringes are for single use only.
Croatian: Filgrastim HEXAL ne sadrži konzervanse: S obzirom na mogući rizik od mikrobiološke kontaminacije,
English: Among these, two cases of platelets < 50 x 109/l were reported and attributed to the leukapheresis procedure.
Croatian: Među njima je broj trombocita < 50 x 109/l zabilježen u dva slučaja i pripisan postupku leukafereze.
English: Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery when compared with allogeneic bone marrow transplantation.
Croatian: Primatelji alogenih progenitorskih stanica iz periferne krvi mobiliziranih filgrastimom imali su znatno brži hematološki oporavak, koji je doveo do značajnog skraćenja vremena do oporavka trombocita bez potpore u usporedbi s alogenom transplantacijom koštane srži.
English: Filgrastim HEXAL is one of a group of products that stimulate the production of white blood cells.
Croatian: Filgrastim HEXAL je jedan iz skupine lijekova koji potiču proizvodnju bijelih krvnih stanica.
English: • abnormal x-rays of the lungs (lung infiltration)
Croatian: • abnormalni rezultati rendgenskog snimanja pluća (infiltrat u plućima)
English: Filgrastim dose adjustment
Croatian: Prilagodba doze filgrastima
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, uslijed čega postaju slabije, krhkije i sklonije lomljenju (osteoporoza) • reakcija na mjestu injekcije
English: In clinical studies, dosing with 30 MU/day (300 μg/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/l, with the median dose frequency being 3 days per week.
Croatian: U kliničkim je ispitivanjima bilo potrebno primjenjivati dozu od 30 MU/dan (300 μg/dan) tijekom 1 - 7 dana tjedno da bi se apsolutni broj neutrofila održao na > 2,0 x 109/l, uz medijan učestalosti doziranja 3 dana tjedno.
English: - experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).
Croatian: - osjetite natečenost lica ili gležnjeva, primijetite krv u mokraći ili smeđe obojanu mokraću ili primijetite da mokrite manje nego obično (glomerulonefritis).
English: • to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
Croatian: • za povećanje broja bijelih krvnih stanica nakon liječenja kemoterapijom kako bi se spriječile infekcije;
English: If you forget to use Filgrastim HEXAL
Croatian: Ako ste zaboravili primijeniti Filgrastim HEXAL
English: Regular urinalysis should be performed to monitor these events.
Croatian: Potrebno je redovito raditi analizu mokraće zbog praćenja ovih promjena.
English: Transformation to leukaemia or myelodysplastic syndrome
Croatian: Prijelaz u leukemiju ili mijelodisplastični sindrom
English: - In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Croatian: U bolesnika, djece ili odraslih s teškom kongenitalnom, cikličkom ili idiopatskom neutropenijom uz apsolutni broj neutrofila (ANC) ≤ 0,5 x 109/l i teškim ili ponavljajućim infekcijama u anamnezi, dugotrajna primjena filgrastima indicirana je za povećanje broja neutrofila i smanjenje incidencije i trajanja događaja povezanih s infekcijom.
English: Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Croatian: Liječenje filgrastimom značajno smanjuje trajanje febrilne neutropenije, primjene antibiotika i hospitalizacije nakon uvodne kemoterapije zbog akutne mijelogene leukemije ili mijeloablativne terapije prije presađivanja koštane srži.
English: Special warnings and precautions across indications
Croatian: Posebna upozorenja i mjere opreza za sve indikacije Preosjetljivost
English: Diluted filgrastim may be adsorbed to glass and plastic materials, unless it is diluted in glucose 50 mg/ml (5%) solution (see section 6.6).
Croatian: Razrijeđeni filgrastim se može adsorbirati na staklo i plastične materijale ako se ne razrijedi u otopini glukoze od 50 mg/ml (5 %) (vidjeti dio 6.6).
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Croatian: Filgrastim se može davati kao 24-satna neprekidna supkutana infuzija ili supkutana injekcija.
English: If required, Filgrastim HEXAL may be diluted in glucose 50 mg/ml (5%) solution.
Croatian: Ukoliko je potrebno, Filgrastim HEXAL se može razrijediti u otopini glukoze50 mg/ml (5 %).
English: - Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Croatian: - Skraćenje trajanja neutropenije i smanjenje incidencije febrilne neutropenije u bolesnika koji se liječe utvrđenom citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnih sindroma) i skraćenje trajanja neutropenije u bolesnika koji primaju mijeloablativnu terapiju prije presađivanja koštane srži u kojih se smatra da postoji povećani rizik od produljenog trajanja teške neutropenije.
English: 1 pre-filled syringe with a needle safety guard 3 pre-filled syringes with a needle safety guard 5 pre-filled syringes with a needle safety guard 10 pre-filled syringes with a needle safety guard
Croatian: 1 napunjena štrcaljka sa sigurnosnom zaštitom za iglu 3 napunjene štrcaljke sa sigurnosnom zaštitom za iglu 5 napunjenih štrcaljki sa sigurnosnom zaštitom za iglu 10 napunjenih štrcaljki sa sigurnosnom zaštitom za iglu
English: • if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen [enlargement of the spleen (splenomegaly) or rupture of the spleen].
Croatian: • ako osjetite bolove u gornjoj lijevoj strani trbuha (abdomena), bol na lijevoj strani ispod rebara ili bol u vršku ramena, jer može postojati problem sa slezenom [povećanje slezene
English: Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Croatian: Prekid terapije filgrastimom obično rezultira 50 %-tnim smanjenjem cirkulirajućih neutrofila unutar 1 do 2 dana, uz vraćanje na normalne razine za
English: Reversal of neutropenia or maintaining normal neutrophil counts: Filgrastim should be given by subcutaneous injection.
Croatian: Oporavak od neutropenije ili održavanje normalnog broja neutrofila: Filgrastim treba davati supkutanom injekcijom.