FrancophonIA/ELRC3.0 huggingface dataset:
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Croatian: Randomizirano, jednostruko slijepo, s jednom dozom, ukriženo ispitivanje u 196 zdravih dragovoljaca pokazalo je da je farmakokinetički profil Biograstima i pri supkutanoj i pri intravenskoj primjeni bio usporediv s farmakokinetičkim profilom referentnog lijeka.
English: Reduce to 0.5 MIU (5 µg)/kg/day
Croatian: Smanjiti na 0,5 MIU (5 μg)/kg/dan
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 veće doze kemoterapije (npr. pune doze prema propisanoj shemi), bolesnik može biti izložen većem riziku od trombocitopenije i anemije.
English: Splenic enlargement was reported to be related to filgrastim therapy in < 3 % of patients.
Croatian: Povećanje slezene povezano s primjenom filgrastima prijavljeno je u < 3 % bolesnika.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Croatian: Nije bilo prijava nuspojava koje bi se mogle izravno pripisati leukocitozi tog stupnja.
English: - if you have specific blood disorders (e.g. Kostman's syndrome, myelodysplastic syndrome,
Croatian: - ako imate određeni krvni poremećaj (Kostmanov sindrom, mijelodisplastični sindrom, razne vrste leukemije).
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Vrlo rijetko (mogu se javiti do 1 na 10 000 osoba)
English: Biograstim is a clear and colourless solution.
Croatian: Biograstim je bistra i bezbojna otopina.
English: Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell disease and only after careful evaluation of the potential risks and benefits.
Croatian: Liječnik mora biti oprezan pri razmatranju primjene filgrastima u bolesnika s anemijom srpastih stanica i mora pažljivo procijeniti moguće rizike i koristi.
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 više kemoterapeutika za koje se zna da izazivaju jaku trombocitopeniju.
English: If you stop using Biograstim
Croatian: Ako prestanete primjenjivati Biograstim
English: Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50 %, 35 %, 25 %, and 10 % of patients respectively, at recommended doses.
Croatian: Reverzibilni, o dozi ovisni, obično blagi do umjereni porast razina laktat-dehidrogenaze (LDH), alkalne fosfataze, mokraćne kiseline u serumu i gama-glutamiltransferaze (GGT) uočen je, redom, u oko 50 %, 35 %, 25 % i 10 % bolesnika pri primjeni filgrastima u preporučenim dozama.
English: Use of filgrastim, either alone or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
Croatian: Primjenom filgrastima, samog ili nakon kemoterapije, mobiliziraju se hematopoetske progenitorske stanice u perifernoj krvi.
English: Hepatomegaly
Croatian: Hepatomegalija
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 napomenuti da ne pokušavate davati injekcije sami sebi ako Vam liječnik ili medicinska sestra nisu objasnili postupak.
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: Znajući koliko su mijeloične stanice koje se brzo umnažaju osjetljive na mijelosupresijsku citotoksičnu kemoterapiju, primjena filgrastima ne preporučuje se 24 sata prije ni 24 sata nakon kemoterapije.
English: How do I give my injection?
Croatian: Kako primijeniti injekciju ?
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - alcohol wipes or similar.
Croatian: Da biste si dali injekciju trebati ćete sljedeće: - napunjenu štrcaljku lijeka Biograstim; - tupfer natopljen alkoholom ili slično.
English: Biograstim is useful in several different conditions, which are: - chemotherapy; - bone marrow transplantation; - severe chronic neutropenia (low white blood cell count); - neutropenia in patients with HIV infection; - peripheral blood stem cell mobilisation (for blood stem cell donation).
Croatian: Primjena lijeka Biograstim korisna je u nekoliko različitih situacija, kao što su: - kemoterapija; - presađivanje koštane srži; - teška kronična neutropenija (nizak broj bijelih krvnih stanica); - neutropenija u bolesnika s HIV-infekcijom; - mobilizacija matičnih stanica periferne krvi (za donacije krvnih matičnih stanica).
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Croatian: Mobilizaciju progenitorskih stanica periferne krvi treba razmatrati samo u davatelja koji zadovoljavaju uobičajene kliničke i laboratorijske kriterije prikladnosti za darovanje matičnih stanica.
English: - Cough, fever and difficult or painful breathing can be signs of serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Croatian: - Kašalj, vrućica i otežano ili bolno disanje mogu biti znakovi ozbiljnih plućnih nuspojava poput upale pluća i akutnog respiratornog distresnog sindroma koji mogu biti smrtonosni.
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 prior to treatment.
Croatian: U nekih bolesnika s teškom kroničnom neutropenijom filgrastim može inducirati i neznatan porast broja eozinofila i bazofila u cirkulaciji u odnosu na broj prije primjene lijeka; neki od tih bolesnika mogu prije početka primjene lijeka imati bazofiliju ili eozinofiliju.
English: As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear.
Croatian: Povećanje slezene je čest nalaz u bolesnika s HIV-infekcijom i u različitim je stupnjevima prisutno u većine bolesnika s AIDS-om, no moguća povezanost s primjenom filgrastima nije jasna.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Croatian: U tim slučajevima filgrastim treba obustaviti i uvesti primjereno liječenje.
English: Increases in volume, measured radiographically, occurred early during filgrastim therapy and tended to plateau.
Croatian: Radiografski izmjereno povećanje volumena javljalo se rano pri primjeni filgrastima i pokazivalo tendenciju k postizanju platoa.
English: The incidence of these events was similar to that reported in cancer patients.
Croatian: Njihova incidencija bila je slična onoj prijavljenoj u onkoloških bolesnika.
English: ● Periodic Safety Update Reports
Croatian: • Periodička izvješća o neškodljivosti
English: Chronic GvHD
Croatian: Kronični GvHD
English: Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Croatian: Budući da litij pospješuje otpuštanje neutrofila, mogao bi pojačati djelovanje filgrastima.
English: If you forget to use Biograstim
Croatian: Ako ste zaboravili primijeniti Biograstim
English: Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day.
Croatian: Nakon što se broj bijelih krvnih stanica normalizira, možda će dozu smanjiti, tako da lijek više nećete primati svaki dan.
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Croatian: Davatelje koji primaju G-CSF radi mobilizacije progenitorskih stanica periferne krvi treba nadzirati sve dok se hematološki pokazatelji ne normaliziraju.
English: If the patient is experiencing fatigue, caution is advised when driving a car or operating machines.
Croatian: Osjeti li bolesnik umor, treba biti oprezan pri upravljanju vozilom ili radu na strojevima.
English: Only clear solutions without particles should be used.
Croatian: Uporabiti se smije samo bistra otopina bez čestica.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Croatian: Razrijeđeni filgrastim se može adsorbirati na staklo i plastični materijal, osim ako se razrijedi kako je niže navedeno.
English: Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Croatian: Stoga će liječnik možda odlučiti da ne primjenjujete ovaj lijek ako dojite.
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive medicinal product.
Croatian: Primjenom filgrastima u bolesnika s HIV-infekcijom održava se normalan broj neutrofila, čime se omogućava predviđeno doziranje antivirotika i/ili mijelosupresijskih lijekova.
English: Your doctor will tell you why you are being treated with Biograstim.
Croatian: Liječnik će Vam objasniti zašto trebate uzimati Biograstim.
English: For example, if you weigh 60 kg your daily dose will be 60 million international units (MIU).
Croatian: Na primjer, ako ste teški 60 kg, dnevna će Vam doza biti 60 milijuna internacionalnih jedinica [MIU].
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Croatian: Funkcija filgrastimom induciranih neutrofila je normalna ili pojačana, što je dokazano testovima za procjenu kemotaksije i fagocitnih funkcija.
English: Biograstim contains sorbitol and sodium
Croatian: Biograstim sadrži sorbitol i natrij
English: Biograstim does not contain any preservative.
Croatian: Biograstim ne sadrži konzervanse.
English: The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Croatian: Djelotvornost i sigurnost primjene Biograstima ispitane su u randomiziranim, kontroliranim ispitivanjima III. faze u bolesnica/bolesnika s rakom dojke, rakom pluća i ne-Hodgkinovim limfomom.
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Croatian: Filgrastim djeluje prvenstveno na prekursore neutrofila, povećavajući tako broj neutrofila.
English: ≥ 1/10,000 to < 1/1,000
Croatian: ≥1/10 000 do <1/1000,
English: Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Croatian: Sindrom povećane propusnosti kapilara prijavljen je nakon primjene G-CSF-a, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
English: In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Croatian: U randomiziranim, placebom kontroliranim kliničkim ispitivanjima filgrastim nije povećao incidenciju nuspojava povezanih s citotoksičnom kemoterapijom.
English: Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
Croatian: Prijavljeni su slučajevi prolaznog sniženja krvnog tlaka, zbog kojeg nisu bile potrebne kliničke mjere.
English: In patients with HIV
Croatian: U bolesnika s HIV-om
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 tumorom, npr. limfomom.
English: The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Croatian: Preporučena doza filgrastima je 0,5 MIU (5 μg)/kg/dan.
English: Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Croatian: Dezinficirajte kožu na mjestu injiciranja tupferom natopljenim alkoholom te nakon toga uhvatite kožu između palca i kažiprsta, bez stiskanja (vidjeti sliku 5).
English: Not known (frequency cannot be estimated from the available data): - cough; fever and difficulty breathing or coughing up blood.
Croatian: Nepoznato (na temelju dostupnih podataka učestalost se ne može odrediti) - kašalj, vrućica i poteškoće s disanjem ili iskašljavanje krvi.
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Croatian: Sigurnost i djelotvornost primjene filgrastima slične su u odraslih i u djece koja primaju citotoksičnu kemoterapiju.
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: Pri neprekidnoj infuziji filgrastima tijekom razdoblja do 28 dana u bolesnika koji su se oporavljali nakon presađivanja autologne koštane srži nije bilo znakova nakupljanja lijeka, a poluvijek eliminacije bio je usporediv.
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: Jedna retrospektivna Europska studija koja ocjenjuje primjenu G-CSF nakon presađivanja alogenih stanica koštane srži kod bolesnika koji boluju od akutne leukemije ukazala je na povećan rizik bolesti davatelja protiv primatelja (GvHD), smrtnosti povezane s terapijom (TRM - treatment related mortality) i smrtnosti nakon davanja G-SCF-a.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Croatian: Za bolesnike koji su liječeni filgrastimom koji je razrijeđen na koncentracije niže od 1,5 MIU (15 μg) po ml, treba se dodati ljudski serumski albumin (HSA) dok se ne postigne koncentracija od 2 mg/ml.
English: Biograstim should not be diluted with sodium chloride solution.
Croatian: Biograstim se ne smije razrjeđivati s otopinom natrijeva klorida.
English: It could be a consequence of a spleen disorder (see section “4.
Croatian: To može biti posljedica poremećaja slezene (vidjeti poglavlje „4. Moguće nuspojave“).
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 mijeloidnih progenitorskih stanica nisu ispitani.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku na sobnoj temperaturi 30 minuta,
English: Not known (frequency cannot be estimated from the available data): - rejection of transplanted bone marrow; - transient low blood pressure; - pain and swelling of the joints, similar to gout.
Croatian: Nepoznato (na temelju dostupnih podataka učestalost se ne može odrediti) - odbacivanje presađene koštane srži; - prolazno niski krvni tlak; - bol i oticanje zglobova, nalik na giht.
English: Acute grade II-IV GvHD
Croatian: Gradus akutnog GvHD-a II-IV
English: - The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Croatian: Odlaganje upotrijebljenih štrcaljki - Zaštita za iglu sprečava ozljede iglom nakon uporabe, stoga nema nekih posebnih mjera opreza prilikom zbrinjavanja.
English: EXP After dilution use within 24 hours.
Croatian: Nakon razrjeđivanja primijeniti unutar 24 sata.
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 prekursora odgovor u smislu povećanja broja neutrofila može biti slabiji (npr. u onih liječenih ekstenzivnom radioterapijom ili kemoterapijom, te onih s tumorom infiltriranim u koštanu srž).
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Croatian: Filgrastim (rekombinantni metionil ljudski čimbenik rasta granulocitnih kolonija) proizveden je tehnologijom rekombinantne DNK u bakteriji Escherichia coli K802.
English: Thirty-one percent (31 %) of patients in studies were documented as having palpable splenomegaly.
Croatian: U 31 % bolesnika u ispitivanjima je dokumentirana palpabilna splenomegalija.
English: For example, if you weigh 60 kg your daily dose will be 30 million international units (MIU).
Croatian: Na primjer, ako ste teški 60 kg, Vaša je dnevna doza 30 milijuna međunarodnih jedinica [MIU].
English: Pseudogout has been reported in patients with cancer treated with filgrastim.
Croatian: Prijavljeni su slučajevi pseudogihta kod bolesnika s karcinomom liječenih filgrastimom.
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: Poluvijek eliminacije filgrastima je 3,5 sati, a klirens oko 0,6 ml/min/kg.
English: Fatigue, generalised weakness
Croatian: Umor, opća slabost
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens (see below).
Croatian: Filgrastim se ne smije davati radi povećavanja doza citotoksične kemoterapije iznad preporučenih doza u terapijskim shemama (vidjeti niže).
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 Summary of Product Characteristics of the specific chemotherapy agents used).
Croatian: Nužan je poseban oprez pri liječenju bolesnika velikim dozama kemoterapeutika jer nije dokazano da se time postiže povoljniji ishod, a povećavanjem doza može se pojačati toksičnost, uključujući učinke na srce, pluća, živčani sustav i kožu (molimo vidjeti Sažetak opisa svojstava lijeka za određeni kemoterapeutik koji se daje).
English: Analysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) Analysis includes patients receiving bone marrow transplant during this period
Croatian: aAnaliza uključuje studije koje se odnose na presađivanje koštane srži u tome periodu; neke studije koristile su GM-CSF (čimbenik rasta granulocitnih-makrofagnih kolonija) bAnaliza uključuje bolesnika koji su u tome periodu podvrgnuti presađivanju koštane srži
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 primjene filgrastima primijenjenog istoga dana kada i mijelosupresijska citotoksična kemoterapija nisu definitivno potvrđene.
English: There have been very few instances of proteinuria/haematuria.
Croatian: Bilo je malobrojnih prijava proteinurije/hematurije.
English: - if you get left upper abdominal pain or pain at the tip of your shoulder.
Croatian: - ako se javi bol u gornjem dijelu trbuha s lijeve strane ili bol u vrhu Vašeg ramena.
English: If leukocyte counts exceed 50 x 10 should be discontinued immediately.
Croatian: Bude li broj leukocita nakon očekivanog smanjenja veći od 50 x 109/l, filgrastim treba odmah obustaviti.
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain.
Croatian: Mogućnost rupture slezene treba uzeti u obzir u davatelja i/ili bolesnika koji se potuže na bol u gornjem lijevom abdominalnom kvadrantu ili vrhu lijevog ramena.
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 primjene filgrastima u bolesnika s mijelodisplastičnim sindromom i s kroničnom mijeloičnom leukemijom nije utvrđena.
English: What Biograstim is used for
Croatian: Za što se Biograstim koristi
English: Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Croatian: Filgrastim se ne smije davati bolesnicima s teškom kongenitalnom neutropenijom (Kostmanov sindrom) u kojih citogenetski nalaz nije uredan (vidjeti niže).
English: Common:
Croatian: Česte:
English: The clinical relevance of this finding to multiple dose administration is not clear.
Croatian: Kliničko značenje tog nalaza u uvjetima višekratnog doziranja nije jasno.
English: Transient, moderate decreases in non-fasting blood glucose have also been seen.
Croatian: Zabilježeno je i prolazno, umjereno sniženje glukoze u krvi u uvjetima bez gladovanja.
English: Undesirable effects possibly related to filgrastim therapy and typically occurring in < 2 % of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis and rash.
Croatian: Nuspojave koje su možda bile povezane s primjenom filgrastima, obično zabilježene u < 2 % bolesnika s teškom kroničnom neutropenijom, su reakcije na mjestu injekcije, glavobolja, hepatomegalija, artralgija, alopecija, osteoporoza i osip.
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Croatian: Infuzijom progenitorskih stanica periferne krvi ubrzava se hematopoetski oporavak, skraćuje se trajanje rizika od hemoragijskih komplikacija i smanjuje potreba za transfuzijama trombocita.
English: However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Croatian: No da bi se terapijski odgovor održao, primjena filgrastima ne smije se prekinuti prije nego što prođe razdoblje očekivanih najnižih vrijednosti broja neutrofila i dok se broj neutrofila ne normalizira.
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Croatian: Preporuke o doziranju pedijatrijskim bolesnicima jednake su onima za odrasle osobe na mijelosupresijskoj citotoksičnoj kemoterapiji.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Croatian: Ako imate bilo kakvih problema, molimo Vas obratite se liječniku ili medicinskoj sestri za pomoć i savjet.
English: Biograstim and severe chronic neutropenia
Croatian: Biograstim i teška kronična neutropenija
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 pri kroničnoj mijeloičnoj leukemiji od akutne mijeloične leukemije.
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: Primjenom filgrastima u bolesnika koji primaju citotoksičnu kemoterapiju značajno se smanjuju incidencija i težina i skraćuje trajanje neutropenije i febrilne neutropenije.