FrancophonIA/ELRC3.0 huggingface dataset:
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 iz seruma iznosi približno 3,5 sati, uz brzinu klirensa od približno 0,6 ml/min/kg.
English: Do not remove the needle cover until you are ready to inject.
Croatian: Nemojte uklanjati plastični poklopac s igle prije nego što budete spremni ubrizgati otopinu.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Croatian: Međutim, s obzirom na moguće rizike povezane s teškom leukocitozom, broj bijelih krvnih stanica potrebno je provjeravati u redovitim vremenskim intervalima tijekom primjene filgrastima.
English: If leukocyte counts exceed 50 x 10
Croatian: Ako broj leukocita prijeđe vrijednost od 50 x 10
English: Other special precautions
Croatian: Druge posebne mjere opreza
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Croatian: • odignute, bolne promjene tamnoljubičaste boje na udovima i ponekad licu i vratu, s vrućicom
English: For maintenance of normal neutrophil counts
Croatian: Za održavanje normalnog broja neutrofila
English: Only use each syringe for one injection.
Croatian: Pojedina štrcaljka smije se uporabiti samo za jednu injekciju.
English: cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Croatian: stanica vraćenih infuzijom i brzine oporavka trombocita nakon visokih doza kemoterapije pokazuje složen, ali kontinuirani odnos.
English: This observation has only been made in patients with congenital neutropenia.
Croatian: To je opaženo samo u bolesnika s kongenitalnom neutropenijom.
English: Grastofil containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Croatian: Grastofil sadrži r-metHuG-CSF (filgrastim) i uzrokuje znatno povećanje broja neutrofila u perifernoj krvi u roku od 24 sata, uz manja povećanja broja monocita.
English: Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα Telephone +30/2106776550
Croatian: Ψυχικό, 15451, Αθήνα Τηλ:+30/2106776550
English: Talk to your doctor, pharmacist or nurse before using Grastofil:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Grastofil.
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Croatian: Filgrastim se ne smije primjenjivati za povećanje doze citotoksične kemoterapije iznad ustanovljenih režima doziranja.
English: Your doctor will tell you how much Grastofil you should take.
Croatian: Liječnik će Vam reći koju količinu lijeka Grastofil trebate primijeniti.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Croatian: Neutrofili stvoreni u odgovoru na filgrastim pokazuju normalnu ili pojačanu funkciju, kako se pokazalo pri ispitivanju kemotaktične i fagocitne funkcije.
English: Hold the syringe with the needle pointing up.
Croatian: Držite štrcaljku s iglom prema gore.
English: Grastofil treatment will last for up to 2 weeks.
Croatian: Liječenje Grastofilom će trajati do 2 tjedna.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Croatian: Bolesnici koji su nedavno imali plućne infiltrate ili pneumoniju mogu biti pod povećanim rizikom.
English: When diluted in 5% glucose, Grastofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Croatian: Kad se razrijedi u 5%-tnoj otopini glukoze, Grastofil je kompatibilan sa staklom i raznim vrstama plastike uključujući PVC, poliolefin (kopolimer polipropilena i polietilena) i polipropilen.
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Croatian: Također se može primijeniti svakodnevno sporom injekcijom u venu (to se još naziva i intravenska infuzija).
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies.
Croatian: Moguće interakcije s drugim čimbenicima rasta krvotvornih stanica i citokinima još nisu ispitane u kliničkim ispitivanjima.
English: Analysis includes studies involving BM transplant during this period; some studies used GM-CSF
Croatian: Analiza uključuje ispitivanja koja su uključivala transplantat koštane srži tijekom tog razdoblja; u nekim se ispitivanjima primjenjivao GM-CSF
English: When peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Croatian: Kad se razmatra transplantacija progenitorskih stanica periferne krvi, savjetuje se planirati postupak mobilizacije matičnih stanica rano tijekom liječenja bolesnika.
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Croatian: 9/l) je bila opažena u 41% zdravih darivatelja, a prolazna trombocitopenija (trombociti < 100 x 10
English: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Croatian: Dokazana je kemijska i fizikalna stabilnost razrijeđene otopine za infuziju u primjeni u trajanju od 24 sata na temperaturi od 2 °C do 8 °C.
English: The effects of Grastofil overdose have not been established.
Croatian: Učinci predoziranja Grastofilom nisu ustanovljeni.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Croatian: Po odgovoru na liječenje, potrebno je odrediti najmanju učinkovitu dozu za održavanje te razine.
English: Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.
Croatian: Filgrastim potiče koštanu srž (tkivo u kojem nastaju nove krvne stanice) da stvara više bijelih krvnih stanica koje pomažu u borbi protiv infekcija.
English: In view of the possible risk of microbial contamination, Grastofil pre-filled syringes are for single use only.
Croatian: S obzirom na opasnost kontaminacije mikrobima, Grastofil u napunjenim štrcaljkama predviđen je isključivo za jednokratnu uporabu.
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 postaju slabije, krhkije i lakše nastaju prijelomi (osteoporoza)
English: • in patients with advanced HIV infection which will help reduce the risk of infections;
Croatian: • u bolesnika s uznapredovalom HIV (virus humane imunodeficijencije) infekcijom radi smanjenja rizika od infekcija,
English: EG LABO-Laboratoires Eurogenerics SAS Telephone +33/1-46.94.86.86
Croatian: EG LABO-Laboratoires Eurogenerics SAS Tél:+33/1-46.94.86.86
English: In some cases, your body may make enough neutrophils, but as a part of your treatment for cancer, your doctor may want to increase the number of certain blood cells (CD34 cells) and collect them.
Croatian: U nekim slučajevima, tijelo može stvarati dovoljno neutrofila, ali liječnik možda želi povećati broj određenih krvnih stanica (CD34 stanice) kako bi ih prikupio u sklopu Vašeg liječenja od raka.
English: Tell your doctor immediately during treatment if:
Croatian: Odmah obavijestite liječnika tijekom liječenja ako:
English: Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Croatian: Grastofil je indiciran za mobilizaciju progenitorskih stanica periferne krvi (PBPC, engl. peripheral blood progenitor cells).
English: These collected cells are given back to you after you receive very high doses of treatment for cancer to make your blood counts get back to normal more quickly.
Croatian: Vam se nakon što primite vrlo visoke doze terapije protiv raka kako bi Vam se broj krvnih stanica brže vratio na normalu.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Croatian: Nastaju i druge promjene krvnih stanica, uključujući anemiju i prolazna povećanja broja mijeloičnih progenitorskih stanica, što zahtijeva pažljivo mjerenje broja krvnih stanica.
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 10
Croatian: Leukaferezu je potrebno provoditi tijekom razdoblja kad se ABN poveća s < 0,5 x 10
English: Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.
Croatian: Grastofil štrcaljka koja je bila izvan hladnjaka dulje od 15 dana ne smije se upotrijebiti nego je treba zbrinuti sukladno nacionalnim propisima.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: For reversal of neutropenia
Croatian: Za obrat neutropenije
English: Your doctor will tell you why you are being treated with Grastofil.
Croatian: Vaš liječnik će Vam objasniti zašto se liječite s Grastofilom.
English: Subsequently, the dose may be individually adjusted every 1-2 weeks to maintain the average neutrophil count between 1.5 x 10
Croatian: Nakon toga, dozu je kod svakog pojedinog bolesnika moguće prilagođavati svaka 1-2 tjedna kako bi se prosječan broj neutrofila održao na vrijednostima između 1,5 x 10
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: Čimbenik poticanja rasta granulocitnih kolonija može potaknuti rast mijeloičnih stanica in vitro i slični se učinci mogu opaziti na nekim nemijeloičnim stanicama in vitro.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Croatian: U bolesnika koji nisu primili mnogo ciklusa kemoterapije obično je dovoljna jedna leukafereza.
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 potrebno je provesti u suradnji s onkološkohematološkim centrom s prihvatljivim iskustvom u tom području u kojem se praćenje progenitorskih krvotvornih stanica može provoditi na ispravan način.
English: For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms).
Croatian: Na primjer, ako težite 60 kilograma Vaša dnevna doza će biti 60 milijuna jedinica (600 mikrograma).
English: You will need to take Grastofil until your white blood cell count is normal.
Croatian: Grastofil ćete morati primati sve dok Vam se broj bijelih krvnih stanica ne normalizira.
English: Grastofil is used to treat children and adolescents who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Croatian: Grastofil se primjenjuje za liječenje djece i adolescenata koji primaju kemoterapiju ili imaju izrazito nizak broj bijelih krvnih stanica (neutropeniju).
English: Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in Escherichia coli (BL21) by recombinant DNA technology.
Croatian: Filgrastim je rekombinantni metionilni ljudski čimbenik poticanja rasta granulocitnih kolonija proizveden u bakteriji Escherichia coli (BL21) tehnologijom rekombinantne DNK.
English: Congenital, idiopathic or cyclic neutropenia: Grastofil should be given by subcutaneous injection.
Croatian: Kongenitalna, idiopatska ili ciklička neutropenija: Grastofil se treba primijeniti putem supkutane injekcije.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Croatian: • povišene razine mokraćne kiseline u krvi, što može prouzročiti giht (hiperuricemiju) (povišenje mokraćne kiseline u krvi)
English: These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Croatian: To mogu biti simptomi stanja koje se naziva „sepsa“ (takozvano „trovanje krvi“), teške infekcije s upalnim odgovorom cijelog tijela koja može biti smrtonosna i potrebna je hitna medicinska pomoć.
English: Special warnings and precautions across indications
Croatian: Posebna upozorenja i mjere opreza u svim indikacijama
English: Filgrastim had no observed effect on the fertility of male or female rats.
Croatian: Filgrastim nije imao zabilježenog učinka na plodnost mužjaka i ženki štakora.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Croatian: Preporučuje se provoditi morfološka i citogenetska ispitivanja koštane srži u bolesnika u redovitim vremenskim razmacima (približno svakih 12 mjeseci).
English: 9/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Croatian: 9/l) nakon primjene filgrastima i leukafereze bila je opažena u 35% ispitanika.
English: Causes of transient neutropenia such as viral infections should be excluded.
Croatian: Potrebno je isključiti uzroke prolazne neutropenije, kao što su virusne infekcije.
English: Among these, two cases of platelets < 50 x 10
Croatian: Među njima su bila zabilježena dva slučaja s brojem trombocita < 50 x 10
English: (Sweets syndrome)
Croatian: (Sweetsov sindrom)
English: Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Croatian: Grastofil je indiciran za liječenje perzistentne neutropenije (ABN manji ili jednak 1,0 x 10
English: Do not use any Grastofil that may be left in the syringe.
Croatian: Nemojte primjenjivati Grastofil koji je preostao u štrcaljki.
English: In some SCN patients, filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia already prior to treatment.
Croatian: U nekih bolesnika s teškom kroničnom neutropenijom, filgrastim može također izazvati manje povećanje broja cirkulirajućih eozinofila i bazofila u odnosu na početne vrijednosti; neki od tih bolesnika mogu imati eozinofiliju ili bazofiliju još prije početka liječenja.
English: Your doctor has prescribed Grastofil, which is used to treat neutropenia (nu-tro-peen-ee-ah), a condition where the body makes too few neutrophils.
Croatian: Liječnik Vam je propisao Grastofil, koji se primjenjuje za liječenje neutropenije, stanja u kojem tijelo stvara premalo neutrofila.
English: 9/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Croatian: 9/l i teškim ili recidivirajućim infekcijama u anamnezi, dugotrajna primjena Grastofila indicirana je za povećanje broja neutrofila i smanjenje incidencije i trajanja događaja povezanih s infekcijom.
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Croatian: Ako primijetite gubitak odgovora ili nemogućnost održavanja odgovora na liječenje filgrastimom, Vaš će liječnik istražiti razloge zašto se to događa, uključujući i mogućnost nastanka protutijela koja neutraliziraju djelovanje filgrastima.
English: If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Croatian: Ako primijetite kapljicu krvi, možete je nježno obrisati komadićem vate ili maramicom.
English: To avoid bending the needle, gently pull the cover from the needle without twisting.
Croatian: Da se igla ne bi savila, pažljivo uklonite plastični poklopac s igle bez zavrtanja.
English: Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/or other myelosuppressive treatments.
Croatian: Primjena filgrastima u bolesnika s HIV-infekcijom održava normalan broj neutrofila što omogućuje planirano doziranje antivirusnih i/ili mijelosupresivnih liječenja.
English: Grastofil contains sorbitol
Croatian: Grastofil sadrži sorbitol
English: The no observed adverse effect level for embryo-fetal toxicity in this study was 10 μg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Croatian: Razina bez opaženog štetnog učinka za embriofetalnu toksičnost u ovom je ispitivanju bila 10 μg/kg/dan, a što odgovara sistemskoj izloženosti približno 3-5 puta većoj od izloženosti koja se bilježi u bolesnika liječenih kliničkom dozom.
English: Grastofil may have a minor influence on your ability to drive and use machines.
Croatian: Grastofil može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Croatian: Osobit oprez potrebno je posvetiti broju mobiliziranih progenitorskih stanica u takvih bolesnika prije primjene visoke doze kemoterapije.
English: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Croatian: Nakon što se postigne obrat neutropenije, potrebno je odrediti najmanju učinkovitu dozu za održavanje normalnog broja neutrofila.
English: Relative risk (95% CI) of GvHD and TRM following treatment with G-CSF after bone marrow (BM) transplantation
Croatian: Relativni rizik (95% CI) za GvHD i mortalitet povezan s liječenjem nakon liječenja G-CSFom nakon transplantacije koštane srži Publikacija
English: Grastofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
Croatian: Grastofil se smije primijenjivati samo u suradnji s onkološkim centrom koji ima iskustva u liječenju čimbenikom poticanja rasta granulocitnih kolonija (G-CSF) i hematologiji te ima neophodne dijagnostičke mogućnosti.
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1-2 days after initiation of Grastofil therapy.
Croatian: U bolesnika koji primaju citotoksičnu kemoterapiju, prolazno povećanje broja neutrofila obično uslijedi 1-2 dana nakon početka terapije Grastofilom.
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Croatian: Odmah se obratite liječniku ako Vam lice ili gležnjevi oteknu, imate krv u mokraći ili smeđe obojenu mokraću ili primijetite da mokrite manje nego obično.
English: The stem cells will then go back into the bone marrow and produce blood cells.
Croatian: Matične stanice se potom vraćaju u koštanu srž i stvaraju krvne stanice.
English: At the end of this period, Grastofil should not be put back in the refrigerator and should be disposed of in accordance with local requirements.
Croatian: Na kraju tog razdoblja, Grastofil se ne smije vratiti u hladnjak nego ga valja zbrinuti sukladno lokalnim propisima.
English: Pack sizes: Cartons containing 1 or 5 pre-filled syringes.
Croatian: Veličina pakiranja: kutije koje sadrže 1 ili 5 napunjenih štrcaljki.
English: Solution for injection/infusion 1 pre-filled syringe (0.5 mL) 5 pre-filled syringes (0.5 mL)
Croatian: Otopina za injekciju/infuziju 1 napunjena štrcaljka (0,5 ml) 5 napunjenih štrcaljki (0,5 ml)
English: Some cases of splenic rupture were fatal.
Croatian: U nekim je slučajevima ruptura slezene imala smrtni ishod.
English: Grastofil should be given by subcutaneous injection.
Croatian: Grastofil se treba primijeniti putem supkutane injekcije.
English: • you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: • razvijete kašalj, vrućicu i otežano disanje (dispneja) jer to mogu biti znakovi akutnog respiratornog distres sindroma (ARDS).
English: In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/kg/day (24 micrograms/kg/day).
Croatian: U kliničkim je ispitivanjima 97% bolesnika koji su odgovorili na liječenje imalo potpuni odgovor pri dozama ≤ 2,4 MU/kg/dan (24 mikrograma/kg/dan).
English: A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal or shoulder tip pain.
Croatian: Dijagnozu rupture slezene potrebno je razmotriti u darivatelja i/ili bolesnika koji navode bol u gornjem lijevom dijelu abdomena ili vrhu ramena.
English: Sixty-five percent of patients studied in a SCN trial program, were under 18 years of age.
Croatian: Šezdeset pet posto bolesnika u kliničkom programu ispitivanja primjene kod teške kronične neutropenije bilo je mlađe od 18 godina.
English: Your doctor will tell you how long you will need to take Grastofil.
Croatian: Liječnik će Vam reći koliko dugo morate primjenjivati Grastofil.
English: Do not use Grastofil if you notice it is cloudy, or there is discoloration or there are particles in it.
Croatian: Nemojte koristiti Grastofil ako primijetite da je otopina zamućena, da je promijenila boju ili sadrži čestice.
English: An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Croatian: Povećana incidencija gubitaka embrija opažena je u kunića pri izloženosti višestruko većoj od kliničke izloženosti i u prisutnosti toksičnosti za majku (vidjeti dio 5.3).
English: Grastofil contains 50 mg sorbitol in each ml.
Croatian: Grastofil sadrži 50 mg sorbitola u jednom ml.
English: The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Croatian: Sigurnost i djelotvornost u novorođenčadi i bolesnika s autoimunom neutropenijom nisu ustanovljene.
English: Discontinue Grastofil
Croatian: Prekinuti Grastofil
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious diseases.
Croatian: Mobilizaciju progenitorskih stanica periferne krvi potrebno je razmatrati samo u darivatelja koji zadovoljavaju normalne kliničke i laboratorijske kriterije prema kojima su pogodni za darivanje matičnih stanica uz posebnu pozornost na hematološke vrijednosti i zarazne bolesti.
English: For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Croatian: Za pacijente koji se liječe filgrastimom razrijeđenim do koncentracije manje od 1,5 MU (15 µg) po ml, potrebno je dodati ljudski serumski albumin (HSA) do konačne koncentracije od 2 mg/ml.