FrancophonIA/ELRC3.0 huggingface dataset:
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 čiji radnici imaju prihvatljivo iskustvo na tom području i u kojem se na ispravan način mogu pratiti hematopoetske progenitorske stanice.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Croatian: Statistička analiza odnosa broja CD34+ stanica primijenjenih reinfuzijom i brzine oporavka broja trombocita nakon visokodozne kemoterapije pokazuje da je taj odnos složen, ali kontinuiran.
English: There were no relevant differences between Ratiograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Croatian: Nije bilo relevantnih razlika između Ratiograstima i referentnog pripravka u trajanju teške neutropenije ni u incidenciji febrilne neutropenije.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Croatian: Leukaferezu treba početi 5. dan i nastaviti do 6. dana, bude li potrebno, da se prikupi 4 x 106 CD34+ stanica/kg tjelesne težine primatelja.
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: 5. Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku na sobnoj temperaturi 30 minuta, odnosno dok ne poprimi sobnu temperaturu ili je držite u rukama nekoliko minuta.
English: Causes of transient neutropenia such as viral infections should be excluded.
Croatian: Valja isključiti uzroke prolazne neutropenije, poput virusnih infekcija.
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: Uočena je povećena incidencija gubitka embrija u kunića pri izloženosti višestruko većoj od kliničke izloženosti te u prisutnosti toksičnosti u majke (vidjeti dio 5.3).
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Croatian: U skotnih štakorica nije uočena toksičnost za majku ili fetalna toksičnost u dozama do 575 µg/kg/dan.
English: Check again to make sure the correct dose of Ratiograstim is in the syringe.
Croatian: 4. Provjerite još jedanput da budete sigurni u točnu dozu lijeka Ratiograstim u štrcaljki.
English: Subcutaneous use and intravenous use.
Croatian: Za supkutanu i intravensku primjenu.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/L and 10 x 109/L.
Croatian: Potom se doza može individualno prilagođavati svakih 1 do 2 tjedna, kako bi se broj neutrofila održavao na vrijednostima između 1,5 x 109/l i 10 x 109/l.
English: A common side effect of Ratiograstim use is pain in your muscles or bones (musculoskeletal pain), which could be relieved by taking standard pain relief medicines (analgesics).
Croatian: Česta nuspojava primjene Ratiograstima je bol u mišićima ili kostima (mišićno-koštana bol), koja se može olakšati uzimanjem standardnih lijekova za ublažavanje boli (analgetika).
English: - if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Croatian: - ako se liječite zbog teške kronične neutropenije i imate krv u mokraći (hematuriju).
English: The choice of route should depend on the individual clinical circumstance.
Croatian: Odabir puta primjene lijeka mora ovisiti o kliničkim okolnostima pojedinog bolesnika.
English: Ratiograstim is a solution for injection/infusion in a pre-filled syringe with or without safety device.
Croatian: Ratiograstim je otopina za injekciju/infuziju u napunjenoj štrcaljki sa ili bez zaštite za iglu.
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost faktora stimulacije rasta granulocita (G-CSF-ova), zaštićeni naziv primijenjenog lijeka potrebno je jasno evidentirati u zdravstvenom kartonu bolesnika.
English: Ratiograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Croatian: Ratiograstim je indiciran za liječenje perzistentne neutropenije (ABN 1,0 x 109/l ili manji) u bolesnika s uznapredovalom HIV-infekcijom, sa svrhom da se smanji rizik od bakterijskih infekcija, kada druge mogućnosti liječenja neutropenije nisu prikladne.
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
Croatian: Gurajte klip sve do broja na štrcaljki koji odgovara dozi lijeka Ratiograstim (u mililitrima, ml) koju Vam je propisao liječnik.
English: In other circumstances, additional leukapheresis may be necessary.
Croatian: U drugim okolnostima možda će trebati veći broj leukafereza.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Croatian: Faktor stimulacije rasta granulocita može poticati rast mijeloičnih stanica in vitro, a također su mogući slični učinci na neke nemijeloične stanice in vitro.
English: Filgrastim 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: Terapija filgrastimom se smije davati samo u suradnji s onkološkim centrom s iskustvom u liječenju faktorom stimulacije rasta granulocita (engl. granulocyte-colony stimulating factor, G-CSF) i hematologijom a koji raspolažu potrebnim dijagnostičkim mogućnostima.
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 MIU/kg/day (3 μg/kg/day).
Croatian: Broj bijelih krvnih stanica od 100 x 109/l ili veći uočen je u manje od 5 % bolesnika oboljelih od raka koji su primali filgrastim u dozama većima od 0,3 MIU/kg/dan (3 μg/kg/dan).
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Croatian: Tijekom kliničkih ispitivanja u bolesnika oboljelih od raka mišićno-koštana bol bila je blaga ili umjerena u 10 % bolesnika i teška u 3 % bolesnika.
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts
Croatian: Javljaju se i druge promjene u krvi, uključujući anemiju i prolazna povećanja broja mijeloičnih matičnih stanica, zbog čega treba pozorno nadzirati broj stanica.
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 poznatog kao „sepsa“ (ili „otrovanje krvi“), teške infekcije s upalnim odgovorom cijelog tijela koja može biti opasna po život i zahtijeva hitno medicinsko liječenje.
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Croatian: Kada se razrjeđuje u 5%-tnoj otopini glukoze (50 mg/ml), Ratiograstim je kompatibilan sa staklom i različitim vrstama plastike, uključujući PVC, poliolefin (kopolimer polipropilena i polietilena) i polipropilen.
English: • unusual hair loss or thinning (alopecia)
Croatian: • neuobičajeni gubitak ili prorjeđivanje kose (alopecija)
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Croatian: Davatelje koji primaju faktor G-CSF radi mobilizacije progenitorskih stanica periferne krvi treba nadzirati sve dok se hematološki pokazatelji ne vrate na normalne vrijednosti.
English: Ratiograstim is a clear and colourless solution.
Croatian: Ratiograstim je bistra i bezbojna otopina.
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Croatian: Filgrastim (rekombinantni metionil ljudski faktor stimulacije rasta granulocita) proizveden je tehnologijom rekombinantne DNK u bakteriji Escherichia coli K802.
English: How do I prepare my Ratiograstim injection?
Croatian: Kako pripremiti Ratiograstim injekciju?
English: Among these, two cases of platelets < 50 x 109/L were reported and attributed to the leukapheresis procedure.
Croatian: Među njima su i dva slučaja s tromobocitima < 50 x 109/l, što je pripisano postupku leukafereze.
English: If you use more Ratiograstim than you should
Croatian: Ako primijenite više lijeka Ratiograstim nego što ste trebali
English: You will normally receive your first dose of Ratiogratsim 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 Ratiograstima barem 24 sata nakon kemoterapije i barem 24 sata nakon primitka transplantata koštane srži.
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: 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: In clinical studies, > 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Croatian: U kliničkim je ispitivanjima > 90 % ispitanika odgovorilo na te doze, a medijan vremena potrebnog za korekciju neutropenije iznosio je 2 dana.
English: Ratiograstim is a biosimilar medicinal product.
Croatian: Ratiograstim je biosličan lijek.
English: Effects of filgrastim on pre-natal development have been studied in rats and rabbits.
Croatian: Proučavani su učinci filgrastima na prenatalni razvoj u štakora i kunića.
English: Ratiograstim may have a minor influence on your ability to drive and use machines.
Croatian: Ratiograstim može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: In patients with HIV infection
Croatian: Bolesnici s HIV-infekcijom
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Ratiograstim - ako ste alergični na filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Croatian: Ako prinos nije zadovoljavajući prema gore navedenim mjerilima, valja razmotriti zamjenske oblike liječenja za koje nije nužna potpora matičnim stanicama.
English: In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima davala se supkutana doza od 23 MIU (230 μg)/m2/dan (4,0 do 8,4 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 više doze kemoterapije (npr. pune doze prema propisanoj shemi), bolesnik može biti izložen većem riziku od trombocitopenije i anemije.
English: However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Croatian: Međutim, tijekom primjene filgrastima radi mobilizacije progenitorskih stanica periferne krvi, filgrastim treba obustaviti ili njegovu dozu smanjiti ako broj leukocita dosegne vrijednost > 70 x 109/l.
English: e. Other special populations
Croatian: Druge posebne populacije
English: • enlargement of the liver (hepatomegaly)
Croatian: • povećanje jetre (hepatomegalija)
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 doza citotoksične kemoterapije povisila iznad doza utvrđenih režima doziranja.
English: Ratiograstim is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Croatian: Ratiograstim se koristi u liječenju djece koja primaju kemoterapiju ili koja boluju od teškog oblika smanjenog broja bijelih krvnih stanica (neutropenije).
English: The efficacy and safety of Ratiograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Croatian: Djelotvornost i sigurnost primjene Ratiograstima ispitane su u randomiziranim, kontroliranim ispitivanjima III. faze u bolesnica/bolesnika s rakom dojke, rakom pluća i ne-Hodgkinovim limfomom.
English: What should I do before I give myself a subcutaneous injection of Ratiograstim?
Croatian: Što trebate napraviti prije nego si date potkožnu injekciju lijeka Ratiograstim?
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: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Ratiograstim 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 Ratiograstima i pri supkutanoj i pri intravenskoj primjeni bio usporediv s farmakokinetičkim profilom referentnog lijeka.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ratiograstim
Croatian: Osim ako Vaš liječnik ne savjetuje drugačije, morate prestati dojiti ako uzimate Ratiograstim.
English: Filgrastim may have a minor influence on the ability to drive and use machines.
Croatian: Filgrastim može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Croatian: Filgrastim je proučavan u ispitivanjima toksičnosti ponovljenih doza koja su trajala 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: 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: It is advisable to wait and see how you feel after using this medicine and before driving or operating machinery.
Croatian: Preporučuje se da prije upravljanja vozilima i rada sa strojevima pričekate kako biste vidjeli kako se osjećate nakon uzimanja ovog lijeka.
English: Based on reported data for another filgrastim product similar to the reference 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 izvornom lijeku, uočeni su slični rezultati uz povećanu malformaciju fetusa pri dozi od 100 µg/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 µg/kg/dan.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Croatian: Stupanj različitosti između pojedinih bolesnika i laboratorijskih metoda određivanja CD34+ stanica pokazuje da je izravna usporedba između metoda teška.
English: During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
Croatian: Pri intermitentnoj primjeni 30 MIU (300 μg) filgrastima/dan tijekom prolaska vremena mogu postojati velike fluktuacije ABN-a.
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: Primjenom filgrastima u bolesnika s HIV-infekcijom održava se normalan broj neutrofila, čime se omogućava predviđeno doziranje antivirotika i/ili mijelosupresijskih lijekova.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, filgrastim should be discontinued immediately.
Croatian: Ako je broj leukocita nakon očekivanih najnižih vrijednosti veći od 50 x 109/l, filgrastim treba odmah obustaviti.
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 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Croatian: U bolesnika koji su prethodno bili podvrgnuti opsežnoj mijelosupresivnoj terapiji mobilizacija progenitorskih stanica periferne krvi možda neće biti dovoljna za postizanje minimalnog prinosa (≥ 2,0 x 106 CD34+ stanica/kg) ili da se u jednakom stupnju ubrza oporavak broja trombocita.
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: Pokazalo se da se povećanje slezene usporava ili zaustavlja smanjenjem doze filgrastima u bolesnika s teškom kroničnom neutropenijom, a u 3 % bolesnika bila je potrebna splenektomija.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne smiju primiti ovaj lijek osim ako je to zaista neophodno.
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 javite svom liječniku ako opazite podbuhlost lica ili otečenost gležnjeva, krv u mokraći ili smeđe obojenu mokraću ili ako primijetite da mokrite manje nego inače.
English: If you forget to use Ratiograstim
Croatian: Ako ste zaboravili primijeniti Ratiograstim
English: Congenital neutropenia
Croatian: Doziranje Kongenitalna neutropenija
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
Croatian: • uzdignute, bolne, tamnoplave promjene na koži na udovima te ponekad na licu i vratu, praćene vrućicom (Sweetov sindrom)
English: You may experience the following side effects:
Croatian: Mogu se javiti sljedeće nuspojave:
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: Kad se planira presađivanje progenitorskih stanica periferne krvi, preporučuje se planirati postupak mobilizacije matičnih stanica rano u tijeku liječenja bolesnika.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Ratiograstim; - alcohol wipes or similar; - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Croatian: - napunjenu štrcaljku lijeka Ratiograstim; - tupfer natopljen alkoholom ili slično; - neprobojni spremnik (plastični spremnik koji ste dobili iz bolnice ili ljekarne) tako da možete sigurno odložiti upotrijebljene štrcaljke.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and foetal weight were observed.
Croatian: Intravenska (80 µg/kg/dan) primjena filgrastima u kunića tijekom razdoblja organogeneze bila je toksična za majku, a zabilježen je i povećan broj spontanih pobačaja, gubitaka nakon implantacije te smanjenje prosječne veličine legla i težine fetusa.
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 kombinaciju bilo kojih od sljedećih simptoma: vrućicu ili drhtanje, odnosno osjećaj velike hladnoće, ubrzane otkucaje srca, smetenost ili dezorijentiranost, nedostatak zraka, jaku bol ili neugodu te ljepljivu ili znojnu kožu.
English: Metabolis m and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Croatian: • promjene u načinu na koji tijelo regulira tekućine unutar tijela, što može dovesti do otečenosti
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 progenitorskih stanica periferne krvi i primatelja mogu biti povezane s većim rizikom od akutne i kronične bolesti GvHD-a u usporedbi s presađivanjem koštane srži.
English: Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
Croatian: Pronađite udobno, dobro osvijetljeno mjesto i stavite sve što trebate tako da Vam je pri ruci (napunjenu štrcaljku lijeka Ratiograstim, tupfer natopljen alkoholom i neprobojni spremnik).
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution for infusion given over 30 minutes (see section 6.6).
Croatian: Filgrastim se može davati kao dnevna supkutana injekcija ili dnevna intravenska infuzija razrijeđena u 5%-tnoj otopini glukoze za infuziju koja se daje tijekom 30 minuta (vidjeti dio 6.6).