FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Croatian: 9/l ili veći uočen je u manje od 5% onkoloških bolesnika koji su primali filgrastim u dozama većima od 0,3 MU/kg/dan (3 µg/kg/dan).
English: Telephone +48/22 -737.79.20
Croatian: Tel: +48/22 -737.79.20
English: In clinical studies and the post-marketing setting pulmonary adverse reactions including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
Croatian: U kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u nekim su slučajevima zabilježene plućne nuspojave uključujući intersticijsku bolest pluća, plućni edem i infiltraciju pluća, s ishodom u obliku respiratornog zatajenja ili akutnog respiratornog distres sindroma (ARDS), koji može imati smrtni ishod (vidjeti dio 4.4).
English: 9/L were reported and attributed to the leukapheresis procedure.
Croatian: 9/l koja su pripisana postupku leukafereze.
English: Your doctor may test your blood at regular intervals to see how well the Grastofil treatment is working.
Croatian: Vaš liječnik Vam može raditi krvne pretrage u redovitim intervalima kako bi ocijenio djelotvornost liječenja Grastofilom.
English: Sweets syndrome
Croatian: Sweetsov sindrom
English: • you experience kidney injury (glomerulonephritis).
Croatian: • razvijete oštećenje bubrega (glomerulonefritis).
English: • increase in white blood cells (leukocytosis)
Croatian: • povećanje broja bijelih krvnih stanica (leukocitoza)
English: What Grastofil contains
Croatian: Što Grastofil sadrži
English: If required, Grastofil may be diluted in 5% glucose.
Croatian: Ako je potrebno, Grastofil se može razrijediti u 5%-tnoj otopini glukoze.
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Croatian: Da bi se odredio najmanji broj ABN kod bolesnika, preporučuje se uzimati uzorke krvi za mjerenje ABN neposredno prije primjene planirane doze filgrastima.
English: The Grastofil syringe has a scale on the syringe barrel.
Croatian: Grastofil štrcaljka ima mjerne oznake na tijelu štrcaljke.
English: • swelling in the hands and feet (oedema peripheral)
Croatian: • oticanje šaka i stopala (periferni edemi)
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 periferne krvi mobiliziranih filgrastimom imali su značajno brži hematološki oporavak, što je dovelo do značajnog smanjenja vremena do oporavka trombocita bez potpore u usporedbi s transplantacijom alogene koštane srži.
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 farmakokinetički i farmakodinamički profil sličan onome kod zdravih pojedinaca.
English: Reduce to 0.5 MU/kg/day (5 micrograms/kg/day)
Croatian: Sniziti na 0,5 MU/kg/dan (5 mikrograma/kg/dan)
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Croatian: Prolazne citogenetske abnormalnosti opažene su u zdravih darivatelja nakon primjene G-CSF-a.
English: Your doctor may then test your blood to see how well your treatment with Grastofil is working and to find the dose that is best for you.
Croatian: Vaš liječnik može Vam napraviti krvne pretrage kako bi ocijenio djelotvornost liječenja Grastofilom te odredio dozu koja je najbolja za Vas.
English: • 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: • dobijete alergijsku reakciju uključujući slabost, naglo sniženje 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: ANC > 1.0 x 10
Croatian: ABN > 1,0 x 10
English: Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Croatian: Darivatelje koji prime G-CSF za mobilizaciju stanica periferne krvi potrebno je pratiti sve dok se hematološki pokazatelji ne vrate na normalne vrijednosti.
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 10
Croatian: U zdravih darivatelja, doza od 1 MU/kg/dan (10 mikrograma/kg/dan) koja se primjenjuje potkožno tijekom 4-5 dana uzastopno omogućuje prikupljanje ≥ 4 x 10
English: Grastofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection
Croatian: Grastofil i neutropenija (nizak broj podvrste bijelih krvnih stanica) u bolesnika s HIV infekcijom
English: Telephone +34/93-473.88.89
Croatian: Tel: +34/93-473.88.89
English: A common side effect of Grastofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Croatian: Česta nuspojava Grastofila je bol u mišićima i kostima (mišićno-koštana bol), koja se može ublažiti uzimanjem uobičajenih lijekova protiv bolova (analgetika).
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient abnormal bone scans.
Croatian: Pojačana krvotvorna aktivnost koštane srži kao odgovor na liječenje čimbenikom rasta povezana je s prolaznim abnormalnim snimkama kostiju.
English: How do I prepare my Grastofil injection?
Croatian: Kako da pripremim injekciju Grastofila?
English: If the ANC decreases to < 1.0 x 10
Croatian: Ako se ABN smanji na < 1,0 x 10
English: België/Belgique/Belgien Eurogenerics SA/NV Telephone +32/2.479.78.78
Croatian: België/Belgique/Belgien Eurogenerics SA/NV Tél/Tel: +32/2.479.78.78
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 liječenja filgrastimom obično rezultira smanjenjem cirkulirajućih neutrofila za 50% u roku od 1 do 2 dana, uz povratak na normalne vrijednosti u roku od 1 do 7 dana.
English: In a separate retrospective international study in patients with acute and chronic myelogenous leukaemias, no effect on the risk of GvHD, TRM and mortality was seen.
Croatian: U posebnom retrospektivnom međunarodnom ispitivanju u bolesnika s akutnim i kroničnim mijelogenim leukemijama nije opažen nikakav učinak na rizik od GvHD-a, mortalitet povezan s liječenjem i mortalitet.
English: Grastofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)
Croatian: Grastofil i presađivanje matičnih stanica iz periferne krvi (matične stanice prikupljene iz krvi i korištene u presađivanju koštane srži)
English: A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomised studies, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Croatian: Metaanaliza ispitivanja alogenih transplantata, koja je uključila rezultate devet prospektivnih randomiziranih ispitivanja, 8 retrospektivnih ispitivanja i 1 ispitivanja parova, nije utvrdila utjecaj na rizik od akutnog GvHD, kroničnog GvHD-a ili rani mortalitet povezan s liječenjem.
English: Centrafarm BV Telephone +31/7650.81.000
Croatian: Nederland Centrafarm BV Tel: +31/7650.81.000
English: However, for a sustained therapeutic response, Grastofil therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Croatian: Međutim, da bi se zadržao odgovor na liječenje, terapija Grastofilom ne smije se prekinuti prije očekivanog najnižeg pada broja neutrofila i njihovog porasta do normalnog raspona vrijednosti.
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Croatian: U bolesnika kojima će se presaditi matične stanice ili koštana srž može se razviti bolest presatka protiv primatelja (GvHD) - to je reakcija stanica darivatelja protiv bolesnika koji prima presadak; znakovi i simptomi uključuju osip na dlanovima ili tabanima te čireve i ranice u ustima, crijevima, jetri, koži ili očima, plućima, rodnici i zgobovima.
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Croatian: Pokazalo se da klirens filgrastima slijedi farmakokinetiku prvog reda kako nakon supkutane, tako i nakon intravenske primjene.
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Croatian: Najozbiljnije nuspojave koje mogu nastati tijekom liječenja filgrastimom uključuju: anafilaktičku reakciju, ozbiljne plućne nuspojave (uključujući intersticijsku upalu pluća i ARDS), stanje povećane kapilarne propusnosti, tešku splenomegaliju/rupturu slezene, napredovanje u mijelodisplastični sindrom ili leukemiju u bolesnika s teškom kroničnom neutropenijom, GvHD u bolesnika kojima je prenesena alogena koštana srž ili su presađene progenitorske stanice periferne krvi i kriza srpastih stanica u bolesnika s anemijom srpastih stanica.
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Croatian: • prije visoke doze kemoterapije radi poticanja stvaranja matičnih stanica koje je moguće prikupiti i vratiti
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Croatian: Bolesnici liječeni mijeloablativnom terapijom nakon koje slijedi transplantacija koštane srži
English: In clinical studies in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Croatian: U kliničkim ispitivanjima u onkoloških bolesnika, mišićno-koštana bol bila je blaga do umjerena u 10% bolesnika te jaka u 3% bolesnika.
English: • you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Croatian: • liječite se zbog teške kronične neutropenije i imate krv u mokraći (hematurija).
English: Luxembourg/Luxemburg Eurogenerics SA/NV Telephone +32/2.479.78.78
Croatian: Luxembourg/Luxemburg Eurogenerics SA/NV Tél/Tel: +32/2.479.78.78
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: • Vam lice ili gležnjevi oteknu, imate krv u mokraći ili smeđe obojenu mokraću ili primijetite da mokrite manje nego obično (glomerulonefritis),
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: U napunjenoj štrcaljki možete opaziti mjehurić zraka.
English: Grastofil and severe chronic neutropenia (low number of a type of white blood cells)
Croatian: Grastofil i teška kronična neutropenija (nizak broj podvrste bijelih krvnih stanica)
English: Some cytotoxic medicinal products exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Croatian: Neki citotoksični lijekovi imaju izrazito toksično djelovanje na krvotvorne stanice preteče i mogu štetno utjecati na njihovu mobilizaciju.
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 fetal weight were observed.
Croatian: Intravenska (80 μg/kg/dan) primjena filgrastima u kunića tijekom razdoblja organogeneze bila je toksična za majku, i povećala je broj spontanih pobačaja, gubitaka nakon implantacije zametka, te smanjila prosječnu veličina živog legla i fetalne težine.
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Croatian: Infuzija progenitorskih stanica periferne krvi ubrzava oporavak krvotvorne funkcije smanjujući trajanje rizika od hemoragijskih komplikacija i potrebu za transfuzijom trombocita.
English: Telephone +386/1-589.67.10
Croatian: Tel:+ 386/1-589.67.10
English: It is supplied in a pre-filled syringe with an injection needle marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel.
Croatian: Isporučuje se u napunjenoj štrcaljki s iglom za injekciju, s označenim mjernim oznakama 1/40 od 0,1 ml do 1 ml na tijelu štrcaljke.
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Croatian: Zdravi darivatelji nemaju izravnu kliničku korist od mobilizacije progenitorskih stanica periferne krvi pa taj postupak treba razmatrati samo u svrhu transplantacije alogenih matičnih stanica.
English: Fluid volume disturbances
Croatian: poremećaji volumena tekućine
English: Risks associated with increased doses of chemotherapy 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 medicinal products may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy medicinal products used).
Croatian: Potrebno je s posebnim oprezom pristupiti uporabi visokih doza kemoterapijskih lijekova u liječenju bolesnika jer se nije pokazalo da to poboljšava smanjenje rezultate liječenja, a pojačane doze kemoterapijskih lijekova mogu dovesti do povećane toksičnosti uključujući srčane, plućne, neurološke i dermatološke učinke (pogledati upute o lijeku za informacije o propisivanju određenih kemoterapijskih lijekova).
English: Common (≥ 1/100 to <
Croatian: Često (≥1/100 i <1/10)
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Croatian: Napredovanje u leukemiju ili mijelodisplastični sindrom Potreban je poseban oprez kod dijagnoze teškom kroničnom neutropenijom kako bi je se razlikovalo od drugih krvotvornih poremećaja kao što su aplastična anemija, mijelodisplazija i mijeloična leukemija.
English: • The other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Croatian: • Drugi sastojci su ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 80 i voda za injekcije.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Croatian: Općenito asimptomatski slučajevi splenomegalije i slučajevi rupture slezene zabilježeni su u bolesnika i zdravih darivatelja nakon primjene filgrastima.
English: What Grastofil is
Croatian: Što je Grastofil
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Croatian: Filgrastim se ne smije primjenjivati kod bolesnika s anamnezom preosjetljivosti na filgrastim ili pegfilgrastim.
English: Grastofil is indicated for the 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 for the 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: Grastofil je indiciran za smanjenje trajanja neutropenije i incidencije febrilne neutropenije u bolesnika liječenih standardnom citotoksičnom kemoterapijom zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnih sindroma) te za smanjenje trajanja neutropenije u bolesnika koji prolaze mijeloablativnu terapiju prije transplantacije koštane srži i u kojih se smatra da postoji povećan rizik od produljene teške neutropenije.
English: These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of, or in addition to bone marrow transplantation.
Croatian: Ove autologne progenitorske stanice periferne krvi mogu se prikupiti i dati infuzijom nakon visokih doza citotoksične terapije, bilo umjesto ili kao dodatak presađivanju koštane srži.
English: Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Croatian: Neutropenija može biti posljedica infiltracije koštane srži uzročnicima oportunističkih infekcija kao što je kompleks Mycobacterium avium ili zloćudnom bolešću kao što je limfom.
English: Grastofil contains no preservative.
Croatian: Grastofil ne sadrži konzervanse.
English: • severe pain in the bones, chest, gut or joints (sickle anaemia with cell crisis)
Croatian: • teška bol u kostima, prsištu, crijevima ili zglobovima (anemija srpastih stanica s krizom)
English: Risk associated with increased doses of myelosuppressive medications Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Croatian: Rizik povezan s povišenim dozama mijelosupresivnih lijekova Liječenje samo filgrastimom ne isključuje pojavu trombocitopenije i anemije zbog mijelosupresivnih lijekova.
English: There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.8 and 5.1).
Croatian: Zabilježeni su slučajevi reakcije presatka protiv primatelja (GvHD) i smrtni ishodi u bolesnika koji su primali G-CSF nakon transplantacije alogene koštane srži (vidjeti dio 4.8 i 5.1).
English: Grastofil works by stimulating the bone marrow to produce more white blood cells.
Croatian: Grastofil djeluje tako što potiče koštanu srž na stvaranje većeg broja bijelih krvnih stanica.
English: What you need to know before you use Grastofil
Croatian: Što morate znati prije nego počnete primjenjivati Grastofil Nemojte primjenjivati Grastofil
English: • rejection of transplanted bone marrow (graft versus host disease)
Croatian: • odbacivanje presađene koštane srži (bolest presatka protiv primatelja)
English: The effects of filgrastim on neutropenia due to bone marrow-infiltrating infection or malignancy have not been well established.
Croatian: Učinci filgrastima na neutropeniju uzrokovanu infekcijom ili zloćudnom bolešću koje infiltriraju koštanu srž nisu dobro ustanovljeni.
English: In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen, this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Croatian: U zdravih se darivatelja matičnih stanica može vidjeti povećanje broja bijelih krvnih stanica (leukocitoza) i smanjenje broja trombocita, što smanjuje sposobnost zgrušavanja krvi (trombocitopenija); Vaš liječnik će pažljivo pratiti ove znakove.
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Croatian: Zabilježeni su slučajevi GvHD-a i smrtni ishodi u bolesnika koji su primali G-CSF nakon transplantacije alogene koštane srži (vidjeti dijelove 4.4 i 5.1).
English: Your doctor will perform regular blood tests to determine the best time to collect the stem cells.
Croatian: Vaš liječnik će redovito raditi krvne pretrage kako bi se odredilo najbolje vrijeme za prikupljanje matičnih stanica.
English: • 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: • osjetite bol u gornjem lijevom dijelu trbuha (abdomena), bol ispod lijevog rebrenog luka ili bol u vrhu ramena, jer to može ukazivati na problem sa slezenom (povećanje slezene (splenomegalija) ili puknuće (ruptura) slezene).
English: If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day.
Croatian: Ako ste darivatelj matičnih stanica za drugu osobu, uobičajena doza je 1 milijun jedinica (10 mikrograma) po kilogramu tjelesne težine svaki dan.
English: (Chondrocalcinosis Pyrophosphate)
Croatian: (pirofosfatna hondrokalcinoza)
English: • high blood pressure (hypertension)
Croatian: • povišen krvni tlak (hipertenzija)
English: These have generally occurred in patients with advanced malignant diseases, sepsis, using multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Croatian: Uglavnom su se očitovali u bolesnika s uznapredovalim malignim bolestima, onih sa sepsom, u bolesnika koji su primali više od jednog kemoterapijskog lijeka i u bolesnika na kojima se provodila afereza (vidjeti dio 4.4).
English: Grastofil may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Croatian: Grastofil se može davati svakodnevno supkutanom injekcijom ili svakodnevno intravenskom infuzijom, razrijeđen u 5%-tnoj otopini glukoze koja se daje tijekom 30 minuta (vidjeti dio 6.6).
English: In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 10
Croatian: U kliničkim je ispitivanjima bila potrebna primjena doze od 30 MU/dan (300 mikrograma/dan) 1 do 7 dana tjedno kako bi se održao ABN > 2,0 x 10
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Croatian: Najčešće prijavljene nuspojave su pireksija, mišićno-koštana bol (koja uključuje bol u kostima, bol u leđima, artralgiju, mialgiju, bol u udovima, mišićno-koštanu bol, mišićno-koštanu bol u prsnom košu, bol u vratu), anemija, povraćanje i mučnina.
English: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Oni mogu biti znaci poremećaja koji se naziva stanjem povećane kapilarne propusnosti, a koji uzrokuje prodiranje krvi iz malih krvnih žila u tjelesne šupljine i zahtijeva hitnu liječničku intervenciju.