FrancophonIA/ELRC3.0 huggingface dataset:
English: If patients with SCN develop abnormal cytogenetics, the risks and benefits of continuing filgrastim should be carefully weighed; filgrastim should be discontinued if MDS or leukaemia occurs.
Croatian: Ako bolesnici s teškom kroničnom neutropenijom razviju abnormalni citogenetski nalaz, rizici i koristi nastavka primjene filgrastima trebaju se pažljivo procijeniti; ako se razvije MDS ili leukemija, primjenu filgrastima potrebno je prekinuti.
English: Accofil and severe chronic neutropenia (low number of a type of white blood cells)
Croatian: Accofil i teška kronična neutropenija (nizak broj podvrste bijelih krvnih stanica)
English: It is unknown whether filgrastim passes over into the breast milk.
Croatian: Nije poznato prelazi li filgrastim u majčino mlijeko.
English: Common but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.
Croatian: Česti ali općenito asimptomatski slučajevi splenomegalije i vrlo rijetki slučajevi rupture slezene zabilježeni su u zdravih darivatelja i bolesnika nakon primjene G-CSF-a.
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Croatian: Preporuke za doziranje u pedijatrijskih bolesnika iste su kao one za odrasle koji primaju mijelosupresivnu citotoksičnu kemoterapiju.
English: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Croatian: • teški bolovi u kostima, prsnom košu, crijevima ili zglobovima (anemija srpastih stanica s krizom)
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 agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents 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: Accofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection
Croatian: Accofil i neutropenija (nizak broj podvrste bijelih krvnih stanica) u bolesnika s HIV infekcijom
English: In the post-marketing setting, isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet, izolirani slučajevi krize srpastih stanica zabilježeni su u bolesnika s anemijom srpastih stanica (vidjeti dio 4.4).
English: A very frequent side effect of Accofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics).
Croatian: Vrlo česta nuspojava Accofila je bol u mišićima i kostima (mišićno-koštana bol), koji se može ublažiti uzimanjem uobičajenih lijekova protiv bolova (analgetika).
English: Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology.
Croatian: Filgrastim je protein koji se proizvodi u bakterijama koje se zovu Escherichia coli rekombinantnom DNA tehnologijom.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Croatian: Slučajevi smanjene gustoće kostiju i osteoporoze zabilježeni su u pedijatrijskih bolesnika s teškom kroničnom neutropenijom koji se dugotrajno liječe filgrastimom.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, filgrastim should be discontinued immediately.
Croatian: Ako broj leukocita prijeđe vrijednost od 50 x 109/l nakon očekivanog pada na najnižu vrijednost, potrebno je odmah prekinuti primjenu filgrastima.
English: • Notice unusual bleeding or bruising that may be (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot.
Croatian: • primijetite neuobičajeno krvarenje ili modrice (to mogu biti simptomi smanjenog broja trombocita u krvi [trombocitopenije]), uz smanjenu sposobnost zgrušavanja krvi.
English: In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Croatian: U bolesnika, bilo djece ili odraslih, s teškom kongenitalnom, cikličkom ili idiopatskom neutropenijom s apsolutnim brojem neutrofila (ABN) od ≤ 0,5 x 109/l i teškim ili recidivirajućim infekcijama u anamnezi, dugotrajna primjena Accofila indicirana je za povećanje broja neutrofila i smanjenje incidencije i trajanja događaja povezanih s infekcijom.
English: Accofil must not be diluted with sodium chloride solutions.
Croatian: Accofil se ne smije razrjeđivati s otopinom natrijeva klorida.
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥20 µg/kg/day) and slightly reduced survival rate (100
Croatian: Potomci štakora koji su primali filgrastim tijekom perinatalnog razdoblja i razdoblja dojenja su zaostajali u vanjskoj diferencijaciji, imali usporen rast (≥20 µg/kg/dan) i nešto manju stopu preživljenja (100 µg/kg/dan).
English: The long-term safety of administration of filgrastim at doses above 24 µg/kg/day in patients with SCN has not been established.
Croatian: Sigurnost dugotrajne primjene filgrastima u dozama većim od 24 µg/kg/dan u bolesnika s teškom kroničnom neutropenijom nije utvrđena.
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Croatian: • bolest koja koja uzrokuje smanjenje gustoće kostiju, zbog čega postaju slabije, krhkije i sklonije nastajanju prijeloma (osteoporoza) • reakcija na mjestu primjene injekcije
English: For infusions filgrastim should be diluted in 20ml of 5% glucose solution (see section 6.6).
Croatian: Filgrastim je, za infuziju, potrebno razrijediti u 20 ml otopine 5%-tne glukoze (vidjeti dio 6.6).
English: For the reversal of neutropenia and maintenance of normal neutrophil counts in patients with HIV infection, filgrastim is administered subcutaneously.
Croatian: Za obrat neutropenije i održavanje normalnog broja neutrofila u bolesnika s HIV infekcijom, filgrastim se primijenjuje potkožno.
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 stanica preteča 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: The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied.
Croatian: Učinci filgrastima u bolesnika sa znatno smanjenim brojem mijeloičnih stanica preteča nisu ispitani.
English: • Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.
Croatian: • Vam se jave nagli simptomi alergije kao što su osip, svrbež ili osip na koži, oticanje lica, usana, jezika ili drugih dijelova tijela, nedostatak daha, hroptanje, otežano disanje, jer to mogu biti znakovi teške alergijske reakcije.
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Croatian: Nije bilo razlika u sigurnosnom profilu za pedijatrijske bolesnike koji su se liječili od teške kronične neutropenije.
English: You should not receive Accofil in the 24 hours before and the 24 hours after receiving chemotherapy.
Croatian: Ne biste smjeli primiti Accofil 24 sata prije i 24 sata nakon što ste primili kemoterapiju.
English: In view of the possible risk of microbial contamination, Accofil pre-filled syringes are for single use only.
Croatian: S obzirom na opasnost kontaminacije mikrobima, Accofil u napunjenim štrcaljkama predviđen je isključivo za jednokratnu uporabu.
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Croatian: U zdravih darivatelja, doza od 1 MU/kg/dan (10mikrograma/kg/dan) koja se primjenjuje potkožno tijekom 4-5 dana uzastopno omogućuje prikupljanje ≥ 4 x 106 CD34+ stanica/kg tjelesne težine primatelja u većine darivatelja nakon dvije leukafereze.
English: The assessment of undesirable effects is based on the following frequency data:
Croatian: Procjena nuspojava temelji se na sljedećim podacima o učestalosti:
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Croatian: Glomerulonefritis Glomerulonefritis je zabilježen u bolesnika koji su primali filgrastim i pegfilgrastim.
English: In normal donors, dyspnoea has been reported commonly and other pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, and hypoxia) have been reported uncommonly.
Croatian: Kod zdravih darivatelja, dispneja je zabilježena često, a druge plućne nuspojave (hemoptiza, plućno krvarenje, plućni infiltrati i hipoksija) zabilježene su manje često.
English: Common: ≥ 1/100 to < 1/10
Croatian: Često: ≥ 1/100 i < 1/10
English: Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000
Croatian: Manje često: ≥ 1/1000 i < 1/100 Rijetko: ≥ 1/10000 i < 1/1000 Vrlo rijetko: < 1/10000
English: During long term use cutaneous vasculitis has been reported in 2% of SCN patients.
Croatian: Tijekom dugotrajne primjene kožni vaskultis zabilježen je u 2 % bolesnika sa SCN-om.
English: These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Ovo mogu biti znaci rijetkog poremećaja (učestalosti 1 na 100 slučajeva) koji se naziva stanjem povećane kapilarne propusnosti, a koji uzrokuje prodiranje krvi iz malih krvnih žila u tjelesne šupljine i zahtijeva hitnu liječničku intervenciju.
English: Filgrastim should be discontinued and appropriate treatment given in these cases.
Croatian: U tim je slučajevima potrebno prekinuti primjenu filgrastima i primijeniti odgovarajuće liječenje.
English: Accofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Croatian: Accofil je bistra bezbojna otopina za injekciju ili infuziju u napunjenoj štrcaljki s iglom za injekciju, s označenim mjernim oznakama 1/40 od 0,1 ml do 1 ml na tijelu štrcaljke.
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 micrograms/kg/day).
Croatian: Preporučena doza filgrastima je 0,5 MU/kg/dan (5 mikrograma/kg/dan).
English: There are no or limited data from the use of filgrastim in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni filgrastima u trudnica ograničeni.
English: Take special care with other products that stimulate white blood cells Accofil is one of a group of products that stimulate the production of white blood cells.
Croatian: Budite posebno oprezni s drugim proizvodima koji stimuliraju bijele krvne stanice
English: In patients with SCN For congenital, idiopathic or cyclic neutropenia, filgrastim should be given by subcutaneous injection.
Croatian: Za kongenitalnu, idiopatsku ili cikličku neutropeniju filgrastim je potrebno primijeniti supkutanom injekcijom.
English: - 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: - vrućica, drhtanje ili osjećaj velike hladnoće, ubrzani otkucaji srca, smetenost ili dezorijentiranost, nedostatak zraka, jaka bol ili nelagoda te vlažna ili znojna koža.
English: In randomised, placebo-controlled clinical studies, 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: - The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Croatian: - Drugi sastojci su acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 80 i voda za injekcije.
English: This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži natrij u količini manjoj od 1mmol natrija (0,035 mg) po dozi, tj. sadrži zanemarive količine natrija.
English: INFORMATION IN BRAILLE Accofil 30 MU/0.5 ml
Croatian: Accofil 30 MU/0,5 ml
English: Some cytotoxic agents 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: Using the pre-filled syringe with a needle safety guard The needle safety guard covers the needle after injection to prevent needle stick injury.
Croatian: Uporaba napunjene štrcaljke sa sigurnosnim štitnikom za iglu Sigurnosni štitnik za iglu prekriva iglu nakon injiciranja kako bi se spriječila ozljeda ubodom igle.
English: Individuals receiving filgrastim who report left upper abdominal and/ or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Croatian: Osobe koje primaju filgrastim i navode bol u gornjem lijevom dijelu abdomena i/ili vrhu ramena potrebno je testirati na povećanu slezenu ili rupturu slezene.
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 and 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 reakcija presatka protiv primatelja (GvHD) - to je reakcija stanica darivatelja protiv bolesnika koji prima presadak; znakovi i simptomi uključuju osip na dlanovima i tabanima te čireve i ranice u ustima, crijevima, jetri, koži ili očima, plućima, rodnici i zgobovima.
English: Acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injection.
Croatian: Acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 80 i voda za injekcije.
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 stanica preteča periferne krvi pa taj postupak treba razmatrati samo u svrhu transplantacije alogenih matičnih stanica.
English: Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MU (5 µg)/kg/day as a single dose or in divided doses.
Croatian: Idiopatska ili ciklička neutropenija Preporučena početna doza je 0,5 MU(5 µg)/kg/dan primijenjena u jednoj ili više doza.
English: Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution over 30 minutes.
Croatian: Filgrastim se može primjenjivati svakodnevno potkožnom injekcijom ili intravenskom infuzijom, razrijeđen u otopini 5%-tne (50 ng/ml) glukoze, u trajanju od 30 minuta.
English: Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Croatian: Primjenu filgrastima potrebno je prekinuti ili smanjiti dozu lijeka ako se broj leukocita poveća na > 70 x109/l.
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)
Croatian: • bolnost i otok sluznice probavnog trakta koja se proteže od usta do anusa (upala sluznice)
English: Use of filgrastim in adults with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Croatian: Primjena filgrastima u djece ili odraslih s teškom kroničnom neutropenijom (teška kongenitalna, ciklička i idiopatska neutropenija) izaziva trajno povećnje ABN u perifernoj krvi i smanjenje infekcija i s time povezanih događaja.
English: Leukocytosisa
Croatian: Leukocitoza
English: In those clinical trials, undesirable effects reported with equal frequency in cancer patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and pain.
Croatian: U tim kliničkim ispitivanjima, nuspojave zabilježene jednakom učestalošću u onkoloških bolesnika liječenih filgrastimom/kemoterapijom i placebom/kemoterapijom uključivale su mučninu i povraćanje, alopeciju, proljev, umor, anoreksiju, mukozitis, glavobolju, kašalj, kožni osip, bol u prsištu, opću slabost, grlobolju, konstipaciju i bol.
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: Međutim, da bi se zadržao odgovor na liječenje, primjenu filgrastima ne smije se prekinuti prije očekivanog najnižeg pada broja neutrofila i njihovog porasta do normalnog raspona vrijednosti.
English: Risk associated with increased doses of myelosuppressive medicinal products 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: Initial dose adjustment to alternate day dosing with 30 MU (300 µg)/day is recommended.
Croatian: Preporučuje se početna prilagodba doze na 30 MU/dan (300
English: Accofil may have a minor influence on the ability to drive and use machines.
Croatian: Accofil može u manjoj mjeri utjecati na sposobnost upravljanja vozilima i strojevima.
English: The needle safety guard will cover the needle when releasing the plunger.
Croatian: Sigurnosni štitnik za iglu prekrit će iglu kad otpustite klip.
English: In a small number of patients (< 10%), doses up to 1.0 MU (10 µg) /kg/day were required to achieve reversal of neutropenia.
Croatian: Malom broju bolesnika (<10%), bile su potrebne doze do 1,0 MU(10 µg)/kg/dan kako bi se postigao obrat neutropenije.
English: In a small number of patients (< 10%), doses up to 1.0 MU(10 µg)/kg/day were required to achieve reversal of neutropenia.
Croatian: Malom broju bolesnika (< 10%), bile su potrebne doze do 1,0 MU (10 µg)/kg/dan kako bi se postigao obrat neutropenije.
English: Accofil 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: Accofil 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: The first dose of Accofil should not be administered less than 24 hours following cytotoxic chemotherapy.
Croatian: Prva doza Accofila ne smije se primijeniti manje od 24 sata nakon citotoksične kemoterapije.
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 na kojoj nisu zabilježenineželjeni učinci za embriofetalnu toksičnost u ovoj studiji iznosila je 10 µg/kg/dan, što je odgovaralo sustavnoj izloženosti od 3 do 5 puta većoj od izloženosti zabilježene u pacijenata koji su liječeni kliničkom dozom.
English: Leukocytosis (WBC > 50 x 109/L) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/L) following filgrastim treatment and leukapheresis was observed in 35% of donors.
Croatian: Leukocitoza (L > 50 x 109/l) je bila opažena u 41% darivatelja, kao i prolazna trombocitopenija (trombociti < 100 x 109/l) nakon liječenja filgrastimom i leukafereza je bila opažena u 35% darivatelja.
English: Dizziness may occur following the administration of Accofil (see section 4.8).
Croatian: Nakon primjene Accofila može se javiti omaglica (vidjeti dio 4.8).
English: Filgrastim had no observed effect on the fertility of male or female rats.
Croatian: Nije zabilježen utjecaj filgrastima na plodnost mužjaka ili ženki štakora.
English: PHARMACEUTICAL FORM Solution for injection or infusion Clear, colourless solution
Croatian: Otopina za injekciju ili infuziju Bistra, bezbojna otopina
English: INFORMATION IN BRAILLE Accofil 48 MU/0.5 ml
Croatian: Accofil 48 MU/0,5 ml
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous or intravenous administration.
Croatian: Pokazalo se da klirens filgrastima slijedi farmakokinetiku prvog reda kako nakon supkutane, tako ili nakon intravenske primjene.
English: f. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Croatian: Nakon ubrizgavanja tekućine izvucite iglu zadržavajući pritisak na klipu i pustite nabor kože.
English: What Accofil is and what it is used for
Croatian: Što je Accofil i za što se koristi Što je Accofil
English: - chemotherapy - bone marrow transplantation - severe chronic neutropenia (low number of a type of white blood cells) - neutropenia (low number of a type of white blood cells) in patients with HIV infection - peripheral blood stem cell mobilisation (to stimulate stem cells to enter the blood stream to be collected and used in bone marrow transplantation).
Croatian: - liječenje kemoterapijom - presađivanje koštane srži - teška kronična neutropenija (nizak broj podvrste bijelih krvnih stanica) - neutropenija (nizak broj podvrste bijelih krvnih stanica) u bolesnika s HIV infekcijom - mobilizacija matičnih stanica iz periferne krvi (kako bi se potaknuo ulazak matičnih stanica u krvotok nakon čega se one prikupljaju i koriste pri presađivanju koštane srži).