FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Croatian: Ne postoji prospektivna, randomizirana usporedba dviju preporučenih metoda mobilizacije (filgrastim sam ili u kombinaciji s mijelosupresivnom kemoterapijom) u iste populacije bolesnika.
English: For maintaining normal neutrophil counts:
Croatian: Za održavanje normalnog broja neutrofila:
English: How do I give my subcutaneous Nivestim injection?
Croatian: Kako sam sebi dati potkožnu injekciju Nivestim?
English: Some cases of splenic rupture were fatal (see section 4.4).
Croatian: Neki slučajevi rupture slezene imali su smrtni ishod (vidjeti dio 4.4).
English: What Nivestim is and what it is used for What you need to know before you use Nivestim How to use Nivestim
Croatian: Što je Nivestim i za što se koristi Što morate znati prije nego počnete primjenjivati Nivestim Kako primjenjivati Nivestim
English: If you think you have injected more than you should, contact your doctor as soon as possible.
Croatian: Ako mislite da ste ubrizgali više Nivestima nego što ste trebali, javite se što prije liječniku.
English: With your other hand, insert the needle at an approximate 45˚ angle.
Croatian: Drugom rukom ubodite iglu pod kutom od otprilike 45˚.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Croatian: Ljudski G-CSF je glikoprotein koji regulira stvaranje i otpuštanje funkcionalnih neutrofila iz koštane srži.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Croatian: Liječnik će Vam možda redovito testirati mokraću ako razvijete ovu nuspojavu ili ako su Vam u mokraći nađeni proteini (proteinurija).
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Croatian: MDS i leukemija su prirodne komplikacije bolesti i njihova povezanost s primjenom filgrastima nije jasna.
English: Filgrastim should be discontinued and appropriate treatment given.
Croatian: Filgrastim treba obustaviti i uvesti odgovarajuće liječenje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from filgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja filgrastimom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Croatian: Moguće interakcije s drugim hematopoetskim čimbenicima rasta i citokinima nisu još istražene u kliničkim ispitivanjima.
English: What Nivestim looks like and contents of the pack
Croatian: Kako Nivestim izgleda i sadržaj pakiranja
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Croatian: Djelotvornost liječenja bila je u te dobne skupine jasna, uključujući i većinu bolesnika s kongenitalnom neutropenijom.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 10
Croatian: Potom se doza može individualno prilagođivati svakih 1 do 2 tjedna kako bi se broj neutrofila održavao između 1,5 x 10
English: Talk to your doctor, pharmacist or nurse before using Nivestim.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Nivestim.
English: Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim.
Croatian: Slučajno izlaganje temperaturama zamrzavanja u trajanju do 24 sata ne utječe na stabilnost Nivestima.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Croatian: Bolesnike koji razviju simptome sindroma povećane propusnosti kapilara treba pažljivo nadzirati i liječiti standardnom simptomatskom terapijom što može uključivati potrebu za intenzivnom skrbi (vidjeti dio 4.8).
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Croatian: Najbolje je svaki dan dati injekciju u drugo mjesto na tijelu kako bi se izbjegao rizik pojave boli na mjestu davanja injekcije.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Croatian: Pri izboru metode mobilizacije valja uzeti u obzir ciljeve liječenja u određenog bolesnika.
English: Nivestim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines.
Croatian: Nivestim je faktor rasta bijelih krvnih stanica (faktor stimulacije kolonije granulocita) i pripada skupini lijekova zvanih citokini.
English: In other circumstances, additional leukapheresis may be necessary.
Croatian: U drugim okolnostima, možda će trebati dodatna leukafereza.
English: In randomised clinical trials, a subcutaneous dose of 230 µg/m2/day (4.0 to 8.4 µg/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima korištene su supkutane doze od 230 µg/m2/dan (4,0 do 8,4 µg/kg/dan).
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Croatian: Ukupne razlike u sigurnosti ili djelotvornosti nisu zabilježene u ispitanika starijih od 65 godina u usporedbi s mladim odraslim ispitanicima (> 18 godina starosti) koji su primali citotoksičnu kemoterapiju, a kliničko iskustvo nije utvrdilo razlike u odgovorima između starijih i mlađih odraslih bolesnika.
English: Overall, reports were more common after IV administration.
Croatian: Sveukupno, takvi su slučajevi bili češći nakon i.v. primjene.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni kako sami sebi dati injekciju ili imate dodatnih pitanja, za pomoć se obratite svom liječniku ili medicinskoj sestri.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 to 16 hours.
Croatian: Nakon supkutane primjene preporučenih doza, koncentracije u serumu održavale su se iznad 10 ng/ml tijekom 8 do 16 sati.
English: Pinch a large area of skin, taking care not to touch the area you have cleaned.
Croatian: Uhvatite veći dio kože prstima jedne ruke, pazeći da pritom ne dodirnete područje koje ste očistili maramicom.
English: Filgrastim should be given by subcutaneous injection.
Croatian: Filgrastim treba davati supkutanom injekcijom.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Croatian: Podaci u tablici u nastavku opisuju nuspojave prijavljene iz kliničkih ispitivanja i spontanog prijavljivanja.
English: ANC = absolute neutrophil count
Croatian: ABN = apsolutni broj neutrofila
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Croatian: Provodit će se redovite krvne pretrage kako bi se pratio broj leukocita u Vašem organizmu.
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Croatian: Neutrofili proizvedeni kao odgovor na filgrastim pokazuju normalnu ili pojačanu funkciju, što je dokazano testovima za procjenu kemotaksije i fagocitnih funkcija.
English: Transfusion reaction e a See section c (Description of selected adverse reactions).
Croatian: Vidjeti dio c („Opis odabranih nuspojava“).
English: cells/kg recipient body weight in the majority of the donors after two leukapheresis.
Croatian: + stanica/kg tjelesne težine primatelja u većine davatelja nakon dvije leukafereze.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Croatian: No pokazalo se da je primjena melfalana, karboplatine ili BCNU zajedno s filgrastimom učinkovita u mobilizaciji matičnih stanica.
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% bolesnika odgovorilo na ove doze, s medijanom vremena potrebnog za korekciju neutropenije od 2 dana.
English: It is recommended that the ANC is measured daily for the first 2-3 days of filgrastim administration.
Croatian: Preporučuje se određivati ABN svakodnevno tijekom prva 2-3 dana primjene filgrastima.
English: Filgrastim dosing should be maintained until the last leukapheresis.
Croatian: Primjenu filgrastima treba nastaviti do zadnje leukafereze.
English: Filgrastim is not indicated for use in these conditions.
Croatian: Filgrastim nije indiciran za primjenu u tim stanjima.
English: Relative Risk (95% CI) of GvHD and TRM Following Treatment with GCSF after Bone Marrow Transplantation Publication
Croatian: Relativni rizik (95% CI) za GvHD i TRM nakon liječenja s G-CSF-om nakon presađivanja koštane srži
English: • liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
Croatian: • oštećenje jetre uzrokovano začepljenjem malih vena unutar jetre (venookluzivna bolest)
English: Nivestim contains sorbitol (E420).
Croatian: Nivestim sadrži sorbitol (E420).
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Croatian: Nema dokaza da se u bolesnika s HIV infekcijom koji primaju filgrastim pojačava replikacija virusa HIV-a.
English: • A sharps container (puncture proof container) for disposing of used syringes safely.
Croatian: • Spremnik za oštre predmete (neprobojni spremnik) za odlaganje upotrijebljenih štrcaljki na siguran način.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.
Croatian: Ako Vi (ili Vaše dijete) imate(ima) nasljedno nepodnošenje fruktoze, rijetki genetski poremećaj, Vi (ili Vaše dijete) ne smijete(smije) primiti ovaj lijek.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima osim s onima koji su navedeni u nastavku.
English: Do not use Nivestim
Croatian: Nemojte primjenjivati Nivestim
English: Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Croatian: Preliminarni podaci u malog broja bolesnika koji su istodobno primali filgrastim i 5-fluorouracil upućuju na to da se neutropenija može pogoršati.
English: Remove the protective cap from the injection needle.
Croatian: Uklonite zaštitnu kapicu s injekcijske igle.
English: Effect of chemotherapy on erythrocytes and thrombocytes
Croatian: Učinak kemoterapije na eritrocite i trombocite
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne 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: Nivestim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Croatian: Nivestim se obično daje dnevnom injekcijom u tkivo neposredno ispod kože (poznata kao supkutana injekcija).
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
Croatian: • visoke razine mokraćne kiseline u krvi, što može uzrokovati giht (hiperuricemija) (povišena razina mokraćne kiseline u krvi)
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Croatian: • smanjen osjet, osobito na koži (hipoestezija)
English: Filgrastim for PBPC mobilisation when used alone:
Croatian: Filgrastim za mobilizaciju KMSPK-ova kada se koristi sam:
English: The dosing in children receiving chemotherapy is the same as for adults.
Croatian: Doziranje u djece koja primaju kemoterapiju isto je kao i u odraslih.
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 bi mogli biti simptomi stanja zvanog „sepsa“ (poznatog i kao „trovanje krvi“), teške infekcije s upalnom reakcijom cijelog tijela koja može biti opasna po život i zahtijeva hitno medicinsko liječenje.
English: The degree of variation between individual patients and between laboratory assays of CD34
Croatian: Stupanj različitosti između pojedinih bolesnika i laboratorijskih metoda brojanja CD34
English: In patients with HIV infection
Croatian: Bolesnici s HIV infekcijom
English: Elevations of neutrophil counts are dose dependent at recommended doses.
Croatian: Porast broja neutrofila ovisan je o dozi u rasponu preporučenih doza.
English: Remove the syringe from the blister pack and check that the solution is clear, colourless and practically free from visible particles.
Croatian: Izvadite štrcaljku iz blister pakiranja i provjerite je li otopina bistra, bezbojna i bez vidljivih čestica.
English: When you have completed the injection, slide the needle guard forward until the needle is completely covered (device ‘clicks' into place).
Croatian: Kad završite s davanjem injekcije, povucite štitnik igle prema naprijed sve dok potpuno ne prekrije iglu (štitnik će škljocnuti kad sjedne na mjesto).
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Croatian: Pri određivanju broja krvotvornih matičnih stanica prikupljenih u bolesnika koji prima filgrastim, posebnu pozornost valja posvetiti metodi kvantifikacije.
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Croatian: 65% bolesnika uključenih u program ispitivanja teške kronične neutropenije bilo je mlađe od 18 godina.
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Croatian: Filgrastim se mora trajno obustaviti u bolesnika koji razviju ozbiljnu alergijsku reakciju.
English: • the front of the thighs, • the abdomen, except for the area around the navel.
Croatian: • prednji dio bedra, • trbuh, osim područja oko pupka.
English: Congenital, idiopathic or cyclic neutropenia: Filgrastim should be given by subcutaneous injection.
Croatian: Kongenitalna, idiopatska ili ciklička neutropenija: Filgrastim treba davati supkutanom injekcijom.
English: The Nivestim syringe plunger stopper and needle cover are not made with natural rubber latex.
Croatian: Čep klipa i poklopac za iglu štrcaljke Nivestima nisu napravljeni od prirodne gume lateksa.
English: - if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Croatian: - ako ste liječeni zbog teške kronične neutropenije i imate krv u mokraći (hematurija).
English: 9/L to > 5.0 x 10
Croatian: 9/l do > 5,0 x 10
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: Nivestim contains sorbitol
Croatian: Nivestim sadrži sorbitol
English: 9/L for 3 more consecutive days
Croatian: 9/l tijekom 3 uzastopna dana
English: cell numbers vary depending on the precise methodology used and recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: + stanica pomoću protočne citometrije se razlikuju ovisno o preciznosti korištene metodologije te stoga preporuke o broju stanica zasnovane na brojenju u drugim laboratorijima valja tumačiti s oprezom.
English: Solution for injection/infusion (injection/infusion).
Croatian: Otopina za injekciju/infuziju (injekcija/infuzija).
English: During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Croatian: Kod dugoročne primjene kutani vaskulitis zabilježen je u 2% bolesnika sa SCN-om.
English: This observation has only been made in patients with congenital neutropenia.
Croatian: To je uočeno samo u bolesnika s kongenitalnom neutropenijom.
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Croatian: Morate reći svom liječniku prije nego primite ovaj lijek ako Vi (ili Vaše dijete) imate(ima) nasljedno nepodnošenje fruktoze ili ako Vaše dijete više ne može konzumirati slatku hranu ili piće zbog pojave mučnine, povraćanja ili neugodnih nuspojava poput nadutosti, grčeva u trbuhu ili proljeva.
English: However, you should not attempt this unless you have been properly trained first by your healthcare provider.
Croatian: Međutim, ne smijete to pokušati prije nego što Vas zdravstveni radnik o tome temeljito poduči.
English: Infections and malignancies causing myelosuppression
Croatian: Infekcije i zloćudne bolesti koje uzrokuju mijelosupresiju
English: • transfusion reaction
Croatian: • reakcija na transfuziju
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 KMSPK, preporučuje se planirati postupak mobilizacije matičnih stanica rano u tijeku liječenja bolesnika.
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 alternativne oblike liječenja za koje nije nužna potpora matičnim stanicama.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Croatian: Proučavani su učinci filgrastima na prenatalni razvoj u štakora i kunića.
English: What Nivestim contains
Croatian: Što Nivestim sadrži
English: If exposure has been greater than 24 hours or frozen more than once, then Nivestim should NOT be used.
Croatian: Ako je smrzavanje trajalo dulje od 24 sata ili se ponovilo više od jedanput, Nivestim se NE smije upotrijebiti.
English: Some cases of splenic rupture were fatal.
Croatian: Neki slučajevi rupture slezene imali su smrtni ishod.
English: Nivestim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within twenty four hours, with minor increases in monocytes.
Croatian: Nivestim koji sadrži r-metHuG-CSF (filgrastim) uzrokuje izrazit porast broja neutrofila u perifernoj krvi unutar 24 sata, kao i manji porast broja monocita.
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 rezultirati otečenošću (poremećaji volumena tekućine)
English: Hospira Zagreb d.o.o.
Croatian: Hospira Zagreb d.o.o. Prudnička cesta 60
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities.
Croatian: Terapija filgrastimom se smije davati samo u suradnji s onkološkim centrom, koji ima iskustva u liječenju s G-CSF, i s hematologijom, a koji raspolažu potrebnom dijagnostičkom opremom.
English: Risk associated with increased doses of myelosuppressive medicinal products
Croatian: Rizik povezan s povećanim dozama mijelosupresivnih lijekova
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: These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: To bi mogli biti simptomi stanja zvanog „sindrom povećane propusnosti kapilara“ koji uzrokuje istjecanje krvi iz malih krvnih žila u tijelo i zahtijeva hitno medicinsko liječenje.
English: In pregnant rats, no maternal or foetal toxicity was observed at doses up to 575 µg/kg/day.
Croatian: U skotnih štakora nije uočena toksičnost za majku ili fetalna toksičnost u dozama do 575 g/kg/dan.
English: Reduce to 0.5 MU (5 µg)/kg/day
Croatian: Smanjiti na 0,5 MU (5 µg)/kg/dan
English: Nivestim is usually given once a day by injection, usually into the tissue just under the skin.
Croatian: Nivestim se obično primjenjuje jedanput dnevno injekcijom, obično u potkožno tkivo.
English: Other special precautions
Croatian: Ostale posebne mjere opreza
English: EXP After dilution use within 24 hours.
Croatian: Nakon razrjeđivanja primijeniti u roku od 24 sata.
English: cells/kg) or acceleration of platelet recovery, to the same degree.
Croatian: + stanica/kg) ili da se u jednakom stupnju ubrza oporavak broja trombocita.
English: Absolute neutrophil count (ANC) should be monitored closely, especially during the first few weeks of filgrastim therapy.
Croatian: Treba pažljivo pratiti apsolutni broj neutrofila (ABN), osobito tijekom prvih nekoliko tjedana primjene filgrastima.
English: After injecting the solution remove the needle from the skin.
Croatian: 11. Nakon ubrizgavanja otopine, izvadite iglu iz kože.
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Croatian: Budući da su podaci o sigurnosti i djelotvornosti u bolesnika sa sekundarnom AML ograničeni, filgrastim treba davati oprezno.
English: Remove the needle from your skin, then let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Croatian: Izvucite iglu iz kože, a zatim otpustite pritisak na klip i dopustite štrcaljki da klizne prema gore sve dok štitnik ne prekrije cijelu iglu i čvrsto sjedne na mjesto.
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: Hypertension Hypotension
Croatian: Hipertenzija Hipotenzija
English: Pack sizes of 1, 5, 8 or 10 pre-filled syringes.
Croatian: Veličine pakiranja: 1, 5, 8 ili 10 napunjenih štrcaljki.
English: Equipment required for administration
Croatian: Pribor potreban za primjenu