FrancophonIA/ELRC3.0 huggingface dataset:
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 pojačati.
English: If you use more Biograstim than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako primijenite više lijeka Biograstim nego što ste trebali, javite se što prije Vašem liječniku ili ljekarniku.
English: Biograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Croatian: Biograstim, koji sadrži r-metHuG-CSF (filgrastim), uzrokuje izrazit porast broja neutrofila u perifernoj krvi unutar 24 sata, i neznatan porast broja monocita.
English: Each mL of solution contains 50 mg of sorbitol.
Croatian: Jedan ml otopine sadrži 50 mg sorbitola.
English: What Biograstim is and what it is used for What you need to know before you use Biograstim How to use Biograstim
Croatian: Što je Biograstim i za što se koristi Što morate znati prije nego počnete primjenjivati Biograstim
English: Try to self-inject at approximately the same time every day.
Croatian: 1. Pokušajte samostalno primijeniti injekciju svaki dan u isto vrijeme.
English: During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim.
Croatian: U kliničkim je ispitivanjima Biograstim primao 541 onkološki bolesnik i 188 zdravih dobrovoljaca.
English: Check again to make sure the correct dose of Biograstim is in the syringe.
Croatian: 4. Provjerite još jedanput da budete sigurni u točnu dozu lijeka Biograstim u štrcaljki.
English: 4.4 Special warnings and precautions for use Special warnings
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Posebna upozorenja
English: Your doctor will tell you when to stop using Biograstim.
Croatian: Liječnik će Vam reći kada trebate prestati primjenjivati Biograstim.
English: Therefore, filgrastim is not indicated for use in these conditions.
Croatian: Stoga primjena filgrastima nije indicirana u tim stanjima.
English: However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Croatian: No budući da je značajan postotak tih bolesnika imao leukemiju, dakle stanje za koje se zna da je povezano sa Sweetovim sindromom, uzročna povezanost s filgrastimom nije dokazana.
English: Your doctor has prescribed Biograstim for you to help your body make more white blood cells.
Croatian: Liječnik Vam je propisao Biograstim kako bi potaknuo Vaše tijelo na veće stvaranje bijelih krvnih stanica.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili na bilo koju od pomoćnih tvari navedenih u dijelu 6.1.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Croatian: Vrijeme i broj leukafereza: obično su dovoljne 1-2 leukafereze, 5. i 6. dan.
English: - Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
Croatian: - Upotrijebljene štrcaljke stavite u neprobojni spremnik i držite spremnik izvan pogleda i dohvata djece.
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 djelatnici imaju prihvatljivo iskustvo na tom području i u kojem se na ispravan način mogu pratiti hematopoetske progenitorske stanice.
English: - Never put the syringes that you have used into your normal household rubbish bin.
Croatian: - Upotrijebljene štrcaljke nikada ne stavljajte u kućni otpad.
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle with or without safety device to prevent needle stick injury and re-use.
Croatian: Napunjena štrcaljka od stakla tipa I, s trajno pričvršćenom iglom od nehrđajućeg čelika, sa ili bez sigurnosne naprave koja sprječava ozljede zbog uboda iglom i ponovnu uporabu.
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 čimbenikom rasta granulocitnih kolonija (granulocyte-colony stimulating factor, G-CSF) i hematologijom a koji raspolažu potrebnim dijagnostičkim mogućnostima.
English: Biograstim and chemotherapy
Croatian: Biograstim i kemoterapija
English: Orient the needle away from you and others and activate the safety device by firmly pushing the plunger (see picture 8).
Croatian: Iglu usmjerite od sebe i drugih osoba i aktivirajte zaštitu za iglu čvrstim pritikom na klip (vidjeti sliku 8).
English: Overall, reports were more common after IV administration.
Croatian: Sveukupno, prijave su bile češće nakon intravenske primjene.
English: What should I do before I give myself a subcutaneous injection of Biograstim?
Croatian: Što trebate napraviti prije nego si date potkožnu injekciju lijeka Biograstim?
English: The excretion of filgrastim in milk has not been studied in animals.
Croatian: Izlučivanje filgrastima u mlijeko životinja nije ispitano.
English: Biograstim is a biosimilar medicinal product.
Croatian: Biograstim je biosličan lijek.
English: Filgrastim has minor or moderate influence on the ability to drive and use machines.
Croatian: Filgrastim neznatno ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Biograstim is a solution for injection or infusion in a pre-filled syringe with or without safety device.
Croatian: Biograstim je otopina za injekciju ili infuziju u napunjenoj štrcaljki sa ili bez zaštite za iglu.
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: Prospektivna, randomizirana usporedba dviju metoda mobilizacije (filgrastim sam, ili u kombinaciji s mijelosupresijskom terapijom) u iste populacije bolesnika nije obavljena.
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Croatian: Porast broja neutrofila ovisan je o dozi u rasponu preporučenih doza.
English: This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Croatian: To će liječniku pokazati kako dobro lijek djeluje i trebate li ga i dalje primjenjivati.
English: This medicine is given by injection, either through an intravenous (IV) infusion (drip) or a subcutaneous (SC) injection (into the tissue just under the skin).
Croatian: Način primjene Lijek se daje u injekciji, ili intravenskom (i.v.) infuzijom (drip) ili supkutanom (s.c.) injekcijom (u tkivo neposredno ispod kože).
English: Where should I give my injection?
Croatian: Na koje mjesto trebate primijeniti injekciju?
English: Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Croatian: Bolesnici s plućnim infiltratima ili pneumonijom u nedavnoj anamnezi, mogu biti izloženi većem riziku.
English: In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
Croatian: U kliničkim je ispitivanjima u 97 % ispitanika koji su odgovarali na terapiju, kompletan odgovor postignut pri dozi od ≤ 2,4 MIU (24 μg)/kg/dan.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with filgrastim should be made taking into account the benefit of breast-feeding to the child and the benefit of filgrastim therapy to the woman.
Croatian: Odluku o tome da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje filgrastimom treba donijeti uzimajući u obzir korist dojenja za dijete u odnosu na korist liječenja filgrastimom za ženu.
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, potrebno je razmotriti alternativne oblike liječenja, za koje nije nužna potpora progenitorskim stanicama.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Croatian: U nekim su slučajevima simptomi recidivirali pri ponovnoj primjeni, što je upućivalo na uzročno-posljedičnu povezanost.
English: There were no differences in the safety profiles for paediatric patients treated for severe chronic neutropenia.
Croatian: Nije bilo razlika u profilu sigurnosti primjene u odnosu na bolesnike liječene zbog teške kronične neutropenije.
English: Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim.
Croatian: Neki bolesnici mogu reagirati vrlo brzo, i znatnim povećanjem broja neutrofila već na prvu dozu filgrastima.
English: It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Croatian: Važno je da se odmah javite liječniku ako osjetite bol u gornjem dijelu trbuha s lijeve strane ili u lijevom ramenu jer to može upućivati na poteškoće sa slezenom.
English: In other circumstances, additional leukaphereses may be necessary.
Croatian: U drugim okolnostima možda će trebati veći broj leukafereza.
English: - Increased spleen size and cases of spleen ruptures have been reported.
Croatian: - Zabilježeni su povećanje slezene i slučajevi prsnuća slezene.
English: Do not use Biograstim in the 24 hours before or the 24 hours after your chemotherapy.
Croatian: Nemojte primjenjivati Biograstim 24 sata prije ili 24 sata nakon kemoterapije.
English: When a peripheral blood progenitor cell transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Croatian: Kada se planira presađivanje progenitorskih stanica periferne krvi, preporučuje se postupak mobilizacije matičnih stanica planirati rano u tijeku liječenja bolesnika.
English: The most suitable places to inject yourself are: - the top of your thighs; and - the abdomen, except for the area around the navel (see picture 3).
Croatian: Najprikladnija mjesta za samostalnu primjenu injekcije su: - gornji dio bedara; te - trbuh, osim područja oko pupka (vidjeti sliku 3).
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Croatian: Gurajte klip sve do broja na štrcaljki koji odgovara dozi lijeka Biograstim (u mililitrima, ml) koju Vam je propisao liječnik.
English: It is important that you dispose of used syringes in a puncture-proof container.
Croatian: Važno je upotrijebljene štrcaljke odložiti u neprobojnom spremniku.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Croatian: Prema nekim podacima iz ispitivanja jednokratnih doza, pri intravenskoj primjeni može se skratiti trajanje učinka lijeka.
English: Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Croatian: Neki citotoksični lijekovi osobito su toksični za hematopoetske progenitorske stanice i mogu štetno utjecati na njihovu mobilizaciju.
English: Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Croatian: Njegova će primjena nakon indukcijske i konsolidacijske terapije akutne mijeloične leukemije možda trajati znatno dulje (do 38 dana), ovisno o vrsti, dozi i shemi primijenjene citotoksične kemoterapije.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim s niže navedenima.
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 progenitorskih stanica, zbog čega treba pozorno nadzirati krvnu sliku.
English: After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Croatian: Nakon razrjeđenja: Dokazana je kemijska i fizikalna stabilnost u primjeni razrijeđene otopine za infuziju tijekom 24 sata na temperaturama od 2˚C do 8˚C.
English: Anaemia, splenomegaly
Croatian: Anemija, splenomegalija
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Multipack Carton - Without Blue Box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU Kutija za višestruko pakiranje - bez plavog okvira
English: If you experience fatigue, do not drive or use any tools or machines.
Croatian: Upravljanje vozilima i strojevima Osjetite li umor, nemojte upravljati vozilom ni rukovati bilo kojim alatom ili strojem.
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Croatian: Acetatna kiselina, ledena Natrijev hidroksid Sorbitol (E420) Polisorbat 80
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Biograstim - ako ste alergični na filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10 % of patients.
Croatian: Bilo je prijava glavobolje i proljeva kratko vrijeme nakon početka primjene filgrastima, obično u manje od 10 % bolesnika.
English: - It is important to contact your doctor immediately if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Croatian: Važno je da se odmah obratite liječniku ako imate bilo koju od sljedećih nuspojava ili njihovu kombinaciju: oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, teškoće disanja, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: There are no adequate data from the use of filgrastim in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni filgrastima u trudnica.
English: - As a very common (may affect more than 1 in 10 people) side effect, filgrastim may cause bone and muscle pain.
Croatian: Kao vrlo čestu nuspojavu (može se javiti u više od 1 na 10 osoba), filgrastim može uzrokovati bol u kostima i mišićima.
English: Your doctor might check your bone density regularly.
Croatian: Liječnik može redovito kontrolirati gustoću kostiju.
English: - Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported.
Croatian: - Prijavljene su alergijske reakcije poput kožnog osipa, uzdignuća po koži koja svrbe i ozbiljnih alergijskih reakcija sa slabosti, padom krvnog tlaka, otežanim disanjem i oteknućem lica.
English: If someone else is injecting you, they can also use the back of your arms (see picture 4).
Croatian: Ako Vam netko drugi daje injekciju, ona se može primijeniti i na stražnji dio nadlaktica (vidjeti sliku
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, uvjeti i vrijeme čuvanja su odgovornost korisnika i normalno ne bi trebali biti dulji od 24 sata na temperaturi od 2˚C do 8˚C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - 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: Da biste si dali injekciju trebati ćete sljedeće: - napunjenu štrcaljku lijeka Biograstim; - tupfer natopljen alkoholom ili slično; - neprobojni spremnik (plastični spremnik koji ste dobili iz bolnice ili ljekarne) tako da možete sigurno odložiti upotrijebljene štrcaljke.
English: Long-term safety follow-up of donors is ongoing.
Croatian: U tijeku je dugoročno praćenje sigurnosti primjene lijeka u davatelja.
English: In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
Croatian: U svim slučajevima ono je pri pregledima bilo blago do umjereno, a klinički je tijek bio dobroćudan; ni u jednog bolesnika nije dijagnosticiran hipersplenizam i ni u jednog nije obavljena splenektomija.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
Croatian: Razrijeđeni se filgrastim može adsorbirati na staklene i plastične materijale, osim ako je razrijeđen kako je navedeno u dijelu 6.6.
English: There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Croatian: Nije bilo relevantnih razlika između Biograstima i referentnog pripravka u trajanju teške neutropenije ni u incidenciji febrilne neutropenije.
English: - If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Biograstim.
Croatian: Ako bolujete od anemije srpastih stanica, svakako to kažite liječniku prije nego što počnete uzimati Biograstim.
English: cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: Rezultati brojanja CD34+ stanica protočnom citometrijom kolebaju ovisno o preciznosti metodologije koja se koristi te stoga preporuke o broju stanica zasnovane na brojenju u drugim laboratorijima treba tumačiti s oprezom.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Croatian: Djelotvornost lijeka bila je u te dobne skupine nedvojbena, uključujući i većinu bolesnika s kongenitalnom neutropenijom.
English: You may experience the following additional side effects:
Croatian: Mogu se dodatno javiti sljedeće nuspojave:
English: Spleen size should be evaluated regularly.
Croatian: Veličinu slezene treba redovito kontrolirati.
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: Pripravci poput melfalana, karmustina (BCNU) i karboplatina, ako se daju tijekom dužeg vremenskog razdoblja prije mobilizacije, mogu smanjiti prinos progenitorskih stanica.
English: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Croatian: Nakon što prođe neutropenija, potrebno je odrediti minimalnu djelotvornu dozu za održavanje normalnog broja neutrofila.
English: Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Croatian: Biograstim je indiciran za mobilizaciju progenitorskih stanica periferne krvi (PBPC).
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “capillary leak syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Ovo mogu biti simptomi manje čestog (može zahvatiti do 1 na 100 osoba) stanja koje se naziva „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
Croatian: Bilo je povremenih prijava Sweetovog sindroma (akutna febrilna dermatoza).
English: Inject the liquid slowly and evenly, always keeping your skin pinched.
Croatian: Injicirajte tekućinu polagano i ravnomjerno, cijelo vrijeme držeći kožu između palca i kažiprsta.
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 HIV-a.
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Croatian: Relativni rizik (95% CI) za GvHD i TRM nakon terapije G-CSF-om nakon transplantacije koštane srži
English: In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with filgrastim should be considered and appropriate medical care given.
Croatian: U slučaju sumnje ili potvrđenih plućnih nuspojava, mora se razmotriti prekid liječenja filgrastimom te pružiti odgovarajuću medicinsku skrb.
English: You will need to have regular blood tests whilst being treated with Biograstim to count the number of neutrophils and other white blood cells in your blood.
Croatian: Za vrijeme primjene lijeka Biograstim morati ćete redovito kontrolirati krvnu sliku, da se odredi broj neutrofila i drugih bijelih krvnih stanica u Vašoj krvi.
English: Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Croatian: U tih bolesnika osobitu pozornost treba posvetiti broju mobiliziranih progenitorskih stanica prije primjene velikih doza kemoterapije.
English: Nausea/Vomiting Constipation, anorexia, diarrhoea, mucositis
Croatian: Konstipacija, anoreksija, proljev, mukozitis
English: Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3 % of patients a splenectomy was required.
Croatian: Pokazalo se da se povećavanje slezene usporava ili zaustavlja smanjenjem doze, a u 3 % bolesnika morala se obaviti splenektomija.
English: The mechanism of vasculitis in patients receiving filgrastim is unknown.
Croatian: Mehanizam pojave vaskulitisa u bolesnika koji primaju filgrastim nije poznat.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥ 1/1000 to < 1/100) in cancer patients undergoing chemotherapy and healthy donors undergoing peripheral blood progenitor cell mobilisation following administration of G-CSFs; see section 4.4 and subsection “Description of selected adverse reactions” of section 4.8.
Croatian: Sindrom povećane propusnosti kapilara, koji može biti životno ugrožavajući ukoliko se ne počne liječiti na vrijeme, prijavljen je manje često (≥ 1/1000 i < 1/100) u bolesnika s rakom koji su na kemoterapiji i zdravih darivatelja u kojih se provodila mobilizacija progenitorskih stanica periferne krvi nakon primjene G-CSF-a; vidjeti dio 4.4 i odjeljak „Opis odabranih nuspojava“ dijela 4.8.
English: Biograstim contains sorbitol.
Croatian: Biograstim sadržava sorbitol.
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je zamućen ili sadržava čestice.