FrancophonIA/ELRC3.0 huggingface dataset:
English: Paina,e
Croatian: Orofaringealna bola,e
English: if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Croatian: - ako se liječite zbog teške kronične neutropenije i imate krv u mokraći (hematuriju).
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics (t(8;21), t(15;17), and inv(16)) have not been established.
Croatian: AML u dobi od < 55 godina s povoljnim citogenetskim nalazom (t(8;21), t(15;17), i inv(16)) nisu ustanovljene.
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Tevagrastim that your doctor prescribed.
Croatian: Gurajte klip sve do broja na štrcaljki koji odgovara dozi lijeka Tevagrastim (u mililitrima, ml) koju Vam je propisao liječnik.
English: Your doctor will tell you how much Tevagrastim you should take.
Croatian: Vaš liječnik će Vam reći koliko Tevagrastima trebate uzeti.
English: Tevagrastim is not recommended during pregnancy.
Croatian: Tevagrastim se ne preporučuje tijekom trudnoće.
English: Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Croatian: Tevagrastim je indiciran za liječenje perzistentne neutropenije (ABN 1,0 x 109/l ili manji) u bolesnika s uznapredovalom HIV-infekcijom, sa svrhom da se smanji rizik od bakterijskih infekcija, kada druge mogućnosti liječenja neutropenije nisu prikladne.
English: Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard.
Croatian: Napunjena štrcaljka (staklo tipa I), s iglom za injekciju (od nehrđajućeg čelika), sa ili bez zaštite za iglu.
English: The stem cells will then go back into the bone marrow and produce blood cells.
Croatian: Matične stanice potom se vraćaju u koštanu srž i proizvode krvne stanice;
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as described 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: In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
Croatian: U randomiziranim kliničkim ispitivanjima davala se supkutana doza od 23 MIU (230 μg )/m2/dan (4,0 do 8,4 μg/kg/dan).
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Croatian: Kada se razrjeđuje u 5%-tnoj otopini glukoze (50 mg/ml), Tevagrastim je kompatibilan sa staklom i različitim vrstama plastike, uključujući PVC, poliolefin (kopolimer polipropilena i polietilena) i polipropilen.
English: Take your Tevagrastim pre-filled syringe out of the refrigerator.
Croatian: Uzmite napunjenu štrcaljku lijeka Tevagrastim iz hladnjaka.
English: In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
Croatian: 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: It is unknown whether filgrastim/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se filgrastim/metaboliti u majčino mlijeko u ljudi.
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 %
English: > 2.0 x 109/L).
Croatian: 109/l).
English: If you forget to use Tevagrastim
Croatian: Ako ste zaboravili primijeniti Tevagrastim
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5 % of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Croatian: Broj bijelih krvnih stanica od 100 x 109/l ili veći uočen je u manje od 5 % bolesnika oboljelih od raka koji su primali filgrastim u dozama većima od 0,3 MIU/kg/dan (3 μg/kg/dan).
English: Your doctor will tell you how long you will need to take Tevagrastim.
Croatian: Vaš liječnik će Vam reći koliko dugo trebate uzimati Tevagrastim.
English: Tevagrastim is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia).
Croatian: Tevagrastim se koristi u liječenju djece koja primaju kemoterapiju ili koja boluju od teškog oblika smanjenog broja bijelih krvnih stanica (neutropenije).
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Croatian: Farmakoterapijska skupina: Imunostimulatori, faktori stimulacije rasta kolonija, ATK oznaka:
English: Nevertheless, a risk of promotion of a malignant myeloid clone can not be excluded.
Croatian: Unatoč tome, ne može se isključiti rizik poticanja rasta klona zloćudnih mijeloičnih stanica.
English: Tevagrastim is a solution for injection/infusion in a pre-filled syringe.
Croatian: Tevagrastim je otopina za injekciju/infuziju u napunjenoj štrcaljki.
English: Tevagrastim is a clear and colourless solution.
Croatian: Tevagrastim je bistra i bezbojna otopina.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Tevagrastim
Croatian: Osim ako Vaš liječnik ne savjetuje drugačije, morate prestati dojiti ako uzimate Tevagrastim.
English: The efficacy and safety of Tevagrastim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Croatian: Djelotvornost i sigurnost primjene Tevagrastima ispitane su u randomiziranim, kontroliranim ispitivanjima III. faze u bolesnica/bolesnika s rakom dojke, rakom pluća i ne-Hodgkinovim limfomom.
English: Tevagrastim may have a minor influence on your ability to drive and use machines.
Croatian: Tevagrastim može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: What should I do before I give myself a subcutaneous injection of Tevagrastim?
Croatian: Što trebate napraviti prije nego si date potkožnu injekciju lijeka Tevagrastim?
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 µg/kg/day).
Croatian: Potomstvo štakora kojima je primjenjivan filgrastim u perinatalnoj fazi i tijekom razdoblja laktacije, pokazuje kašnjenje u vanjskoj diferencijaciji i retardaciju rasta (≥ 20 µg/kg/dan) te nešto nižu stopu preživljenja (100 µg/kg/dan).
English: - The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Croatian: - Drugi sastojci su: natrijev hidroksid, ledena acetatna kiselina, sorbitol, polisorbat 80, voda za injekcije.
English: Check the appearance of Tevagrastim.
Croatian: Provjerite izgled lijeka Tevagrastim.
English: Tevagrastim is a biosimilar medicinal product.
Croatian: Tevagrastim je biosličan lijek.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Croatian: • promjene u načinu na koji tijelo regulira tekućine unutar tijela, što može dovesti do otečenosti (poremećaji volumena tekućine)
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Croatian: Razrijeđeni filgrastim se može adsorbirati na staklo i plastični materijal, osim ako se ne razrijedi kako je niže navedeno.
English: Tevagrastim 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: - if you have a combination of any of the following symptoms: fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Croatian: - ako imate kombinaciju bilo kojih od sljedećih simptoma: vrućicu ili drhtanje, odnosno osjećaj velike hladnoće, ubrzane otkucaje srca, smetenost ili dezorijentiranost, nedostatak zraka, jaku bol ili neugodu te ljepljivu ili znojnu kožu.
English: If you use more Tevagrastim than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako primjenite više lijeka Tevagrastim nego što ste trebali, javite se što prije Vašem liječniku ili ljekarniku.
English: Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in Escherichia coli K802 by recombinant DNA technology.
Croatian: Filgrastim (rekombinantni metionil ljudski faktor stimulacije rasta granulocita) proizveden je tehnologijom rekombinantne DNK u bakteriji Escherichia coli K802. Pomoćna tvar s poznatim učinkom
English: You will normally receive your first dose of Tevagrastim at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Croatian: Obično ćete primiti svoju prvu dozu Tevagrastima barem 24 sata nakon kemoterapije i barem 24 sata nakon primitka transplantata koštane srži.
English: The needle safety guard covers the needle after injection to prevent needle stick injury.
Croatian: Zaštita za iglu prekriva iglu nakon injiciranja da bi se spriječile eventualne ozljede.
English: You will need to take Tevagrastim until your white blood cell count is normal.
Croatian: Tevagrastim ćete morati uzimati dok se broj Vaših leukocita ne vrati u normalu.
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon injiciranja tekućine, izvadite iglu i pustite kožu između prstiju.
English: Normal donors are given a dose of a 10 μg/kg/day, administered subcutaneously for 4 to 5 consecutive days.
Croatian: Zdravim se davateljima daje doza od 10 μg /kg/dan supkutano tijekom 4 do 5 uzastopnih dana.
English: Filgrastim
Croatian: filgrastima.
English: How is Tevagrastim given and much should I take?
Croatian: Kako se Tevagrastim primjenjuje i koliko Tevagrastima moram uzeti?
English: Tevagrastim contains sorbitol
Croatian: Tevagrastim sadrži sorbitol
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
Croatian: • uzdignute, bolne, tamnoplave promjene na koži na udovima te ponekad na licu i vratu praćene vrućicom (Sweetov sindrom)
English: • disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
Croatian: • bolest koja uzrokuje smanjenje gustoće kostiju, zbog čega su kosti slabije, krhkije i sklonije lomu (osteoporoza) • reakcija na mjestu injekcije
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Tevagrastim was comparable to that of the reference product after subcutaneous and intravenous administration.
Croatian: 5.2 Farmakokinetička svojstva Randomizirano, jednostruko slijepo, s jednom dozom, ukriženo ispitivanje u 196 zdravih dragovoljaca pokazalo je da je farmakokinetički profil Tevagrastima i pri supkutanoj i pri intravenskoj primjeni bio usporediv s farmakokinetičkim profilom referentnog lijeka.
English: It is important to contact your doctor immediately - if 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: Važno je da se odmah obratite liječniku - ako dobijete alergijsku reakciju, uključujući slabost, pad 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: Tevagrastim has not been tested in pregnant or breast-feeding women.
Croatian: Tevagrastim nije ispitivan na trudnicama ili dojiljama.
English: • increase of certain enzymes in the blood
Croatian: • porast određenih enzima u krvi • promjene rezultata krvnih pretraga
English: Teva Finland Oy Puh/Tel: +358 20 180 5900
Croatian: Puh/Tel: +358 20 180 5900
English: Tevagrastim stimulates the bone marrow to produce new white cells quickly.
Croatian: Tevagrastim stimulira koštanu srž da brže proizvodi nove bijele stanice.
English: Tevagrastim does not contain any preservative.
Croatian: Tevagrastim ne sadržava konzervans.
English: Acute grade II-IV GvHD
Croatian: GvHD-a II-IV
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 Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Croatian: U bolesnika, djece i odraslih, s teškom kongenitalnom cikličkom ili idiopatskom neutropenijom i apsolutnim brojem neutrofila (ABN) ≤ 0,5 x 109/l, kao i s teškim ili rekurentnim infekcijama u anamnezi, dugotrajna primjena Tevagrastima se koristi za povećanje broja neutrofila i za smanjenje incidencije i skraćivanje trajanja događaja povezanih s infekcijama.
English: After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Croatian: Nakon injiciranja tekućine, izvadite iglu zadržavajući pritisak na klipu i nakon toga pustite kožu između prstiju.
English: These could be symptoms of condition called “capillary leak syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Ovi simptomi se obično brzo razvijaju, a mogu biti simptomi stanja koje se naziva „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
Croatian: Način primjene Filgrastim se može davati kao 30-minutna ili 24-satna intravenska infuzija ili kao neprekidna 24-satna supkutana infuzija.
English: Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Croatian: Tevagrastim je indiciran i za mobilizaciju progenitorskih stanica periferne krvi.
English: What you need to know before you use Tevagrastim Do not use Tevagrastim
Croatian: Što morate znati prije nego počnete primjenjivati Tevagrastim
English: If the ANC decreases to < 1.0 x 109/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps
Croatian: Obustaviti filgrastim Smanji li se ABN tijekom trajanja terapije na < 1,0 x 109/l, dozu filgrastima treba ponovno povećavati u skladu s gornjom shemom.
English: What Tevagrastim is and what it is used for What Tevagrastim is
Croatian: Što je Tevagrastim i za što se koristi
English: - 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: - ako imate bilo koju od sljedećih nuspojava ili njihovu kombinaciju: oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, otežano disanje, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: Decreased appetitee Blood lactate dehydrogen ase increased
Croatian: Povišena laktat dehidrogenaza u krvi
English: See also section 4.8.
Croatian: (vidjeti dijelove 4.8 i 5.1).
English: Tevagrastim must not be diluted with sodium chloride solution.
Croatian: Tevagrastim se ne smije razrjeđivati s otopinom natrijeva klorida.
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Croatian: Filgrastim se ne smije primjenjivati u bolesnika s anamnezom preosjetljivosti na filgrastim ili pegfilgrastim.
English: If required, Tevagrastim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Croatian: Po potrebi, Tevagrastim se može razrijediti u 5% -tnoj otopini glukoze za infuziju (50 mg/ml).
English: Tevagrastim 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: Tevagrastim je indiciran za skraćivanje trajanja neutropenije i smanjenje incidencije febrilne neutropenije u bolesnika s malignim bolestima koji se liječe citotoksičnom kemoterapijom (osim kronične mijeloične leukemije i mijelodisplastičnih sindroma) i za skraćivanje trajanja neutropenije u bolesnika koji su prije presađivanja koštane srži primili mijeloablacijsku terapiju, izloženih povećanom riziku od produljene, teške neutropenije.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Tevagrastim; - alcohol wipes or similar.
Croatian: - napunjenu štrcaljku lijeka Tevagrastim; - tupfer natopljen alkoholom ili slično;
English: Solution for injection/infusion
Croatian: Otopina za injekciju/infuziju.
English: if 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: - ako osjetite bol u gornjem lijevom dijelu trbuha (abdomena), bol na lijevoj strani ispod rebara ili bol pri vrhu ramena, jer možete imati problem sa slezenom (uvećanje slezene (splenomegalija) ili puknuće (ruptura) slezene).
English: Capillary leak syndromea Aortitis
Croatian: Sindrom povećane propusnosti kapilaraa Aortitis
English: In a small number of patients (< 10 %), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve reversal of neutropenia.
Croatian: U malog broja bolesnika (< 10 %) za ispravljanje neutropenije bile su nužne doze do 1,0 MIU (10
English: The first dose of ffilgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Croatian: Prva doza filgrastima smije se dati najmanje 24 sata nakon citotoksične kemoterapije.
English: Permanently discontinue Tevagrastim in patients with clinically significant hypersensitivity.
Croatian: Liječenje Tevagrastimom mora se trajno prekinuti u bolesnika u kojih se razvije klinički značajna preosjetljivost.
English: The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Croatian: Mijelodisplastični sindrom ili kronična mijeloična leukemija Sigurnost i djelotvornost filgrastima u bolesnika s mijelodisplastičnim sindromom ili s kroničnom mijeloičnom leukemijom nisu ustanovljene.
English: - The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required.
Croatian: Odlaganje upotrijebljenih štrcaljki - Zaštita za iglu sprečava ozljede iglom nakon uporabe, stoga nema nekih posebnih mjera opreza prilikom zbrinjavanja.
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Croatian: Postojeći podaci pokazuju da imunološke interakcije između presađenih alogenih progenitorskih stanica periferne krvi i primatelja mogu biti povezane s većim rizikom od akutne i kronične bolesti
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Tevagrastim Lijek čuvajte izvan pogleda i dohvata djece.
English: - if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: - ako počnete kašljati, dobijete vrućicu ili počnete otežano disati (dispneja) jer to mogu biti znakovi akutnog sindroma respiratornog distresa (ARDS). - ako se u Vas razvije oštećenje bubrega (glomerulonefritis).
English: How to store Tevagrastim
Croatian: Kako primjenjivati Tevagrastim
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy c. Description of selected adverse reactions
Croatian: b Zabilježena su slučajevi GvHD-a i smrtnih ishoda u bolesnika nakon alogene transplantacije koštane srži (vidjeti dio c) c Uključuje bol u kostima, bol u leđima, artralgiju, mialgiju, bol u ekstremitetima, bol u mišićima i kostima, bol u mišićima i kostima prsnog koša, bol u vratu d Slučajevi su uočeni nakon stavljanja lijeka u promet u bolesnika koji se podvrgavaju transplantaciji koštane srži ili mobilizaciji progenitorskih stanica periferne krvi e Štetni događaji s većom incidencijom u bolesnika liječenih filgrastimom nego u onih koji su primali placebo, te povezani s posljedicama podležeće zloćudne bolesti ili citotoksične kemoterapije c.
English: EU/1/08/445/005 EU/1/08/445/006 EU/1/08/445/007 EU/1/08/445/008 EU/1/08/445/012 EU/1/08/445/013 EU/1/08/445/014
Croatian: EU/1/08/445/001 EU/1/08/445/002 EU/1/08/445/003 EU/1/08/445/004 EU/1/08/445/009 EU/1/08/445/010 EU/1/08/445/011 EU/1/08/445/005 EU/1/08/445/006 EU/1/08/445/007 EU/1/08/445/008 EU/1/08/445/012 EU/1/08/445/013 EU/1/08/445/014
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL (60 MIU/mL, 600 microgram/mL).
Croatian: Jedna napunjena štrcaljka sadrži 30 milijuna internacionalnih jedinica [MIU] (300 mikrograma) filgrastima u 0,5 ml (60 MIU /ml, 600 mikrograma/ml).
English: 5.2 Pharmacokinetic properties
Croatian: FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
English: Dispose of the syringe as instructed by your doctor, nurse or pharmacist.
Croatian: Štrcaljku zbrinite kako su Vam objasnili liječnik, medicinska sestra ili ljekarnik.
English: • low blood pressure (hypotension)
Croatian: • nizak krvni tlak (hipotenzija) • visok krvni tlak (hipertenzija)
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Croatian: • umor • bolovi i oticanje sluznice probavnog trakta od usta do anusa (upala sluznice)
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of >4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Croatian: Primjenom filgrastima u zdravih davatelja u svrhu mobilizacije progenitorskih stanica periferne krvi prije alogenog presađivanja tih stanica, u većine se davatelja dvjema leukaferezama prikupi ≥ 4 x 106 CD34 +* stanica po kg tjelesne težine davatelja.
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,
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET