FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Nivestim 12 MU/0.2 ml
Slovenian: Nivestim 12 M e./0,2 ml
English: It is advisable to wait and see how you feel after taking Nivestim and before driving or operating machinery.
Slovenian: Pred vožnjo avtomobila ali upravljanjem strojev je priporočljivo počakati, da vidite, kako se počutite po tem, ko vzamete zdravilo Nivestim.
English: • pain and swelling of the joints, similar to gout (pseudogout)
Slovenian: • bolečina v sklepih in zatekanje sklepov, podobno putiki (psevdoputika)
English: • The other ingredients are acetic acid (glacial), sodium hydroxide, sorbitol E420, polysorbate 80, and water for injections.
Slovenian: • Druge pomožne snovi so: koncentrirana ocetna kislina, natrijev hidroksid, sorbitol E420, polisorbat 80, voda za injekcije.
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Slovenian: Za mobilizacijo PBPC pri normalnih darovalcih pred alogensko presaditvijo PBPC
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction (hypersensitivity).
Slovenian: • se vam pojavijo nenadni znaki alergije, kot so izpuščaj, srbečica ali koprivnica na koži, otekanje obraza, ustnic, jezika ali drugih delov telesa, kratka sapa, piskajoče ali oteženo dihanje.
English: • the front of the thighs, • the abdomen, except for the area around the navel.
Slovenian: • trebuh, razen predela okoli popka.
English: The recommended dose of filgrastim is 0.5 MU (5 µg)/kg/day.
Slovenian: Priporočeni odmerek filgrastima je 0,5 M e. (5 µg)/kg/dan.
English: The results of flow cytometric analysis of CD34
Slovenian: Rezultati meritev števila celic CD34
English: Nivestim must not be diluted with sodium chloride solution.
Slovenian: Zdravila Nivestim se ne sme redčiti z raztopinami natrijevega klorida.
English: If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: • inflammation of the lungs (interstitial lung disease)
Slovenian: • vnetje pljuč (intersticijska bolezen pljuč)
English: 1 pre-filled syringe with 0.5 ml 5 pre-filled syringes with 0.5 ml 8 pre-filled syringes with 0.5 ml 10 pre-filled syringes with 0.5 ml
Slovenian: raztopina za injiciranje/infundiranje 1 napolnjena brizga z 0,5 ml raztopine 5 napolnjenih brizg z 0,5 ml raztopine 8 napolnjenih brizg z 0,5 ml raztopine 10 napolnjenih brizg z 0,5 ml raztopine
English: Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts.
Slovenian: Pri povečevanju števila nevtrofilcev deluje filgrastim predvsem na predhodnike nevtrofilcev in tako poveča število nevtrofilcev.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Slovenian: Pri bolnikih, ki se zdravijo z mieloablativno terapijo, ki ji sledi presaditev kostnega mozga
English: Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Slovenian: Pri bolnikih z osteoporotičnimi obolenji kosti, ki se neprekinjeno zdravijo s filgrastimom dlje kot 6 mesecev, je lahko indicirano spremljanje gostote kosti.
English: • bleeding from the lung (pulmonary haemorrhage)
Slovenian: • krvavitev iz pljuč (pljučna hemoragija)
English: The recommended starting dose of filgrastim is 1.0 MU (10 µg)/kg/day.
Slovenian: Priporočeni začetni odmerek filgrastima je 1,0 M e. (10 µg)/kg/dan.
English: Special precautions in sickle cell trait and sickle cell disease
Slovenian: Posebni previdnostni ukrepi pri bolnikih z genetsko predispozicijo za srpaste celice in pri anemiji srpastih celic
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy.
Slovenian: Zdravljenje samo s filgrastimom ne preprečuje pojava trombocitopenije in anemije, ki se pojavita zaradi mielosupresivne kemoterapije.
English: You do not have to remove the air bubble before injecting.
Slovenian: Morda boste v brizgi opazili majhen zračni mehurček, ki ga ni treba odstraniti pred injiciranjem.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Slovenian: Če se pri vas pojavi ta neželeni učinek ali če v urinu odkrijejo beljakovine (proteinurija), bo morda zdravnik redno preverjal vaš urin.
English: Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Slovenian: Dnevni odmerek filgrastima je treba uporabljati, dokler se število nevtrofilcev ne premakne s pričakovane najnižje vrednosti in se povrne v območje normalnih vrednosti.
English: Filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Slovenian: Filgrastim je treba razredčiti z 20 ml 5-odstotne raztopine glukoze (glejte poglavje 6.6).
English: Blood cell counts
Slovenian: Število krvnih celic
English: Information on self administration by the patient
Slovenian: Navodila o samoinjiciranju zdravila za bolnike
English: Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain.
Slovenian: Vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečine v okončinah, mišično-skeletne bolečine, mišično-skeletne bolečine v prsih, bolečine v vratu.
English: • rejection of transplanted bone marrow (graft versus host disease)
Slovenian: • zavrnitev presajenega kostnega mozga (reakcija presadka proti gostitelju)
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Slovenian: Pri zdravih darovalcih in pri bolnikih so po uporabi filgrastima poročali o običajno asimptomatskih primerih splenomegalije in o primerih rupture vranice.
English: Remove the Nivestim syringe from the fridge and allow it to reach room temperature (approximately 25 C).
Slovenian: Vzemite brizgo zdravila Nivestim iz hladilnika in pustite, da se ogreje na sobno temperaturo (približno 25 C), kar bo trajalo od 15 do 30 minut.
English: Pre-filled syringe (type I glass), with injection needle (stainless steel) with a needle guard, containing 0.2 ml solution for injection/infusion.
Slovenian: Napolnjena brizga (iz stekla tipa I) z injekcijsko iglo (iz nerjavečega jekla) z varnostno zaščito, ki vsebuje 0,2 ml raztopine za injiciranje/infundiranje.
English: Rare (≥ 1/10,000 to
Slovenian: Redki (> 1/10.000 do <
English: A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Slovenian: Pri bolnikih, ki imajo hude okužbe, je možno premisliti o hitrejšem povečevanju odmerka.
English: Each ml contains 60 million units [MU] (600 g) or 96 million units [MU] (960 g) of filgrastim.
Slovenian: En mililiter vsebuje 60 milijonov enot [M e.] (600 µg) ali 96 milijonov enot [M e.] (960 µg)
English: • decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
Slovenian: • zmanjšanje števila trombocitov, kar zmanjša sposobnost strjevanja krvi (trombocitopenija)
English: • inflammation of the lung (bronchitis)
Slovenian: • vnetje pljuč (bronhitis)
English: Acetic acid glacial, sodium hydroxide, polysorbate 80, sorbitol (E420) and water for injections..
Slovenian: Koncentrirana ocetna kislina, natrijev hidroksid, polisorbat 80, sorbitol (E420) in voda za injekcije.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious disease.
Slovenian: Mobilizacijo matičnih celic v periferno kri je možno uporabiti le pri tistih darovalcih, ki ustrezajo normalnim kliničnim in laboratorijskim kriterijem primernosti za darovanje matičnih celic.
English: Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
Slovenian: Če opazite zabuhlost obraza ali gležnjev, kri v urinu ali rjavo obarvan urin, ali če opazite, da urinirate manj kot običajno, takoj pokličite svojega zdravnika.
English: Nivestim 30 MU/0.5 ml
Slovenian: Nivestim 30 M e./0,5 ml
English: The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5 to 7 consecutive days.
Slovenian: Priporočeni odmerek filgrastima za mobilizacijo krvotvornih matičnih celic v periferno kri pri samostojni uporabi je 1,0 M e. (10 µg)/kg/dan od 5 do 7 zaporednih dni.
English: Pre-filled syringe (type I glass), with injection needle (stainless steel) with a needle guard, containing 0.5 ml solution for injection/infusion
Slovenian: Napolnjena brizga (iz stekla tipa I) z injekcijsko iglo (iz nerjavečega jekla) z varnostno zaščito, ki vsebuje 0,5 ml raztopine za injiciranje/infundiranje.
English: For infusions filgrastim should be diluted in 20 ml of 5% glucose solution (see section 6.6).
Slovenian: Za infundiranje je treba filgrastim razredčiti z 20 ml 5-odstotne raztopine glukoze (glejte poglavje 6.6).
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Slovenian: Pri normalnih darovalcih so po uporabi G-CSF opazili prehodno nenormalen citogenski izvid .
English: Make sure you have your sharps container nearby.
Slovenian: V bližini morate imeti vsebnik za odlaganje ostrih odpadkov.
English: Fatigue a
Slovenian: Uporabno do
English: Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medications.
Slovenian: Zdravljenje s filgrastimom samim ne izključuje možnosti pojava trombocitopenije in anemije pri jemanju mielosupresivnega zdravila.
English: There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c).
Slovenian: Pri bolnikih so po alogeni presaditvi kostnega mozga poročali o GvHD in smrtnih primerih (glejte poglavje c).
English: Transient thrombocytopenia (platelets < 100 x 10
Slovenian: Prehodno trombocitopenijo (število trombocitov < 100 x 10
English: Nivestim is one of a group of products that stimulate the production of white blood cells.
Slovenian: Zdravilo Nivestim sodi v skupino zdravil, ki spodbujajo nastanek belih krvničk.
English: Patients with a recent history of lung infiltrates or pneumonia may be at higher risk.
Slovenian: Tveganje je lahko večje pri bolnikih z nedavno anamnezo pljučnih infiltratov ali pljučnice.
English: Uncommon (≥ 1/1,000 to
Slovenian: Občasni (>1/1.000 do <
English: Common (≥ 1/100 to
Slovenian: Pogosti (> 1/100 do <
English: • generalised weakness (asthenia)
Slovenian: • splošna oslabelost (astenija)
English: Complete blood cell counts with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
Slovenian: Pred zdravljenjem je treba opraviti preiskavo celotne krvne slike z diferencialno krvno sliko in številom trombocitov ter ovrednotiti morfologijo kostnega mozga in kariotipa.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, ki so bili zdravljeni s filgrastimom, so poročali o preobčutljivosti, vključno z anafilaktičnimi reakcijami, ki se pojavijo med začetnim ali nadaljnjim zdravljenjem.
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Slovenian: Pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
English: The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Slovenian: Bolnik sme prejeti prvi odmerek filgrastima najmanj 24 ur po citotoksični kemoterapiji.
English: Use of UltraSafe Passive Needle Guard for Nivestim 30 MU/0.5 ml solution for injection/infusion and Nivestim 48 MU/0.5 ml solution for injection/infusion
Slovenian: Uporaba pasivne varnostne zaščite za iglo UltraSafe za zdravilo Nivestim 30 M e./ 0,5 ml raztopino za injiciranje/ infundiranje in zdravilo Nivestim 48 M e./0,5 ml raztopino za injiciranje/ infundiranje
English: Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Slovenian: Po uporabi G-CSF so poročali o neželenih učinkih na pljučih, še posebno o intersticijski bolezni pljuč.
English: The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia.
Slovenian: V tej starostni skupini so bili večinoma bolniki s prirojeno nevtropenijo; učinkovitost zdravljenja je bila pri njih dokazana.
English: Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
Slovenian: V kliničnih študijah in v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah, vključno z anafilakso, izpuščajem, urtikarijo, angioedemom, dispnejo in hipotenzijo, ki so se pojavile na začetku ali v nadaljevanju zdravljenja.
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Slovenian: Ugotovljeno je bilo, da krvotvorne matične celice, ki so bile mobilizirane s filgrastimom, zmanjšajo stopnjo in trajanje trombocitopenije po mielosupresivni ali mieloablativni kemoterapiji.
English: Long term administration may be required to maintain the ANC > 2.0 x 10
Slovenian: Za ohranjanje vrednosti ANC > 2,0 x 10
English: 9/L) following filgrastim and leukapheresis was observed in
Slovenian: 9/l) po prejemu filgrastima in levkaferezi pa pri 35 %
English: Pulmonary adverse effects
Slovenian: Neželeni učinki na pljuča
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Slovenian: Pri bolnikih, ki so prejemali filgrastim in pegfilgrastim, so poročali o glomerulonefritisu.
English: EXP After dilution use within 24 hours.
Slovenian: Uporabno do Po redčenju zdravilo uporabite v 24 urah.
English: Water for injections
Slovenian: Oprema, ki je potrebna za injiciranje
English: Injecting the solution with an air bubble present is harmless.
Slovenian: Če je prisoten zračni mehurček, injiciranje raztopine ni nevarno.
English: Nivestim 48 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 96 million units [MU] (960 micrograms [µg]) of filgrastim*.
Slovenian: Nivestim 48 M e./0,5 ml raztopina za injiciranje/infundiranje En ml raztopine za injiciranje ali infundiranje vsebuje 96 milijonov enot [M e.] (960 mikrogramov [µg]) filgrastima*.
English: 5 pre-filled syringes with 0.2 ml 8 pre-filled syringes with 0.2 ml 10 pre-filled syringes with 0.2 ml.
Slovenian: raztopina za injiciranje/infundiranje 1 napolnjena brizga z 0,2 ml raztopine 5 napolnjenih brizg z 0,2 ml raztopine 8 napolnjenih brizg z 0,2 ml raztopine 10 napolnjenih brizg z 0,2 ml raztopine
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by transplantation.
Slovenian: Pri bolnikih, ki so prejemali velike odmerke kemoterapije, ki jim je sledila avtologna presaditev kostnega mozga, so občasno poročali o žilnih boleznih, vključno z venookluzivno boleznijo in motnjami volumna tekočin.
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro.
English: A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Slovenian: Pred dajanjem zdravila mora biti pri bolniku narejena podrobna anamneza, povezana s simptomi dedne intolerance za fruktozo.
English: Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
English: Glomerulonephritis Urine abnormality
Slovenian: Bolezni sečil disurija hematurija proteinurija glomerulonefritis nenormalni izvidi preiskav urina
English: Other special populations
Slovenian: e. Druge posebne skupine bolnikov
English: Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Slovenian: Filgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic.
English: However, in view of the potential risks associated with severe leucocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
Slovenian: Poročali niso o nobenih neželenih učinkih, ki bi jih lahko neposredno pripisali tej stopnji levkocitoze, vendar je treba glede na potencialno tveganje, povezano s pojavom hude levkocitoze, pri teh bolnikih med zdravljenjem s filgrastimom redno določati število belih krvničk.
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Slovenian: Pri bolnikih, ki so se zdravili s filgrastimom, so poročali o primerih Sweetovega sindroma (akutni febrilni nevtrofilni dermatozi).
English: • soreness and swelling of the digestive tract lining which runs from the mouth to the anus
Slovenian: • občutljivost in zatekanje sluznice prebavnega trakta, ki poteka od ust do zadnjika (vnetje sluznice)
English: • nose bleeds (epistaxis)
Slovenian: • krvavitev iz nosu (epistaksa)
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Slovenian: • spremenjeno telesno uravnavanje tekočin, ki lahko povzroči zabuhlost (motnje volumna tekočine)
English: Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Slovenian: Pri bolnikih, pri katerih se pojavi resna alergijska reakcija, je treba zdravljenje s filgrastimom trajno prekiniti.
English: Each pre-filled syringe contains 48 million units (MU) (480 micrograms [µg]) of filgrastim in 0.5 ml (0.96 mg/ml).
Slovenian: Ena napolnjena brizga vsebuje 48 milijonov enot (M e.) (480 mikrogramov [µg]) filgrastima v 0,5 ml (0,96 mg/ml).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 9/L for 3 more consecutive days
Slovenian: 9/l nadaljnje
English: Nivestim 12 MU/0.2 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Slovenian: Nivestim 12 M e./0,2 ml raztopina za injiciranje/infundiranje En ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov enot [M e.] (600 mikrogramov [µg]) filgrastima*.
English: Kidney injury has been seen in patients who received filgrastim.
Slovenian: Pri bolnikih, ki prejemajo filgrastim, so opazili poškodbo ledvic.
English: Dizziness Hypoaesthesia Paraesthesia
Slovenian: Bolezni živčevja glavobol omotica hipestezija parestezija
English: • bone density decreased
Slovenian: • zmanjšana gostota kosti
English: Graft versus Host Disease b
Slovenian: Reakcija presadka proti gostitelju (GvHD - Graft versus Host Disease)
English: Talk to your doctor, pharmacist or nurse before using Nivestim.
Slovenian: Pred uporabo zdravila se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Each pre-filled syringe contains 48 million units (MU) (480 g) of filgrastim in 0.5 ml (0.96 mg/ml)
Slovenian: Ena napolnjena brizga vsebuje 48 milijonov enot (M e.) (480 µg) filgrastima v 0,5 ml (0,96 mg/ml).
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe chronic neutropenia receiving chronic treatment with filgrastim.
Slovenian: Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki prejemajo kronično zdravljenje s filgrastimom, so poročali o primerih zmanjšane kostne gostote in osteoporoze.
English: even if their signs of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav kažejo znake bolezni, podobne vašim.
English: How do I administer my Nivestim?
Slovenian: Kako naj si injiciram zdravilo Nivestim?
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Slovenian: Po uporabi filgrastima so poročali o splenomegaliji in rupturi vranice.
English: Permanently discontinue filgrastim in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba zdravljenje s filgrastimom trajno prekiniti.
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Slovenian: Pri rakavih bolnikih, ki so bili zdravljeni s filgrastimom, so poročali o psevdoprotinu (pirofosfatna hondrokalcinoza).
English: Nivestim 30 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [µg]) of filgrastim*.
Slovenian: Nivestim 30 M e./0,5 ml raztopina za injiciranje/infundiranje En ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov enot [M e.] (600 mikrogramov [µg]) filgrastima*.
English: Acute Grade II - IV GvHD
Slovenian: N Akutna GvHD stopnje IIIV
English: What Nivestim contains
Slovenian: Kaj vsebuje zdravilo Nivestim
English: Nivestim contains sodium
Slovenian: Zdravilo Nivestim vsebuje natrij
English: Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 10
Slovenian: Pri bolnikih s hudo kronično nevtropenijo, pri katerih se pojavi trombocitopenija (število trombocitov < 100 x 10
English: Nivestim 48 MU/0.5 ml injection/infusion filgrastim
Slovenian: Nivestim 48 M e./0,5 ml injekcija/infuzija filgrastim s.c./i.v.
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Slovenian: V kliničnem preskušanju bolnikov s SCN, ki so dobivali filgrastim, so poročali o mielodisplastičnih sindromih (MDS) ali levkemiji, ki pa niso bili pogosti (pri približno 3 %).
English: In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of filgrastim therapy.
Slovenian: Pri bolnikih, ki prejemajo citotoksično kemoterapijo, je običajno opaziti prehodno povečanje števila nevtrofilcev od 1 do 2 dni po uvedbi zdravljenja s filgrastimom, vendar pa se za doseganje trajnejšega terapevtskega odziva zdravljenja s filgrastimom ne sme prekiniti, dokler se število nevtrofilcev ne premakne s pričakovane najnižje vrednosti in se povrne v območje normalnih vrednosti.
English: • dizziness
Slovenian: • izpuščaj
English: Each pre-filled syringe contains 12 million units (MU) (120 micrograms [µg]) of filgrastim in 0.2 ml (0.6 mg/ml).
Slovenian: Ena napolnjena brizga vsebuje 12 milijonov enot (M e.) (120 mikrogramov [µg]) filgrastima v 0,2 ml (0,6 mg/ml).