FrancophonIA/ELRC3.0 huggingface dataset:
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Slovenian: Mielodisplastični sindromi in levkemija so običajni zapleti pri tem obolenju, njihova povezanost z uporabo filgrastima pa je negotova.
English: Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Zdravniki morajo biti previdni pri predpisovanju filgrastima bolnikom s srpastocelično zasnovo ali srpastocelično anemijo.
English: This observation has only been made in patients with congenital neutropenia.
Slovenian: Ugotovili so jih samo pri bolnikih s prirojeno nevtropenijo.
English: Pulmonary haemorrhage
Slovenian: • mišični krč
English: • allergic reaction (hypersensitivity)
Slovenian: • alergijske reakcije (preobčutljivost na zdravilo)
English: • rejection of transplanted bone marrow (graft versus host disease)
Slovenian: • zavrnitev presajenega kostnega mozga (bolezen presadka proti gostitelju)
English: In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen, this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Slovenian: Pri zdravih darovalcih matičnih celic so opazili povečanje števila belih krvnih celic (levkocitoza), zmanjšanje števila trombocitov, kar zmanjša sposobnost vaše krvi za strjevanje (trombocitopenija), zato bo to spremljal zdravnik.
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 10
Slovenian: Pri večini zdravih darovalcev subkutano uporabljeni odmerek filgrastima 10 mikrogramov/kg/dan 4 do 5 zaporednih dni omogoča pridobitev ≥ 4 x 10
English: The long-term safety of administration of Grastofil at doses above 2.4 MU/kg/day (24 micrograms/kg/day) in patients with SCN has not been established.
Slovenian: Varnost dolgotrajne uporabe Grastofila v odmerkih več kot 2,4 M e./kg/dan (24 mikrogramov/kg/dan) pri bolnikih s hudo kronično nevtropenijo ni bila dokazana.
English: Grastofil for PBPC mobilisation when used alone
Slovenian: Grastofil za izplavljanje PBPC, če se uporablja samostojno:
English: Kidney injury has been seen in patients who received filgrastim.
Slovenian: Poškodba ledvic se je pojavila pri bolnikih, ki so dobivali filgrastim.
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Slovenian: • oteklost in/ali tekočina v pljučih (pljučni edem)
English: Telephone +43/1-367.85.85.0
Slovenian: Tel:+43/1-367.85.85.0
English: Do not use any Grastofil that may be left in the syringe.
Slovenian: Zdravila Grastofil, ki lahko ostane v brizgi, ne uporabljajte.
English: Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Slovenian: Infundiranje PBPC spodbuja hematopoetsko okrevanje, s čimer skrajša obdobje tveganja za pojav zapletov s krvavitvami in zmanjša potrebo po transfuzijah trombocitov.
English: Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Slovenian: Po neprekinjenem infundiranju filgrastima, ki je pri bolnikih, ki okrevajo po avtologni presaditvi kostnega mozga, trajalo do 28 dni, ni bilo nobenih dokazov kopičenja zdravila v telesu, razpolovni čas izločanja pa je bil primerljiv.
English: The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose.
Slovenian: Običajni začetni odmerek je med 0,5 milijonov enot (5 mikrogramov) in 1,2 milijonoma enot (12 mikrogramov) na kilogram telesne mase vsak dan, v enem ali deljenih odmerkih.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults, children and adolescents receiving cytotoxic chemotherapy suggesting no agerelated differences in the pharmacokinetics of filgrastim.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima pri odraslih, otrocih in mladostnikih, ki prejemajo citotoksično kemoterapijo, podobni, kar nakazuje, da od starosti odvisnih razlik v farmakokinetiki filgrastima ni.
English: How do I prepare my Grastofil injection?
Slovenian: Kako pripraviti svojo injekcijo zdravila Grastofil?
English: • swelling in the hands and feet (oedema peripheral)
Slovenian: • oteklost dlani in stopal (periferni edem)
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali, so pireksija, mišično-skeletna bolečina (ki vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečino v okončinah, mišičnoskeletno bolečino, mišično-skeletno bolečino v prsnem košu, bolečino v vratu), anemija, bruhanje in navzea.
English: Grastofil contains 50 mg sorbitol in each ml.
Slovenian: Zdravilo Grastofil vsebuje 50 mg sorbitola na mililiter.
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Slovenian: • boleče izbočene rane vijolične barve na okončinah in včasih na obrazu in vratu z zvišano telesno temperaturo (Sweetov sindrom)
English: cells/kg recipient bodyweight.
Slovenian: +/kg prejemnikove telesne mase.
English: You will normally receive your first dose of Grastofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Slovenian: Običajno boste prejeli prvi odmerek zdravila Grastofil vsaj 24 ur po kemoterapiji in vsaj 24 ur po presaditvi kostnega mozga.
English: It is supplied in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Slovenian: Na voljo je v napolnjeni injekcijski brizgi z merilno lestvico z 1/40 natisnjenimi oznakami od 0,1 ml do 1 ml na telesu brizge in z injekcijsko iglo.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults, children and adolescents receiving cytotoxic chemotherapy.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima pri odraslih, otrocih in mladostnikih, ki prejemajo citotoksično kemoterapijo, podobni.
English: Idiopathic or cyclic neutropenia: the recommended starting dose is 0.5 MU/kg/day (5 micrograms/kg/day) as a single dose or in divided doses.
Slovenian: Idiopatska ali ciklična nevtropenija: priporočeni začetni odmerek je 0,5 M e./kg/dan (5 mikrogramov/kg/dan) v enkratnem odmerku ali v deljenih odmerkih.
English: The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day.
Slovenian: Običajni začetni odmerek je med 0,1 milijon enot (1 mikrogram) in 0,4 milijoni enot (4 mikrogrami) na kilogram telesne mase vsak dan.
English: It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
Slovenian: Trenutno ni jasno, ali dolgotrajno zdravljenje bolnikov s hudo kronično nevtropenijo poveča bolnikovo nagnjenje k pojavu citogenetskih nenormalnosti, mielodisplastičnega sindroma ali levkemične preobrazbe.
English: Grastofil has not been tested in pregnant or breast-feeding women.
Slovenian: Zdravila Grastofil pri nosečnicah ali ženskah, ki dojijo, niso preučevali.
English: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injections.
Slovenian: Ledocetna kislina, natrijev hidroksid, sorbitol (E420), polisorbat 80 in voda za injekcije.
English: Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Slovenian: Grastofil je treba razredčiti v 20 ml 5-odstotne raztopine glukoze (glejte poglavje 6.6).
English: • inflammation of the lungs (interstitial lung disease)
Slovenian: • vnetje pljuč (intersticijska pljučna bolezen)
English: STADAPHARM GmbH Telephone +49/6101.603.0
Slovenian: Deutschland STADAPHARM GmbH Tel. +49/6101.603.0
English: Do not put the cover back on used needles, as you may accidentally prick yourself.
Slovenian: Na uporabljeno iglo ne natikajte pokrovčka, da se po nesreči ne vbodete.
English: • 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).
Slovenian: • začutite bolečino v levem zgornjem delu trebuha (abdomna), bolečino pod levim delom prsnega koša ali na vrhu rame, saj morda obstajajo težave z vranico (povečanje vranice (splenomegalija) ali raztrganje vranice).
English: During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Slovenian: Pri dolgotrajni uporabi so poročali o kožnem vaskulitisu pri 2 % bolnikov s hudo kronično nevtropenijo.
English: In order to determine a patient's trough or nadir ANC, it is recommended that blood samples are taken for ANC measurement immediately prior to any scheduled dosing with filgrastim.
Slovenian: Vzorec krvi za določitev ANC, ko je ta vrednost najnižja, je priporočljivo vzeti tik pred vsakim predvidenim dajanjem filgrastima.
English: Grastofil contains no preservative.
Slovenian: Zdravilo Grastofil ne vsebuje konzervansov.
English: Grastofil for PBPC mobilisation after myelosuppressive chemotherapy Grastofil should be given by subcutaneous injection.
Slovenian: Grastofil za izplavljanje PBPC po mielosupresivni kemoterapiji: Grastofil je treba dati s subkutano injekcijo.
English: Common (≥ 1/100 to <
Slovenian: Pogosti (≥ 1/100 do < 1/10)
English: Grastofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy
Slovenian: Zdravilo Grastofil in nevtropenija (nizko število vrste belih krvnih celic), povezana s kemoterapijo
English: • you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Slovenian: • se pojavi kašelj, zvišana telesna temperatura ali težave z dihanjem (dispneja), je to lahko znak sindroma akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome).
English: In patients with known bone marrow-infiltrating infections or malignancy, consider appropriate therapy for treatment of the underlying condition in addition to administration of filgrastim for treatment of neutropenia.
Slovenian: Pri bolnikih z znano infiltracijo okužbe ali malignim obolenjem kostnega mozga je treba poleg filgrastima za zdravljenje nevtropenije ustrezno zdraviti tudi osnovno bolezen.
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Slovenian: Uporaba filgrastima za izplavljanje PBPC pri zdravih darovalcih pred alogensko presaditvijo PBPC
English: Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic medicinal products may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy medicinal products used).
Slovenian: Tveganja, povezana z velikimi odmerki kemoterapije Posebna previdnost je potrebna pri zdravljenju bolnikov, ki prejemajo velike odmerke kemoterapije, ker ni bilo dokazano, da bi se glede tumorja izboljšal izid zdravljenja in povečevanje odmerka kemoterapevtikov ima lahko za posledico povečanje škodljivih učinkov, vključno z učinki na srce, pljuča, živčevje in kožo (glejte informacije za predpisovanje posameznih kemoterapevtikov, ki so bili uporabljeni).
English: • get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen).
Slovenian: • začutite bolečino v levem zgornjem delu trebuha (abdomna), bolečino pod levim delom prsnega koša ali na vrhu leve rame (to so lahko simptomi povečane vranice (splenomegalija) ali možnega raztrganja vranice),
English: • to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
Slovenian: • za povečanje števila belih krvnih celic po zdravljenju s kemoterapijo za pomoč pri preprečevanju okužb;
English: In patients treated with myeloablative therapy followed by bone marrow transplantation
Slovenian: Bolniki, zdravljeni z mieloablativno terapijo, ki ji sledi presaditev kostnega mozga
English: 9/L after the expected nadir, filgrastim should be discontinued immediately.
Slovenian: 9/l, je treba z zdravljenjem s filgrastimom takoj prenehati.
English: Grastofil may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Slovenian: Grastofil se lahko daje dnevno v obliki subkutane injekcije ali v obliki 30-minutne intravenske infuzije, razredčene v 5-odstotni raztopini glukoze (glejte poglavje 6.6).
English: Special precautions in normal donors undergoing peripheral blood progenitor cell mobilisation
Slovenian: Posebni previdnostni ukrepi pri zdravih darovalcih pred alogensko presaditvijo v periferno kri izplavljenih matičnih celic
English: Reduce to 0.5 MU/kg/day (5 micrograms/kg/day)
Slovenian: Odmerek zmanjšajte na 0,5 M e./kg/dan (5 mikrogramov/kg/dan)
English: Filgrastim is not recommended during pregnancy.
Slovenian: Filgrastima ne uporabljajte pri nosečnicah.
English: Dilution to a final concentration less than 0.2 MU (2 µg) per mL is not recommended at any time.
Slovenian: Raztopine ni nikoli priporočljivo razredčiti na končno koncentracijo, manjšo od 0,2 M e. (2 mikrograma) na mililiter.
English: Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim.
Slovenian: Filgrastima se ne sme dajati bolnikom s preobčutljivostjo na filgrastim ali pegfilgrastim v anamnezi.
English: The first dose of Grastofil should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Slovenian: Prvi odmerek Grastofila je treba dati vsaj 24 ur po citotoksični kemoterapiji in vsaj 24 ur po infuziji kostnega mozga.
English: The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Slovenian: Najresnejši neželeni učinki, ki se lahko pojavijo med zdravljenjem s filgrastimom, vključujejo: anafilaktično reakcijo, resne pljučne neželene dogodke (vključno z intersticijsko pljučnico in ARDS), sindrom povečane prepustnosti kapilar, hudo splenomegalijo/raztrganje vranice, razvoj v mielodisplastični sindrom ali levkemijo pri bolnikih s hudo kronično nevtropenijo, bolezen presadka proti gostitelju (GvHD - Graft versus Host Disease) pri bolnikih z alogeno presaditvijo kostnega mozga ali presaditvijo perifernih krvotvornih matičnih celic in srpastocelična kriza pri bolnikih s srpastocelično boleznijo.
English: • changes in blood chemistry
Slovenian: • spremenjena krvna slika
English: Grastofil dose adjustment
Slovenian: Prilagoditev odmerka Grastofila
English: Fluid volume disturbances
Slovenian: motnje volumna tekočin
English: Congenital neutropenia: the recommended starting dose is 1.2 MU/kg/day (12 micrograms/kg/day) as a single dose or in divided doses.
Slovenian: Prirojena nevtropenija: priporočeni začetni odmerek je 1,2 M e./kg/dan (12 mikrogramov/kg/dan) v enkratnem odmerku ali v deljenih odmerkih.
English: Elevations of neutrophil counts are dose-dependent at recommended doses.
Slovenian: V območju priporočenih odmerkov je povečanje števila nevtrofilcev odvisno od odmerka.
English: Type I glass pre-filled syringe with permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Slovenian: Napolnjene injekcijske brizge so iz stekla tipa I z neločljivo pritrjeno nerjavečo jekleno iglo na konici in merilno lestvico z 1/40 natisnjenimi oznakami od 0,1 ml do 1 ml na telesu brizge.
English: Some cytotoxic medicinal products exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation.
Slovenian: Nekatera citotoksična zdravila so posebno toksična za krvotvorne matične celice in lahko neugodno vplivajo na izplavljanje matičnih celic v periferno kri.
English: 9/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 x 10
Slovenian: 9/l) opazili pri 41 % zdravih darovalcev, pri 35 % darovalcev pa so po zdravljenju s filgrastimom in levkaferezi opazili prehodno trombocitopenijo (število trombocitov < 100 x 10
English: The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day.
Slovenian: Običajni odmerek je 0,5 milijonov enot (5 mikrogramov) na kilogram telesne mase vsak dan.
English: Grastofil pre-filled syringe contains dry natural rubber The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.
Slovenian: Zdravilo Grastofil napolnjena injekcijska brizga vsebuje suho naravno gumo Pokrovček za iglo napolnjene injekcijske brizge vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijsko reakcijo.
English: Daily dosing with Grastofil should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Slovenian: Dnevno odmerjanje Grastofila se mora nadaljevati, dokler ne mine obdobje pričakovanega najmanjšega števila nevtrofilcev in se njihovo število normalizira.
English: Grastofil may have a minor influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Grastofil ima lahko blag vpliv na vašo sposobnost upravljanja vozil in strojev.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrov igle napolnjene injekcijske brizge lahko vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
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 uporaba PBPC, izplavljenih s filgrastimom, zmanjša izrazitost in trajanje trombocitopenije po mielosupresivni ali mieloablacijski kemoterapiji.
English: Telephone +385/1.3764.111
Slovenian: STADA d.o.o Tel: +385/1.3764.111
English: The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion.
Slovenian: Običajni začetni odmerek je 1 milijon enot (10 mikrogramov) na kilogram telesne mase vsak dan v obliki infuzije.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Grastofil.
Slovenian: Če uporabljate zdravilo Grastofil morate prenehati z dojenjem, razen če vam zdravnik naroči drugače.
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Slovenian: Za izplavljanje PBPC pri zdravih darovalcih pred alogensko presaditvijo PBPC
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 osnovno osteoporotično boleznijo kosti, ki filgrastim neprekinjeno prejemajo več kot 6 mesecev, je lahko potrebno spremljanje gostote kosti.
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Slovenian: Trajanje prisotnosti zvišane telesne temperature se pri bolnikih, pri katerih se je izvajalo mieloablacijsko zdravljenje in nato presaditev kostnega mozga, ni skrajšalo.
English: Hold the syringe with the needle pointing up.
Slovenian: Injekcijsko brizgo držite tako, da je igla obrnjena navzgor.
English: For infusions Grastofil should be diluted in 20 mL of 5% glucose solution (see section 6.6).
Slovenian: Grastofil je treba za infundiranje razredčiti v 20 ml 5-odstotne raztopine glukoze (glejte poglavje 6.6).
English: You may change the injection site if you notice the area is red or sore.
Slovenian: V primeru, da opazite rdeče ali vneto območje, lahko zamenjate mesto injiciranja.
English: However, for a sustained therapeutic response, Grastofil therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Slovenian: Če želimo doseči dolgotrajni učinek zdravljenja, pa zdravljenja z Grastofilom ne smemo prekiniti, dokler ne mine obdobje pričakovanega najmanjšega števila nevtrofilcev in se njihovo število normalizira.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Filgrastim ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • bumpy skin rash (rash macuo-papular)
Slovenian: • buličast kožni izpuščaj (makulo-papularni izpuščaj)
English: Leukocytosis White blood cell counts of 100 x 10
Slovenian: Levkocitoza Po zdravljenju s filgrastimom so levkocitozo (število belih krvnih celic > 50 x 10
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in cancer patients treated with filgrastim.
Slovenian: Psevdoprotin (pirofosfatna hondrokalcinoza) Pri rakavih bolnikih, zdravljenih s filgrastimom, so poročali o psevdoprotinu (pirofosfatna hondrokalcinoza).
English: (Chondrocalcinosis Pyrophosphate)
Slovenian: (pirofosfatna hondrokalcinoza )
English: Please tell your doctor immediately during treatment with Grastofil, if you:
Slovenian: Med zdravljenjem z zdravilom Grastofil takoj obvestite zdravnika, če:
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Grastofil.
Slovenian: Pred začetkom uporabe zdravila Grastofil se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The recommended starting dose of Grastofil is 1.0 MU/kg/day (10 micrograms/kg/day).
Slovenian: Priporočeni začetni odmerek Grastofila je 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
English: Long term treatment with Grastofil may be required to maintain a normal number of white cells in your blood.
Slovenian: Morda bo za vzdrževanje normalnega števila belih krvničk v vaši krvi potrebno dolgoročno zdravljenje z zdravilom Grastofil.
English: Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid hyperplasia in bone marrow, extramedullary granulopoiesis and splenic enlargement.
Slovenian: V študijah so zabeležili spremembe, ki so bile posledica pričakovanih farmakoloških učinkov, vključno s povečanjem števila levkocitov, mieloidno hiperplazijo v kostnem mozgu, ekstramedularno granulopoezo in povečanjem vranice.
English: • are pregnant, or breast-feeding;
Slovenian: • če ste noseči ali dojite,
English: Long-term administration may be required to maintain the ANC > 2.0 x 10
Slovenian: Za vzdrževanje ANC na ravni > 2,0 x 9/l bo morda potrebna dolgotrajna uporaba zdravila.