FrancophonIA/ELRC3.0 huggingface dataset:
English: In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Slovenian: Pri oceni števila matičnih celic, zbranih pri bolnikih, ki se zdravijo s filgrastimom, je treba posvetiti posebno pozornost kvantifikacijski metodi.
English: 9/L and 10 x 10
Slovenian: 9/l in 10 x 10
English: There were no differences in the safety profiles for paediatric patients treated for SCN.
Slovenian: Razlik v profilih varnosti za pediatrične bolnike, zdravljene zaradi SCN, ni bilo.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Slovenian: Obstajajo dokazi iz študije o uporabi enkratnih odmerkov, ki kažejo, da je lahko pri intravenskem dajanju zdravila trajanje učinka krajše.
English: Your doctor will tell you how much Nivestim you should take.
Slovenian: Zdravnik vam bo povedal, koliko zdravila Nivestim morate vzeti.
English: Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Slovenian: Farmakoterapevtska skupina: Citokini, oznaka ATC: L03AA02.
English: cell numbers vary depending on the precise methodology used and recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Slovenian: + s pretočno citometrijo se med seboj razlikujejo glede na dejansko uporabljeno metodologijo, zato je treba priporočila o številu celic, ki temeljijo na študijah v drugih laboratorijih, interpretirati previdno.
English: White blood cell counts of 100 x 10
Slovenian: Število belih krvničk 100 x 10
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Slovenian: Varnosti in učinkovitosti uporabe filgrastima še niso ovrednotili pri normalnih darovalcih, mlajših od 16 let ali starejših od 60 let.
English: When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Slovenian: Če je predvidena presaditev PBPC, je priporočljivo, da je postopek mobilizacije matičnih celic načrtovan v zgodnjem obdobju zdravljenja bolnika.
English: During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Slovenian: Med dolgotrajno uporabo so o kožnem vaskulitisu poročali pri 2 % bolnikov s SCN.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Slovenian: Če je potrebna več kot ena levkafereza, je treba posvetiti posebno pozornost darovalcem, ki so imeli pred levkaferezo število trombocitov < 100 x 10
English: Regular urinalysis should be performed to monitor these events.
Slovenian: Za spremljanje morebitnih pojavov teh dogodkov je treba redno opravljati preiskave urina.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Slovenian: • vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2
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.
Slovenian: Po indukcijski in konsolidacijski fazi zdravljenja akutne mieloične levkemije je lahko trajanje zdravljenja bistveno daljše (do 38 dni), odvisno od vrste, odmerka in sheme uporabljene citotoksične kemoterapije.
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Slovenian: Podatki v spodnjih preglednicah opisujejo neželene učinke, o katerih so poročali v kliničnih preskušanjih in spontanih poročilih.
English: What you need to know before you use Nivestim
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nivestim
English: Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh.
Slovenian: Odločite se, kam si boste injicirali zdravilo Nivestim - najdite mesto na sprednji strani trebuha ali na sprednji strani stegen.
English: What Nivestim is and what it is used for
Slovenian: Kaj je zdravilo Nivestim in za kaj ga uporabljamo
English: Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Slovenian: Pojavijo se tudi druge spremembe krvnih celic, vključno z anemijo in prehodnim povečanjem mieloičnih matičnih celic, zaradi katerih je potrebno skrbno spremljanje števila celic.
English: Take special care with other products that stimulate white blood cells
Slovenian: Bodite posebej previdni pri drugih zdravilih, ki spodbujajo bele krvničke
English: Remove the needle from your skin, then let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Slovenian: Iglo umaknite s kože, nato pa spustite bat in počakajte, da se brizga premika navzgor, dokler ni celotna igla zaščitena in zaskoči na mestu.
English: In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
Slovenian: V kliničnih preskušanjih pri bolnikih z rakom je bila mišično-skeletna bolečina pri 10 % bolnikov blaga ali zmerna in pri 3 % bolnikov huda.
English: Other medicines and Nivestim
Slovenian: Druga zdravila in zdravilo Nivestim
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Slovenian: O vašem tveganju za razvoj krvnega raka in preiskavah, ki jih je treba opraviti, se posvetujte s svojim zdravnikom.
English: If yields are inadequate, as measured by the criteria above, alternative forms of treatment, not requiring progenitor support should be considered.
Slovenian: Če so deleži celic po zgoraj navedenih kriterijih nezadostni, je treba premisliti o drugih oblikah zdravljenja, ki ne zahtevajo predhodne podpore matičnih celic.
English: Paediatric population
Slovenian: d. Pediatrična populacija
English: Pull the plunger back slightly to check if any blood appears in the syringe.
Slovenian: Bat potegnite nekoliko nazaj in preverite, ali je v brizgi vidna kri.
English: Granulocyte colony-stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Slovenian: Granulocitne kolonije spodbujajoči faktor lahko spodbuja rast mieloičnih celic in vitro, podobne učinke pa je možno opaziti tudi pri nekaterih nemieloičnih celicah in vitro.
English: Relative Risk (95% CI) of GvHD and TRM Following Treatment with GCSF after Bone Marrow Transplantation Publication
Slovenian: Relativno tveganje (95 % IZ) pri GvHD in TRM Po zdravljenju z G-CSF po presaditvi kostnega mozga Objava
English: If you become pregnant during Nivestim treatment, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom Nivestim zanosite, o tem obvestite svojega zdravnika.
English: - if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Slovenian: - če vas zdravijo zaradi hude kronične nevtropenije in imate kri v urinu (hematurija).
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se filgrastim/presnovki izločajo v materino mleko.
English: Overall, reports were more common after IV administration.
Slovenian: Na splošno so bile te reakcije pogostejše po i.v.
English: Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient.
Slovenian: Časovni razpored levkafereze: pogosto zadostujeta ena ali dve levkaferezi 5. in 6. dan, v drugačnih okoliščinah pa je lahko potrebna dodatna levkafereza.
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)).
Slovenian: Če ste bolnik s hudo kronično nevtropenijo, lahko pri vas obstaja tveganje za nastanek krvnega raka (levkemija, mielodisplastični sindrom (MDS - myelodisplastic syndrome)).
English: Solution for injection/infusion (injection/infusion).
Slovenian: raztopina za injiciranje/infundiranje (injekcija/infuzija)
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če niste prepričani, ali si boste lahko sami dali injekcijo, oziroma če imate kakšna vprašanja, prosite zdravnika ali medicinsko sestro za pomoč.
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.
Slovenian: Prospektivnih randomiziranih primerjav priporočenih metod mobilizacije (z uporabo filgrastima samega, ali v kombinaciji z mielosupresivno kemoterapijo) pri isti populaciji bolnikov ni.
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Slovenian: Pričakovati je, da bo po uveljavljeni kemoterapiji za trdne tumorje, limfome in limfatično levkemijo zdravljenje, ki je potrebno za izpolnitev teh pogojev, trajalo do 14 dni.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja že razredčenega zdravila glejte poglavje 6.3.
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Slovenian: V nekaterih primerih so se simptomi ponovno pojavili pri ponovni uporabi zdravila, kar kaže na vzročno povezavo.
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Slovenian: Če ste izpustili injekcijo ali ste si injicirali premalo zdravila, se čim prej posvetujte z zdravnikom.
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.
Slovenian: Mobilizacijo in aferezne postopke je treba opravljati v sodelovanju z onkološkohematološkim centrom, ki ima sprejemljive izkušnje na tem področju in v katerem je mogoče pravilno spremljanje krvotvornih matičnih celic.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below.
Slovenian: Tega zdravila tudi ne smete mešati z drugimi zdravili, razen s tistimi, ki so navedena v nadaljevanju.
English: Ensure the needle guard covers the needle according to the instructions for active needle guard or passive needle guard below.
Slovenian: Prepričajte se, da pokrovček igle prekriva iglo v skladu s spodnjimi navodili za aktivno zaščito igle ali pasivno zaščito igle.
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.
Slovenian: Če zdravilo ni uporabljeno takoj, je uporabnik odgovoren za čas in pogoje shranjevanja zdravila pred uporabo, ki običajno ne bi smeli trajati dlje od 24 ur pri temperaturi od 2 °C do 8 °C, razen če je redčenje zdravila potekalo v nadzorovanih in validiranih aseptičnih pogojih.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Slovenian: Učinke filgrastima na prenatalni razvoj so preučevali pri podganah in kuncih.
English: In most cases, aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see section 4.8).
Slovenian: Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je izzvenel po ukinitvi G-CSF (glejte poglavje 4.8).
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (> 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Slovenian: V celoti niso opazili razlik v varnosti ali učinkovitosti med preiskovanci, starejšimi od 65 let, in mlajšimi odraslimi preiskovanci (starimi > 18 let), ki so prejemali citotoksično kemoterapijo, klinične izkušnje pa niso pokazale razlik v odzivih med starejšimi in mlajšimi odraslimi bolniki.
English: How do I give my subcutaneous Nivestim injection?
Slovenian: Kako naj si dam subkutano injekcijo zdravila Nivestim?
English: 9/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps.
Slovenian: 9/l, je treba odmerek filgrastima ponovno postopno povečevati v skladu z zgoraj navedenimi koraki.
English: - if you experience kidney injury (glomerulonephritis).
Slovenian: - če imate poškodbo ledvic (glomerulonefritis).
English: If you develop or are likely to develop cancers of the blood, you should not use Nivestim, unless instructed by your doctor.
Slovenian: Če se pri vas razvije krvni rak ali je verjetno, da se bo, zdravila Nivestim ne smete uporabljajti, razen če vam tega ne naroči vaš zdravnik.
English: Other special precautions
Slovenian: Drugi posebni previdnostni ukrepi
English: 9/L or greater have been observed in less than 5% of cancer patients receiving filgrastim at doses above 0.3 MU/kg/day (3 µg/kg/day).
Slovenian: 9/l ali več so ugotovili pri manj kot 5 % bolnikov z rakom, ki so prejemali filgrastim v odmerkih večjih od 0,3 M e./kg/dan (3 µg/kg/dan).
English: cells/kg) or acceleration of platelet recovery, to the same degree.
Slovenian: + celic/kg) oziroma pospešili povečevanje števila trombocitov v enaki meri.
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 to 16 hours.
Slovenian: Po subkutani uporabi priporočenih odmerkov so bile serumske koncentracije še 8 do 16 ur večje od 10 ng/ml.
English: These could be symptoms of a condition called “sepsis” (also called “blood poisoning”), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
Slovenian: To so lahko simptomi bolezenskega stanja, imenovanega ''sepsa'' (ki jo imenujemo tudi ''zastrupitev krvi''), hude okužbe z vnetnim odzivom po vsem telesu, ki je lahko smrtno nevarna in zahteva nujno medicinsko pomoč.
English: Paediatric use in the SCN and cancer settings
Slovenian: Pediatrična uporaba zdravila v primeru SCN in rakavih obolenj
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Slovenian: Če se ne odzivate več na zdravljenje s filgrastimom ali z njim ni mogoče vzdrževati odziva, bo zdravnik preučil razloge za to, vključno s tem ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje filgrastima.
English: In patients with HIV infection
Slovenian: Pri bolnikih, ki so okuženi z virusom HIV
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Slovenian: Petinšestdeset odstotkov bolnikov, vključenih v program preskušanja za zdravljenje hude kronične nevtropenije, je bilo mlajših od 18 let.
English: The recommendation of a minimum yields of ≥ 2.0 x 10
Slovenian: Najmanjši priporočeni deleži ≥ 2,0 x 10
English: Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Slovenian: Filgrastim je indiciran za mobilizacijo krvotvornih matičnih celic v periferno kri (»peripherial blood progenitor cells« - PBPCs).
English: Filgrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Slovenian: Filgrastim je indiciran tudi za zdravljenje dolgotrajne nevtropenije (vrednost ANC manjša ali enaka 1,0 x 10
English: Effect of chemotherapy on erythrocytes and thrombocytes
Slovenian: Učinek kemoterapije na eritrocite in trombocite
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.
Slovenian: Preliminarni podatki, dobljeni pri manjšem številu bolnikov, ki so se sočasno zdravili s filgrastimom in 5-fluorouracilom, kažejo, da se stopnja izraženosti nevtropenije lahko še poveča.
English: Check the date on the pack to make sure that the medicine has not passed the expiry date.
Slovenian: Preverite datum na pakiranju, da ne boste uporabili zdravila s pretečenim rokom uporabnosti.
English: In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.
Slovenian: Zaradi možnega tveganje za mikrobiološko kontaminacijo so brizge Nivestim namenjene samo za enkratno uporabo.
English: Urinalysis monitoring is recommended.
Slovenian: Priporočljivo je spremljanje s preiskavami urina.
English: Nivestim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines.
Slovenian: Zdravilo Nivestim je rastni faktor za bele krvničke (granulocitne kolonije stimulirajoči faktor) in spada v skupino zdravil, imenovanih citokini.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Nivestim.
Slovenian: Razen če vam zdravnik ne naroči drugače, morate med jemanjem zdravila Nivestim prenehati z dojenjem.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Slovenian: Kot pri drugih krvotvornih rastnih faktorjih so tudi pri G-CSF dokazali, da in vitro spodbuja človeške endotelijske celice.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from filgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s filgrastimom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Slovenian: Tveganja za napredovanje mieloidnega rakastega klona ni možno izključiti.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Slovenian: Na splošno so dogodki glomerulonefritisa izzveneli po zmanjšanju odmerka ali prenehanju dajanja filgrastima ali pegfilgrastima.
English: Infections and malignancies causing myelosuppression
Slovenian: Okužbe in malignomi, ki povzročajo mielosupresijo
English: There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Slovenian: V literaturi so opisani primeri, pri katerih je bilo dokazano prehajanje filgrastima preko placente pri nosečnicah.
English: Transfusion reaction e a See section c (Description of selected adverse reactions).
Slovenian: Glejte poglavje c (Opis izbranih neželenih učinkov).
English: In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
Slovenian: Glede na omejene podatke o varnosti in učinkovitosti uporabe pri bolnikih s sekundarno AML je treba filgrastim uporabljati previdno.
English: Risk associated with increased doses of myelosuppressive medicinal products
Slovenian: Tveganje, povezano s povečanimi odmerki mielosupresivnih zdravil
English: The dosing in children receiving chemotherapy is the same as for adults.
Slovenian: Odmerjanje pri otrocih, ki prejemajo kemoterapijo, je enako kot pri odraslih.
English: Do not use Nivestim
Slovenian: Ne uporabljajte zdravila Nivestim
English: In normal donors, a 10 µg/kg/day dose administered subcutaneously for 4 to 5 consecutive days allows a collection of ≥ 4 x 10
Slovenian: Pri normalnih darovalcih dajanje subkutanega odmerka 10 µg/kg/dan 4 do 5 zaporednih dni omogoča, da se zbere ≥ 4 x 10
English: Пфайзер Люксембург САРЛ, Клон
Slovenian: Пфайзер Люксембург САРЛ, Клон България Тел.
English: If you use more Nivestim than you should
Slovenian: Če ste uporabili večji odmerek zdravila Nivestim, kot bi smeli
English: In randomised clinical trials, a subcutaneous dose of 230 µg/m2/day (4.0 to 8.4 µg/kg/day) was used.
Slovenian: V randomiziranih kliničnih študijah so uporabili subkutani odmerek 230 µg/m2/dan (4,0 do 8,4 µg/kg/dan).
English: In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Slovenian: V kliničnih študijah se je > 90 % bolnikov odzvalo na zdravljenje pri teh odmerkih, pri čemer je bila nevtropenija odpravljena v 2 dneh (mediana vrednost).
English: Risks associated with increased doses of chemotherapy
Slovenian: Tveganja, povezana s povečanimi odmerki kemoterapije
English: Filgrastim is not indicated for use in these conditions.
Slovenian: Filgrastim ni indiciran za uporabo pri teh boleznih.
English: The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.
Slovenian: Varnosti in učinkovitosti filgrastima, uporabljenega na isti dan kot mielosupresivna citotoksična kemoterapija, niso dokončno ugotovili.
English: Use of filgrastim, either alone, or after chemotherapy, mobilises haematopoietic progenitor cells into the peripheral blood.
Slovenian: Uporaba filgrastima, bodisi samega ali po kemoterapiji, mobilizira krvotvorne matične celice v periferno kri.
English: Nivestim is usually given once a day by injection, usually into the tissue just under the skin.
Slovenian: Zdravilo Nivestim se običajno daje enkrat na dan z injekcijo, in sicer v tkivo tik pod kožo.
English: For maintaining normal neutrophil counts:
Slovenian: Za ohranjanje normalnega števila nevtrofilcev:
English: Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Nevtrofilci, ki nastanejo zaradi odziva na filgrastim, kažejo normalno ali okrepljeno delovanje, kar je bilo dokazano s testi kemotaktičnega in fagocitnega delovanja.
English: An increased incidence of embryo loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Slovenian: Pri kuncih so ugotovili večjo incidenco izgube zarodkov pri visokih večkratnikih klinične izpostavitve in ob hkratni toksičnosti za mater (glejte poglavje 5.3).
English: Elevations of neutrophil counts are dose dependent at recommended doses.
Slovenian: Povečanje števila nevtrofilcev je pri priporočenih odmerkih odvisno od odmerka.
English: Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities.
Slovenian: Zdravljenje s filgrastimom je treba izvajati izključno v sodelovanju z onkološkim centrom, ki ima izkušnje na področju zdravljenja z G-CSF in hematologije ter ima tudi vso potrebno diagnostično opremo.
English: Your doctor will tell you how long you will need to take Nivestim.
Slovenian: Zdravnik vam bo povedal, koliko časa morate jemati zdravilo Nivestim.
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).
Slovenian: Pri potomcih podgan, ki so jim dali pegfilgrastim v času poroda ali dojenja, so opazili zamudo v zunanji diferenciaciji in rasti (≥20 µg/kg/dan) in nekoliko zamnjšano stopnjo preživetja (100 µg/kg/dan).
English: In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Slovenian: Zaradi občutljivosti hitro delečih se mieloičnih celic na mielosupresivno citotoksično kemoterapijo filgrastima ni priporočljivo uporabljati v obdobju od 24 ur pred do 24 ur po kemoterapiji.