natgillin/translations-raw huggingface dataset:
A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Zmanjšanje števila belih krvničk (nevtropenija) se lahko pojavi zaradi številnih razlogov in zmanjša sposobnost telesa za boj proti okužbam.
Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Vezavna protitelesa se pojavijo po pričakovanjih pri vseh bioloških zdravilih, vendar jih doslej niso povezovali z nevtralizacijskim delovanjem.
If you do see blood inside the syringe, remove the needle and re-insert it in a different site.
Če vidite kri v brizgi, potegnite iglo ven in jo ponovno vbodite na drugo mesto.
- osteoporosis (bone disease).
osteoporozo (bolezen kosti).
cells/kg is based on published experience resulting in adequate haematologic reconstitution.
+ celic/kg temeljijo na objavljenih podatkih, po katerih so dosegli zadostno hematološko obnovo.
Causes of transient neutropenia, such as viral infections should be excluded.
Izključiti je treba vzroke prehodne nevtropenije, na primer virusno okužbo.
The choice of route should depend on the individual clinical circumstance.
Izbira poti uporabe zdravila naj bo odvisna od kliničnih okoliščin pri posamezniku.
This section contains information on how to give yourself an injection of Nivestim.
To poglavje vsebuje informacije o tem, kako naj si sami injicirate zdravilo Nivestim.
In clinical trials, 97% of patients who responded had a complete response at doses ≤ 24 µg/kg/day.
V kliničnih preskušanjih je imelo 97 % bolnikov, ki so se odzvali na zdravljenje, popoln odziv pri odmerkih  24 µg/kg/dan.
Most people can learn to give themselves a subcutaneous injection, but if you are experiencing a lot of difficulty, please do not be afraid to ask for help and advice from your doctor or nurse.
Večina ljudi se lahko nauči, kako naj si sami dajo subkutano injekcijo, če pa imate veliko težav s tem, se ne bojte prositi zdravnika ali medicinsko sestro za pomoč in nasvet.
Remove the syringe from the blister pack and check that the solution is clear, colourless and practically free from visible particles.
Vzemite brizgo iz pretisnega omota in preverite, ali je raztopina bistra, brezbarvna in praktično ne vsebuje vidnih delcev.
9/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
9/l) pri bolnikih z napredovalo okužbo s HIV, z namenom zmanjšanja tveganja za bakterijske okužbe, kadar so druge možnosti za zdravljenje nevtropenije neprimerne.
- if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section
- če ste alergični na filgrastim ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
The long-term safety of filgrastim administration above 24 µg/kg/day in patients with SCN has not been established.
Varnost dolgotrajne uporabe filgrastima v odmerkih večjih od 24 µg/kg/dan pri bolnikih s SCN še ni bila ugotovljena.
The volume of distribution in blood is approximately 150 ml/kg.
Porazdelitveni volumen zdravila v krvi je približno 150ml/kg.
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.
Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo AML, starih < 55 let, in dobro citogenetiko (t(8;21), t(15;17), ter inv(16)) še nista bili ugotovljeni.
Medicines (containing sorbitol/fructose) given intravenously may be life-threatening and should be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Zdravila, ki vsebujejo sorbitol/fruktozo, aplicirana intravensko, so lahko življenjsko ogrožujoča in morajo biti pri tej starostni skupini kontraindicirana, razen če so klinično nujno potrebna in če na voljo ni druge alternative.
• changes in blood chemistry
• spremembe v kemijski sestavi krvi
Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim.
Naključna izpostavljenost zmrzovanju do 24 ur ne bo vplivala na stabilnost zdravila Nivestim.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Možnih medsebojnih delovanj z drugimi hematopoetskimi rastnimi faktorji in citokini v kliničnih preskušanjih še niso raziskovali.
Some cases of splenic rupture were fatal (see section 4.4).
Nekateri primeri rupture vranice so bili smrtni (glejte poglavje 4.4).
Only clear solutions without particles should be used.
Uporabiti smete samo bistre raztopine brez delcev.
If exposure has been greater than 24 hours or frozen more than once, then Nivestim should NOT be used.
Če je bilo zdravilo Nivestim zamrznjeno več kot 24 ur ali zamrznjeno večkrat, se ga NE sme uporabiti.
Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 10
Nato je možno odmerek individualno prilagajati na 1 do 2 tedna, za ohranjanje povprečnega števila nevtrofilcev med 1,5 x 10
If you think you have injected more than you should, contact your doctor as soon as possible.
Če mislite, da ste si injicirali več zdravila, kot bi smeli, se čim prej posvetujte z zdravnikom.
Loss of response to filgrastim
Izguba odziva na filgrastim
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Priporočljivo je, da center za odvzem krvi sistematično beleži in spremlja darovalce izvornih celic vsaj še deset let ter darovalcem tako zagotovi dolgoročno varnost.
Period of Study
Čas izvajanja študije
There are 1, 5, 8 or 10 syringes in each pack.
V vsakem pakiranju je 1, 5, 8 ali 10 brizg.
The degree of variation between individual patients and between laboratory assays of CD34
Stopnja variabilnosti med posameznimi bolniki in med laboratorijskimi preiskavami za določanje števila CD34
*recombinant methionyl granulocyte colony-stimulating factor G-CSF produced in Escherichia coli (BL21) by recombinant DNA technology.
*rekombinantni metionil granulocitne kolonije stimulirajoči faktor G-CSF, pridobljen iz Escherichia coli (BL21) s pomočjo rekombinantne DNK tehnologije
If you forget to use Nivestim
Če ste pozabili uporabiti zdravilo Nivestim
Do not use this medicine if you notice it is cloudy or there are particles in it.
Ne uporabljajte tega zdravila, če opazite, da je motno ali da vsebuje delce.
Try to self-inject at approximately the same time every day.
Zdravilo si skušajte injicirati vsak dan ob približno istem času.
Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI).
Pri dojenčkih in majhnih otrocih (mlajših od 2 let) morda še ni diagnosticirana dedna intoleranca za fruktozo.
• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
• bolezen, zaradi katere postajajo kosti manj goste in zato šibkejše, bolj krhke in bolj nagnjene k zlomom (osteoporoza)
Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Humani G-CSF je glikoprotein, ki uravnava nastajanje in sproščanje funkcionalnih nevtrofilcev iz kostnega mozga.
• lungs do not function as they should, causing breathlessness (respiratory failure)
• pljuča ne delujejo, kot bi morala, kar povzroča zasoplost (odpoved dihanja)
4.8 Undesirable effects a.
4.8 Neželeni učinki a. Povzetek varnostnega profila
In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Pri oceni števila matičnih celic, zbranih pri bolnikih, ki se zdravijo s filgrastimom, je treba posvetiti posebno pozornost kvantifikacijski metodi.
9/L and 10 x 10
9/l in 10 x 10
There were no differences in the safety profiles for paediatric patients treated for SCN.
Razlik v profilih varnosti za pediatrične bolnike, zdravljene zaradi SCN, ni bilo.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Obstajajo dokazi iz študije o uporabi enkratnih odmerkov, ki kažejo, da je lahko pri intravenskem dajanju zdravila trajanje učinka krajše.
Your doctor will tell you how much Nivestim you should take.
Zdravnik vam bo povedal, koliko zdravila Nivestim morate vzeti.
Pharmacotherapeutic group: Cytokines, ATC code: L03AA02
Farmakoterapevtska skupina: Citokini, oznaka ATC: L03AA02.
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.
+ 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.
White blood cell counts of 100 x 10
Število belih krvničk 100 x 10
The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Varnosti in učinkovitosti uporabe filgrastima še niso ovrednotili pri normalnih darovalcih, mlajših od 16 let ali starejših od 60 let.
When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Če je predvidena presaditev PBPC, je priporočljivo, da je postopek mobilizacije matičnih celic načrtovan v zgodnjem obdobju zdravljenja bolnika.
During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Med dolgotrajno uporabo so o kožnem vaskulitisu poročali pri 2 % bolnikov s SCN.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Če je potrebna več kot ena levkafereza, je treba posvetiti posebno pozornost darovalcem, ki so imeli pred levkaferezo število trombocitov < 100 x 10
Regular urinalysis should be performed to monitor these events.
Za spremljanje morebitnih pojavov teh dogodkov je treba redno opravljati preiskave urina.
• inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2
• vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2
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.
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.
The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Podatki v spodnjih preglednicah opisujejo neželene učinke, o katerih so poročali v kliničnih preskušanjih in spontanih poročilih.
What you need to know before you use Nivestim
Kaj morate vedeti, preden boste uporabili zdravilo Nivestim
Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh.
Odločite se, kam si boste injicirali zdravilo Nivestim - najdite mesto na sprednji strani trebuha ali na sprednji strani stegen.
What Nivestim is and what it is used for
Kaj je zdravilo Nivestim in za kaj ga uporabljamo
Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Pojavijo se tudi druge spremembe krvnih celic, vključno z anemijo in prehodnim povečanjem mieloičnih matičnih celic, zaradi katerih je potrebno skrbno spremljanje števila celic.
Take special care with other products that stimulate white blood cells
Bodite posebej previdni pri drugih zdravilih, ki spodbujajo bele krvničke
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.
Iglo umaknite s kože, nato pa spustite bat in počakajte, da se brizga premika navzgor, dokler ni celotna igla zaščitena in zaskoči na mestu.
In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients.
V kliničnih preskušanjih pri bolnikih z rakom je bila mišično-skeletna bolečina pri 10 % bolnikov blaga ali zmerna in pri 3 % bolnikov huda.
Other medicines and Nivestim
Druga zdravila in zdravilo Nivestim
You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
O vašem tveganju za razvoj krvnega raka in preiskavah, ki jih je treba opraviti, se posvetujte s svojim zdravnikom.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment, not requiring progenitor support should be considered.
Če so deleži celic po zgoraj navedenih kriterijih nezadostni, je treba premisliti o drugih oblikah zdravljenja, ki ne zahtevajo predhodne podpore matičnih celic.
Paediatric population
d. Pediatrična populacija
Pull the plunger back slightly to check if any blood appears in the syringe.
Bat potegnite nekoliko nazaj in preverite, ali je v brizgi vidna kri.
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.
Granulocitne kolonije spodbujajoči faktor lahko spodbuja rast mieloičnih celic in vitro, podobne učinke pa je možno opaziti tudi pri nekaterih nemieloičnih celicah in vitro.
Relative Risk (95% CI) of GvHD and TRM Following Treatment with GCSF after Bone Marrow Transplantation Publication
Relativno tveganje (95 % IZ) pri GvHD in TRM Po zdravljenju z G-CSF po presaditvi kostnega mozga Objava
If you become pregnant during Nivestim treatment, please inform your doctor.
Če med zdravljenjem z zdravilom Nivestim zanosite, o tem obvestite svojega zdravnika.
- if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
- če vas zdravijo zaradi hude kronične nevtropenije in imate kri v urinu (hematurija).
It is unknown whether filgrastim/metabolites are excreted in human milk.
Ni znano, ali se filgrastim/presnovki izločajo v materino mleko.
Overall, reports were more common after IV administration.
Na splošno so bile te reakcije pogostejše po i.v.
Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient.
Časovni razpored levkafereze: pogosto zadostujeta ena ali dve levkaferezi 5. in 6. dan, v drugačnih okoliščinah pa je lahko potrebna dodatna levkafereza.
If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)).
Če ste bolnik s hudo kronično nevtropenijo, lahko pri vas obstaja tveganje za nastanek krvnega raka (levkemija, mielodisplastični sindrom (MDS - myelodisplastic syndrome)).
Solution for injection/infusion (injection/infusion).
raztopina za injiciranje/infundiranje (injekcija/infuzija)
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Če niste prepričani, ali si boste lahko sami dali injekcijo, oziroma če imate kakšna vprašanja, prosite zdravnika ali medicinsko sestro za pomoč.
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.
Prospektivnih randomiziranih primerjav priporočenih metod mobilizacije (z uporabo filgrastima samega, ali v kombinaciji z mielosupresivno kemoterapijo) pri isti populaciji bolnikov ni.
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.
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.
For storage conditions after dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja že razredčenega zdravila glejte poglavje 6.3.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
V nekaterih primerih so se simptomi ponovno pojavili pri ponovni uporabi zdravila, kar kaže na vzročno povezavo.
If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Če ste izpustili injekcijo ali ste si injicirali premalo zdravila, se čim prej posvetujte z zdravnikom.
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.
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.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Tega zdravila tudi ne smete mešati z drugimi zdravili, razen s tistimi, ki so navedena v nadaljevanju.
Ensure the needle guard covers the needle according to the instructions for active needle guard or passive needle guard below.
Prepričajte se, da pokrovček igle prekriva iglo v skladu s spodnjimi navodili za aktivno zaščito igle ali pasivno zaščito igle.
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.
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.
Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Učinke filgrastima na prenatalni razvoj so preučevali pri podganah in kuncih.
In most cases, aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see section 4.8).
Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je izzvenel po ukinitvi G-CSF (glejte poglavje 4.8).
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.
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.
How do I give my subcutaneous Nivestim injection?
Kako naj si dam subkutano injekcijo zdravila Nivestim?
9/L during the treatment period the dose of filgrastim should be re-escalated according to the above steps.
9/l, je treba odmerek filgrastima ponovno postopno povečevati v skladu z zgoraj navedenimi koraki.
- if you experience kidney injury (glomerulonephritis).
- če imate poškodbo ledvic (glomerulonefritis).
If you develop or are likely to develop cancers of the blood, you should not use Nivestim, unless instructed by your doctor.
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.
Other special precautions
Drugi posebni previdnostni ukrepi
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).
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).
cells/kg) or acceleration of platelet recovery, to the same degree.
+ celic/kg) oziroma pospešili povečevanje števila trombocitov v enaki meri.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8 to 16 hours.
Po subkutani uporabi priporočenih odmerkov so bile serumske koncentracije še 8 do 16 ur večje od 10 ng/ml.
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.
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.
Paediatric use in the SCN and cancer settings
Pediatrična uporaba zdravila v primeru SCN in rakavih obolenj
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.
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.
In patients with HIV infection
Pri bolnikih, ki so okuženi z virusom HIV
Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Petinšestdeset odstotkov bolnikov, vključenih v program preskušanja za zdravljenje hude kronične nevtropenije, je bilo mlajših od 18 let.
The recommendation of a minimum yields of ≥ 2.0 x 10
Najmanjši priporočeni deleži ≥ 2,0 x 10
Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
Filgrastim je indiciran za mobilizacijo krvotvornih matičnih celic v periferno kri (»peripherial blood progenitor cells« - PBPCs).
Filgrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10
Filgrastim je indiciran tudi za zdravljenje dolgotrajne nevtropenije (vrednost ANC manjša ali enaka 1,0 x 10
Effect of chemotherapy on erythrocytes and thrombocytes
Učinek kemoterapije na eritrocite in trombocite
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
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.
Check the date on the pack to make sure that the medicine has not passed the expiry date.
Preverite datum na pakiranju, da ne boste uporabili zdravila s pretečenim rokom uporabnosti.
In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.
Zaradi možnega tveganje za mikrobiološko kontaminacijo so brizge Nivestim namenjene samo za enkratno uporabo.
Urinalysis monitoring is recommended.
Priporočljivo je spremljanje s preiskavami urina.
Nivestim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines.
Zdravilo Nivestim je rastni faktor za bele krvničke (granulocitne kolonije stimulirajoči faktor) in spada v skupino zdravil, imenovanih citokini.
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Nivestim.
Razen če vam zdravnik ne naroči drugače, morate med jemanjem zdravila Nivestim prenehati z dojenjem.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Kot pri drugih krvotvornih rastnih faktorjih so tudi pri G-CSF dokazali, da in vitro spodbuja človeške endotelijske celice.