natgillin/translations-raw huggingface dataset:
Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty. 
Potisnite bat s počasnim in stalnim pritiskom in pri tem konstantno držite kožo, dokler ni brizga prazna.
The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population. 
Edini neželeni učinek, o katerem so dosledno poročali, je bila mišično-skeletna bolečina‚ ki se ne razlikuje od izkušenj v odrasli populaciji.
In other circumstances, additional leukaphereses may be necessary. 
V drugih okoliščinah utegnejo biti potrebne dodatne levkafereze.
Remove the needle and let go of your skin. 
Odstranite iglo in spustite kožo.
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. 
Če zdravilo prejemate v obliki subkutane injekcije, vam bo zdravnik morda predlagal, da se naučite, kako si injekcijo date sami.
See section 2 “What you need to know before you use Grastofil”. 
Glejte poglavje 2 "Kaj morate vedeti, preden boste uporabili zdravilo Grastofil".
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Tega zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, navedenimi v poglavju 6.6. 6.3 Rok uporabnosti
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 ni uporabljeno takoj, je za čas shranjevanja med uporabo in razmere pred uporabo odgovoren uporabnik, ta čas pa običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
These collected cells are given back to you after you receive very high doses of treatment for cancer to make your blood counts get back to normal more quickly. 
Tako odvzete celice vam bodo vrnjene po tem, ko boste prejeli zelo velike odmerke zdravila za raka, da bi se število krvnih celic hitreje vrnilo na normalne vrednosti.
Subcutaneous and intravenous use. 
za subkutano in intravensko uporabo
Do not remove the needle cover until you are ready to inject. 
Ne odstranite pokrovčka igle, dokler niste pripravljeni za injiciranje.
These changes all reversed after discontinuation of treatment. 
Po prenehanju zdravljenja so vse spremembe izginile.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical studies. 
Možnih medsebojnih delovanj z drugimi hematopoetskimi rastnimi faktorji in citokini v kliničnih študijah še niso raziskovali.
How long will I have to take Grastofil? 
Kako dolgo bom moral uporabljati zdravilo Grastofil?
Diluted filgrastim may be adsorbed to glass and plastic materials. 
Razredčeni filgrastim se lahko adsorbira na steklene in plastične materiale.
The clinical relevance of this finding to multiple dose administration is not clear. 
Klinična pomembnost tega izsledka v zvezi z večkratnimi odmerki ni jasna.
Leave the syringe at room temperature (15ºC to 25 ºC) for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes. 
Pustite brizgo na sobni temperaturi (15 ºC do 25 ºC) približno 30 minut ali nežno držite napolnjeno brizgo v roki za nekaj minut.
Rates of generation of antibodies against filgrastim is generally low. 
Stopnje nastanka protiteles proti filgrastimu so na splošno nizke.
cells/kg) or acceleration of platelet recovery to the same degree. 
+/kg) ali za pospešitev obnove trombocitov na enako raven.
Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed. 
Bat potisnite počasi navzgor do številke (v ml), ki ustreza odmerku zdravila Grastofil, ki vam ga je predpisal zdravnik.
Grastofil can be used: 
Zdravilo Grastofil se lahko uporablja:
In some cases, your body may make enough neutrophils, but as a part of your treatment for cancer, your doctor may want to increase the number of certain blood cells (CD34 cells) and collect them. 
V nekaterih primerih telo morda tvori dovolj nevtrofilcev, vendar želi zdravnik kot del zdravljenja raka povečati število določenih krvnih celic (celice CD34) zaradi odvzema.
Yields in excess of this minimum yield appear to correlate with more rapid recovery; those below with slower recovery. 
Zdi se, da deleži, večji od tega najmanjšega deleža, korelirajo s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
The subcutaneous route is preferred in most cases. 
V večini primerov ima prednost subkutana uporaba.
• osteoporosis (bone disease), 
• osteoporozo (bolezen kosti),
• increase of certain enzymes in the blood 
• zvišane ravni nekaterih encimov v krvi
Some cases of splenic rupture were fatal. 
Nekateri primeri raztrganja vranice so bili usodni.
This section contains information on how to give yourself an injection of Grastofil. 
To poglavje vsebuje informacije o tem, kako si dati injekcijo zdravila Grastofil.
To give yourself a subcutaneous injection you will need: 
Za samoinjiciranje subkutane injekcije boste potrebovali:
What should I do before I give myself a subcutaneous injection of Grastofil? 
Kaj moram narediti, preden si dam podkožno injekcijo Grastofil?
Analysis includes studies involving BM transplant during this period; some studies used GM-CSF 
Analiza vključuje študije v zvezi s presaditvijo kostnega mozga v tem časovnem obdobju; v nekaterih študijah je bila uporabljena GM-CSF
Remember: if you have any problems, please ask your doctor or nurse for help and advice. 
Ne pozabite: če imate kakršne koli težave, prosite zdravnika ali medicinsko sestro za pomoč in nasvet.
• in patients with advanced HIV infection which will help reduce the risk of infections; 
• pri bolnikih z napredovalo okužbo s HIV za pomoč pri zmanjšanju tveganja za okužbe;
Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02 
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA02.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND REACH OF CHILDREN 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 vloge dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
Only clear solutions without particles should be used. 
Uporabljate lahko samo bistre raztopine brez delcev.
This leaflet was last revised in MM/YYYY 
Navodilo je bilo nazadnje revidirano dne: MM/LLLL
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. 
Priporoča se, da center za odvzem krvi sistematično beleži in spremlja darovalce matičnih celic vsaj še deset let ter darovalcem tako zagotovi dolgoročno varnost.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect. 
Iz študije o dajanju enkratnega odmerka obstajajo dokazi, da lahko intravenski način dajanja zdravila skrajša trajanje učinka.
The data in the tables below describe adverse reactions reported from clinical studies and spontaneous reporting. 
Podatki v spodnjih preglednicah opisujejo neželene učinke, o katerih so poročali v kliničnih študijah in v spontanem poročanju.
• before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. 
• pred velikimi odmerki kemoterapije, da lahko kostni mozeg proizvaja več matičnih celic, ki jih je možno odvzeti in vam jih vrniti po zdravljenju.
• if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 
• če ste alergični na filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If someone else is injecting you, they can also use the back of your arms. 
Če vam nekdo drug pomaga z injiciranjem, lahko injicira tudi v zadnji del roke.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered. 
Če deleži celic po zgoraj navedenih merilih niso zadostni, je treba razmisliti o drugih oblikah zdravljenja, ki ne zahtevajo predhodne podpore matičnih celic.
Regular blood tests will be taken to monitor the number of white blood cells in your body. 
Z rednimi krvnimi preiskavami bodo spremljali število belih krvnih celic v telesu.
There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication. 
Ni nobenih dokazov za to, da bi pri bolnikih, okuženih s HIV, zdravljenje s filgrastimom povzročilo povečanje replikacije HIV.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. 
V nekaterih primerih so se simptomi med ponovno uporabo ponovili, kar nakazuje vzročno povezavo.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient. 
Izbira metode izplavljanja je odvisna od splošnih ciljev zdravljenja pri posameznem bolniku.
The recommendation of a minimum yield of ≥ 2.0 x 10 
Najmanjši priporočeni delež ≥ 2,0 x 10
Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria). 
Zdravnik bo morda redno opravljal preiskave urina, če se pri vas pojavlja ta neželeni učinek ali če v urinu odkrije beljakovine (proteinurija).
The best places to inject are the top of the thighs and the abdomen. 
Najboljši mesti za injiciranje sta zgornji del stegen in trebuh.
The degree of variation between individual patients and between laboratory assays of CD34 
Delež odstopanja med posameznimi bolniki in med laboratorijskimi testi za celice CD34
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte v hladilniku (2 ºC-8 ºC).
Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days. 
Po uveljavljeni kemoterapiji za trdne tumorje, limfome in pri limfoidni levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
Do not rub the injection site. 
Ne drgnite na mestu injiciranja.
In clinical studies in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients. 
V kliničnih študijah z bolniki z rakom je bila mišično-skeletna bolečina blaga ali zmerna pri 10 % in huda pri 3 % bolnikov.
Filgrastim should be discontinued and appropriate treatment given. 
Z uporabo filgrastima je treba prenehati in uvesti ustrezno zdravljenje.
Absolute neutrophil count (ANC) 
Absolutno število nevtrofilcev (ANC)
A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. 
Število belih krvnih celic se lahko zmanjša (nevtropenija) iz več razlogov, povzroči pa manjšo sposobnost telesa za boj proti okužbam.
For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient. 
Pri bolnikih, pri katerih se ni izvajala obsežna kemoterapija, pogosto zadošča ena levkafereza.
If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor. 
Če se pri vas razvije krvni rak ali je verjetno, da se bo, zdravila Grastofil ne smete uporabljati, razen če vam tako naroči vaš zdravnik.
In clinical studies, > 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days. 
V kliničnih študijah se je > 90 % bolnikov odzvalo na te odmerke in za odpravo nevtropenije so v povprečju potrebovali 2 dni.
In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation. 
Pri ocenjevanju števila matičnih celic, dobljenih pri bolnikih, ki prejemajo filgrastim, je treba posebno pozornost nameniti načinu kvantifikacije.
Grastofil dosing should be maintained until the last leukapheresis. 
Z dajanjem Grastofila je treba nadaljevati do zadnje levkafereze.
• transfusion reaction 
• reakcije na transfuzijo
cells/kg is based on published experience resulting in adequate haematologic reconstitution. 
celic/kg temelji na objavljenih podatkih, po katerih je to število zadostovalo za hematološko obnovo.
It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months). 
Priporočljivo je izvajati morfološke in citogenetske preiskave kostnega mozga v rednih časovnih presledkih (približno na vsakih 12 mesecev).
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 akutno mieloično levkemijo, ki so mlajši od 55 let in imajo dobro citogenetiko [t(8; 21), t(15; 17) in inv (16)], nista bili dokazani.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells. 
Tako kot drugi hematopoetski rastni faktorji je tudi G-CSF in vitro izkazal spodbujevalen učinek na človeške endotelijske celice.
ANC should be monitored closely, especially during the first few weeks of filgrastim therapy. 
ANC je treba skrbno spremljati, zlasti v obdobju prvih nekaj tednov zdravljenja s filgrastimom.
There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously. 
Obstaja pozitivna linearna korelacija med odmerkom in koncentracijo filgrastima v serumu, bodisi po intravenski ali subkutani uporabi.
The usual dose of Grastofil varies depending on your illness and weight. 
Običajni odmerek zdravila Grastofil je odvisen od vaše bolezni in telesne mase.
Some cases of splenic rupture were fatal (see section 4.4). 
Nekateri primeri raztrganja vranice so bili usodni (glejte poglavje 4.4.
• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis) 
• bolezen, zaradi katere se manjša gostota kosti, ki zato postajajo šibke, krhkejše in bolj nagnjene k zlomom (osteoporoza)
Your doctor may want to monitor you closely, see section 4 of the package leaflet. 
Zdravnik vas bo morda bolj natančno spremljal, glejte poglavje 4 navodila za uporabo.
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, obstaja morda tveganje za razvoj krvnega raka (levkemija, mielodisplastični sindrom (MDS)).
Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Grastofil. 
Nenamerna enkratna izpostavljenost zamrzovalnim temperaturam, nima vpliva na stabilnost zdravila Grastofil.
• decreased feeling of sensitivity, especially in the skin (hypoaesthesia) 
• zmanjšan občutek za čutenje, zlasti na koži (hipestezija)
Haematuria was common and proteinuria occurred in a small number of patients. 
Pogosta je bila hematurija in pri majhnem številu bolnikov se je pojavila proteinurija.
In other circumstances, additional leukaphereses are recommended. 
V drugih okoliščinah so priporočljive dodatne levkafereze.
The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established. 
Varnost in učinkovitost filgrastima, uporabljenega na isti dan, kot je bila uporabljena mielosupresivna citotoksična kemoterapija, nista bili dokončno potrjeni.
This medicinal product contains 50 mg sorbitol. 
To zdravilo vsebuje 50 mg sorbitola.
Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements. 
Brizg zdravila Grastofil, ki so zunaj hladilnika dlje kot 15 dni, ne smete uporabiti in jih morate zavreči v skladu z lokalnimi predpisi.
Subsequently, the dose may be individually adjusted every 1-2 weeks to maintain the average neutrophil count between 1.5 x 10 
Nato je mogoče odmerek individualno prilagajati na vsak(a) 1-2 tedna, da se ohrani povprečno število nevtrofilcev med 1,5 x 10
At the end of this period, Grastofil should not be put back in the refrigerator and should be disposed of in accordance with local requirements. 
Po tem obdobju se zdravila Grastofil ne sme shraniti nazaj v hladilnik in ga je treba zavreči v skladu z lokalnimi predpisi.
If you forget to use Grastofil 
Če ste pozabili uporabiti zdravilo Grastofil
Grastofil is injected into the tissue just under the skin. 
Grastofil se vbrizga v tkivo tik pod kožo.
The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia. 
Učinkovitost zdravljenja v tej starostni skupini, ki je vključevala večinoma bolnike s prirojeno nevtropenijo, je bila očitna.
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 indukcijskem in konsolidacijskem zdravljenju akutne mieloične levkemije je trajanje zdravljenja lahko znatno daljše (tudi do 38 dni), odvisno od vrste, odmerka in sheme odmerjanja citotoksične kemoterapije.
When peripheral blood progenitor cell 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 krvotvornih matičnih celic iz periferne krvi, je postopek izplavljanja matičnih celic priporočljivo načrtovati v zgodnjem obdobju bolnikovega zdravljenja.
There is insufficient data to evaluate filgrastim use in elderly subjects for other approved Grastofil indications. 
Za ovrednotenje uporabe filgrastima pri starejših osebah pri drugih odobrenih indikacijah ni dovolj podatkov.
Once Grastofil has been out at room temperature it should not be put back into the refrigerator. 
Ko je zdravilo Grastofil shranjeno pri sobni temperaturi, ga ne smete več dati nazaj v hladilnik.
It is unknown whether filgrastim / metabolites are excreted in human milk. 
Ni znano, ali se filgrastim/presnovki izločajo v materino mleko.
Neutropenia may be a long-standing condition where your body does not make enough neutrophils, or it may be caused by drugs used to treat cancer. 
Nevtropenija je lahko dolgotrajna bolezen, pri kateri telo ne tvori dovolj nevtrofilcev, lahko pa jo povzročijo tudi zdravila za zdravljenje raka.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 - 16 hours. 
Po subkutanem dajanju priporočenega odmerka se je serumska koncentracija vzdrževala nad vrednostjo 10 ng/ml 8 do 16 ur.
Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded. 
Tveganja za napredovanje mieloidnega rakastega klona ne moremo izključiti.
The solution should be visually inspected prior to use. 
Raztopino morate pred uporabo vizualno pregledati.
If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. 
Če opazite kapljico krvi, jo nežno obrišite z bombažno vato ali robčkom.
It can also be given as a daily slow injection into the vein (known as an intravenous infusion). 
Daje se lahko tudi s počasnim injiciranjem v veno (znano kot intravensko infundiranje).
For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL. 
Pri bolnikih, ki se zdravijo s filgrastimom, razredčenim na koncentracije pod 1,5 M e. (15 mikrogramov) na mililiter, je treba dodati humani serumski albumin (HSA) do končne koncentracije 2 mg/ml.
Grastofil is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). 
Zdravilo Grastofil se običajno daje vsakodnevno z injekcijo v tkivo tik pod kožo (znano kot subkutana injekcija).
Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in Escherichia coli (BL21) by recombinant DNA technology. 
Filgrastim je rekombinantni metionilirani humani granulocitne kolonije spodbujajoči faktor pridobljen v Escherichia coli (BL21) s pomočjo rekombinantne DNA tehnologije.
Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. 
Kemična in fizikalna stabilnost razredčene raztopine za infundiranje med uporabo sta bili dokazani za obdobje 24 ur pri temperaturi od 2 °C do 8 °C.
Urinalysis monitoring is recommended. 
Priporoča se spremljanje z analizo urina.
What Grastofil is and what it is used for 
Kaj je zdravilo Grastofil in za kaj ga uporabljamo
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal. 
Darovalce, ki za izplavljanje PBPC dobivajo G-CSF, je treba spremljati, dokler se jim hematološke vrednosti ne normalizirajo.
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 pojavi izguba odziva ali neuspeh pri vzdrževanju odziva na zdravljenje s filgrastimom, bo zdravnik preučil razloge za to, vključno s tem, ali so se pri vas razvila protitelesa, ki nevtralizirajo aktivnost filgrastima.
Grastofil is available in packs containing 1 and 5 pre-filled syringes. 
Zdravilo Grastofil je na voljo v pakiranjih, ki vsebujejo 1 in 5 napolnjenih injekcijskih brizg.
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. 
Zdravnika takoj pokličite, če se vam pojavi otekanje obraza ali gležnjev, kri v urinu ali rjavo obarvan urin ali če opazite, da urinirate manj kot običajno.
In pregnant rats, no maternal or fetal toxicity was observed at doses up to 575 μg/kg/day. 
Pri brejih podganah niso opazili nobene toksičnosti za samice ali plod pri odmerkih do 575 mikrogramov/kg/dan.
Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection. 
Filgrastim spodbuja kostni mozeg (tkivo, kjer nastajajo nove krvne celice), da proizvaja več belih krvnih celic, ki telesu pomagajo v boju z okužbami.
• you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). 
• se zdravite zaradi hude kronične nevtropenije in imate kri v urinu (hematurija).
The safety and efficacy of filgrastim has not been assessed in normal donors less than 16 years or greater than 60 years of age. 
Varnost in učinkovitost filgrastima pri zdravih darovalcih, mlajših od 16 ali starejših od 60 let, nista bili ocenjeni.
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 stanja, imenovanega "sepsa" (tudi "zastrupitev krvi"), resne okužbe z vnetnim odzivom celega telesa, ki je lahko smrtno nevarna in jo je treba urgentno zdraviti.
Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines. 
Zdravilo Grastofil je rastni faktor belih krvnih celic (granulocitne kolonije spodbujajoči faktor) in sodi v skupino zdravil, imenovanih citokini.
Other medicines and Grastofil 
Druga zdravila in zdravilo Grastofil