natgillin/translations-raw huggingface dataset:
Tablet core: 
Ledvična okvara:
It is therefore difficult to recommend an optimum method. 
Zaradi tega je težko priporočiti optimalno metodo.
The significance of these changes is unknown. 
Pomen teh sprememb ni znan.
These can be taken from you or from a donor. 
Te lahko odvzamejo od vas ali od darovalca.
These will be monitored by your doctor. 
To bo spremljal vaš zdravnik.
10291 Prigorje Brdovečko Croatia 
10291 Prigorje Brdovečko Hrvaška
Date of first authorisation: 08 June 2010 Date of latest renewal: 27 May 2015 
Datum prve odobritve: 08 junij 2010 Datum zadnjega podaljšanja: 27 maj 2015
The syringe is now ready for use. 
Brizga je zdaj pripravljena za uporabo.
If you are a stem cell donor, you must be aged between 16 and 60 years. 
Če ste darovalec matičnih celic, morate biti stari med 16 in 60 let.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful. 
Čeprav tega medsebojnega delovanja formalno niso raziskovali, pa ni nobenih dokazov, da je tako medsebojno delovanje škodljivo.
Wash your hands thoroughly with soap and water. 
Temeljito si umijte roke z milom in vodo.
cells mean that direct comparison between different studies is difficult. 
+ celic pomeni, da je neposredna primerjava med različnima študijama težavna.
These changes all reversed after discontinuation of treatment. 
Vse te spremembe so po prenehanju zdravljenja izzvenele.
The most suitable places for injection are: 
Najprimernejša mesta za injiciranje so:
European Retrospective Study (2004) 
Evropska retrospektivna študija (2004)
The subcutaneous route is preferred in most cases. 
Subkutana pot uporabe je v večini primerov najprimernejša.
Do not increase the dose your doctor has given you. 
Ne povečajte odmerka, ki vam ga je dal zdravnik.
You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home. 
Vi oziroma osebe, ki skrbijo za vas, se lahko naučite, kako dajati podkožne injekcije tako, da lahko zdravljenje nadaljujete doma.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: 
NASLEDNJE INFORMACIJE SO NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU:
Your healthcare professional should always record the exact product you are using. 
Vaš zdravstveni delavec mora vedno zabeležiti točno ime zdravila, ki ga uporabljate.
This should be considered when interpreting bone-imaging results. 
To je treba upoštevati pri interpretaciji izvidov slikanja kosti.
9/L, with the median dose frequency being 3 days per week. 
9/l, pri čemer je bila mediana pogostnost odmerjanja 3 dni na teden.
• Antiseptic wipes (if recommended by your doctor or nurse). 
• antiseptične robčke (če sta vam jih priporočila zdravnik ali medicinska sestra).
Regular monitoring of blood counts is recommended (see above). 
Priporočljivo je redno spremljanje krvne slike (glejte zgoraj).
Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. 
Rastni faktorji so beljakovine, ki jih telo naravno proizvaja, vendar pa jih je mogoče izdelati tudi s pomočjo biotehnologije za uporabo kot zdravilo.
You will need to have your injections at about the same time every day. 
Injekcije si boste morali dajati vsak dan ob približno istem času.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Dose adjustment is not required in these circumstances. 
V teh primerih ni potrebna prilagoditev odmerka.
This medicine may cause dizziness. 
To zdravilo lahko povzroči omotico.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of. 
Po tem obdobju se zdravila ne sme shraniti nazaj v hladilnik in ga je potrebno uničiti.
• NEVER put used syringes into your normal household waste bin. 
• Uporabljenih brizg NIKOLI ne odlagajte med običajne gospodinjske odpadke.
How is Nivestim given and how much should I take? 
Kako se daje zdravilo Nivestim in koliko ga moram vzeti?
However, you should not attempt this unless you have been properly trained first by your healthcare provider. 
Vendar pa tega ne poskušajte, če vas zdravstveni delavec za to ni najprej ustrezno usposobil.
DATE OF REVISION OF THE TEXT 
DATUM ZADNJE REVIZIJE BESEDILA:
ANC = absolute neutrophil count 
ANC = absolutno število nevtrofilcev (absolute neutrophil count)
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10 
Levkaferezo je treba začeti 5. dan in z njo nadaljevati do 6. dne, če je potrebno, da bo zbranih 4 x 10
The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population. 
Edini neželen dogodek, ki so ga dosledno poročali, je bil mišično-skeletna bolečina, to pa se ne razlikuje od izkušenj pri odraslih populaciji.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response. 
Po enem ali dveh tednih zdravljenja je možno začetni odmerek podvojiti ali razpoloviti, odvisno od bolnikovega odziva.
A risk to the newborns/infants cannot be excluded. 
Tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
For intravenous or subcutaneous use. 
za intravensko ali subkutano uporabo
For reversal of neutropenia: 
Za odpravljanje nevtropenije:
Your doctor may want to monitor you closely, see section 4 of the package leaflet. 
Zdravnik vas bo morda želel pozorno spremljati, glejte poglavje 4 v teh navodilih za uporabo.
The clinical relevance of this finding to multiple dose administration is not clear. 
Klinični pomen te ugotovitve pri uporabi večkratnih odmerkov ni jasen.
The frozen pre-filled syringes can be thawed and then refrigerated for future use. 
Zamrznjene napolnjene brizge je možno odmrzniti in jih nato shraniti na hladnem za nadaljnjo uporabo.
It is important to tell your doctor if you: - are pregnant or breast-feeding; - think you may be pregnant; or - are planning to have a baby. 
Pomembno je, da svojemu zdravniku poveste, če: - ste noseči ali dojite, - mislite da ste noseči ali - načrtujete nosečnost.
• trouble sleeping (insomnia) 
• težave s spanjem (nespečnost)
When the response has been obtained the minimal effective dose to maintain this level should be established. 
Ko je dosežen odziv, je treba določiti minimalni učinkoviti odmerek za ohranjanje te vrednosti.
If your nurse or doctor recommends it, clean the area of skin with an antiseptic wipe. 
Če zdravnik ali medicinska sestra to priporočata, očistite izbrani del kože z antiseptičnim robčkom.
• The active substance is filgrastim. 
• Učinkovina je filgrastim.
a Analysis includes studies involving BM transplant during this period; some studies used GM-CSF. 
Analiza je vključevala študije presaditve kostnega mozga v tem obdobju; v nekaterih študijah so uporabili GM-CSF.
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made. 
V klinična preskušanja s filgrastimom je bilo vključeno majhno število starejših bolnikov, vendar pri tej skupini niso bile opravljene posebne študije, zato ni mogoče podati posebnih priporočil za odmerjanje.
Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery. 
Zdi se, da so deleži, večji od teh najmanjših deležev, povezani s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
• increase of certain enzymes in the blood 
• zvišanje določenih encimov v krvi
This medicine contains 50 mg sorbitol in each ml. 
To zdravilo vsebuje 50 mg sorbitola v vsakem ml raztopine.
How long will I have to take Nivestim? 
Koliko časa bom moral jemati zdravilo Nivestim?
• unusual change in the urine 
• neobičajne spremembe urina
Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed. 
Najdite prijetno in dobro osvetljeno delovno mesto, kjer si boste dali injekcijo zdravila, in preverite odmerek, ki vam ga je predpisal zdravnik.
Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections. 
Če se boste naučili, kako si lahko zdravilo injicirate sami, vam ne bo treba čakati doma, da pride medicinska sestra ali vsak dan oditi v bolnišnico oziroma na kliniko, da prejmete injekcijo.
The passive needle guard will NOT activate unless the ENTIRE dose has been given. 
Pasivna zaščita za iglo se NE aktivira, razen če aplicirate CELOTEN odmerek.
Rate of generation of antibodies against filgrastim is generally low. 
Stopnja nastajanja protiteles proti filgrastimu je na splošno nizka.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. 
Če imate (ali ima vaš otrok) dedno intoleranco za fruktozo, redko genetsko bolezen, vi (ali vaš otrok) ne smete dobiti tega zdravila.
Perform the injection using the technique described above. 
Injicirajte si zdravilo na način, kot je opisano zgoraj.
With your other hand, insert the needle at an approximate 45˚ angle. 
Z drugo roko vbodite iglo v kožo pod kotom približno 45˚.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient. 
Pri izbiri mobilizacijske metode je treba upoštevati splošne cilje zdravljenja pri posameznem bolniku.
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.
Meta-Analysis (2003) 
Metaanaliza (2003)
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).