natgillin/translations-raw huggingface dataset:
Biograstim treatment will last for up to 2 weeks and in exceptional cases longer. 
Zdravljenje z zdravilom Biograstim bo trajalo do dveh tednov, le v izjemnih primerih bo trajalo dlje.
Dose adjustment is not required in these circumstances. 
Prilagajanje odmerka v tem primeru ni potrebno.
Do not remove the cover from the syringe until you are ready to inject. 
Ne snemajte pokrovčka z injekcijske brizge, dokler niste pripravljeni na injiciranje.
Possible side effects”). 
Možni neželeni učinki«).
Musculoskeletal pain is usually controlled with standard analgesics. 
Mišičnoskeletno bolečino običajno obvladujemo s standardnimi analgetiki.
Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). 
Zaradi tega moramo velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day. 
Ko se število belih krvničk v vaši krvi povrne na običajno raven, je pogostost odmerjanja zdravila mogoče zmanjšati na manj kot enkrat dnevno.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient. 
Metodo zbiranja je potrebno izbrati glede na splošne cilje zdravljenja pri posameznem bolniku.
From a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega vidika morate zdravilo porabiti takoj.
Do not warm Biograstim in any other way (for example, do not warm it in a microwave or in hot water). 
Zdravila Biograstim ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Germany 
AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Nemčija
The needle will be covered by the protective sleeve so that you cannot prick yourself. 
Igla se bo pokrila z zaščitnim tulcem, da se ne morete zbosti.
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. 
Če to zdravilo prejemate s subkutanim injiciranjem, vam lahko vaš zdravnik predlaga, da se sami naučite dajati injekcije.
The clinical relevance of this finding to multiple dose administration is not clear. 
Klinična pomembnost te ugotovitve v zvezi z večkratnimi odmerki ni jasna.
Therefore, your doctor may decide that you should not use this medicine. 
Zato se vaš zdravnik lahko odloči, da ne smete jemati tega zdravila.
Idiopathic or cyclic neutropenia 
Idiopatična ali ciklična nevtropenija
Subcutaneous use and intravenous use. 
Za subkutano in intravensko uporabo.
Very rare: Not known: 
Zelo redki: neznana:
Filgrastim has minor or moderate influence on the ability to drive and use machines. 
Filgrastim ima zanemarljiv ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response. 
Po eno- ali dvotedenskem zdravljenju se začetni odmerek lahko podvoji ali prepolovi, odvisno od odziva bolnika.
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte v hladilniku (2 C - 8 C).
The incidence of these events was similar to that reported in cancer patients. 
Pojav teh neželenih učinkov je podoben tistemu, o katerem so poročali pri bolnikih z rakom.
It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. 
Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravnim beljakovinam (faktor, ki spodbuja razvoj granulocitov [G-CSF]), ki jih izdeluje vaše lastno telo.
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 zdravila ne porabite takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi med 2 in 8 °C, razen če postopek redčenja ni potekal v nadzorovanih in preverjeno aseptičnih pogojih.
What should I do before I give myself a subcutaneous injection of Biograstim? 
Kaj moram narediti, preden si dam subkutano injekcijo zdravila Biograstim?
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 so v njem delci.
This medicinal product must not be mixed with other medicinal products except those mentioned below. 
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena spodaj.
Thirty-one percent (31 %) of patients in studies were documented as having palpable splenomegaly. 
Pri enaintridesetih odstotkih (31 %) bolnikov, ki so sodelovali v raziskavah, so zabeležili otipljivo splenomegalijo.
Special requirements 
Posebne zahteve
Your doctor will tell you when to stop using Biograstim. 
Vaš zdravnik vam bo povedal, kdaj morate prenehati jemati zdravilo Biograstim.
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 izvornih celic vsaj še 10 let ter darovalcem tako zagotovi dolgoročno varnost.
No undesirable effects directly attributable to this degree of leukocytosis have been reported. 
Ne poročajo o neželenih učinkih, ki bi jih bilo možno neposredno pripisati tej stopnji levkocitoze.
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. 
Na voljo še ni naključnih primerjav obeh priporočenih metod zbiranja (metodo filgrastim samo ali v kombinaciji z mielosupresivno kemoterapijo) v okviru ene skupine bolnikov.
The solution should be visually inspected prior to use. 
Pred uporabo morate raztopino vizualno pregledati.
Push the plunger up to the number (mL) on the syringe that matches the dose of Biograstim that your doctor prescribed. 
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Biograstim, ki vam ga je predpisal vaš zdravnik.
This section contains information on how to give yourself an injection of Biograstim. 
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Biograstim.
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 kliničnih preskušanjih s filgrastimom je sodelovalo tudi manjše število starejših bolnikov, vendar posebnih raziskav v tej skupini niso izvajali, zato priporočenih odmerkov ne moremo navesti.
Yields in excess of this minimum yield appear to correlate with more rapid recovery, those below with slower recovery. 
Vrednosti nad minimalnim številom so najverjetneje povezane s hitrim okrevanjem, tiste pod minimalnim številom pa s počasnim okrevanjem.
Put the needle fully into the skin as shown by your nurse or doctor (see picture 6). 
Potisnite iglo do konca v kožo, kot vam je pokazal zdravnik ali medicinska sestra (glejte sliko 6).
In other circumstances, additional leukaphereses are recommended. 
V drugih primerih se priporočajo dodatne levkafereze.
Orient the needle away from you and others and activate the safety device by firmly pushing the plunger (see picture 8). 
Iglo obrnite stran od sebe in drugih ter aktivirajte varnostni pripomoček, tako da trdno pritisnete bat (glejte sliko 8).
Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02 
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA02
If you experience fatigue, do not drive or use any tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Če se počutite utrujeni, ne vozite in ne uporabljajte nobenega orodja ali strojev.
Undesirable effect 
Neželeni učinek
In other circumstances, additional leukaphereses may be necessary. 
V drugih primerih bo morda potrebna še dodatna levkafereza.
Check the appearance of Biograstim. 
Preverite videz raztopine Biograstima.
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 filgrastima pri bolnikih z de novo AML, mlajših od 55 let in z ugodno citogenetiko [t(8;21), t(15;17) in inv(16)], nista ugotovljeni.
Fatigue, generalised weakness 
Pogosti utrujenost, splošna oslabelost
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect. 
Iz raziskave o dajanju enkratnega odmerka obstajajo dokazi, da intravenski način dajanja zdravila lahko skrajša trajanje učinka.
Regular urinanalysis should be performed to monitor this event. 
Za spremljanje teh bolezenskih stanj je potrebna redna urinska analiza.
Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim. 
Ker litij pospešuje sproščanje nevtrofilcev, je mogoče, da potencira učinek filgrastima.
The choice of route should depend on the individual clinical circumstance. 
Izbira za en ali drug način dajanja zdravila bi morala biti odvisna od posameznih kliničnih okoliščin.
Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli. 
Filgrastim je beljakovina, ki jo izdelujejo s pomočjo biotehnologije v bakterijah, ki se imenujejo Escherichia coli.
Spleen size should be evaluated regularly. 
Velikost vranice je potrebno redno pregledovati.
Biograstim has not been tested in pregnant women. 
Zdravila Biograstim pri nosečnicah niso preizkusili.
The assessment of undesirable effects is based on the following frequency data: Very common: 
Neželeni učinki so opredeljeni po pogostnosti: Zelo pogosti:
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 limfoidini levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
For maintaining normal neutrophil counts 
Ohranjanje normalnega števila nevtrofilcev
The most suitable places to inject yourself are: - the top of your thighs; and - the abdomen, except for the area around the navel (see picture 3). 
Najprimernejši mesti za samoinjiciranje sta: - zgornji del stegen; in - trebuh, razen predela okrog popka (glejte sliko 3).
Your doctor will monitor your blood to determine the best time to collect the stem cells. 
Vaš zdravnik bo spremljal vašo kri, zato da določi najprimernejši čas za zbiranje izvornih celic.
If someone else is injecting you, they can also use the back of your arms (see picture 4). 
Če vam daje injekcijo kdo drug, vam jo lahko da tudi v zadnji del nadlakti (glejte sliko 4).
Check again to make sure the correct dose of Biograstim is in the syringe. 
Še enkrat preverite, če je v brizgi ustrezen odmerek zdravila Biograstim.
Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells. 
Filgrastim spodbuja kostni mozeg (tkivo, kjer nastajajo krvničke), da proizvaja več krvničk, še posebej določene vrste belih krvničk.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials. 
Možnih interakcij z drugimi hemotopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso posebej raziskali.
Try to self-inject at approximately the same time every day. 
Potrudite se, da si boste zdravilo vbrizgali vsak dan ob približno enakem času.
Other medicines and Biograstim 
Druga zdravila in zdravilo Biograstim
If you think you are having this type of reaction, you must stop your Biograstim injection and get medical help immediately. 
Če menite, da se je pri vas pojavila takšna reakcija, prenehajte z odmerjanjem zdravila Biograstim in takoj poiščite zdravniško pomoč.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. 
V nekaterih primerih so se simptomi ob vnovični izpostavitvi ponovno pojavili, kar nakazuje vzročni odnos.
A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality. 
Metaanaliza študije alogenskih presaditev, vključno z rezultati devetih prospektivnih randomiziranih preskušanj, 8 retrospektivnih študij in 1 s primerom nadzirane študije ni pokazala učinka na tveganje za akutno GvHD, kronično GvHD ali zgodnjo z zdravljenjem povezano smrtnostjo.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration. 
Randomizirane, enojno slepe navzkrižne študije z enkratnim odmerkom pri 196 zdravih prostovoljcih so pokazale, da je farmakokinetičen profil zdravila Biograstim primerljiv s profilom referenčnega zdravila po subkutanem in intravenskem apliciranju.
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 za hudo mieloično levkemijo je trajanje zdravljenja lahko znatno daljše (tudi do 38 dni), odvisno od vrste, odmerka in sheme odmerjanja citotoksične kemoterapije.
The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies. 
Varnostni profil zdravila Biograstim v kliničnih študij se je ujemal z varnostnim profilom referenčnega zdravila, prav tako uporabljenega v teh študijah.
Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation 
Relativno tveganje (95-% IZ) za GvHD in TRM po zdravljenju z G-CSF po presaditvi kostnega mozga
The excretion of filgrastim in milk has not been studied in animals. 
Izločanja filgrastima v mleko pri živalih, niso raziskali.
If the patient is experiencing fatigue, caution is advised when driving a car or operating machines. 
Če se bolnik počuti utrujenega, mora biti pri vožnji avtomobila ali pri upravljanju s stroji previden.
However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established. 
Ker pa je velik odstotek teh bolnikov obolelih za levkemijo (gre za stanje, za katerega vemo, da je povezano s Sweetovim sindromom), vzročna povezava s filgrastimom ni bila ugotovljena.
Each mL of solution contains 50 mg of sorbitol. 
1 ml raztopine vsebuje 50 mg sorbitola.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. 
Pomembno je, da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
A risk of promotion of a malignant myeloid clone can not be excluded. 
Tveganja za napredovanje mieloidnega rakastega klona ne moremo izključiti.
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. 
Postopek zbiranja in afereze bi moral potekati v sodelovanju z onkološko-hematološkim centrom, ki ima ustrezne izkušnje na tem področju in v katerem lahko na ustrezen način spremljajo krvotvorne matične celice.
The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma. 
Učinkovitost in varnost Biograstima sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne-Hodkinovim limfomom.
Inject the liquid slowly and evenly, always keeping your skin pinched. 
Tekočino injicirajte počasi in enakomerno; pri tem ves čas s palcem in kazalcem držite kožno gubo.
Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient. 
Časovna razporeditev levkaferez: običajno zadostujeta 1 do 2 levkafrezi 5. in 6. dan.
Some cases of splenic rupture were fatal. 
Nekateri primeri pretrganja vranice so bili usodni.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro. 
Faktor, ki spodbuja rast granulocitnih kolonij, lahko spodbudi rast mieloičnih celic in vitro; podobni učinki bi se lahko pojavili pri nekaterih nemieloičnih celicah in vitro.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. 
Še posebej previdni moramo biti, kadar je predpisano eno samo ali več kemoterapevtskih učinkovin, za katere se ve, da povzročajo hudo trombocitopenijo.
Your doctor or nurse will give you instructions on how to do this. 
O tem vas bosta poučila vaš zdravnik ali medicinska sestra.
Your doctor will tell you why you are being treated with Biograstim. 
Prav tako vam bo zdravnik razložil, zakaj se zdravite z zdravilom Biograstim.
The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally. 
Občasno so poročali o pojavu Sweetovega sindroma (akutna febrilna dermatoza).
The mechanism of vasculitis in patients receiving filgrastim is unknown. 
Mehanizem kožnega vaskulitisa pri bolnikih, ki prejemajo filgrastmi, ni znan.
Unspecified pain 
Občasni nespecifična bolečina
Filgrastim dosing should be maintained until the last leukapheresis. 
Odmerjanje filgrastima naj traja vse do zadnje levkafereze.
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 pridobljenih matičnih celic pri bolnikih, ki so prejemali filgrastim, je treba posebej paziti na metodo za ugotavljanje količinske sestave.
Infections and malignancies causing myelosuppression 
Okužbe in maligna obolenja, ki povzročajo mielosupresijo
The amount of Biograstim you need, will depend on the condition you are taking Biograstim for and on your bodyweight. 
Količina zdravila Biograstim, ki jo potrebujete, je odvisna od stanja, zaradi katerega morate jemati zdravilo, in od vaše telesne mase.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered. 
Če je število glede na zgornje kriterije prenizko, je potrebno razmisliti o alternativnih oblikah zdravljenja, pri katerih ni potrebe po matičnih celicah.
When a 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 matičnih celic iz periferne krvi, je zbiranje izvornih celic priporočljivo načrtovati v zgodnji fazi zdravljenja bolnika.
In view of the possible risk of microbial contamination, Biograstim syringes are for single use only. 
Ker obstaja tveganje mikrobne kontaminacije so z zdravilom Biograstim napolnjene brizge namenjene izključno enkratni uporabi.
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. 
Če imate kakršne koli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za pomoč in nasvet.
In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy. 
V randomiziranih, s placebom nadzorovanih kliničnih študijah, filgrastim ni povzročil zvečanja števila neželenih učinkov, povezanih s citotoksično kemoterapijo.
The causal association with filgrastim has not been established. 
Vzročna povezava s filgrastimom ni bila ugotovljena.
- if you have sickle cell disease (an inherited disease characterised by sickle-shaped red blood cells). 
- če imate srpasto anemijo (dedno bolezen, za katero so značilne srpasto oblikovane rdeče krvničke).
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/mL for 8 to 16 hours. 
Po subkutanem aplikaciji priporočenih odmerkov je bila koncentracija seruma naslednjih 8 do 16 ur višja od 10 ng/ml.
The efficacy of treatment was clear for this age group, which included most patients with congenital neutropenia. 
Učinkovitost zdravljenja pri tej starostni skupini, v kateri so bili tudi bolniki s kongenitalno nevtropenijo, je bila jasna.
Take your Biograstim pre-filled syringe out of the refrigerator. 
Vzemite napolnjeno injekcijsko brizgo z zdravilom Biograstim iz hladilnika.
Analysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) Analysis includes patients receiving bone marrow transplant during this period 
1995-2000b aAnaliza vključuje študije, ki zajemajo presaditev kostnega mozga v tem obdobju; nekatere študije uporabljajo GM-CSF (faktor, ki spodbuja rast granulocitno-makrofagnih kolonij) bAnaliza vključuje bolnike, ki jim je bil v tem obdobju presajen kostni mozeg
Your doctor has prescribed Biograstim for you to help your body make more white blood cells. 
Zdravnik vam je predpisal zdravilo Biograstim zato, da bi vaše telo lahko proizvajalo več belih krvničk.
This observation has only been made in patients with congenital neutropenia. 
Te nepravilnosti so bile opažene samo pri bolnikih s kongenitalno nevtropenijo.
● Periodic Safety Update Reports 
• Redno posodobljena poročila o varnosti zdravila (PSUR)
Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). 
Zdravilo Biograstim se uporablja za zbiranje perifernih krvotvornih matičnih celic (PBPC).
Splenic enlargement is a direct effect of treatment with filgrastim. 
Zvečanje vranice je neposreden učinek zdravljenja s filgrastimom.
Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally. 
Občasno so poročali o prehodnem zvišanju krvnega tlaka; klinično zdravljenje ni bilo potrebno.
To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Biograstim; - alcohol wipes or similar; - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely. 
Za subkutano samoinjiciranje boste potrebovali: - napolnjeno injekcijsko brizgo z zdravilom Biograstim, - alkoholne krpice ali podobno, - vsebnik, odporen na vbode (plastičen vsebnik, ki ga dobite v bolnišnici ali lekarni), tako da boste lahko varno odlagali uporabljene brizge brez varnostnega pripomočka.
What Biograstim is and what it is used for What you need to know before you use Biograstim How to use Biograstim 
Kaj je zdravilo Biograstim in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Biograstim Kako uporabljati zdravilo Biograstim Možni neželeni učinki
- Never put the syringes that you have used into your normal household rubbish bin. 
- Uporabljenih brizg nikoli ne odložite v koš, ki ga uporabljate za odlaganje ostalih gospodinjskih odpadkov.
Biograstim contains sorbitol. 
Zdravilo Biograstim vsebuje sorbitol.
Some patients may respond very rapidly and with a considerable increase in neutrophil count to the initial dose of filgrastim. 
Nekateri bolniki se lahko zelo hitro in z znatnim povečanjem števila nevtrofilcev odzovejo na začetni odmerek filgrastima.
Before you stop using Biograstim, talk to your doctor. 
Če ste prenehali uporabljati zdravilo Biograstim Preden prenehate uporabljati zdravilo Biograstim se pogovorite z vašim zdravnikom.