natgillin/translations-raw huggingface dataset:
Some cases of splenic rupture were fatal. 
Nekateri primeri raztrganja vranice so bili smrtni.
It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine. 
Pomembno je, da zdravniku poveste, ali ste noseči, menite, da ste noseči ali nameravate zanositi, saj se zdravnik lahko odloči, da zdravila ne smete uporabljati.
ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days 
ITT = populacija z namenom zdravljenja (Intent-to-treat) (vsi randomizirani bolniki) SD = standardna deviacija d = dni
Therefore, no adjustment of the dose is necessary for elderly patients. 
Zato pri starejših bolnikih prilagoditev odmerka ni potrebna.
The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %. 
Povprečna molekulska masa je približno 39 kDa, od tega predstavlja beljakovinski del približno 48 %.
If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection. 
Če pade število belih krvnih celic na nizko raven, jih morda v telesu ne bo dovolj za boj proti bakterijam in lahko boste izpostavljeni večjemu tveganju za okužbo.
If you have a fever or any of these symptoms, it is important to contact your doctor immediately. 
Če imate zvišano telesno temperaturo ali katerega od teh simptomov, je pomembno, da se takoj posvetujete z zdravnikom.
● Risk Management Plan (RMP) 
ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
Currently available data are described in section 5.2, but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. 
Te celice so zelo občutljive na učinke kemoterapije, ki lahko povzroči zmanjšanje števila teh celic v telesu.
White blood cells are important as they help your body fight infection. 
Bele krvne celice so pomembne, saj telesu pomagajo v boju proti okužbam.
Median ANC (x 109 cells/l) 
Mediana vrednost ANC (x 109 celic/l)
Tell your doctor if you experience these symptoms. 
Povejte zdravniku, če se pri vas pojavijo ti simptomi.
Most biological medicinal products elicit some level of anti-drug antibody response. 
Večina bioloških zdravil izzove določeno stopnjo protitelesnega odziva na zdravilo.
This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg). 
To lahko povzroči manjše farmakodinamične odzive pri debelih bolnikih (> 95 kg).
Your doctor may suggest that you learn how to inject yourself with this medicine. 
Vaš zdravnik vam lahko predlaga, da se naučite, kako si zdravilo injicirate sami.
Your doctor or nurse will give you instructions on how to do this. 
Vaš zdravnik ali medicinska sestra vas bosta o tem poučila.
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Allergic reactions and immunogenicity 
Alergijske reakcije in imunogenost
Take the medicine out of the refrigerator. 
Zdravilo vzemite iz hladilnika.
How are the injections given? 
Kako se dajejo injekcije?
If you have missed an injection, contact your doctor to discuss when you should inject the next dose. 
Če ste izpustili injekcijo, se posvetujte z zdravnikom, kdaj naj si injicirate naslednji odmerek.
It is unknown whether the active substance in this medicine passes into the breast milk. 
Ni znano, ali učinkovina tega zdravila prehaja v materino mleko.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product. 
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately. 
Če menite, da imate to vrsto reakcije, morate prenehati z injiciranjem zdravila Lonquex in takoj poiskati zdravniško pomoč.
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. 
Za izboljšanje sledljivosti bioloških zdravil je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolniško kartoteko.
See leaflet for further information. 
Za več informacij glejte navodilo.
Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice. 
Samoinjiciranje zdravila Lonquex lahko izvajajo le bolniki, ki so dobro motivirani, ustrezno usposobljeni in imajo dostop do nasveta strokovnjaka.
• if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na lipegfilgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Only use each syringe for one injection. 
Vsako injekcijsko brizgo uporabite samo za eno injiciranje.
Do not remove the needle cover from the syringe until you are ready to inject. 
Ne snemajte pokrovčka igle z injekcijske brizge, dokler niste pripravljeni na injiciranje.
Tell your doctor if you experience severe musculoskeletal pain. 
Obvestite zdravnika, če se pri vas pojavi huda mišično-skeletna bolečina.
Pull straight as shown in pictures 2 and 3. 
Potegnite ga naravnost, kot prikazujeta sliki 2 in 3.
Haematopoietic system 
Hematopoetski sistem
If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered. 
Če se pojavi resna alergijska reakcija, je treba uvesti ustrezno zdravljenje in bolnika nekaj dni natančno spremljati.
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. 
Možnosti medsebojnega delovanja z litijem, ki prav tako spodbuja sproščanje nevtrofilcev, niso posebej preučili.
Consequent decrease in efficacy in these patients cannot be excluded on current data. 
Na podlagi trenutnih podatkov ni mogoče izključiti posledične zmanjšane učinkovitosti pri teh bolnikih.
The use of three different chemotherapy regimens, with varying myelosuppressive effects and age distributions, complicated the comparison of efficacy across age groups (see section 4.2). 
Zaradi uporabe treh različnih shem kemoterapije z različnimi mielosupresivnimi učinki in starostnimi porazdelitvami je bila primerjava učinkovitosti v starostnih skupinah zapletena (glejte poglavje 4.2).
This is known as a subcutaneous injection. 
Temu se reče subkutana injekcija.
G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis. 
G-CSF poveča tudi protibakterijsko aktivnost nevtrofilcev, vključno s fagocitozo.
Pull straight as shown in pictures 1 and 2. 
Potegnite ga naravnost, kot prikazujeta sliki 1 in 2.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. 
Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin istega terapevtskega razreda.
It must be a clear and colourless liquid. 
Tekočina mora biti bistra in brezbarvna.
Do not shake Lonquex vigorously as this may affect its activity. 
Zdravila Lonquex ne stresajte močno, saj lahko to vpliva na njegovo aktivnost.
In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim. 
V kliničnih študijah z omejenim številom starejših bolnikov ni bilo pomembnih razlik zaradi starosti, povezanih s profili učinkovitosti ali varnosti lipegfilgrastima.
Do not use it if the date has passed the last day of the month shown. 
Ne uporabite zdravila, če je zadnji dan navedenega meseca že potekel.
It belongs to a group of proteins called cytokines and is 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 naravni beljakovini (granulocitne kolonije stimulirajoči faktor [G-CSF]), ki jo izdeluje vaše lastno telo.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. 
Za bolnike z nedavno anamnezo pljučnih infiltratov ali pljučnice je lahko tveganje večje.
Then release the plunger. 
Nato bat izpustite.
What you should do before your injection 
Kaj morate narediti pred injiciranjem
Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells. 
Lipegfilgrastim spodbuja kostni mozeg (tkivo, kjer nastajajo nove krvne celice) k tvorbi več belih krvnih celic.
*See section “Description of selected adverse reactions” below Description of selected adverse reactions 
*glejte spodnje poglavje "Opis izbranih neželenih učinkov"
The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe) if the PEG moiety and the carbohydrate linker are included. 
Koncentracija je 20,9 mg/ml (tj. 12,6 mg na napolnjeno injekcijsko brizgo), če sta vključena tudi PEG in vezni ogljikov hidrat.
The solution should be visually inspected before use. 
Raztopino morate pred uporabo vizualno pregledati.
Drug-specific antibodies emerging after start of treatment were detected in 0.86 % of the subjects receiving lipegfilgrastim, in 1.06 % of the subjects receiving pegfilgrastim and in 1.65 % of the subjects receiving placebo. 
Protitelesa, specifična za zdravilo, ki so se pojavljala po začetku zdravljenja, so zaznali pri 0,86 % oseb, ki so prejemale lipegfilgrastim, pri 1,06 % oseb, ki so prejemale pegfilgrastim, in pri 1,65 % oseb, ki so prejemale placebo.
These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood. 
Ti rezultati kažejo, da G-CSF del lipegfilgrastima daje pričakovano aktivnost tega rastnega faktorja: stimulacija proliferacije krvotvornih predniških celic, diferenciacija v zrele celice in sproščanje v periferno kri.
Blood and lymphatic system disorders - Splenic rupture including some fatal cases (see section 4.4) - Sickle cell crisis in patients with sickle cell anaemia (see section 4.4) 
Bolezni krvi in limfatičnega sistema - ruptura vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4) - srpastocelična kriza pri bolnikih s srpastocelično anemijo (glejte poglavje 4.4)
Musculoskeletal pain is generally of mild to moderate severity, transient and can be controlled in most patients with standard analgesics. 
Mišično-skeletna bolečina je običajno blaga do zmerna, prehodna in jo je mogoče pri večini bolnikov obvladati s standardnimi analgetiki.
• Do not put the cover back on used needles. 
- Ne nameščajte pokrovčka nazaj na uporabljene igle.
These could be symptoms of a condition reported with frequency not known (cannot be estimated from the available data), called “capillary leak syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention. 
To so lahko simptomi stanja, o katerem so poročali z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov), imenovanega "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu in zahteva nujno zdravniško pomoč.
Table 3: DSN, SN and FN in cycle 1 of study XM22-04 (ITT) Placebo (n = 125) 
Preglednica 3: THN, SN in FN v 1. ciklu študije XM22-04 (ITT) Placebo (n = 125)
These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly-growing cells). 
Povzroči ju lahko citotoksična kemoterapija (zdravila, ki uničijo hitrorastoče celice).
The experience in children is limited to a single-dose phase 1 study in 21 paediatric patients aged 2 to <18 years (see section 5.1), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults. 
Izkušnje pri otrocih so omejene na študijo faze 1 z enim odmerkom pri 21 pediatričnih bolnikih, starih 2 do < 18 let (glejte poglavje 5.1), v kateri se niso pokazale razlike v varnostnem profilu lipegfilgrastima pri otrocih v primerjavi z odraslimi.
Study days, injection of lipegfilgrastim at day 0 
Dnevi študije, injiciranje lipegfilgrastima na 0. dan
You should therefore interrupt breast-feeding during treatment.. 
Zato morate med zdravljenjem dojenje prekiniti.
Do not touch the needle or push the plunger. 
Ne dotikajte se igle in ne pritiskajte na bat.
• It is important to contact your doctor immediately if you have any of the following symptoms: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. 
- Pomembno je, da se takoj posvetujete z zdravnikom, če imate katerega koli od naslednjih simptomov: oteklost ali zabuhlost, ki jo lahko spremlja manj pogosto odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
• if you have sickle cell anaemia, which is an inherited disease characterised by sickle-shaped red blood cells. 
- če imate srpastocelično anemijo, ki je dedna bolezen, za katero je značilna srpasta oblika rdečih krvnih celic.
When the main study was finalised, the incidence of death was 7.2 % (placebo) and 12.5 % (6 mg lipegfilgrastim) although after the 360-day follow-up period the overall incidence of death was similar between placebo and lipegfilgrastim (44.8 % and 44.0 %; safety population). 
Ob zaključku glavne študije je bila incidenca smrti 7,2 % (placebo) oz. 12,5 % (6 mg lipegfilgrastim), čeprav je bila po 360dnevnem obdobju spremljanja splošna incidenca smrti med placebom in lipegfilgrastimom podobna (44,8 % oz. 44,0 %; populacijska študija varnosti).
This section contains information on how to give yourself an injection of Lonquex under the skin. 
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Lonquex pod kožo.
The adverse reactions listed below in table 1 are classified according to system organ class. 
Neželeni učinki so opredeljeni spodaj v preglednici 1 glede na organske sisteme.
The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Lonquex pri otrocih in mladostnikih, starih do 17 let, še nista bili dokazani.
Pull slightly on the plunger to check that a blood vessel has not been punctured. 
Nekoliko izvlecite bat, da se prepričate, da niste prebodli krvne žile.
Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility (see section 5.3). 
Študije na živalih z G-CSF in derivati ne kažejo škodljivih učinkov na plodnost (glejte poglavje 5.3).
There could be a risk of reacting to Lonquex too. 
Morda obstaja tveganje, da boste imeli tudi reakcijo na zdravilo Lonquex.
• 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.
Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound). 
Zaradi tega moramo velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim. 
Lipegfilgrastim se veže na receptorje humanega G-CSF, kot sta filgrastim in pegfilgrastim.
The most frequent undesirable effects are musculoskeletal pain and nausea. 
Najpogostejša neželena učinka sta mišično-skeletna bolečina in navzea.
In vitro data indicate that lipegfilgrastim is has little or no direct or immune system-mediated effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 activity. 
Medsebojno delovanje z zdravili Podatki in vitro kažejo, da lipegfilgrastim neposredno ali preko imunskega sistema le malo ali sploh ne učinkuje na aktivnost encimov CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP3A4/5.
Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called Escherichia coli. 
Lipegfilgrastim je dolgodelujoča modificirana beljakovina, ki jo izdelujejo biotehnološko v bakteriji, imenovani Escherichia coli.
After injecting the liquid, remove the needle and let go of your skin. 
Po injiciranju tekočine odstranite iglo in spustite kožo.
Lonquex has no or negligible influence on the ability to drive and use machines. 
Zdravilo Lonquex nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Before you give yourself a Lonquex injection, you must do the following: 
Preden si daste injekcijo z zdravilom Lonquex, naredite naslednje:
Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity. 
Pri bolnikih, preobčutljivih na G-CSF ali derivate, obstaja tudi tveganje za preobčutljivostne reakcije na lipegfilgrastim zaradi možne navzkrižne reaktivnosti.
• Musculoskeletal pains such as bone pain and pain in the joints, muscles, limbs, chest, neck or back. 
• mišično-skeletna bolečina, kot so bolečina v kosteh in sklepih, mišicah, okončinah, prsnem košu, vratu ali hrbtu.
Elevations in alkaline phosphatase and lactate dehydrogenase most likely originate from the increase in neutrophils. 
Zvišanje alkalne fosfataze in laktat dehidrogenaze najverjetneje izvira iz zvišanja števila nevtrofilcev.
The maximum blood concentrations were reached after a median time (tmax) of 23.9 hours, 30.0 hours and 95.8 hours, respectively. 
Največje koncentracije v krvi so bile dosežene po medianem času (tmax) 23,9 ur, 30,0 ur oz. 95,8 ur.
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. 
Zdravljenje z zdravilom Lonquex smejo uvesti in nadzirati samo zdravniki z izkušnjami v onkologiji ali hematologiji.
Therefore, lipegfilgrastim is not likely to affect metabolism via human cytochrome P450 enzymes. 
Zato ni verjetno, da bi lipegfilgrastim vplival na presnovo prek humanih encimov citokroma P450.
Lonquex may be removed from the refrigerator and stored below 25°C for a maximum single period of up to 3 days. 
Zdravilo Lonquex lahko odstranite iz hladilnika in shranite pri temperaturi do 25 °C za največ enkratno 3-dnevno obdobje.
Only clear, colourless solutions without particles should be used. 
Uporabite lahko samo bistre, brezbarvne raztopine brez delcev.
See section 4.2. 
Glejte poglavje 4.2.
This medicinal product contains sorbitol. 
To zdravilo vsebuje sorbitol.
Pack sizes of 1 pre-filled syringe with or without safety device (which prevents needle stick injury and re-use). 
Velikost pakiranja je 1 napolnjena injekcijska brizga z varnostnim pripomočkom (ki preprečuje poškodbo zaradi vboda igle in ponovno uporabo) ali brez njega.
In animal models, concomitant administration of G-CSF and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression. 
V živalskih modelih se je pokazalo, da sočasno dajanje G-CSF in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
In this limited study XM22-06, bioavailability of lipegfilgrastim and observed differences among the injection sites were higher in male subjects compared to female subjects. 
V tej omejeni študiji XM22-06 so bile biološka uporabnost lipegfilgrastima in opažene razlike med mesti injiciranja večje pri moških v primerjavi z ženskami.
There is evidence that filgrastim and pegfilgrastim may be transported at low levels over the placenta in rats, although no information is available for lipegfilgrastim. 
Obstajajo dokazi, da lahko filgrastim in pegfilgrastim pri podganah v manjši stopnji prehajata skozi posteljico, vendar za lipegfilgrastim informacije niso na voljo.
This effect includes not only the neutrophil lineage but extends to other single lineage and multilineage progenitors and pluripotent haematopoietic stem cells. 
Ta učinek ne vključuje samo linije nevtrofilcev, temveč se razteza tudi na druge enolinijske in večlinijske predniške celice in pluripotentne krvotvorne matične celice.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature (not above 25°C) or hold the pre-filled syringe gently in your hand for a few minutes. 
Da bo injiciranje manj neprijetno, pustite napolnjeno injekcijsko brizgo stati 30 minut zunaj hladilnika, da doseže sobno temperaturo (ne več kot 25 °C), ali napolnjeno injekcijsko brizgo nekaj minut nežno držite v roki.
• a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely. 
- vsebnik, odporen na vbode (plastični vsebnik, ki ga dobite v bolnišnici ali lekarni), da lahko varno zavržete uporabljene injekcijske brizge.
Equipment that you need 
Potrebni pripomočki
If you see blood in the syringe, remove the needle and re-insert it in another place. 
Če v injekcijski brizgi opazite kri, iglo izvlecite in jo zabodite na drugem mestu.
Lipegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. 
Lipegfilgrastim je trajnejša oblika filgrastima zaradi zmanjšanega ledvičnega očistka.
The entire needle and syringe will be drawn back automatically and covered so that you cannot prick yourself (see picture 11). 
Celotna igla in injekcijska brizga se samodejno vpotegneta in prekrijeta, zato se ne morete zbosti (glejte sliko 11).
Hypersensitivity reactions such as allergic skin reactions, urticaria, angioedema and serious allergic reactions may occur. 
Pojavijo se lahko preobčutljivostne reakcije, kot so alergijske reakcije kože, urtikarija, angioedem in resne alergijske reakcije.
Physicians should therefore exercise caution when administering Lonquex in patients with sickle cell anaemia, monitor appropriate clinical parameters and laboratory results and be attentive to the possible association of lipegfilgrastim with splenic enlargement and vaso-occlusive crisis. 
Zdravniki morajo zato ravnati previdno, ko dajejo zdravilo Lonquex bolnikom s srpastocelično anemijo, spremljati ustrezne klinične parametre in laboratorijske rezultate ter pozorno spremljati možno povezavo lipegfilgrastima s povečanjem vranice in vazookluzivno krizo.
For patients with increased risk on hypokalaemia due to underling disease or co-medications, it is recommended to monitor the serum potassium level carefully and to substitute potassium if necessary. 
Za bolnike s povečanim tveganjem za hipokaliemijo zaradi osnovne bolezni ali sočasnih zdravil se priporoča natančno spremljanje ravni kalija v serumu in dodajanje kalija, če je potrebno.
Leukocytosis*, Splenomegaly* 
Občasni levkocitoza*, splenomegalija*
Push the plunger as far as it will go to inject all the liquid. 
Bat potisnite do konca, da injicirate celotno tekočino.
Once removed from the refrigerator, the medicine must be used within this period or disposed of. 
Ko zdravilo odstranite iz hladilnika, ga morate v tem obdobju uporabiti ali zavreči.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia. 
Posebno pozornost je treba nameniti razlikovanju diagnoze blastne transformacije kronične mieloične levkemije od akutne mieloične levkemije.
Not known (frequency cannot be estimated from the available data): 
- krvavitev iz pljuč Neznana (pogostosti mogoče oceniti iz razpoložljivih podatkov)