natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with Lonquex in all subsets of the paediatric population in the treatment of chemotherapy-induced neutropenia and prevention of chemotherapy-induced febrile neutropenia (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Lonquex za vse podskupine pediatrične populacije za zdravljenje s kemoterapijo povzročene nevtropenije in preprečevanje s kemoterapijo povzročene febrilne nevtropenije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Information required for using the pre-filled syringe can be found under “Information for injecting yourself”. 
Informacije, potrebne za uporabo napolnjene injekcijske brizge, so v poglavju "Informacije o samoinjiciranju".
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim. 
Na splošno so se primeri glomerulonefritisa razrešili z zmanjšanjem odmerka ali ukinitvijo filgrastima, lenograstima ali pegfilgrastima.
It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen. 
Pomembno je, da se takoj posvetujete z zdravnikom, če začutite bolečino v zgornjem levem delu trebuha ali bolečino v levem ramenu, saj sta lahko povezani s težavami z vranico.
Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]). 
Napolnjena injekcijska brizga (steklo tipa I) s čepom na batu [iz bromobutilne gume, prevlečene s poli(etilen-ko-tetrafluoroetilenom)] in pritrjeno injekcijsko iglo (nerjavno jeklo, velikosti 29 G [0,34 mm] ali 27 G [0,4 mm] x 12,7 mm [0,5 palca]).
There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women. 
Podatki o uporabi lipegfilgrastima pri nosečnicah so zelo omejeni (manj kot 300 izpostavljenih nosečnosti).
Table 2: DSN, severe neutropenia (SN) and febrile neutropenia (FN) in cycle 1 of study XM22-03 (ITT) 
Preglednica 2: THN, huda nevtropenija (SN, severe neutropenia) in febrilna nevropenija (FN) v 1. ciklu študije XM22-03 (ITT)
Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet's syndrome) - Cutaneous vasculitis 
Bolezni kože in podkožja - akutna febrilna nevtrofilna dermatoza (Sweetov sindrom) - kožni vaskulitis
The injection is given into the tissue just under the skin (subcutaneous injection). 
Injekcija se da v tkivo tik pod kožo (subkutana injekcija).
It is unknown whether lipegfilgrastim/metabolites are excreted in human milk. 
Ni znano, ali se lipegfilgrastim/presnovki izločajo v materino mleko.
• if you have previously experienced allergic reactions to other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs). 
- če ste že imeli alergijsko reakcijo na drugo podobno zdravilo (npr. filgrastim, lenograstim ali pegfilgrastim iz skupine G-CSF).
Each pack contains 1 pre-filled syringe with or without safety device. 
Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo z varnostnim pripomočkom ali brez njega.
Put the needle fully into the skin as shown by your doctor or nurse. 
Iglo potisnite do konca v kožo, kot vam je pokazal zdravnik ali medicinska sestra.
Certain adverse reactions have not yet been observed with lipegfilgrastim, but are generally accepted as being attributable to G-CSF and derivatives: 
Z lipegfilgrastimom nekaterih neželenih učinkov še niso opazili, vendar prevladuje mnenje, da jih je mogoče pripisati G-CSF in derivatom:
Vigorous shaking should be avoided. 
Preprečiti je treba sunkovito stresanje.
If WBC counts exceed 50 x 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately. 
Če število belih krvnih celic preseže 50 x 109/l po pričakovani najnižji ravni, je treba z uporabo lipegfilgrastima takoj prenehati.
The solution should be allowed to reach a comfortable temperature (15°C - 25°C) for injection. 
Raztopina mora pred injiciranjem doseči prijetno temperaturo (15 °C-25 °C).
Median serum concentration of lipegfilgrastim (ng/ml) 
Mediana koncentracija lipegfilgrastima v serumu (ng/ml)
In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF. 
Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je minil po ukinitvi
Other medicines and Lonquex 
Druga zdravila in zdravilo Lonquex
You will need to give yourself the injection into the tissue just under the skin. 
Injekcijo si boste morali sami dati v tkivo tik pod kožo.
Check the appearance of Lonquex. 
Preverite videz zdravila Lonquex.
Treatment-related adverse events were back pain, bone pain and increased neutrophil count (1 event each). 
Neželeni učinki, povezani z zdravljenjem, so bili bolečine v hrbtu, bolečine v kosteh in povečano število nevtrofilcev (po 1 dogodek za vsak učinek).
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. 
Povečana krvotvorna aktivnost kostnega mozga kot odziv na zdravljenje z rastnim faktorjem je bila povezana s prehodnimi pozitivnimi izvidi slikanja kosti.
Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no associated clinical effects. 
Pojavi se lahko reverzibilno, blago do zmerno zvišanje alkalne fosfataze in laktat dehidrogenaze, brez povezanih kliničnih učinkov.
Elevation in white blood cells (WBC) is consistent with the pharmacodynamic effects of lipegfilgrastim. 
Zvišanje belih krvnih celic je v skladu s farmakodinamičnimi učinki lipegfilgrastima.
95 % CI 
95-% IZ
- Aortitis (see section 4.4) 
- aortitis (glejte poglavje 4.4).
The angle between the syringe and skin should not be too narrow (at least 45°, see picture 8). 
Kot med injekcijsko brizgo in kožo ne sme biti preozek (vsaj 45 °, glejte sliko 8).
Published information on G-CSF and derivatives reveal no evidence of adverse effects on fertility and embryo-foetal development in rats or pre-/postnatal effects other than those related to maternal toxicity as well. 
G-CSF in derivatih ne vsebujejo dokazov o neželenih učinkih na plodnost, razvoj zarodka/plodu pri podganah ali o prenatalnih in postnatalnih učinkih razen tistih, ki se nanašajo tudi na toksičnost za mater.
This medicine is given as an injection using a pre-filled syringe. 
To zdravilo se daje kot injekcija z uporabo napolnjene injekcijske brizge.
Special care should be taken when administering single or combination chemotherapeutic medicinal products that are known to cause severe thrombocytopenia. 
Še posebej previdni moramo biti, kadar sta predpisana en sam kemoterapevtik ali kombinacija kemoterapevtikov, za katere se ve, da povzročajo hudo trombocitopenijo.
Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA14 
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA14
As a precautionary measure, it is preferable to avoid the use of Lonquex during pregnancy. 
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Lonquex bolje izogibati.
Do not use any Lonquex that is left in the syringe. 
Ne uporabite zdravila Lonquex, ki ostane v injekcijski brizgi.
The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy. 
Varnosti in učinkovitosti zdravila Lonquex niso preučili pri bolnikih, ki prejemajo visokoodmerno kemoterapijo.
No neutralising antibodies against lipegfilgrastim were observed. 
Nevtralizirajočih protiteles proti lipegfilgrastimu niso opazili.
Lonquex does not contain any preservative. 
Zdravilo Lonquex ne vsebuje konzervansov.
Your doctor has prescribed Lonquex for you in order to reduce the duration of a condition called neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). 
Vaš zdravnik vam je predpisal zdravilo Lonquex, da skrajša trajanje stanja, imenovanega nevtropenija (nizko število belih krvnih celic) in pojav febrilne nevtropenije (nizko število belih krvnih celic z zvišano telesno temperaturo).
Concomitant use of lipegfilgrastim with any chemotherapeutic medicinal product has not been evaluated in patients. 
Sočasne uporabe lipegfilgrastima in katerega koli kemoterapevtika pri bolnikih niso ocenili.
The mean terminal half-lives were approximately 29 and 31 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy. 
Povprečna končna razpolovna časa sta bila približno 29 in 31 ur po enem subkutanem injiciranju 6 mg lipegfilgrastima v prvem ciklu kemoterapije.
Figure 1: Profile of median serum concentration of lipegfilgrastim and median ANC in chemotherapy-treated patients after a single 6 mg injection of lipegfilgrastim 
Slika 1: Profil mediane koncentracije lipegfilgrastima v serumu in mediane vrednosti ANC pri bolnikih, ki se zdravijo s kemoterapijo, po eni 6-miligramski injekciji lipegfilgrastima
Lipegfilgrastim and filgrastim induced a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. 
Lipegfilgrastim in filgrastim sta v roku 24 ur inducirala opazno zvišanje števila nevtrofilcev v periferni krvi, z blagim zvišanjem monocitov in/ali limfocitov.
Blood alkaline phosphatase increased*, Blood lactate dehydrogenase increased* 
Občasni zvišanje alkalne fosfataze v krvi*, zvišanje laktatdehidrogenaze v krvi*
Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow. 
Humani G-CSF je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
The linear pathway is likely due to extracellular protein degradation by neutrophil elastase and other plasma proteases. 
Linearna pot je verjetno posledica zunajcelične razgradnje proteina s pomočjo nevtrofilnih elastaz in drugih plazemskih proteaz.
The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count). 
Simptomi, ki so se pojavili, vključujejo povišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev (npr. C-reaktivnega proteina in števila belih krvnih celic).
Animal studies have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Contents of the pack and other information What Lonquex contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Lonquex
What you need to know before you use Lonquex Do not use Lonquex: 
Kaj morate vedeti, preden boste uporabili zdravilo Lonquex Ne uporabljajte zdravila Lonquex:
Lonquex is a clear and colourless solution. 
Zdravilo Lonquex je bistra in brezbarvna raztopina.
Lonquex has not been tested in pregnant women. 
Zdravila Lonquex pri nosečnicah niso preučevali.
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. 
Na diagnozo rupture vranice moramo biti pozorni pri bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v konici leve rame.
p-value SN 
vrednost p SN
This medicine should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. 
To zdravilo morate prejeti približno 24 ur po zadnjem odmerku kemoterapije ob koncu vsakega cikla kemoterapije.
An analysis of anti-drug antibodies of 579 patients and healthy volunteers treated with lipegfilgrastim, 188 patients and healthy volunteers treated with pegfilgrastim and 121 patients treated with placebo was performed. 
Opravili so analizo protiteles proti zdravilu pri 579 bolnikih in zdravih prostovoljcih, zdravljenih z lipegfilgrastimom, 188 bolnikih in zdravih prostovoljcih, zdravljenih s pegfilgrastimom, in
● At the request of the European Medicines Agency; 
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
The angle between the syringe and skin should not be too narrow (at least 45°, see picture 7). 
Kot med injekcijsko brizgo in kožo ne sme biti preozek (vsaj 45°, glejte sliko 7).
The safety and efficacy of Lonquex have not been investigated in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia; it should therefore not be used in such patients. 
Varnosti in učinkovitosti zdravila Lonquex niso preučili pri bolnikih s kronično mieloično levkemijo, mielodisplastičnimi sindromi ali sekundarno akutno mieloično levkemijo, zato zdravila pri teh bolnikih ni dovoljeno uporabiti.
Each pre-filled syringe is for single use only. 
Vsaka napolnjena injekcijska brizga je samo za enkratno uporabo.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na napolnjeno injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Lipegfilgrastim is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes. 
Lipegfilgrastim se internalizira s pomočjo nevtrofilcev (nelinearni proces), nato pa ga v celici razgradijo endogeni proteolitični encimi.
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of lipegfilgrastim is not expected to be affected by renal or hepatic impairment. 
Zaradi mehanizma očistka, ki ga sprožijo nevtrofilci, se ne pričakuje, da bi na farmakokinetiko lipegfilgrastima vplivala ledvična ali jetrna okvara.
Patients were randomised 2:1 to receive either 6 mg lipegfilgrastim or placebo. 
Bolniki so bili randomizirani v razmerju 2:1 na prejemanje 6 mg lipegfilgrastima ali placeba.
Lonquex should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. 
Zdravila Lonquex ne smete uporabljati za povečanje odmerka citotoksične kemoterapije zunaj uveljavljenih shem odmerjanja.
If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. 
Če opazite zračne mehurčke, s prsti nežno potolcite po injekcijski brizgi, da se mehurčki dvignejo na vrh.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. 
da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy. 
Zdravljenje z lipegfilgrastimom ne prepreči z mielosupresivno kemoterapijo povzročene trombocitopenije in anemije.
Solution for injection in pre-filled syringe 1 pre-filled syringe of 0.6 ml solution 1 pre-filled syringe of 0.6 ml solution with safety device 
raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,6 ml raztopine 1 napolnjena injekcijska brizga z 0,6 ml raztopine z varnostnim pripomočkom
You may notice small air bubbles in the pre-filled syringe. 
Morda boste v napolnjeni injekcijski brizgi opazili majhne zračne mehurčke.
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, Lonquex should be administered approximately 24 hours after administration of cytotoxic chemotherapy. 
Zaradi možne občutljivosti mieloičnih celic, ki se hitro delijo, na citotoksično kemoterapijo je treba zdravilo Lonquex dati približno 24 ur po uporabi citotoksične kemoterapije.
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 9). 
Tekočino si počasi in enakomerno injicirajte v tkivo, pri tem pa ves čas držite kožo (glejte sliko 9).
The most frequent adverse reactions include musculoskeletal pains such as bone pain and myalgia. 
Najpogostejši neželeni učinki vključujejo mišično-skeletne bolečine, kot sta bolečina v kosteh in mialgija.
Consistent with a self-regulating clearance mechanism, the serum concentration of lipegfilgrastim declines slowly during the chemotherapy-induced transient neutrophil nadir and rapidly at the following onset of neutrophil recovery (see figure 1). 
V skladu z avtoregulacijskim mehanizmom očistka serumska koncentracija lipegfilgrastima počasi upada med s kemoterapijo povzročenim prehodnim najnižjim stanjem nevtrofilcev in se nato ob nastopu okrevanja nevtrofilcev hitro zniža (glejte sliko 1).
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in pictures 4 and 5). 
Če vam injekcijo daje kdo drug, lahko uporabi tudi hrbtni in stranski del nadlakti (glejte sive predele na slikah 4 in 5).
Lonquex contains sorbitol and sodium 
Zdravilo Lonquex vsebuje sorbitol in natrij
Skin reactions* 
Pogosti kožne reakcije*
Where your injection should be given 
Kam si morate dati injekcijo
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in pictures 5 and 6). 
Če vam injekcijo daje kdo drug, lahko uporabi tudi hrbtni in stranski del nadlakti (glejte sive predele na slikah 5 in 6).
Capillary leak syndrome* Aortitis* 
Neznana sindrom kapilarnega prepuščanja*, aortitis*
Incidence (%) Odds ratio 95 % CI 
Incidenca (%) Razmerje obetov 95-% IZ
• Cough, fever and difficult or painful breathing can be signs of uncommon serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal. 
- Kašelj, zvišana telesna temperatura in težave ali bolečine pri dihanju so lahko znaki občasnih resnih neželenih učinkov na pljuča, kot sta pljučnica in akutni sindrom dihalne stiske, ki sta lahko smrtna.
This medicine contains 30 mg sorbitol in each pre-filled syringe. 
To zdravilo vsebuje 30 mg sorbitola v eni napolnjeni injekcijski brizgi.
The injections should be given into the abdomen, upper arm or thigh. 
Injekcije je treba dajati v trebuh, nadlaket ali stegno.
However cases of severe musculoskeletal pain (mainly bone pain and back pain) have been reported, including cases that led to hospitalisation. 
(večinoma bolečini v kosteh in hrbtu), vključno s primeri, pri katerih je bila potrebna hospitalizacija.
Lonquex is indicated in adults for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). 
Zdravilo Lonquex je indicirano pri odraslih za skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri bolnikih, ki prejemajo citotoksično kemoterapijo za maligne tvorbe (z izjemo kronične mieloične levkemije in mielodisplastičnih sindromov).
Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy. 
Odmerjanje lipegfilgrastima enkrat na cikel so preučili v dveh osrednjih randomiziranih, dvojno slepih kliničnih študijah pri bolnikih, zdravljenih z mielosupresivno kemoterapijo.
If you use more Lonquex than you should, talk to your doctor. 
Če ste uporabili večji odmerek zdravila Lonquex, kot bi smeli Če ste uporabili večji odmerek zdravila Lonquex, kot bi smeli, se posvetujte z zdravnikom.
You will normally inject your dose of Lonquex approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. 
Običajno si boste odmerek zdravila Lonquex injicirali približno 24 ur po zadnjem odmerku kemoterapije ob koncu vsakega cikla kemoterapije.
The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS) (see section 4.8). 
Pojav pljučnih simptomov kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov in poslabšanjem delovanja pljuč skupaj z zvišanjem števila nevtrofilcev so lahko predhodni znaki sindroma akutne dihalne stiske pri odraslih (Acute Respiratory
Open the blister and take the pre-filled syringe out of the blister (see picture 1). 
Odprite pretisni omot in napolnjeno injekcijsko brizgo vzemite ven iz pretisnega omota (glejte sliko 1).
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched. 
Tekočino si počasi in enakomerno injicirajte v tkivo, pri tem pa ves čas držite kožo.
Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs). 
Pri bolnikih z rakom so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu) z drugimi zdravili, kot je to (npr. filgrastim, lenograstim ali pegfilgrastim skupine G-CSF).
In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ultrasound). 
V primeru prevelikega odmerjanja je treba redno spremljati število belih krvnih celic in trombocitov ter skrbno nadzirati velikost vranice (npr. s kliničnim pregledom, z ultrazvokom).
Regular monitoring of the platelet count and haematocrit is recommended. 
Priporoča se redno spremljanje števila trombocitov in hematokrita.
• The other ingredients (excipients) are glacial acetic acid, sodium hydroxide , sorbitol (E420), polysorbate 20 and water for injections. 
- Druge sestavine zdravila (pomožne snovi) so ledocetna kislina, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.
Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 
Neželeni učinki, povezani z žiljem Po uporabi G-CSF ali derivatov so poročali o sindromu kapilarne prepustnosti, za katerega so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracija.
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help. 
Če ste negotovi glede samoinjiciranja ali če imate kakšna vprašanja, se za pomoč obrnite na svojega zdravnika ali medicinsko sestro.
Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8). 
Lipegfilgrastim lahko povzroči tudi reverzibilno trombocitopenijo (glejte poglavje 4.8).
Each pre-filled syringe contains 30 mg sorbitol. 
Ena napolnjena injekcijska brizga vsebuje 30 mg sorbitola.
The recommended dose is one pre-filled syringe (6 mg lipegfilgrastim) once per chemotherapy cycle. 
Priporočeni odmerek je Priporočeni odmerek je ena napolnjena injekcijska brizga (6 mg lipegfilgrastima) enkrat na cikel kemoterapije.
In 3 studies (XM22-01, XM22-05, XM22-06) in healthy volunteers, the maximum blood concentration was reached after a median of 30 to 36 hours and the average terminal half-life ranged from approximately 32 to 62 hours after a single subcutaneous injection of 6 mg lipegfilgrastim. 
V 3 študijah (XM22-01, XM22-05, XM22-06) z zdravimi prostovoljci je bila največja koncentracija v krvi dosežena po mediani 30 do 36 ur, povprečni končni razpolovni čas pa je bil v razponu od približno 32 do 62 ur po subkutanem injiciranju enega odmerka 6 mg lipegfilgrastima.
Δ LS mean (least square mean difference lipegfilgrastim - placebo), CI and p-value out of multivariate Poisson regression analysis 
Δ povprečje LS (povprečna razlika najmanjših kvadratov lipegfilgrastim - placebo), IZ in vrednost p iz multivariantne Poissonove regresijske analize
Excipients: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections. 
Pomožne snovi: ledocet, natrijev hidroksid, sorbitol (E420), polisorbat 20 in voda za injekcije.