FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Lonquex u svim podskupinama pedijatrijske populacije u liječenju kemoterapijom izazvane neutropenije i sprječavanju kemoterapijom izazvane febrilne neutropenije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: No adverse events directly attributable to leukocytosis have been reported.
Croatian: Nisu zabilježeni nikakvi štetni događaji koji bi se mogli izravno pripisati leukocitozi.
English: Lonquex is a clear and colourless solution.
Croatian: Lonquex je bistra i bezbojna otopina.
English: These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see section 4.4).
Croatian: Ove plućne nuspojave također mogu uključivati: plućni edem, plućne infiltrate, plućnu fibrozu, respiratorno zatajenje ili ARDS (vidjeti dio 4.4).
English: 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.
Croatian: 21 pedijatrijskog bolesnika u dobi od 2 do < 18 godina (vidjeti dio 5.1), koje nije pokazalo razliku sigurnosnog profila lipegfilgrastima u djece u usporedbi s onim u odraslih.
English: Lipegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes saturated at higher doses.
Croatian: Čini se da se lipegfilgrastim uglavnom eliminira klirensom posredovanim neutrofilima, koji postaje zasićen pri višim dozama.
English: Put the needle fully into the skin as shown by your doctor or nurse.
Croatian: Ubodite iglu u kožu do kraja, kako su Vam pokazali liječnik ili medicinska sestra.
English: It is unknown whether the active substance in this medicine passes into the breast milk.
Croatian: Nije poznato izlučuje li se djelatna tvar u ovom lijeku u majčino mlijeko.
English: Mean ± SD (d) Δ LS mean 95 % CI
Croatian: Srednja vrijednost ± SD (d) Δ LS srednja vrijednost 95 % CI
English: Merckle GmbH, Graf-Arco-Straße 3 89079 Ulm Germany
Croatian: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim.
Croatian: Općenito, događaji glomerulonefritisa povukli su se nakon sniženja doze ili prekida primjene filgrastima, lenograstima ili pegfilgrastima.
English: 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.
Croatian: Sigurnost i djelotvornost Lonquexa nisu ispitani u bolesnika s kroničnom mijeloičnom leukemijom, mijelodisplastičnim sindromima ili sekundarnom akutnom mijeloičnom leukemijom pa se stoga ne smije primjenjivati u takvih bolesnika.
English: Elevation in white blood cells (WBC) is consistent with the pharmacodynamic effects of lipegfilgrastim.
Croatian: Povećanje broja bijelih krvnih stanica sukladno je farmakodinamičkim učincima lipegfilgrastima.
English: 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.
Croatian: Kod bolesnika s povećanim rizikom za nastanak hipokalemije, zbog osnovne bolesti ili istovremeno primijenih lijekova, preporučuje se pažljivo nadzirati razinu kalija u serumu i po potrebi nadoknaditi kalij.
English: 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).
Croatian: Liječnik Vam je propisao Lonquex kako bi se skratilo trajanje stanja koje se zove neutropenija (nizak broj bijelih krvnih stanica) i smanjila pojava febrilne neutropenije (nizak broj bijelih krvnih stanica s vrućicom).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Njemačka Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: ● 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.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Where your injection should be given
Croatian: Gdje treba dati injekciju
English: This medicine should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Croatian: Ovaj lijek treba dati približno 24 sata nakon zadnje doze kemoterapije na kraju svakog ciklusa kemoterapije.
English: Only use each syringe for one injection.
Croatian: Uvijek upotrijebite novu štrcaljku za novu injekciju.
English: You will normally inject your dose of Lonquex approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Croatian: Obično ćete ubrizgati svoju dozu Lonquexa približno 24 sata nakon zadnje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: However cases of severe musculoskeletal pain (mainly bone pain and back pain) have been reported, including cases that led to hospitalisation.
Croatian: (uglavnom koštane boli i boli u leđima), uključujući slučajeve koji su doveli do hospitalizacije.
English: Table 1: Adverse reactions System organ class
Croatian: Tablica 1: Nuspojave Klasifikacija organskih sustava Učestalost
English: You may notice small air bubbles in the pre-filled syringe.
Croatian: U napunjenoj štrcaljki možete opaziti sitne mjehuriće zraka.
English: Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no associated clinical effects.
Croatian: Mogu nastati reverzibilna, blaga do umjerena povišenja alkalne fosfataze i laktat dehidrogenaze, bez s time povezanih kliničkih učinaka.
English: A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Croatian: Dijagnozu rupture slezene treba razmotriti u bolesnika koji navode bol u gornjem lijevom dijelu abdomena ili vrhu ramena.
English: To give yourself an injection into the tissue under the skin you will need:
Croatian: Kako biste sami sebi dali injekciju u tkivo ispod kože, bit će Vam potrebno sljedeće:
English: What you need to know before you use Lonquex Do not use Lonquex:
Croatian: Što morate znati prije nego počnete primjenjivati Lonquex Nemojte primjenjivati Lonquex:
English: This effect includes not only the neutrophil lineage but extends to other single lineage and multilineage progenitors and pluripotent haematopoietic stem cells.
Croatian: Ovaj učinak uključuje ne samo neutrofilnu lozu, nego zahvaća i jednu ili više drugih loza progenitorskih stanica i pluripotentnih krvotvornih matičnih stanica.
English: Special care should be taken when administering single or combination chemotherapeutic medicinal products that are known to cause severe thrombocytopenia.
Croatian: Potreban je poseban oprez kad se primjenjuje bilo jedan kemoterapijski lijek ili kombinirana kemoterapija za koje se zna da uzrokuju tešku trombocitopeniju.
English: Table 2: DSN, severe neutropenia (SN) and febrile neutropenia (FN) in cycle 1 of study XM22-03 (ITT)
Croatian: Tablica 2: Trajanje teške neutropenije (TTN), teška neutropenija (TN) i febrilna neutropenija (FN) u 1. ciklusu ispitivanja XM22-03 (ITT)
English: Blood alkaline phosphatase increased*, Blood lactate dehydrogenase increased*
Croatian: Manje često povišena alkalna fosfataza u krvi*, povišena laktat dehidrogenaza u krvi*
English: 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]).
Croatian: Napunjena štrcaljka (staklo tipa I) s čepom klipa [poli(etilen-ko-tetrafluoroetilen)-obložena brombutilna guma] i pričvršćenom iglom za injekciju (nehrđajuči čelik, 29G [0,34 mm] ili 27G
English: A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Croatian: Broj leukocita treba provjeravati u redovitim vremenskim intervalima tijekom terapije, zbog kliničkih učinaka lipegfilgrastima i mogućeg nastanka leukocitoze.
English: The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers.
Croatian: Simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
English: Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Croatian: Glomerulonefritis je prijavljen u bolesnika koji su primali filgrastim, lenograstim ili pegfilgrastim.
English: Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet's syndrome) - Cutaneous vasculitis
Croatian: Poremećaji kože i potkožnog tkiva akutna febrilna neutrofilna dermatoza (Sweetov sindrom) kožni vaskulitis
English: The study showed non-inferiority of 6 mg lipegfilgrastim to 6 mg pegfilgrastim for the primary endpoint, duration of severe neutropenia (DSN) in the first cycle of chemotherapy (see table 2).
Croatian: Ispitivanje je pokazalo neinferiornost 6 mg lipegfilgrastima u odnosu na 6 mg pegfilgrastima u pogledu primarnog ishoda, trajanja teške neutropenije (TTN) u prvom ciklusu kemoterapije (vidjeti tablicu 2).
English: 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
Croatian: Otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,6 ml otopine 1 napunjena štrcaljka s 0,6 ml otopine sa sigurnosnom napravom
English: Skin reactions such as erythema and rash may occur.
Croatian: Mogu nastati kožne reakcije kao što su eritem i osip.
English: This medicine contains 30 mg sorbitol in each pre-filled syringe.
Croatian: Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki.
English: 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).
Croatian: Lonquex je indiciran u odraslih za smanjenje duljine trajanja neutropenije i incidencije febrilne neutropenije u bolesnika koji se liječe citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnih sindroma).
English: This is known as a subcutaneous injection.
Croatian: To se zove potkožna, tj. supkutana injekcija.
English: Do not pick up the pre-filled syringe by the plunger or needle cover.
Croatian: Nemojte uhvatiti napunjenu štrcaljku za klip ili poklopac igle.
English: • Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.
Croatian: • niske razine kalija u krvi, što može prouzročiti mišićnu slabost, trzanje mišića ili poremećen srčani ritam
English: ● Periodic safety update reports
Croatian: • Periodička izvješća o neškodljivosti
English: The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy.
Croatian: Sigurnost i djelotvornost Lonquexa nisu ispitane u bolesnika koji primaju visoko-doznu kemoterapiju.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Croatian: S vrhom štrcaljke usmjerenim prema gore, istisnite sav zrak iz štrcaljke tako što ćete polako potiskivati klip prema gore.
English: 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).
Croatian: Sukladno samoregulirajućem mehanizmu klirensa, koncentracija lipegfilgrastima u serumu sporo opada tijekom kemoterapijom izazvanot prolaznog najnižeg sniženja broja neutrofila i brzo nakon početka oporavka neutrofila (vidjeti sliku 1).
English: Sodium.
Croatian: Natrij.
English: 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.
Croatian: Srednji terminalni poluvijek iznosio je približno 29 odnosno 31 sat nakon jedne supkutane injekcije 6 mg lipegfilgrastima u prvom ciklusu kemoterapije.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da ne pokušate sami sebi dati injekciju ako Vam liječnik ili medicinska sestra prethodno nisu posebno podučili kako to učiniti.
English: Disposing of used syringes
Croatian: Zbrinjavanje upotrijebljenih štrcaljki
English: 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).
Croatian: U slučaju predoziranja, broj bijelih krvnih stanica i trombocita treba redovito provjeravati i pažljivo nadzirati veličinu slezene (npr. kliničkim pregledom, ultrazvukom).
English: Each pre-filled syringe contains 30 mg sorbitol.
Croatian: Jedna napunjena štrcaljka sadrži 30 mg sorbitola.
English: This medicine is given as an injection using a pre-filled syringe.
Croatian: Ovaj se lijek daje kao injekcija pomoću napunjene štrcaljke.
English: Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
Croatian: 4.2 Doziranje i način primjene Liječenje Lonquexom trebaju započeti i nadzirati liječnici s iskustvom u onkologiji ili hematologiji.
English: 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.
Croatian: Zbog moguće osjetljivosti mijeloičnih stanica koje se brzo dijele na citotoksičnu kemoterapiju, Lonquex treba primjenjivati približno 24 sata nakon primjene citotoksične kemoterapije.
English: The most frequent adverse reactions include musculoskeletal pains such as bone pain and myalgia.
Croatian: Najčešće nuspojave uključuju mišićno-koštane bolove poput bolova u kostima i mialgije.
English: Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8).
Croatian: Lipegfilgrastim također može prouzročiti reverzibilnu trombocitopeniju (vidjeti dio 4.8).
English: • The active substance is lipegfilgrastim.
Croatian: • Djelatna tvar je lipegfilgrastim.
English: How you should inject yourself
Croatian: Kako trebate sami sebi dati injekciju
English: It is unknown whether lipegfilgrastim/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se lipegfilgrastim/metaboliti u majčino mlijeko.
English: Some cases of splenic rupture were fatal.
Croatian: Neki slučajevi prsnuća slezene završili su smrću.
English: • The other ingredients (excipients) are glacial acetic acid, sodium hydroxide , sorbitol (E420), polysorbate 20 and water for injections.
Croatian: • Drugi sastojci (pomoćne tvari) su: ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Croatian: Pojačana krvotvorna aktivnost koštane srži kao odgovor na terapiju faktorom rasta povezana je s prolaznim pozitivnim nalazima u kostima na metodama oslikavanja.
English: Open the blister and take the pre-filled syringe out of the blister.
Croatian: Otvorite blister i izvadite napunjenu štrcaljku iz blistera.
English: Solution for injection in pre-filled syringe (injection) Clear, colourless solution
Croatian: Otopina za injekciju u napunjenoj štrcaljki (injekcija) Bistra, bezbojna otopina
English: Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
Croatian: Ubrizgajte tekućinu u tkivo polako i jednoliko, cijelo vrijeme držeći nabor kože između prstiju
English: A post-authorisation safety study XM22-ONC-40041 was conducted to collect data of disease progression and mortality in patients with advanced squamous or non-squamous cell lung cancer receiving lipegfilgrastim in addition to the platinum-based chemotherapy.
Croatian: Ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet XM22-ONC-40041 bilo je provedeno radi prikupljanja podataka o napredovanju bolesti i smrtnosti u bolesnika s uznapredovalim rakom pluća skvamoznih ili neskvamoznih stanica koji su primali lipegfilgrastim u kombinaciji s kemoterapijom na bazi platine.
English: Figure 1: Profile of median serum concentration of lipegfilgrastim and median ANC in chemotherapy-treated patients after a single 6 mg injection of lipegfilgrastim
Croatian: Slika 1: Profil medijana serumske koncentracije lipegfilgrastima i medijana apsolutnog broja neutrofila (ABN) u bolesnika liječenih kemoterapijom nakon jedne injekcije 6 mg lipegfilgrastima
English: No neutralising antibodies against lipegfilgrastim were observed.
Croatian: Nisu opažena neutralizirajuća protutijela na lipegfilgrastim.
English: Lonquex contains the active substance lipegfilgrastim.
Croatian: Lonquex sadrži djelatnu tvar lipegfilgrastim.
English: Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy.
Croatian: Doziranje lipegfilgrastima jedanput po ciklusu ispitano je u dva ključna randomizirana, dvostruko slijepa klinička ispitivanja u bolesnika na mijelosupresivnoj kemoterapiji.
English: The safety and efficacy of Lonquex have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.
Croatian: Sigurnost i djelotvornost Lonquexa nisu procijenjene u bolesnika koji primaju kemoterapiju povezanu s kasnom mijelosupresijom, npr. nitrozourejama.
English: Lipegfilgrastim ANC
Croatian: Lipegfilgrastim ABN
English: The injections should be given into the abdomen, upper arm or thigh.
Croatian: Injekciju treba dati u abdomen, nadlakticu ili natkoljenicu.
English: There is no experience with overdose of lipegfilgrastim.
Croatian: Ne postoji iskustvo s predoziranjem lipegfilgrastimom.
English: • Sickle cell crises in patients with sickle cell anaemia.
Croatian: • krize srpastih stanica u bolesnika s anemijom srpastih stanica
English: Patients were randomised 2:1 to receive either 6 mg lipegfilgrastim or placebo.
Croatian: Bolesnici su bili randomizirani 2:1 u skupinu koja je primala 6 mg lipegfilgrastima ili placebo.
English: Hold the syringe and gently remove the cover from the needle without twisting.
Croatian: Držite štrcaljku i pažljivo, bez savijanja, uklonite poklopac s igle.
English: Vigorous shaking should be avoided.
Croatian: Potrebno je izbjegavati žustro potresanje.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8).
Croatian: Sindrom povećane propusnosti kapilara, koji može biti životno ugrožavajući ako se ne počne liječiti na vrijeme, prijavljen je većinom u bolesnika s rakom koji su na kemoterapiji nakon primjene G-CSF ili njegovih derivata (vidjeti dio 4.4 i dio 4.8).
English: Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Croatian: Teva Biotech GmbH Dornierstraße 10 89079 Ulm
English: There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women.
Croatian: Podaci o primjeni lipegfilgrastima u trudnica vrlo su ograničeni (manje od 300 trudnoća).
English: The recommended dose is one pre-filled syringe (6 mg lipegfilgrastim) once per chemotherapy cycle.
Croatian: Koja je preporučena doza Preporučena doza je jedna napunjena štrcaljka (6 mg lipegfilgrastima) jedanput po ciklusu kemoterapije.
English: The solution should be visually inspected before use.
Croatian: Prije primjene otopinu treba vizualno pregledati.
English: Regular monitoring of the platelet count and haematocrit is recommended.
Croatian: Preporučuje se redoviti nadzor broja trombocita i hematokrita.
English: Lipegfilgrastim is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes.
Croatian: Lipegfilgrastim ulazi u neutrofile (nelinearni proces), potom ga proteolitički enzimi razgrađuju unutar stanice.
English: Excipients: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Croatian: Pomoćne tvari: ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: Hypersensitivity reactions*
Croatian: Manje često reakcije preosjetljivosti*
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4).
Croatian: Zabilježene su plućne nuspojave, osobito intersticijska pneumonija (vidjeti dio 4.4).
English: After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the mean maximum blood concentration of 149 ng/ml was reached after a median tmax of 8 hours and the mean terminal half-life was approximately 34 hours.
Croatian: Nakon jedne supkutane injekcije od 6 mg lipegfilgrastima u četvrtom ciklusu, srednja maksimalna koncentracija u krvi od 149 ng/ml postignuta je nakon medijana tmax od 8 sati, a srednji terminalni poluvijek iznosio je približno 34 sata.
English: The first pivotal (phase III) clinical study XM22-03 was an active-controlled study in 202 patients with stage II-IV breast cancer receiving up to 4 cycles of chemotherapy consisting of doxorubicin and docetaxel.
Croatian: Prvo ključno (faze III) kliničko ispitivanje XM22-03 bilo je ispitivanje s aktivnom kontrolom u kojem je 202 bolesnika s karcinomom dojke stadija II-IV primalo do 4 ciklusa kemoterapije koja se je sastojala od doksorubicina i docetaksela.
English: After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the maximum blood concentrations were lower than observed in the first cycle (mean values 77 and 111 ng/ml) and were reached after median tmax of 8 hours.
Croatian: 6 mg lipegfilgrastima u četvrtom ciklusu, maksimalne koncentracije u krvi bile su niže od onih opaženih u prvom ciklusu (srednje vrijednosti 77 odnosno 111 ng/ml) i postignute su nakon medijana tmax od 8 sati.
English: Leukocytosis*, Splenomegaly*
Croatian: Manje često leukocitoza*, splenomegalija*
English: 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.
Croatian: U 3 ispitivanja (XM22-01, XM22-05, XM22-06) u zdravih dobrovoljaca, maksimalna koncentracija u krvi postignuta je nakon medijana od 30 do 36 sati, a prosječni terminalni poluvijek je bio u rasponu od približno 32 do 62 sata nakon jednokratne supkutane injekcije 6 mg lipegfilgrastima.
English: Skin reactions*
Croatian: Često kožne reakcije*