natgillin/translations-raw huggingface dataset:
A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
Broj leukocita treba provjeravati u redovitim vremenskim intervalima tijekom terapije, zbog kliničkih učinaka lipegfilgrastima i mogućeg nastanka leukocitoze.
The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers.
Simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Glomerulonefritis je prijavljen u bolesnika koji su primali filgrastim, lenograstim ili pegfilgrastim.
Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet's syndrome) - Cutaneous vasculitis
Poremećaji kože i potkožnog tkiva akutna febrilna neutrofilna dermatoza (Sweetov sindrom) kožni vaskulitis
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).
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).
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
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
Skin reactions such as erythema and rash may occur.
Mogu nastati kožne reakcije kao što su eritem i osip.
This medicine contains 30 mg sorbitol in each pre-filled syringe.
Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki.
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).
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).
This is known as a subcutaneous injection.
To se zove potkožna, tj. supkutana injekcija.
Do not pick up the pre-filled syringe by the plunger or needle cover.
Nemojte uhvatiti napunjenu štrcaljku za klip ili poklopac igle.
• Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.
• niske razine kalija u krvi, što može prouzročiti mišićnu slabost, trzanje mišića ili poremećen srčani ritam
● Periodic safety update reports
• Periodička izvješća o neškodljivosti
The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy.
Sigurnost i djelotvornost Lonquexa nisu ispitane u bolesnika koji primaju visoko-doznu kemoterapiju.
With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
S vrhom štrcaljke usmjerenim prema gore, istisnite sav zrak iz štrcaljke tako što ćete polako potiskivati klip prema gore.
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).
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).
Sodium.
Natrij.
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.
Srednji terminalni poluvijek iznosio je približno 29 odnosno 31 sat nakon jedne supkutane injekcije 6 mg lipegfilgrastima u prvom ciklusu kemoterapije.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Važno je da ne pokušate sami sebi dati injekciju ako Vam liječnik ili medicinska sestra prethodno nisu posebno podučili kako to učiniti.
Disposing of used syringes
Zbrinjavanje upotrijebljenih štrcaljki
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).
U slučaju predoziranja, broj bijelih krvnih stanica i trombocita treba redovito provjeravati i pažljivo nadzirati veličinu slezene (npr. kliničkim pregledom, ultrazvukom).
Each pre-filled syringe contains 30 mg sorbitol.
Jedna napunjena štrcaljka sadrži 30 mg sorbitola.
This medicine is given as an injection using a pre-filled syringe.
Ovaj se lijek daje kao injekcija pomoću napunjene štrcaljke.
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
4.2 Doziranje i način primjene Liječenje Lonquexom trebaju započeti i nadzirati liječnici s iskustvom u onkologiji ili hematologiji.
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.
Zbog moguće osjetljivosti mijeloičnih stanica koje se brzo dijele na citotoksičnu kemoterapiju, Lonquex treba primjenjivati približno 24 sata nakon primjene citotoksične kemoterapije.
The most frequent adverse reactions include musculoskeletal pains such as bone pain and myalgia.
Najčešće nuspojave uključuju mišićno-koštane bolove poput bolova u kostima i mialgije.
Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8).
Lipegfilgrastim također može prouzročiti reverzibilnu trombocitopeniju (vidjeti dio 4.8).
• The active substance is lipegfilgrastim.
• Djelatna tvar je lipegfilgrastim.
How you should inject yourself
Kako trebate sami sebi dati injekciju
It is unknown whether lipegfilgrastim/metabolites are excreted in human milk.
Nije poznato izlučuju li se lipegfilgrastim/metaboliti u majčino mlijeko.
Some cases of splenic rupture were fatal.
Neki slučajevi prsnuća slezene završili su smrću.
• The other ingredients (excipients) are glacial acetic acid, sodium hydroxide , sorbitol (E420), polysorbate 20 and water for injections.
• Drugi sastojci (pomoćne tvari) su: ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20 i voda za injekcije.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Pojačana krvotvorna aktivnost koštane srži kao odgovor na terapiju faktorom rasta povezana je s prolaznim pozitivnim nalazima u kostima na metodama oslikavanja.
Open the blister and take the pre-filled syringe out of the blister.
Otvorite blister i izvadite napunjenu štrcaljku iz blistera.
Solution for injection in pre-filled syringe (injection) Clear, colourless solution
Otopina za injekciju u napunjenoj štrcaljki (injekcija) Bistra, bezbojna otopina
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
Ubrizgajte tekućinu u tkivo polako i jednoliko, cijelo vrijeme držeći nabor kože između prstiju
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.
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.
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 medijana serumske koncentracije lipegfilgrastima i medijana apsolutnog broja neutrofila (ABN) u bolesnika liječenih kemoterapijom nakon jedne injekcije 6 mg lipegfilgrastima
No neutralising antibodies against lipegfilgrastim were observed.
Nisu opažena neutralizirajuća protutijela na lipegfilgrastim.
Lonquex contains the active substance lipegfilgrastim.
Lonquex sadrži djelatnu tvar lipegfilgrastim.
Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy.
Doziranje lipegfilgrastima jedanput po ciklusu ispitano je u dva ključna randomizirana, dvostruko slijepa klinička ispitivanja u bolesnika na mijelosupresivnoj kemoterapiji.
The safety and efficacy of Lonquex have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.
Sigurnost i djelotvornost Lonquexa nisu procijenjene u bolesnika koji primaju kemoterapiju povezanu s kasnom mijelosupresijom, npr. nitrozourejama.
Lipegfilgrastim ANC
Lipegfilgrastim ABN
The injections should be given into the abdomen, upper arm or thigh.
Injekciju treba dati u abdomen, nadlakticu ili natkoljenicu.
There is no experience with overdose of lipegfilgrastim.
Ne postoji iskustvo s predoziranjem lipegfilgrastimom.
• Sickle cell crises in patients with sickle cell anaemia.
• krize srpastih stanica u bolesnika s anemijom srpastih stanica
Patients were randomised 2:1 to receive either 6 mg lipegfilgrastim or placebo.
Bolesnici su bili randomizirani 2:1 u skupinu koja je primala 6 mg lipegfilgrastima ili placebo.
Hold the syringe and gently remove the cover from the needle without twisting.
Držite štrcaljku i pažljivo, bez savijanja, uklonite poklopac s igle.
Vigorous shaking should be avoided.
Potrebno je izbjegavati žustro potresanje.
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).
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).
Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Teva Biotech GmbH Dornierstraße 10 89079 Ulm
There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women.
Podaci o primjeni lipegfilgrastima u trudnica vrlo su ograničeni (manje od 300 trudnoća).
The recommended dose is one pre-filled syringe (6 mg lipegfilgrastim) once per chemotherapy cycle.
Koja je preporučena doza Preporučena doza je jedna napunjena štrcaljka (6 mg lipegfilgrastima) jedanput po ciklusu kemoterapije.
The solution should be visually inspected before use.
Prije primjene otopinu treba vizualno pregledati.
Regular monitoring of the platelet count and haematocrit is recommended.
Preporučuje se redoviti nadzor broja trombocita i hematokrita.
Lipegfilgrastim is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes.
Lipegfilgrastim ulazi u neutrofile (nelinearni proces), potom ga proteolitički enzimi razgrađuju unutar stanice.
Excipients: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Pomoćne tvari: ledena acetatna kiselina, natrijev hidroksid, sorbitol (E420), polisorbat 20 i voda za injekcije.
Hypersensitivity reactions*
Manje često reakcije preosjetljivosti*
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4).
Zabilježene su plućne nuspojave, osobito intersticijska pneumonija (vidjeti dio 4.4).
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.
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.
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.
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.
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.
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.
Leukocytosis*, Splenomegaly*
Manje često leukocitoza*, splenomegalija*
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.
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.
Skin reactions*
Često kožne reakcije*
These have generally occurred in patients suffering from advanced malignant diseases, having sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Obično su se javili u bolesnika s uznapredovalom malignom bolesti, sepsom, bolesnika koji su uzimali kemoterapiju s više lijekova ili bolesnika na aferezi (vidjeti dio 4.4).
Information for injecting yourself
Informacije za samoubrizgavanje
The solution is injected subcutaneously (SC).
Otopina se injicira supkutano (s.c.).
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
What Lonquex is and what it is used for What Lonquex is
Što je Lonquex i za što se koristi Što je Lonquex
Odds ratio (lipegfilgrastim / placebo), CI and p-value out of multivariate logistic regression analysis
Omjer šansi (lipegfilgrastim/placebo), CI i p-vrijednost iz multivarijatne logističke regresijske analize
Lonquex is a solution for injection (injection) in pre-filled syringe with a fixed injection needle in a blister.
Lonquex je otopina za injekciju (injekcija) u napunjenoj štrcaljki sa pričvršćenom iglom koja se nalazi u blisteru.
Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine.
Lipegfilgrastim je kovalentni konjugat filgrastima i jedne molekule metoksipolietilenglikola (PEG) preko ugljikohidratne poveznice, koji se sastoji od glicina, N-acetilneuraminske kiseline i
If you forget to use Lonquex
Ako ste zaboravili primijeniti Lonquex
• Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
- Odložite upotrijebljene štrcaljke u neprobojni spremnik i čuvajte ga izvan pogleda i dohvata djece.
Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim (see section 4.8) and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives (see section 4.8).
Nakon primjene lipegfilgrastima (vidjeti dio 4.8) bili su zabilježeni općenito asimptomatski slučajevi splenomegalije, a nakon primjene G-CSF ili derivata rijetki slučajevi rupture slezene, uključujući one sa smrtnim ishodom (vidjeti dio 4.8).
Capillary leak syndrome* Aortitis*
Nepoznato sindrom povećane propusnosti kapilara*, aortitis*
Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Lipegfilgrastim se metabolizira putem unutarstanične ili izvanstanične razgradnje proteolitičkim enzimima.
Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Postavite sve što Vam je potrebno na dohvat ruke (Lonquex napunjena štrcaljka, vatica natopljena alkoholom i mali zavoj od gaze ili sterilna gaza).
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj. zanemarive količine natrija.
In a phase 1 study of 21 children aged between 2 and 16 years with Ewing family of tumours or rhabdomyosarcoma, lipegfilgrastim was administered as a single subcutaneous dose of 100 μg/kg (up to a maximum of 6 mg, which is the fixed dose for adults) 24 hours after the end of the last chemotherapy treatment in week 1 of the regimen.
U ispitivanju faze 1 u 21 djeteta u dobi između 2 i 16 godina s tumorom iz skupine Ewingovih tumora ili rabdomiosarkomom, lipegfilgrastim je bio primijenjen kao jedna supkutana doza od 100 μg/kg (do najviše 6 mg, što je fiksna doza za odrasle) 24 sata nakon završetka zadnje kemoterapije u 1. tjednu protokola.
In 2 studies (XM22-02 and XM22-03) in patients with breast cancer receiving chemotherapy consisting of doxorubicin and docetaxel, mean maximum blood concentrations of 227 and 262 ng/ml were reached after median times to maximum concentration (tmax) of 44 and 48 hours.
U 2 ispitivanja (XM22-02 and XM22-03) u bolesnika s karcinomom dojke koji su primali kemoterapiju doksorubicinom i docetakselom, srednje maksimalne koncentracije u krvi od 227 i 262 ng/ml postignute su nakon medijana vremena do maksimalne koncentracije (tmax) od 44 odnosno 48 sati.
Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see section 4.8).
Bolesnici s anemijom srpastih stanica Kriza srpastih stanica je bila povezivana s primjenom G-CSF ili derivata u bolesnika s anemijom srpastih stanica (vidjeti dio 4.8).
The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Djelatna tvar je kovalentni konjugat filgrastima** i metoksipolietilenglikola (PEG) preko ugljikohidratne poveznice.
Injection site reactions such as injection site induration and injection site pain may occur.
Mogu nastati reakcije na mjestu injekcije, kao što su otvrdnuće na mjestu injekcije i bol na mjestu injekcije.
ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
ITT = populacija koju se namjeravalo liječiti (svi randomizirani bolesnici)
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Dezinficirajte mjesto injiciranja na koži tako što ćete palcem i kažiprstom uhvatiti nabor kože, bez stiskanja, i obrisati ga pomoću vatice natopljene alkoholom (vidjeti sliku 7).
Dispose of this medicine as instructed by your doctor, pharmacist or nurse.
Zbrinite ovaj lijek prema uputama Vašeg liječnika, ljekarnika ili medicinske sestre.
• Skin reactions, such as redness or rash.
• glavobolja • kožne reakcije, kao što su crvenilo ili osip
Incidence (%) Odds ratio 95 % CI
Incidencija (%) Omjer šansi 95% CI
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 po napunjenoj štrcaljki)
The most frequent undesirable effects are musculoskeletal pain and nausea.
Najčešće su nuspojave mišićno-koštana bol i mučnina.
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 6).
Dezinficirajte mjesto injiciranja na koži tako što ćete palcem i kažiprstom uhvatiti nabor kože, bez stiskanja, i obrisati ga pomoću vatice natopljene alkoholom (vidjeti sliku 6).
One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
Po jednom ciklusu kemoterapije preporučuje se jedna doza od 6 mg lipegfilgrastima (jedna napunjena štrcaljka lijeka Lonquex), koja se daje približno 24 sata nakon citotoksične kemoterapije.
Hypokalaemia has been reported (see section 4.4).
Zabilježena je hipokalemija (vidjeti dio 4.4).
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of lipegfilgrastim is not expected to be affected by renal or hepatic impairment.
Bolesnici s oštećenjem funkcije bubrega ili jetre Zbog mehanizma klirensa posredovanog neutrofilima, ne očekuje se da će na farmakokinetiku lipegfilgrastima utjecati oštećenje funkcije bubrega ili jetre.
In a study (XM22-04) in patients with non-small cell lung cancer receiving chemotherapy consisting of cisplatin and etoposide, the mean maximum blood concentration of 317 ng/ml was reached after a median tmax of 24 hours and the mean terminal half-life was approximately 28 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
U ispitivanju (XM22-04) u bolesnika s karcinomom pluća ne-malih stanica koji su primali kemoterapiju sastavljenu od cisplatina i etoposida, srednja maksimalna koncentracija u krvi od 317 ng/ml postignuta je nakon medijana tmax od 24 sata,a srednji terminalni poluvijek iznosio je približno 28 sati nakon jedne supkutane injekcije 6 mg lipegfilgrastima u prvom ciklusu kemoterapije.
Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Zabilježena je splenomegalija, općenito asimptomatska (vidjeti dio 4.4).
Hypokalaemia may occur (see section 4.8).
Može nastati hipokalemija (vidjeti dio 4.8).
See leaflet for further information.
Za dodatne informacije pogledajte uputu o lijeku.
Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Filgrastim je neglikozilirani rekombinantni metionilni humani G-CSF.
How Lonquex works
Kako Lonquex djeluje
Δ LS mean (least square mean difference lipegfilgrastim - placebo), CI and p-value out of multivariate Poisson regression analysis
Δ LS srednja vrijednost (razlika srednje vrijednosti lipegfilgrastim - placebo procijenjene metodom najmanjih kvadrata), CI i p-vrijednost iz multivarijantne Poissonove regresijske analize
Package leaflet: Information for the user Lonquex 6 mg solution for injection in pre-filled syringe lipegfilgrastim
Uputa o lijeku: Informacije za korisnika Lonquex 6 mg otopina za injekciju u napunjenoj štrcaljki lipegfilgrastim
Lonquex 6 mg injection lipegfilgrastim
Lonquex 6 mg injekcija lipegfilgrastim s.c.