natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Neulasta’ s benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Neulasta pri skrajšanju trajanja nevtropenije in zmanjševanju pojavljanja febrilne nevtropenije pri bolnikih z malignimi obolenji, ki se zdravijo s citotoksično kemoterapijo, večje od z njim povezanih tveganj.
The Committee recommended that Neulasta be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Neulasta odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the EU for Neulasta to Amgen Europe B. V. on 22 August 2002.
Evropska komisija je dovoljenje za promet z zdravilom Neulasta, veljavno po vsej Evropski uniji, odobrila družbi Amgen Europe B. V. dne 22. avgusta 2002.
The marketing authorisation was renewed on 22 August 2007.
Dovoljenje za promet je bilo podaljšano 22. avgusta 2007.
The full EPAR for Neulasta can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Neulasta je na voljo tukaj.
Solution for injection Solution for injection
(steklena) napolnjena brizga
Subcutaneous use Subcutaneous use
Raztopina za injiciranje
pre-filled syringe (glass) pre-filled syringe (glass)
(steklena) napolnjena brizga
1 pre-filled syringe 1 pre-filled syringe (non-blister)
1 napolnjena brizga (v nepretisni ovojnini)
1 pre-filled syringe
1 napolnjena injekcijski brizga s ščitnikom igle
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima * v 0, 6 ml raztopine za injiciranje.
The concentration is 10 mg/ ml based on protein only**.
Koncentracija je 10 mg/ ml na podlagi beljakovine same **.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ ml if the PEG moiety is included.
* Pegfilgrastim izdelujejo s tehnologijo rekombinantne DNA v celicah Escherichia coli kateri sledi konjugacija z polietilenglikolom (PEG). ** Če je vključen še delež PEG, je koncentracija 20 mg/ ml.
For more information, see section 5.1.
Za podrobnosti glejte poglavje 5. 1.
Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
Pomožne snovi z znanim delovanjem: sorbitol E420, natrijev acetat (glejte poglavje 4. 4).
Solution for injection.
Raztopina za injiciranje (injekcija).
Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/ or haematology.
Zdravljenje z Neulasto morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ ali hematologiji.
One 6 mg dose (a single pre-filled syringe) of Neulasta is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Za vsak cikel kemoterapije priporočajo en 6- miligramski odmerek (eno napolnjeno injekcijsko brizgo) Neulaste, ki je dana v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
Neulasta is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba Neulaste ni priporočljiva pri otrocih, mlajših od 18 let.
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Pri bolnikih z de novo akutno mieloično levkemijo omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5. 1).
The safety and efficacy of Neulasta have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Varnost in učinkovitost zdravila Neulasta nista raziskani pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo (AML), zato ga pri takšnih bolnikih ne smete uporabljati.
The safety and efficacy of Neulasta administration in de novo AML patients aged < 55 years with cytogenetics t(15; 17) have not been established.
Varnost in učinkovitost Neulaste pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t( 15; 17), nista ugotovljeni.
The safety and efficacy of Neulasta have not been investigated in patients receiving high dose chemotherapy.
Varnosti in učinkovitosti Neulaste niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
Rare (≥ 1/ 10,000 to < 1/ 1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Po uporabi G- CSF so opisani redki primeri (≥ 1/ 10. 000 do < 1/ 1. 000) neželenih učinkov na pljučih, zlasti intersticijske pljučnice.
In such circumstances Neulasta should be discontinued at the discretion of the physician and the appropriate treatment given.
V takem primeru je treba Neulasto po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare (< 1/ 10,000) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/ 100 do < 1/ 10), a v splošnem asimptomatskih primerih splenomegalije, zelo redko (< 1/ 10. 000) pa o primerih rupture vranice, vključno z nekaterimi smrtnimi primeri.
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Zato moramo skrbno spremljati velikost vranice (denimo, s kliničnim pregledom, ultrazvokom).
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Na diagnozo rupture vranice moramo misliti pri dajalcih in/ ali bolnikih, ki poročajo o bolečini v zgornjem levem delu trebuha ali v predelu leve lopatice.
Treatment with Neulasta alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Zdravljenje s samo Neulasto ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje mielosupresivna kemoterapija s polnimi odmerki po predpisani shemi.
Neulasta should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Neulaste ne smete uporabljati za zvečevanje odmerka citotoksične kemoterapije preko uveljavljenih shem odmerjanja.
Therefore, physicians should exercise caution when administering Neulasta in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neulasta with splenic enlargement and vaso-occlusive crisis.
Zato morajo biti zdravniki previdni, kadar dajejo Neulasto bolnikom s srpasto anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo Neulaste z zvečanjem vranice in vazookluzivno krizo.
White blood cell counts of 100 x 109/ l or greater have been observed in less than 1% of patients receiving Neulasta.
Pri manj kot 1% bolnikov, ki dobivajo Neulasto, so opazili število belih krvničk, ki je enako 100 x 109/ l ali višje.
Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of Neulasta.
Takšno zvišanje belih krvničk je prehodno, opazimo ga tipično 24 do 48 ur po uporabi zdravila in se sklada s farmakodinamskimi učinki Neulaste.
The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Varnosti in učinkovitosti Neulaste za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
3 The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
3 Pokrovček igle pri napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroča alergične reakcije.
This should be considered when interpreting bone-imaging results.
Povečana hemopoetična aktivnost kostnega mozga zaradi zdravljenja z rastnimi dejavniki je bila povezana s prehodnimi pozitivnimi izvidi pri slikanju kosti, kar je treba upoštevati pri interpretaciji izvidov na podlagi slikanja kosti.
Neulasta contains sorbitol.
Neulasta vsebuje sorbitol.
Neulasta contains less than 1 mmol (23 mg) sodium per 6 mg dose, i. e. essentially ‘ sodium-free’.
Neulasta vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni ˝brez natrija˝.
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neulasta should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba Neulasto dati približno 24 ur po aplikaciji citotoksične kemoterapije.
In clinical studies, Neulasta has been safely administered 14 days before chemotherapy.
V kliničnih študijah so Neulasto varno dajali 14 dni pred kemoterapijo.
Concomitant use of Neulasta with any chemotherapy agent has not been evaluated in patients.
Sočasne uporabe Neulaste s katerimkoli kemoterapevtskim sredstvom pri bolnikih niso ovrednotili.
In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Pokazali so, da v živalskih modelih sočasna uporaba Neulaste in 5- fluorouracila (5- FU) ali drugih antimetabolitov okrepi mielosupresijo.
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e. g., nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti Neulaste niso ovrednotili.
Specific interaction or metabolism studies have not been performed, however, clinical studies have not indicated an interaction of Neulasta with any other medicinal products.
Posebnih študij medsebojnega delovanja ali presnove niso opravili, vendar klinične raziskave niso pokazale medsebojnega delovanja Neulaste s kakšnimi drugimi zdravili.
Neulasta should not be used during pregnancy unless clearly necessary.
Neulaste med nosečnostjo ne smete uporabljati, razen če je to očitno potrebno.
There is no clinical experience with breast-feeding women, therefore Neulasta should not be administered to women who are breast-feeding.
Z doječimi materami ni kliničnih izkušenj, zato pri ženskah, ki dojijo, Neulaste ne smete uporabljati.
In randomised clinical studies in patients with malignancy receiving Neulasta after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy.
V randomiziranih kliničnih študijah pri bolnikih z maligno boleznijo, ki so po citotoksični kemoterapiji dobivali Neulasto, sta večino neželenih učinkov povzročili osnovna maligna bolezen ali citotoksična kemoterapija.
4 Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neulasta.
4 Med začetnim ali nadaljnjim zdravljenjem z Neulasto so bile opisane alergijske reakcije, vključno z anafilaksijo, izpuščajem na koži, urtikarijo, angioedemom, dispnejo, hipotenzijo, reakcijami na mestu injiciranja, eritemom in zardevanjem.
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were common (1/ 100 to < 1/ 10); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were very common (1/ 10) in patients receiving Neulasta following cytotoxic chemotherapy.
Reverzibilno, blago do zmerno zvišanje sečne kisline in alkalne fosfataze brez pridruženih kliničnih učinkov se je pojavilo pogosto (≥ 1/ 100 do < 1/ 10); reverzibilno, blago do zmerno zvišanje laktatne dehidrogenaze brez pridruženih kliničnih učinkov se je pojavilo zelo pogosto (≥ 1/ 10) pri bolnikih, ki so dobivali Neulasto po citotoksični kemoterapiji.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.4).
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/ 100 do < 1/ 10), a v splošnem asimptomatskih primerih splenomegalije, zelo redko pa o primerih rupture vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4. 4).
Rare (1/ 10,000 to < 1/ 1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Opisani so redki (≥ 1/ 10. 000 do < 1/ 1. 000) neželeni učinki na pljučih, vključno z intersticijsko pljučnico, pljučnim edemom, pljučnimi infiltrati in pljučno fibrozo.
Some of the reported cases have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4)
V nekaterih opisanih primerih je prišlo do respiracijske insuficience ali sindroma akutne dihalne stiske (ARDS), ki sta lahko usodna (glejte poglavje 4. 4).
Rare (1/ 10,000 to < 1/ 1,000) cases of thrombocytopenia and leukocytosis have been reported.
Poročali so o redkih (≥ 1/ 10. 000 do < 1/ 1. 000) primerih trombocitopenije in levkocitoze.
Rare (1/ 10,000 to < 1/ 1,000) cases of Sweet’ s syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Redko (≥ 1/ 10. 000 do < 1/ 1. 000) so poročali o primerih Sweetovega sindroma, čeprav imajo lahko tu vpliv tudi osnovne hematološke maligne bolezni.
Very rare (< 1/ 10,000) events of cutaneous vasculitis have been reported in patients treated with Neulasta.
Pri bolnikih, zdravljenih z Neulasto, so zelo redko (< 1/ 10. 000) poročali o primerih kožnega vaskulitisa.
The mechanism of vasculitis in patients receiving Neulasta is unknown.
Mehanizem vaskulitisa pri bolnikih, ki prejemajo Neulasto, še ni pojasnjen.
Very rare (< 1/ 10,000) elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Zelo redko (< 1/ 10. 000) so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov ALT (alanin- aminotransferaze) ali AST (aspartat - aminotransferaze).
Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje 4. 4).
There is no experience with overdose of Neulasta in humans.
S prevelikim odmerjanjem Neulaste pri ljudeh ni izkušenj.
Cytokines, ATC Code:
Citokini, oznaka ATC:
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Faktor, ki stimulira človeške granulocitne kolonije (G- CSF), je glikoprotein, ki uravnava nastajanje nevtrofilcev in njihovo sproščanje iz kostnega mozga.
Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Pegfilgrastim je kovalenten konjugat rekombinantnega človeškega G- CSF (r- metHuG- CSF) z eno samo molekulo 20 kd polietilenglikola (PEG).
Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/ or lymphocytes.
Dokazali so, da imata pegfilgrastim in filgrastim enak način delovanja, v 24 urah povzročita izrazito zvišanje števila nevtrofilcev v periferni krvi, medtem ko je zvišanje monocitov in/ ali limfocitov manjše.
Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show
Podobno kot pri filgrastimu nevtrofilci, ki nastanejo v odgovor na pegfilgrastim, kažejo
5 normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
5 normalno ali zvečano delovanje, kot kažejo testi kemotaktične in fagocitne funkcije.
G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro.
G- CSF lahko pospešuje rast mieloidnih celic, z malignimi celicami vred, in vitro, podobne učinke pa lahko vidimo na nekaterih nemieloidnih celicah in vitro.
In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile neutropenia.
Poročajo, da je ta odmerna shema v odsotnosti podpore s strani rastnega faktorja povzročila nevtropenijo 4. stopnje, ki je povprečno trajala 5 do 7 dni, in 30- 40 -% incidenco febrilne nevtropenije.
In one study (n=157), which used a 6mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
V eni študiji (n=157), v kateri so uporabili stalni odmerek 6 mg pegfilgrastima, je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1, 8 dni, v skupini s filgrastimom pa 1, 6 dni (razlika 0, 23 dneva, 95- odstotni interval zaupanja - 0, 15, 0, 63).
Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients (difference 7%, 95% CI of -19%, 5%).
V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13%, pri bolnikih, zdravljenih s filgrastimom, pa 20% (razlika 7%, 95 -% interval zaupanja - 19%, 5%).
In a second study (n=310), which used a weight-adjusted dose (100 micrograms/ kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI -0.36, 0.30).
V drugi študiji (n=310), v kateri so uporabljali za telesno maso popravljen odmerek (100 mikrogramov/ kg), je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1, 7 dni, v skupini s filgrastimom pa 1, 8 dni (razlika 0, 03 dneva, 95- odstotni interval zaupanja - 0, 36, 0, 30).
The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%).
Celotna pogostost febrilne nevtropenije je bila pri bolnikih, zdravljenih s pegfilgrastimom, 9%, pri bolnikih, zdravljenih s filgrastimom, pa 18% (razlika 9%, 95 -% interval zaupanja - 16, 8%, - 1, 1%).
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/ m2 every 3 weeks for 4 cycles).
V dvojno slepi, s placebom kontrolirani študiji pri bolnicah z rakom na dojki so ocenili učinek pegfilgrastima na incidenco febrilne nevtropenije po uporabi takšne sheme kemoterapije, ki je povezana z 10– 20% deležem febrilne nevtropenije (docetaksel 100 mg/ m2 na 3 tedne, 4 cikluse).
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1% versus 17%, p < 0.001).
Incidenca febrilne nevtropenije je bila nižja pri bolnicah, ki so dobivale pegfilgrastim, kot pri tistih, ki so dobivale placebo (1% v primerjavi s 17%, p < 0, 001).
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001)
Med prejemnicami pegfilgrastima je bila tudi manjša incidenca hospitalizacij in intravensko uporabljene antiinfektivne terapije, povezanih s klinično diagnozo febrilne nevtropenije, kot med prejemnicami placeba (1% v primerjavi s 14%, p < 0, 001, ter 2% v primerjavi z 10%, p < 0, 001).
Long term outcome was not studied (see section 4.4).
Dolgoročnega izida niso raziskali (glejte poglavje 4. 4).
6 Figure 1.
V skladu z avtoregulacijskim mehanizmom očistka se serumska koncentracija pegfilgrastima ob nastopu okrevanja nevtrofilcev hitro zniža (glejte sliko 1).
Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - 'Absolute Neutrophil Count') pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6- miligramski injekciji
(ng/ ml) Pegfilgrastim Conc.
konc. pegfilgrastima Pegfilgrastim Conc. mediana serumske konc. pegfilgrastima
Study Day
dan raziskave Study Day
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/ foetal toxicity (embryo loss) at low subcutaneous doses.
Pri potomcih brejih podgan, ki so jim subkutano dali pegfilgrastim, niso opazili neželenih učinkov, pri kuncih pa so pokazali, da pegfilgrastim v majhnih subkutanih odmerkih povzroča toksičnost za zarodek in plod (izgubo zarodka).
Sodium acetate* Sorbitol (E420) Polysorbate 20 Water for injections
natrijev acetat * sorbitol (E420) polisorbat 20 voda za injekcije
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Zdravilo se ne sme mešati z drugimi
7 6.3 Shelf life
7
Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Neulasta sme biti izpostavljena sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
Neulasta left at room temperature for more than 72 hours should be discarded.
Neulasto, ki je bila na sobni temperaturi več kot 72 ur, je treba zavreči.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neulasta.
Če je Neulasta pomotoma izpostavljena temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njeni stabilnosti.
0.6 ml of solution for injection in a pre-filled syringe (Type I glass), with a rubber stopper, and with a stainless steel needle.
0, 6 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (iz stekla tipa I) z batnim zamaškom in nerjavno iglo.
Pack size of one, in either blistered, with or without an automatic needle guard or non-blistered packaging.
Pakiranje po 1 s pretisnimi omoti z avtomatičnim ščitnikom igle ali brez njega, ali v pakiranju brez pretisnih omotov.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suh naravni kavčuk (derivat lateksa) (glejte poglavje 4. 4).
Before administration, Neulasta solution should be inspected visually for particulate matter.
Pred uporabo morate raztopino Neulaste pregledati glede vidnih delcev.
EU/ 1/ 02/ 227/ 001 1 pack blistered syringe EU/ 1/ 02/ 227/ 002 1 pack unblistered syringe EU/ 1/ 02/ 227/ 004 1 pack blistered syringe with needle guard
EU/ 1/ 02/ 227/ 001 – pakiranje po 1 v pretisnem omotu EU/ 1/ 02/ 227/ 002 – pakiranje po 1 brez pretisnega omota EU/ 1/ 02/ 227/ 004 – pakiranje po 1 v pretisnem omotu s ščitnikom igle
22 August 2002 Date of last renewal:
22. avgust 2002 Datum podaljšanja dovoljenja za promet: