natgillin/translations-raw huggingface dataset:
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neupopeg
m Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba
ed should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
V kliničnih študijah so
Concomitant
pr Neupopeg varno dajali 14 dni pred kemoterapijo.
is use of Neupopeg with any chemotherapy agent has not been evaluated in patients.
Sočasne uporabe Neupopega s katerimkoli kemoterapevtskim sredstvom pri bolnikih niso ovrednotili.
In animal models
Pokazali so, da v živalskih modelih
or concomitant administration of Neupopeg and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
za sočasna uporaba Neupopega in 5- fluorouracila (5- FU) ali drugih antimetabolitov okrepi mielosupresijo.
th au Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical studies.
a Možnih interakcij z drugimi hemopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso
ng The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
nj posebej raziskovali. lje Potenciala za medsebojno delovanje z litijem, ki tudi pospešuje sproščanje nevtrofilcev, niso posebej raziskali.
There is no evidence that such an interaction would be harmful. lo
Ni dokazov, da bi bilo takšno medsebojno delovanje škodljivo. vo
The safety and efficacy of Neupopeg have not been evaluated in patients receiving chemotherapy o
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, do
associated with delayed myelosuppression e. g., nitrosoureas. tn uc
varnosti in učinkovitosti Neupopega niso ovrednotili. ā
Specific interaction or metabolism studies have not been performed, however, clinical studies have not indicated an interaction of Neupopeg with any other medicinal products. od
Posebnih študij medsebojnega delovanja ali presnove niso opravili, vendar klinične raziskave niso pokazale medsebojnega delovanja Neupopega s kakšnimi drugimi zdravili. ve
4.6 Pregnancy and lactation pr
4. 6 Nosečnost in dojenje a m
shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5. 3).
The potential risk for humans is unknown. in ic
Potencialno tveganje za ljudi ni znano. ni
Neupopeg should not be used during pregnancy unless clearly necessary. ed
Neupopega med nosečnostjo ne smete uporabljati, razen če je to očitno potrebno. lo
There is no clinical experience with breast-feeding women, therefore Neupopeg should not be M
Z doječimi materami ni kliničnih izkušenj, zato pri ženskah, ki dojijo, Neupopega ne smete vi
administered to women who are breast-feeding.
uporabljati. ra
4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji Zd
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 Neupopeg.
4 Med začetnim ali nadaljnjim zdravljenjem z Neupopegom 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 Neupopeg following cytotoxic chemotherapy.
Navzejo so opazili pri zdravih prostovoljcih in pri
Nausea was observed in healthy volunteers and patients receiving chemotherapy.
et bolnikih, ki so dobivali kemoterapijo.
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
m 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
ed pegfilgrastim (see section 4.4).
o (glejte poglavje 4. 4).
Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and
Med drugimi pogosto opisanimi neželenimi učinki so bolečine, bolečine na
or Rare (≥ 1/ 10,000 to < 1/ 1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary
pr mestu injiciranja, bolečine v prsih (ki ne izvirajo od srca), glavobol, artralgija, mialgija, bolečine v hrbtu, udih, vratu in osteomuskularne bolečine.
th oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
za 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
V nekaterih opisanih primerih je
au have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4)
a prišlo do respiracijske insuficience ali sindroma akutne dihalne stiske (ARDS), ki sta lahko usodna
ng Rare (≥ 1/ 10,000 to < 1/ 1,000) cases of thrombocytopenia and leukocytosis have been reported. lo
nj (glejte poglavje 4. 4). lje Poročali so o redkih (≥ 1/ 10. 000 do < 1/ 1. 000) primerih trombocitopenije in levkocitoze. vo
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. o tn
Redko (≥ 1/ 10. 000 do < 1/ 1. 000) so poročali o primerih Sweetovega sindroma, čeprav imajo lahko tu vpliv tudi osnovne hematološke maligne bolezni. do
Very rare (< 1/ 10,000) events of cutaneous vasculitis have been reported in patients treated with uc
Pri bolnikih, zdravljenih z Neupopegom, so zelo redko (< 1/ 10. 000) poročali o primerih kožnega ā
Neupopeg.
vaskulitisa.
The mechanism of vasculitis in patients receiving Neupopeg is unknown. od
Mehanizem vaskulitisa pri bolnikih, ki prejemajo Neupopeg, še ni pojasnjen. ve
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 pr
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 - a
following cytotoxic chemotherapy.
aminotransferaze).
These elevations are transient and return to baseline. al
Ta zvišanja so prehodna in vrednosti se vrnejo na izhodiščne. m
Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section in
Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje ni
4.4). ic ed
4. 4). lo
4.9 Overdose M
4. 9 Preveliko odmerjanje vi
There is no experience with overdose of Neupopeg in humans.
S prevelikim odmerjanjem Neupopega pri ljudeh ni izkušenj. ra Zd
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
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
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
Over the entire study, the rate of febrile neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated patients
V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13%, pri
ed (difference 7%, 95% CI of -19%, 5%).
V
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
pr 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
The
za dni, v skupini s filgrastimom pa 1, 8 dni (razlika 0, 03 dneva, 95- odstotni interval zaupanja - 0, 36, 0, 30).
or 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%).
th au 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 er regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/ m2 every 3 weeks for ng 4 cycles).
a nj 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 lje povezana z 10– 20% deležem febrilne nevtropenije (docetaksel 100 mg/ m2 na 3 tedne, 4 cikluse).
The lo
Devetstoosemindvajset bolnic so randomizirali na en odmerek pegfilgrastima ali placeba, uporabljen vo
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 do
associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group tn
Med prejemnicami pegfilgrastima je bila tudi manjša incidenca hospitalizacij in intravensko uporabljene antiinfektivne terapije, povezanih s klinično diagnozo febrilne nevtropenije, ā
compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001) uc
kot med prejemnicami placeba (1% v primerjavi s 14%, p < 0, 001, ter 2% v primerjavi z 10%, p < 0, 001). ve
A small (n=83), Phase II, randomised, double-blind study in patients receiving chemotherapy for od
Majhna (n = 83) randomizirana, dvojno slepa študija II. faze pri bolnikih, ki so dobivali kemoterapijo a
de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, administered during induction chemotherapy.
zaradi de novo akutne mieloične levkemije, je primerjala pegfilgrastim (enkraten odmerek 6 mg) s m
estimated as 22 days in both treatment groups.
Ocenjeni mediani čas do okrevanja po hudi nevtropeniji je bil v obeh obravnavanih skupinah 22 dni.
Long term outcome was not studied (see section 4.4). al
poglavje 4. 4). lo
5.2 Pharmacokinetic properties in ic
5. 2 Farmakokinetične lastnosti vi
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim ed
Po enem samem subkutanem odmerku pegfilgrastima se najvišja serumska koncentracija ra
occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
pegfilgrastima pojavi 16 do 120 ur po odmerku, serumske koncentracije pegfilgrastima se vzdržujejo v obdobju nevtropenije po mielosupresivni kemoterapiji.
The elimination of pegfilgrastim is M
Izločanje pegfilgrastima iz telesa je glede na Zd
non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
odmerek nelinearno; serumski očistek pegfilgrastima se z naraščajočim odmerkom zmanjšuje.
Figure 1.
V skladu z avtoregulacijskim mehanizmom očistka se serumska koncentracija pegfilgrastima ob nastopu okrevanja nevtrofilcev hitro zniža (glejte sliko 1).
10
et 10
1 1
0. 1
is
za
or Study Day
dan raziskave Study Day
th Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not
a nj Zaradi mehanizma očistka, ki ga sprožijo nevtrofilci, ne pričakujemo, da bi na farmakokinetiko pegfilgrastima vplivala ledvična ali jetrna okvara.
In a open label, single dose study (n=31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim. er ng Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults. lo o
Omejeni podatki kažejo, da je farmakokinetika pegfilgrastima pri starejših osebah (> 65 let) podobna do
5.3 Preclinical safety data tn
kot pri odraslih.
Preclinical data from conventional studies of repeated dose toxicity revealed the expected uc
Predklinični podatki o varnosti ā ve
pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, od
Predklinični podatki iz konvencionalnih študij toksičnosti pri ponavljajočih odmerkih so razkrili pričakovane farmakološke učinke, ki so zajemali zvišanje števila levkocitov, mieloidno hiperplazijo v kostnem mozgu, ekstramedularno hematopoezo in zvečanje vranice. a m
extramedullary haematopoiesis and splenic enlargement. pr
Pri potomcih brejih podgan, ki so jim subkutano dali pegfilgrastim, niso opazili neželenih učinkov, pri ni
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 al
kuncih pa so pokazali, da pegfilgrastim v majhnih subkutanih odmerkih povzroča toksičnost za zarodek in plod (izgubo zarodka).
In rat studies, it was shown that pegfilgrastim may cross the placenta. in
Pomen teh ugotovitev za ljudi ni znan. lo vi
The relevance of these findings for humans is not known. ic ed
Zd
PHARMACEUTICAL PARTICULARS M
FARMACEVTSKI PODATKI
This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
zdravili, predvsem z raztopinami natrijevega klorida
6.3 Shelf life
7 6. 3 Rok uporabnosti
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neupopeg.
et obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
Keep the container in the outer carton, in order to protect from light.
m Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
ed 6.5 Nature and contents of container
o 6. 5 Vrsta ovojnine in vsebina
is 0.6 ml of solution for injection in a pre-filled syringe (Type I glass), with a rubber stopper, and with a
pr 0, 6 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (iz stekla tipa I) z batnim zamaškom in
or stainless steel needle.
za nerjavno iglo.
th The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suh naravni kavčuk (derivat lateksa) (glejte
au section 4.4).
a poglavje 4. 4).
Not all pack sizes may be marketed. er ng
nj Na trgu morda ni vseh pakiranj. lje 6. 6 Posebni varnostni ukrepi za odstranjevanje vo
6.6 Special precautions for disposal and other handling lo
Neupopeg je sterilna raztopina, ne vsebuje sredstev za konzerviranje. do
Only a o
Pred uporabo morate raztopino Neupopega pregledati glede vidnih delcev.
solution that is clear and colourless should be injected. tn uc
Injicirati smete samo raztopino, ki je bistra in brezbarvna. ā ve
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive. od
Zaradi čezmernega stresanja se lahko pegfilgrastim agregira, s čimer postane biološko neaktiven.
Allow the pre-filled syringe to reach room temperature before injecting. pr
Pred injiciranjem naj se napolnjena injekcijska brizga segreje na sobno temperaturo. a m
Any unused product or waste material should be disposed of in accordance with local requirements. al in
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi. ni
MARKETING AUTHORISATION HOLDER ic ed
IMETNIK DOVOLJENJA ZA PROMET lo
Dompé Biotec S. p. A.
Dompé Biotec S. p. A. vi
Via San Martino 12 M
Via San Martino 12 ra
I-20122 Milan Italy
I- 20122 Milan Italija Zd
16 July 2007 10.
16. julij 2007
ed is or th au er ng lo o tn uc od pr al in ic ed M 1.
et m o pr za a nj lje vo do ā ve a m ni lo vi ra Zd
The potency of this product should not be compared to the potency of another pegylated or non- pegylated protein of the same therapeutic class.
m Učinkovitost tega sredstva ne gre primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
For more information, see section 5.1
Za podrobnosti glejte poglavje 5. 1.
PHARMACEUTICAL FORM er ng
a nj * Na podlagi beljakovine same.
Solution for injection in a pre-filled pen (SureClick). lo
Raztopina za injiciranje (injekcijo) v napolnjenem injekcijskem peresniku (SureClick). do
Clear, colourless solution for injection. o tn uc
Bistra, brezbarvna raztopina za injiciranje. ā ve
CLINICAL PARTICULARS od
KLINIČNI PODATKI a
4.1 Therapeutic indications pr
4. 1 Terapevtske indikacije m
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 al
Skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri bolnikih, zdravljenih s ni
myelodysplastic syndromes). in ic
citotoksično kemoterapijo za maligne bolezni (z izjemo kronične mieloidne levkemije in mielodisplastičnih sindromov). lo
4.2 Posology and method of administration ed
4. 2 Odmerjanje in način uporabe vi ra
Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/ or M
Zd
One 6 mg dose (a single pre-filled pen) of Neupopeg (SureClick) 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 (en napolnjen injekcijski peresnik) Neupopega (SureClick), ki je dan v obliki subkutane injekcije približno 24 ur po citotoksični kemoterapiji.
4.3 Contraindications
10 4. 3 Kontraindikacije
Limited clinical data suggest a similar 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).
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Granulocitne kolonije spodbujajoči faktor lahko spodbudi rast mieloičnih celic in vitro; podobni učinki
The safety and efficacy of Neupopeg 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.
m Varnost in učinkovitost zdravila Neupopeg nista raziskani pri bolnikih z mielodisplastičnim sindromom, kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo (AML), zato
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
pr diagnoze blastne transformacije kronične mieloične levkemije od akutne mieloične levkemije.
ed The safety and efficacy of Neupopeg administration in de novo AML patients aged < 55 years with cytogenetics t(15; 17) have not been established.
za Varnost in učinkovitost Neupopega pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t( 15; 17), nista ugotovljeni.
is or The safety and efficacy of Neupopeg have not been investigated in patients receiving high dose
a Varnosti in učinkovitosti Neupopega niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih
au Rare (≥ 1/ 10,000 to < 1/ 1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
nj odmerkih. lje Po uporabi G- CSF so opisani redki primeri (≥ 1/ 10. 000 do < 1/ 1. 000) neželenih učinkov na pljučih, vo
Patients with a recent history of pulmonary infiltrates or er pneumonia may be at higher risk. ng
Bolj ogroženi utegnejo biti bolniki z nedavno anamnezo pljučnih infiltratov ali pljučnice. do
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological lo
Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov, in poslabšanje pljučne funkcije skupaj z zvečanim številom nevtrofilcev ā
In such o
utegnejo biti preliminarni znaki sindroma dihalne stiske odraslih (ARDS - 'Adult Respiratory Distress Syndrome').
circumstances Neupopeg should be discontinued at the discretion of the physician and the appropriate tn
V takem primeru je treba Neupopeg po presoji zdravnika prenehati dajati in poskrbeti za ve
treatment given. uc
ustrezno zdravljenje. a
Common (≥ 1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare od
Po uporabi pegfilgrastima so poročali o pogostih (≥ 1/ 100 do < 1/ 10), a v splošnem asimptomatskih m
Therefore, spleen size should be carefully monitored (e. g. clinical pr
Zato moramo skrbno spremljati velikost vranice (denimo, s kliničnim pregledom, ni
examination, ultrasound).
ultrazvokom).
A diagnosis of splenic rupture should be considered in patients reporting left al
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. lo
Treatment with Neupopeg alone does not preclude thrombocytopenia and anaemia because full dose ic
Zdravljenje s samo Neupopegom ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje vi
Regular monitoring of ed
Priporočajo redno spremljanje ra
platelet count and haematocrit is recommended.
števila trombocitov in hematokrita.
The safety and efficacy of Neupopeg for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
11 Varnosti in učinkovitosti Neupopega za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko prirojeno motnjo intolerance za fruktozo ne smejo dobiti
Neupopeg contains less than 1 mmol (23 mg) sodium per 6 mg dose, i. e. essentially ‘ sodium-free’.
et tega zdravila.
4.5 Interaction with other medicinal products and other forms of interaction
m Neupopeg 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‚ Neupopeg
o pr 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
ed should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
za Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba Neupopeg dati približno 24 ur po aplikaciji citotoksične kemoterapije.
Concomitant
Sočasne uporabe Neupopega s katerimkoli