FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 22. avgust 2002
English: Neupopeg should not be used during pregnancy unless clearly necessary.
Slovenian: Neupopega med nosečnostjo ne smete uporabljati, razen če je to očitno potrebno.
English: • Do not put the cover back on used needles.
Slovenian: • Ne nameščajte pokrovčka nazaj na uporabljene igle.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C ).
English: Pharmacotherapeutic group: Cytokines, ATC Code: L03AA13
Slovenian: Farmakoterapevtska skupina: Citokini, oznaka ATC: L03AA13
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološko aktivne substance
English: WHAT NEUPOPEG IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE NEUPOPEG IN ZA KAJ GA UPORABLJAMO
English: There are no adequate data from the use of pegfilgrastim in pregnant women.
Slovenian: O uporabi pegfilgrastima pri nosečnicah ni zadostnih podatkov.
English: If you use more Neupopeg than you should
Slovenian: Če ste uporabili večji odmerek Neupopega, kot bi smeli
English: Your doctor has given you Neupopeg to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal Neupopeg, da bi spodbudil vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
English: 6.6 Special precautions for disposal and other handling The carton contains a package leaflet with the full instructions for use and handling.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Škatla vsebuje navodilo za uporabo z natančnimi navodili za uporabo in rokovanje.
English: Do not warm Neupopeg in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Neupopega ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči
English: Put the needle fully into the skin as shown by your nurse or doctor.
Slovenian: Potisnite iglo do konca v kožo, kot vam je pokazal zdravnik ali medicinska sestra.
English: • Disinfect your skin by using an alcohol wipe.
Slovenian: • Razkužite si kožo z alkoholno krpico
English: Nausea was observed in healthy volunteers and patients receiving chemotherapy.
Slovenian: Navzejo so opazili pri zdravih prostovoljcih in pri bolnikih, ki so dobivali kemoterapijo.
English: If you experience difficulties choose a more firm injection site.
Slovenian: Če se pojavijo težave, izberite čvrstejše mesto za injiciranje.
English: Not all pack sizes may be marketed.
Slovenian: Na trgu morda ni vseh pakiranj.
English: If you forget to inject Neupopeg
Slovenian: Če ste si pozabili injicirati Neupopeg
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neupopeg.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden uporabite zdravilo Neupopeg.
English: • Remove the grey needle shield (see picture 2).
Slovenian: • Snemite sivi pokrovček igle (glejte sliko 2).
English: Pack size of one, for single use only.
Slovenian: Pakiranje po ena, za enkratno uporabo.
English: • if you have sickle cell anaemia;
Slovenian: • če imate srpasto anemijo;
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Slovenian: Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravni beljakovini (t. i. granulocitne kolonije stimulirajočemu faktorju), ki nastaja v telesu.
English: Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical studies.
Slovenian: Možnih interakcij z drugimi hemopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso posebej raziskovali.
English: Therefore, physicians should exercise caution when administering Neupopeg in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neupopeg with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar dajejo Neupopeg bolnikom s srpasto anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo Neupopega z zvečanjem vranice in vazookluzivno krizo.
English: Specific interaction or metabolism studies have not been performed, however, clinical studies have not indicated an interaction of Neupopeg with any other medicinal products.
Slovenian: Posebnih študij medsebojnega delovanja ali presnove niso opravili, vendar klinične raziskave niso pokazale medsebojnega delovanja Neupopega s kakšnimi drugimi zdravili.
English: However, the long-term effects of Neupopeg have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Slovenian: Vendar dolgoročni učinki zdravila Neupopeg pri akutni mieloični levkemiji niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
English: Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Slovenian: Zdravljenje z Neupopegom morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
English: B CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z DRAVILOM
English: Choose a site at least 5 cm away from the belly button (navel) (see picture 4).
Slovenian: Izberite primerno mesto, ki je vsaj 5 cm oddaljeno od popka (glejte sliko 4).
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Slovenian: Podobno kot pri filgrastimu nevtrofilci, ki nastanejo v odgovor na pegfilgrastim, kažejo normalno ali zvečano delovanje, kot kažejo testi kemotaktične in fagocitne funkcije.
English: If you have forgotten a dose of Neupopeg, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste pozabili odmerek Neupopega, se posvetujte z zdravnikom glede tega, kdaj si boste injicirali naslednji odmerek.
English: Some of the reported cases have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4)
Slovenian: V nekaterih opisanih primerih je prišlo do respiracijske insuficience ali sindroma akutne dihalne stiske (ARDS), ki sta lahko usodna (glejte poglavje 4.4).
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of Neupopeg.
Slovenian: Takšno zvišanje belih krvničk je prehodno, opazimo ga tipično 24 do 48 ur po uporabi zdravila in se sklada s farmakodinamskimi učinki Neupopega.
English: If needed, you may cover the injection site with a bandage.
Slovenian: Če je potrebno, lahko injekcijsko mesto prekrijete s povojem.
English: Find a comfortable, well-lit, clean place and put all the equipment you need within reach.
Slovenian: Poiščite si udoben, dobro osvetljen prostor in si pripravite vse, kar boste potrebovali, tako da bo
English: If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Safety cover out
Slovenian: Varnostni pokrovček umaknjen
English: Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Slovenian: Razkužite si kožo z alkoholno krpico in primite kožo s palcem in kazalcem, ne da bi jo stiskali.
English: The safety and efficacy of Neupopeg for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti Neupopega za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: This is called a subcutaneous injection.
Slovenian: Temu pravimo subkutano injiciranje.
English: How to give an injection into the thigh or back of the arm
Slovenian: Kako dati injekcijo v stegno ali zadnji del nadlakta
English: What should I do before I give myself a subcutaneous injection of Neupopeg?
Slovenian: Kaj moram narediti, preden si dam subkutano injekcijo Neupopega?
English: In animal models concomitant administration of Neupopeg and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Slovenian: Pokazali so, da v živalskih modelih sočasna uporaba Neupopega in 5-fluorouracila (5-FU) ali drugih antimetabolitov okrepi mielosupresijo.
English: Neupopeg contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free'.
Slovenian: Neupopeg vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar v bistvu pomeni ˝brez natrija˝.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Slovenian: 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 utegnejo biti preliminarni znaki sindroma dihalne stiske odraslih (ARDS - 'Adult Respiratory Distress Syndrome').
English: After use (needle safety cover down)
Slovenian: Po uporabi (varnostni pokrovček je spuščen)
English: In clinical studies, Neupopeg has been safely administered 14 days before chemotherapy.
Slovenian: V kliničnih študijah so Neupopeg varno dajali 14 dni pred kemoterapijo.
English: Neupopeg left at room temperature for more than 72 hours should be discarded.
Slovenian: Neupopeg, ki je bil na sobni temperaturi več kot 72 ur, je treba zavreči.
English: Pinch the skin of the abdomen firmly between the thumb and fingers creating a space at least 3 cm wide (twice the width of the tip of the pre-filled pen).
Slovenian: Trdno primite kožo na trebuhu med palec in kazalec, tako da boste oblikovali vsaj 3 cm široko kožno gubo (dvakratna širina konice napolnjenega injekcijskga peresnika).
English: The safety and efficacy of Neupopeg administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Slovenian: Varnost in učinkovitost Neupopega pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
English: Inject the liquid slowly and evenly, always keeping your skin pinched.
Slovenian: Tekočino injicirajte počasi in enakomerno; pri tem ves čas s palcem in kazalcem držite kožno
English: 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.
Slovenian: Varnost in učinkovitost zdravila Neupopeg 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.
English: Do not remove the cover from the syringe until you are ready to inject.
Slovenian: Ne snemite pokrovčka z injekcijske brizge, dokler niste pripravljeni na vbrizgavanje.
English: C. After the second “click” (or a count of 15) lift the pre-filled pen from the injection site.
Slovenian: C. Ko boste zaslišali drugi “klik” (ali prešteli do 15), dvignite napolnjeni injekcijski peresnik z mesta za injiciranje.
English: Do not shake Neupopeg vigorously as this may affect its activity
Slovenian: Zdravila Neupopeg ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: Before use (without grey needle shield)
Slovenian: Pred uporabo (brez sivega pokrovčka igle)
English: B. While holding the pre-filled pen in place, (1) press and (2) release the green button on top.
Slovenian: B. Ko držite napolnjeni injekcijski peresnik tako pritisnjen na kožo, (1) pritisnite in (2) spustite zeleni gumb na vrhu.
English: Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - 'Absolute Neutrophil Count') pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji
English: The recommended sites for injection using the pre-filled pen are the top of the thigh and the back of the arm if given by a nurse or carer (see picture 1).
Slovenian: Priporočeni mesti za injiciranje z napolnjenim injekcijskim peresnikom sta zgornji del stegen in zadnji del nadlakta, če vam daje injekcijo medicinska sestra ali negovalec (glejte sliko 1).
English: Neupopeg is for use in adults aged 18 and over.
Slovenian: Neupopeg je namenjena uporabi pri odraslih, starih 18 ali več let.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN ZA SPROŠČANJE SERIJE
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Slovenian: A. IZDELOVALEC BIOLOŠKO AKTIVNE SUBSTANCE IN IMETNIK DOVOLJENJA ZA IZDELAVO, ODGOVOREN
English: Like all medicines, Neupopeg can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi Neupopeg neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Pack size of one.
Slovenian: Pakiranje po ena.
English: The needle safety cover will move down over the needle and lock into place.
Slovenian: Varnostni pokrovček igle se bo pomaknil navzdol preko igle in se bo zaskočil.
English: The safety and efficacy of Neupopeg have not been investigated in patients receiving high dose chemotherapy.
Slovenian: Varnosti in učinkovitosti Neupopega niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
English: 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.
Slovenian: 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.
English: Your doctor has decided it would be best for you to inject Neupopeg yourself.
Slovenian: Vaš zdravnik se je odločil, da bi bilo za vas najboljše, če si Neupopeg injicirate sami.
English: Maintain firm skin pinch for entire procedure (see picture 5).
Slovenian: Kožno gubo trdno držite skozi celoten postopek (glejte sliko 5).
English: Important information about some of the ingredients of Neupopeg Neupopeg contains sorbitol (a type of sugar).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Neupopeg Neupopeg vsebuje sorbitol (vrsto sladkorja).
English: In such circumstances Neupopeg should be discontinued at the discretion of the physician and the appropriate treatment given.
Slovenian: V takem primeru je treba Neupopeg po presoji zdravnika prenehati dajati in poskrbeti za ustrezno zdravljenje.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure 1).
Slovenian: V skladu z avtoregulacijskim mehanizmom očistka se serumska koncentracija pegfilgrastima ob nastopu okrevanja nevtrofilcev hitro zniža (glejte sliko 1).
English: 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.
Slovenian: 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 Neupopeg po citotoksični kemoterapiji.
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back.
Slovenian: Pogosti neželeni učinki (verjetno je, da se bodo pojavili pri manj kot 1 od 10 bolnikov) vključujejo bolečino in pordelost na mestu injiciranja, glavobole in splošne bolečine ter bolečine v sklepih, mišicah, prsih, okončinah, vratu ali hrbtu.
English: The mechanism of vasculitis in patients receiving Neupopeg is unknown.
Slovenian: Mehanizem vaskulitisa pri bolnikih, ki prejemajo Neupopeg, še ni pojasnjen.
English: Your doctor may decide that it would be more convenient for you to inject Neupopeg yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si Neupopeg injicirate sami.
English: Treatment with Neupopeg alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Slovenian: Zdravljenje s samo Neupopegom ne prepreči trombocitopenije in anemije, ker se hkrati vzdržuje mielosupresivna kemoterapija s polnimi odmerki po predpisani shemi.
English: Instructions for injecting with the Neupopeg pre-filled syringe This section contains information on how to give yourself an injection of Neupopeg.
Slovenian: Navodila za injiciranje Neupopega z uporabo napolnjene injekcijske brizge To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Neupopeg.
English: Before use (with grey needle shield)
Slovenian: Pred uporabo (s sivim pokrovčkom igle)
English: Neupopeg has not been tested in pregnant women.
Slovenian: Neupopega pri nosečnicah niso preskusili.
English: • Due to the protective safety cover it is not recommended to put the grey needle shield back on the used pre-filled pen.
Slovenian: • Zaradi varnostnega pokrovčka ni priporočljivo, da bi sivi ščitnik igle nameščali nazaj na • Zaradi varnostnega pokrovčka ni priporočljivo, da bi sivi ščitnik igle nameščali nazaj na
English: Neupopeg may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Slovenian: Neupopeg sme biti izpostavljena sobni temperaturi (ne nad 30 °C) za enkratno obdobje, ki ne sme preseči 72 ur.
English: Neupopeg is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Slovenian: Neupopeg se uporablja za skrajšanje trajanja nevtropenije (zmanjšano število belih krvničk) in zmanjševanje pojavljanja febrilne nevtropenije (zmanjšano število belih krvničk z zvišano telesno temperaturo), ki ju lahko povzroča uporaba citotoksične kemoterapije (zdravila, ki uničujejo hitro rastoče celice).
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilu.
English: The objective of the skin pinch technique is to create a firm site for the injection
Slovenian: Namen tega, da naredite kožno gubo, je zagotoviti čvrsto mesto za injiciranje.
English: How do you, or the person injecting you, use Neupopeg pre-filled syringe?
Slovenian: Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo Neupopega?
English: 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).
Slovenian: Skrajšanje trajanja nevtropenije in incidence febrilne nevtropenije pri bolnikih, zdravljenih s citotoksično kemoterapijo za maligne bolezni (z izjemo kronične mieloidne levkemije in mielodisplastičnih sindromov).
English: Equipment: To give yourself a subcutaneous injection you will need:
Slovenian: Za subkutano samoinjiciranje boste potrebovali:
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neupopeg should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Slovenian: Zaradi možne občutljivosti hitro se delečih mieloidnih celic za citotoksično kemoterapijo je treba Neupopeg dati približno 24 ur po aplikaciji citotoksične kemoterapije.
English: To perform a successful injection a firm injection area is required.
Slovenian: Za uspešno injiciranje je potrebna čvrsta površina kože za injiciranje.
English: • The pre-filled pen has a safety cover that will protect you from needle sticks or loss of medicine by accidental bumping or touching.
Slovenian: • Napolnjeni injekcijski peresnik ima varnostni pokrovček, ki preprečuje, da bi se po nesreči zbodli z iglo ali da bi zaradi naključnega sunka ali dotika prišlo do izgube zdravila.
English: Neupopeg may be used if it is accidentally frozen for a single period of less than 24 hours.
Slovenian: Neupopeg smete uporabiti, če je bil pomotoma zamrznjena eno samo obdobje, krajše od 24 ur.
English: 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.
Slovenian: Različne stopnje okvare ledvic (vključno s končno odpovedjo ledvic) v odprti študiji posamičnega odmerka (n = 31) niso vplivale na farmakokinetiko pegfilgrastima.
English: Each pen may only be used once.
Slovenian: Vsak injekcijski peresnik se sme uporabiti le enkrat.
English: Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section
Slovenian: Pri bolnikih s srpasto anemijo so v posameznih primerih poročali o srpastocelični krizi (glejte poglavje
English: Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and neck pain.
Slovenian: Med drugimi pogosto opisanimi neželenimi učinki so bolečine, bolečine na mestu injiciranja, bolečine v prsih (ki ne izvirajo od srca), glavobol, artralgija, mialgija, bolečine v hrbtu, udih, vratu in osteomuskularne bolečine.
English: Marketing Authorisation Holder:
Slovenian: Navodilo je bilo odobreno:
English: There is no clinical experience with breast-feeding women, therefore Neupopeg should not be administered to women who are breast-feeding.
Slovenian: Z doječimi materami ni kliničnih izkušenj, zato pri ženskah, ki dojijo, Neupopega ne smete uporabljati.
English: 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
Slovenian: 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).
English: Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Slovenian: Okvara ledvic: pri bolnikih z okvaro ledvic odmerka ni treba spreminjati; to velja tudi za bolnike s končno odpovedjo ledvic.