natgillin/translations-raw huggingface dataset:
What is BTVPUR AlSap 8? 
Kaj je zdravilo BTVPUR AlSap 8?
What is BTVPUR AlSap 8 used for? 
Za kaj se zdravilo BTVPUR AlSap 8 uporablja?
How has BTVPUR AlSap 8 been studied? 
Kako je bilo zdravilo BTVPUR AlSap 8 raziskano?
How does BTVPUR AlSap 8 work? 
Kako zdravilo BTVPUR AlSap 8 deluje?
The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide ratiopharm with a physician educational pack containing the following: 
Država članica mora zagotoviti, da bo imetnik dovoljenja za promet z zdravilom poskrbel, da bodo vsi zdravniki, za katere se pričakuje, da bodo zdravilo Leflunomide ratiopharm predpisovali ali uporabljali, dobili izobraževalno gradivo, ki vsebuje:
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT. 
Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih za izplavljanje v primeru zvišanih vrednosti ALT.
These measures will help to protect the environment. 
S temi ukrepi boste pomagali ohranjati okolje.
• change or absence of menstrual period* 
• sprememba ali izostanek menstruacije*;
TTP=time to progression; “ne” indicates that it could not be estimated or it was not yet reached. 
ČDN = čas do napredovanja; "no" pomeni, ni bilo mogoče oceniti ali še ni doseženo.
• allergic reactions (see above) 
• alergijske reakcije (glejte zgoraj);
Overall survival (Primary endpoint) 
Celotno preživetje (primarna končna točka)
Vial 24 months 
Viala 24 mesecev
Median duration of follow-up was 77 months. 
Mediano trajanje spremljanja je bilo 77 mesecev.
Shake well for complete solubilisation of powder (the powder will be dissolved in less than 90 seconds). 
Dobro pretresite, da se prašek popolnoma raztopi (prašek se bo raztopil v manj kot 90 sekundah).
However, the distribution of OS was not significantly different between the 2 groups. 
Toda porazdelitev celotnega preživetja se med obema skupinama ni značilno razlikovala.
The expiry date refers to the last day of that month. 
Datum preteka roka uporabe se nanaša na zadnji dan meseca.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 May 2010 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Date of first authorisation: 10 maj 2010
The effect appears to be less pronounced than in patients with 1-3 positive nodes. 
Kaže, da je učinek manj izrazit kot pri bolnicah z 1-3 pozitivnimi bezgavkami.
From a microbiological point of view, the reconstituted solution should be used immediately. 
Iz mikrobiološkega vidika pa je treba pripravljeno raztopino uporabiti takoj.
You will be given Docefrez by a healthcare professional in the hospital. 
Zdravilo Docefrez vam bo v bolnišnici dal strokovni zdravstveni delavec.
*: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population. 
*: Korigirano za mnogokratne primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
Statistical analysis 
Statistična analiza
An appropriate aseptic technique should be used for all steps. 
V vseh korakih uporabite ustrezno aseptično tehniko.
Side effects marked with “*” have been reported when Docefrez was given in combination. 
Stranski učinki označeni z “*” so bili opaženi v primerih, ko je Docefrez bil predpisan v kombinaciji.
Elderly patients treated with TCF should be closely monitored. 
Starejše bolnike, ki dobivajo TCF, je treba natančno nadzirati.
Medium time to progression (weeks): 
Mediana časa do napredovanja (tedni):
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02 
Farmakoterapevtska skupina: taksani, oznaka ATC: L01CD02
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Zdravnika ali medicinsko sestro opozorite, če uživate ali ste nedavno uživali kakšna druga zdravila, vključno z zdravili, ki jih prejmete brez recepta.
If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued. 
Če bolnik tudi pri odmerku 60 mg/m še doživlja te reakcije, je treba zdravljenje prekiniti.
Post-marketing experience 
Pomarketinške izkušnje
• bleeding from the nose 
• krvavitve iz nosu;
• loss of appetite (anorexia), weight gain or loss* 
• izguba apetita (anoreksija), izguba ali pridobivanje teže*.
An interim analysis was performed with a median follow up of 55 months. 
Narejena je bila vmesna analiza z mediano 55-mesečnim spremljanjem.
When Docefrez is given in combination with other anti-cancer medicines, the frequency or severity of some side effects may increase. 
Če je Docefrez predpisan v kombinaciji z drugimi zdravili proti raku, se lahko resnost ali pogostost stranskih učinkov poveča.
Your doctor will calculate your dose according to your body surface area in square metres (depends on weight and height) and your general condition. 
Zdravnik bo izračunal vaš dnevni odmerek glede na površino vašega telesa v m² (odvisno od telesne mase in višine) in vašega splošnega stanja.
Docefrez vials should be stored in a refrigerator. 
Docefrez viale morate hraniti v hladilniku.
Medicines should not be disposed of via wastewater or household waste. 
Zdravil ne smete odstranjevati v odpadne vode ali gospodinjske odpadke.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6
An effective method of contraception should be used during treatment. 
Med zdravljanjem je treba uporabljati učinkovit način kontracepcije.
≥35 years 
≥35 let
Each carton contains: 
V vsakem pakiranju je :
• swelling caused by fluids from the lymph nodes spreading to uncommon places 
• otekline zaradi tekočin iz limfnih žlez, ki se širijo na neobičajnih mestih;
• fever*: tell your doctor or nurse immediately 
• povišana telesna temperatura*: nemudoma obvestite zdravnika ali medicinsko sestro;
The MAH must ensure that the system of pharmacovigilance, as described in version 6 (dated January 2010) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance kot je opisan v različici 6 (z datumom Januar 2010) , predstavljen v Modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
However, given that it can cause dizziness, tiredness and fainting, you should not drive or use machines if you experience any of these side effects. 
Kljub temu, glede na to, da lahko povzroči vrtoglavico, utrujenost in omedlevico, v primeru da se pojavijo ti neželeni učinki ne vozite ali uporabljajte strojev.
It is administered through a drip into a vein (intravenous infusion) for about one hour. 
Daje se v žilo (intravenozna infuzija) približno eno uro.
White lyophilised powder. 
Beli liofiliziran prašek.
Like all medicines, Docefrez can cause side effects, although not everybody gets them. 
Kot vsa zdravila lahko Docefrez povzroči neželene učinke, ki pa se ne pojavijo pri vseh osebah.
There are no studies on the effects of Docefrez on the ability to drive and use machines. 
Ni raziskav o vplivu Docefreza na zmožnost vožnje in uporabe strojev.
The beneficial effect of TAC was not proven in patients with 4 and more positive nodes (37% of the population) at the interim analysis stage. 
Ugodni učinek TAC ni bil dokazan pri bolnicah s 4 ali več pozitivnimi bezgavkami (37 % populacije) na stopnji vmesne analize.
Your doctor may change the dose and/or frequency of administration depending on the results of your blood tests, your general condition and the occurence of certain side effects. 
Vaš zdravnik bo morda spremenil odmerek in/ali pogostost odmerjanja glede na rezultate krvnih preiskav, vaše splošno stanje in pojav določenih neželenih učinkov.
Store in a refrigerator (2ºC - 8ºC). 
Hranite v hladilniku (2ºC - 8ºC).
The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favor of TPF as compared to PF. 
Lestvica stanja zmogljivosti s podlestvicama za glavo in vrat (PSS-HN), namenjenima merjenju razumljivosti govora, sposobnosti uživanja hrane na javnem mestu in normalnosti hrane, je signifikantno govorila v korist TPF v primerjavi s PF.
The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established. 
Varnost in učinkovitost zdravila docetaksela za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
• CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3. 
Za pogoje shranjevanje pripravljenega in razredčenega zdravila glejte poglavje 6.3.
(see sections 4.4 and 4.8). 
(glejte poglavje 4.4).
The infusion should be used within 4 hours below 25 ºC. 
Infuzijo morate uporabiti v roku 4 ur (pod 25 ºC).
The incidence of serious adverse events was higher in the elderly patients compared to younger patients. 
Incidenca resnih neželenih učinkov je bila pri starejših bolnikih večja kot pri mlajših.
You should usually receive your Docefrez infusion every three weeks. 
Infuzijo Docefrez-a običajno prejmete vsake tri tedne.
4.1.4 Remove the syringe and needle and shake well for complete solubilisation of powder. 
4.1.4 Odstranite brizgo in iglo ter dobro pretresite, za popolno solubilizacijo praška.
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed. 
Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj) poročani v > 10 %.
75 mg/m2 (see sections 4.4 and 5.2). 
75 mg/m2 (glejte poglavji 4.4 in 5.2).
Each pack contains: 1 powder vial and 1 solvent vial. 
Vsako pakiranje vsebuje: 1 vialo s praškom in 1 vialo z vehiklom.
• decreased number of platelets (increased risk of unexpected bleedings) 
• znižano število trombocitov (povečana nevarnost nepričakovane krvavitve);
Intravenous use, after reconstitution and dilution. 
Intravenozna uporaba, po pripravi in razredčitvi.
Docetaxel plus trastuzumab1 n=92 
Docetaksel in trastuzumab1 n = 92
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified. 
Vloga temelji na referenčnem zdravilu, za katerega niso bila ugotovljena varnostna vprašanja,
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. 
Simptomi kot so abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC). 
HER2-pozitivnosti v tej odločilni študiji je bila imunohistokemija (IHK).
4.1.3 Inject the entire contents of the syringe into the corresponding Docefrez vial. 
4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo Docefreza.
What Docefrez looks like and contents of the pack 
Kakšen je Docefrez in vsebina pakiranja
Before each Docefrez dose, you will have blood tests to check that your blood cell counts and liver function are adequate. 
Pred vsakim odmerkom Docefrez boste imeli pregled krvi za preverjanje ali je število vaših rdečih krvnih celic in delovanje jeter primerno.
Docetaxel1 n=94 
Docetaksel1 n = 94
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table. 
Podatke o preživetju, mediano časa do napredovanja in delež odziva v dveh krakih te raziskave prikazuje naslednja preglednica:
• dripping or running nose; inflammation of the throat and nose* 
• kapljanje iz nosu; vnetje grla in nosu*;
Detailed information on this medicine is available on the European Medicines Agency web site: ://www.ema.europa.eu 
Podrobne informacije o zdravilu je na voljo na spletni strani Evropske agencije za zdravila (EMA): ://www.ema.europa.eu
Docefrez is incompatible with PVC equipment or devices. 
Docefrez ni združljiv s PVC opremo ali napravami.
Dry skin; Desquamation 
Suha koža, luščenje
Acute leukaemia / Myelodysplastic syndrome 
Akutna levkemija / mielodisplastični sindrom
• raised liver enzymes (in blood tests) 
• krvavitve; • povišani jetrni encimi (v krvnih testih);
Congestive Heart Failure (CHF) has been reported in 18 of 1276 patiens during the follow-up period. 
Opisano je bilo tudi kongestivno srčno popuščanje pri 18 od 1276 bolnicah v obdobju spremljanja.
The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF). 
(PBN), je pokazala 29 % zmanjšanje tveganja za napredovanje ali smrt ter 22-mesečno izboljšanje medianega PBN (35,5 mesecev pri TPF in 13,1 pri PF).
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favor of the TCF arm. 
V celoti pa rezultati kakovosti življenja in klinične koristi dosledno kažejo izboljšanje v kraku s TCF.
In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3). 
V nekliničnih študijah je bilo dokazano, da ima docetaxel genotoksične učinke in lahko vpliva na plodnost moških (glejte oddelek 5.3).
Do not use any PVC equipment or device. 
Ne uporabljajte opreme ali naprav iz PVC-ja.
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
V primeru dodatnih vprašanj o uporabi izdelka, se obrnite na zdravnika ali medicinsko sestro.
The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks). 
Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1.000 mg/m2 in mediani čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. 
Če kateri izmed stranskih učinkov postane resnejši ali če opazite stranske učinke, ki niso navedeni v tej brošuri, povejte zdravniku ali medicinski sestri.
Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p=0.01, using the EORTC QLQ-C30 scale). 
Pri bolnikih, zdravljenih s TPF, se je lestvica globalnega zdravja signifikantno manj poslabšala kot pri tistih, ki so bili zdravljeni s PF (p = 0,01, uporabljena je bila lestvica EORTC QLQ-C30).
• headache* , insomnia* 
• glavobol* , nespečnost*;
• feeling of numbness or pins and needles, taste disturbances (due to nerve damage) 
• občutek otrplosti ali mravljincev, motnje okusa (zaradi poškodovanih živcev);
Reduced tolerance of docetaxel may occur, even at lower doses. 
Celo pri zmanjšanih odmerkih se lahko pojavi zmanjšanje tolerance docetaksela.
- If you have any further questions, ask your doctor or nurse. 
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali z bolnišničnim farmacevtom.
Tell your doctor if you have: - heart problems - liver problems - kidney problems 
Zdravnika opozorite v primeru: težav s srcem težav z jetri težav z ledvicami
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume from the appropriate number of reconstituted solutions using graduated syringes fitted with a needle. 
Odvisno od potrebnega odmerka za pacienta v mg, aseptično izvlecite potrebno količino iz ustreznega števila pripravljenih raztopin s pomočjo oštevilčene brizge z iglo.
The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1). 
Pri bolnicah s 4+ bezgavkami razmerje korist/tveganje za TAC v vmesnih analizah ni bilo docela definirano (glejte poglavje 5.1).
Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMA): ://www.ema.europa.eu.
4.2 Preparation of the infusion solution 
4.2 Priprava infuzijske raztopine
The required number of Docefrez powder vials should be allowed to reach room temperature (between 15°C - 25°C) for 5 minutes. 
Ustrezno število vial s praškom Docefrez pustite stati na sobni temperaturi (od 15°C do 25°C) 5 minut.
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed: 
Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih:
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor 
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor
If you are a man being treated with Docefrez you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility. 
Če ste moški, ki se zdravi z Docefrezom, se vam svetuje, da med zdravljenjem in vsaj 6 mesecev po njem ne oplodite svoje partnerice ter, da poiščete nasvet glede konzervacije sperme, kajti Docetaksel lahko vpliva na plodnost moškega.
Women of childbearing potential /contraception: 
Ženske v rodni dobi/kontracepcija
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies. 
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
Overall response rate (%) 
Celotni delež odziva (%)
See leaflet for further information. 
Za dodatne informacije glejte brošuro.
• inflammation of the eye or increased watering of the eyes 
• vnetje oči ali povečano solzenje;
The most frequent side effects of Docefrez, when given alone, are decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness (all very common). 
Najpogostejši neželeni učinek zdravila Docefrez ob samostojni uporabi, je zmanjšanje število rdečih krvnih celic ali belih krvnih celic, plešavost, slabost, bruhanje, vnetja v ustni votlini, diareja in utrujenost (vsi zelo pogosti).
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis. 
Za hudo prizadetost nohtov so značilni hipo ali hiperpigmentacija in včasih bolečine in oniholiza.
A drug interaction study performed in patients receiving ketoconazole and docetaxel showed that the clearance of docetaxel was reduced by half by ketoconazole, probably because the metabolism of docetaxel involves CYP3A4 as a major (single) metabolic pathway. 
Študija interakcije, ki so jo izvajali pri bolnikih, ki so jemali ketokonazol in docetaksel, je pokazala, da je ketokonazol za polovico zmanjšal očistek docetaksela, verjetno zato ker metabolizem docetaksela vključuje CYP3A4 kot glavno (edino) metabolično pot.
4.2.1 More than one vial of reconstituted solution may be necessary to obtain the required dose for the patient. 
4.2.1 Za pripravo potrebnega odmerka za pacienta boste morda morali uporabiti več kot eno vialo.
The solvent is a viscous, clear and colourless solution. 
Vehikel je viskozna, bistra in brezbarvna raztopina.
4.2.5 As with all parenteral products, Docefrez reconstituted solution and solution for infusion should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docefrez pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Hazard ratio: 1.032 [95% CI: 0.876; 1.216] 
Razmerje tveganj: 1,032 [95 % IZ: 0,876, 1,216]
The reconstituted solution contains ~ 24 mg/ml docetaxel, corresponding with an extractable volume of approximately 20 mg/0.84 ml and 80 mg/3.36 ml. 
Pripravljena raztopina vsebuje približno ~ 24 mg/ml docetaksela, kar ustreza izločeni količini od približno 20 mg/0,84 ml in 80 mg/3,36 ml.
In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2). 
Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
Uncommon side effects: 
Neobičajni stranski učinki:
Treatment difference: 7.1% [95% CI: 0.7; 13.5] 
Razlika zdravljenj: 7,1 % [95 % IZ: 0,7, 13,5]
95% CI p= 
95 % IZ p =
• fungal infection of the mouth (oral candidiasis) 
• glivične infekcije ust (oralna kandidoza);
The benefit/risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage. 
Na tej stopnji analize razmerje med koristjo in tveganjem ni bilo povsem definirano pri bolnicah s 4 ali več pozitivnimi bezgavkami.
Fluid retention (severe/lifethreatening: 1%). 
zastajanje tekočine (hudo/smrtno nevarno: 1 %)
Docetaxel was administered as a 1-hour infusion, all other drugs were given intravenously on day 1 every three weeks. 
Zdravilo Docetaksel je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy-2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week). 
Lokoregionalno terapijo z obsevanjem so aplicirali bodisi s konvencionalno frakcijo (1,8 Gy - 2,0 Gy enkrat na dan, 5 dni na teden v celotnem odmerku 66 do 70 Gy), ali s pospešenimi/ hiperfrakcioniranimi shemami obsevalnega zdravljenja (dvakrat na dan, z minimalnim intervalom med frakcijama 6 ur, 5 dni na teden).
Side effects may occur with certain frequencies, which are defined as follows: - very common: affects more than 1 user in 10 - common: affects 1 to 10 users in 100 - uncommon: affects 1 to 10 users in 1,000 - rare: affects 1 to 10 users in 10,000 - very rare: affects less than 1 user in 10,000 - not known: frequency cannot be estimated from the available data. 
Stranski učinki se lahko pojavijo različno pogosto, kar je določeno kot sledi: - zelo pogosti se pojavijo pri več kot 1 uporabniku na 10 uporabnikov - pogosti: učinek pri 1 do 10 uporabnikov na 100 uporabnikov - občasni: učinek pri 1 do 10 uporabnikov na 1.000 uporabnikov - redki: učinek pri 1 do 10 uporabnikov na 10.000 uporabnikov - zelo redki: učinek pri manj kot 1 uporabniku na 10.000 uporabnikov
In the pivotal SCCHN studies, patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g. day 6-15) in all subsequent cycles. 
V ključni SCCHN študiji pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.