natgillin/translations-raw huggingface dataset:
There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1). 
Zabilježeni su slučajevi GvHD-a i smrtni ishodi u bolesnika koji su primali G-CSF nakon transplantacije alogene koštane srži (vidjeti dio 4.4 i 5.1).
f. Find a comfortable, well-lit place and put everything you need where you can reach them (the Accofil pre-filled syringe and alcohol swab). 
Pronađite udobno, dobro osvijetljeno mjesto i stavite sve što trebate tako da Vam je pri ruci
These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of, or in addition to bone marrow transplantation. 
Ove autologne stanice preteče periferne krvi mogu se prikupiti i dati infuzijom nakon visokih doza citotoksične terapije, bilo umjesto ili kao dodatak presađivanju koštane srži.
Proteinuria Urine abnormality Glomerulonephr 
Poremećaji bubrega i mokraćnog sustava dizurija hematurija proteinurija abnormalno-sti u urinu glomerulonefri tis
Pre-filled syringe without needle safety guard b. 
Napunjena igla bez sigurnosnog štitnika za iglu b.
The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU (5 µg)/kg/day given daily from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. 
Preporučena doza filgrastima za mobilizaciju stanica preteča periferne krvi nakon mijelosupresivne kemoterapije iznosi 0,5 MU (5 µg)/kg/dan i daje se svakodnevno od prvog dana nakon završetka kemoterapije do očekivanog najnižeg pada broja neutrofila te njihovog oporavka do normalnog raspona vrijednosti.
In order to improve traceability of granulocyte-colony stimulating factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient file Accofil should not be diluted with sodium chloride solution. 
U cilju poboljšanja praćenja čimbenika poticanja rasta kolonije granulocita, naziv lijeka (Accofil) i broj serije primijenjenog lijeka treba se jasno zabilježiti u pacijentov karton.
Reduce to 0.5 MU (5 µg)/kg/day 
Sniziti na 0,5 MU (5 µg)/kg/dan
What Accofil is used for 
Za što se Accofil koristi
Once the neutrophil nadir has been passed, the daily dose of filgrastim should be titrated against the neutrophil response as follows: 
Nakon prestanka pada broja neutrofila na najnižu vrijednost, dnevnu dozu filgrastima potrebno je prilagoditi odgovoru neutrofila na sljedeći način:
The recommended starting dose of filgrastim is 0.1 MU (1 µg )/kg/day given daily with titration up to a maximum of 0.4 MU (4 µg )/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/L). 
Preporučena početna doza filgrastima je 0,1 MU (1 µg)/kg/dan primijenjena svakodnevno uz titraciju do najviše 0,4 MU (4 µg)/kg/dan dok se ne postigne normalan broj neutrofila koji je moguće održati (ABN > 2,0 x 109/l).
The recommended starting dose of filgrastim is 0.1 MU (1 µg)/kg/day, with titration up to a maximum of 0.4 MU (4 µg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/L). 
Preporučena početna doza filgrastima je 0,1 MU (1 µg)/kg/dan uz titraciju do najviše 0,4 MU (4 µg)/kg/dan dok se ne postigne normalan broj neutrofila koji je moguće održati (ABN > 2,0 x 109/l).
If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)) You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done. 
Ako ste bolesnik s teškom kroničnom neutropenijom, možete biti izloženi riziku od pojave raka krvi (leukemije, mijelodisplastičnog sindroma (MDS)).
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with filgrastim. 
Preosjetljivost, uključujući anafilaktičke reakcije, zabilježeni su na početku ili kasnije tijekom liječenja u bolesnika koji su primali filgrastim.
In this leaflet 
Pogledajte dio
Special precautions in normal donors undergoing peripheral blood progenitor cell mobilization 
Posebne mjere opreza u zdravih darivatelja u kojih se provodi mobilizacija stanica preteča periferne krvi
Dose reductions were noted to slow or stop the progression of splenic enlargement and in 3% of patients a splenectomy was required. 
Primijećeno je da sniženje doze usporava ili zaustavlja daljnje povećanje slezene, dok je u 3% bolesnika bilo potrebno napraviti splenektomiju.
• decrease of platelets which reduces the ability of blood to clot (thrombocytopenia) 
• smanjenje broja trombocita što smanjuje sposobnost zgrušavanja krvi (trombocitopenija)
Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy. 
Podaci iz kliničkih ispitivanja u pedijatrijskih bolesnika pokazuju da su sigurnost i djelotvornost filgrastima u djece koja primaju citotoksičnu kemoterapiju slične onima u odraslih.
Permanently discontinue filgrastim in patients with clinically significant hypersensitivity. 
Primjenu filgrastima potrebno je trajno prekinuti u bolesnika s klinički značajnom preosjetljivošću.
If you get any side effects, talk to your doctor. 
Ako osjetite ove simptome, obavijestite svog liječnika.
Each pre-filled syringe contains 0.5 ml of solution. 
Svaka napunjena štrcaljka sadrži 0,5 ml otopine.
Analysis includes studies involving BM transplant during this period; some studies used GM-CSF Analysis includes patients receiving BM transplant during this period Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation 
Analiza uključuje ispitivanja koja su uključivala transplantat koštane srži tijekom tog razdoblja; u nekim se ispitivanjima primjenjivao GM-CSF
What you need to know before you use Accofil Do not use Accofil - If you are allergic (hypersensitive) to filgrastim or any of the other ingredients of this medicine (listed in section 6). 
Ako ste alergični na filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
In clinical studies, dosing with 30 MU (300 µg)/day on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week. 
U kliničkim je ispitivanjima bila potrebna primjena doze od 30 MU(300 µg)/dan 1 do 7 dana tjedno kako bi se održao ABN > 2,0 x 109/l, uz medijan učestalosti doziranja od 3 dana tjedno.
In clinical studies, dosing with 30 MU (300 µg )/day on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week. 
U kliničkim je ispitivanjima bila potrebna primjena doze od 30 MU (300 µg)/dan 1 do 7 dana tjedno kako bi se održao ABN > 2,0 x 109/l, uz medijan učestalosti doziranja od 3 dana tjedno.
Subsequently, the dose may be individually adjusted every 1-2 weeks to maintain the average neutrophil count between 1.5 x 109/L and 10 x 109/L.A faster schedule of dose escalation may be considered in patients presenting with severe infections. 
Nakon toga, dozu je kod svakog pojedinog bolesnika moguće prilagođavati svaka 1-2 tjedna kako bi se prosječan broj neutrofila održao na vrijednostima između 1,5 x 109/l i 10 x 109/l.
Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended. 
Ne preporučuje se preuranjeni prekid liječenja filgrastimom, prije očekivanog pada broja neutrofila na najnižu vrijednost.
Using the pre-filled syringe with a needle safety guard 
Uporaba napunjene štrcaljke sa sigurnosnim štitnikom za iglu
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND REACH OF CHILDREN 
6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy 
bol u vratu dSlučajevi opaženi nakon stavljanja filgrastima u promet u bolesnika kojima je transplantirana koštana srž ili je rađena mobilizacija stanica preteča koštane srži eNuspojave s povećanom učestalošću kod bolesnika koji su primali filgrastim u usporedbi s placebom te koje su povezane s posljedicama osnovne maligne bolesti ili citotoksične kemoterapije
Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. 
Svakodnevnu primjenu filgrastima potrebno je nastaviti sve do prestanka očekivanog najnižeg pada broja neutrofila i njihovog porasta do normalnog raspona vrijednosti.
How to store Accofil 
Kako primjenjivati Accofil
In the post-marketing setting cutaneous vasculitis has been reported in patients treated with filgrastim. 
Nakon stavljanja lijeka u promet, zabilježen je kožni vaskulitis u bolesnika liječenih filgrastimom.
Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. 
Polako i jednoliko potišćite klip sve dok se ne primijeni cijela doza i dok se klip ne može dalje potisnuti.
Using the pre-filled syringe without a needle safety guard 
Uporaba napunjene štrcaljke bez sigurnosnog štitnika za iglu
• worsening of rheumatoid arthritis 
(Sweetsov sindrom) • pogoršanje reumatoidnog artritisa
Bronchitis Upper respiratory tract infection Urinary tract infection 
Infekcije i infestacije sepsa bronhitis infekcija gornjih dišnih puteva infekcija mokraćnog sustava
Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion. 
Jedna napunjena štrcaljka sadrži 30 MU (što odgovara 300 mikrograma) filgrastima u 0,5 ml otopine za injekciju ili infuziju.
Congenital neutropenia The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses. 
Kongenitalna neutropenija Preporučena početna doza je 1,2 MU (12 µg))/kg/dan primijenjena u jednoj ili više doza.
• Get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder( these may be symptoms of enlarge spleen (splenomegaly) or possibly rupture of spleen). 
• osjetite bol u gornjem dijelu trbuha (abdomena), bol ispod lijeve strane prsnog koša ili na vrhu lijevog ramena (to mogu biti simptomi povećane slezene (splenomegalija) ili rupture slezene).
Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms of filgrastim in 0.5 ml solution for injection or infusion. 
Jedna napunjena štrcaljka sadrži 48 MU (što odgovara 480 mikrograma) filgrastima u 0,5 ml otopine za injekciju ili infuziju.
MedDRA system organ class 
MedDRA klasifikacij a organskih sustava
Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established. 
Sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom nisu ustanovljene.
See leaflet for further information. 
Dodatne informacije potražite u Uputi o lijeku.
For mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5-7 consecutive days. 
ABN = apsolutni broj neutrofila Mobilizacija stanica preteča periferne krvi u bolesnika u tijeku mijelosupresivnog i mijeloablativnog liječenja nakon kojeg slijedi transplantacija autolognih stanica preteča periferne krvi Preporučena doza filgrastima za mobilizaciju stanica preteča periferne krvi kad se primjenjuje sam iznosi 1,0 MU(10 µg)/kg/dan tijekom 5 do 7 uzastopnih dana.
Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 ml, corresponding to 0.6 mg/ml. 
Svaka napunjena šrcaljka sadrži 30 MU (300 mikrograma) filgrastima u 0,5 ml, što odgovara koncentraciji od 0,6 mg/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton - Pre-filled syringe with a needle safety guard in blister pack 
- Napunjena štrcaljka sa sigurnosnim štitnikom za iglu u blister pakiranju
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. 
Nakon primjene G-CSF-a zabilježene su plućne nuspojave, osobito intersticijska pneumonija.
Cases of Sweets syndrome (acute febrile dermatosis) have been reported in the post-marketing setting. 
Nakon stavljanja lijeka u promet zabilježeni su slučajevi Sweetsovog sindroma (akutne febrilne dermatoze).
Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 ml, corresponding to 0.96 mg/ml. 
Svaka napunjena šrcaljka sadrži 48 MU (480 mikrograma) filgrastima u 0,5 ml, što odgovara koncentraciji od 0,96 mg/ml.
Respiratory failurea 
Plućne nuspojave
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim. 
Jedan ml otopine sadrži 60 milijuna jedinica (MU) (što odgovara 600 mikrograma [µg]) filgrastima.
Pre-filled syringe with needle safety guard h. 
Napunjena štrcaljka sa sigurnosnim štitnikom za iglu h.
Gammaglutamyl transferase increased Aspartate aminotransfera se increased 
Poremećaji jetre i žuči povišena alkalna fosfataza u krvi hepatomegali ja povišena gamaglutamil transferaza povišena aspartat aminotransfera za
Metabolism and nutrition disorders 
Nuspojave klasifikacij a organskih sustava
For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 - 5 consecutive days. 
Za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja, filgrastim je potrebno primijeniti u dozi od 1,0 MU (10 µg)/kg/dan tijekom 4-5 uzastopnih dana.
Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it. Do not put the cover back on used needles, as you may accidentally prick yourself. 
Nemojte stavljati poklopac natrag na korištene igle, jer se možete slučajno ubosti.
• inflammation of the blood vessels in the skin (cutaneous vasculitis) 
• upala krvnih žila kože (kožni vaskulitis)
Accofil and bone marrow transplantation 
Accofil i presađivanje koštane srži
• if you get left upper belly (abdonimal) pain, pain below the left rib cage or pain at the tip of your shoulder since this may relate to a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).. 
• ako osjetite bol u gornjem lijevom dijelu trbuha, bol ispod lijevog rebrenog luka ili bol u vrhu ramena, budući da to može biti povezano s tegobama sa slezenom (povećanje slezene (splenomegalija) ili ruptura slezene).
The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. 
Sigurnost i djelotvornost Accofila u djece koja primaju citotoksičnu kemoterapiju slične su onima u odraslih.
Dizziness, Hypoaesthesia, Paraesthesia 
Poremećaji živčanog sustava glavoboljaa omaglica, hipoestezija, parestezija
How Accofil is given 
Kako se Accofil primjenjuje
Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. 
Uvijek držite nabor kože između prstiju te polako i jednoliko potiskujte klip dok ne primijenite cijelu dozu i dok se klip ne bude mogao dalje potisnuti.
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim. 
Slučajevi splenomegalije i rupture slezene zabilježeni su manje često nakon primjene filgrastima.
Pyrophosphate) Fluid volume 
(poremećaj volumena tekućine)
Name and address of the manufacturer(s) of the biological active substance(s) Intas Pharmaceuticals Ltd. 
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
Name and address of the manufacturer(s) responsible for batch release Accord Healthcare Ltd. 
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Malaise e 
I DOHVATA
Cutaneous vasculitis 
kožni vaskulitisa
Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. 
Posebna upozorenja i mjere opreza za sve indikacije Filgrastim se ne smije primjenjivati za povećanje doze citotoksične kemoterapije iznad doza propisanih u standardnim kemoterapijskim protokolima.
The mechanism of vasculitis in patients receiving Filgrastim is unknown. 
Nije poznat mehanizam vaskulitisa kod bolesnika koji primaju filgrastim.
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti svog liječnika, ljekarnika ili medicinsku sestru.
Very common side effects (seen in more than 1 in 10 people who take Accofil): 
Vrlo česte nuspojave (javljaju se u više od 1 na 10 osoba koje primaju Accofil):
Cutaneous vasculitis has been reported in patients treated with Filgrastim. 
Kožni vaskulitis zabilježen je kod bolesnika liječenih filgrastimom.
Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim. 
Manje česti slučajevi splenomegalije i rupture slezene zabilježeni su nakon primjene filgrastima.
Transfusion reactione a See section 4.8, Description of selected adverse reactions b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section 4.8, Description of selected adverse reactions) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, 
Ozljede, trovanja i procedural ne komplikaci je tranfuzijska reakcijae aVidjeti odjeljak 4.8, Opis odabranih nuspojava bZabilježeni su slučajevi GvHD-a i smrtni ishodi u bolesnika nakon transplantacije alogene koštane srži (vidjeti odjeljak 4.8, Opis odabranih nuspojava) Uključuje koštanu bol, bol u leđima, artralgiju, mialgiju, bol u udovima, mišićno-koštanu bol prsišta, bol u vratu dSlučajevi opaženi nakon stavljanja filgrastima u promet u bolesnika kojima je transplantirana koštana srž ili je rađena mobilizacija stanica preteča koštane srži eNuspojave s povećanom učestalošću kod bolesnika koji su primali filgrastim u usporedbi s placebom te koje su povezane s posljedicama osnovne maligne bolesti ili citotoksične kemoterapije
Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim. 
Nakon primjene filgrastima vrlo često su prijavljeni slučajevi splenomegalije a slučajevi rupture slezene često.
Special precautions in recipients of allogeneic PBPC mobilised with filgrastim 
Posebne mjere opreza u primatelja alogenih stanica preteča periferne krvi mobiliziranih filgrastimom
Thrombocytopenia has been reported commonly in patients receiving filgrastim. 
Trombocitopenija je često zabilježena u bolesnika koji primaju filgrastim.
Rare side effects (seen in more than 1 in 10,000 people taking Accofil): 
Rijetke nuspojave (javljaju se u više od 1 na 10.000 osoba koje primaju Accofil):
EU/1/14/946/003 - 1 prefilled syringe EU/1/14/946/004 - 5 prefilled syringes EU/1/14/946/012 - 3 prefilled syringe EU/1/14/946/015 - 10 prefilled syringe 
EU/1/14/946/003 - 1 napunjena štrcaljka EU/1/14/946/004 - 5 napunjenih štrcaljki EU/1/14/946/012 - 3 napunjene štrcaljke EU/1/14/946/015 - 10 napunjenih štrcaljki
Sarkhej Bavla Highway 
Procjena prinosa stanica preteča
Oropharyngeal paina,e 
Proljeva,e
EU/1/14/946/011 - 1 prefilled syringe with a needle safety guard EU/1/14/946/014 - 5 prefilled syringes with a needle safety guard EU/1/14/946/013 - 3 prefilled syringe with a needle safety guard EU/1/14/946/016 - 10 prefilled syringe with a needle safety guard EU/1/14/946/018 - 7 prefilled syringe with a needle safety guard 
EU/1/14/946/011 - 1 napunjena štrcaljka sa sigurnosnin štitnikom za iglu EU/1/14/946/014 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/013 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/016 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/018 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy. 
Pokazalo se da primjena filgrastimom mobiliziranih stanica preteča periferne krvi smanjuje jačinu i trajanje trombocitopenije nakon mijelosupresivne ili mijeloablativne kemoterapije.
TRM 
Nuspojave
EU/1/14/946/001 - 1 prefilled syringe EU/1/14/946/002 - 5 prefilled syringes EU/1/14/946/006 - 3 prefilled syringe EU/1/14/946/009 - 10 prefilled syringe 
EU/1/14/946/001 - 1 napunjena štrcaljka EU/1/14/946/002 - 5 napunjenih štrcaljki EU/1/14/946/006 - 3 napunjene štrcaljke EU/1/14/946/009 - 10 napunjenih štrcaljki
• pain when passing urine (dysuria) 
• bol prilikom mokrenja (dizurija)
Acute respiratory distress syndromea 
hemoptiza dispneja kašalja akutni respiratorni distres
Subcutaneous or intravenous use. 
Za potkožnu primjenu ili primjenu u venu.
µg/kg/day). 
(300 mikrograma).
EU/1/14/946/005 - 1 prefilled syringe with a needle safety guard EU/1/14/946/008 - 5 prefilled syringes with a needle safety guard EU/1/14/946/007 - 3 prefilled syringe with a needle safety guard EU/1/14/946/010 - 10 prefilled syringe with a needle safety guard EU/1/14/946/017 - 7 prefilled syringe with a needle safety guard 
EU/1/14/946/005 - 1 napunjena štrcaljka sa sigurnosnim štitnikom za iglu EU/1/14/946/008 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/007 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/010 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/017 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
Patients with renal impairment 
Bolesnici s teškom kroničnom neutropenijom
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml). 
Jedna štrcaljka sadrži 30 MU filgrastima u 0,5 ml (0,6 mg/ml).
Special precautions in sickle cell trait and sickle cell disease 
Posebne mjere opreza kod nasljednog obilježja srpastih stanica i anemije srpastih stanica
Special population 
Posebna populacija Starije osobe
Muscle spasms Osteoporosis 
Druge posebne mjere opreza Osteoporoza
Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration. 
Nakon primjene čimbenika poticanja granulocitnih kolonija (G-CSF) zabilježena je pojava stanja povećane kapilarne propusnosti („sindrom kapilarnog curenja“), koje karakteriziraju hipotenzija,
In patients with severe chronic neutropenia (SCN) Congenital neutropenia 
Pedijatrijski bolesnici s teškom kroničnom neutropenijom
How do I inject Accofil myself? 
Kako samostalno primijeniti injekciju lijekaAccofil?
Common side effects (seen in more than 1 in 100 people taking Accofil): 
Česte nuspojave (javljaju se u više od 1 na 100 osoba koje primaju Accofil)
Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 
6. FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari acetatna kiselina, ledena natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
Prior exposure to cytotoxic agents 
Prethodno izlaganje citotoksičnim lijekovima
Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim 
Uputa o lijeku: Informacije za korisnika Accofil 48 MU/0,5 ml (0,96 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim 
Uputa o lijeku: Informacije za korisnika Accofil 30 MU/0,5 ml (0,6 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml). 
Jedna štrcaljka sadrži 48 MU filgrastima u 0,5 ml (0,96 mg/ml).