natgillin/translations-raw huggingface dataset:
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 Acute Respiratory Distress Syndrome (ARDS). 
Pojava plućnih simptoma, kao što su kašalj, vrućica i dispneja, povezanih s radiološkim znacima plućnih infiltrata i pogoršanjem funkcije pluća uz povišen broj neutrofila mogu biti prethodni znaci akutnog respiratornog distres sindroma (engl. acute respiratory distress syndrome, ARDS).
6.6 Special precautions for disposal and other handling Before administration, Fulphila solution should be inspected visually for particulate matter. 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene potrebno je provjeriti sadrži li otopina lijeka Fulphila vidljive čestice.
The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. 
Sigurnost i djelotvornost pegfilgrastima u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih davatelja nije odgovarajuće ispitana.
Loss of response to Fulphila 
Gubitak odgovora na lijek Fulphila
Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless steel needle with or without an automatic needle guard. 
Napunjena štrcaljka (staklo tipa I), s čepom od bromobutilne gume obloženim fluorotec slojem i iglom od nehrđajućeg čelika, sa ili bez automatskog štitnika za iglu.
Healthcare professionals only The trade name of the administered product should be clearly recorded in the patient file. 
Samo za zdravstvene radnike Zaštićeni naziv primijenjenog lijeka mora se jasno navesti u bolesnikovoj medicinskoj dokumentaciji.
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]). 
Reakcije preosjetljivosti, uključujući osip na koži, urtikariju, angioedem, dispneju, eritem, navale crvenila i hipotenziju, javljale su se tijekom prvog ili sljedećeg liječenja pegfilgrastimom (manje često [≥ 1/1000 i < 1/100]).
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. 
U potomstvu skotnih ženki štakora kojima je supkutano primijenjen pegfilgrastim nisu primijećene nuspojave, ali se pokazalo da je pegfilgrastim u zečeva uzrokovao embrionalnu/fetalnu toksičnost (gubitak embrija) pri kumulativnim dozama koje su bile oko 4 puta veće od preporučene doze za ljude, no isto se nije pookazalo kod primjene doza koje odgovaraju preporučenoj dozi za ljude.
Glomerulonephritis2 
Glomerulonefritis2
Turn the plunger to move the label into a position where you can remove the syringe label. 
Okrenite klip u položaj da možete odlijepiti naljepnicu sa štrcaljke.
• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider. 
Važno je da ne pokušavate dati sebi injekciju ako niste prošli obuku kod svojeg liječnika ili zdravstvenog radnika.
Uncommon side effects (may affect up to 1 in 100 people) - allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch. 
Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) - reakcije alergijskog tipa, uključujući crvenilo i navale crvenila, osip na koži, izdignuta područja kože koja svrbe.
• The expiry date printed on the label has passed the last day of the month shown. 
• Ako je rok valjanosti otisnut na naljepnici istekao, odnosno ako je prošao posljednji dan navedenog mjeseca.
These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body. 
Ovo mogu biti znakovi stanja koje se zove „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela.
Fulphila contains sorbitol and sodium acetate This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL. 
Fulphila sadrži sorbitol i natrijev acetat Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki što odgovara 50 mg/ml.
Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4). 
Manje često su ovi slučajevi rezultirali respiratornim zatajenjem ili akutnim respiratornim distres sindromom (ARDS), koji mogu imati smrtni ishod (vidjeti dio 4.4).
Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculo-skeletal pain, neck pain) 
Mišićno-koštana bol (mijalgija, artralgija, bol u udovima, bol u leđima, mišićnokoštana bol, bol u vratu)
The safety and efficacy of pegfilgrastim 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. 
Sigurnost i djelotvornost pegfilgrastima nisu ispitivane u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnom akutnom mijeloičnom leukemijom (AML), stoga se lijek ne smije primjenjivati u tih bolesnika.
G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar effects may be seen on some non-myeloid cells in vitro. 
G-CSF može potaknuti rast mijeloidnih stanica, uključujući zloćudne stanice, in vitro a slični učinci mogu se primijetiti i na nekim nemijeloičnim stanicama in vitro.
For further instructions on how to inject yourself with pegfilgrastim, please read the instructions for use at the end of this leaflet. 
Dodatne upute o tome kako samostalno injicirati pegfilgrastim potražite u dijelu na kraju ove upute o lijeku.
 Do not use the pre-filled syringe if: 
Ne upotrebljavajte napunjenu štrcaljku:
Fulphila 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). 
Fulphila se primjenjuje za smanjenje trajanja neutropenije (smanjenog broja bijelih krvnih stanica) i pojave febrilne neutropenije (smanjeni broj bijelih krvnih stanica praćen vrućicom), koji se mogu javiti uslijed primjene citotoksične kemoterapije (lijekova koji uništavaju brzorastuće stanice).
Pack size of one pre-filled syringe, in blistered packaging. 
Veličina pakiranja: jedna napunjena štrcaljka u blister pakiranju.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za pegfilgrastim, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) pegfilgrastim nepromijenjen, uz predložene izmjene informacija o lijeku.
INFORMATION IN BRAILLE Fulphila 
16. PODACI NA BRAILLEOVOM PISMU fulphila
Driving and using machines Fulphila has no or negligible effect on the ability to drive or use machines. 
Upravljanje vozilima i strojevima Fulphila ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Splenic rupture2 
Splenomegalija2; Ruptura slezene2
Nausea1 
Mučnina1
For more information, see section 5.1 Excipient with known effect 
Za više informacija vidjeti dio 5.1
The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. 
Uobičajena doza je 6 mg primijenjena jednom supkutanom injekcijom (injekcija pod kožu) pomoću napunjene štrcaljke, koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of -16.8 %,-1.1 %). 
Ukupna stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 9%, a 18% u bolesnika liječenih filgrastimom (razlika 9%, 95% CI od -16,8%, -1,1%).
Then LIFT the syringe off skin. 
Zatim ODIGNITE štrcaljku od kože.
Fulphila is injected subcutaneously. 
Fulphila se injicira supkutano.
Injection site reactions, including injection site erythema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim. 
Reakcije na mjestu injiciranja, uključujući eritem na mjestu injiciranja (manje često) kao i bol na mjestu injiciranja (često) javljale su se prilikom prvog ili sljedećih liječenja pegfilgrastimom.
Rare side effects (may affect up to 1 in 1,000 people) - inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. 
Rijetke nuspojave (mogu se javiti u manje od 1 na 1 000 osoba) - upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), pogledajte dio 2. - krvarenje iz pluća (plućna hemoragija).
Each pack contains 1 glass pre-filled syringe 
Svako pakiranje sadrži 1 staklenu napunjenu štrcaljku.
Fulphila contains the active substance pegfilgrastim. 
Fulphila sadrži djelatnu tvar pegfilgrastim.
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
Remove and save the pre-filled syringe label. 
Odlijepite i sačuvajte naljepnicu sa štrcaljke.
Τηλ: +30 210 9891 777 
BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε. Τηλ: +30 210 9891 777
This section contains information on how to give yourself an injection of Fulphila. 
Ovo poglavlje sadrži upute o samoprimjeni injekcije lijeka Fulphila.
What Fulphila looks like and contents of the pack Fulphila is a clear, colourless solution for injection in a glass pre-filled syringe with an attached stainless steel needle and needle cap. 
Fulphila je bistra, bezbojna otopina za injekciju u napunjenoj staklenoj štrcaljki s pričvršćenom iglom od nehrđajućeg čelika i kapicom za iglu.
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. 
Pomoćne tvari su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001). 
Incidencija bolničkog liječenja i intravenske primjene antiinfektivnih lijekova, povezanog s kliničkom dijagnozom febrilne neutropenije, bila je niža u skupini liječenoj pegfilgrastimom nego u skupini koja je primala placebo (1% prema 14%, p<0,001 te 2% prema 10%, p<0,001).
Keep the syringe and sharps disposal container out of sight and reach of children. 
Čuvajte štrcaljku i spremnik za odlaganje oštrih predmeta izvan pogleda i dohvata djece.
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. 
U fazi II (n=37) multicentričnog, randomiziranog, otvorenog ispitivanja pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon 1. ciklusa kemoterapije vinkristinom, doksorubicinom i ciklofosfamidom (VAdriaC/IE) uočeno je dulje trajanje teške neutropenije (neutrofili < 0,5 x 109) u mlađe djece u dobi od 0-5 godina (8,9 dana) u odnosu na stariju djecu u dobi 6-11 i 12-21 godine (6 odnosno 3,7 dana) te odrasle.
Mylan Healthcare GmbH Tel: + 49-(0) 511 475 43 400 
Mylan Helathcare GmbH Tel: + 49-(0)511 475 43 400
Thrombocytopenia1 Leukocytosis1 
Trombocitopenija1; Leukocitoza1
These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4). 
Obično su se javili u bolesnika s uznapredovalom malignom bolesti, sepsom, bolesnika koji su uzimali kemoterapiju s više lijekova ili bolesnika na aferezi (vidjeti dio 4.4).
The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas. 
Sigurnost i djelotvornost pegfilgrastima nisu ispitivane u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time. 
Ako se tijekom primjene pegfilgrastima u bolesnika razvio StevensJohnsonov sindrom, ni u jednom trenutku se ne smije ponovno započeti tog bolesnika liječiti pegfilgrastimom.
The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (Area Under Curve (AUC)) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1). 
Djeca u najmlađoj dobnoj skupini (0 - 5 godina) imala su veću srednju ekspoziciju pegfilgrastimu (područje ispod krivulje, AUC) (± standardno odstupanje) (47,9 ± 22,5 µg·hr/ml) u odnosu na stariju djecu u dobi od 6 - 11, odnosno 12 - 21 godine (22,0 ± 13,1 µg·hr/ml te 29,3 ± 23,2 µg·hr/ml) (vidjeti dio 5.1).
Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2). 
Dodatno je primijećena i veća incidencija febrilne neutropenije u mlađe djece u dobi od 0-5 godina (75%) u usporedbi sa starijom djecom u dobi od 6-11 i 12-21 godine (70% odnosno 33%) odnosno odraslima (vidjeti dio 4.8 i 5.2).
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below. 
Sindrom povećane propusnosti kapilara, koji može biti životno ugrožavajući ukoliko se ne počne liječiti na vrijeme, prijavljen je manje često (≥ 1/1000 i < 1/100) u bolesnika s rakom koji su na kemoterapiji nakon primjene faktora stimulacije rasta granulocita; vidjeti dio 4.4 i dio
Step 2: Get ready 
Korak 2: Pripremite se A.
 Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe. 
 Ne pokušavajte ukloniti prozirni sigurnosni štitnik štrcaljke s napunjene štrcaljke.
1 single use pre-filled syringe with automatic needle guard (0.6 mL). 
1 napunjena štrcaljka za jednokratnu upotrebu s automatskim štitnikom za iglu (0,6 ml).
The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001). 
Incidencija febrilne neutropenije bila je niža u bolesnica randomiziranih u grupu koja je dobivala pegfilgrastima u usporedbi s bolesnicama koje su dobivale placebo (1% prema 17%, p<0,001).
Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of -19 %, 5 %). 
Tijekom cijelog ispitivanja stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 13%, a 20% u bolesnika liječenih filgrastimom (razlika 7%, 95% CI od -19%, 5%).
Mylan Healthcare Norge AS Tel: + 47 66 75 33 00 
Mylan Healthcare norge AS Tel: + 47 66 75 33 00 (Sverige)
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m² every 3 weeks for 4 cycles). 
U placebo kontroliranom, dvostruko slijepom ispitivanju provedenom u bolesnica s karcinomom dojke, ispitivan je učinak pegfilgrastima na incidenciju pojave febrilne neutropenije nakon primjene kemoterapijskog režima povezanog s razvojem febrilne neutropenije sa stopom od 10 - 20% (docetaksel 100 mg/m² svaka 3 tjedna tijekom 4 ciklusa).
Instructions for injecting with the Fulphila pre-filled syringe 
Upute za injiciranje Fulphila napunjene štrcaljke
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima* u 0,6 ml otopine za injekciju.
For further instructions on how to inject yourself with Fulphila, please read the instructions for use at the end of this leaflet. 
Dodatne upute o tome kako samostalno injicirati lijek Fulphila potražite u dijelu na kraju ove upute o lijeku.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER WITH SYRINGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER PAKIRANJE ZA ŠTRCALJKU
 Do not grasp the grey needle cap. 
X Ne hvatajte sivu kapicu igle.
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL. 
Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki, što odgovara 50 mg/ml.
• The grey needle cap is missing or not securely attached. 
• Ako nema sive kapice na igli ili ona nije dobro pričvršćena.
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). 
Bolesnici s mijeloičnom leukemijom ili mijelodisplastičkim sindromima Ograničeni klinički podaci upućuju na usporediv učinak pegfilgrastima i filgrastima na vrijeme potrebno za oporavak od teške neutropenije u bolesnika s de novo akutnom mijeloičnom leukemijom (AML) (vidjeti dio 5.1).
It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen. 
Ako osjetite bol u gornjoj lijevoj strani trbuha ili bol u lijevom ramenu važno je da se odmah obratite svom liječniku jer to može upućivati na problem sa slezenom. - problemi s disanjem.
A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, 
U malom (n=83), randomiziranom, dvostruko slijepom ispitivanju faze II, u bolesnika s de novo akutnom mijeloičnom leukemijom liječenih kemoterapijom uspoređivan je pegfilgrastim (pojedinačna doza od 6 mg) s filgrastimom, primjenjivanima tijekom indukcijske kemoterapije.
If you use more Fulphila than you should If you use more Fulphila than you should, contact your doctor, pharmacist or nurse. 
Ako primijenite više lijeka Fulphila nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. 
Jednokratna doza pegfilgrastima od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
 Do not put the grey needle cap back on used pre-filled syringes. 
X Ne vraćajte sivu kapicu za iglu na iskorištenu štrcaljku.
The most suitable places to inject yourself are: 
Možete injicirati na sljedeća mjesta:
A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults. 
Primijećena je veća učestalost ozbiljnih nuspojava u mlađe djece, u dobi 0 - 5 godina (92%) u odnosu na stariju djecu, u dobi 6 - 11 godina (80%) i 1221 godina (67%), odnosno odrasle.
NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S. 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan S.A.S.
1 single use pre-filled syringe (0.6 mL). 
1 napunjena štrcaljka za jednokratnu upotrebu (0,6 ml).
In a second study (n = 310), which used a weight-adjusted dose (100 mcg /kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI -0.36, 0.30). 
U drugom ispitivanju (n=310), u kojemu je primjenjivana doza prilagođena tjelesnoj težini (100 µg/kg), srednje trajanje neutropenije 4. stupnja u skupini liječenoj pegfilgrastimom iznosilo je 1,7 dana, u usporedbi s 1,8 dana u skupini liječenoj filgrastimom (razlika 0,03 dana, 95% CI -0,36, 0,30).
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL solution for injection (10 mg/mL). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
 Do not attempt to activate the pre-filled syringe prior to injection. 
 Ne pokušavajte aktivirati napunjenu štrcaljku prije injiciranja.
Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients. 
Istodobna primjena pegfilgrastima i kemoterapije nije procijenjena u bolesnika.
 Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject. 
Ne skidajte sivu kapicu igle s napunjene štrcaljke sve dok niste spremni injicirati lijek.
How do I prepare my Fulphila injection? 
Kako se priprema injekcija lijeka Fulphila?
If there is blood, press a cotton ball or gauze pad on your injection site. 
Ukoliko ima krvi, na mjesto injiciranja pritisnite jastučić od vate ili gaze.
Injection site pain1 Non-cardiac chest pain 
Ne-kardijalna bol u prsištu
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
Each pack contains 1 pre-filled syringe. 
U svakom pakiranju nalazi se 1 napunjena štrcaljka.
Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously. 
Istraživanja provedena u štakora ukazala su i na to da supkutana primjena pegfilgrastima nema utjecaja na reproduktivne sposobnosti, plodnost, ciklus estrusa, dane između parenja i koitusa i intrauterino preživljavanje.
If you notice a spot of blood at the injection site dab with a cotton ball or tissues. 
Ako primijetite točkicu krvi na mjestu injiciranja, lagano pritisnite vatom ili maramicom.
Do not remove the needle cap from the syringe until you are ready to inject. 
Ne uklanjajte zaštitnu kapicu za iglu sa štrcaljke prije nego što ste spremni za injiciranje.
Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis); Haemoptysis 
Plućne nuspojave (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza);
- swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. 
• oticanje ili podbuhlost, što može biti povezano s rjeđom učestalošću mokrenja, otežano disanje, oticanje trbuha i osjećaj punoće, te opći osjećaj umora.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulphila 6 mg injection pegfilgrastim 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Fulphila 6 mg injekcija pegfilgrastim s.c.