FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack contains 1 glass pre-filled syringe
Slovenian: Vsaka škatla vsebuje 1 stekleno napolnjeno injekcijsko brizgo
English: If you use more Fulphila than you should If you use more Fulphila than you should, contact your doctor, pharmacist or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila Fulphila, kot bi smeli Če ste uporabili večji odmerek zdravila Fulphila, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC , ODGOVOREN ZA SPROŠČANJE SERIJ
English: Loss of response to Fulphila
Slovenian: Izguba odziva na zdravilo Fulphila
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Fulphila.
Slovenian: Če je zdravilo Fulphila pomotoma izpostavljeno temperaturam pod lediščem za enkratno obdobje, ki ne preseže 24 ur, to ne škoduje njegovi stabilnosti.
English: In an 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: 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]).
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije preobčutljivostnega tipa, vključno z izpuščajem na koži, urtikarijo, angioedemom, dispnejo, eritemom, zardevanjem in hipotenzijo (občasno [≥ 1/1.000 do < 1/100]).
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001).
Slovenian: Incidenca febrilne nevtropenije je bila nižja pri bolnicah, ki so dobivale pegfilgrastim, kot pri tistih, ki so dobivale placebo (1 % v primerjavi s 17 %, p < 0,001).
English: • 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.
Slovenian: • oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Fulphila pri otrocih in mladostnikih ni priporočljiva.
English: How do I prepare my Fulphila injection?
Slovenian: Kako si pripravim injekcijo zdravila Fulphila?
English: Sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI natrijev acetat, sorbitol (E420), polisorbat 20, voda za injekcije.
English: Stop using Fulphila if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se vam pojavijo ti simptomi, prenehajte uporabljati zdravilo Fulphila in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Slovenian: V obdobju trženja zdravila so poročali o primerih sindroma kapilarne prepustnosti med uporabo granulocitne kolonije spodbujajočega faktorja.
English: 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.
Slovenian: Občasno (≥ 1/1.000 do < 1/100) so pri bolnikih z rakom, ki so prejemali kemoterapijo po uporabi granulocitne kolonije spodbujajočega faktorja, poročali o sindromu kapilarne prepustnosti, ki je lahko življenjsko ogožujoč, če ni zdravljen takoj; glejte poglavje 4.4 in poglavje “Opis izbranih neželenih učinkov” spodaj.
English: For further instructions on how to inject yourself with pegfilgrastim, please read the instructions for use at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje pegfilgrastima si preberite v poglavju na koncu tega navodila za uporabo.
English: 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 %).
Slovenian: V celotni študiji je bila pogostost febrilne nevtropenije pri bolnikih, zdravljenih s pegfilgrastimom, 13 %, pri bolnikih, zdravljenih s filgrastimom, pa 20 % (razlika 7 %, 95 % IZ je -19 %, 5 %).
English: 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).
Slovenian: V najmlajši starostni skupini (od 0 do 5 let) je bila povprečna izpostavljenost pegfilgrastimu (območje pod krivuljo (AUC)) (± standardni odklon) večja (47,9 ± 22,5 µg·h/ml) kot med otroki, starimi od 6 do 11 (22,0 ± 13,1 µg·h/ml) in od 12 do 21 let (29,3 ± 23,2 µg·h/ml) (glejte poglavje 5.1).
English: This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 6 mg odmerek, kar pomeni, da je praktično “brez natrija”.
English: Each pack contains 1 pre-filled syringe.
Slovenian: Vsaka škatla vsebuje 1 napolnjeno injekcijsko brizgo.
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis); Haemoptysis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sindrom akutne dihalne stiske2; pljučne neželene reakcije (intersticijska pljučnica, pljučni edem, pljučni infiltrati in pljučna fibroza), hemoptiza pljučna hemoragija
English: BGP Products ApS Tlf: + 45 28116932
Slovenian: Danmark BGP Products ApS Tlf: + 45 28116932
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings.
Slovenian: Povečana hemopoetična aktivnost kostnega mozga zaradi zdravljenja z rastnimi dejavniki je bila povezana s prehodnimi pozitivnimi izvidi pri slikanju kosti, kar je treba upoštevati pri interpretaciji izvidov na podlagi slikanja kosti.
English: 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.
Slovenian: Fulphila je bistra, brezbarvna raztopina za injiciranje v napolnjeni stekleni injekcijski brizgi s pričvrščeno iglo iz nerjavečega jekla in pokrovčkom igle.
English: Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients.
Slovenian: Sočasne uporabe pegfilgrastima s katerim koli kemoterapevtskim zdravilom pri bolnikih niso ovrednotili.
English: Common side effects (may affect up to 1 in 10 people) - pain at the site of injection.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - bolečina na mestu injiciranja.
English: 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).
Slovenian: Poleg tega so pri mlajših otrocih, starih od 0 do 5 let, ugotovili večjo incidenco febrilne nevtropenije (75 %) kot pri starejših otrocih, starih od 6 do 11 (70 %) in 12 do 21 let (33 %) ter pri odraslih (glejte poglavji 4.8 in 5.2).
English: 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.
Slovenian: faze pri pediatričnih bolnikih s sarkomom (n = 37), ki so dobili 100 µg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0 do 5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 x 109) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let (6 dni) in 12 do 21 let (3,7 dni) in pri odraslih.
English: 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).
Slovenian: Med prejemnicami pegfilgrastima je bila tudi manjša incidenca hospitalizacij in intravensko uporabljene antiinfektivne terapije, povezanih s klinično diagnozo febrilne nevtropenije, kot med prejemnicami placeba (1 % v primerjavi s 14 %, p < 0,001, ter 2 % v primerjavi z 10 %, p < 0,001).
English: What Fulphila contains - The active substance is pegfilgrastim.
Slovenian: Kaj vsebuje zdravilo Fulphila - Učinkovina je pegfilgrastim.
English: - 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.
Slovenian: - oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
English: 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.
Slovenian: Napolnjena injekcijska brizga (iz stekla tipa I) z zamaškom iz bromobutilne gume, premazanim s fluorotecom, in nerjavečo jekleno iglo z avtomatskim ščitnikom igle ali brez njega.
English: Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater or household waste.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je zdravilo motno ali da v njem plavajo delci.
English: Mylan Medical S.A.S Tel: +33 1 56 64 10 70
Slovenian: Mylan Medical S.A.S Tél : +33 1 56 64 10 70
English: Pack size of one pre-filled syringe, in blistered packaging.
Slovenian: Pakiranje z eno napolnjeno injekcijsko brizgo v pretisnem omotu.
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95 % CI -0.15, 0.63).
Slovenian: V eni študiji (n = 157), v kateri so uporabili stalni odmerek 6 mg pegfilgrastima, je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,8 dni, v skupini s filgrastimom pa 1,6 dni (razlika 0,23 dneva, 95 % IZ je -0,15, 0,63).
English: Do not remove the needle cap from the syringe until you are ready to inject.
Slovenian: Ne snemite pokrovčka igle z injekcijske brizge, dokler niste pripravljeni na injiciranje.
English: A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Slovenian: 4. korak: Zaključek A Zavrzite uporabljeno injekcijsko brizgo in drugo opremo v vsebnik za ostre odpadke.
English: How to use Fulphila
Slovenian: Kako uporabljati zdravilo Fulphila
English: 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).
Slovenian: V drugi študiji (n = 310), v kateri so uporabljali telesni masi prilagojen odmerek (100 μg/kg), je bilo srednje trajanje nevtropenije 4. stopnje v skupini s pegfilgrastimom 1,7 dni, v skupini s filgrastimom pa 1,8 dni (razlika 0,03 dneva, 95 % IZ je -0,36, 0,30).
English: Open the tray, peeling away the cover.
Slovenian: B. Odprite podlogo, tako da z nje odlepite pokrivno folijo.
English: Fulphila contains the active substance pegfilgrastim.
Slovenian: Zdravilo Fulphila vsebuje učinkovino pegfilgrastim.
English: For further instructions on how to inject yourself with Fulphila, please read the instructions for use at the end of this leaflet.
Slovenian: Nadaljnja navodila za samoinjiciranje zdravila Fulphila si preberite v poglavju na koncu tega navodila za uporabo.
English: Inspect the medicine and pre-filled syringe.
Slovenian: C. Preglejte zdravilo in napolnjeno injekcijsko brizgo.
English: Pegfilgrastim has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Pegfilgrastim nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba spreminjati; to velja tudi za bolnike s končno odpovedjo ledvic.
English: Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4).
Slovenian: Pri bolnikih, ki prejemajo pegfilgrastim, se lahko pojavijo resne alergijske reakcije, vključno z anafilaksijo (občasno) (glejte poglavje 4.4).
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim.
Slovenian: Ob uporabi pegfilgrastima so poročali o hudih kožnih reakcijah (Stevens-Johnsonov sindrom).
English: This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Slovenian: To zdravilo vsebuje 30 mg sorbitola v vsaki napolnjeni brizgi, kar je enakovredno 50 mg/ml.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ni dovolj podatkov o izločanju pegfilgrastima/presnovkov v materino mleko.
English: 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.
Slovenian: Pri mlajših otrocih, starih od 0 do 5 let, so ugotovili večjo pogostnost resnih neželenih reakcij (92 %) kot pri starejših otrocih, starih od 6 do 11 (80 %) in 12 do 21 let (67 %) ter pri odraslih.
English: Fulphila contains sorbitol and sodium acetate This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Slovenian: Zdravilo Fulphila vsebuje sorbitol in natrijev acetat To zdravilo vsebuje 30 mg sorbitola v posamezni napolnjeni injekcijski brizgi, kar je enakovredno 50 mg/ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL solution for injection (10 mg/mL).
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima v 0,6 ml raztopine za injiciranje (10 mg/ml).
English:  Do not attempt to activate the pre-filled syringe prior to injection.
Slovenian: X Ne poskušajte aktivirati napolnjene injekcijske brizge pred injiciranjem.
English: - if you get left upper abdominal pain or pain at the tip of your shoulder.
Slovenian: - če začutite bolečino levo zgoraj v trebuhu ali v predelu lopatice.
English: - coughing up blood (haemoptysis).
Slovenian: - izkašljevanje krvi (hemoptiza).
English: - experience a cough, fever and difficulty breathing.
Slovenian: - če začnete kašljati, se vam zviša telesna temperatura in začnete težko dihati.
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Slovenian: do IV. stadiju na mielosupresivni kemoterapiji z doksorubicinom in docetakselom je uporaba pegfilgrastima v obliki enega samega odmerka na cikel skrajšala trajanje nevtropenije in incidenco febrilne nevtropenije, podobno kot so opazili pri vsakodnevni uporabi filgrastima (mediana števila dnevnih aplikacij je bila 11).
English:  Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Slovenian: X Ne poskušajte odstraniti prozornega varnostnega ščitnika z napolnjene injekcijske brizge.
English: The syringe is provided with a blister wrapping, the syringe is provided with an automatic needle guard.
Slovenian: Injekcijska brizga ima pretisni omot in avtomatski ščitnik igle.
English: - Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Slovenian: - pri bolnikih z rakom in zdravih darovalcih so redko poročali o vnetju aorte (velike žile, ki prenaša kri od srca po telesu).
English: - cutaneous vasculitis (inflammation of the blood vessels in the skin).
Slovenian: - kožni vaskulitis (vnetje krvnih žil v koži).
English:  Do not put the grey needle cap back on used pre-filled syringes.
Slovenian: X Sivega pokrovčka igle ne nameščajte nazaj na uporabljeno injekcijsko brizgo.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina za injiciranje.
English: 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.
Slovenian: Za vsak cikel kemoterapije je priporočen en 6-miligramski odmerek (eno napolnjeno injekcijsko brizgo) pegfilgrastima, ki je dan vsaj 24 ur po citotoksični kemoterapiji.
English:  Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Slovenian: X Ne odstranite sivega pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni za injiciranje.
English: Sickle cell crisis2; Splenomegaly2;
Slovenian: srpastocelična kriza2; splenomegalija2; ruptura vranice2
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulphila 6 mg injection pegfilgrastim
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Fulphila 6 mg injekcija pegfilgrastim s.c.
English: Fulphila 6 mg solution for injection in pre-filled syringe pegfilgrastim
Slovenian: Fulphila 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
English: Glomerulonephritis2
Slovenian: Bolezni sečil glomerulonefritis2
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English:  Do not grasp the grey needle cap.
Slovenian: X Ne primite brizge za sivi pokrovček igle.
English: 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).
Slovenian: Bolniki z mieloidno levkemijo ali mielodisplastičnimi sindromi Pri bolnikih z de novo akutno mieloično levkemijo (AML) omejeni klinični podatki kažejo primerljiv učinek pegfilgrastima in filgrastima na čas do okrevanja po hudi nevtropeniji (glejte poglavje 5.1).
English: SC
Slovenian: ANC
English: 1 single use pre-filled syringe with automatic needle guard (0.6 mL).
Slovenian: 1 napolnjena injekcijska brizga z avtomatskim ščitnikom igle (0,6 ml) za enkratno uporabo.
English: If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Slovenian: Če imate kakšna vprašanja o injiciranju zdravila, se za pomoč obrnite na svojega zdravnika, medicinsko sestro ali farmacevta.
English: Thrombocytopenia1 Leukocytosis1
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija1; levkocitoza1
English: NAME OF THE MEDICINAL PRODUCT Fulphila 6 mg solution for injection pegfilgrastim
Slovenian: IME ZDRAVILA Fulphila 6 mg raztopina za injiciranje pegfilgrastim
English: The pre-filled syringe should be allowed to reach room temperature before injecting.
Slovenian: Pred injiciranjem morate počakati, da napolnjena injekcijska brizga doseže sobno temperaturo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 6 mg pegfilgrastima* v 0,6 ml raztopine za injiciranje.
English: 1 single use pre-filled syringe (0.6 mL).
Slovenian: 1 napolnjena injekcijska brizga (0,6 ml) za enkratno uporabo.
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Slovenian: Občasno so se bolnikom, ki so po citotoksični kemoterapiji dobili pegfilgrastim, pojavila zvišanja jetrnih funkcijskih testov za ALT (alanin-aminotransferaze) ali AST (aspartat-aminotransferaze).
English: Capillary leak syndrome1
Slovenian: Bolezni živčevja glavobol1 Žilne bolezni sindrom kapilarne prepustnosti1
English: Injection site reactions, including injection site erythema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim.
Slovenian: Med začetnim ali nadaljnjim zdravljenjem s pegfilgrastimom so se pojavile reakcije na mestu injiciranja, vključno z eritemom na mestu injiciranja (občasno) kot tudi bolečino na mestu injiciranja (pogosto).
English:  Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.
Slovenian: X Ne poskušajte odstraniti nalepke z valja napolnjene injekcijske brizge pred dajanjem injekcije.
English: For more information, see section 5.1 Excipient with known effect
Slovenian: Za podrobnosti glejte poglavje 5.1.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.
Slovenian: Če uporabljate zdravilo Fulphila, morate prenehati dojiti, razen če vam zdravnik ne naroči drugače.
English: Subcutaneous use
Slovenian: DRUGI PODATKI subkutana uporaba
English: This section contains information on how to give yourself an injection of Fulphila.
Slovenian: Navodila za injiciranje zdravila Fulphila z uporabo napolnjene injekcijske brizge To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Fulphila.
English:  Do not touch the injection site before injecting.
Slovenian: X Pred injiciranjem se ne dotikajte mesta injiciranja.
English: What you need to know before you use Fulphila 3.
Slovenian: Kaj je zdravilo Fulphila in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Fulphila Kako uporabljati zdravilo Fulphila Možni neželeni učinki
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Slovenian: Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti pegfilgrastima niso ovrednotili.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim.
Slovenian: Pri manj kot 1 % bolnikov, ki so dobivali pegfilgrastim, so opazili število belih krvničk, ki je enako 100 × 109/l ali večje.
English: NAME OF THE MEDICINAL PRODUCT Fulphila 6 mg solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Fulphila 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi