FrancophonIA/ELRC3.0 huggingface dataset:
English: Fulphila is injected subcutaneously.
Croatian: Fulphila se injicira supkutano.
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.
Croatian: 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.
English: 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.
Croatian: 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).
English: Each pack contains 1 glass pre-filled syringe
Croatian: Svako pakiranje sadrži 1 staklenu napunjenu štrcaljku.
English: Fulphila contains the active substance pegfilgrastim.
Croatian: Fulphila sadrži djelatnu tvar pegfilgrastim.
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
English: Remove and save the pre-filled syringe label.
Croatian: Odlijepite i sačuvajte naljepnicu sa štrcaljke.
English: Τηλ: +30 210 9891 777
Croatian: BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε. Τηλ: +30 210 9891 777
English: This section contains information on how to give yourself an injection of Fulphila.
Croatian: Ovo poglavlje sadrži upute o samoprimjeni injekcije lijeka Fulphila.
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.
Croatian: Fulphila je bistra, bezbojna otopina za injekciju u napunjenoj staklenoj štrcaljki s pričvršćenom iglom od nehrđajućeg čelika i kapicom za iglu.
English: - The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Croatian: Pomoćne tvari su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
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).
Croatian: 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).
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Croatian: Čuvajte štrcaljku i spremnik za odlaganje oštrih predmeta izvan pogleda i dohvata djece.
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.
Croatian: 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.
English: Mylan Healthcare GmbH Tel: + 49-(0) 511 475 43 400
Croatian: Mylan Helathcare GmbH Tel: + 49-(0)511 475 43 400
English: Thrombocytopenia1 Leukocytosis1
Croatian: Trombocitopenija1; Leukocitoza1
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section 4.4).
Croatian: 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).
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Croatian: Sigurnost i djelotvornost pegfilgrastima nisu ispitivane u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
English: If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Croatian: Ako se tijekom primjene pegfilgrastima u bolesnika razvio StevensJohnsonov sindrom, ni u jednom trenutku se ne smije ponovno započeti tog bolesnika liječiti pegfilgrastimom.
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).
Croatian: 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).
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).
Croatian: 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).
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.
Croatian: 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
English: Step 2: Get ready
Croatian: Korak 2: Pripremite se A.
English:  Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Croatian:  Ne pokušavajte ukloniti prozirni sigurnosni štitnik štrcaljke s napunjene štrcaljke.
English: 1 single use pre-filled syringe with automatic needle guard (0.6 mL).
Croatian: 1 napunjena štrcaljka za jednokratnu upotrebu s automatskim štitnikom za iglu (0,6 ml).
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001).
Croatian: 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).
English: BGP Products ApS Tlf: + 45 28116932
Croatian: Danmark BGP Products ApS Tlf: + 45 28116932
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 %).
Croatian: 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%).
English: Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
Croatian: Mylan Healthcare norge AS Tel: + 47 66 75 33 00 (Sverige)
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m² every 3 weeks for 4 cycles).
Croatian: 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).
English: Instructions for injecting with the Fulphila pre-filled syringe
Croatian: Upute za injiciranje Fulphila napunjene štrcaljke
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima* u 0,6 ml otopine za injekciju.
English: For further instructions on how to inject yourself with Fulphila, please read the instructions for use at the end of this leaflet.
Croatian: Dodatne upute o tome kako samostalno injicirati lijek Fulphila potražite u dijelu na kraju ove upute o lijeku.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER WITH SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER PAKIRANJE ZA ŠTRCALJKU
English:  Do not grasp the grey needle cap.
Croatian: X Ne hvatajte sivu kapicu igle.
English: Mylan Medical S.A.S Tel: +33 1 56 64 10 70
Croatian: Mylan Medical S.A.S Tél : +33 1 56 64 10 70
English: This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Croatian: Ovaj lijek sadrži 30 mg sorbitola u jednoj napunjenoj štrcaljki, što odgovara 50 mg/ml.
English: • The grey needle cap is missing or not securely attached.
Croatian: • Ako nema sive kapice na igli ili ona nije dobro pričvršćena.
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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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,
Croatian: 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.
English: If you use more Fulphila than you should If you use more Fulphila than you should, contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Fulphila nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
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.
Croatian: Jednokratna doza pegfilgrastima od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English:  Do not put the grey needle cap back on used pre-filled syringes.
Croatian: X Ne vraćajte sivu kapicu za iglu na iskorištenu štrcaljku.
English: The most suitable places to inject yourself are:
Croatian: Možete injicirati na sljedeća mjesta:
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.
Croatian: 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.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan S.A.S.
English: 1 single use pre-filled syringe (0.6 mL).
Croatian: 1 napunjena štrcaljka za jednokratnu upotrebu (0,6 ml).
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).
Croatian: 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).
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).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
English:  Do not attempt to activate the pre-filled syringe prior to injection.
Croatian:  Ne pokušavajte aktivirati napunjenu štrcaljku prije injiciranja.
English: Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients.
Croatian: Istodobna primjena pegfilgrastima i kemoterapije nije procijenjena u bolesnika.
English:  Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Croatian: Ne skidajte sivu kapicu igle s napunjene štrcaljke sve dok niste spremni injicirati lijek.
English: How do I prepare my Fulphila injection?
Croatian: Kako se priprema injekcija lijeka Fulphila?
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Croatian: Ukoliko ima krvi, na mjesto injiciranja pritisnite jastučić od vate ili gaze.
English: Injection site pain1 Non-cardiac chest pain
Croatian: Ne-kardijalna bol u prsištu
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Each pack contains 1 pre-filled syringe.
Croatian: U svakom pakiranju nalazi se 1 napunjena štrcaljka.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Croatian: 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.
English: If you notice a spot of blood at the injection site dab with a cotton ball or tissues.
Croatian: Ako primijetite točkicu krvi na mjestu injiciranja, lagano pritisnite vatom ili maramicom.
English: Do not remove the needle cap from the syringe until you are ready to inject.
Croatian: Ne uklanjajte zaštitnu kapicu za iglu sa štrcaljke prije nego što ste spremni za injiciranje.
English: Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis); Haemoptysis
Croatian: Plućne nuspojave (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza);
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.
Croatian: • oticanje ili podbuhlost, što može biti povezano s rjeđom učestalošću mokrenja, otežano disanje, oticanje trbuha i osjećaj punoće, te opći osjećaj umora.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulphila 6 mg injection pegfilgrastim
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Fulphila 6 mg injekcija pegfilgrastim s.c.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Croatian: U zdravih ispitanika i bolesnika oboljelih od raka nakon primjene G-CSF-a zabilježen je aortitis, čiji su simptomi uključivali vrućicu, bol u abdomenu, malaksalost, bol u leđima i povišene upalne markere (npr. C-reaktivni protein i broj leukocita).
English: - if you get left upper abdominal pain or pain at the tip of your shoulder.
Croatian: Pogledajte dio 4. - ako osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena.
English: The syringe is provided with a blister wrapping, the syringe is provided with an automatic needle guard.
Croatian: Štrcaljka se nalazi u blister pakiranju i ima automatski štitnik za iglu.
English: Fulphila 6 mg solution for injection in pre-filled syringe pegfilgrastim
Croatian: Fulphila 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: • the top of your thighs; and
Croatian: • Gornji dio bedra.
English: Sickle cell crisis2; Splenomegaly2;
Croatian: Kriza srpastih stanica2;
English: - bleeding from the lung (pulmonary haemorrhage).
Croatian: - kožni vaskulitis (upala krvnih žila kože).
English: Headache1
Croatian: Glavobolja1
English: - sickle cell crises in patients with sickle cell anaemia.
Croatian: - kriza srpastih stanica kod pacijenata s anemijom srpastih stanica. - povećanje slezene. - prsnuće slezene.
English: NAME OF THE MEDICINAL PRODUCT Fulphila 6 mg solution for injection pegfilgrastim
Croatian: NAZIV LIJEKA Fulphila 6 mg otopina za injekciju pegfilgrastim
English:  Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.
Croatian:  Ne pokušavajte odlijepiti odvojivu naljepnicu sa spremnika napunjene štrcaljke prije primjene injekcije.
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).
Croatian: 6 mg, srednje vrijeme trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosilo je 1,8 dana, a 1,6 dana u skupini koja je primala filgrastim (razlika od 0,23 dana, 95% CI - 0,15, 0,63).
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
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.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je zamućen ili ako u njemu uočite čestice.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Croatian: Koncentracija iznosi 10 mg/ml samo na temelju proteinskog dijela**. * Proizveden u stanicama Escherichia coli tehnologijom rekombinantne DNK i zatim konjugiran s polietilenglikolom (PEG).
English: How to store Fulphila
Croatian: Kako primjenjivati lijek Fulphila
English:  Do not reuse the pre-filled syringe.
Croatian: X Nemojte ponovno upotrebljavati iskorištenu štrcaljku.
English: Anaphylaxis
Croatian: Hemoptiza
English: Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
Croatian: Uhvatite napunjenu štrcaljku za sigurnosni štitnik kako biste je izvadili iz podloška.
English: What you need to know before you use Fulphila 3.
Croatian: Što je Fulphila i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Fulphila Kako primjenjivati lijek Fulphila Moguće nuspojave
English: - damage to the tiny filters inside your kidneys (glomerulonephritis).
Croatian: - oštećenje sitnih filtera unutar bubrega (glomerulonefritis). - crvenilo na mjestu primjene injekcije. - iskašljavanje krvi (hemoptiza).
English:  Do not touch the injection site before injecting.
Croatian: X Ne dirajte očišćeno mjesto prije injiciranja.
English: Water for injections *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat* sorbitol (E420) polisorbat 20 voda za injekcije * Natrijev acetat pripremljen je titracijom ledene acetatne kiseline s natrijevim hidroksidom.
English: - if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
Croatian: To može biti znak problema sa slezenom (povećanje slezene); - ako ste nedavno imali ozbiljniju infekciju pluća (upalu pluća), tekućinu u plućima (edem pluća), upalne procese u području pluća (intersticijska bolest pluća) ili neuobičajeni rentgenski nalaz pluća (plućna infiltracija); - ako imate saznanje o poremećenom broju krvnih stanica (npr. povećanje broja bijelih krvnih stanica ili anemiju) ili smanjeni broj krvnih pločica koji može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: Do not shake the pre-filled syringe.
Croatian:  Ne tresite napunjenu štrcaljku.
English:  Do not shake the pre-filled syringe.
Croatian: Ne tresite napunjenu štrcaljku.
English: Your doctor may monitor your condition more closely.
Croatian: Vaš liječnik će možda pratiti pobliže Vaše stanje; - ako bolujete od anemije srpastih stanica.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in
Croatian: Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml otopine.
English: - if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, these could be signs of a severe allergic reaction.
Croatian: Vaš liječnik će možda pratiti pobliže Vaše stanje; - ako primijetite iznenadne znakove alergije kao što su osip, svrbež ili koprivnjača na koži, oticanje lica, usana, jezika ili drugih dijelova tijela, nedostatak zraka, piskanje ili otežano disanje, to bi mogli biti znakovi teške alergijske reakcije. - u bolesnika oboljelih od raka i zdravih darivatelja rijetko je zabilježena upala aorte (velike krvne žile koja prenosi krv iz srca u tijelo), čiji simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
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.
Croatian: Manje često su u bolesnika, koji su nakon citotoksične kemoterapije primili pegfilgrastim, zabilježeni slučajevi povišenja vrijednosti testova jetrene funkcije za ALT (alanin aminotransferaze) ili AST (aspartat aminotransferaze).
English: Hold the syringe barrel and gently take the cap from the needle without twisting.
Croatian: Prije injiciranja lijeka Fulphila morate učiniti sljedeće: Držite tijelo štrcaljke i pažljivo skinite zaštitnu kapicu s igle bez okretanja.
English: The pre-filled syringe should be allowed to reach room temperature before injecting.
Croatian: Prije injiciranja pričekajte da napunjena štrcaljka dosegne sobnu temperaturu.