FrancophonIA/ELRC3.0 huggingface dataset:
English: Pelmeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Croatian: Liječenje Pelmegom mora započeti i nadzirati liječnik s iskustvom u onkologiji i/ili hematologiji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1328/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1328/001
English: Pelmeg is a biosimilar medicinal product.
Croatian: Pelmeg je biosličan lijek.
English: If you develop or are likely to develop cancers of the blood, you should not use Pelmeg, unless instructed by your doctor.
Croatian: Ako imate ili postoji neposredna opasnost od razvoja oblika raka krvi, ne smijete primjenjivati Pelmeg, osim u slučaju da je to savjet Vašeg liječnika.
English: Sweet's syndrome (acute febrile dermatosis)1,2; Cutaneous vasculitis1,2
Croatian: Sweetov sindrom (akutna febrilna dermatoza)1,2; kožni vaskulitis1,2
English: Do not shake Pelmeg vigorously as this may affect its activity.
Croatian: Ne tresite snažno Pelmeg jer to može utjecati na aktivnost lijeka.
English: If you have forgotten a dose of Pelmeg, you should contact your doctor to discuss when you should inject the next dose.
Croatian: Ako zaboravite primijeniti dozu lijeka Pelmeg, upitajte liječnika kada biste trebali injicirati sljedeću dozu.
English: Pelmeg may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Croatian: Pelmeg se može izložiti sobnoj temperaturi (ne višoj od 30 ºC) tijekom jednokratnog razdoblja od najviše 96 sati.
English: If you forget to inject Pelmeg
Croatian: Ako ste zaboravili primijeniti Pelmeg
English: Your doctor will check your blood and urine regularly as Pelmeg can harm the tiny filters inside your kidneys (glomerulonephritis).
Croatian: Liječnik će Vam redovito provjeravati krv i mokraću jer Pelmeg može oštetiti sitne filtre unutar bubrega (glomerulonefritis).
English: Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pelmeg.
Croatian: Slučajno izlaganje Pelmega temperaturama zamrzavanja u dva zasebna vremenska razdoblja, svako u trajanju kraćem od 72 sata, nema štetan utjecaj na stabilnost Pelmega.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,6 ml
English: The safety and efficacy of Pelmeg administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established.
Croatian: Sigurnost i djelotvornost primjene Pelmega u bolesnika s de novo AML-om mlađih od 55 godina s citogenetskim nalazom t (15;17) nisu ustanovljene.
English: Pelmeg has no or negligible effect on the ability to drive or use machines.
Croatian: Pelmeg ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Croatian:  ako ste alergični na pegfilgrastim, filgrastim, proteine dobivene iz E. coli ili neki drugi sastojak ovog lijeka.
English: For further instructions on how to inject yourself with Pelmeg, please read the section at the end of this leaflet.
Croatian: Dodatne upute o tome kako samostalno primjenjivati Pelmeg potražite u dijelu na kraju ove upute o lijeku.
English: You may take Pelmeg out of the refrigerator and keep it at room temperature (not above 30° C) for no longer than 4 days.
Croatian: Pelmeg možete izvaditi iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 30 ºC), ali ne dulje od 4 dana.
English: Pelmeg is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Pelmeg tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: What Pelmeg looks like and contents of the pack Pelmeg is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Croatian: Kako Pelmeg izgleda i sadržaj pakiranja Pelmeg je bistra, bezbojna otopina za injekciju u napunjenoj štrcaljki (6 mg/0,6 ml).
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelmeg.
Croatian: Prijavljene su teške kožne reakcije (Stevens-Johnsonov sindrom) povezane s primjenom lijeka
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Croatian: * Proizveden u stanicama Escherichia coli tehnologijom rekombinantne DNA i zatim konjugiran s polietilenglikolom (PEG).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Croatian: Stevens-Johnsonov sindrom, koji se može pojaviti kao crvenkaste mrlje u obliku mete ili kružne mrlje često sa središnjim mjehurićima na trupu, ljuštenje kože, vrijedovi u ustima, grlu, nosu, na genitalijama i očima, čemu može prethoditi vrućica i simptomi nalik gripi.
English: Your doctor has given you Pelmeg to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Croatian: Liječnik Vam je propisao Pelmeg za poticanje funkcije koštane srži (dio kosti koji stvara krvne stanice) kako bi stvorila više bijelih krvnih stanica za borbu tijela protiv infekcija.
English: • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Croatian:  zabilježen je Sweetov sindrom (ljubičaste, izdignute, bolne promjene na udovima, i ponekad i na licu i na vratu, praćene vrućicom), no i drugi faktori u tome mogu imati ulogu
English: The safety and efficacy of Pelmeg for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Croatian: Sigurnost i djelotvornost Pelmega u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih davatelja nisu odgovarajuće ispitane.
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Croatian:  oštećenje sitnih filtara unutar bubrega (glomerulonefritis)
English: In such circumstances Pelmeg should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Croatian: U takvim slučajevima, prema procjeni liječnika primjenu Pelmega treba prekinuti i primijeniti odgovarajuće liječenje (vidjeti dio 4.8).
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
Croatian:  ozbiljne alergijske reakcije, uključujući anafilaksiju (slabost, pad krvnog tlaka, otežano disanje,
English: Pinch your injection site to create a firm surface.
Croatian: C Uhvatite nabor kože na mjestu injiciranja kako biste stvorili čvrstu površinu.
English: • breathing problems.
Croatian:  problemi s disanjem.
English: What Pelmeg is and what it is used for
Croatian: Što se nalazi u ovoj uputi: Što je Pelmeg i za što se koristi
English: INFORMATION IN BRAILLE Pelmeg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pelmeg
English: How to use Pelmeg
Croatian: Kako primjenjivati Pelmeg
English: QR code to be included <www.pelmeg.eu>
Croatian: [QR kod www.pelmeg.eu]
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Croatian:  bolovi općenito te bolovi u zglobovima i mišićima  moguće su i promjene u krvi, ali one će se otkriti prilikom rutinskih krvnih pretraga.
English: In order to improve the traceability of biologic medicinal products, the tradename and the batch number of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati u zdravstvenom kartonu bolesnika.
English: 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 %).
Croatian: 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 %).
English: Manufacturer PharmaKorell GmbH Marie-Curie-Strasse 8 D-79539 Lörrach Germany
Croatian: PharmaKorell GmbH Marie-Curie-Strasse 8 79539 Lörrach
English: The safety and efficacy of Pelmeg have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Croatian: Sigurnost i djelotvornost Pelmega nisu ispitivane u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnim AML-om, stoga se lijek ne smije primjenjivati u tih bolesnika.
English: Pulmonary hemorrhage
Croatian: hemoptiza plućna hemoragija
English: Pelmeg contains the active substance pegfilgrastim.
Croatian: Pelmeg sadrži djelatnu tvar pegfilgrastim.
English: Inspect the medicine and pre-filled syringe.
Croatian: C Provjerite lijek i napunjenu štrcaljku
English: Pelmeg is used in adult patients 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).
Croatian: Pelmeg se primjenjuje u odraslih bolesnika za smanjenje trajanja neutropenije (smanjeni broj bijelih krvnih stanica) i pojave febrilne neutropenije (smanjeni broj bijelih krvnih stanica praćen vrućicom), koje se mogu pojaviti uslijed primjene citotoksične kemoterapije (lijekova koji uništavaju brzorastuće stanice).
English: Pelmeg contains sorbitol (E 420) and sodium acetate
Croatian: Pelmeg sadrži sorbitol (E420) i natrijev acetat
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/mL and 29.3 ± 23.2 μg·hr/mL, respectively) (see section 5.1).
Croatian: Djeca u najmlađoj dobnoj skupini (0 - 5 godina) imala su veću srednju vrijednost izloženosti pegfilgrastimu (AUC) (± standardno odstupanje) (47,9 ± 22,5 μg·h/ml) u odnosu na stariju djecu u dobi 6 - 11 godina, odnosno 12 - 21 godine (22,0 ± 13,1 μg·h/ml te 29,3 ± 23,2 μg·h/ml) (vidjeti dio 5.1).
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Croatian: Glomerulonefritis Prijavljen je glomerulonefritis u bolesnika koji su primali filgrastim i pegfilgrastim.
English: • allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
Croatian:  reakcije alergijskog tipa, uključujući crvenilo i navale crvenila, osip na koži, izdignuta područja kože koja svrbe
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Pelmeg should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Croatian: Zbog moguće osjetljivosti brzo dijelećih mijeloidnih stanica na citotoksičnu kemoterapiju, Pelmeg treba primijeniti najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: Permanently discontinue Pelmeg in patients with clinically significant hypersensitivity.
Croatian: Liječenje Pelmegom mora se trajno prekinuti u bolesnika koji razviju klinički značajnu preosjetljivost.
English: Instructions for use Guide to parts
Croatian: Priručnik o dijelovima
English: The safety and efficacy of Pelmeg have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Croatian: Sigurnost i djelotvornost Pelmega nisu ispitivane u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Croatian: Sindrom povećane propusnosti kapilara Sindrom povećane propusnosti kapilara prijavljen je nakon primjene faktora stimulacije rasta granulocita, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
English: The safety and efficacy of Pelmeg have not been investigated in patients receiving high dose chemotherapy.
Croatian: Nisu provedena ispitivanja sigurnosti i djelotvornosti Pelmega u bolesnika koji primaju visokodoznu kemoterapiju.
English: Do not administer Pelmeg to patients with a history of hypersensitivity to pegfilgrastim or filgrastim.
Croatian: Pelmeg se ne smije primjenjivati kod bolesnika s preosjetljivosti na pegfilgrastim ili filgrastim u anamnezi.
English: • if you have sickle cell anaemia.
Croatian:  ako bolujete od anemije srpastih stanica.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: One 6 mg dose (a single pre-filled syringe) of Pelmeg is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Jednokratna doza Pelmega od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: • The active substance is pegfilgrastim.
Croatian:  Djelatna tvar je pegfilgrastim.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Croatian: 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
English: StevensJohnson syndrome
Croatian: Stevens-John sonov sindrom
English: 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.
Croatian: može potaknuti rast mijeloidnih stanica, uključujući zloćudne stanice, in vitro, a slični učinci mogu se primijetiti i na nekim nemijeloidnim stanicama in vitro.
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva bol u kostima mišićno-koštana bol (mijalgija, artralgija, bol u udovima, bol u leđima, mišićno koštana bol, bol u vratu)
English: • if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
Croatian: Vam je poremećen broj krvnih stanica (npr. povećanje broja bijelih krvnih stanica ili anemija) ili smanjen broj krvnih pločica što može uzrokovati poremećaje u zgrušavanju (trombocitopenija).
English: Therefore, physicians should use caution when prescribing Pelmeg in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Croatian: pažljivo pratiti odgovarajuće kliničke i laboratorijske parametre te paziti na moguću povezanost ovog lijeka s povećanjem slezene i vazookluzivnom krizom.
English: Concomitant use of Pelmeg with any chemotherapy agent has not been evaluated in patients.
Croatian: Istodobna primjena Pelmega i kemoterapije nije procijenjena u bolesnika.
English: Pelmeg is injected subcutaneously.
Croatian: Pelmeg se injicira supkutano.
English: There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk a risk to the newborns/infants cannot be excluded.
Croatian: Nema dovoljno podataka o izlučivanju pegfilgrastima/metabolita u majčino mlijeko.
English: Open the tray, peeling away the cover.
Croatian: B Otvorite podložak odvajanjem pokrova.
English: • The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections.
Croatian:  Drugi sastojci su natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg /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
Croatian: U drugom ispitivanju (n = 310), u kojemu je primjenjivana doza prilagođena tjelesnoj težini (100 μg/kg), srednja vrijednost trajanja neutropenije 4. stupnja u skupini liječenoj pegfilgrastimom iznosila je 1,7 dana, u usporedbi s 1,8 dana u skupini liječenoj filgrastimom (razlika
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 koji mogu biti povezani s rjeđim mokrenjem, otežano disanje, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: Do not use Pelmeg if
Croatian: Nemojte primjenjivati Pelmeg
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
English: • Bleeding from the lung (pulmonary haemorrhage).
Croatian:  krvarenje iz pluća (plućna hemoragija).
English: • 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 pojaviti u do 1 na 1000 osoba)  upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), pogledajte dio 2
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 12 - 21 godina
English: Pelmeg 6 mg solution for injection in pre-filled syringe
Croatian: Pelmeg 6 mg otopina za injekciju u napunjenoj štrcaljki
English: Transient elevations in
Croatian:  povećanje slezene
English: If you use more Pelmeg than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Pelmeg nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
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: U jednom ispitivanju (n = 157), u kojemu je primjenjivana fiksna doza pegfilgrastima od 6 mg, srednja vrijednost trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosila je 1,8 dana, a 1,6 dana u skupini koja je primala filgrastim (razlika od 0,23 dana,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Pelmeg 6 mg solution for injection in pre-filled syringe pegfilgrastim
Croatian: Pelmeg 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Croatian: Splenomegalija i ruptura slezene Nakon primjene pegfilgrastima prijavljeni su obično asimptomatski slučajevi splenomegalije i rupture slezene, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
Croatian: Ovo mogu biti znakovi stanja koje se zove „sindrom povećane propusnosti kapilara“ koji uzrokuje istjecanje krvi iz malih krvnih žila unutar tijela.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat* sorbitol (E420) polisorbat 20 voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Step 2: Get ready A Wash your hands thoroughly.
Croatian: 2. korak: Pripremite se
English: Excipients: sodium acetate, sorbitol (E 420), polysorbate 20, and water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev acetat, sorbitol (E420), polisorbat 20 i voda za injekcije.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelmeg.
Croatian: Kada primjenjujete Pelmeg morate prekinuti s dojenjem, osim ako Vam je liječnik savjetovao drugačije.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Croatian: Pedijatrijska populacija Farmakokinetika pegfilgrastima ispitivana je u 37 pedijatrijskih bolesnika sa sarkomom koji su primali
English: How to store Pelmeg
Croatian: Moguće nuspojave Kako čuvati Pelmeg
English: NAME OF THE MEDICINAL PRODUCT Pelmeg 6 mg solution for injection pegfilgrastim NAME OF THE MARKETING AUTHORISATION HOLDER Mundipharma EXPIRY DATE
Croatian: NAZIV LIJEKA Pelmeg 6 mg otopina za injekciju pegfilgrastim NAZIV NOSITELJA
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: Aortitis 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 experience a cough, fever and difficulty breathing.
Croatian: Molimo da obavijestite svog liječnika ako kašljete, imate vrućicu ili otežano dišete.
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se pojaviti u manje od 1 na 100 osoba):
English: Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Croatian: (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza);
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch
Croatian:  ako imate alergijsku reakciju koja uključuje slabost, pad krvnog tlaka, otežano disanje, oticanje lica (anafilaksa), crvenilo i navale crvenila, osip na koži ili područja kože koja svrbe  ako počnete kašljati, imate vrućicu ili otežano disanje; to može biti znak sindroma akutnog respiratornog distresa
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Pelmeg Lijek čuvajte izvan pogleda i dohvata djece.
English: Median Serum Pegfilgrastim Conc.
Croatian: Pelmeg 6 mg pegfilgrastim s.c.