FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will also check your urine regularly as other medicines similar to this one (e.g. other granulocyte colony stimulating factors such as filgrastim, lenograstim or pegfilgrastim) can possibly harm the tiny filters inside your kidneys (glomerulonephritis; see section “4.
Croatian: Vaš će liječnik također redovito provjeravati Vašu mokraću, jer drugi lijekovi slični ovome (npr. drugi faktori stimulacije granulocitnih kolonija poput filgrastima, lenograstima ili pegfilgrastima) mogu oštetiti sićušne filtre u Vašim bubrezima (glomerulonefritis, pogledajte dio 4 „Moguće nuspojave”).
English: In animal models, concomitant administration of G-CSF and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Croatian: Na životinjskim modelima, pokazano je da istovremena primjena G-CSF i 5-fluorouracila (5-FU) ili drugih antimetabolita pojačava mijelosupresiju.
English: Lonquex does not contain any preservative.
Croatian: Lonquex ne sadrži nikakve konzervanse.
English: In such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given.
Croatian: U takvim okolnostima potrebno je prekinuti primjenu Lonquexa prema prosudbi liječnika i dati odgovarajuće liječenje.
English: The incidence of FN varied according to age (from 14.3 % to 71.4 %), with the highest frequency in the oldest age group.
Croatian: (od 14,3 % do 71,4 %) s najvećom učestalošću u najstarijoj dobnoj skupini.
English: When the main study was finalised, the incidence of death was 7.2 % (placebo) and 12.5 % (6 mg lipegfilgrastim) although after the 360-day follow-up period the overall incidence of death was similar between placebo and lipegfilgrastim (44.8 % and 44.0 %; safety population).
Croatian: Kad je dovršeno glavno ispitivanje, incidencija smrtnih slučajeva bila je 7,2 % (placebo) i 12,5 % (6 mg lipegfilgrastima), iako nakon razdoblja praćenja od 360 dana, ukupna incidencija smrti bila je slična između placeba i lipefilgrastima (44,8 % odnosno 44,0 %; populacija na kojoj je ispitana sigurnost).
English: If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Croatian: Ako su prisutni mjehurići zraka, nježno kucnite prstom po štrcaljki sve dok se mjehurići zraka ne podignu do vrha štrcaljke.
English: As a precautionary measure, it is preferable to avoid the use of Lonquex during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Lonquex tijekom trudnoće.
English: • Do not put the cover back on used needles.
Croatian: Nemojte vraćati poklopac na upotrijebljenu iglu.
English: If you use more Lonquex than you should
Croatian: Ako primijenite više Lonquexa nego što ste trebali
English: The adverse reactions listed below in table 1 are classified according to system organ class.
Croatian: Niže navedene nuspojave u tablici 1 kategorizirane su prema klasifikaciji organskih sustava.
English: Lonquex contains sorbitol and sodium
Croatian: Lonquex sadrži sorbitol i natrij
English: See section 4.2.
Croatian: Vidjeti dio 4.2.
English: • a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Croatian: - neprobojni spremnik (plastični spremnik koji se može nabaviti u bolnici ili ljekarni) tako da u njega možete na siguran način odložiti upotrijebljene štrcaljke.
English: Do not use this medicine if you notice that it is cloudy or there are particles in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je zamućen ili da sadrži čestice.
English: Median ANC (x 109 cells/l)
Croatian: Medijan ABN (x 109 stanica/l)
English: How to prepare for your injection
Croatian: Kako se pripremiti za injekciju
English: The angle between the syringe and skin should not be too narrow (at least 45°, see picture 8).
Croatian: Kut između štrcaljke i kože ne smije biti preoštar (najmanje 45°, vidjeti sliku 8).
English: Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity.
Croatian: Bolesnici koji su preosjetljivi na G-CSF ili derivate također su pod rizikom od reakcija preosjetljivosti na lipegfilgrastim zbog moguće ukrižene reakcije.
English: In this limited study XM22-06, bioavailability of lipegfilgrastim and observed differences among the injection sites were higher in male subjects compared to female subjects.
Croatian: U ovom ograničenom ispitivanju XM22-06, bioraspoloživost lipegfilgrastima i opažene razlike među mjestima primjene injekcija bile su više u muškaraca nego u žena.
English: ● At the request of the European Medicines Agency;
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Croatian: Povucite malo klip kako biste provjerili da niste probili krvnu žilu.
English: • Damage to the tiny filters inside your kidneys (glomerulonephritis; see section 2 under
Croatian: • oštećenje sićušnih filtera u Vašim bubrezima (glomerulonefritis, pogledajte dio 2 pod
English: 0.121 to 1.260
Croatian: 0,121 do 1,260
English: The maximum blood concentrations were reached after a median time (tmax) of 23.9 hours, 30.0 hours and 95.8 hours, respectively.
Croatian: Maksimalna koncentracija u krvi dosegnuta je nakon medijana vremena (tmax) od 23,9 sati, 30,0 sati, odnosno 95,8 sati.
English: Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound).
Croatian: Stoga je potrebno pažljivo pratiti veličinu slezene (npr. kliničkim pregledom, ultrazvukom).
English: The angle between the syringe and skin should not be too narrow (at least 45°, see picture 7).
Croatian: Kut između štrcaljke i kože ne smije biti preoštar (najmanje 45°, vidjeti sliku 7).
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Croatian: Posebnu je pažnju potrebno posvetiti kako bi se razlikovala dijagnoza blastične transformacije kronične mijeloične leukemije od akutne mijeloične leukemije.
English: It could be a consequence of a spleen disorder (see section4 “Possible side effects”).
Croatian: To može biti posljedica poremećaja slezene (vidjeti dio 4. „Moguće nuspojave”).
English: These could be symptoms of a condition reported with frequency not known (cannot be estimated from the available data), 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 simptomi stanja zabilježenog s nepoznatom učestalošću (ne može se procijeniti iz dostupnih podataka), koje se naziva „sindrom povećane propusnosti kapilara“ koji uzrokuje izlaženje krvi iz malih krvnih žila unutar tijela i zahtijeva hitnu liječničku pomoć.
English: 2031 GA Haarlem Netherlands
Croatian: 2031 GA Haarlem Nizozemska
English: The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim.
Croatian: Sigurnost lipegfilgrastima procijenjena je na temelju rezultata kliničkih ispitivanja u 506 bolesnika i 76 zdravih dobrovoljaca koji su najmanje jedanput bili liječeni lipegfilgrastimom.
English: • Plum-coloured raised painful sores on the limbs and sometimes the face and neck with fever
Croatian: • uzdignute bolne ranice ljubičaste boje na udovima te ponekad na licu i vratu, s vrućicom
English: 0.206 to 0.512
Croatian: 0,206 do 0,512
English: Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called Escherichia coli.
Croatian: Lipegfilgrastim je dugodjelujući modificirani protein proizveden biotehnologijom u bakteriji koja se zove Escherichia coli.
English: It is important to 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: Važno je odmah javiti se liječniku ako osjetite bol u gornjoj lijevoj strani trbuha ili u lijevom ramenu budući da to može biti povezano s tegobama sa slezenom.
English: Drug-specific antibodies emerging after start of treatment were detected in 0.86 % of the subjects receiving lipegfilgrastim, in 1.06 % of the subjects receiving pegfilgrastim and in 1.65 % of the subjects receiving placebo.
Croatian: Specifična protutijela na lijek koja su se pojavila nakon početka liječenja otkrivena su u 0,86 % ispitanika koji su primali lipegfilgrastim, u 1,06 % ispitanika koji su primali pegfilgrastim i u 1,65 % ispitanika koji su primali placebo.
English: Median serum concentration of lipegfilgrastim (ng/ml)
Croatian: Medijan serumske koncentracije lipegfilgrastima (ng/ml)
English: • Musculoskeletal pains such as bone pain and pain in the joints, muscles, limbs, chest, neck or back.
Croatian: • mišićno-koštana bol, primjerice bol u kostima i bol u zglobovima, mišićima, udovima, prsnom košu, vratu ili leđima.
English: Therefore, lipegfilgrastim is not likely to affect metabolism via human cytochrome P450 enzymes.
Croatian: Stoga lipegfilgrastim najvjerojatnije neće utjecati na metabolizam putem enzima citokroma P450.
English: Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja G-CSF i derivata na životinjama ne ukazuju na štetne učinke na plodnost (vidjeti dio 5.3).
English: • if you have sickle cell anaemia, which is an inherited disease characterised by sickle-shaped red blood cells.
Croatian: • ako imate anemiju srpastih stanica, što je nasljedna bolest čija je značajka srpasti oblik crvenih krvnih stanica.
English: • It is important to contact your doctor immediately if you have any of the following symptoms: 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: • Važno je da se odmah obratite liječniku ako imate bilo koji od sljedećih simptoma: oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, otežano disanje, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: Lonquex should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Croatian: Lonquex se ne smije primjenjivati kako bi se doza citotoksičnih kemoterapeutika povisila iznad ustanovljenih režima doziranja.
English: Elevations in alkaline phosphatase and lactate dehydrogenase most likely originate from the increase in neutrophils.
Croatian: Porast alkalne fosfataze i laktat dehidrogenaze najvjerojatnije proizlaze iz povećanja broja neutrofila.
English: Check the appearance of Lonquex.
Croatian: Provjerite izgled lijeka Lonquex.
English: These findings are consistent with results from G-CSF and derivatives.
Croatian: Ovi nalazi sukladni su rezultatima ispitivanja G-CSF i derivata.
English: - Aortitis (see section 4.4)
Croatian: Aortitis (vidjeti dio 4.4)
English: In a study of toxicity to reproduction and development in rabbits, an increased incidence of post-implantation loss and abortion has been observed at high doses of lipegfilgrastim, likely owing to
Croatian: U ispitivanju toksičnosti za reprodukciju i razvoj na kunićima, povećana incidencija gubitaka nakon implantacije i pobačaja opažena je pri visokim dozama lipegfilgrastima, najvjerojatnije zbog prejakog
English: The use of three different chemotherapy regimens, with varying myelosuppressive effects and age distributions, complicated the comparison of efficacy across age groups (see section 4.2).
Croatian: Primjena tri različita protokola kemoterapije, uz različite mijelosupresivne učinke i dobne raspodjele, otežala je usporedbu djelotvornosti među dobnim skupinama (vidjeti dio 4.2).
English: The results of the study are presented in table 3.
Croatian: Rezultati ispitivanja prikazani su u tablici
English: • Local reactions at the injection site, such as pain or hardening.
Croatian: • lokalne reakcije na mjestu primjene injekcije, kao što su bol i otvrdnuće
English: After subcutaneous injection of 6 mg lipegfilgrastim at three different sites (upper arm, abdomen and thigh) in healthy volunteers, the bioavailability (peak concentration and area under the curve [AUC]) was lower after subcutaneous injection in the thigh compared to subcutaneous injection in the abdomen and in the upper arm.
Croatian: Nakon supkutane injekcije 6 mg lipegfilgrastima na tri različita mjesta (nadlaktica, abdomen i natkoljenica) u zdravih dobrovoljaca, bioraspoloživost (vršna koncentracija i površina ispod krivulje [AUC]) bila je niža nakon supkutane injekcije u natkoljenicu u odnosu na subkutanu injekciju u abdomen i nadlakticu.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni kako da sami sebi date injekciju ili imate dodatnih pitanja, molimo da se obratite liječniku ili medicinskoj sestri za pomoć.
English: **Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in Escherichia coli cells by recombinant DNA technology.
Croatian: **Filgrastim (rekombinantni metionilni humani faktor stimulacije granulocitnih kolonija [G-CSF]) proizvodi se u stanicama Escherichia coli tehnologijom rekombinantne DNK.
English: You will need to give yourself the injection into the tissue just under the skin.
Croatian: Trebat ćete si dati injekciju u tkivo neposredno ispod kože.
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Croatian: Pritisnite mjesto injekcije komadićem zavoja od gaze ili sterilnom gazom na nekoliko sekundi.
English: Do not use any Lonquex that is left in the syringe.
Croatian: Nemojte primijeniti Lonquex koji je preostao u štrcaljki.
English: Treatment-related adverse events were back pain, bone pain and increased neutrophil count (1 event each).
Croatian: Štetni događaji povezani s liječenjem bili su bol u leđima, bol u kostima i povećan broj neutrofila (jedan slučaj svakog događaja).
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal 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: Hypersensitivity reactions such as allergic skin reactions, urticaria, angioedema and serious allergic reactions may occur.
Croatian: Mogu nastati reakcije preosjetljivosti, kao što su alergijske kožne reakcije, urtikarija, angioedem i ozbiljne alergijske reakcije.
English: Once removed from the refrigerator, the medicine must be used within this period or disposed of.
Croatian: Nakon što se jednom izvadi iz hladnjaka, lijek se mora primijeniti u tom razdoblju ili baciti.
English: *See section “Description of selected adverse reactions” below Description of selected adverse reactions
Croatian: “Opis odabranih nuspojava”, niže Opis odabranih nuspojava
English: • Rise in white blood cells.
Croatian: • povećanje broja bijelih krvnih stanica
English: Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim.
Croatian: Lipegfilgrastim se veže za receptor humanog G-CSF poput filgrastima i pegfilgrastima.
English: If WBC counts exceed 50 x 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately.
Croatian: Ako broj leukocita premaši 50 x 109/l nakon očekivanog pada na najnižu vrijednost, potrebno je odmah prekinuti primjenu lipegfilgrastima.
English: An analysis of anti-drug antibodies of 579 patients and healthy volunteers treated with lipegfilgrastim, 188 patients and healthy volunteers treated with pegfilgrastim and 121 patients treated with placebo was performed.
Croatian: Provedena je analiza protutijela na lijek kod 579 bolesnika i zdravih dobrovoljaca liječenih lipegfilgrastimom, 188 bolesnika i zdravih dobrovoljaca liječenih pegfilgrastimom i 121 bolesnika liječenih placebom.
English: Lonquex has no or negligible influence on the ability to drive and use machines.
Croatian: Lonquex ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: -0.461 to 0.089
Croatian: -0,461 do 0,089
English: Musculoskeletal pain is generally of mild to moderate severity, transient and can be controlled in most patients with standard analgesics.
Croatian: Mišićno koštana bol općenito je blage do umjerene težine, prolazne naravi i u većine se bolesnika može kontrolirati standardnim analgeticima.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Croatian: Bolesnici koji razviju simptome sindroma povećane propusnosti kapilara moraju se pažljivo nadzirati i primiti standardno simptomatsko liječenje, koje može uključivati i potrebu za intenzivnom njegom (vidjeti dio 4.8).
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i na naljepnici napunjene štrcaljke iza oznake „EXP“.
English: • Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported uncommonly (may affect up to 1 in 100 people).
Croatian: • Alergijske reakcije kao što su kožni osip, odignuta područja na koži koja svrbe i ozbiljne alergijske reakcije sa slabošću, padom krvnog tlaka, otežanim disanjem i otokom lica bile su zabilježene manje često (mogu se javiti u do 1 na 100 osoba).
English: Breast-feeding should be discontinued during treatment with Lonquex.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Lonquex.
English: You should therefore interrupt breast-feeding during treatment..
Croatian: Stoga tijekom liječenja trebate prekinuti dojenje.
English: • Increased spleen size has been reported uncommonly and cases of splenic ruptures have been reported with other medicines similar to Lonquex.
Croatian: • Povećana slezena zabilježena je manje često i slučajevi prsnuća slezene zabilježeni su uz druge lijekove slične Lonquexu.
English: If you have any problems, please ask your doctor or nurse for help and advice.
Croatian: Ako imate poteškoća, molimo da se obratite svom liječniku ili medicinskoj sestri za pomoć i savjet.
English: While the plunger is still pressed all the way down, remove the needle from the skin (see picture 10).
Croatian: Dok je klip i dalje potisnut do kraja, izvucite iglu iz kože (vidjeti sliku 10).
English: There is no evidence that lipegfilgrastim is teratogenic.
Croatian: Nema dokaza da je lipegfilgrastim teratogen.
English: The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS) (see section 4.8).
Croatian: Početak plućnih simptoma kao što su kašalj, vrućica i dispneja povezani s radiološkim znakovima plućnih infiltrata i pogoršanja plućne funkcije zajedno s povišenim brojem neutrofila mogu biti preliminarni znakovi akutnog respiratornog distres-sindroma (ARDS) (vidjeti dio 4.8).
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
Croatian: Faktor stimulacije granulocitnih kolonija može poticati rast mijeloidnih stanica i nekih nemijeloidnih stanica in vitro.
English: Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy.
Croatian: Liječenje s lipegfilgrastimom ne sprječava trombocitopeniju i anemiju koje su uzrokovane mijelosupresivnom kemoterapijom.
English: These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly-growing cells).
Croatian: Ta stanja može uzrokovati primjena citotoksične kemoterapije (lijekova koji uništavaju stanice koje se brzo dijele).
English: What Lonquex looks like and contents of the pack
Croatian: Kako Lonquex izgleda i sadržaj pakiranja
English: Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells.
Croatian: Lipegfilgrastim potiče koštanu srž (tkivo u kojem se stvaraju nove krvne stanice) na pojačano stvaranje bijelih krvnih stanica.
English: Physicians should therefore exercise caution when administering Lonquex in patients with sickle cell anaemia, monitor appropriate clinical parameters and laboratory results and be attentive to the possible association of lipegfilgrastim with splenic enlargement and vaso-occlusive crisis.
Croatian: Liječnici stoga trebaju biti oprezni kad primjenjuju Lonquex u bolesnika s anemijom srpastih stanica, pratiti odgovarajuće kliničke parametre i laboratorijske rezultate te paziti na moguću povezanost lipegfilgrastima s povećanjem slezene i vazookluzivnim krizama.
English: Incidence (%) 95 % CI
Croatian: Incidencija (%) 95% CI
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: Each pack contains 1 pre-filled syringe with or without safety device.
Croatian: Jedno pakiranje sadrži 1 napunjenu štrcaljku sa sigurnosnom napravom ili bez nje.
English: Open the blister and take the pre-filled syringe out of the blister (see picture 1).
Croatian: Otvorite blister i izvadite napunjenu štrcaljku iz blistera (vidjeti sliku 1).
English: A trend towards a decrease in lipegfilgrastim exposure was observed with increase in weight.
Croatian: Opažen je trend smanjenja izloženosti lipegfilgrastimu s povećanjem tjelesne težine.
English: • Cough, fever and difficult or painful breathing can be signs of uncommon serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Croatian: • Kašalj, vrućica i otežano ili bolno disanje mogu biti znakovi manje čestih, ozbiljnih plućnih nuspojava, kao što su upala pluća i akutni respiratorni distres-sindrom, koji mogu imati smrtni ishod.
English: Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Croatian: Sindrom povećane propusnosti kapilara prijavljen je nakon primjene G-CSF ili njegovih derivata, a karakteriziraju ga hipotenzija, hipoalbuminemija, edemi i hemokoncentracija.
English: Patients with myeloid leukaemia or myelodysplastic syndromes
Croatian: Bolesnici s mijeloičnom leukemijom ili mijelodisplastičnim sindromima
English: • Never put the syringes that you have used into your normal household rubbish bin.
Croatian: - Nikad nemojte odlagati štrcaljke koje se upotrijebili u kućnu kantu za otpad.
English: The linear pathway is likely due to extracellular protein degradation by neutrophil elastase and other plasma proteases.
Croatian: Linearni put najvjerojatnije je posljedica izvanstanične razgradnje proteina neutrofilnom elastazom i drugim plazmatskim proteazama.
English: Only clear, colourless solutions without particles should be used.
Croatian: Smiju se primijeniti samo bistre, bezbojne otopine koje ne sadrže čestice.