FrancophonIA/ELRC3.0 huggingface dataset:
English: A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Croatian: Izvadite podlogu napunjene štrcaljke iz pakiranja i prikupite pribor potreban za davanje injekcije: alkoholne maramice, pamučnu vatu ili jastučić gaze, flaster i spremnik za odlaganje oštrih predmeta (nije uključeno).
English: Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Croatian: Bol u kostima je uglavnom bila blaga do umjerena, prolazna i u većine bolesnika se mogla kontrolirati standardnim analgeticima.
English: • Dose delivery will start and take about 45 minutes to complete.
Croatian: • Primjena doze će od početka do završetka trajati oko 45 minuta.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicine.
Croatian: Takav je porast broja leukocita prolazan, tipično se uočava od 24 do 48 sati nakon primjene lijeka i u skladu je s farmakodinamičkim učincima ovog lijeka.
English: • what action to take in a suspected case of failed delivery or incomplete delivery of the dose and if symptoms of serious infection that may indicate a missed dose present.
Croatian: • Što poduzeti u u slučaju sumnje na neuspješnu ili djelomičnu primjenu doze, ili ako se jave simptomi ozbiljne infekcije koja može značiti propuštenu dozu.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Croatian: Nuspojave su bile slične onima koje se javljaju kod nižih doza pegfilgrastima.
English: There is a small cannula which sits just under your skin.
Croatian: Odmah ispod Vaše kože nalazi se mala kanila.
English: • The used syringe should be disposed of in accordance with local requirements.
Croatian: • Iskorištene štrcaljke treba zbrinuti u skladu s lokalnim propisima.
English: For subcutaneous use.
Croatian: Za supkutanu primjenu.
English: No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Croatian: Ne preporučuje se promjena doze u bolesnika s oštećenom bubrežnom funkcijom, uključujući i one s terminalnim stadijem bolesti bubrega.
English: • how to monitor the on-body injector
Croatian: • kako nadzirati on-body injektor
English: • damage to the tiny filters inside your kidneys (glomerulonephritis).
Croatian: • oštećenje sitnih filtera unutar bubrega (glomerulonefritis).
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost lijekova koji sadrže faktore stimulacije granulocitnih kolonija (G-CSF), naziv primijenjenog lijeka mora se jasno evidentirati u bolesnikovoj medicinskoj dokumentaciji.
English: Avoid getting lotions, creams, oils or cleaning agents near the on-body injector, as these products may loosen the adhesive.
Croatian: Izbjegavajte nanošenje losiona, krema, ulja i sredstava za čišćenje blizu on-body injektora jer ti proizvodi mogu oslabiti adhezijsko sredstvo.
English: What to do if you hear beeping or when you look at the status light and it is flashing red.
Croatian: Što učiniti ako čujete zvučne signale ili statusna lampica svijetli crveno.
English: Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
Croatian: Moguće interakcije s drugim hematopoetskim faktorima rasta i citokinima nisu posebno ispitivane u kliničkim ispitivanjima.
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Croatian: Pegfilgastrim nije utjecao na svojstva reprodukcije ili plodnost muških i ženskih štakora nakon što su dobivali tjedne kumulativne doze, otprilike 6 do 9 puta više od doza preporučenih za ljude (procjena temeljem površine tijela) (vidjeti dio 5.3).
English: Important: read the package leaflet before handling pre-filled syringe.
Croatian: Važno: Pročitajte uputu o lijeku prije rukovanja napunjenom štrcaljkom.
English: Comprehensive instructions for use for healthcare professionals and patients are given in the package leaflet.
Croatian: Detaljne upute o primjeni za zdravstvene radnike i bolesnike dostupne su u uputi o lijeku.
English: Avoid injecting into areas with scars or stretch marks.
Croatian: Izbjegavajte injicirati u područja s ožiljcima ili strijama.
English: Step 4: Finish
Croatian: Korak 4: Završni korak
English: • If you hear beeping, or when you check the status light and it is flashing red, contact your healthcare provider immediately.
Croatian: • Ako čujete zvučne signale ili ako provjerom ustanovite da statusna lampica svijetli crveno, odmah obavijestite svog zdravstvenog radnika.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see figure 1).
Croatian: U skladu sa samoregulirajućim mehanizmom klirensa, koncentracija pegfilgrastima u serumu brzo opada s početkom oporavka neutrofila (vidjeti sliku 1).
English: Use a new pre-filled syringe and call your doctor or healthcare provider.
Croatian: Upotrijebite novu napunjeno štrcaljku i pozovite svog liječnika ili zdravstvenog djelatnika.
English: Excipients with known effect Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 30 mg sorbitola (E420) (vidjeti dio 4.4).
English: Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Croatian: Neulasta se može izložiti sobnoj temperaturi (ne višoj od 30 °C) jednokratno, tijekom najviše 72 sata.
English: The MAH shall ensure that in each Member State where Neulasta on-body injector is marketed, all patients/carers who are expected to use Neulasta on-body injector are provided with a patient alert card to be disseminated through the prescribing physicians.
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici gdje se na tržište stavlja Neulasta on-body injektor, svi bolesnici/njegovatelji koji će koristiti Neulasta on-body injektor dobiju karticu s upozorenjima za bolesnika od liječnika koji propisuje lijek.
English: • Do not expose the on-body injector to direct sunlight.
Croatian: • Ne izlažite on-body injektor izravnoj sunčevoj svjetlosti.
English: What Neulasta is and what it is used for What you need to know before you use Neulasta How to use Neulasta
Croatian: Što je Neulasta i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Neulasta Kako primjenjivati lijek Neulasta Moguće nuspojave
English: B Grab the edge of the adhesive pad.
Croatian: B Primite rub ljepljive podloge.
English: Ask your caregiver to be nearby for the first use.
Croatian: Zamolite svog njegovatelja da bude prisutan kod prve primjene lijeka.
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Croatian: Stopa stvaranja antitijela protiv pegfilgrastima je u pravilu niska.
English: The on-body injector will use sounds and lights to let you know its status.
Croatian: On-body injektor će Vas zvučnim i svjetlosnim signalima obavijestiti o svom statusu.
English: Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Croatian: Amgen NV Telecomlaan 5-7 1831 Diegem Belgija
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Croatian: Pegfilgrastim je kovalentni konjugat rekombinantnog ljudskog G-CSF-a (r-metHuG-CSF) s jednom molekulom polietilen-glikola (PEG) od 20 kd.
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 DNK i zatim konjugiran s polietilenglikolom (PEG).
English: Hypersensitivity to the active substance or to any of the excipients.
Croatian: Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Croatian: Općenito su se slučajevi glomerulonefritisa riješili nakon smanjenja doze ili prestanka primjene filgrastima i pegfilgrastima.
English: Equipment that you need
Croatian: Potrebni pribor
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: Bolesnike koji razviju sindrom povećane propusnosti kapilara mora se pažljivo nadzirati i primijeniti uobičajenu simptomatsku terapiju, koja može uključivati i potrebu za intenzivnim liječenjem (vidjeti dio 4.8).
English: The least-squares geometric mean ratios (90% CIs) (on-body injector to manual injection) were 0.97 (0.83, 1.14) for Cmax and 1.00 (0.84, 1.20) for AUC0-inf within the pre-specified bioequivalence limit of 0.80 to 1.25, and established bioequivalence between the two delivery methods of a single 6 mg dose of pegfilgrastim.
Croatian: Omjeri geometrijskih sredina dobivenih metodom najmanjih kvadrata (90% CI) (on-body injektor naspram ručnoj injekciji) bili su 0,97 (0,83, 1,14) za Cmax i 1,00 (0,84, 1,20) za AUC0-inf unutar prethodno definirane granice bioekvivalencije od 0,80 do 1,25 i utvrđene bioekvivalencije između dvije metode primjene jednokratne doze pegfilgrastima od 6 mg.
English: • the abdomen, except for the area around the navel.
Croatian: • trbuh, osim područja oko pupka.
English: Your doctor has given you Neulasta 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 lijek Neulasta za poticanje funkcije koštane srži (dio kosti koji stvara krvne stanice) kako bi stvorila više bijelih krvnih stanica za borbu tijela protiv infekcija.
English: Allergies
Croatian: Alergije
English: What Neulasta looks like and contents of the pack
Croatian: Vidjeti dio 2. Kako Neulasta izgleda i sadržaj pakiranja
English: Splenomegaly and splenic rupture
Croatian: Splenomegalija i ruptura slezene
English: If you develop or are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your doctor.
Croatian: Ukoliko imate ili postoji neposredna opasnost od razvoja oblika raka krvi, ne biste trebali primjenjivati Neulastu, osim u slučaju da je to savjet Vašeg liječnika.
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: Contact your healthcare provider immediately.
Croatian: Odmah obavijestite svog zdravstvenog radnika.
English: Some cases of splenic rupture were fatal.
Croatian: Neki slučajevi prsnuća slezene su imali smrtni ishod.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Croatian: Ove su nuspojave uočene nakon stavljanja lijeka u promet, ali ne i u randomiziranim, kontroliranim kliničkim ispitivanjima u odraslih bolesnika.
English: • during the monitoring of your on-body injector you are concerned that it is leaking; or
Croatian: • tijekom praćenja svog on-body injektora posumnjate da uređaj propušta; ili
English: • If the status light is flashing red, you may not have received your full dose and you may need a replacement dose.
Croatian: • Ako statusna lampica svijetli crveno, možda niste primili cijelu dozu; možda ćete trebati nadomjesnu dozu.
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: • Sweetov sindrom (ljubičaste, izdignute, bolne promjene na udovima, i ponekad i na licu i na vratu, praćene vrućicom) se pojavljivao, no i drugi faktori u tome mogu imati ulogu.
English: • general aches and pains in the joints and muscles.
Croatian: • bolovi općenito te bolovi u zglobovima i mišićima.
English: Red flashing status light
Croatian: Crveno treptajuće svjetlo statusne lampice
English: • Belly, except for a 5 cm (2-inch) area right around your belly button.
Croatian: • Trbuh, osim u području od 5 cm oko pupka.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Turn the plunger to move the label into a position where you can remove the syringe label.
Croatian: Okrenite klip u položaj da možete odlijepiti naljepnicu štrcaljke.
English: • after the injection is complete you are concerned that you may not have received the full dose.
Croatian: • nakon što je injekcija primijenjena posumnjate da niste primili cijelu dozu.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Croatian: Ljudski faktor stimulacije rasta granulocita (G-CSF) je glikoprotein, koji regulira stvaranje i otpuštanje neutrofila iz koštane srži.
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: • 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.
English: Step 3: Inject A Hold the pinch.
Croatian: Korak 3: Injiciranje A Držite nabor kože.
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.
Croatian: U otvorenom ispitivanju pojedinačne doze (n = 31) različiti stadiji oštećenja funkcije bubrega, uključujući terminalni stadij bolesti, nisu utjecali na farmakokinetiku pegfilgrastima.
English: Neulasta has no or negligible effect on the ability to drive or use machines.
Croatian: Neulasta ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: “BEEPS”
Croatian: „BIP“
English: Pegfilgrastim has no or negligible influence on the ability to drive and use machines.
Croatian: Pegfilgrastim ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could dislodge the cannula leading to a missed or incomplete dose of Neulasta.
Croatian: • Injektor ima samoljepljivu podlogu kako bi se pričvrstio na kožu, ne koristite dodatna sredstva kako biste ga pričvrstili jer to može izmaknuti kanilu i dovesti do propuštene ili nepotpune doze lijeka Neulasta.
English: Urinalysis monitoring is recommended.
Croatian: Preporučuje se praćenje rezultata analize urina.
English: Clean the injection site with an alcohol wipe.
Croatian: Očistite mjesto injiciranja vatom natopljenom alkoholom.
English: Your doctor may decide that it would be more convenient for you to use Neulasta with the on-body injector.
Croatian: Vaš liječnik može odlučiti da bi Vam bilo pogodnije primjenjivati lijek Neulasta pomoću on-body injektora.
English: The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Croatian: Mehanizam nastanka vaskulitisa u bolesnika koji primaju pegfilgrastim nije poznat.
English: After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Croatian: Nakon što ste oslobodili klip, sigurnosni štitnik napunjene štrcaljke prekrit će iglu za injekciju.
English: Dispose of it in a sharps disposal container as instructed by your healthcare provider or in accordance with local requirements.
Croatian: Odložite ga u spremnik za odlaganje oštrih predmeta po uputama Vašeg zdravstvenog radnika ili u skladu s nacionalnim propisima.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Croatian: Pojava plućnih simptoma, kao što su kašalj, vrućica i dispneja, povezanih s radiološkim znacima plućnih infiltrata i pogoršanjem funkcije pluća uz povišen broj neutrofila mogu biti prethodni znaci akutnog respiratornog distres sindroma (ARDS).
English: Disposing of used syringes
Croatian: Uklanjanje upotrijebljenih štrcaljki
English: Do not try to do this yourself, as you may accidently move it and dislodge the cannula from your skin leading to a missed or incomplete dose of Neulasta.
Croatian: Ne pokušavajte ovo raditi sami jer biste mogli slučajno pomaknuti on-body injektor i ukloniti kanilu iz kože što će dovesti do propuštene ili nepotpune doze Neulaste.
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 do < 1/100) u bolesnika s rakom koji su na kemoterapiji nakon primjene faktora stimulacije rasta granulocita; vidjeti dio 4.4 i dio „Opis odabranih nuspojava“ ispod.
English: Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, which becomes saturated at higher doses.
Croatian: Čini se da se pegfilgrastim uglavnom eliminira klirensom posredovanim neutrofilima, koji postaje zasićen pri višim dozama.
English: • if you experience a cough, fever and difficulty breathing.
Croatian: • ako počnete kašljati, imate vrućicu ili otežano disanje.
English: The pre-filled syringe for use with the on-body injector may be exposed at room temperature for no longer than 36 hours prior to filling the on-body injector.
Croatian: Napunjena štrcaljka za uporabu s on-body injektorom može se izložiti sobnoj temperaturi ne dulje od 36 sati prije punjenja on-body injektora.
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Croatian: U skladu s kliničkim učincima i mogućnošću razvoja leukocitoze, tijekom trajanja liječenja treba redovito kontrolirati broj leukocita.
English: The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
Croatian: Sigurnost i djelotvornost Neulaste u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih davatelja nije odgovarajuće ispitana.
English: If leukocyte counts exceed 50 x 10
Croatian: Ako broj leukocita nakon očekivane najniže vrijednosti prelazi 50 x 10
English: A Your dose delivery will take around 45 minutes to complete.
Croatian: Primanje doze traje otprilike 45 minuta.
English: Do not use any Neulasta that is left in the syringe.
Croatian: Ne koristite lijek Neulasta koja je ostala u štrcaljki.
English: Do not remove the on-body injector at this time.
Croatian: Ne skidajte on-body injektor u ovom razdoblju.
English: What if my application site is red or tender after on-body injector removal?
Croatian: Što ako je mjesto primjene lijeka crveno ili osjetljivo nakon skidanja on-body injektora?
English: The on-body injector contains three silver oxide batteries and includes an adhesive patch made from non-woven polyester tape single coated with a polyacrylate adhesive.
Croatian: On-body injektor sadrži tri baterije sa srebrovim oksidom i uključuje adhezivni naljepak izrađen od netkane poliesterske trake presvučene jednim slojem adhezijskog sredstva od poliakrilata.
English: To give yourself a subcutaneous injection you will need:
Croatian: Za samoprimjenu potkožne injekcije trebate:
English: How do I give my injection?
Croatian: Kako ću primjeniti injekciju?
English: EU/1/02/227/001 - 1 pack blistered syringe EU/1/02/227/002 - 1 pack unblistered syringe EU/1/02/227/004 - 1 pack blistered syringe with needle guard EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector
Croatian: EU/1/02/227/001 - pakiranje od 1 štrcaljke u blisteru EU/1/02/227/002 - pakiranje od 1 štrcaljke bez blistera EU/1/02/227/004 - pakiranje od 1 štrcaljke u blisteru sa štitnikom za iglu EU/1/02/227/005 - pakiranje od 1 štrcaljke u blisteru s on-body injektorom u blisteru
English: The safety and efficacy of pegfilgrastim 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 pegfilgrastima nije ispitivana u bolesnika s mijelodisplastičnim sindromom, kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnom AML, stoga se lijek ne smije primjenjivati u tih bolesnika.
English: Three reported cases show a causal relationship between the adverse drug reaction (ADR) StevensJohnson syndrome and pegfilgrastim.
Croatian: Tri prijavljena slučaja ukazuju na postojanje uzročno-posljedične veze između nuspojave Stevens-Johnsonova sindroma i pegfilgrastima.
English: On-body injector, the fluid path is made from polypropylene, cyclic olefin copolymer, silicone rubber and fluorinated ethylene propylene (FEP), with a stainless steel 28 gauge needle.
Croatian: On-body injektor sadrži put za tekućinu izrađen od polipropilena, kopolimera cikličkog olefina, silikonske gume i flouriranog etilen-propilena (FEP), s iglom od nehrđajućeg čelika promjera 28 G.
English: Clear, colourless solution for injection.
Croatian: Bistra, bezbojna otopina za injekciju.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: It must be a clear and colourless liquid.
Croatian: Tekućina mora biti bistra i bezbojna.
English: Before use
Croatian: Prije primjene
English: Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
Croatian: Povećana hematopoetska aktivnost koštane srži kao odgovor na terapiju faktorima rasta povezana je s prolaznim pozitivnim nalazima pri dijagnostičkom snimanju koštane srži.
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,