FrancophonIA/ELRC3.0 huggingface dataset:
English: Check to see if your on-body injector is empty.
Croatian: Provjerite je li Vaš on-body injektor prazan.
English: The safety and efficacy of Neulasta in children has not yet been established.
Croatian: Sigurnost i djelotvornost Neulaste u djece nisu još ustanovljene.
English: If this happens, you may not receive your dose of Neulasta.
Croatian: Ukoliko se to dogodi, možda nećete primiti Vašu dozu lijeka Neulasta.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Ne primjenjujte injekciju na područjima gdje je koža osjetljiva, s krvnim podljevima, crvena ili tvrda.
English: Step 1: Monitor your on-body injector A For the next 27 hours, occasionally check the status light for at least 10 seconds.
Croatian: Korak 1: Pratite svoj on-body injektor A Sljedećih 27 sati povremeno provjerite statusnu lampicu najmanje 10 sekundi.
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adrese proizvođača biološke djelatne tvari
English: Check the instructions at the end of this leaflet and contact your healthcare provider if:
Croatian: Provjerite upute za uporabu na kraju ove upute o lijeku i obratite se svom zdravstvenom radniku ako:
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Croatian: Ukoliko primijetite gubitak odgovora na liječenje pegfilgrastimom ili nemogućnost održavanja odgovora, Vaš će liječnik istražiti razloge zašto se to događa, uključujući i mogućnost nastanka antitijela koja neutraliziraju aktivnost pegfilgrastima.
English: If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Croatian: Ako se broj bijelih krvnih stanica znatno smanji, u tijelu ih neće ostati dovoljno za borbu protiv bakterija te se može povećati rizik od infekcija.
English: This is known as a subcutaneous injection.
Croatian: To se naziva potkožnom injekcijom.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Croatian: Nađite pogodnu, dobro osvijetljenu, čistu površinu i stavite potrebni pribor na dohvat ruke.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možda ćete primijetiti male mjehuriće zraka u napunjenoj štrcaljki.
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon injiciranja tekućine, uklonite iglu i pustite kožu.
English: Do not use the pre-filled syringe if it has been dropped on a hard surface.
Croatian: Ne upotrebljavajte napunjenu štrcaljku ukoliko je prethodno pala na tvrdu površinu.
English: In the event of a partial or missed dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered.
Croatian: U slučaju djelomične ili propuštene doze, bolesnici mogu imati povećani rizik od događaja poput neutropenije, febrilne neutropenije i/ili infekcije nego da je doza primijenjena ispravno.
English: Clean your skin by using an alcohol wipe.
Croatian: Očistite kožu koristeći vatu natopljenu alkoholom.
English: Activity
Croatian: Aktivnosti
English: Do not shake Neulasta vigorously as this may affect its activity.
Croatian: Ne tresite snažno lijek Neulasta jer to može utjecati na njezinu aktivnost.
English: • breathing problems.
Croatian: • problemi s disanjem.
English: Your white blood cell count may become high for a short period of time.
Croatian: Broj bijelih krvnih stanica može nakratko porasti.
English: Stop using Neulasta if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite koristiti lijek Neulasta ako razvijete ove simptome i obratite se liječniku ili odmah potražite medicinsku pomoć.
English: Loss of response to pegfilgrastim
Croatian: Gubitak odgovora na pegfilgrastim
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja pegfilgrastimom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Croatian: U većini slučajeva aortitis je dijagnosticiran CT snimkom i uglavnom se povukao nakon prestanka primjene G-CSF-a.
English: Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Croatian: Neulasta se može upotrijebiti ako je bila slučajno zamrznuta jednokratno i kraće od 24 sata.
English: 100% (full)
Croatian: 100% (puno)
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Croatian: Osobitu pozornost treba obratiti na razlikovanje dijagnoze blastične transformacije u kroničnoj mijeloičnoj leukemiji od AML.
English: The patient should also be given the Patient Alert Card.
Croatian: Bolesniku također treba uručiti karticu s upozorenjima za bolesnika.
English: Important
Croatian: Važno
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: To može biti znak akutnog respiratornog distres sindroma odraslih (ARDS);
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Croatian: Recite odmah svom liječniku ako imate neku od navedenih nuspojava ili kombinaciju navedenih nuspojava:
English: Other warnings
Croatian: Druga upozorenja
English: However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Croatian: Međutim, dugoročni učinci pegfilgrastima na AML nisu ustanovljeni, stoga se lijek mora primjenjivati s oprezom u toj populaciji bolesnika.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Croatian: Ovaj se lijek ne smije miješati s drugim lijekovima, osobito ne s otopinama natrijevog klorida.
English: Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Croatian: Liječenje lijekom Neulasta mora započeti i nadzirati liječnik s iskustvom u onkologiji i/ili hematologiji.
English: Push the plunger down with a slow constant pressure.
Croatian: Gurajte klip prema dolje polaganim, stalnim pritiskom.
English: Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Croatian: Presnažno protresanje može prouzročiti agregaciju pegfilgrastima te ga tako učiniti biološki neaktivnim.
English: • the top of your thighs; and
Croatian: • gornji dio bedara; i
English: Medicines should be disposed of in accordance with local requirements.
Croatian: Lijekovi se trebaju odlagati u skladu s lokalnim propisima.
English: For patients who have reactions to acrylic adhesives, use of this product may result in an allergic reaction.
Croatian: Za bolesnike koji imaju reakcije na adhezijska sredstva od akrila, uporaba ovog proizvoda može uzrokovati alergijsku reakciju.
English: • The on-body injector contains batteries, electronics, and a needle.
Croatian: • On-body injektor sadrži baterije, elektroničke dijelove i iglu.
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neulasta.
Croatian: Slučajno jednokratno izlaganje temperaturama zamrzavanja u razdoblju kraćem od 24 sata ne utječe nepovoljno na stabilnost Neulaste.
English: Push the plunger all the way down as far as it will go to inject all the liquid.
Croatian: Gurajte klip do kraja dokle god je moguće kako bi injicirali svu tekućinu.
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Croatian: Te su stanice vrlo osjetljive na kemoterapiju koja može uzrokovati smanjenje njihovog broja u Vašem tijelu.
English: Your doctor will tell you what you can take to ease the bone pain.
Croatian: Liječnik će Vam savjetovati što uzeti kako biste ublažili bol u kostima.
English: • how to recognise signs from the device (e.g. adhesion issues, fill indicator not moved, no beeping sound, status light has not flashed etc.) that there has been a failure in the delivery of the intended dose
Croatian: • kako prepoznati znakove na uređaju (npr. problemi s prijanjanjem, indikator punjenja se nije pomaknuo, nema zvučnog signala, svjetlo na statusnoj lampici ne bljeska itd.) koji ukazuju na neuspješnu primjenu namijenjene doze
English: Median Absolute Neutrophil Count (cells x 109/l)
Croatian: Medijan apsolutnog broja neutrofila (stanice x 109/l)
English: Plan to be in a place where you or your caregiver can appropriately monitor the on-body injector for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery.
Croatian: Planirajte biti na mjestu gdje Vi ili Vaš njegovatelj možete odgovarajuće pratiti on-body injektor tijekom otprilike 45 minuta primjene Neulaste i jednog sata nakon dobivanja lijeka.
English: Keep the container in the outer carton in order to protect from light.
Croatian: Spremnik čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: For example AVOID, travelling, driving, or operating heavy machines during 26-29 hours following application of the on-body injector (this includes the 45-minute dose delivery period plus an hour post-delivery).
Croatian: Na primjer, IZBJEGAVAJTE putovati, upravljati vozilima i raditi sa strojevima 26 - 29 sati nakon što ste postavili on-body injektor (to uključuje vrijeme primanja doze koje traje 45 minuta i još vrijeme od jednog sata nakon primanja).
English: In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Croatian: Na životinjskim modelima se pokazalo da je istodobna primjena Neulaste i 5-fluorouracila (5-FU) ili drugih antimetabolita potencirala mijelosupresiju.
English: If you are injecting yourself and have forgotten your dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.
Croatian: Ako sami injicirate i zaboravili ste si dati svoju dozu Neulaste, upitajte liječnika kada biste trebali injicirati sljedeću dozu.
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Croatian: Najčešće prijavljene nuspojave bile su bol u kostima (vrlo često [≥ 1/10]) i mišićno-koštana bol (često [≥ 1/100 do < 1/10]).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pegfilgrastim, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za pegfilgrastim, znanstveni zaključci CHMP-a su sljedeći:
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rukovanju s lijekom prije primjene vidjeti dio 6.6.
English: Figure 1.
Croatian: Slika 1.
English: This should be considered when interpreting bone-imaging results.
Croatian: To treba imati na umu prilikom interpretacije dobivenih nalaza snimanja kostane srži.
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Croatian: Slično kao i kod filgrastima, neutrofili nastali kao odgovor na pegfilgrastim imaju normalnu ili poboljšanu funkciju, kako je pokazano ispitivanjima kemotaktičke i fagocitne funkcije.
English: • Do not sleep on the on-body injector or apply pressure during wear, especially during dose delivery.
Croatian: • Ne spavajte na on-body injektoru i ne stvarajte pritisak tijekom nošenja, naročito za vrijeme dobivanja doze.
English: You will need to give yourself the injection into the tissue just under the skin.
Croatian: Injekciju ćete si morati dati u tkivo odmah ispod kože.
English: 9/L after the expected nadir, this medicine should be discontinued immediately.
Croatian: 9/L, liječenje ovim lijekom treba odmah prekinuti.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Where should I give my injection?
Croatian: Gdje trebam primijeniti injekciju?
English: Solution for injection (injection).
Croatian: Otopina za injekciju (injekcija).
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: Provjerite rok valjanosti na naljepnici napunjene štrcaljke (EXP).
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Croatian: Podaci u sljedećoj tablici prikazuju nuspojave prijavljene tijekom kliničkih ispitivanja i spontanog prijavljivanja.
English: There is a risk of medication error, particularly a partial or missed dose of pegfilgrastim, in the event of a device failure or malfunction with the on-body injector.
Croatian: Postoji rizik od medikacijske pogreške, osobito djelomične ili propuštene doze pegfilgrastima, u slučaju neispravnosti ili kvara on-body injektora.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Croatian: Ovaj lijek se ne smije koristiti kako bi se povisila doza citotoksične kemoterapije iznad doza utvrđenih režima doziranja.
English: If someone else is injecting you, they can also use the back of your arms.
Croatian: Ako Vam netko drugi daje injekciju, može to činiti i u stražnji dio nadlaktice.
English: Guide to parts
Croatian: Priručnik o dijelovima
English: What should I do before I give myself a subcutaneous injection of Neulasta?
Croatian: Što trebam učiniti prije samoprimjene potkožne injekcije Neulaste?
English: • Neulasta is given as an injection into the tissue just under the skin (subcutaneous injection).
Croatian: • Neulasta se daje kao injekcija u tkivo odmah ispod kože (potkožna injekcija).
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Croatian: Potencijal za interakciju s litijem, koji također potiče otpuštanje neutrofila, nije posebno istraživan.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Talk to your doctor, pharmacist or nurse before using Neulasta:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene Neulaste:
English: • inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: Approximately 27 hours after the on-body injector is applied to the patient's skin, Neulasta will be delivered over approximately 45 minutes.
Croatian: Otprilike 27 sati nakon postavljanja on-body injektora na kožu bolesnika, Neulasta će biti primjenjena tijekom otprilike 45 minuta.
English: • Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.
Croatian: • Obavijestite svog zdravstvenog radnika ako ste imali teške kožne reakcije na adhezijska sredstva od akrila.
English: As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Croatian: Kao i drugi hematopoetski faktori rasta, G-CSF pokazuje in vitro stimulirajuća svojstva na ljudske endotelne stanice.
English: Check the appearance of Neulasta.
Croatian: Provjerite izgled Neulaste.
English: Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Croatian: Jednokratna doza od 300 μg/kg primijenjena je supkutano ograničenom broju zdravih dobrovoljaca i bolesnika s rakom pluća ne-malih stanica bez pojave ozbiljnih reakcija.
English: C Pinch your injection site to create a firm surface.
Croatian: C Uhvatite nabor kože na mjestu injiciranja kako biste stvorili čvrstu površinu.
English: The on-body injector is working properly.
Croatian: On-body injektor radi ispravno.
English: EU/1/02/227/001 - 1 pack EU/1/02/227/004 - 1 pack with needle guard EU/1/02/227/005 - 1 pack with on-body injector
Croatian: EU/1/02/227/001 - 1 pakiranje EU/1/02/227/004 - 1 pakiranje sa štitnikom za iglu EU/1/02/227/005 - 1 pakiranje s on-body injektorom
English: C Inspect the medicine and pre-filled syringe.
Croatian: C Provjerite lijek i napunjenu štrcaljku Lijek
English: The most common adverse reaction reported was bone pain (see section 5.1 and 5.2).
Croatian: Najčešće prijavljena nuspojava bila je bol u kostima (vidjeti dijelove 5.1 i 5.2).
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je zamućen ili ako u njemu uočite čestice.
English: Your doctor may decide that it would be more convenient for you to inject Neulasta yourself.
Croatian: Vaš liječnik može odlučiti da će Vama biti pogodnije ako si sami injicirate lijek Neulasta.
English: Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Croatian: Potreban je poseban oprez pri primjeni pojedinačnih ili kombiniranih kemoterapeutika za koje se zna da uzrokuju tešku trombocitopeniju.
English: pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti pegfilgrastim tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Croatian: Manje često su prijavljeni slučajevi Sweetova sindroma, iako u nekim slučajevima ulogu u tome može imati i postojeća hematološka zloćudna bolest.
English: For further information on use with the on-body injector, please read the instructions for use at the end of this leaflet.
Croatian: Za daljnje informacije o tome kako koristiti on-body injektor, molimo pročitajte upute za uporabu na kraju ove upute o lijeku.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Croatian: * Natrijev acetat nastaje titracijom ledene acetatne kiseline s natrijevim hidroksidom.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to 7 days, and a 30-40% incidence of febrile neutropenia.
Croatian: Bez potpore faktorom rasta primijećeno je da takav režim rezultira srednjim trajanjem neutropenije 4. stupnja od 5 do 7 dana te incidenciju pojave febrilne neutropenije od 30 do 40%.
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu prijavljene nuspojave koje bi se mogle izravno pripisati tom stupnju leukocitoze.
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Croatian: • Važno je da ne pokušavate dati sebi injekciju ukoliko niste prošli obuku kod svojeg liječnika ili zdravstvenog djelatnika.
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta.
Croatian: Prijavljene su teške kožne reakcije (Stevens-Johnsonov sindrom) povezane s primjenom lijeka Neulasta.
English: Elevations in uric acid
Croatian: Povišena razina mokraćne kiseline
English: 1 See section “Description of selected adverse reactions” below.
Croatian: “Opis odabranih nuspojava“ ispod.
English: B Examine the injection site.
Croatian: B Pregledajte mjesto injiciranja
English: Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Croatian: Korak 4: Završni korak A Odložite iskorištenu napunjenu štrcaljku i ostali pribor u spremnik za odlaganje oštrih predmeta.
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Ne koristite napunjenu štrcaljku ako je prošao posljednji dan navedenog mjeseca.
English: Therefore, physicians should use caution when prescribing pegfilgrastim 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 medicine with splenic enlargement and vaso-occlusive crisis.
Croatian: Stoga liječnici trebaju s oprezom prepisivati pegfilgrastim u bolesnika s nasljednim obilježjem srpastih stanica ili s bolesti srpastih stanica, pažljivo pratiti odgovarajuće kliničke i laboratorijske parametre te paziti na moguću povezanost ovog lijeka s povećanjem slezene i vazookluzivnom krizom.
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Croatian: Dokazano je da pegfilgrastim i filgrastim imaju jednak mehanizam djelovanja i dovode do znatnog porast broja neutrofila u perifernoj krvi unutar 24 sata te manjeg porasta broja monocita i/ili limfocita.
English: B After about 27 hours, your on-body injector will produce a series of beeps to let you know your dose delivery is about to begin.
Croatian: B Nakon otprilike 27 sati, Vaš on-body injektor će se oglasiti serijom zvučnih signala kako bi Vas obavijestio da će započeti s primjenom doze.
English: The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
Croatian: Sigurnost i djelotvornost primjene pegfilgrastima u bolesnika s de novo AML mlađih od 55 godina s citogenetskim nalazom t(15;17) nisu utvrđeni.
English: Injecting the solution with the air bubble is harmless.
Croatian: Injiciranje otopine s mjehurićima zraka je bezopasno.
English: On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za pegfilgrastim, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) pegfilgrastim nepromijenjen, uz predložene izmjene informacija o lijeku.
English: • Mark the box of the description that represents your on-body injector after it has been used.
Croatian: • Označite kućicu kraj opisa koji predstavlja Vaš on-body injektor nakon uporabe.