FrancophonIA/ELRC3.0 huggingface dataset:
English: - reminds the healthcare professionals to verify that the patients/caregivers can demonstrate using the dummy pen confidently and competently to be able to prepare and administer the medicine successfully when at home. - includes information on how to receive further checklists or demonstration device(s).
Croatian: - podsjeća zdravstvene radnike da potvrde znaju li bolesnici/skrbnici pouzdano i kompetentno koristiti brizgalicu za vježbu kako bi mogli uspješno pripremiti i primjenjivati lijek kod kuće. - sadrži informacije o tome kako primati dodatne liste provjere ili pokazni(e) uređaj(e).
English: The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Croatian: Sigurnost i učinkovitost terapije jednom dozom lijeka Aranesp svaka tri tjedna u smanjivanju potrebe za transfuzijom crvenih krvnih stanica u bolesnika na kemoterapiji utvrđena je u randomiziranom, dvostruko slijepom, multinacionalnom ispitivanju.
English: Part of the pre-filled pen may be broken even if you cannot see the break.
Croatian: Dio u brizgalici može puknuti iako puknuće nije vidljivo.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an open-label study.
Croatian: Preživljenje i napredovanje tumora bili su ispitani u 5 velikih kontroliranih ispitivanja koja su uključila ukupno 2833 bolesnika, od kojih su 4 bila dvostruko slijepa, placebom kontrolirana ispitivanja, a jedno je bilo otvorenog tipa.
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Ne smije se primijeniti ako je prošao posljednji dan navedenog mjeseca.
English: Contact your healthcare provider immediately.
Croatian: Odmah se obratite svom zdravstvenom radniku.
English: If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered.
Croatian: Ako se isključe tipični uzroci izostanka odgovora i bolesnik ima retikulocitopeniju, potrebno je uzeti u obzir pregled koštane srži.
English: If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Croatian: Ako primijetite točkicu krvi, možete je nježno ukloniti pamučnom vatom ili maramicom.
English: A reticulocyte count should be considered as part of the evaluation.
Croatian: Kao dio procjene treba uzeti u obzir i određivanje broja retikulocita.
English: If you are receiving chemotherapy
Croatian: Ako primate kemoterapiju
English: Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.
Croatian: Potkraj ciklusa kemoterapije, osobito ako ste ih primili mnogo, broj Vaših crvenih krvnih stanica može se smanjiti, što Vas čini anemičnima.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Croatian: • oticanje lica, usana, usta, jezika ili grla što može uzrokovati teškoće gutanja ili disanja
English: Thereafter the haemoglobin can be measured at longer intervals.
Croatian: Nakon toga hemoglobin se može mjeriti u dužim razmacima.
English: The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Croatian: Odluka o primjeni rekombinantnih eritropoetina mora se temeljiti na procjeni koristi i rizika za svakog individualnog bolesnika te se trebaju uzeti u obzir specifične kliničke okolnosti.
English: The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Croatian: Stvaranje eritropoetina ponajprije se odvija u bubrezima i njima je regulirano kao odgovor na promjene u oksigenaciji tkiva.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Ne primjenjujte injekciju na područjima gdje je koža nježna, s modricama, crvena ili tvrda.
English: • 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or
Croatian: • 500 mikrograma jednom svaka tri tjedna (6,75 mikrograma lijeka Aranesp po kilogramu Vaše tjelesne težine), ili
English: Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dL or less.
Croatian: Nakon krvnih pretraga, Vaš liječnik je odlučio da trebate primjenjivati Aranesp kada je vrijednost Vašeg hemoglobina 10 g/dl ili niža.
English: Step 2: Get ready E Pull the grey cap straight off, only when you are ready to inject.
Croatian: Korak 2: Pripremite se E Povucite ravno sivi pokrov tek kada ste spremni injicirati.
English: Talk to your doctor, pharmacist or nurse before using Aranesp.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Aranesp.
English: The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
Croatian: Neugodan osjećaj na mjestu injiciranja obično je bio blag i prolazne prirode te se većinom javljao nakon prve injekcije.
English: If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Croatian: Ukoliko je teško kontrolirati krvni tlak uvođenjem odgovarajućih mjera, hemoglobin se može sniziti smanjivanjem doze ili prestankom terapije lijekom Aranesp (vidjeti dio 4.2).
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Croatian: Ishod ukupnog preživljenja u ispitivanjima nije bio moguće zadovoljavajuće objasniti razlikama u incidenciji tromboze i povezanih komplikacija između onih koji su primili rekombinantni ljudski eritropoetin i onih u kontrolnoj skupini.
English: • Bruising and bleeding at the site of injection
Croatian: • modrice i krvarenje na mjestu injiciranja
English: Caution should be exercised when prescribing Aranesp to pregnant women.
Croatian: Nužan je oprez pri propisivanju lijeka Aranesp trudnicama.
English: Aranesp is administered either subcutaneously or intravenously as described in the posology.
Croatian: Aranesp se primjenjuje supkutano ili intravenski kao što je opisano kod doziranja.
English: Do not try to inject yourself if you have not been trained.
Croatian: Ne pokušavajte sami injicirati lijek ako niste izvježbani.
English: Therapy with Aranesp can result in polycythaemia if the haemoglobin is not carefully monitored and the dose appropriately adjusted.
Croatian: Terapija lijekom Aranesp može rezultirati policitemijom ako hemoglobin nije pažljivo praćen i doza odgovarajuće prilagođena.
English: The haemoglobin should be measured every one or two weeks until it is stable.
Croatian: Hemoglobin treba mjeriti svaki tjedan ili svaka dva tjedna dok ne postane stabilan.
English: Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite uzimati Aranesp ako se razviju ovi simptomi i obratite se Vašem liječniku ili odmah potražite liječničku pomoć.
English: What you need to know before you use Aranesp
Croatian: Što morate znati prije nego počnete primjenjivati Aranesp
English: • 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.
Croatian: • 2,25 mikrograma (jednom tjedno) lijeka Aranesp po kilogramu vaše tjelesne težine.
English: There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Croatian: Prema tome, postoji dosljedan dokaz koji ukazuje da mogu postojati značajne štetnosti za bolesnike s rakom koji su liječeni rekombinantnim ljudskim eritropoetinom.
English: Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
Croatian: Dezinficirajte kožu vatom natopljenom alkoholom, te uhvatite (bez stiskanja) nabor kože između palca i kažiprsta.
English: Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater in vivo activity.
Croatian: Zbog povećanog ugljikohidratnog sadržaja darbepoetin alfa ima dulji terminalni poluvijek od r-HuEPO i posljedično veću in vivo aktivnost.
English: The marketing authorisation holder (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 zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Croatian: No, postoji mogućnost interakcije s tvarima koje se u velikoj mjeri vežu na crvene krvne stanice poput ciklosporina i takrolimusa.
English: Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Croatian: Humani eritropoetin je endogeni glikoproteinski hormon koji je primarni regulator eritropoeze preko specifičnog međudjelovanja s receptorom eritropoetina koji se nalazi na eritroidnim progenitornim stanicama u koštanoj srži.
English: A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Croatian: U analizama podataka na razini bolesnika koji su provedeni na više od 13 900 bolesnika s rakom (kemo-, radio-, kemoradio- ili bez terapije) u 53 kontrolirana klinička ispitivanja primijenjeno je nekoliko epoetina.
English: Dose increases must not be made more frequently than once every four weeks.
Croatian: Doza se ne smije povećavati češće od jednom svaka 4 tjedna.
English: It is important to keep the skin pinched when injecting.
Croatian: Važno je držati tako kožu za vrijeme davanja injekcije.
English: Stretch your skin firmly by moving your thumb and fingers in opposite directions, creating an area about 5 cm (2-inches) wide.
Croatian: Čvrsto rastegnite komad kože pomicanjem palca i prstiju u suprotnim smjerovima kako biste stvorili površinu širine oko 5 cm (2 inča).
English: In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Croatian: Oštećeni bubrezi ne stvaraju dovoljno prirodnog hormona eritropoetina, što često može uzrokovati anemiju.
English: • The expiry date printed on the label has passed the last day of the month shown.
Croatian: • Ukoliko je rok valjanosti otisnut na etiketi istekao, odnosno prošao je posljednji dan navedenog mjeseca
English: Important: read the package leaflet before handling pre-filled syringe.
Croatian: Važno: pročitajte uputu o lijeku prije rukovanja napunjenom štrcaljkom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 June 2001
Croatian: Datum prvog odobrenja: 8. lipnja 2001.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Croatian: Može se također pojaviti vrijed u ustima, grlu, nosu, spolovilu i očima (crvene i otečene oči).
English: In order to correct your anaemia, your initial dose will be
Croatian: Da bi se liječila anemija, početna doza će biti:
English: If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Croatian: Ako je potrebno prilagođavanje doze da bi se hemoglobin održao na željenoj razini, preporučuje se prilagođavanje doze za otprilike 25%.
English: In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Croatian: Pretklinička ispitivanja pokazala su da je bubrežni klirens minimalan (do 2% od ukupnog klirensa) i da ne utječe na poluvijek darbepoetina alfa u serumu.
English: Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
Croatian: Kad je postignut terapijski učinak za pojedinog bolesnika, dozu treba smanjiti za 25 do 50% kako bi se osigurala primjena najniže odobrene doze lijeka Aranesp potrebne za odgovarajuću kontrolu simptoma anemije.
English: Instructions for use: Guide to parts
Croatian: Upute za primjenu: Priručnik o dijelovima
English: What Aranesp contains
Croatian: Što Aranesp sadrži
English: What should I do before I give myself a subcutaneous injection of Aranesp?
Croatian: Što trebam učiniti prije samoprimjene potkožne injekcije lijeka Aranesp?
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to Aranesp (see section 4.8).
Croatian: Pokazalo se da ta antitijela ukriženo reagiraju sa svim eritropoetinskim proteinima pa se bolesnike kod kojih se sumnja ili je potvrđena prisutnost neutralizirajućih antitijela na eritropoetin ne smije prebacivati na Aranesp (vidjeti dio 4.8).
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
Croatian: Povećan relativni rizik od tromboembolijskih događaja (RR 1,67, 95% CI: 1,35; 2,06; 35 ispitivanja i 6769 bolesnika) zabilježen je kod bolesnika liječenih rekombinantnim ljudskim eritropoetinom.
English: Using your Aranesp SureClick pre-filled pens
Croatian: Korištenje Vaših Aranesp SureClick napunjenih brizgalica
English: In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
Croatian: U tom ispitivanju srednja vrijednost (SD) poluvijeka bila je 74 (SD 27) sata.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Croatian: B POGURNITE klip polaganim i postojanim potiskom dok ne čujete škljocanje.
English: EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Croatian: EPO-ANE-3010, randomizirano, otvoreno, multicentrično ispitivanje provedeno je na 2098 anemičnih žena s metastatskim karcinomom dojke koje su primile prvu ili drugu liniju kemoterapije.
English: How do I give my injection?
Croatian: Kako ću primijeniti injekciju?
English: MedDRA system organ class
Croatian: MedDRA klasifikacija organskih sustava
English: In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
Croatian: U svim ispitivanjima na štakorima i psima, darbepoetin alfa je pokazao znatno povećanje hemoglobina, hematokrita, broja crvenih krvnih stanica i retikulocita, što odgovara očekivanim farmakološkim učincima.
English: Aranesp should be used with caution in patients with epilepsy.
Croatian: Aranesp se mora primjenjivati s oprezom kod bolesnika s epilepsijom.
English: Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed.
Croatian: Primijećeno je i poboljšanje kod umora bolesnika mjereno prema „FACT-fatigue“ (Functional Assessment of Cancer Therapy - fatigue) skali.
English: • Choose a different site each time you give yourself an injection.
Croatian: • Birajte svaki put drugo mjesto gdje si dajete injekciju.
English: D Prepare and clean your injection site.
Croatian: D Pripremite i očistite mjesto injiciranja.
English: Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 990114, 20000161, 20010145, 20030232, and 20070782) a Hypersensitivity events includes all events under the hypersensitivity SMQ.
Croatian: Izvor: uključuje 8 randomiziranih, dvostruko slijepih, placebom kontroliranih ispitivanja (980291-raspored 1 i 2, 980297, 990114, 20000161, 20010145, 20030232 i 20070782) a Događaji preosjetljivosti uključuju sve događaje navedene u SMQ za preosjetljivost.
English: Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.
Croatian: Podaci su prikazani odvojeno za bolesnike s kroničnim zatajenjem bubrega i bolesnike s rakom kao odraz različitog profila nuspojava u ovim populacijama.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Croatian: Metaanaliza je također pokazala konzistentan i značajan porast relativnog rizika tromboembolijskih događaja kod bolesnika s rakom koji su primali rekombinantni ljudski eritropoetin (vidjeti dio 4.4).
English: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Croatian: Na temelju gore navedenog, u nekim kliničkim slučajevima transfuzija krvi treba biti terapija izbora za liječenje anemije kod bolesnika s rakom.
English: Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
Croatian: Zbog povećanja sadržaja ugljikohidrata, razina darbepoetina alfa ostaje u cirkulaciji iznad minimalne koncentracije potrebne za stimuliranje eritropoeze, i to dulje od ekvivalentne molarne doze r-HuEPO-a, što omogućuje isti biološki odgovor, uz rjeđu primjenu darbepoetina alfa.
English: If you use more Aranesp than you should
Croatian: Ako ste primijenili veću dozu lijeka Aranesp nego što ste trebali
English: What Aranesp looks like and contents of the pack
Croatian: Kako Aranesp izgleda i sadržaj pakovanja
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 etiketu sa štrcaljke.
English: Disposing of used syringes
Croatian: Odlaganje upotrijebljenih štrcaljki
English: Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dL.
Croatian: Liječnik će Vam reći koliko lijeka Aranesp ćete morati primjenjivati i koliko često da bi održali razinu hemoglobina između 10 i 12 g/dl.
English: Cancer patients receiving chemotherapy
Croatian: Bolesnici s rakom koji primaju kemoterapiju
English: If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks.
Croatian: Ako je liječnik odlučio promijeniti Vaše liječenje prelaskom s r-HuEPO-a (eritropoetin proizveden genskom tehnologijom) na Aranesp, odredit će trebate li primati Aranesp injekciju jednom tjedno ili jednom u dva tjedna.
English: It is important to push down through the “snap” to deliver your full dose.
Croatian: Važno je gurati do kraja kroz škljocanje kako bi se primijenila cijela doza.
English: The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dL, is unclear because few patients with these characteristics were included in the data reviewed.
Croatian: Nije jasan opseg do kojeg se ti ishodi mogu primijeniti na davanje rekombinantnog ljudskog eritropoetina bolesnicima s rakom, liječenih kemoterapijom da bi se postigle koncentracije hemoglobina niže od 13 g/dl, jer je malo bolesnika s tim karakteristikama bilo uključeno u obrađenim podacima.
English: These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 mcg/kg weekly and 3 to 9 mcg/kg every two weeks).
Croatian: Ti parametri bili su sukladni farmakokinetici linearne doze u širokom rasponu doza (0,5 do 8 µg/kg tjedno i 3 do 9 µg/kg svaka dva tjedna).
English: Remove the pre-filled syringe from the refrigerator.
Croatian: Izvadite napunjenu štrcaljku iz hladnjaka.
English: - Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Croatian: - Budite posebno oprezni s ostalim lijekovima koji potiču stvaranje eritrocita: Aranesp je jedan iz grupe lijekova koji potiču stvaranje eritrocita kao što to čini ljudski eritropoetin.
English: Remove the needle and let go of your skin.
Croatian: Izvucite iglu i pustite kožu.
English: In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
Croatian: U ispitivanjima provedenim na štakorima i zečevima nisu primijećeni klinički značajni dokazi o štetnim učincima na trudnoću, embrio-fetalni razvoj, porođaj ili postnatalni razvoj.
English: Check that it is the correct dose that your doctor has prescribed.
Croatian: • Provjerite je li to ispravna doza, odnosno doza koju Vam je propisao Vaš liječnik.
English: B Inspect the pre-filled pen.
Croatian: B Provjerite napunjenu brizgalicu.
English: - The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by genetechnology).
Croatian: - Djelatna tvar je darbepoetin alfa, r-HuEPO (eritropoetin proizveden genskom tehnologijom).
English: The frequency is estimated from clinical trial data as common in cancer patients and was also common in the placebo groups.
Croatian: Učestalost je procijenjena iz podataka kliničkog ispitivanja kao česta kod bolesnika s rakom i također je bila česta u placebo grupi.
English: Clearance of darbepoetin alfa is 1.9 mL/hr/kg (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 mL/kg).
Croatian: Klirens darbepoetina alfa je 1,9 ml/sat/kg (SD 0,56) i volumen distribucije (Vss) je otprilike jednak volumenu u plazmi (50 ml/kg).
English: Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure, since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Croatian: Potreban je oprez kod povećanja doze lijeka Aranesp u bolesnika s kroničnim zatajenjem bubrega, budući da visoke kumulativne doze epoetina mogu biti povezane s povećanim rizikom mortaliteta te s ozbiljnim kardiovaskularnim i cerebrovaskularnim događajima.
English: Step 3: Inject G Hold the stretch or pinch.
Croatian: Korak 3: Injiciranje G Držite kožu rastegnutu ili u naboru.
English: ESAs are not indicated for use in this patient population.
Croatian: LSE nisu indicirane za primjenu kod te populacije bolesnika.
English: Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Croatian: Pogrešna primjena lijeka Aranesp zdravim osobama može dovesti do pretjeranog povećanja volumena krvnih stanica.