FrancophonIA/ELRC3.0 huggingface dataset:
English: Further injections are given by your doctor or, after you have been trained, you can inject NeoRecormon yourself (see instructions at the end of this leaflet.)
Croatian: Daljnje injekcije će Vam davati liječnik ili, nakon odgovarajuće edukacije, NeoRecormon možete injicirati i sami (pogledajte upute za uporabu na kraju ove upute o lijeku).
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Croatian: Ovakvi slučajevi prijavljeni su kod bolesnika s hepatitisom C liječenih interferonom i ribavirinom kada su istodobno korišteni epoetini.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta therapy to the woman.
Croatian: Odluku o tome treba li nastaviti ili prekinuti dojenje odnosno treba li nastaviti ili prekinuti terapiju epoetinom beta treba donijeti uzimajući u obzir korist dojenja za dijete i korist terapije epoetinom beta za majku.
English: Pharmacotherapeutic group: antianemic, ATC code: B03XA01
Croatian: Farmakoterapijska skupina: antianemici, ATK oznaka: B03XA01
English: People who are not on haemodialysis will usually have injections under the skin.
Croatian: Osobe koje se ne podvrgavaju hemodijalizi obično će injekcije dobivati pod kožu.
English: · Do not use if the syringe has been frozen.
Croatian: Nemojte upotrijebiti štrcaljku ako je bila zamrznuta.
English: Your doctor will regularly check your blood pressure, particularly at the beginning of therapy.
Croatian: Liječnik će Vam redovito provjeravati krvni tlak, osobito na početku liječenja.
English: It needs to be treated at once.
Croatian: Takvo se stanje odmah mora liječiti.
English: The maximum dose should not exceed 60,000 IU per week.
Croatian: Maksimalna doza ne smije prelaziti 60 000 IU tjedno.
English: It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
Croatian: Stoga se preporučuje kontrola krvnog tlaka, osobito u početnoj fazi liječenja bolesnika s rakom.
English: In patients treated with NeoRecormon, this incidence is 7 % compared to 4 % in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
Croatian: U bolesnika liječenih lijekom NeoRecormon incidencija je 7%, u usporedbi s 4% u kontrolnoj skupini; to nije povezano s porastom mortaliteta uslijed tromboembolije u usporedbi s kontrolnom skupinom.
English: NeoRecormon injections can then be given by a trained nurse, doctor or other professional.
Croatian: Injekcije lijeka NeoRecormon može Vam dati educirana medicinska sestra, liječnik ili neki drugi zdravstveni radnik.
English: It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
Croatian: Preporučuje se redovita kontrola broja trombocita kroz prvih 8 tjedana terapije.
English: · in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative
Croatian: ● u novorođenčadi ili male djece do 3 godine starosti, budući da otapalo lijeka NeoRecormon Multidose sadrži benzilni alkohol kao konzervans.
English: These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Croatian: Ove reakcije bile su blage ili umjerene prirode te su se povlačile nakon nekoliko sati ili dana.
English: These serious skin rashes are often preceded by fever and /or flu-like symptoms.
Croatian: Ovim ozbiljnim kožnim osipima često prethode vrućica i/ili simptomi nalik gripi.
English: Roche Polska Sp.z o.o.
Croatian: Polska Roche Polska Sp.z o.o.
English: ·Do not inject into a muscle.
Croatian: Nemojte injicirati u mišić.
English: As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Croatian: Kako su bili zabilježeni izolirani slučajevi anafilaktoidnih reakcija, preporučuje se primjena prve doze pod nadzorom liječnika.
English: After the injection: follow steps 17 to 19.
Croatian: Nakon injiciranja slijedite korake 17 - 19.
English: During the entire treatment period, a PCV of 48 % should not be exceeded.
Croatian: Tijekom cijelog trajanja terapije hematokrit ne smije biti viši od 48%.
English: 18 Move the safety shield forward 90°, away from the syringe barrel (A).
Croatian: Pomaknite zaštitni pokrov za 90° u smjeru suprotnom od tijela štrcaljke (A).
English: Preparation of a single injection (1) Before withdrawing each dose disinfect the rubber seal of the device with alcohol.
Croatian: Priprema pojedinačne injekcije (1) Prije izvlačenja svake doze, dezinficirajte gumeni zatvarač nastavka alkoholom.
English: Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/benefit assessment for homologous transfusions.
Croatian: Liječenje treba primjenjivati samo u bolesnika u kojih je posebno važno izbjeći homolognu transfuziju krvi, uzimajući u obzir procjenu rizika i koristi homologne transfuzije.
English: Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50 % in order to maintain haemoglobin at that level.
Croatian: Kada se postigne terapijski cilj za pojedinog bolesnika, dozu treba smanjiti za 25 do 50% radi održavanja hemoglobina na toj razini.
English: Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Croatian: Farmakokinetička ispitivanja na zdravim dobrovoljcima i uremičnim bolesnicima pokazala su da je poluvijek intravenski primijenjenog epoetina beta između 4 i 12 sati te da volumen raspodjele odgovara jednom do dva puta volumena plazme.
English: Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
Croatian: Nedostatak folatne kiseline i vitamina B12 treba isključiti jer ova stanja smanjuju učinkovitost lijeka NeoRecormon.
English: Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Croatian: Ispitivanja na životinjama su pokazala da epoetin beta ne povećava mijelotoksičnost citostatika kao što su etoposid, cisplatin, ciklofosfamid i fluorouracil.
English: · Always keep the syringe dry.
Croatian: ● Štrcaljku uvijek održavajte suhom.
English: The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
Croatian: Biološka djelotvornost epoetina beta utvrđena je nakon intravenske i supkutane primjene u različitih životinjskih modela in vivo (normalnih i uremičnih štakora, policitemičnih miševa, pasa).
English: This should avoid a blockage in the tubing of the dialysis system.
Croatian: Na taj bi se način trebala izbjeći blokada u cijevima sustava za dijalizu.
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Croatian: U nekoliko kontroliranih ispitivanja nije se pokazalo da epoetini poboljšavaju ukupno preživljenje ili smanjuju rizik od napredovanja tumora u bolesnika s anemijom povezanom s rakom.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Croatian: U četiri placebo kontrolirana ispitivanja omjeri rizika za ukupno preživljenje kretali su se u rasponu od 1,25 do 2,47 u korist kontrolnih skupina.
English: What NeoRecormon is and what it is used for
Croatian: Što je NeoRecormon i za što se koristi
English: · Set aside the syringe for 30 minutes so it can warm up on its own to room temperature.
Croatian: Pričekajte 30 minuta da se štrcaljka sama ugrije na sobnu temperaturu.
English: Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click” (B).
Croatian: Držeći štrcaljku jednom rukom, odlučnim i brzim pokretom pritisnite zaštitni zatvarač o ravnu površinu dok ne čujete „klik“ (B).
English: When you donate blood, NeoRecormon will be given to you at the end of a donation session.
Croatian: Prilikom davanja krvi, NeoRecormon će Vam biti dan na kraju postupka.
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: Analiza podataka na razini pojedinog bolesnika provedena je na više od 13900 bolesnika s rakom (na kemoterapiji, radioterapiji, kemoradioterapiji ili bez terapije) koji su sudjelovali u 53 kontrolirana klinička ispitivanja koja su obuhvaćala nekoliko epoetina.
English: If you are a cancer patient you should be aware that NeoRecormon may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Croatian: Bolujete li od raka, imajte na umu da NeoRecormon može djelovati kao faktor rasta za krvne stanice i da u pojedinim okolnostima može imati negativan učinak na rak.
English: This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
Croatian: Količina krvi, koju je potrebno izvaditi, mora se izračunati tako da bude dovoljna da se izbjegnu homologne transfuzije krvi.
English: (4) Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
Croatian: (4) Izvadite iz blistera nastavak za pripremu i izvlačenje (koje omogućava sterilnu izmjenu zraka) i uklonite zaštitni pokrov sa šiljka.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Croatian: Kontrolirana klinička ispitivanja nisu pokazala značajne koristi koje bi se mogle pripisati primjeni epoetina, kada se koncentracija hemoglobina poveća iznad razine neophodne za kontrolu simptoma anemije i izbjegavanje transfuzije krvi.
English: How to store NeoRecormon · Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati NeoRecormon ● Lijek čuvajte izvan pogleda i dohvata djece.
English: In trials, children usually needed higher doses of NeoRecormon (the younger the child, the higher the dose).
Croatian: Tijekom kliničkih ispitivanja djeci je obično trebala veća doza lijeka NeoRecormon (što je dijete bilo mlađe, potrebna doza je bila veća).
English: Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
Croatian: Napišite na naljepnicu datum pripreme i rok valjanosti otopine (rok valjanosti je 1 mjesec nakon pripreme).
English: Injections are given under the skin.
Croatian: Injekcija se daje pod kožu.
English: · Keep your fingers behind the safety shield and away from the needle at all times.
Croatian: ● U svakom trenutku prste držite iza zaštitnog pokrova i podalje od igle.
English: (3) Disinfect the rubber seal with alcohol.
Croatian: (3) Dezinficirajte gumeni zatvarač alkoholom.
English: · Injection needle(s) (27G or 30G (depending on the prescribed strengths of the medicine) with safety shield (used for priming, setting the dose and injecting the medicine).
Croatian: ● Igla(e) za injekciju veličine 27G ili 30G (ovisno o propisanoj jačini lijeka) sa zaštitnim pokrovom (za provjeru protoka, odmjeravanje doze i injiciranje lijeka).
English: After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Croatian: Nakon jednokratne primjene epoetina beta nije uočeno djelovanje na ponašanje ili lokomotornu aktivnost miša te cirkulatornu i respiratornu funkciju pasa.
English: Before withdrawing each dose disinfect the rubber seal of the withdrawal device with alcohol to prevent contamination of the contents by repeated needle insertions.
Croatian: Prije izvlačenja svake pojedine doze gumeni zatvarač nastavka za izvlačenje treba dezinficirati alkoholom kako bi se spriječilo zagađenje sadržaja uslijed ponavljanih uboda iglom.
English: 7 Place the syringe on a clean, flat surface until ready for use.
Croatian: Odložite štrcaljku na čistu i ravnu površinu dok ne budete spremni za uporabu.
English: The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.
Croatian: Doza lijeka NeoRecormon ovisi o Vašem stanju, razini crvenih krvnih stanica i količini krvi koja će se dati prije operacije.
English: Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
Croatian: Rezultati kliničkih ispitivanja provedenih u djece pokazali su u prosjeku da što su djeca mlađa, to su potrebne više doze lijeka NeoRecormon.
English: If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Croatian: Ukoliko se kod Vas pojave neuobičajeno 'zviždanje' pri disanju ili otežano disanje, otečen jezik, lice ili grlo, ili oticanje oko mjesta na kojem je primijenjena injekcija, ako osjećate omaglicu, nesvjesticu ili padnete u nesvijest, odmah se obratite liječniku.
English: Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Croatian: Epoetin beta se proizvodi uz pomoć specijalizirane genetičke tehnologije i djeluje identično prirodnom hormonu eritropoetinu.
English: Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
Croatian: Osobito se na početku liječenja preporučuje redovito praćenje krvnog tlaka, uključujući razdoblja između dijaliza.
English: The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
Croatian: Potrebna količina predonirane krvi izražava se u jedinicama, gdje jedna jedinica odgovara 180 ml eritrocita.
English: If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.
Croatian: Ukoliko Vaš organizam proizvodi neutralizirajuća antitijela, liječnik će Vam ukinuti terapiju lijekom NeoRecormon i odrediti najbolji način liječenja anemije.
English: NeoRecormon has no influence on the ability to drive and use machines.
Croatian: NeoRecormon ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose).
Croatian: Nakon toga se u razmacima od jedan ili dva tjedna odredi doza za svakog bolesnika posebno (doza održavanja).
English: Not included in the box: · 1 alcohol swab.
Croatian: Nije uključeno u pakiranje: ● 1 tupfer natopljen alkoholom
English: An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95 % CI: 1.13, 2.31).
Croatian: U ukupnoj populaciji primijećen je povećani relativni rizik od tromboembolijskih događaja (RR 1,62, 95% CI: 1,13; 2,31).
English: Take special care with other products that stimulate red blood cell production:
Croatian: Budite osobito oprezni pri uzimanju drugih lijekova koji potiču proizvodnju crvenih krvnih stanica:
English: · Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
Croatian: Odmah se obratite svom liječniku ako Vam se jave: glavobolje, pogotovo nagle, probadajuće glavobolje nalik migreni, smetenost, poremećaji govora, nesigurnost pri hodu, napadaji ili konvulzije.
English: Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula.
Croatian: Obje varijable određuju endogenu rezervu eritrocita, koja se može izračunati prema sljedećoj formuli.
English: NeoRecormon pre-filled syringe Instructions for Use
Croatian: NeoRecormon napunjena štrcaljka Upute za uporabu
English: Do not inject within 5 cm (2 inches) area directly around your belly button.
Croatian: Nemojte injicirati unutar područja 5 cm od pupka.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Croatian: Eritropoetinski receptori mogu se nalaziti na površini različitih tumorskih stanica.
English: It is unlikely to be serious.
Croatian: Vrlo je mala mogućnost da ćete zbog toga imati ozbiljne posljedice.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Croatian: Meta-analize također konzistentno ukazuju na značajno povećan relativni rizik od tromboembolijskih događaja kod bolesnika s rakom koji primaju rekombinantni humani eritropoetin (vidjeti dio 4.4).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o pripremi lijeka prije primjene vidjeti dio 6.6.
English: * produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology Excipient(s) with known effect
Croatian: * proizvedenog na stanicama ovarija kineskog hrčka tehnologijom rekombinantne DNK Pomoćne tvari s poznatim učinkom:
English: Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.
Croatian: Istraživanja na kulturama stanica ljudske koštane srži, pokazala su da epoetin beta potiče eritropoezu specifično, ne utječući na leukopoezu.
English: Endogenous red cell reserve [ml]
Croatian: Endogena rezerva eritrocita [ml]
English: Other medicines and NeoRecormon
Croatian: Drugi lijekovi i NeoRecormon
English: In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Croatian: U indikaciji „povećanja količine autologne krvi“: infarkt miokarda ili moždani udar u mjesecu koji prethodi liječenju, nestabilna angina pectoris ili povećani rizik od tromboze dubokih vena poput venske tromboembolije u povijesti bolesti.
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 12 -14 g/dl.
Croatian: Ciljna koncentracija hemoglobina u dva je ispitivanja bila >13 g/dl, a u preostala tri ispitivanja bila je 12 - 14 g/dl.
English: If blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon therapy is recommended.
Croatian: Ako se povišenja krvnog tlaka ne mogu kontrolirati lijekovima, preporučuje se privremeni prekid liječenja lijekom NeoRecormon.
English: - Increasing the yield of autologous blood from patients in a pre-donation programme.
Croatian: Povećanje količine autologne krvi u bolesnika u predonacijskom programu.
English: · People donating their own blood before surgery Injections are given into a vein over two minutes, or under the skin.
Croatian: • Osobe koje daju vlastitu krv prije operacije Injekcije se daju u venu tijekom dvije minute ili ih se primjenjuje pod kožu.
English: In placebo controlled trials temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4).
Croatian: U placebom kontroliranim ispitivanjima privremeni nedostatak željeza bio je izraženiji u bolesnika liječenih lijekom NeoRecormon nego u kontrolnim skupinama (vidjeti dio 4.4).
English: Your injections are given under the skin or into a vein.
Croatian: Injekcije se daju pod kožu ili u venu.
English: What NeoRecormon is and what it is used for What you need to know before you use NeoRecormon How to use NeoRecormon
Croatian: Što je NeoRecormon i za što se koristi Što morate znati prije nego počnete primjenjivati NeoRecormon
English: · Keep your syringe out of direct sunlight.
Croatian: Nemojte izlagati štrcaljku izravnoj sunčevoj svjetlosti.
English: Therapy with NeoRecormon should be initiated by physicians experienced in the above mentioned indications.
Croatian: Liječenje NeoRecormonom treba započeti liječnik s iskustvom u gore navedenim indikacijama.
English: Remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe.
Croatian: Veće mjehuriće zraka uklonite laganim kuckanjem prstima po tijelu štrcaljke sve dok se mjehurići ne podignu na vrh štrcaljke.
English: NeoRecormon is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Croatian: NeoRecormon je lijek iz skupine lijekova koji potiču proizvodnju crvenih krvnih stanica kao što to čini ljudski protein eritropoetin.
English: 10 Prepare the syringe and needle: follow steps 11 to 14.
Croatian: Pripremite štrcaljku i iglu: slijedite korake 11 - 14.
English: To maintain an Hb of between 10 and 12 g/dl, the dosage is initially reduced to half of the previously administered amount.
Croatian: Hb između 10 i 12 g/dl, doza se najprije smanji na polovicu ranije davane količine.
English: Important: Always keep the sharps disposal container out of reach of children.
Croatian: Važna napomena: Spremnik za oštre predmete uvijek držite izvan dohvata djece.
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Croatian: Upravljanje vozilima i strojevima Nisu primijećeni učinci na sposobnost upravljanja motornim vozilima i strojevima.
English: The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight.
Croatian: Doza lijeka NeoRecormon ovisi o stanju Vaše bolesti, načinu davanja injekcije (pod kožu ili u venu) i Vašoj tjelesnoj masi.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
Croatian: Čimbenici koje prilikom ove procjene treba uzeti u obzir uključuju tip tumora i njegov stadij, stupanj anemije, očekivano preživljenje bolesnika, uvjete u kojima se bolesnik liječi i bolesnikove želje (vidjeti dio 5.1).
English: Keep pressing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
Croatian: Nastavite potiskivati klip sve dok količina lijeka NeoRecormon u štrcaljki ne bude jednaka propisanoj.
English: Administering the intravenous injection via injection port Preparing for injection: follow steps 1 to 8.
Croatian: Primjena intravenske injekcije putem katetera Priprema za injiciranje: slijedite korake 1 - 8.
English: In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly.
Croatian: Kod nedonoščadi može doći do blagog porasta broja trombocita, posebno do 12.-14. dana života pa stoga broj trombocita treba redovito kontrolirati.
English: What NeoRecormon looks like and contents of the pack
Croatian: Kako NeoRecormon izgleda i sadržaj pakiranja
English: May be harmful for people with phenylketonuria.
Croatian: To može biti štetno za osobe koje boluju od fenilketonurije.