FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid the risk of contamination of the contents always observe aseptic techniques (i.e. use disposable sterile syringes and needles to administer each dose) and strictly follow the handling instructions below.
Croatian: Da bi se izbjeglo zagađenje sadržaja, uvijek treba primjenjivati aseptičke tehnike (tj. za primjenu svake doze lijeka koristite sterilne štrcaljke i igle za jednokratnu uporabu) i strogo se pridržavati niže navedenih uputa za rukovanje.
English: Even at very high serum levels no symptoms of poisoning have been observed.
Croatian: Čak ni pri vrlo visokim koncentracijama u serumu, nisu opaženi nikakvi simptomi trovanja.
English: NeoRecormon is indicated for:
Croatian: NeoRecormon je indiciran za:
English: · Hold the syringe by the barrel and push the needle onto the syringe (B).
Croatian: ● Štrcaljku držite za tijelo štrcaljke i nataknite iglu na štrcaljku (B).
English: Put the protective cap on the top of the device.
Croatian: Na vrh nastavka stavite zaštitni zatvarač.
English: Your doctor may treat the high blood pressure with drugs.
Croatian: Vaš liječnik može visok krvni tlak liječiti lijekovima.
English: Special Warning: During treatment with NeoRecormon
Croatian: Posebna upozorenja: Tijekom liječenja lijekom NeoRecormon
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C - 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost pripremljene otopine je jedan mjesec na 2°C - 8°C.
English: In some patients, a fall in serum iron parameters is observed (see section 4.4).
Croatian: U nekih bolesnika zapažen je pad parametara serumskog željeza (vidjeti dio 4.4).
English: If you are a patient with chronic kidney disease, and particularly if you do not respond properly to NeoRecormon, your doctor will check your dose of NeoRecormon because repeatedly increasing your dose of NeoRecormon if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Croatian: Ako ste bolesnik s kroničnom bolesti bubrega, a osobito ako ne odgovarate na lijek NeoRecormon na odgovarajući način,Vaš će liječnik provjeriti Vašu dozu lijeka NeoRecormon jer opetovano povećavanje doze lijeka NeoRecormon, ako ne odgovarate na liječenje, može povećati rizik od problema sa srcem ili krvnim žilama i može povećati rizik od srčanog udara, moždanog udara i smrti.
English: It contains a hormone called epoetin beta, which stimulates the production of red blood cells.
Croatian: Sadrži hormon epoetin beta koji stimulira proizvodnju crvenih krvnih stanica.
English: Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Croatian: što treba uzeti u obzir u bolesnika s teškim oblicima fenilketonurije.
English: Instructions for Use intended for healthcare professional only
Croatian: Upute za uporabu namijenjene samo zdravstvenim radnicima Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
Croatian: NeoRecormon treba primjenjivati s oprezom u slučaju refraktorne anemije sa suviškom blasta u transformaciji, epilepsije, trombocitoze i kroničnog zatajenja jetre.
English: An increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
Croatian: Može se pojaviti povišenje krvnog tlaka ili pogoršanje postojeće hipertenzije, osobito u slučaju brzog rasta hematokrita.
English: Leave the needle cap on while it warms up.
Croatian: Ostavite zatvarač igle na štrcaljki dok se ona ne ugrije.
English: (8) Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial.
Croatian: (8) Uvedite iglu kroz zatvarač do dubine od oko 1 cm i polako ubrizgajte otapalo u bočicu.
English: Treatment with NeoRecormon is normally a long-term therapy.
Croatian: Liječenje lijekom NeoRecormon obično je dugoročna terapija.
English: What NeoRecormon contains
Croatian: Što NeoRecormon sadrži
English: Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with NeoRecormon are expected to experience adverse reactions.
Croatian: Na temelju rezultata kliničkih ispitivanja koja su uključivala 1725 bolesnika, očekuje se da će otprilike 8 % bolesnika liječenih lijekom NeoRecormon razviti nuspojave.
English: NeoRecormon is provided in the following pack-sizes:
Croatian: NeoRecormon je dostupan u sljedećim veličinama pakiranja:
English: If you are a kidney patient under haemodialysis, your doctor may adjust your dose of heparin.
Croatian: Ako ste bubrežni bolesnik na hemodijalizi, liječnik bi Vam mogao prilagoditi dozu heparina.
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
Croatian: Nakon započetog liječenja liječnik će održavati razinu Vašeg hemoglobina između 10 i 12 g/dl.
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: Odluku o davanju rekombinantnih eritropoetina treba, u suradnji s pojedinim bolesnikom, temeljiti na procjeni koristi i rizika koja u obzir treba uzeti specifične kliničke okolnosti.
English: The NeoRecormon pre-filled syringe is ready for use.
Croatian: NeoRecormon napunjena štrcaljka je spremna za uporabu.
English: Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia.
Croatian: Bolesnike treba pomno nadzirati da bi se zajamčila primjena najniže odobrene doze lijeka NeoRecormon koja omogućava odgovarajuću kontrolu simptoma anemije.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Croatian: Kategorije učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform antierythropoietin antibody testing.
Croatian: Paradoksalno sniženje vrijednosti hemoglobina i razvoj teške anemije povezan s niskim brojem retikulocita zahtijeva trenutni prekid terapije epoetinom i testiranje na antieritropoetinska antitijela.
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: Rezultat ukupnog preživljenja u ispitivanjima ne može se zadovoljavajuće objasniti razlikama u učestalosti pojave tromboze i s njom povezanih komplikacija između ispitanika koji su primali rekombinantni humani eritropoetin i ispitanika u kontrolnoj skupini.
English: Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Croatian: Ovaj je postupak indiciran samo u bolesnika s umjerenom anemijom (hemoglobin 10 - 13g/dl [6,21 - 8,07 mmol/l], bez nedostatka željeza) kada postupak prikupljanja krvi nije moguć ili nije dovoljan, za planirani operativni zahvat koji zahtijeva velike količine krvi (4 ili više jedinica krvi za žene odnosno 5 ili više jedinica krvi za muškarce).
English: For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular: - only patients with a PCV ³ 33 % (haemoglobin ³ 11 g/dl [6.83 mmol/l]) should donate; - special care should be taken with patients below 50 kg weight; - the single volume drawn should not exceed approx. 12 % of the patient's estimated blood volume.
Croatian: Kada se NeoRecormon primjenjuje u okviru autolognog predonacijskog programa, treba slijediti službene smjernice o principima doniranja krvi, a posebno sljedeće: - samo bolesnici s hematokritom ≥ 33% (hemoglobin ≥ 11 g/dl [6,83 mmol/l]) mogu donirati; - posebnu pažnju treba obratiti bolesnicima lakšim od 50 kg; - pojedinačni volumen krvi uzet od bolesnika ne smije biti veći od oko 12 % procijenjenog ukupnog volumena krvi.
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa, reported an incidence of stroke as common.
Croatian: Prema podacima iz kontroliranih kliničkih ispitivanja s epoetinom alfa odnosno darbepoetinom alfa, prijavljena incidencija moždanoga udara bila je često.
English: In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
Croatian: Kod bolesnika u programu predonacije autologne krvi može doći do porasta broja trombocita, uglavnom unutar normalnih granica.
English: Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less.
Croatian: Liječnik može započeti liječenje lijekom NeoRecormon ako Vam je hemoglobin 10 g/dl ili niži.
English: If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether treatment is right for you.
Croatian: Ako bolujete od nefroskleroze i niste na dijalizi, Vaš će liječnik odlučiti je li navedeno liječenje odgovarajuće za Vas.
English: · Do not try to remove the used injection needle from the used syringe.
Croatian: Nemojte pokušavati skinuti upotrijebljenu iglu s upotrijebljene štrcaljke.
English: Treatment with NeoRecormon is divided into two stages.
Croatian: Liječenje lijekom NeoRecormon dijeli se u dvije faze.
English: · Gently twist until it is fully attached (C)
Croatian: ● Lagano okrećite iglu dok ne bude potpuno pričvršćena za štrcaljku (C).
English: Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
Croatian: U kliničkim ispitivanjima zapažena je nešto veća učestalost tromboembolijskih događaja u bolesnika s rakom liječenih lijekom NeoRecormon, u odnosu na neliječenu kontrolnu skupinu ili placebo.
English: Change vein with each injection to prevent soreness in one spot.
Croatian: Za svaku injekciju odaberite drugu venu kako biste izbjegli bol na jednom mjestu.
English: NeoRecormon has not shown evidence of impaired fertility in animals.
Croatian: Nema dokaza da NeoRecormon utječe na smanjenje plodnosti u životinja.
English: An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Croatian: Porast ugradnje 3H-timidina u eritroidne stanice slezene s jezgrom nađen je in vitro (kultura stanica slezene miša) nakon inkubacije s epoetinom beta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 16 July 1997
Croatian: Datum prvog odobrenja: 16. srpnja 1997.
English: Phenylalanine (up to 5.0 mg/vial) Sodium (less than 1 mmol per dose) Benzyl alcohol (up to 40 mg per multidose solvent ampoule)
Croatian: fenilalanin (do 5,0 mg/bočici) natrij (manje od 1 mmol po dozi) benzilni alkohol (do 40 mg po višedoznoj ampuli s otapalom)
English: · Check the liquid in the syringe.
Croatian: Provjerite izgled tekućine u štrcaljki.
English: Roche Pharma AG Emil-Barell-Strasse 1
Croatian: Emil-Barell-Strasse 1
English: These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Croatian: Ti simptomi uključuju: vrućicu, zimicu, glavobolje, bolove u udovima i kostima i/ili opće loše osjećanje.
English: - Prevention of anaemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.
Croatian: Prevenciju anemije u nedonoščadi porođajne mase od 750 do 1500 g i gestacijske dobi manje od 34 tjedna.
English: · Do not push or pull the plunger.
Croatian: ● Nemojte pritiskati niti izvlačiti klip.
English: · Do not inject into vein or into a muscle
Croatian: Nemojte injicirati u venu ili mišić.
English: Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Croatian: Teško preopterećenje aluminijem nastalo zbog liječenja zatajenja bubrega, može ugroziti učinkovitost lijeka NeoRecormon.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6 (sadržaj priložene ampule s otapalom).
English: If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses of NeoRecormon.
Croatian: Ako ne budete dovoljno dobro odgovarali na lijek NeoRecormon, liječnik će provjeriti Vašu dozu i obavijestiti Vas ako morate promijeniti doze lijeka NeoRecormon.
English: If there is an increase in platelets of more than 150 x 109/l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
Croatian: Ukoliko je porast trombocita veći od 150 x 109/l ili ako broj trombocita prijeđe normalnu razinu, treba prekinuti liječenje lijekom NeoRecormon.
English: The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Croatian: Ispitivanje nije postiglo niti jedan od glavnih ciljeva koji su bili prikazati smanjenje rizika od smrti bez obzira na uzrok te smanjenje rizika oboljenja od kardiovaskularnih bolesti ili završne faze bolesti bubrega.
English: Caution should be exercised with escalation of NeoRecormon 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 prilikom povećanja doza lijeka NeoRecormon u bolesnika s kroničnim zatajenjem bubrega jer visoke kumulativne doze epoetina mogu biti povezane s povećanim rizikom od smrtnosti te ozbiljnih kardiovaskularnih i cerebrovaskularnih događaja.
English: (9) Swirl the vial gently until the lyophilisate has dissolved.
Croatian: (9) Lagano kružno okrećite bočicu dok se liofilizat ne otopi.
English: Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care.
Croatian: Moguća je pojava hipertenzivnih kriza uz simptome nalik simptomima encefalopatije koje zahtijevaju hitnu liječničku intervenciju i intenzivnu medicinsku skrb.
English: The dosage may be increased every 4 weeks by 3 x 20 IU/kg and week if the increase of Hb is not adequate (< 0.25 g/dl per week).
Croatian: Doza se može povećavati svaka 4 tjedna za 3 x 20 IU/kg tjel. mase tjedno, ako porast Hb nije zadovoljavajući (< 0,25 g/dl tjedno).
English: (5) Remove the needle cover and carefully expel air from the needle by holding the syringe vertically and gently pressing the plunger upwards until a bead of liquid appears at the needle tip.
Croatian: (5) Odstranite pokrov igle i iz nje pažljivo istjerajte zrak držeći štrcaljku uspravno i lagano potiskujući klip dok se na vrhu igle ne pojavi kapljica tekućine.
English: In very rare cases, epoetin beta treatment-related anaphylactoid reactions have been reported.
Croatian: U vrlo rijetkim slučajevima zabilježene su anafilaktoidne reakcije povezane s liječenjem epoetinom beta.
English: These increases in blood pressure can be treated with medicinal products.
Croatian: Ova povišenja krvnog tlaka mogu se liječiti lijekovima.
English: If you develop a serious rash or another of these skin symptoms, stop taking NeoRecormon and contact your doctor or seek medical attention immediately.
Croatian: U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati NeoRecormon i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: The doctor may continue to increase your dose at monthly intervals if necessary.
Croatian: Ako je potrebno, liječnik može nastaviti povećavati dozu u mjesečnim razmacima.
English: Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
Croatian: Uporaba lijeka NeoRecormon u ovoj indikaciji mora se odvagnuti obzirom na poznati povećani rizik od tromboembolijskih događaja.
English: After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Croatian: Nakon supkutane primjene epoetina beta u uremičnih bolesnika, produžena apsorpcija rezultira koncentracijskim platoom u serumu, zbog čega se maksimalna koncentracija postiže u prosjeku nakon
English: EXP The reconstituted solution is stable for 1 month if stored at 2°C - 8°C (in a refrigerator)
Croatian: Pripremljena otopina stabilna je 1 mjesec, ako se čuva na 2°C - 8°C (u hladnjaku)
English: The haemoglobin values should not exceed a value of 12 g/dL.
Croatian: Vrijednosti hemoglobina ne smiju prijeći 12 g/dl.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Croatian: Ta su ispitivanja pokazala dosljedan, neobjašnjiv, statistički značajan porast mortaliteta u bolesnika s anemijom povezanom s raznim uobičajenim vrstama raka koji su primali rekombinantni humani eritropoetin, u odnosu na bolesnike u kontrolnim skupinama.
English: For epoetin beta no clinical data on exposed pregnancies are available.
Croatian: Trudnoća Nema kliničkih podataka o izloženosti trudnica epoetinu beta.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Croatian: Vaš liječnik će primijeniti najnižu dozu koja će učinkovito kontrolirati simptome anemije.
English: · Do not use NeoRecormon after the expiry date which is stated on the carton and label.
Croatian: NeoRecormon se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
English: Stop using if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite primjenjivati lijek u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: L-Glutamic acid, L-Phenylalanine.
Croatian: L-glutamatna kiselina, L-fenilalanin.
English: Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration.
Croatian: Bolesnici koji su stabilni pri režimu doziranja jednom tjedno, mogu se prebaciti na režim primjene jednom u dva tjedna.
English: · If you have low blood pressure or shunt complications you may be at risk of shunt thrombosis (a blood clot in the vessel used for connection to the dialysis system).
Croatian: Imate li nizak krvni tlak ili komplikacije sa šantom, mogli biste biti u opasnosti od tromboze šanta (krvnog ugruška u žili koja se koristi za spajanje na sustav za dijalizu).
English: Two of the studies recruited patients who were being treated with chemotherapy.
Croatian: U dva su ispitivanja uključivani bolesnici liječeni kemoterapijom.
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Croatian: Epoetini su faktori rasta koji primarno stimuliraju proizvodnju crvenih krvnih stanica.
English: If the haemoglobin level continues to increase, therapy should be interrupted until the hemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Croatian: Ako vrijednost hemoglobina nastavi rasti, terapiju treba prekinuti dok se vrijednost hemoglobina (Hb) ne počne spuštati, kada terapiju treba ponovo započeti dozom koja je otprilike 25% niža od prijašnje primijenjene doze.
English: The number of platelets can rise slightly to moderately during epoetin treatment, and this can cause changes in blood clotting.
Croatian: Broj trombocita može se tijekom liječenja epoetinom blago do umjereno povećati, što može uzrokovati promjene u zgrušavanju krvi.
English: Preparation of NeoRecormon Multidose solution (1) Take the vial with the freeze-dried substance out of the package.
Croatian: Priprema NeoRecormon Multidose otopine (1) Izvadite bočicu s liofilizatom iz kutije.
English: C. OTHER CONDITIONS AND REQUIREMENT OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
Croatian: Vaš će liječnik provoditi redovite krvne pretrage kako bi mjerenjem razine hemoglobina pratio odgovor anemije na liječenje.
English: Additional side effects in people donating their own blood before surgery · A slight increase in the occurrence of blood clots has been observed.
Croatian: Dodatne nuspojave u bolesnika koji daju vlastitu krv prije operacije • Primijećena je blago povećana pojava krvnih ugrušaka.
English: Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy.
Croatian: Liječnik može visoki tlak liječiti lijekovima ili privremeno obustaviti liječenje lijekom NeoRecormon.
English: 9 Choose an injection site: · The recommended injection sites are the top of your thigh or the lower part of your abdomen below the belly button.
Croatian: Preporučena mjesta injiciranja su gornji dio bedra ili donji dio trbuha ispod pupka.
English: Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles.
Croatian: Izvadite iz kutije jednu napunjenu štrcaljku i provjerite je li otopina bistra, bezbojna i gotovo bez vidljivih čestica.
English: - The active substance is epoetin beta.
Croatian: Djelatna tvar je epoetin beta.
English: In patients with baseline haemoglobin ≤ 10 g/dl (n=899), the hazard ratio point estimate for survival was 0.98 (95 % CI 0.68 to 1.40).
Croatian: U bolesnika s početnom razinom hemoglobina ≤ 10 g/dl (n=899), procjena omjera rizika za preživljenje bila je 0,98 (95% CI 0,68 - 1,40).
English: Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Croatian: Izvucite iglu brzo i pritisnite mjesto injiciranja suhim sterilnim jastučićem.
English: Therapy should be reinitiated at approximately 25 % lower than the previous dose after haemoglobin levels fall to 12 g/dl (7.5 mmol/l) or below.
Croatian: Terapiju treba ponovo započeti dozom otprilike 25% nižom od prethodne kada razina hemoglobina padne na 12 g/dl (7,5 mmol/l) ili ispod.
English: · Symptomatic anaemia caused by chronic kidney disease
Croatian: • Simptomatska anemija uzrokovana kroničnom bolesti bubrega
English: (3) Remove the needle cover and insert the needle through the rubber seal of the device.
Croatian: (3) Odstranite pokrov igle i uvedite iglu kroz gumeni zatvarač nastavka.
English: It is unknown whether epoetin beta is excreted in human milk.
Croatian: Nije poznato izlučuje li se epoetin beta u majčino mlijeko.
English: · Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
Croatian: ● Rijetko (mogu se javiti u do 1 na 1000 osoba) su primijećene alergije ili kožne reakcije poput osipa ili koprivnjače, svrbeža ili sličnih reakcija oko mjesta primjene injekcije.