FrancophonIA/ELRC3.0 huggingface dataset:
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: Mehanizam djelovanja Humani eritropoetin je endogeni glikoproteinski hormon koji je primarni regulator eritropoeze kroz specifičnu interakciju s receptorom eritropoetina koji se nalazi na eritroidnim progenitornim stanicama u koštanoj srži.
English: Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells.
Croatian: Eritropoetin se stvara u bubrezima i stimulira Vašu koštanu srž na stvaranje crvenih krvnih stanica.
English: Do not touch the needle or needle shield or push the plunger (see picture 5).
Croatian: Ne smijete dodirivati iglu ili štitnik za iglu ili gurati klip (vidjeti sliku 5).
English: Data from three placebo-controlled clinical studies in 586 anaemic cancer patients conducted with epoetin theta, showed no negative effect of epoetin theta on survival.
Croatian: Podaci iz tri placebom kontrolirana klinička ispitivanja, koja su uključivala 586 anemičnih bolesnika s karcinomom provedenih s epoetinom theta, ne pokazuju negativni efekt epoetina theta na preživljavanje.
English: For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Za ugodniju primjenu injekcije, ostavite napunjenu štrcaljku 30 minuta kako bi dosegla sobnu temperaturu (ne iznad 25°C) ili je nježno držite u ruci nekoliko minuta.
English: Shunt thrombosis*
Croatian: Tromboza šanta*
English: The dose may be increased after 4 weeks to 80 IU/kg, 3 times per week, and by further increases of 25% of the previous dose at monthly intervals, if needed.
Croatian: Ta se doza nakon 4 tjedna može povećati na 80 IU/kg, 3 puta tjedno, a dalje, po potrebi, povećavati za 25% prethodne doze u razmacima od mjesec dana.
English: If you think you have injected more Biopoin than you should, contact your doctor.
Croatian: Ako mislite da ste primjenili veću dozu lijeka Biopoin nego što ste trebali, obratite se liječniku.
English: Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life.
Croatian: Može se čuvati na sobnoj temperaturi (ne iznad 25 °C) do najviše 7 dana unutar roka valjanosti.
English: Hypertension*
Croatian: Hipertenzija*
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Croatian: Držeći štrcaljku okrenutu prema gore, istisnite sav zrak iz štrcaljke polako gurajući klip prema gore.
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Ostali pripravci za liječenje anemije, ATK oznaka: B03XA01
English: In the case of injections into veins, your dosage may be switched to 2 injections weekly.
Croatian: U slučaju injekcija u vene, doza se može promijeniti na 2 injekcije tjedno.
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 preživljavanja u ispitivanjima nije bilo moguće zadovoljavajuće objasniti razlikama u incidenciji tromboze i povezanih komplikacija između onih koji su primili rekombinantni humani eritropeotin i onih u kontrolnoj skupini.
English: The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Croatian: Sigurnosna naprava za iglu sprječava ozljede iglom nakon primjene, stoga nisu potrebne posebne mjere opreza prilikom odlaganja upotrijebljenih štrcaljki.
English: In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary to decreased maternal body weight were observed at doses sufficiently in excess to the recommended human dose.
Croatian: U ispitivanjima reproduktivne toksičnosti s drugim epoetinima, učinci opaženi pri dozama koje su bile značajno više od preporučene doze u ljudi, interpretirani su kao posljedica smanjene tjelesne težine majke.
English: Check again to make sure the correct dose of Biopoin is in the syringe.
Croatian: Ponovo provjerite je li doza lijeka Biopoin u štrcaljki ispravna doza.
English: Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be switched to twice-weekly administration.
Croatian: Intravenska primjena: Kod stabilnih bolesnika režim primjene od tri puta tjedno može se zamijeniti režimom primjene od dva puta tjedno.
English: It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk.
Croatian: Nije poznato izlučuju li se epoetin theta/metaboliti u majčino mlijeko, ali podaci za novorođenčad ne pokazuju apsorpciju ili farmakološku aktivnost eritropoetina primijenjenog tijekom dojenja.
English: If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Croatian: Ako vrijednosti hemoglobina nastave rasti, terapiju treba prekinuti sve dok vrijednosti hemoglobina ne počnu padati i tada terapiju ponovo započeti s dozom koja je oko 25% niža od prethodno primijenjene doze.
English: The injections are given under the skin or into a vein.
Croatian: Injekcije se daju pod kožu ili u venu.
English: In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in haemoglobin and the target haemoglobin value should be determined individually taking into account the clinical picture.
Croatian: U bolesnika s hipertenzijom ili postojećim kardiovaskularnim, cerebrovaskularnim ili perifernim vaskularnim bolestima, porast hemoglobina i ciljnu vrijednost hemoglobina treba odrediti u svakog pojedinačnog bolesnika, uzimajući u obzir kliničku sliku.
English: The maximum dose should not exceed 60,000 IU.
Croatian: Najviša doza ne smije prelaziti 60 000 IU.
English: Common (may affect up to 1 in 10 people) - Headache; - High blood pressure; - Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; - Skin reactions, such as rash, itching or reactions around the injection site.
Croatian: Često (mogu se javiti u do 1 na 10 osoba) - glavobolja; - visoki krvni tlak; - simptomi nalik gripi, poput vrućice, zimice, osjećaja slabosti, umora; - kožne reakcije poput osipa, svrbeža ili reakcija oko mjesta primjene injekcije.
English: The syringe has a scale on the syringe barrel.
Croatian: Štrcaljka ima skalu na tijelu štrcaljke.
English: Confirm visually that the needle is fully engaged in the safety shield under the lock (see picture 15).
Croatian: Vizualno potvrdite da je cijela igla učvršćena unutar sigurnosnog štitnika ispod sklopke (vidjeti sliku 15).
English: If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions, tell your doctor immediately.
Croatian: Ako se jave glavobolje, posebno nagle, probadajuće glavobolje nalik migreni, zbunjenost, poremećaj govora, nestabilan hod, napadaji ili konvulzije, odmah obavijestite svog liječnika.
English: The haemoglobin levels remained within the desired target range and epoetin theta was well tolerated over a period of up to 15 months.
Croatian: Vrijednosti hemoglobina ostale su unutar željenog ciljnog raspona te je zabilježena dobra podnošljivost epoetina theta u periodu do 15 mjeseci.
English: The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks).
Croatian: Doza se može nakon 4 tjedna povećati na 40 IU/kg, 3 puta tjedno, ako porast hemoglobina nije adekvatan (< 1 g/dl [0,62 mmol/l] unutar 4 tjedna).
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (see section
Croatian: Kao i kod svih faktora rasta, i kod epoetina postoji mogućnost stimuliranja rasta bilo koje vrste maligniteta (vidjeti dio 5.1).
English: If you are on dialysis, medicines that prevent blood coagulation are used.
Croatian: Ako ste na dijalizi, primjenjuju se lijekovi koji sprječavaju zgrušavanje krvi.
English: Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
Croatian: Liječnik će provjeriti postoji li neki drugi uzrok anemije te napraviti krvne pretrage ili pregled koštane srži.
English: If, after an additional 4 weeks of therapy, the haemoglobin increase is still insufficient an increase of the weekly dose to 60,000 IU should be considered.
Croatian: Ako se ni nakon dodatna 4 tjedna terapije ne zabilježi dostatan rast hemoglobina, treba razmotriti povećanje tjedne doze na 60 000 IU.
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 tomu, postoje dosljedni dokazi koji sugeriraju da može postojati značajna šteta za bolesnike s karcinomom koji su liječeni rekombinantnim humanim eritropoetinom.
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response.
Croatian: Popratne infekcije, upalne ili traumatske epizode, okultni gubitak krvi, hemoliza, trovanje aluminijem, podležeće hematološke bolesti ili fibroza koštane srži također mogu ugroziti eritropoetski odgovor.
English: In the clinical studies, patients not yet undergoing dialysis (subcutaneous administration) discontinued the study more frequently than haemodialysis patients (intravenous administration) as they had to terminate the study when starting dialysis.
Croatian: U kliničkim ispitivanja bolesnici koji još nisu bili na dijalizi (supkutana primjena) češće su prekidali ispitivanje nego bolesnici koji su bili na hemodijalizi (intravenska primjena) jer su morali završiti ispitivanje na početku dijalize.
English: In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients in the maintenance phase study and 111 patients in the long-term study.
Croatian: U kliničkim ispitivanjima bolesnici koji još nisu bili na dijalizi dobivali su epoetin theta jednom tjedno, i to 174 bolesnika u fazi održavanja i 111 bolesnika u dugoročnom ispitivanju.
English: If signs and symptoms suggestive of these reactions appear, epoetin theta should be withdrawn immediately and an alternative treatment considered.
Croatian: U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu epoetina theta i razmisliti o zamjenskom liječenju.
English: This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Croatian: To je stoga što se tijekom liječenja ne može sa apsolutnom sigurnošću isključiti mogućnost ubrzanog napredovanja bubrežne bolesti.
English: No accumulation of epoetin theta was observed.
Croatian: Nije zabilježena akumulacija epoetina theta.
English: These antibodies have been shown to cross-react with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to epoetin theta (see section 4.8).
Croatian: Pokazalo se da ta antitijela unakrsno reagiraju sa svim epoetinima, pa bolesnike kod kojih se sumnja ili u kojih je potvrđena prisutnost neutralizirajućih antitijela na eritropoetin ne treba prebacivati na epoetin theta (vidjeti dio 4.8).
English: In order to improve the traceability of epoetins, the name of the administered epoetin should be clearly recorded in the patient file.
Croatian: Da bi se poboljšala sljedivost epoetina, potrebno je čitko zabilježiti naziv primijenjenog epoetina u medicinsku dokumentaciju bolesnika.
English: Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients not yet undergoing dialysis, who were on stable treatment with epoetin beta.
Croatian: Provedena su dva randomizirana kontrolirana ispitivanja koja su uključivala 270 bolesnika na hemodijalizi i 288 bolesnika koji još nisu bili na dijalizi, a koji su bili na stabilnoj terapiji epoetinom beta.
English: What you need to know before you use Biopoin 3.
Croatian: Što morate znati prije nego počnete primjenjivati Biopoin
English: In patients with cancer receiving chemotherapy the aetiology of anaemia is multifactorial.
Croatian: U bolesnika s karcinomom koji primaju kemoterapiju etiologija anemije je multifaktorijalna.
English: Move the safety shield away from the needle and toward the syringe barrel.
Croatian: Pomaknite sigurnosni štitnik od igle i prema tijelu štrcaljke.
English: Stop using Biopoin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite primjenjivati lijek Biopoin u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: Only clear, colourless solutions without particles should be used.
Croatian: Smiju se primijeniti samo bistre, bezbojne otopine bez vidljivih čestica.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative epoetin doses independent of the diabetes or dialysis status was observed (see sections 4.2 and section 4.4).
Croatian: Opažena je tendencija prema povećanom procijenjenom riziku od smrtnosti svih uzroka te kardiovaskularnih i cerebrovaskularnih događaja povezanih s višim kumulativnim dozama epoetina neovisno o prisutnosti dijabetesa ili statusu dijalize (vidjeti dijelove 4.2 i 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 osnovi gore navedenog, u nekim kliničkim slučajevima transfuzija krvi je terapija izbora za liječenje anemije u bolesnika s karcinomom.
English: It is unknown whether the active substance in this medicine passes over to the breast milk.
Croatian: Nije poznato izlučuje li se djelatna tvar iz ovog lijeka u majčino mlijeko.
English: The needle shield will retract completely when you insert the needle into the skin (see picture 10).
Croatian: Štitnik za iglu će se potpuno uvući kada ubodete iglu u kožu (vidjeti sliku 10).
English: Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Croatian: Neklinički podaci o epoetinu theta ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: If you are a patient with chronic renal failure, your doctor will check that a particular blood parameter (haemoglobin) does not exceed a defined threshold.
Croatian: Ako imate kronično zatajenje bubrega, liječnik će provjeriti je li vrijednost određenog krvnog parametra (hemoglobina) unutar predviđenih granica.
English: Further increases of 25% of the previous dose may be made at monthly intervals until the individual target haemoglobin level is obtained.
Croatian: Doza se dalje može povećavati za 25% od prethodne doze u intervalima od mjesec dana dok se ne dosegne ciljna vrijednost hemoglobina.
English: Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.
Croatian: Epoetin theta ima identičan slijed aminokiselina i po svom sastavu ugljikohidrata (glikozilacija) sličan je endogenom humanom eritropoetinu.
English: Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary.
Croatian: Liječnik će redovito provjeravati Vašu krvnu sliku i prilagođavati dozu lijeka ili po potrebi prekinuti liječenje.
English: Patients should be monitored closely to ensure that the lowest approved dose of epoetin theta is used to provide adequate control of the symptoms of anaemia.
Croatian: Bolesnike treba pažljivo pratiti kako bi se osigurala primjena najniže odobrene doze epoetina theta kojom se postiže adekvatna kontrola simptoma anemije.
English: Caution should be exercised with escalation of epoetin theta 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 povećavanja doza epoetina theta u bolesnika s kroničnim zatajenjem bubrega, budući da visoke kumulativne doze epoetina mogu biti povezane s povećanim rizikom od smrtnosti te ozbiljnih kardiovaskularnih i cerebrovaskularnih događaja.
English: This medicine may not be suitable for the following patients.
Croatian: Ovaj lijek može biti neprikladan za skupine bolesnika navedene u daljnjem tekstu.
English: One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Croatian: Jedna od najčešćih nuspojava tijekom liječenja epoetinom theta je porast krvnog tlaka ili pogoršanje postojeće hipertenzije osobito tijekom početne faze liječenja.
English: Common in patients with chronic renal failure (may affect up to 1 in 10 people) - Blood clot in the arterio-venous fistula in patients on dialysis.
Croatian: Često u bolesnika s kroničnim zatajenjem bubrega (mogu se javiti u do 1 na 10 osoba) - krvni ugrušak u arterijsko-venskoj fistuli u bolesnika na dijalizi.
English: Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.
Croatian: Nakon što se intenzivnijom terapijom uspostavi kontrola hipertenzije, ponovno treba započeti liječenje epoetinom theta smanjenom dozom.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni epoetina theta u trudnica ograničeni (manje od 300 ishoda trudnoća).
English: ≥ 1/100 to < 1/10;
Croatian: ≥ 1/100 do < 1/10;
English: In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady state.
Croatian: Kod bolesnika s karcinomom na kemoterapiji, nakon ponovljene supkutane primjene epoetina theta od 20.000 IU jednom tjedno, terminalni poluvijek je 29 sati nakon prve doze i 28 sati u stanju dinamičke ravnoteže.
English: Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.
Croatian: Zabilježeni su i simptomi nalik gripi poput groznice, zimice i astenije.
English: Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Croatian: Zlouporaba epoetina theta u zdravih osoba može dovesti do izrazitog porasta hemoglobina i hematokrita.
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Croatian: Na mjesto primjene injekcije pritisnite komadić gaze ili sterilnog štapića s gazom i držite nekoliko sekundi.
English: Push the safety shield towards the needle (see picture 12).
Croatian: Potisnite sigurnosni štitnik prema igli (vidjeti sliku 12).
English: During haemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Croatian: Tijekom hemodijalize kod bolesnika liječenih epoetinom theta može biti potrebno pojačati antikoagulantnu terapiju kako bi se spriječilo zgrušavanje arterijsko-venskog šanta.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: The solution is clear and colourless.
Croatian: Otopina je bistra i bezbojna.
English: Do not remove the needle cover from the syringe until you are ready to inject.
Croatian: Ne skidajte zaštitni poklopac s igle na štrcaljki dok niste spremni za primjenu.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Croatian: Metaanalize također konzistentno indiciraju na povećan relativni rizik od tromboembolijskih događaja u bolesnika s karcinomom koji primaju rekombinantni humani eritropoetin (vidjeti dio 4.4).
English: The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.
Croatian: Terminalni poluvijek veći je nakon intravenske primjene, s prosjekom od 25 sati nakon jednostruke doze i 34 sata u stanju dinamičke ravnoteže nakon ponovljenih doza tri puta tjedno, bez dovođenja do akumulacije epoetina theta.
English: Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.
Croatian: Supkutana primjena: Tjedna doza može se dati jednom injekcijom tjedno ili tri puta tjedno.
English: Treatment for anaemia is given to adult patients with chronic renal failure or to adult patients with non-myeloid cancer (cancer not originating in the bone marrow) who at the same time are receiving chemotherapy (medicines to treat cancer).
Croatian: Liječenje anemije se primjenjuje u odraslih bolesnika s kroničnim zatajenjem bubrega ili u odraslih bolesnika s nemijeloičnom zloćudnom bolešću (rakom koji ne potječe iz koštane srži), koji istovremeno primaju kemoterapiju (lijekove za liječenje raka).
English: If you stop using Biopoin
Croatian: Ako prestanete primjenjivati Biopoin
English: Frequency groupings are defined according to the following convention:
Croatian: Njihova je učestalost definirana kako slijedi: Vrlo često:
English: Biopoin contains sodium
Croatian: Biopoin sadrži natrij
English: Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients with impaired liver function or homozygous sickle cell anaemia.
Croatian: Posebne populacije Zbog ograničenog iskustva, djelotvornost i sigurnost epoetina theta ne mogu se procijeniti u bolesnika s oštećenom jetrenom funkcijom ili homozigotnom anemijom srpastih stanica.
English: You will need to give yourself the injection into the tissue just under the skin.
Croatian: Injekciju ćete si morati dati u tkivo pod kožom.
English: The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy.
Croatian: Farmakokinetička svojstva epoetina theta ispitana su u zdravih dobrovoljaca, u bolesnika s kroničnim zatajenjem bubrega i u bolesnika s karcinomom na kemoterapiji.
English: The angle between the syringe and skin should not be too narrow (at least 45°, see pictures 9 and 10).
Croatian: Kut između štrcaljke i kože ne smije biti preuzak (najmanje 45°, vidjeti slike 9 i 10).
English: Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
Croatian: Polagano i ravnomjerno ubrizgavajte otopinu u tkivo, držeći stalno nabor kože (vidjeti sliku 11).