FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to use Silapo
Croatian: Ako ste zaboravili primijeniti Silapo
English: Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.
Croatian: Nakon toga, liječnik može zatražiti krvne pretrage da vidi je li potrebno prilagoditi dozu.
English: Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Croatian: Srednja vrijednost razine hemoglobina tijekom postoperacijskog razdoblja bila je slična u obje skupine.
English: At the start of your therapy, Silapo is injected by medical or nursing staff.
Croatian: Na početku vašeg liječenja Silapo će injicirati medicinsko osoblje.
English: Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at risk of having a problemof the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Croatian: Liječnik će provjeriti da Vaš hemoglobin ne prelazi određenu razinu jer vas visoke koncentracije hemoglobina mogu dovesti u opasnost od problema sa srcem ili krvnim žilama i mogu povećati rizik od infarkta miokarda, moždanog udara i smrti.
English: A half-life of approximately 6 hours has been reported in children.
Croatian: Izvješteno je da je poluvijek eritropoetina kod djece približno 6 sati.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima te pomno pratiti imaju li kožne reakcije.
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Croatian: U randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju u 4 (4,7%) ispitanika nastupili su trombotički vaskularni događaji (iznenadna smrt, ishemijski moždani udar, embolija i flebitis).
English: Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/kg body weight 2 times weekly for 3 weeks prior to surgery.
Croatian: Pacijente sa srednje jakom anemijom (hematokrit 33-39%) kojima se planira uzeti ≥4 jedinice krvi potrebno je liječiti Silapom u dozi od 600 IU/kg tjelesne težine 2 puta tjedno tijekom 3 tjedna prije operacije.
English: What Silapo contains
Croatian: Što Silapo sadrži
English: Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Croatian: - Silapo je indiciran u odraslih koji nemaju nedostatak željeza prije velikog elektivnog ortopedskog kirurškog zahvata, za koje se smatra da imaju visoki rizik od komplikacija transfuzije, radi smanjenja izlaganja transfuzijama alogene krvi.
English: Hamster Ovary (CHO) cell line).
Croatian: Chinese Hamster Ovary [CHO])
English: Stop using Silapo if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite primjenjivati lijek Silapo u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: At each step, the increase or reduction in dose should be of 25 IU/kg 3 times per week.
Croatian: Svako povećanje ili smanjenje doze treba iznositi 25 IU/kg 3 puta na tjedan.
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Croatian: Epoetini su faktori rasta koji prvenstveno potiču stvaranje crvenih krvnih stanica.
English: Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p<0.001).
Croatian: Tijekom prva 24 tjedna ispitivanja eritroidni odgovor dokazan je u 27/85 (31,8%) ispitanika u skupini koja je primala epoetin alfa u usporedbi s 2/45 (4,4%) ispitanika u skupini koja je primala placebo (p < 0,001).
English: *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Croatian: *proizveden tehnologijom rekombinantne DNA na staničnoj liniji ovarija kineskog hrčka (engl.
English: In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Croatian: Kod pacijenata kod kojih se pojavi iznenadan izostanak djelotvornosti definiran smanjenjem hemoglobina (1-2 g/dl mjesečno) s povećanom potrebom transfuzije, potrebno je odrediti broj retikulocita i ispitati tipični uzrok neodgovaranja na terapiju (npr. nedostatak željeza, folata ili vitamina B12, trovanje aluminijem, infekcija ili upala, gubitak krvi i hemoliza).
English: Dose increase
Croatian: Povećanje doze
English: Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Croatian: Može se javiti tromboza ˝šanta˝, pogotovo kod pacijenata koji imaju tendenciju prema hipotenziji ili imaju komplikacije zbog arteriovenske fistule (npr. stenoza, aneurizma itd.).
English: Subcutaneous route
Croatian: Supkutani put
English: A slower injection is preferable in patients who react to the treatment with “flu-like” symptoms.
Croatian: Poželjnije je polakše injiciranje kod pacijenata koji na liječenje reagiraju pojavom simptoma sličnih gripi.
English: Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
Croatian: Preporučuje se redovno pratiti broja retikulocita radi uočavanja moguće pojave nedostatka djelotvornosti kod pacijenata s kroničnim zatajenjem bubrega.
English: Hypertensive crisis with encephalopathylike symptoms can occur.
Croatian: Može se pojaviti hipertenzivna kriza ili simptomi slični encefalopatiji.
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Silapo.
Croatian: Odmah recite svom liječniku ili medicinskoj sestri ako ste primijetili bilo koji od ovih događaja ili ako ste primijetili bilo koje učinke dok primate liječenje Silapom.
English: The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
Croatian: Najveća razina je uvijek značajno niža od najveće razine koja se postiže nakon intravenske primjene lijeka (približno jedna dvadesetina vrijednosti).
English: You should discuss this information with your doctor.
Croatian: Trebali bi o tome razgovarati sa svojim liječnikom.
English: Remove the syringe from the blister and check that the solution is clear, colourless and practically free from visible particles.
Croatian: Izvadite štrcaljku iz blistera i provjerite je li tekućina bistra, bezbojna i praktički bez vidljivih čestica.
English: Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
Croatian: Druga opcija je dati injekciju na kraju postupka dijalize kroz cijev i iglu fistule nakon čega treba dati 10 ml natrijevog-klorida i 9 mg/ml (0,9%) otopine za injekciju radi ispiranje igle i osiguranja zadovoljavajućeg injiciranja lijeka u cirkulaciju.
English: Hypertension may occur in epoetin alfa treated patients.
Croatian: Hipertenzija se može pojaviti kod pacijenata koji primaju epoetin alfa.
English: If erythropoietin is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose of ciclosporin adjusted as the haematocrit rises.
Croatian: Ukoliko se eritropoetin daje istovremeno s ciklosporinom, potrebno je pratiti razinu ciklosporina u krvi i prilagoditi njegovu dozu kako se povećava hematokrit.
English: If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
Croatian: Ukoliko se primijeti povećana razina kalija (ili u povećanju), treba razmotriti prestanak unosa eritropoetina dok se ne korigira hiperkalemija.
English: The recommended starting dose of Silapo is 450 IU/kg (maximum total dose is 40 000 IU).
Croatian: Preporučena početna doza Silapa iznosi 450 IU/kg (maksimalna ukupna doza iznosi 40 000 IU).
English: Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Croatian: Šesnaest posto bolesnika koji su primali 300 IU/kg epoetina alfa, 23 % bolesnika koji su primali 100 IU/kg epoetina alfa i 45% bolesnika koji su primali placebo trebalo je transfuziju.
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Croatian: Učinak epoetina alfa (300 IU/kg ili 100 IU/kg) na izloženost transfuziji alogene krvi ocijenjen je u dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju u odraslih bolesnika koji nemaju nedostatak željeza predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu.
English: If the patient loses response or haemoglobin concentration drops by ≥1 g/dl upon dose reduction the dose should be increased by one dosing step.
Croatian: Ako u bolesnika dođe do gubitka odgovora ili se prilikom smanjenja doze koncentracija hemoglobina smanji za ≥ 1 g/dl, dozu je potrebno povećati za jedan dozni korak.
English: In that stratum, 20/40 (50%) subjects without prior transfusions demonstrated erythroid response during the first 24 weeks, compared with 7/31 (22.6%) subjects with prior transfusions (two subjects with prior transfusion reached primary endpoint based on reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline).
Croatian: U tom je sloju 20/40 (50%) ispitanika bez prethodnih transfuzija pokazalo eritroidni odgovor tijekom prva 24 tjedna, u usporedbi sa 7/31 (22,6%) ispitanika koji su prethodno primali transfuzije (dva ispitanika s prethodnim transfuzijama dosegla su primarnu mjeru ishoda određenu kao smanjenje broja jedinica crvenih krvnih stanica primljenih transfuzijom za apsolutni broj od najmanje 4 jedinice svakih 8 tjedana, u usporedbi s 8 tjedana prije početka ispitivanja).
English: Following subcutaneous injection, serum levels of erythropoietin are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and 18 hours postdose.
Croatian: Razina eritropoetina u serumu je puno niža nakon supkutane injekcije nego nakon intravenske injekcije, sporo se povećava i doseže vrhunac 12-18 sati nakon primjene lijeka.
English: In controlled clinical studies, use of epoetin alfa and other ESAs have shown:
Croatian: U kontroliranim kliničkim ispitivanjima, primjena epoetina alfa i drugih faktora stimulacije eritropoeze pokazala je slijedeće:
English: Do not use this medicine after the expiry date which is stated on the label and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju.
English: It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
Croatian: Preporučuje se redovito kontrolirati broj trombocita tijekom prvih 8 tjedana terapije.
English: Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Croatian: - Liječenje anemije i smanjenje potreba za transfuzijom kod odraslih pacijenata koji primaju kemoterapiju zbog solidnih tumora, malignih limfoma ili multiplog mijeloma, a koji su pod rizikom od transfuzije prema procjeni općeg stanja pacijenta (npr. kardiovaskularni status, anemija prisutna prije početka kemoterapije).
English: Silapo should be administered either subcutaneously or intravenously.
Croatian: Silapo treba primijeniti ili supkutano ili intravenski.
English: Tumour growth potential
Croatian: Potencijal rasta tumora
English: This is given three times a week, injected into a vein (over 1-5 minutes).
Croatian: Daje se tri puta tjedno injekcijom u venu (tijekom 1-5 minuta).
English: As with other haematopoietic growth factors, erythropoietin has shown in vitro stimulating properties on human endothelial cells.
Croatian: Kao i drugi hematopoetski faktori rasta i eritropoetin je in vitro pokazao stimulirajuće djelovanje na ljudske endotelne stanice.
English: The recommended dose is 600 IU/kg administered subcutaneously weekly for three weeks (days -21,14 and -7) prior to surgery and on the day of surgery.
Croatian: Preporučena doza Silapa je 600 IU/kg, koja se primjenjuje supkutano svakog tjedna tijekom tri tjedna (dani -21, -14 i -7) prije kirurškog zahvata i na sam dan kirurškog zahvata (dan 0).
English: In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: iron supplementation, e.g. 200-300 mg/day orally (100-200 mg/day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ml oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose transferrin saturation is below 20%.
Croatian: Da bi se osigurao optimalan odgovor na eritropoetin, treba osigurati adekvatne zalihe željeza. - nadoknada željeza npr. 200-300 mg/dnevno oralno (100-200 mg/dnevno za pedijatrijske pacijente) preporučuje se kod pacijenata s kroničnim zatajenjem bubrega čije su vrijednosti feritina ispod 100 ng/ml - nadoknada željeza 200-300 mg/dnevno preporučuje se svim pacijentima s malignim bolestima kod kojih je zasićenje transferina ispod 20%. - u odraslih bolesnika predviđenih za veliki elektivni ortopedski kirurški zahvat, nadoknada željeza (elementarno željezo, 200 mg/dan peroralno) treba se primijeniti tijekom trajanja terapije epoetinom zeta.
English: • Blood clots may also form in your haemodialysis system.
Croatian: • može također doći do stvaranja krvnih ugrušaka u sistemu za hemodijalizu.
English: Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥1.5 g/dl from baseline or a reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline, and a response duration of at least 8 weeks.
Croatian: International Working Group, IWG) iz 2006. kao porast hemoglobina ≥ 1,5 g/dl od početnih vrijednosti ili smanjenje broja jedinica crvenih krvnih stanica primljenih transfuzijom za apsolutni broj od najmanje 4 jedinice svakih 8 tjedana, u usporedbi s 8 tjedana prije početka ispitivanja te trajanje odgovora od najmanje 8 tjedana.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see sections 4.2 and 4.4).
Croatian: Primijećena je tendencija povećanja procijenjenog rizika od smrti zbog bilo kojeg uzroka te kardiovaskularnih i cerebrovaskularnih događaja, neovisno o dijabetesu ili statusu dijalize (vidjeti dijelove 4.2 i 4.4).
English: The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Croatian: Četiri ugljikohidratna lanca pričvršćena su za protein preko tri N-glikozidne veze i jedne O-glikozidne veze.
English: Some patients with more extended dosing intervals (greater than once weekly) of epoetin may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin dose.
Croatian: U nekih bolesnika u kojih je interval doziranja epoetina produljen (dulji od jedanput tjedno) prikladna razina hemoglobina se možda neće održati (vidjeti dio 5.1) te može zahtijevati povišenje doze epoetina.
English: The starting dose is 450 IU per kilogram bodyweight once a week.
Croatian: Početna doza iznosi 450 IU po kilogramu tjelesne težine jednom tjedno.
English: Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
Croatian: Odrasli i pedijatrijski pacijenti na hemodijalizi, odrasli pacijenti na peritonejskoj dijalizi i odrasli pacijenti s renalnom insuficijencijom koji još nisu na dijalizi
English: Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ≤10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).
Croatian: - Silapo se može koristiti za povećanje koncentracije hemoglobina kod simptomatske anemije (koncentracija hemoglobina ≤ 10 g/dl) u odraslih osoba s primarnim mijelodisplastičnim sindromom (MDS) niskog ili srednjeg-1 rizika i niskom razinom eritropoetina u serumu (< 200 mU/ml).
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Croatian: U otvorenim ispitivanjima nije bilo razlike u ukupnom preživljenju pacijenata liječenih rekombinantnim humanim eritropoetinom i kontrolnom skupinom.
English: in adult patients receiving chemotherapy for solid tumours, malignant lymphoma (cancer of the lymphatic system) or multiple myeloma (bone marrow cancer) to treat anaemia and reduce the need for a blood transfusion, if the doctor decides there may be a high risk for needing for a blood transfusion.
Croatian: - kod odraslih pacijenata na kemoterapiji zbog solidnih tumora, malignih limfoma (rak limfnog sustava) ili multiplog mijeloma (rak koštane srži) radi liječenja anemije i smanjenja potrebe za transfuzijom krvi, ukoliko liječnik odluči da postoji veliki rizik potrebe transfuzije krvi.
English: Solution for injection in pre-filled syringe.
Croatian: Otopina za injekciju u napunjenoj štrcaljki.
English: A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
Croatian: U randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju procijenjene su djelotvornost i sigurnost epoetina alfa u odraslih bolesnika s anemijom i mijelodisplastičnim sindromom niskog ili srednjeg-1 rizika.
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: Ova ispitivanja pokazala su konzistentnu, neobjašnjivu, statistički značajnu veću smrtnosti pacijenata s anemijom zbog različitih čestih malignih bolesti koji primaju rekombinantni humani eritropoetin u odnosu na kontrolnu skupinu.
English: The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Croatian: Cilj je doseći razinu hemoglobina između 10 i 12 g/dl (6,2 - 7,5 mmol/l), osim kod pedijatrijskih pacijenata kod kojih bi koncentracija hemoglobina trebala biti između 9,5 i 11 g/l (5,9-6,8 mmol/l).
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 hemoglobina i razvoj jake anemije povezane s niskim brojem retikulocita znak je za prestanak terapije epoetinom i testiranje prisutnosti protutijela na eritropoetin.
English: Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Croatian: Treba obratiti pozornost na naglu pojavu glavobolje slične migreni kao mogućeg znaka upozorenja.
English: Talk to your doctor before using Silapo if you know you are suffering, or have suffered, from any of the following: epileptic seizures liver disease cancer anaemia from other causes heart disease (such as angina) disorders of blood circulation resulting in pins and needles or cold hands or feet or muscle cramps in the legs blood clots/blood clotting disorders kidney disease.
Croatian: Obratite se svom liječniku prije nego uzmete Silapo koliko imate ili ste imali nešto od nabrojanog: - epileptičke napade - bolest jetre - rak - anemiju zbog drugih uzroka - bolest srca (poput angine) - poremećaje cirkulacije krvi koji rezultiraju probadanjem i bockanjem ili hladnim rukama ili stopalima ili grčenjem mišića nogu - krvne ugruške/poremećaje zgrušavanja krvi - bolest bubrega.
English: Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
Croatian: Kongestija dišnih putova, koja uključuje kongestiju gornjeg dijela dišnih putova, nosna kongestija i nazofaringitis, bila je prijavljena u ispitivanjima s produljenim intervalom doziranja u odraslih bolesnika s insuficijencijom bubrega koji još nisu na dijalizi.
English: Silapo should also be used with caution in the presence of epilepsy and chronic liver failure.
Croatian: Silapo treba primjenjivati s oprezom u slučaju epilepsije i kroničnog zatajenja jetre.
English: Blood pressure should be closely monitored and adequately controlled in all epoetin treatment naïve as well as pre-treated patients before, at initiation of, and during treatment with Silapo.
Croatian: Potrebno je pomno nadzirati krvni tlak i adekvatno ga kontrolirati na početku i za vrijeme liječenja Silapom kod svih osoba koje se prvi put liječe epoetinom kao i kod onih koji su već liječeni.
English: Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Croatian: Ispitanici su stratificirani prema razini eritropoetina u serumu (engl. serum erythropoetin, sEPO) i statusu prethodnih transfuzija na probiru.
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dl, > 10 to ≤ 13 g/dl and > 13 g/dl).
Croatian: Bolesnici su podijeljeni u skupine prema početnoj razini hemoglobina (≤ 10 g/dl, > 10 do ≤ 13 g/dl i > 13 g/dl).
English: Your doctorwill monitor your blood pressure regularly while you are using Silapo.
Croatian: Liječnik će redovito pratiti Vaš krvni tlak dok koristite Silapo.
English: It is recommended that the platelet count is regularly checked during the first 8 weeks of therapy.
Croatian: Preporučuje se redovito provjeravati broj trombocita tijekom prvih 8 tjedana liječenja.
English: After removing one syringe from the blister pack the solution should be checked to ensure that it is clear, colourless and practically free from visible particles.
Croatian: Nakon vađenja štrcaljke iz blister pakiranja, potrebno je provjeriti je li tekućina bistra, bezbojna i praktički bez vidljivih čestica.
English: Cancer patients on erythropoietin should have haemoglobin (the part of a red blood cell that carries oxygen) levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Croatian: Kod pacijenata s rakom koji primaju eritropoetin, treba redovito mjeriti razinu hemoglobina (dio crvenih krvnih stanica koji nosi kisik) sve dok se ne postigne stabilna razina, a zatim povremeno.