FrancophonIA/ELRC3.0 huggingface dataset:
English: When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Croatian: Kad je neophodno prilagoditi dozu, to treba učiniti postepeno kroz najmanje četiri tjedna.
English: Your doctor may decide that it is better for you to receive Silapo by injection under the skin (subcutaneous) rather than into a vein (intravenous).
Croatian: Vaš liječnik može odlučiti da je za Vas bolje da primate Silapo injekcijom pod kožu (supkutano) umjesto u venu (intravenski).
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: This regresses during the course of continued therapy.
Croatian: To se smanjuje tijekom daljnje terapije.
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 nivou pacijenta provedena je na više od 13 900 pacijenata s malignim bolestima (kemo-, radio-, kemoradio-, ili bez terapije) koji su sudjelovali u 53 kontrolirana klinička ispitivanja koja su uključivala nekoliko epoetina.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Croatian: Vaš liječnik će primijeniti najnižu učinkovitu dozu koja će kontrolirati simptome anemije.
English: Dose (IU/kg given 3 times per week)
Croatian: doza (IU/kg primijenjena 3 puta na tjedan)
English: What Silapo is and what it is used for What you need to know before you use Silapo How to use Silapo
Croatian: Što je Silapo i za što se koristi Što morate znati prije nego počnete primjenjivati Silapo
English: The recommended dosing regimen is described in the following diagram:
Croatian: Preporučeno doziranje opisano je u dijagramu koji slijedi:
English: The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenous medicinal product and is approximately 20%.
Croatian: Bioraspoloživost supkutano injiciranog eritropoetina je puno niža od intravenski primijenjenog lijeka i iznosi približno 20%.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Croatian: Mogu se pojaviti i vrijedovi u ustima, grlu, nosu, genitalijama i očima (crvene i otečene oči).
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Croatian: Primjena epoetina nije odobrena u liječenju anemije povezane s hepatitisom C.
English: This is given 3 times a week by injection under the skin.
Croatian: Daje se 3 puta tjedno injekcijom pod kožu.
English: Your doctor may check your shunt and prescribe a medicinal product to prevent thrombosis.
Croatian: Liječnik može provjeriti Vaš ˝šant˝ i propisati lijek radi sprječavanja tromboze.
English: Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed.
Croatian: U tri su slučaja trombotički vaskularni događaji bili potvrđeni, a u jednom slučaju (iznenadna smrt) tromboembolijski događaj nije bio potvrđen.
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
English: A systematic review has also been performed involving more than 9 000 cancer patients participating in 57 clinical trials.
Croatian: Napravljen je i sistematski pregled 57 kliničkih ispitivanja koja su uključivala više od 9 000 pacijenata s malignim bolestima.
English: • Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment.
Croatian: • Krvni ugrušci (uključujući duboku vensku trombozu i embolizam) koji mogu zahtijevati hitno zbrinjavanje.
English: Haemoglobin levels should be monitored regularly.
Croatian: Razinu hemoglobina treba redovito pratiti.
English: However, your doctor may decide that it is right for you to learn how to inject Silapo under the skin (subcutaneously) yourself.
Croatian: Međutim, liječnik može odlučiti da je za Vas dobro da sami naučite injicirati Silapo pod kožu (supkutano).
English: This is given subcutaneously once every week, with not less than 5 days between doses.
Croatian: Daje se supkutano jednom tjedno svakog tjedna, s razmakom između doza od najmanje 5 dana.
English: Use in adult patients in an autologous predonation programme The recommended starting dose is 600 IU/kg.
Croatian: Primjena kod odraslih pacijenata u autolognom predonacijskom programu Preporučena početna doza je 600 IU/kg.
English: A maximum volume of 1 ml at one injection site should generally not be exceeded.
Croatian: Općenito, ne bi trebalo prijeći maksimalni volumen od 1 ml na jednom mjestu injiciranja.
English: Consequently, haemoglobin and blood pressure should be closely monitored.
Croatian: Zbog toga treba pomno kontrolirati hemoglobin i krvni tlak.
English: There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
Croatian: U literaturi postoje proturječni izvještaji o ulozi eritropoetina kao značajnog proliferatora tumora.
English: If this occurs it can result in severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
Croatian: Ukoliko se takvo što pojavi, to može rezultirati teškom anemijom čiji su simptomi neobičan umor, osjećaj omamljenosti ili nedostatak daha.
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o pripremi lijeka prije primjene, vidjeti dio 6.6.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Croatian: • visoka razina kalija u krvi koja može uzrokovati neuobičajeni srčani ritam (to je vrlo česta nuspojava u bolesnika na dijalizi).
English: Usual maintenance dose
Croatian: medijan uobičajena doza održavanja
English: Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Croatian: Protutijelima posredovana eritroblastopenija (PRCA) prijavljena je mjesecima ili godinama nakon liječenja epoetinom alfa.
English: Silapo should be given by the intravenous route.
Croatian: Silapo treba primijeniti intravenskim putem.
English: PRCA may be caused by the production of antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
Croatian: PRCA može biti uzrokovana stvaranjem protutijela protiv proizvoda s eritropoetinom i naposljetku, na vlastiti eritropoetin.
English: Do not use Silapo if:
Croatian: Ne primjenjujte Silapo ako:
English: • Swelling of the ankles, feet or fingers
Croatian: • oticanje zglobova, nogu ili prstiju
English: Alternatively, your doctor may recommend a starting dose of 450 IU/kg once a week.
Croatian: Alternativno, vaš liječnik može preporučiti početnu dozu od 450 IU/kg jedanput tjedno.
English: • An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment.
Croatian: • može doći do povećanja razina malih krvnih stanica (nazvanih krvne pločice), koje su obično uključene u stvaranje krvnog ugruška, osobito na početku liječenja.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; lifeexpectancy; the environment in which the patient is being treated; and patient preference (see section
Croatian: Faktori koje treba razmotriti u ovoj procijeni uključuju vrstu tumora i njegov stadij, stupanj anemije, očekivano preživljenje, okolinu u kojoj se pacijent liječi i želju pacijenta (vidjeti dio 5.1).
English: If you do not respond adequately to Silapo, your doctor will check your dose and will inform you if you need to change doses of Silapo.
Croatian: Ako ne budete odgovarali na liječenje Silapom na odgovarajući način, Vaš liječnik će provjeriti Vašu dozu i obavijestiti Vas ako morate promijeniti doze Silapa.
English: During treatment with Silapo
Croatian: Za vrijeme liječenja Silapoom
English: The pre-filled syringe is ready for use.
Croatian: Napunjena štrcaljka je spremna za upotrebu.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Croatian: Osipi mogu prerasti u široko rasprostranjeno ljuštenje kože i po život opasne komplikacije.
English: Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Croatian: Druga dva manja randomizirana, placebo kontrolirana ispitivanja nisu pokazala značajno poboljšanje parametara kvalitete života prema upitniku EORTC-QLQ-C30 (eng.
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: S obzirom na gore navedeno, u nekim kliničkim situacijama transfuzija krvi bi trebala biti tretman izbora u liječenju anemije kod pacijenata s malignim bolestima.
English: - Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if you have low blood pressure or if your arteriovenous fistula has complications.
Croatian: - Začepljenje spoja između arterije i vene (tromboza ˝šanta˝) može se pojaviti pogotovo ako imate niski krvni tlak ili ako imate komplikacije arteriovenske fistule.
English: Adverse drug reactions reported by ≥1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Croatian: Nuspojave prijavljene u ≥ 1% ispitanika liječenih epoetinom alfa u ovim ispitivanjima prikazane su u tablici u nastavku.
English: Tell your doctor or nurse immediately if you notice any of the effects in this list.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ukoliko primijetite bilo koji učinak s ovog popisa.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6 769 patients) was observed in patients treated with recombinant human erythropoietin.
Croatian: Povećan relativni rizik od tromboembolijskih događaja (RR 1,67, 95% CI: 1,35, 2,06, 35 ispitivanja i 6 769 pacijenata) primijećen je kod pacijenata koji se liječe rekombinantnim humanim eritropoetinom.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Croatian: Eritropoetinski receptori mogu biti izraženi na površini različitih tumorskih stanica.
English: Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning signal.
Croatian: Potrebno je obratiti posebnu pažnju na iznenadne teške glavobolje poput migrene kao mogući znak upozorenja.
English: Other medicines and Silapo
Croatian: Drugi lijekovi i Silapo
English: What Silapo looks like and contents of the pack
Croatian: Kako Silapo izgleda i sadržaj pakiranja
English: Data from clinical studies with Silapo are in line with the safety profile of other authorised erythropoietins.
Croatian: Podaci iz kliničkih ispitivanja s Silapom su u skladu s podacima o sigurnosti drugih odobrenih eritropoetina.
English: The starting dose may be adjusted by your doctor until your condition is controlled.
Croatian: Liječnik može prilagoditi početnu dozu dok se ne postigne kontrola nad vašim stanjem.
English: The pre-filled syringes contain between 0.3 and 1 ml solution, depending on the content of epoetin zeta (see “What Silapo contains”).
Croatian: Napunjene štrcaljke sadrže između 0,3 i 1 ml otopine, ovisno o sadržaju epoetina zeta (vidjeti ˝Što Silapo sadrži˝).
English: In animal studies, erythropoietin has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Croatian: Ispitivanja na životinjama pokazala su da eritropoetin smanjuje tjelesnu težinu fetusa, usporava okoštavanje i povećava fetalnu smrtnost kad se primjenjuje u tjednoj dozi približno 20 puta većoj od preporučene tjedne doze za ljude.
English: 25 and 50 IU/kg 2 times per week into 2 equal doses.
Croatian: 50 IU/kg 2 puta na tjedan u 2 jednake doze.
English: Intravenous injection
Croatian: Intravenska injekcija
English: Good injection sites are the top of the thigh and around the tummy (abdomen) but away from the navel.
Croatian: Pogodna mjesta za injiciranje su vrh bedra, područje oko trbuha (abdomena), ali dalje od pupka.
English: The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Croatian: Odluka o primjeni rekombinantnog eritropoetina treba se bazirati na procijeni omjera rizika i dobrobiti uzimajući u obzir specifični klinički kontekst, uz uključivanje samog pacijenta.
English: Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving 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: Liječenje treba primijeniti samo kod pacijenata s umjerenom anemijom (bez nedostatka željeza) ukoliko nisu dostupni ili su nedostatni postupci čuvanja krvi u slučaju velikih elektivnih kirurških zahvata koji zahtijevaju velike količine krvi (4 ili više jedinica krvi za žene ili 5 ili više jedinica krvi za muškarce).
English: There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Croatian: Postoji povećan rizik od tromboemoličkog događaja kod pacijenata s malignim bolestima koji se liječe rekombinantnim humanim eritropoetinom, a ne može se isključiti ni negativni učinak na ukupno preživljenje.
English: All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Croatian: Sve ove dodatne uzročnike anemije treba detaljno razmotriti kod odlučivanja o povećanju doze eritropoetina kod pacijenata s malignim bolestima.
English: If you are a cancer patient, you should be aware that Silapo may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Croatian: Ukoliko imate rak, trebate biti svjesni da Silapo može djelovati kao faktor rasta crvenih krvnih stanica i da u nekim slučajevima može imati negativan učinak na vašu bolest.
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: Ukupni ishod preživljenja u ispitivanju ne može se na zadovoljavajući način objasniti razlikom u incidenciji tromboze ili povezanih komplikacija između onih koji su dobivali rekombinantni humani eritropoetin i onih u kontrolnoj skupini.
English: Consequently, erythropoietin should generally be used during pregnancy and lactation only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Posljedično, eritropoetin bi trebalo koristiti tijekom trudnoće i dojenja samo ako je potencijalna dobrobit veća od potencijalnog rizika za fetus.
English: Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Croatian: Predoziranje eritropoetinom može izazvati učinak koji se nadovezuje na farmakološki učinak hormona.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2 833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Croatian: Preživljenje i napredovanje tumora ispitivani su u pet velikih kontroliranih ispitivanja koja su uključivala 2 833 pacijenta, od kojih su četiri bila dvostruko slijepa, placebo kontrolirana ispitivanja, a jedno otvoreno ispitivanje.
English: The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Croatian: U kojoj mjeri se ovi učinci mogu pripisati primjeni rekombinantnog humanog eritropoetina kod pacijenata s malignim bolestima liječenih kemoterapijom radi postizanja koncentracije hemoglobina manjeg od 13 g/dl je nejasna jer je samo nekoliko pacijenata s takvim karakteristikama bilo uključeno u podatke koji su analizirani.
English: • the blister sealing is broken or the blister is damaged in any way
Croatian: • pokrov blistera nije cjelovit ili je blister na bilo koji način oštećen
English: Warnings and precautions
Croatian: Upozorenje i mjere opreza
English: Silapo therapy is usually started under medical supervision.
Croatian: Liječenje Silapoom obično započinje pod liječničkim nadzorom.
English: Silapo contains phenylalanine
Croatian: Silapo sadrži fenilalanin
English: This is given 2 times a week by injection into a vein.
Croatian: Daje se 2 puta tjedno injekcijom u venu.
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 zadovoljilo ni primarni cilj dokazivanja smanjenja rizika svih vrsta smrtnosti, kardiovaskularnog morbiditeta niti završne faze bubrežne bolesti.
English: • It may have been accidentally frozen.
Croatian: • ukoliko je došlo do nehotičnog zamrzavanja.
English: Therefore, routine volume replacement should be performed in such patients.
Croatian: Zbog toga je kod takvih pacijenata potrebna rutinska nadoknada volumena.
English: Silapo must not be administered by intravenous infusion.
Croatian: Silapo se ne smije primijeniti intravenskom infuzijom.
English: Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Croatian: Mjerenje eritropoetina nakon višestrukih intravenski primijenjenih doza pokazala su da je poluvijek eritropoetina približno 4 sata kod zdravih dobrovoljaca i nešto duži, približno 5 sati, kod pacijenata s kroničnim zatajenjem bubrega.
English: Do not shake.
Croatian: Ne protresati.
English: Silapo therapy should continue until one month after the end of chemotherapy.
Croatian: Terapiju Silapom treba nastaviti još mjesec dana nakon završetka kemoterapije.
English: • have severe disorders of the veins and arteries
Croatian: • • imate teške poremećaje vena i arterija
English: • Silapo is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Croatian: • Silapo se daje injekcijom pod kožu svaki tjedan tijekom tri tjedna prije kirurškog zahvata i na sam dan kirurškog zahvata.
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the name of the prescribed ESA should be clearly recorded (or: stated) in the patient file.
Croatian: ErythropoeisisStimulating Agents), potrebno je jasno zabilježiti (ili iskazati) naziv propisanog ESA lijeka u pacijentovoj dokumentaciji.
English: The dose should remain the same while the change is being made.
Croatian: Za vrijeme promjene, doza bi trebala ostati nepromijenjena.
English: If you stop using Silapo
Croatian: Ako prestanete primjenjivati Silapo
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: Jednom kad se dostignu terapijski ciljevi za određenog pacijenta, potrebno je smanjiti dozu za 25 do 50% da bi se održala postignuta razina hemoglobina.
English: Cancer patients
Croatian: Pacijenti s rakom
English: Other side effects:
Croatian: Druge nuspojave:
English: For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Croatian: Kod kućne primjene, pacijent može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne iznad 25°C) jednokratno u trajanju do 3 dana.
English: After 4 weeks of treatment the time to first transfusion was further increased in the epoetin alfa group (142 vs. 50 days, p=0.007).
Croatian: Nakon 4 tjedna liječenja vrijeme do prve transfuzije dodatno se produljilo u skupini koja je primala epoetin alfa (142 naspram 50 dana, p = 0,007).
English: This medicine contains up to 0.5 mg phenylalanine in each dosage unit.
Croatian: Ovaj lijek sadrži do 0,5 mg fenilalanina u jednoj doznoj jedinici.
English: In case Silapo is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Croatian: Ukoliko se Silapo injicira pod kožu (supkutano), možete također sami injicirati otopinu nakon što vam se pokaže kako se to radi.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in Silapo dosage.
Croatian: To se očituje stalnim smanjenjem hemoglobina usprkos povećanju doze Silapa.
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 značajnu dobrobit koja bi se pripisala primjeni epoetina kad je koncentracija hemoglobina povećana iznad vrijednosti neophodnih za kontrolu simptoma anemije i sprječavanje transfuzije krvi.
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Croatian: U dva ispitivanja ciljna koncentracija hemoglobina bila je >13 g/dl, a u preostala tri ispitivanja 12-14 g/dl.
English: It is not known whether exogenous epoetin zeta is excreted in human milk.
Croatian: Nije poznato da li se egzogeni epoetin zeta izlučuje u majčino mlijeko.
English: If PRCA, a very rare condition, occurs, the Silapo therapy will be stopped and your doctor will determine the best course of action to treat the anaemia.
Croatian: Ukoliko se pojavi PRCA, koja je vrlo rijetko stanje, prekinut će se liječenje Silapom i vaš liječnik će odlučiti o najboljim postupcima za liječenja anemije.
English: Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Silapo.
Croatian: Kao i kod svih pacijenata koji primaju eritropoetin, za vrijeme liječenja Silapom može doći do porasta krvnog tlaka.
English: When a dose adjustment is necessary, this should be done in steps of 25 IU/kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Croatian: Kad je neophodno prilagoditi dozu, to treba učiniti postepeno s 25 IU/kg, 3 puta na tjedan u razmacima od najmanje četiri tjedna dok se ne postigne željeni cilj.
English: Patients should not be switched to another medicinal product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Croatian: Pacijente ne treba prebacivati na terapiju drugim lijekom jer protutijela na eritropoetin reagiraju i s drugom eritropoetinima.
English: Epoetin zeta is identical in its amino acid sequence and similar in carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Croatian: Epoetin zeta ima identičan redoslijed aminokiselina i sličan sastav ugljikohidrata kao i endogeni ljudski eritropoetin izoliran iz urina anemičnih pacijenata.