FrancophonIA/ELRC3.0 huggingface dataset:
English: To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
Croatian: Kako bi se osigurala učinkovita eritropoeza, kod svih bolesnika treba procijeniti status željeza prije i nakon liječenja.
English: If your doctor suspects or confirms that you have this condition, you must not be treated with Biopoin or another epoetin.
Croatian: Ako Vaš liječnik sumnja na tu bolest ili je potvrdi, ne smijete uzimati Biopoin ili neki drugi epoetin.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Croatian: Vaš će liječnik primijeniti najnižu učinkovitu dozu za kontrolu simptoma anemije.
English: Your doctor will work out the right dose for you.
Croatian: Liječnik će Vam odrediti odgovarajuću dozu.
English: If you do not respond adequately to Biopoin, your doctor will check your dose and will inform you if you need to change doses of Biopoin.
Croatian: Ako ne odgovorite na Biopoin na odgovarajući način, Vaš liječnik će provjeriti dozu koju primate i obavijestiti Vas trebate li promijeniti doze Biopoina.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Biopoin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Biopoin uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Hypertensive crisis*
Croatian: Hipertenzivna kriza*
English: If these reactions occur, they require the immediate attention of a physician and intensive medical care.
Croatian: U slučaju pojave takvih reakcija, potrebna je hitna liječnička pomoć i intenzivna medicinska skrb.
English: If necessary, your doctor will increase your dose at monthly intervals.
Croatian: Ako je potrebno, liječnik će povećavati tu dozu u razmacima od mjesec dana.
English: What Biopoin looks like and contents of the pack
Croatian: Kako Biopoin izgleda i sadržaj pakiranja
English: The extent of absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites.
Croatian: Omjer apsorpcije (AUC) bio je nešto veći nakon injekcije primijenjene u trbuh u odnosu na druga mjesta primjene.
English: Treatment with Biopoin is normally a long-term therapy.
Croatian: Liječenje lijekom Biopoin je obično dugotrajno.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Do not inject a double dose to make up for a forgotten dose.
Croatian: Ne primjenjujte dvostruku dozu kako biste nadoknadili onu koju ste zaboravili primjeniti.
English: The use of this medicine by healthy people can excessively increase certain blood parameters and in so doing cause problems with the heart or blood vessels that can be life threatening.
Croatian: Uzimanje ovog lijeka kod zdravih ljudi može uzrokovati prekomjerni porast određenih krvnih parametara te posljedično tome probleme sa srcem ili krvnim žilama, koji mogu biti opasni po život.
English: - Serious skin rashes:
Croatian: - Ozbiljni kožni osipi:
English: Factors that should be considered in this assessment should include the type of tumour and its stage, the degree of anaemia, life-expectancy, the environment in which the patient is being treated, and patient preference (see section 5.1).
Croatian: Čimbenici koje treba uzeti u obzir prilikom procjene su vrsta tumora i njegov stadij, stupanj anemije, očekivano trajanje života, okolina u kojoj se bolesnik liječi i sklonosti bolesnika (vidjeti dio 5.1).
English: Once an adequate number of red blood cells has been reached, the maintenance dose required to keep the number constant will be determined by your doctor.
Croatian: Nakon što se dosegne primjeren broj crvenih krvnih stanica, liječnik određuje dozu potrebnu za održavanje njihovog stalnog broja.
English: The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site of injection.
Croatian: Mjesta primjene injekcije treba rotirati, a injekciju davati sporo kako bi se izbjegla bol na mjestu primjene.
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Croatian: Također, provedena sustavna revizija uključivala je više od 9000 bolesnika s karcinomom koji su sudjelovali u 57 kliničkih ispitivanja.
English: If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to undergo dialysis, your doctor will consider whether treatment is suitable for you.
Croatian: Ako imate otvrdnuće krvnih žila u bubrezima (nefrosklerozu), ali ne trebate dijalizu, liječnik će razmotriti je li ovo liječenje prikladno za Vas.
English: Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Croatian: Jednom kad se lijek izvadi iz hladnjaka, mora se primijeniti unutar tog razdoblja ili baciti.
English: Biopoin has not been tested in pregnant women.
Croatian: Nije ispitivana primjena lijeka Biopoin u trudnica.
English: The dose of Biopoin (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Croatian: Doza lijeka Biopoin (izražena u internacionalnim jedinicama ili IU) ovisi o stanju Vaše bolesti, Vašoj tjelesnoj težini i načinu primjene injekcije (potkožno [supkutana injekcija] ili u venu [intravenska injekcija]).
English: If there are particles in it or if it is cloudy, you must not use it.
Croatian: Ako otopina sadrži čestice ili ako je zamućena, ne smijete je primijeniti.
English: Adverse reactions listed below in table 1 are classified according to System Organ Class.
Croatian: Nuspojave navedene u tablici 1 klasificirane su prema klasifikaciji organskih sustava.
English: It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Croatian: Otopinu treba ostaviti da dosegne ugodnu temperaturu (15 °C-25 °C) za injekciju.
English: In addition, the iron level in your blood will be checked before and during treatment with this medicine.
Croatian: Dodatno, koncentracije željeza u krvi će se provjeriti prije i nakon liječenja ovim lijekom.
English: If you are receiving Biopoin as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Croatian: Ako primate Biopoin otopinu za injekciju potkožno, liječnik Vam može predložiti da naučite kako sami primjenjivati ovaj lijek.
English: Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed.
Croatian: Nakon supkutane injekcije od 40 IU/kg tjelesne težine epoetina theta na tri različita mjesta primjene (gornji dio ruke, abdomen, bedro) u zdravih dobrovoljaca, zabilježene su slične koncentracije u plazmi.
English: If blood pressure values remain high, temporary interruption of epoetin theta therapy may be required.
Croatian: Ako vrijednosti krvnog tlaka ostanu visoke, može biti potrebno privremeno prekinuti terapiju epoetinom theta.
English: Epoetin theta has no or negligible influence on the ability to drive and use machines.
Croatian: Epoetin theta ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The biological efficacy of epoetin theta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (mice, rats, dogs).
Croatian: Pretklinička djelotvornost Biološka djelotvornost epoetina theta dokazana je nakon intravenske i supkutane primjene u različitim životinjskim modelima in vivo (miševi, štakori, psi).
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: Preživljavanje i napredovanje tumora bilo je ispitivano u pet velikih kontroliranih ispitivanja koja su uključivala ukupno 2833 bolesnika, od kojih su četiri bila dvostruko slijepa, placebom kontrolirana ispitivanja, a jedno je bilo otvorenog tipa.
English: The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Croatian: Stvaranje eritropoetina primarno se odvija i regulirano je bubrezima kao odgovor na promjene u oksigenaciji tkiva.
English: If you think you are having this type of reaction, you must stop your Biopoin injection and get medical help immediately.
Croatian: Ako mislite da imate takve reakcije, morate prekinuti primjenu Biopoin injekcije i odmah zatražiti liječničku pomoć.
English: If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Croatian: Ako su prisutni mjehurići zraka, lagano kucnite prstom po štrcaljki kako bi se mjehurići zraka podigli prema vrhu.
English: If you use more Biopoin than you should
Croatian: Ako primjenite više lijeka Biopoin nego što ste trebali
English: Animal studies with other epoetins do not indicate direct harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja drugih epoetina na životinjama ne ukazuju na izravan štetan učinak na reprodukciju (vidjeti dio 5.3).
English: Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Croatian: Biopoin sadrži djelatnu tvar epoetin theta, koja je skoro identična eritropoetinu, prirodnom hormonu koji stvara Vaše tijelo.
English: If you feel tired and weak or experience breathlessness, you must consult your doctor.
Croatian: Ako ste umorni, osjećate slabost ili nedostatak zraka, morate se obratiti svom liječniku.
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 za primjenu rekombinantnih eritropoetina treba se zasnivati na procjeni koristi i rizika za svakog pojedinog bolesnika koje trebaju uzeti u obzir specifični klinički kontekst.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju ako Vas liječnik ili medicinska sestra za to nisu posebno obučili.
English: This medicine does not affect your ability to drive and use machines.
Croatian: Ovaj lijek ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% compared with intravenous administration.
Croatian: Prosječna bioraspoloživost epoetina theta primijenjenog supkutano je oko 31% u odnosu na intravensku primjenu.
English: You may experience the following additional side effects:
Croatian: Vidjeti također dio 2. Moguće su i sljedeće dodatne nuspojave:
English: You will usually receive Biopoin until 1 month after the end of chemotherapy.
Croatian: Biopoin se obično primjenjuje do mjesec dana nakon završetka kemoterapije.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Croatian: Ako niste sigurni kako sami sebi dati injekciju ili ako imate pitanja, obratite se svom liječniku ili medicinskoj sestri za pomoć.
English: The first study was conducted in 186 anaemic patients with non-myeloid malignancies (55% with haematological malignancies and 45% with solid tumours) receiving non-platinum chemotherapy.
Croatian: Prvo ispitivanje provedeno je u 186 bolesnika s anemijom i nemijeloičnim malignim bolestima (55% s hematološkom malignom bolešću i 45% sa solidnim tumorima) koji su primali kemoterapiju bez platine.
English: If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level.
Croatian: U slučaju teške policitemije, mogu biti indicirane konvencionalne metode (flebotomija) radi smanjenja razine hemoglobina.
English: If your iron level is too low, your doctor may also prescribe you an iron preparation.
Croatian: Ako je koncentracija željeza preniska, liječnik će Vam možda propisati i neki od pripravaka željeza.
English: Each pre-filled syringe is for single use only.
Croatian: Svaka napunjena štrcaljka namijenjena je samo za jednokratnu uporabu.
English: Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose increase of existing antihypertensive medicinal products.
Croatian: Porasti krvnog tlaka, mogu zahtijevati liječenje antihipertenzivnim lijekovima ili povećanje doze postojećeg antihipertenzivnog lijeka.
English: The most frequent adverse reactions are hypertension, influenza-like illness and headache.
Croatian: Najčešće nuspojave su hipertenzija, bolest nalik gripi i glavobolja.
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Croatian: U nekoliko kontroliranih ispitivanja epoetini nisu pokazali da poboljšavaju ukupno preživljavanje ili smanjuju rizik progresije tumora kod bolesnika s anemijom povezanom s karcinomom.
English: Push the plunger up to the number (IU) on the syringe that matches the dose of Biopoin that your doctor prescribed.
Croatian: Polagano pritisnite klip štrcaljke do broja (IU) na štrcaljki koji odgovara dozi lijeka Biopoin koju Vam je propisao liječnik.
English: 89079 Ulm Germany
Croatian: 89079 Ulm
English: Patients on haemodialysis will usually receive the injection at the end of dialysis via an arterio-venous fistula.
Croatian: Bolesnici na hemodijalizi obično dobivaju injekciju na kraju dijalize putem arterijsko-venske fistule.
English: Otherwise the increased number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection between an artery and a vein which is surgically prepared in dialysis patients).
Croatian: U protivnom povećani broj crvenih krvnih stanica može uzrokovati blokadu arterijsko-venske fistule (umjetni spoj između arterije i vene koji se priprema kirurški kod bolesnika na dijalizi).
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon primjene injekcije, izvadite iglu i pustite kožu.
English: Depending on your individual situation a blood transfusion may be preferable.
Croatian: Ovisno o Vašem stanju, možda će biti potrebno napraviti transfuziju krvi.
English: Take one blister with a pre-filled syringe out of the refrigerator.
Croatian: Izvadite jedan blister s napunjenom štrcaljkom iz hladnjaka.
English: The median time to response was similar in the treatment groups with 56 days in haemodialysis patients and 49 days in patients not yet undergoing dialysis.
Croatian: Srednje vrijeme do odgovora bilo je slično, odnosno 56 dana u skupini na dijalizi te 49 dana u bolesnika koji još nisu bili na dijalizi.
English: If you have missed an injection, or injected too little, talk to your doctor.
Croatian: Ako ste propustili injekciju, ili primjenili premalu dozu, obratite se svom liječniku.
English: The needle will be shielded and locked automatically so that you can not prick yourself (see picture 12).
Croatian: Igla će automatski biti zaštićena i zakočena pa ne postoji opasnost da biste se mogli ubosti (vidjeti sliku 12).
English: Subcutaneous injections should be given into the abdomen, arm or thigh.
Croatian: Supkutanu injekciju treba primijeniti u abdomen, ruku ili bedro.
English: After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase.
Croatian: Nakon primjene epoetina theta došlo je do porasta broja eritrocita, vrijednosti hematokrita i broja retikulocita.
English: Position the safety shield approximately 45° against a flat surface (see picture 13).
Croatian: Postavite sigurnosni štitnik na približno 45° u odnosu na ravnu površinu (vidjeti sliku 13).
English: For instructions on how to inject the medicinal product, see package leaflet.
Croatian: Za upute o tome kako ubrizgati lijek vidjeti Uputu o lijeku.
English: Biopoin is a clear and colourless solution for injection in pre-filled syringe along with an injection needle.
Croatian: Biopoin je bistra i bezbojna otopina za injekciju u napunjenoj štrcaljki zajedno s injekcijskom iglom.
English: Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase.
Croatian: Kod bolesnika s kroničnim zatajenjem bubrega hipertenzija se češće javlja tijekom faze korekcije nego tijekom faze održavanja.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama Plana.
English: If you are a patient with chronic renal failure, and particularly if you do not respond properly to Biopoin, your doctor will check your dose of Biopoin because repeatedly increasing your dose of Biopoin 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 kroničnim zatajenjem bubrega, osobito ako ne odgovorite na Biopoin na primjeren način, liječnik će provjeriti Vašu dozu Biopoina jer ponavljano povećavanje doze Biopoina zbog izostanka odgovora na liječenje može povećati rizik od nastanka tegoba sa srcem ili krvnim žilama i može povisiti rizik od srčanog udara, moždanog udara i smrti.
English: A reticulocyte count should be considered as part of the evaluation.
Croatian: Broj retikulocita također treba uzeti u obzir kao dio procjene bolesnika.
English: If you are a cancer patient you should be aware that this medicine may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Croatian: Ako imate zloćudnu bolest, morate biti upoznati s činjenicom da ovaj lijek može djelovati kao čimbenik rasta krvnih stanica i u nekim slučajevima negativno djelovati na Vašu zloćudnu bolest.
English: The second study was conducted in 223 patients with various solid tumours receiving platinum-containing chemotherapy.
Croatian: Drugo ispitivanje provedeno je kod 223 bolesnika s raznim solidnim tumorima koji su primali kemoterapiju koja je sadržavala platinu.
English: Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Croatian: Liječnik će redovito provjeravati Vašu krvnu sliku radi kontrole raznih krvnih sastojaka i njihovih razina.
English: The therapeutic margin of epoetin theta is very wide.
Croatian: Terapijska širina epoetina theta vrlo je velika.
English: Influenza-like illness*
Croatian: Bolest nalik gripi*
English: Two of the studies recruited patients who were being treated with chemotherapy.
Croatian: Dva od ispitivanja uključivala su bolesnike koji su bili liječeni kemoterapijom.
English: The injection will be given once-weekly.
Croatian: Injekcija se daje jednom tjedno.
English: During the evaluation period (weeks 15 to 26), the mean and median level of haemoglobin in patients treated with epoetin theta was virtually identical to their baseline haemoglobin level.
Croatian: Tijekom razdoblja evaluacije (15. do 26. tjedan), srednja vrijednost hemoglobina u bolesnika liječenih epoetinom theta bila je skoro identična njihovoj osnovnoj vrijednosti hemoglobina.
English: The injection is given either into a vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection).
Croatian: Injekcija se daje ili u venu (intravenska injekcija) ili u tkivo pod kožom (supkutana injekcija).
English: Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.
Croatian: Neklinički podaci s drugim epoetinima ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja genotoksičnosti i reproduktivne toksičnosti.
English: This section contains information on how to give yourself an injection of Biopoin under the skin.
Croatian: Ovaj dio sadrži upute za samoprimjenu injekcije lijeka Biopoin pod kožu.
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 these two studies, 180 haemodialysis patients and 193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and a similar safety profile as epoetin beta.
Croatian: U ta dva ispitivanja, 180 bolesnika koji su bili na hemodijalizi i 193 bolesnika koji nisu bili na dijalizi prebačeni su iz faze održavanja epoetinom beta na terapiju epoetinom theta u razdoblju od šest mjeseci tijekom kojeg su vrijednosti hemoglobina bile stabilne, a profil sigurnosti sličan onome tijekom primjene epoetina beta.
English: - Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar, druge epoetine i njihove derivate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure.
Croatian: Stoga je kod bolesnika liječenih epoetinom theta potrebno pažljivo praćenje i kontrola krvnog tlaka.
English: The solution for injection should not be shaken.
Croatian: Otopina za injekciju ne smije se mućkati.
English: In pre-dialysis patients with chronic renal failure following subcutaneous injection of 40 IU/kg body weight, the protracted absorption results in a concentration plateau, whereby the maximum concentration is reached after an average of approximately 14 hours.
Croatian: Kod bolesnika s kroničnim zatajenjem bubrega prije dijalize, nakon supkutane injekcije od 40 IU/kg tjelesne težine, produljena apsorpcija dovodi do koncentracijskog platoa, dok se najviša koncentracija u prosjeku postiže otprilike nakon 14 sati.
English: Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
Croatian: Stoga liječnik može odlučiti ne dopustiti Vam uzimanje ovog lijeka ako dojite.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when the haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Croatian: Kontrolirana klinička ispitivanja nisu pokazala značajne prednosti koje bi se mogle pripisati primjeni epoetina kod bolesnika u kojih su koncentracije hemoglobina povećane iznad razine potrebne za kontrolu simptoma anemije i izbjegavanje transfuzije krvi.