FrancophonIA/ELRC3.0 huggingface dataset:
English: In both studies, treatment with epoetin theta resulted in a significant haemoglobin response (p < 0.001), defined as an increase in haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements (p < 0.05) in comparison to placebo.
Slovenian: V obeh študijah je zdravljenje z epoetinom theta povzročilo pomemben hemoglobinski odziv (p < 0,001), opredeljen kot povečanje koncentracije hemoglobina za ≥ 2 g/dl brez transfuzije, in pomembno zmanjšanje potrebe po transfuziji (p < 0,05) v primerjavi s placebom.
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.
Slovenian: Zaradi omejenih izkušenj učinkovitosti in varnosti epoetina theta ni bilo mogoče oceniti pri bolnikih z oslabljenim delovanjem jeter ali homozigotno anemijo srpastih celic.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Slovenian: Dve od teh študij sta vključili bolnike, ki so se zdravili s kemoterapijo.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (see section
Slovenian: Kot pri vseh rastnih faktorjih tudi pri epoetinih obstaja tveganje, da bodo stimulirali rast katere koli vrste malignosti (glejte poglavje 5.1).
English: Anaemia in cancer patients
Slovenian: Anemija pri bolnikih z rakom
English: In addition, the iron level in your blood will be checked before and during treatment with this medicine.
Slovenian: Poleg tega bodo pred zdravljenjem s tem zdravilom in med njim preverjali raven železa v krvi.
English: Treatment with Biopoin is normally a long-term therapy.
Slovenian: Zdravljenje z zdravilom Biopoin je navadno dolgotrajno.
English: Do not attempt to give this medicine to yourself without this training.
Slovenian: Zdravila Biopoin si ne poskušajte dati sami brez usposabljanja.
English: If you are on dialysis, medicines that prevent blood coagulation are used.
Slovenian: Če ste na dializi, se uporabljajo zdravila, ki preprečujejo strjevanje krvi.
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.
Slovenian: Glede na navedeno je v nekaterih kliničnih primerih krvna transfuzija boljše zdravljenje za obravnavo anemije pri bolnikih z rakom.
English: You can now use the pre-filled syringe.
Slovenian: Zdaj lahko uporabite napolnjeno injekcijsko brizgo.
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.
Slovenian: V več nadzorovanih študijah epoetini niso pokazali izboljšanja preživetja ali zmanjšanja tveganja napredovanja tumorja pri bolnikih z anemijo, povezano z rakom.
English: Only use each syringe for one injection.
Slovenian: Eno brizgo uporabite samo za eno injiciranje.
English: PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Slovenian: pomeni, da je telo prenehalo ali zmanjšalo tvorbo rdečih krvničk, kar povzroča hudo anemijo.
English: How to prepare for your injection
Slovenian: Kako se pripravite na injiciranje
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.
Slovenian: Če imate kronično ledvično odpoved, in še zlasti, če se na zdravilo Biopoin niste ustrezno odzvali, bo zdravnik večkrat preverjal vaš odmerek zdravila Biopoin, saj lahko, če se na zdravljenje ne odzivate, stalno povečevanje odmerka zdravila Biopoin poveča možnost za težave s srcem ali krvnimi žilami in lahko poveča tveganje za srčni infarkt, možgansko kap ali smrt.
English: Disposing of used syringes
Slovenian: Odstranjevanje uporabljenih brizg
English: It must be a clear and colourless liquid.
Slovenian: Tekočina mora biti prozorna in brezbarvna.
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.
Slovenian: Ni jasno, v kolikšnem obsegu ti rezultati veljajo za uporabo rekombinantnega humanega eritropoetina pri bolnikih z rakom, ki se zdravijo s kemoterapijo, za doseganje koncentracij hemoglobina, manjših od 13 g/dl, saj je bilo v pregledane podatke vključenih malo bolnikov s temi značilnostmi.
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.
Slovenian: V kliničnih študijah so bolniki, pri katerih se še ni opravljala dializa, (subkutana uporaba) študijo prekinili pogosteje kot bolniki na hemodializi (intravenska uporaba), saj so morali študijo prekiniti ob začetku dialize.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Slovenian: Zdravnik bo za nadzor simptomov vaše anemije uporabil najmajši učinkoviti odmerek.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Biopoin, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Check the appearance of Biopoin.
Slovenian: Preverite videz zdravila Biopoin.
English: Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure.
Slovenian: Zato je treba pri bolnikih, ki se zdravijo z epoetinom theta, skrbno spremljati in nadzorovati krvni tlak.
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.
Slovenian: Nadzorovana klinična preskušanja niso pokazala pomembnih koristi, povezanih z dajanjem epoetinov, kadar je koncentracija hemoglobina večja od ravni, potrebne za nadzorovanje simptomov anemije in odsotnost krvne transfuzije.
English: Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
Slovenian: Epoetin theta (rekombinantni humani eritropoetin) se s tehnologijo rekombinantne DNA izdeluje v celicah jajčnika kitajskega hrčka (CHO-K1).
English: Following intravenous administration, the volume of distribution approximates to total blood volume.
Slovenian: Po intravenski uporabi je prostornina porazdelitve približno enaka kot skupna prostornina krvi.
English: 89079 Ulm Germany
Slovenian: 89079 Ulm
English: Injections are given under the skin.
Slovenian: Injekcije se dajejo pod kožo.
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.
Slovenian: Med ocenjevanjem (od 15. do 26. tedna) je bila srednja in mediana raven hemoglobina pri bolnikih, ki so jih zdravili z epoetinom theta, skoraj enaka kot izhodiščna raven hemoglobina.
English: Treatment with epoetin theta is divided into two stages.
Slovenian: Zdravljenje z epoetinom theta poteka v dveh fazah.
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.
Slovenian: Če vidite zračne mehurčke, s prsti nežno potrkajte brizgo, dokler se mehurčki ne dvignejo na vrh brizge.
English: Pure red cell aplasia (PRCA)*
Slovenian: Bolezni krvi in limfatičnega sistema čista aplazija rdečih krvničk (PRCA)*
English: This section contains information on how to give yourself an injection of Biopoin under the skin.
Slovenian: To poglavje vsebuje informacije o samostojnem injiciranju zdravila Biopoin pod kožo.
English: If blood pressure values remain high, temporary interruption of epoetin theta therapy may be required.
Slovenian: Če je vrednost krvnega tlaka še vedno velika, bo morda treba začasno prekiniti zdravljenje z epoetinom theta.
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.
Slovenian: Mediana časa do odziva je bila podobna v skupinah z bolniki, ki so se s tem zdravilom zdravili 56 dni in so prejemali hemodializo, in skupinah z bolniki, ki so se s tem zdravilom zdravili 49 dni in niso prejemali dialize.
English: Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase.
Slovenian: Hipertenzija se pri bolnikih s kronično ledvično odpovedjo pogosteje pojavi med korekcijsko fazo kot vzdrževalno fazo.
English: Contents of the pack and other information What Biopoin contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Biopoin
English: What you need to know before you use Biopoin Do NOT use Biopoin
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Biopoin NE uporabljajte zdravila Biopoin
English: Check again to make sure the correct dose of Biopoin is in the syringe.
Slovenian: Ponovno preverite, ali je v brizgi ustrezen odmerek zdravila Biopoin.
English: Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.
Slovenian: Ko je hipertenzija ob uporabi intenzivnejšega zdravljenja nadzorovana, je treba zdravljenje z epoetinom theta ponovno uvesti z zmanjšanim odmerkom.
English: If you think you are having this type of reaction, you must stop your Biopoin injection and get medical help immediately.
Slovenian: Če menite, da imate to vrsto reakcije, morate prenehati injicirati zdravilo Biopoin in takoj poiskati zdravniško pomoč.
English: Subcutaneous injections should be given into the abdomen, arm or thigh.
Slovenian: Subkutano injiciranje se sme dajati samo v abdomen, roko ali stegno.
English: Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose increase of existing antihypertensive medicinal products.
Slovenian: Zvišanje krvnega tlaka lahko zahteva zdravljenje z antihipertenzivi ali povečanje odmerka obstoječega antihipertenziva.
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti, oznaka ATC: B03XA01 Mehanizem delovanja
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.
Slovenian: V teh dveh študijah so pri 180 bolnikih na hemodializi in 193 brez dialize vzdrževalno zdravljenje z epoetinom beta za šest mesecev zamenjali z epoetinom theta, kar je pokazalo stabilne vrednosti hemoglobina in podoben varnostni profil kot pri epoetinu beta.
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.
Slovenian: Po štirih tednih se lahko odmerek poveča na 80 i.e./kg trikrat na teden, pozneje pa po potrebi za 25 % predhodnega odmerka v mesečnih presledkih.
English: If signs and symptoms suggestive of these reactions appear, epoetin theta should be withdrawn immediately and an alternative treatment considered.
Slovenian: Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z epoetinom theta takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
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.
Slovenian: Te študije so pokazale skladno nepojasnjeno statistično pomembno čezmerno umrljivost pri bolnikih, pri katerih je bila anemija povezana z različnimi pogostimi raki in ki so prejemali rekombinantni humani eritropoetin, v primerjavi s kontrolnimi skupinami.
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.
Slovenian: Humani eritropoetin je endogeni glikoproteinski hormon, ki je primarni regulator eritrocitopoeze, saj ima posebno interakcijo z receptorjem eritropoetina na eritroidne progenitorne celice v kostnem mozgu.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Slovenian: Pri bolnikih s hepatitisom C, zdravljenih z interferonom in ribavarinom, so o teh primerih poročali ob sočasnem zdravljenju z epoetini.
English: If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Slovenian: Če niste prepričani, da si želite injicirati zdravilo, ali imate kakršna koli vprašanja, se za pomoč obrnite na zdravnika ali medicinsko sestro.
English: Thromboembolic events
Slovenian: Pogosti trombembolični dogodki
English: The second study was conducted in 223 patients with various solid tumours receiving platinum-containing chemotherapy.
Slovenian: Drugo študijo so opravili pri 233 bolnikih z različnimi solidnimi tumorji, ki so prejemali kemoterapijo s platino.
English: If you think you have injected more Biopoin than you should, contact your doctor.
Slovenian: Če menite, da ste si injicirali večji odmerek zdravila Biopoin, kot bi smeli, se obrnite na zdravnika.
English: Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.
Slovenian: Subkutana uporaba: tedenski odmerek se lahko daje kot eno injiciranje na teden ali trikrat na teden.
English: If you have missed an injection, or injected too little, talk to your doctor.
Slovenian: Če ste si pozabili injicirati zdravilo ali ste injicirali premajhen odmerek, se pogovorite z zdravnikom.
English: Only clear, colourless solutions without particles should be used.
Slovenian: Uporabljajte le bistre, brezbarvne raztopine brez delcev.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Slovenian: Medtem ko je brizga obrnjena navzgor, iz nje iztisnite ves zrak, tako da bat počasi potiskate navzgor.
English: Box for the prescribed dose Subcutaneous or intravenous use
Slovenian: Škatla za predpisano odmerjanje subkutana ali intravenska uporaba
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).
Slovenian: Opazili so nagnjenost k povečanemu tveganju za umrljivost zaradi vseh razlogov, kardiovaskularne in cerebrovaskularne dogodke, povezane z večjimi kumulativnimi odmerki epoetina neodvisno od sladkorne bolezni ali statusa dialize (glejte poglavji 4.2 in 4.4).
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.
Slovenian: Za udobnejše injiciranje počakajte 30 minut, da napolnjena injekcijska brizga doseže sobno temperaturo (največ 25 °C), ali pa jo za nekaj minut nežno stisnite v dlan.
English: Not known in patients with chronic renal failure (frequency cannot be estimated from the available data) - Cases of a condition called pure red cell aplasia (PRCA) have been reported.
Slovenian: Neželeni učinek neznane pogostnosti pri bolnikih s kronično ledvično odpovedjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - Poročali so o primerih stanja, imenovanega čista aplazija rdečih krvničk (PRCA).
English: It is recommended that haemoglobin measurement, a complete blood count and platelet count be performed regularly.
Slovenian: Priporočeno je, da se redno opravljajo meritve hemoglobina, celotna krvna slika in preiskava števila trombocitov.
English: The therapeutic margin of epoetin theta is very wide.
Slovenian: Terapevtski interval epoetina theta je zelo velik.
English: It may also be necessary to reduce your dose of Biopoin or to stop the treatment with Biopoin for a short period of time.
Slovenian: Morda bo treba zmanjšati odmerek zdravila Biopoin ali začasno prekiniti jemanje zdravila Biopoin.
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.
Slovenian: Bolnike je treba skrbno spremljati, da se tako zagotovi, da se za zadostni nadzor simptomov anemije uporablja najmanjši odobreni odmerek epoetina theta.
English: If the frequency of administration is changed, dose adjustments may be necessary.
Slovenian: Če se spremeni pogostost uporabe, bo morda treba prilagoditi odmerek.
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Slovenian: Epoetini so rastni faktorji, ki primarno stimulirajo tvorbo rdečih krvničk.
English: The pharmacokinetics of epoetin theta are independent of age or gender.
Slovenian: Farmakokinetika epoetina theta ni odvisna od starosti ali spola.
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.
Slovenian: Če je povečanje hemoglobina po dodatnih štirih tednih še vedno nezadostno, je treba razmisliti o povečanju tedenskega odmerka na 60.000 i.e.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%.
Slovenian: Splošna Pri vseh bolnikih z vrednostmi feritina v serumu, manjšimi od 100 µg/l, ali saturacijo transferina,
English: Symptomatic anaemia associated with chronic renal failure The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty.
Slovenian: Simptomatska anemija, povezana s kronično ledvično odpovedjo Uporabo epoetina theta pri bolnikih z nefrosklerozo, ki se še ne zdravijo z dializo, je treba določati individualno, ker morebitnega pospešenega razvoja ledvične odpovedi ni mogoče z gotovostjo izključiti.
English: The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site of injection.
Slovenian: Injiciranje je treba opraviti počasi, da se izognete neugodju na mestu injiciranja.
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Slovenian: Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in splošno breme bolezni; nujna je zdravnikova ocena kliničnega poteka in stanja pri posameznem bolniku.
English: The most frequent adverse reactions are hypertension, influenza-like illness and headache.
Slovenian: Najpogostejši neželeni učinki so hipertenzija, bolezen, podobna gripi, in glavobol.
English: Do not inject a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
Slovenian: Dve randomizirani, nadzorovani študiji sta se opravili pri 270 bolnikih na hemodializi in 288 bolnikih brez dialize, pri katerih je bilo zdravljenje z epoetinom beta stabilno.
English: There is a cap at the end of the needle container.
Slovenian: Na koncu vsebnika za iglo je pokrovček.
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.
Slovenian: Eden najpogostejših neželenih učinkov med zdravljenjem z epoetinom theta je zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije, predvsem med začetno fazo zdravljenja.
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.
Slovenian: Pri zviševanju odmerkov epoetina theta bolnikom s kronično ledvično odpovedjo je potrebna pozornost, saj so lahko visoki kumulativni odmerki epoetina povezani z večjim tveganjem za smrtnost, resne kardiovaskularne in cerebrovaskularne dogodke.
English: Confirm visually that the needle is fully engaged in the safety shield under the lock (see picture 15).
Slovenian: Vizualno preverite, ali je igla povsem vpeta v varnostnem pokrovčku pod zaklepom (glejte sliko 15).
English: The maximum dose should not exceed 60,000 IU.
Slovenian: Največji odmerek ne sme preseči 60.000 i.e.
English: These may be signs of severely elevated blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even if your blood pressure is usually normal or low.
Slovenian: To so lahko znaki hudo zvišanega krvnega tlaka (ki je pogost pri bolnikih s kronično ledvično odpovedjo, pojavijo se lahko pri največ 1 od 10 bolnikov), tudi če je vaš krvni tlak navadno normalen ali nizek.
English: Put the needle fully into the skin as shown by your doctor or nurse.
Slovenian: Iglo popolnoma potisnite v kožo, kot sta vam pokazala zdravnik ali medicinska sestra.
English: Biopoin is a clear and colourless solution for injection in pre-filled syringe along with an injection needle.
Slovenian: Zdravilo Biopoin je bistra in brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi z injekcijsko iglo.
English: Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be switched to twice-weekly administration.
Slovenian: Intravenska uporaba: pri bolnikih, pri katerih je raven stabilna ob trikratnem odmerjanju na teden, lahko preidete na uporabo dvakrat na teden.
English: The injection is given either into a vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection).
Slovenian: Injiciranje se daje v veno (intravensko) ali tkivo tik pod kožo (subkutano).
English: No accumulation of epoetin theta was observed.
Slovenian: Kopičenja epoetina theta niso opazili.
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.
Slovenian: Pri bolnikih s kronično ledvično odpovedjo, ki se še ne zdravijo z dializo in so prejeli 40 i.e./kg telesne mase v obliki subkutane injekcije, je podaljšana absorpcija povzročila koncentracijski plato, pri čemer se je največja koncentracija v povprečju dosegla po približno 14 urah.
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.
Slovenian: Če vam zdravilo Biopoin injicirajo pod kožo, bo morda zdravnik predlagal, da se naučite samostojnega iniciranja zdravila.