natgillin/translations-raw huggingface dataset:
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).
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).
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.
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.
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.
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).
It is recommended that haemoglobin measurement, a complete blood count and platelet count be performed regularly.
Priporočeno je, da se redno opravljajo meritve hemoglobina, celotna krvna slika in preiskava števila trombocitov.
The therapeutic margin of epoetin theta is very wide.
Terapevtski interval epoetina theta je zelo velik.
It may also be necessary to reduce your dose of Biopoin or to stop the treatment with Biopoin for a short period of time.
Morda bo treba zmanjšati odmerek zdravila Biopoin ali začasno prekiniti jemanje zdravila Biopoin.
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.
Bolnike je treba skrbno spremljati, da se tako zagotovi, da se za zadostni nadzor simptomov anemije uporablja najmanjši odobreni odmerek epoetina theta.
If the frequency of administration is changed, dose adjustments may be necessary.
Če se spremeni pogostost uporabe, bo morda treba prilagoditi odmerek.
Epoetins are growth factors that primarily stimulate red blood cell production.
Epoetini so rastni faktorji, ki primarno stimulirajo tvorbo rdečih krvničk.
The pharmacokinetics of epoetin theta are independent of age or gender.
Farmakokinetika epoetina theta ni odvisna od starosti ali spola.
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.
Če je povečanje hemoglobina po dodatnih štirih tednih še vedno nezadostno, je treba razmisliti o povečanju tedenskega odmerka na 60.000 i.e.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%.
Splošna Pri vseh bolnikih z vrednostmi feritina v serumu, manjšimi od 100 µg/l, ali saturacijo transferina,
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.
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.
The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site of injection.
Injiciranje je treba opraviti počasi, da se izognete neugodju na mestu injiciranja.
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.
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.
The most frequent adverse reactions are hypertension, influenza-like illness and headache.
Najpogostejši neželeni učinki so hipertenzija, bolezen, podobna gripi, in glavobol.
Do not inject a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
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.
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.
There is a cap at the end of the needle container.
Na koncu vsebnika za iglo je pokrovček.
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.
Eden najpogostejših neželenih učinkov med zdravljenjem z epoetinom theta je zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije, predvsem med začetno fazo zdravljenja.
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.
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.
Confirm visually that the needle is fully engaged in the safety shield under the lock (see picture 15).
Vizualno preverite, ali je igla povsem vpeta v varnostnem pokrovčku pod zaklepom (glejte sliko 15).
The maximum dose should not exceed 60,000 IU.
Največji odmerek ne sme preseči 60.000 i.e.
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.
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.
Put the needle fully into the skin as shown by your doctor or nurse.
Iglo popolnoma potisnite v kožo, kot sta vam pokazala zdravnik ali medicinska sestra.
Biopoin is a clear and colourless solution for injection in pre-filled syringe along with an injection needle.
Zdravilo Biopoin je bistra in brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi z injekcijsko iglo.
Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be switched to twice-weekly administration.
Intravenska uporaba: pri bolnikih, pri katerih je raven stabilna ob trikratnem odmerjanju na teden, lahko preidete na uporabo dvakrat na teden.
The injection is given either into a vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection).
Injiciranje se daje v veno (intravensko) ali tkivo tik pod kožo (subkutano).
No accumulation of epoetin theta was observed.
Kopičenja epoetina theta niso opazili.
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.
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.
If you are receiving Biopoin as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Če vam zdravilo Biopoin injicirajo pod kožo, bo morda zdravnik predlagal, da se naučite samostojnega iniciranja zdravila.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women.
Podatkov o uporabi epoetina theta pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Patients who do not have to undergo dialysis are usally given the injections under the skin.
Bolnikom, ki jim ni treba opravljati dialize, se zdravilo navadno injicira pod kožo.
If the frequency of administration is changed, haemoglobin level should be monitored closely and dose adjustments may be necessary.
Če se spremeni pogostost uporabe, je treba skrbno spremljati raven hemoglobina in morda prilagoditi odmerek.
If you forget to use Biopoin
Če ste pozabili uporabiti zdravilo Biopoin
If these reactions occur, they require the immediate attention of a physician and intensive medical care.
Pojav teh reakcij zahteva takojšnje ukrepanje zdravnika in intenzivno nego.
The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy.
Farmakokinetiko epoetina theta so preučili pri zdravih prostovoljcih, bolnikih s kronično ledvično okvaro in bolnikih z rakom, ki so prejemali kemoterapijo.
In addition, a reduction of the administered dose of epoetin theta needs to be considered.
Poleg tega je treba razmisliti o zmanjšanju odmerka epoetina theta.
The angle between the syringe and skin should not be too narrow (at least 45°, see pictures 9 and 10).
Kot med brizgo in kožo naj ne bo preoster (vsaj 45°, glejte sliki 9 in 10).
During haemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Med hemodializo bodo bolniki, ki se zdravijo z epoetinom theta, morda potrebovali intenzivnejše zdravljenje z antikoagulanti, da se tako prepreči strjevanje krvi v arteriovenskem spoju.
If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4).
PRCA, je treba zdravljenje z epoetinom theta prekiniti, bolniki pa ne smejo preiti na drug rekombinantni epoetin (glejte poglavje 4.4).
Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Neustrezna uporaba epoetina theta pri zdravih osebah lahko povzroči povečanje hemoglobina in hematokrita.
The injections are given under the skin or into a vein.
Injekcije se dajejo pod kožo ali v veno.
Push the safety shield towards the needle (see picture 12).
Varnostni pokrovček potisnite proti igli (glejte sliko 12).
You will need to give yourself the injection into the tissue just under the skin.
Zdravilo si boste morali injicirati v tkivo tik pod kožo.
- The active substance is epoetin theta.
- Zdravilna učinkovina je epoetin theta.
Do not touch the needle or needle shield or push the plunger (see picture 5).
Ne dotikajte se igle ali zaščite igle in ne potiskajte bata (glejte sliko 5).
In patients with cancer receiving chemotherapy the aetiology of anaemia is multifactorial.
Pri bolnikih z rakom, ki prejemajo kemoterapijo, ima etiologija anemije več dejavnikov.
The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.
Končni razpolovni čas je daljši po intravenski uporabi, ko je bil v povprečju 25 ur po enkratnem odmerjanju in 34 ur v stanju dinamičnega ravnovesja po večkratnem odmerjanju trikrat na teden, ne da bi se ob tem pojavilo kopičenje epoetina theta.
If you stop using Biopoin
Če ste prenehali uporabljati zdravilo Biopoin
Symptomatic anaemia associated chronic renal failure Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively).
Simptomatska anemija, povezana s kronično ledvično odpovedjo Podatki iz študij korekcijske faze pri 284 bolnikih s kronično ledvično okvaro kažejo, da so bili odstotki odziva (opredeljenega kot raven hemoglobina, višja od 11 g/dl pri dveh zaporednih meritvah) v skupini, ki je prejemala epoetin theta, (88,4 % v študijah pri bolnikih na dializi in 89,4 % pri bolnikih brez dialize) primerljivi s skupino, ki je prejemala epoetin beta (86,2 % oziroma 81,0 %).
The angle between the syringe and skin should not be too narrow (at least 45°, see picture 8).
Kot med brizgo in kožo naj ne bo preoster (vsaj 45°, glejte sliko 8).
In the case of injections into veins, your dosage may be switched to 2 injections weekly.
Pri injiciranju v veno se lahko odmerek spremeni na 2 injekciji na teden.
Position the safety shield approximately 45° against a flat surface (see picture 13).
Varnostni pokrovček nastavite na ravno površino pod približno 45° (glejte sliko 13).
In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady state.
Pri bolnikih z rakom, ki so prejemali kemoterapijo, je bil po večkratni subkutani uporabi odmerka 20.000 i.e.epoetina theta enkrat na teden končni razpolovni čas 29 ur po prvem odmerku in 28 ur v stanju dinamičnega ravnovesja.
Common in cancer patients (may affect up to 1 in 10 people) - Joint pain.
Pogosti pri bolnikih z rakom (pojavijo se lahko pri največ 1 od 10 bolnikov) - bolečina v sklepih
Press down the needle with a firm, quick motion until a distinct audible click is heard (see picture 14).
Iglo pritisnite s čvrstim, hitrim gibom, da zaslišite jasen klik (glejte sliko 14).
Check the expiry date on the pre-filled syringe label (EXP).
Preverite rok uporabnosti na oznaki napolnjene injekcijske brizge (Uporabno do).
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Zdravljenje z epoetinom theta smejo uvesti samo zdravniki z izkušnjami pri naštetih indikacijah.
Skin reactions such as rash, pruritus or injection site reactions may occur.
Pojavijo se lahko kožne reakcije, kot so izpuščaj, pruritus ali reakcije na mestu injiciranja.
Move the safety shield away from the needle and toward the syringe barrel.
Varnostni pokrovček premaknite od igle proti cevi brizge.
Treatment with epoetin theta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l).
Zdravljenje z epoetinom theta je treba začasno prekiniti, če je raven hemoglobina višja od 13 g/dl (8,07 mmol/l).
If epoetin theta is substituted for another epoetin, haemoglobin level should be monitored closely and the same route of administration should be used.
Če se epoetin theta zamenja z drugim epoetinom, je treba skrbno spremljati raven hemoglobina in uporabiti enako pot.
Treatment for anaemia is given to adult patients with chronic renal failure or to adult patients with non-myeloid cancer (cancer not originating in the bone marrow) who at the same time are receiving chemotherapy (medicines to treat cancer).
Anemija se zdravi pri odraslih bolnikih s kronično ledvično odpovedjo ali odraslih bolnikih, z nemieloidnim rakom (rak, ki ne izvira iz kostnega mozga), ki se hkrati zdravijo s kemoterapijo (zdravila za zdravljenje raka).
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at a temperature not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Za ambulantno uporabo lahko bolnik zdravilo vzame iz hladilnika in ga shranjuje pri temperaturi, nižji od 25 °C, do sedem dni.
Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins.
Subkutana uporaba se priporoča pri bolnikih na hemodializi, da se izognete predrtju perifernih ven.
In controlled clinical studies, use of epoetins has shown: - shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl (8.69 mmol/l), - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin value of 12-14 g/dl (7.45-8.69 mmol/l), - increased risk of death when administered to target a haemoglobin value of 12 g/dl (7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
- skrajšan čas do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki se zdravijo z obsevanjem, kadar so se dajali za ciljno raven hemoglobina, višjo od 14 g/dl (8,69 mmol/l); - skrajšano splošno preživetje in povečano število smrti, povezanih z napredovanjem bolezni v štirih mesecih, pri bolnikih z metastatskim rakom dojke, ki prejemajo kemoterapijo, kadar so se dajali za ciljno vrednost hemoglobina od 12 do 14 g/dl (7,45-8,69 mmol/l); - povečano tveganje smrti, kadar so se bolnikom z aktivno maligno boleznijo, ki ne prejemajo kemoterapije ali obsevanja, dajali za ciljno vrednost hemoglobina 12 g/dl (7,45 mmol/l).
The solution is clear and colourless.
Raztopina je prozorna in brezbarvna.
Open the needle bag at the flaps (see picture 1).
Odprite vrečko za iglo na jezičkih (glejte sliko 1).
In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous administration of 40 IU/kg body weight epoetin theta three times weekly.
Pri bolnikih s kronično ledvično odpovedjo na hemodializi je bil razpolovni čas izločanja epoetina theta 6 ur po enkratnem odmerjanju in 4 ure v stanju dinamičnega ravnovesja po večkratnem intravenskem odmerjanju 40 i.e./kg telesne mase epoetina theta trikrat na teden.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).
Točkovna ocena razmerja tveganja metaanalize podatkov stopnje preživetja je bila 1,08 v korist kontrolnih skupin (95-odstotni IZ: 0,99, 1,18; 42 preskušanj in 8167 bolnikov).
Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin theta is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Bolnike je treba skrbno spremljati, da se zagotovi, da se za zadostni nadzor simptomov anemije uporablja najmanjši odobreni učinkoviti odmerek epoetina theta, medtem ko se koncentracije hemoglobina vzdržuje pri 12 g/dl (7,45 mmol/l) ali manj.
If epoetin theta is substituted for another epoetin, the same route of administration should be used.
Če se epoetin theta zamenja z drugim epoetinom, je treba uporabiti enako pot.
If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions, tell your doctor immediately.
Če se pojavijo glavoboli, predvsem nenadni, zbadajoči glavoboli, podobni migreni, zmedenost, motnje govora, nestabilna hoja, epileptični napadi, to takoj povejte zdravniku.
The recommended initial dose is 20,000 IU, independent of bodyweight, given once-weekly.
Priporočeni začetni odmerek je 20.000 i.e., ne glede na telesno maso, ki se daje enkrat na teden.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi razlik med bolniki se lahko opazijo občasne posamezne vrednosti hemoglobina, ki so večje ali manjše od želene ravni.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
V odprti študiji ni bilo razlike v splošnem preživetju skupin bolnikov, ki so jih zdravili z rekombinantnim humanim eritropoetinom, in kontrolnih skupin.
The needle is surrounded by a retractable needle shield.
Igla je obdana z vskočno zaščito igle.
These antibodies have been shown to cross-react with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to epoetin theta (see section 4.8).
Pokazali so, da ta protitelesa navzkrižno reagirajo z vsemi epoetini, zato se pri bolnikih s sumom na nevtralizirajoča protitelesa proti eritropoetinu ali njihovo potrditvijo epoetin theta ne sme uvajati (glejte poglavje 4.8).
Once you have removed your medicine from the refrigerator you must use it within this period or it must be discarded.
Ko ste zdravilo vzeli iz hladilnika, ga morate uporabiti v sedmih dneh ali zavreči.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Torej obstajajo skladni dokazi, ki kažejo, da so lahko bolniki z rakom, ki se zdravijo z rekombinantnim humanim eritropoetinom, izpostavljeni pomembni nevarnosti.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is erythropoietin deficiency.
Tvorba endogenega eritropoetina je poslabšana pri bolnikih s kronično ledvično odpovedjo, zato je pri njih primerni vzrok anemije pomanjkanje eritropoetina.
Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Rezultati metaanaliz so konsistentni glede značilnega zvišanja relativnega tveganja trombemboličnih dogodkov pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin (glejte poglavje 4.4).
Put the shielded needle without hesitation and in one continuous motion fully into the skin as shown by your doctor or nurse.
Zaščiteno iglo brez oklevanja in z enim neprekinjenim gibom popolnoma potisnite v kožo, kot sta vam pokazala zdravnik ali medicinska sestra.
If you are being treated with Biopoin, the dose of the anticoagulant medicine may have to be increased.
Če se zdravite z zdravilom Biopoin, bo morda treba povečati odmerek zdravila proti strjevanju krvi.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when epoetins were administered to target a haemoglobin level in excess of 12 g/dl (7.45 mmol/l).
V kliničnih preskušanjih so opazili povečano tveganje smrti in resnih kardiovaskularnih dogodkov, kadar so bile ob dajanju epoetina ciljne ravni hemoglobina višje od 12 g/dl (7,45 mmol/l).
Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4).
Pojavi se lahko tromboza spoja, predvsem pri bolnikih, nagnjenih k hipertenziji in pri katerih se na arteriovenskih fistulah pojavljajo zapleti (npr. stenoze, anevrizme) (glejte poglavje 4.4).
What Biopoin is and what it is used for What Biopoin is
Kaj je zdravilo Biopoin in za kaj ga uporabljamo Kaj je zdravilo Biopoin
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.
Podatke posameznega bolnika so analizirali pri več kot 13.900 bolnikih z rakom (zdravljenih s kemoterapijo, radioterapijo, kemoradioterapijo ali brez zdravljenja), ki so sodelovali v