natgillin/translations-raw huggingface dataset:
The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Biološko uspešnost eritropoetina so dokazali na različnih živalskih modelih in vivo (normalne in slabokrvne podgane, policitemične miši).
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.
Preživetje in napredovanje tumorjev so raziskovali v petih velikih kontroliranih študijah, v katere je bilo vključenih vsega skupaj 2 833 bolnikov, od katerih so bile štiri študije dvojno slepe in nadzorovane s placebom, ena pa je bila študija odprtega tipa.
Please discuss this with your doctor.
O tem se pogovorite s svojim zdravnikom.
He/she will work out the correct dose of Silapo for you to use, how long the treatment should continue and by what route the medicine will be given.
Določil bo pravilni odmerek zdravila Silapo za vas, kako dolgo bo zdravljenje trajalo in na kakšen način boste zdravilo prejemali.
Haemoglobin levels should be monitored regularly.
Nivo hemoglobina je treba redno spremljati.
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).
Študija ni dosegla niti primarnega cilja, da bi dokazala zmanjšanje tveganja za umrljivost zaradi vseh vzrokov, za srčno-žilno obolevnost ali končno ledvično odpoved.
Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Pojavijo se lahko tudi razjede v ustih, grlu, nosu, na genitalijah in očeh (rdeče in otekle oči).
The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Ciljna koncentracija hemoglobina je bila v dveh študijah >13 g/dl, v preostalih treh študijah pa od 12 do 14 g/dl.
In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4).
Pri večini teh bolnikov so opazili prisotnost eritropoetinskih protiteles (glejte poglavji 4.3 in 4.4).
Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Prevelik odmerek eritropoetina ima lahko posledice v obliki podaljšanja farmakoloških učinkov hormona.
These changes are interpreted as being secondary to decreased maternal body weight gain.
Razlogi so, da so te spremembe sekundarne posledice znižane rasti telesne mase pri materah.
The starting dose may be adjusted by your doctor until your condition is controlled.
Začetni odmerek bo mogoče Vaš zdravnik prilagajal po potrebi, dokler Vaše stanje ne bo pod nadzorom.
Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).
Pri 2 preskušancih so bili prisotni pomembni dejavniki tveganja (atrijska fibrilacija, srčno popuščanje in tromboflebitis).
Adverse drug reactions reported by ≥1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Neželeni učinki zdravila, o katerih je poročalo ≥ 1 % preskušancev, zdravljenih z epoetinom alfa v teh študijah, so prikazani v spodnji preglednici.
These increases in blood pressure can be treated with medicinal products.
Ta zvišanja krvnega tlaka lahko zdravimo z zdravili.
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.
Dva drugi manjši, randomizirani, s placebom kontrolirani preskušanji nista ugotovila signifikantnega napredka v parametrih kvalitete življenja, merjenih s skalama EORTC-QLQ-C30 oziroma CLAS.
This is given 3 times a week.
Daje se trikrat tedensko.
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• Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment.
• Krvni strdki (vključno z globoko vensko trombozo in embolijo), ki jih bo morda treba nujno zdraviti.
More severe cases have been observed with long-acting epoetins.
Pri dolgodelujočih epoetinih so opazili več hujših primerov.
This is given subcutaneously once every week, with not less than 5 days between doses.
Ta odmerek dajemo subkutano enkrat tedensko z vsaj 5-dnevnimi presledki med odmerki.
Therefore, routine volume replacement should be performed in such patients.
Zato je pri takšnih bolnikih treba izvesti rutinsko nadomeščanje volumna.
Surgery patients
Kirurški bolniki
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.
Če imate raka, se morate zavedati, da lahko zdravilo Silapo deluje kot rastni faktor za krvne celice in v nekaterih primerih negativno vpliva na vašo bolezen.
When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Kadar je potrebno spremeniti odmerek, je treba spremembo izvesti po korakih v najmanj štirih tednih.
However, since ciclosporin is bound by red blood cells there is potential for interactions with other medicinal products.
Ker pa rdeče krvne celice vežejo ciklosporin, obstaja vseeno možnost, da do interakcij z drugimi zdravili prihaja.
What Silapo is and what it is used for
Kaj je zdravilo Silapo in za kaj ga uporabljamo
The injections are given in the limbs or the anterior abdominal wall.
Injekcije se daje v ude ali v sprednjo trebušno steno.
Extending dose intervals may require an increase in dose.
Pri podaljšanih odmernih intervalih bo morda potrebno zvišati odmerek.
Appropriate dose titration should be considered.
Razmisliti morate o primerni titraciji odmerka.
The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dl as a higher haemoglobin level may increase the risk of blood clots and death.
Namen zdravljenja je ohranjati vašo raven hemoglobina med 10 in 12 g/dl, saj višje ravni hemoglobina lahko povečajo tveganje za krvne strdke in smrt.
If you use more Silapo than you should
Če ste uporabili večji odmerek zdravila Silapo, kot bi smeli
Your doctor may check your shunt and prescribe a medicinal product to prevent thrombosis.
Zdravnik bo morda pregledal šant in predpisal zdravilo za preprečevanje tromboze.
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.
Če se na zdravilo Silapo ne odzivate ustrezno, bo zdravnik preveril Vaš odmerek in Vas obvestil, če morate odmerek spremeniti.
Although this complication is very rare, you should be aware that if you develop it, you would need to have regular blood transfusions, possibly lifelong, to treat your anaemia and the Silapo therapy would have to be discontinued.
Čeprav se ta zaplet pojavlja redko, se morate zavedati, da boste v primeru, če bi prišlo do njega, potrebovali za zdravljenje anemije redne transfuzije krvi, morda celo življenje, in da se bo zdravljenje z zdravilom Silapo prekinilo.
This is given 2 times a week by injection into a vein.
Daje se ga dvakrat tedensko s injekcijo v veno.
Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Zvišan krvni tlak bo morda treba zdraviti z zdravili (ali prilagoditi odmerke zdravil, ki jih že jemljete za visok krvni tlak).
The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenous medicinal product and is approximately 20%.
Biorazpoložljivost eritropoetina, ki se injicira subkutano, je veliko nižja kot pri zdravilu, ki se ga injicira intravensko in je približno približno 20%.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
V večini primerov se vrednosti feritina v serumu znižajo hkrati z zvišanjem hematokrita.
Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
O takih primerih so poročali pri bolnikih s hepatitisom C, ki so bili zdravljeni z interferonom in ribavirinom in so sočasno prejemali tudi epoetine.
All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Vse te dodatne faktorje pri anemiji je treba skrbno pretehtati pri bolnikih z rakom, ko se odloča o zvišanju odmerka eritropoetina.
This is given three times a week, injected into a vein (over 1-5 minutes).
Daje se trikrat tedensko kot injekcijo v veno (v času 1-5 minuti).
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Receptorji eritropoetina so lahko izraženi na površini številnih tumorskih celic.
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.
Študije na živalih so pokazale, da eritropoetin zmanjšuje telesno maso ploda, zakasni osifikacijo in povečuje smrtnost pri plodih, če se ga daje v tedenskih odmerkih, ki so približno dvajsetkratna vrednost priporočenega tedenskega odmerka za ljudi.
The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
Vrh je vedno bistveno niže kot v primeru intravenskega dajanja (približno 1/20 te vrednosti).
Take one sealed syringe blister and leave it to stand for a few minutes until it reaches room temperature prior to using it.
Vzemite ovojnino z zapečateno injekcijsko brizgo in jo pustite, da stoji nekaj minut in da se pred uporabo ogreje na sobno temperaturo.
These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Pred pojavom teh hudih kožnih izpuščajev pogosto nastopi zvišana telesna temperatura in/ali se pojavijo gripi podobni simptomi.
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.
Ko enkrat dosežete terapevtske cilje za posameznega bolnika, morate odmerek zmanjšati za 25 do 50 %, da bi tako ohranili doseženo koncentracijo hemoglobina.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
V večjem številu kontroliranih kliničnih študij, pri katerih so epoetine dajali bolnikom z različnimi vrstami raka, vključno z rakom glave in vratu, pljučnim rakom ter rakom dojke, so ugotovili nepojasnjeno čezmerno smrtnost.
The upper limit of the target haemoglobin concentration should not be exceeded.
Zgornje meje za ciljno koncentracijo hemoglobina ni dovoljeno preseči.
Your doctor can decide whether Silapo is not working properly for you and will end the treatment, if necessary.
Vaš zdravnik lahko odloči, če zdravilo Silapo ne učinkuje pravilno, in bo po potrebi zdravljenje prekinil.
• Blood clots may also form in your haemodialysis system.
• Krvni strdki lahko nastanejo tudi v hemodializnem sistemu.
Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Od skupno 3 417 preskušancev v 25 randomiziranih, dvojno slepih, s placebom ali s standardno nego nadzorovanih študijah, so splošni varnostni profil epoetina alfa ocenili pri 2 094 anemičnih preskušancih.
You should inform the doctor or nurse immediately if you think too much Silapo has been injected.
Svojega zdravnika ali medicinsko sestro morate nemudoma obvestiti, če mislite, da vam je bilo injicirano preveč zdravila Silapo.
The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Eritropoetski odziv, ki so ga opazili v obeh skupinah zdravljenja, se je odrazil v podobnih deležih transfuzij (16 % v skupini s 600 i.e./kg na teden in 20 % v skupini s 300 i.e/kg na dan).
If no cause is identified, a bone marrow examination should be considered for diagnosis of PRCA.
Če vzroka ni najti, je treba premisliti o preiskavi kostnega mozga za diagnosticiranje PRCA.
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.
Povečano relativno tveganje za tromboembolične dogodke (RR 1,67, 95 % CI: 1,35, 2,06, 35 preskušanj in 6 769 bolnikov) so opazili pri bolnikih, ki so jih zdravili z rekombinantnim humanim eritropoetinom.
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.
V večjemu številu kontroliranih študij za epoetine ni bilo dokazano, da izboljšajo skupno preživetje ali zmanjšajo tveganje napredovanja tumorja pri bolnikih z anemijo, ki je povezana z rakom.
Silapo must not be shaken or mixed with any other liquid.
Zdravilo Silapo se ne sme stresati ali pa mešati z drugimi tekočinami.
This is given 3 times a week by injection under the skin.
Daje se ga trikrat tedensko z injiciranjem pod kožo.
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.
Kontrolirana klinična preskušanja niso pokazala koristi, ki bi jih lahko pripisali epoetinom, kadar se koncentracijo hemoglobina poveča čez raven, ki je potrebna za nadzorovanje simptomov anemije in izogibanje transfuziji krvi.
Your healthcare professional will always record the exact product you are using.
Vaš zdravnik bo vedno zabeležil, katero zdravilo uporabljate.
No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Ni dokazov za medsebojno delovanje med epoetinom alfa in G-CSF ali GM-CSF glede na in vitro hematološko diferenciacijo ali proliferacijo vzorcev tumorjev, ki so bili pridobljeni z biopsijo.
Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Silapo.
Kot pri vseh bolnikih, ki prejemajo eritropoetin, tudi med zdravljenjem z zdravilom Silapo krvni tlak lahko naraste.
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.
Rezultata skupnega preživetja v preskušanjih niso mogli zadovoljivo razložiti z razlikami v pojavnosti tromboze in povezanih zapletov pri tistih, ki so prejemali rekombinantni humani eritropoetin in tistih v kontrolni skupini.
• If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
• Če se s preiskavami krvi ugotovi, da je hemoglobin pred kirurškim posegom previsok, se zdravljenje prekine.
Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Šestnajst odstotkov bolnikov, zdravljenih z epoetinom alfa 300 i.e./kg, 23 % bolnikov, zdravljenih z epoetinom alfa 100 i.e./kg in 45 % bolnikov, zdravljenih s placebom, je potrebovalo transfuzijo.
All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
Vsi TVE so se pojavili v skupini, ki se je zdravila z epoetinom alfa, in sicer v prvih 24 tednih študije.
This medicinal product is for single use only.
Zdravilo je samo za enkratno uporabo.
If you are receiving haemodialysis:
Če ste na hemodializi:
Silapo therapy is usually started under medical supervision.
Zdravljenje z zdravilom Silapo se običajno začenja pod zdravniškim nadzorom.
Chronic renal failure patients treated with Silapo by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to Silapo treatment in patients who previously responded to such therapy.
Bolnike s kronično ledvično okvaro, ki zdravilo Silapo prejemajo subkutano, je treba redno spremljati glede izgube učinkovitosti, ki se kaže kot odsotnost ali zmanjšan odziv na zdravljenje z zdravilom Silapo, pri tistih bolnikih, ki so se predhodno že odzvali na tako zdravljenje.
Data from clinical studies with Silapo are in line with the safety profile of other authorised erythropoietins.
Podatki iz kliničnih študij z zdravilom Silapo so v skladu z varnostnim profilom drugih eritropoetinov z dovoljenjem za promet.
Silapo therapy should continue until one month after the end of chemotherapy.
S terapijo z zdravilom Silapo moramo nadaljevati še en mesec po zaključku kemoterapije.
if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
če ste naročeni na večji elektivni ortopedski kirurški poseg (kot je operacija kolka ali kolena) in:
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In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
V študiji odprtega tipa ni bilo razlik v celotnem preživetju med bolniki, ki so jih zdravili z rekombinantnim humanim eritropoetinom in kontrolami.
Cancer patients
Bolniki z rakom
This is more likely if you have low blood pressure or if your fistula has complications.
Verjetnost je večja, če imate nizek krvni tlak ali zaplete s fistulo.
• Increased blood pressure.
• Zvišan krvni tlak.
Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Eritropoetin je glikoprotein, ki kot faktor za pospeševanje mitoze in kot hormon za diferenciacijo stimulira nastanek eritrocitov iz celic predhodnikov.
Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Recepte za dializo je treba periodično prilagajati, da urea, kreatinin in kalij ostanejo v želenih mejah.
Moreover, monitoring of the blood pressure is recommended particularly at the start of therapy.
Poleg tega je priporočeno tudi redno spremljanje krvnega tlaka, še posebej na začetku zdravljenja.
In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake.
Pri bolnikih s kronično ledvično okvaro je popravek anemije imel za posledico povečan apetit, in povečan vnos kalija in proteinov.
However, your doctor may decide that it is right for you to learn how to inject Silapo under the skin (subcutaneously) yourself.
Lahko pa se bo zdravnik odločil, da se lahko naučite, kako si zdravilo Silapo pod kožo (subkutano) injicirate sami.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Štiri ogljikovodikove verige so s tremi N-glikozidnimi vezmi in eno O-glikozidno vezjo pritrjene na protein.
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).
Tovrstno zdravljenje smemo predpisati samo bolnikom z zmerno anemijo (hemoglobin (brez pomanjkanja železa), kadar postopki za zmanjšanje izgube krvi niso na razpolago ali če ne zadoščajo za načrtovani večji kirurški poseg, pri katerem je potrebna večja količina krvi (4 ali več enot krvi za ženske oz. 5 ali več enot za moške).
Adult patients on peritoneal dialysis
Odrasli bolniki na peritonealni dializi
Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥1.5 g/dl from baseline or a reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline, and a response duration of at least 8 weeks.
Eritroidni odziv so opredelili po merilih Mednarodne delovne skupine (IWG - International Working Group) iz leta 2006 kot zvišanje ravni hemoglobina za ≥ 1,5 g/dl od izhodišča ali zmanjšanje absolutnega števila enot koncentriranih eritrocitov, prejetih s transfuzijo, za vsaj 4 enote vsakih 8 tednov v primerjavi z 8 tedni pred izhodiščem in trajanje odziva vsaj 8 tednov.
Consequently, erythropoietin should generally be used during pregnancy and lactation only if the potential benefit outweighs the potential risk to the foetus.
Zato se med nosečnostjo in dojenjem eritropoetin v splošnem sme uporabljati le, če možne koristi odtehtajo možna tveganja za plod.
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.
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
The most frequent adverse reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Najpogostejši neželeni učinek, ki se pojavi med zdravljenjem z epoetinom alfa, je od odmerka odvisno zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije.
The percentage of subjects who were transfused in the epoetin alfa group decreased from 51.8% in the 8 weeks prior to baseline to 24.7% between weeks 16 and 24, compared to the placebo group which had an increase in transfusion rate from 48.9% to 54.1% over the same time periods.
Odstotek preskušancev, ki so prejeli transfuzijo, iz skupine, ki je prejemala epoetin alfa, se je zmanjšal z 51,8 % pri 8 tednih pred izhodiščem na 24,7 % v času med 16. in 24. tednom v primerjavi s skupino, ki je prejemala placebo, pri kateri se je stopnja transfuzije v istem obdobju povečala z 48,9 % na 54,1 %.
After administration of erythropoietin, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the
Po injiciranju eritropoetina se dvigne tako število eritrocitov, vrednosti Hb in število retikulocitov, kot tudi hitrost vgrajevanja
Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).
Uporabo je treba omejiti na bolnike z zmerno anemijo (npr. razpon koncentracije hemoglobina od 10 do 13 g/dl), ki jim program avtolognega darovanja krvi ni na voljo in pri katerih se pričakuje zmerna izguba krvi (od 900 do 1 800 ml).
Handling instructions for Silapo:
Navodila za rokovanje z zdravilom Silapo:
If possible, iron supplementation should be initiated prior to starting epoetin zeta therapy to achieve adequate iron stores.
Če je mogoče, je treba z nadomeščanjem železa začeti pred zdravljenjem z epoetinom zeta, da se dosežejo ustrezne zaloge železa.
In 2 studies with extended interval dosing of erythropoietin (3 times per week, once weekly, once every 2 weeks and once every 4 weeks) some patients with longer dosing intervals did not maintain adequate haemoglobin levels and reached protocol-defined haemoglobin withdrawal criteria (0% in once weekly, 3.7% in once-every-2-weeks and 3.3% in the once-every-4-weeks groups).
V dveh študijah s podaljšanim odmernim intervalom eritropoetina (trikrat tedensko, enkrat tedensko, enkrat na dva tedna in enkrat na štiri tedne) nekateri bolniki s podaljšanim odmernim intervalom niso ohranili ustreznih nivojev hemoglobina in so dosegli v protokolu podane izključitvene kriterije (0 % v skupini z enkrat tedenskim odmerjanjem, 3,7 % pri odmerjanju enkrat na dva tedna in 3,3 % pri odmerjanju enkrat na 4 tedne).