natgillin/translations-raw huggingface dataset:
The use of Epoetin alfa HEXAL in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Pri bolnikih, naročenih na večji elektivni ortopedski kirurški poseg in ki niso vključeni v program avtolognega zbiranja krvi, je uporaba zdravila Epoetin alfa HEXAL kontraindicirana, če imajo hudo koronarno, periferno arterijsko, karotidno ali cerebrovaskularno bolezen ali so nedavno preboleli miokardni infarkt ali cerebrovaskularni dogodek.
Epoetin alfa HEXAL is prescribed to stimulate your bone marrow to produce more red blood cells.
Zdravilo Epoetin alfa HEXAL se predpisuje za spodbujanje kostnega mozga k tvorbi rdečih krvnih celic.
Subcutaneous administration
Subkutano dajanje
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Pomožne snovi: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, glicin, polisorbat 80, klorovodikova kislina (za prilagajanje pH), natrijev hidroksid (za prilagajanje pH) in voda za injekcije.
Epoetin alfa HEXAL is presented as a clear, colourless solution for injection in a pre-filled syringe.
Zdravilo Epoetin alfa HEXAL je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi.
Reticulocyte count increase ≥ 40,000/µL or Hb increase ≥ 1 g/dL
Zvečano število retikulocitov za ≥ 40.000/µl ali zvečanje koncentracije Hb za ≥ 1 g/dl
In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg Pokazalo se je, da epoetin alfa pri bolnikih, naročenih na večji elektivni ortopedski kirurški poseg s hemoglobinom pred zdravljenjem > 10 do ≤ 13 g/dl, zmanjšuje tveganje za prejem alogenske transfuzije in pospeši eritroidno okrevanje (povečane ravni hemoglobina, ravni hematokrita in števila retikulocitov).
Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]; 1,404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
1.404 izpostavljene osebe z rakom v 16 študijah z anemijo, ki je posledica kemoterapije; 147 izpostavljenih oseb v 2 študijah za avtolognim darovanjem krvi, 213 izpostavljenih oseb v 1 študiji v kirurškem obdobju in 102 izpostavljeni osebi v 2 študijah pri MDS.
Patients with CRF not on dialysis demonstrated a dose-dependent and sustained increase in haematocrit when epoetin alfa was administered by either an intravenous or subcutaneous route.
Pri bolnikih s kronično ledvično odpovedjo, ki se še ne zdravijo z dializo, se je pokazalo od odmerka odvisno in trajno povečanje hematokrita, ko so epoetin alfa dajali bodisi intravensko ali subkutano.
• The usual dose is 600 IU per kilogram body weight twice a week.
• Običajni odmerek je 600 i.e. na kilogram telesne mase dvakrat na teden.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/L) over a four week period should be avoided.
Izogibati se je treba zviševanju hemoglobina za več kot 2 g/dl (1,25 mmol/l) v obdobju štirih tednov.
• if you know, or think that it may have been accidentally frozen, or
• če veste ali mislite, da je bilo morda nehote zamrznjeno ali, • če je prišlo do okvare hladilnika.
Epoetin alfa exhibits a dose-related effect on haematological parameters which is independent of route of administration.
Farmakokinetično/farmakodinamično razmerje Epoetin alfa kaže od odmerka odvisen učinek na hematološke parametre, kar ni odvisno od poti uporabe.
Epoetin alfa does not induce bacterial gene mutation (Ames Test), chromosomal aberrations in mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus.
Pri testih mutacij genov bakterij (Amesov test), kromosomskih aberacij na celicah sesalcev, pri mikronukleusnem testu pri miših ali mutacij genov v lokusu HGPRT uporaba epoetina alfa ni povzročila nobenih sprememb.
Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Napolnjena injekcijska brizga z varnostno zaščito za iglo Med tem, ko kožo še naprej držite med palcem in kazalcem, bat počasi in enakomerno potiskajte, dokler ni vbrizgan celoten odmerek, bata pa ni mogoče potisniti še naprej.
Before use, leave the Epoetin alfa HEXAL syringe to stand until it reaches room temperature.
Pred uporabo počakajte, da zdravilo Epoetin alfa HEXAL doseže sobno temperaturo.
The absolute bioavailability of subcutaneous injectable epoetin alfa is approximately 20% in healthy subjects.
Absolutna biološka uporabnost subkutano injiciranega epoetina alfa pri zdravih osebah je približno
Due to intra-patient variability, occasional individual haemoglobin concentrations for a patient above and below the desired haemoglobin concentration range may be observed.
Zaradi razlik med bolniki se lahko včasih pri posameznih bolnikih opazijo koncentracije hemoglobina, ki so večje ali manjše od želenega razpona koncentracije hemoglobina.
Epoetin alfa HEXAL is not approved in the management of anaemia associated with hepatitis C.
Zdravilo Epoetin alfa HEXAL ni odobreno za obravnavanje anemije, povezane s hepatitisom C.
Epoetin alfa is not approved in the management of anaemia associated with hepatitis C.
Uporaba epoetina alfa ni odobrena za obravnavanje anemije, povezane s hepatitisom C.
Remove one syringe from the pack and remove the protective cap from the injection needle.
Iz ovojnine vzemite eno injekcijsko brizgo in z igle odstranite varnostni pokrovček.
In addition, there was no statistical difference between the proportion of patients requiring pRBC transfusions between the Epoetin alfa group and placebo.
Poleg tega med skupinama z epoetinom alfa in placebom ni bilo statistične razlike med deležem bolnikov,
Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
Citotoksičnega delovanja epoetina alfa na celice kostnega mozga niso zaznali.
In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, Epoetin alfa HEXAL 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Kadar moramo zaradi zdravstvenih razlogov skrajšati čas pred kirurškim posegom na manj kot tri tedne, je treba dajati 300 i.e./kg zdravila Epoetin alfa HEXAL subkutano na dan, in sicer 10 dni zapored pred kirurškim posegom, na dan kirurškega posega in še štiri dni takoj po njem.
Iron supplements and other blood stimulants may increase the effectiveness of Epoetin alfa HEXAL.
Dodatki železa in druga sredstva za spodbujanje tvorbe krvi lahko povečajo učinkovitost zdravila
In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
Pri bolnikih s kronično ledvično odpovedjo, pri katerih je intravenski dostop rutinsko na razpolago (bolniki na hemodializi), je zaželeno intravensko dajanje zdravila Epoetin alfa HEXAL.
Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18).
Mediano skupno preživetje v skupini epoetin alfa in standardna nega je bilo 17,8 meseca v primerjavi s 18,0 meseci v skupini samo s standardno nego (razmerje ogroženosti 1,07; 95 % IZ: 0,97; 1,18).
In paediatric patients the recommended haemoglobin concentration range is between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Pri pediatričnih bolnikih je priporočeni razpon koncentracije hemoglobina med 9,5 g/dl in 11 g/dl (med 5,9 in 6,8 mmol/l).
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Če heparinizacija ni optimalna, je možna zapora dializnega sistema.
Epoetin alfa HEXAL is a sterile but unpreserved product and is for single use only.
Zdravilo Epoetin alfa HEXAL je sterilno, brez dodatka konzervansa, namenjeno zgolj enkratni uporabi.
Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
V odprti podaljšek študije, ki je pokazal izboljšanje kakovosti življenja, ki se je ohranilo dodatnih 12 mesecev,
Do not freeze or shake.
Ne zamrzujte in ne stresajte.
If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production).
• pri hudo anemičnih odraslih bolnikih, ki se še ne zdravijo z dializo Če imate bolezen ledvic, vam morda primanjkuje rdečih krvnih celic, če vaše ledvice ne izdelujejo dovolj eritropoetina (potrebnega za tvorbo rdečih krvnih celic).
- For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
(elementarno železo 200 mg/dan peroralno) dajati več tednov pred začetkom avtolognega deponiranja, da se dosežejo velike zaloge železa pred začetkom zdravljenja z epoetinom alfa, in ves cikel zdravljenja z epoetinom alfa.
- For chronic renal failure patients, iron supplementation (elemental iron 200 to 300 mg/day orally for adults and 100 to 200 mg/day orally for paediatrics) is recommended if serum ferritin levels are below 100 ng/mL.
(elementarno železo 200 do 300 mg/dan peroralno za odrasle in 100 do 200 mg/dan peroralno za otroke), če je vrednost feritina v serumu manjša od 100 ng/ml.
Epoetin alfa HEXAL contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Zdravilo Epoetin alfa HEXAL vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni „brez natrija“.
If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin concentration has increased ≥ 1 g/dL (≥ 0.62 mmol/L) or the reticulocyte count has increased ≥ 40,000 cells/µL, the dose should remain at 300 IU/kg 3 times per week.
Če se je po dodatnih 4 tednih zdravljenja z odmerki 300 i.e./kg, 3krat na teden, koncentracija hemoglobina zvečala za ≥ 1 g/dl (≥ 0,62 mmol/l) in se je število retikulocitov zvečalo za ≥ 40.000 celic/µl nad izhodiščno vrednost, naj odmerek ostane
- If the haemoglobin concentration has increased by at least 1 g/dL (0.62 mmol/L) or the reticulocyte count has increased ≥ 40,000 cells/µL above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
- Če se je koncentracija hemoglobina zvečala za vsaj 1 g/dl (0,62 mmol/l) ali se je število retikulocitov po 4 tednih zdravljenja zvečalo za ≥ 40.000 celic/µl nad izhodiščno vrednost, mora odmerek ostati 150 i.e./kg, 3-krat na teden ali 450 i.e./kg 1-krat na teden.
If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range of between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L) is achieved (this should be done in steps of at least four weeks).
Po potrebi odmerek vsakič zvečamo ali zmanjšamo za 25 i.e./kg (3-krat na teden), dokler ne dosežemo želenega razpona koncentracije hemoglobina med 9,5 g/dl in 11 g/dl (med 5,9 in 6,8 mmol/l) (to je treba narediti postopoma z vsaj štiritedenskimi časovnimi presledki).
Side effects from an overdose of Epoetin alfa HEXAL are unlikely.
Ni verjetno, da bi se pojavili neželeni učinki zaradi prevelikega odmerka zdravila Epoetin alfa HEXAL.
Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Epoetin alfa je kopija človeške beljakovine eritropoetina in ima enako delovanje.
Only take one dose of Epoetin alfa HEXAL from each syringe.
Uporabite le en odmerek zdravila Epoetin alfa HEXAL iz vsake injekcijske brizge.
Prolonged vigorous shaking may damage the product.
Daljše močno tresenje lahko zdravilo okvari.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s z zdravnikom, farmacevtom ali medicinsko sestro.
Epoetin alfa HEXAL should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Zdravilo Epoetin alfa HEXAL se daje z namenom zvišati hemoglobin na raven do 11 g/dl (6,8 mmol/l).
All of the responding subjects were in the stratum with sEPO < 200 mU/mL during screening.
Vse odzivne osebe so bile med presejanjem v skupini s sEPO < 200 me./ml.
* Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1.
Proizveden v ovarijskih celicah kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Epoetin alfa HEXAL dose by about 25 to 50%.
Če se koncentracija hemoglobina zveča za več kot 2 g/dl (1,25 mmol/l) na mesec, ali če raven koncentracije hemoglobina preseže 12 g/dl (7,5 mmol/l), zmanjšajte odmerek zdravila Epoetin alfa HEXAL za približno 25 do 50 %.
Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 mL of isotonic saline to rinse the tubing and ensure satisfactory injection of the product into the circulation (see Posology, “Adult haemodialysis patients”).
Zdravilo lahko injiciramo tudi po končani dializi, in sicer preko fistulne cevke z iglo, skozi katero nato injiciramo še 10 ml izotonične fiziološke raztopine, s čimer izperemo cevje in zagotovimo ustrezno injiciranje zdravila v krvni obtok (glejte Odmerjanje, “Odrasli bolniki, ki se zdravijo s hemodializo”).
A randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Pri 2.098 anemičnih ženskah z metastatskim rakom dojke, ki so prejele kemoterapijo prve izbire ali druge izbire, so izvedli randomizirano, odprto, multicentrično študijo.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Zdravilo Epoetin alfa HEXAL je indicirano za zdravljenje simptomatske anemije, povezane s kronično ledvično odpovedjo:
Instructions on how to inject Epoetin alfa HEXAL yourself
Navodila, kako si sami injicirate zdravilo Epoetin alfa HEXAL
If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L) is achieved (this should be done in steps of at least four weeks).
Po potrebi odmerek vsakič zvečamo ali zmanjšamo za 25 i.e./kg (3-krat na teden), dokler ne dosežemo želenega razpona koncentracije hemoglobina med 10 g/dl in 12 g/dl (med 6,2 in 7,5 mmol/l) (to je treba narediti postopoma z vsaj štiritedenskimi časovnimi presledki).
- If the haemoglobin concentration has increased < 1 g/dL (< 0.62 mmol/L) and the reticulocyte count has increased < 40,000 cells/µL above baseline, response is unlikely and treatment should be discontinued.
- Če se je koncentracija hemoglobina zvečala za < 1 g/dl (< 0,62 mmol/l) in se je število retikulocitov zvečalo za < 40.000 celic/µl nad izhodiščno vrednost, je odziv na zdravljenje malo verjeten, zato ga je treba prekiniti.
The mean CL/F for the 150 IU/kg, 3 times-per-week and 40,000 IU, once-weekly regimens in the anaemic cancer subjects were 45.8 and 11.3 mL/h/kg, respectively.
3-krat na teden in 40.000 i.e. enkrat na teden pri anemičnih osebah z rakom je bil 45,8 oz. 11,3 ml/h/kg.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
375 bolnikov z anemijo z različnimi nemieloidnimi malignimi obolenji, ki so se zdravili s kemoterapijo brez platine, so z meritvami, ki so jih izvedli s pomočjo naslednjih inštrumentov in lestvic: splošna lestvica za funkcionalno oceno zdravljenja anemičnih bolnikov z rakom (FACT-An
Epoetin alfa HEXAL should be administered as a subcutaneous injection.
Zdravilo Epoetin alfa HEXAL je treba dati v obliki subkutane injekcije.
- decreased locoregional control in patients with advanced head and neck cancer receiving radiation therapy when administered to achieve a haemoglobin concentration level of greater than 14 g/dL (8.7 mmol/L),
- zmanjšan lokoregionalni nadzor pri bolnikih z napredovalim rakom glave ali vratu, ki so prejemali radioterapijo, kadar so prejemali odmerke za doseganje ravni koncentracije hemoglobina, večje od 14 g/dl (8,7 mmol/l); - krajši čas splošnega preživetja in povečanje incidence smrti, pripisane napredovanju bolezni po
Adult peritoneal dialysis patients
Odrasli bolniki, ki se zdravijo s peritonealno dializo
In chronic renal failure patients the rate of increase in haemoglobin should be approximately 1 g/dL (0.62 mmol/L) per month and should not exceed 2 g/dL (1.25 mmol/L) per month to minimise risks of an increase in hypertension.
1 g/dl (0,62 mmol/l) na mesec in ne sme presegati 2 g/dl (1,25 mmol/l) na mesec, da se zmanjša tveganje zvišanja pri hipertenziji.
Instructions on how to inject yourself with Epoetin alfa HEXAL can be found at the end of this leaflet.
Navodila za to, kako si sami injicirate zdravilo Epoetin alfa HEXAL, lahko najdete na koncu tega navodila za uporabo zdravila.
Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure.
Med zdravljenjem z epoetinom alfa so se pri bolnikih s predhodno normalnim ali nizkim krvnim tlakom pojavili hipertenzijska kriza z encefalopatijo in epileptičnimi napadi, ki so zahtevali takojšnjo zdravniško pomoč in intenzivno nego.
• The starting dose is 450 IU per kilogram bodyweight once a week.
• Začetni odmerek je 450 i.e. na kilogram telesne mase enkrat na teden.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially “sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na napolnjeno injekcijsko brizgo, kar v bistvu pomeni ‘brez natrija'.
This section contains information on how to give yourself an injection of Epoetin alfa HEXAL.
To poglavje vsebuje navodila za to, kako morate sami sebi dajati injekcije zdravila Epoetin alfa
Dose hold and decrease: Epoetin alfa should be withheld when the haemoglobin concentration exceeds 12 g/dL (7.5 mmol/L).
Začasna prekinitev odmerjanja in zmanjšanje odmerka: Dajanje epoetina alfa je treba začasno prekiniti, kadar koncentracija hemoglobina preseže 12 g/dl (7,5 mmol/l).
• The recommended dose is 600 IU per kilogram body weight once a week.
• Priporočeni odmerek zdravila je 600 i.e. na kilogram telesne mase enkrat na teden.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema aplazija rdečih krvnih celic3,
The pre-filled syringe should not be shaken.
Napolnjenih injekcijskih brizg ne stresajte.
Form a skin fold by pinching the skin between thumb and forefinger.
Kožo primite med palec in kazalec tako, da naredite kožno gubo.
In these trials, epoetin alfa administered 3 times per week and once weekly has been shown to increase haemoglobin and decrease transfusion requirements after the first month of therapy in anaemic cancer patients.
Pri anemičnih bolnikih z rakom se je v teh preskušanjih pokazalo, da epoetin alfa, dan 3-krat na teden ali enkrat na teden, povečuje hemoglobin in zmanjšuje potrebo po transfuziji po prvem mesecu zdravljenja.
In cancer patients receiving chemotherapy, the 2 to 3 week delay between ESA administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).
Pri ocenjevanju ustreznosti zdravljenja z epoetinom alfa pri bolnikih z rakom, ki se zdravijo s kemoterapijo, je treba upoštevati, da se eritrociti, ki nastanejo zaradi prisotnosti eritropoetina, pojavijo po 2- do 3-tednih po začetku zdravljenja z ESA (bolnik s tveganjem za transfuzijo).
The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation programme.
Uporaba epoetina alfa pri nosečnicah, naročenih na kirurški poseg, ki sodelujejo v preddonorskem programu avtolognega zbiranja krvi, se ne priporoča.
• unusual tiredness,
• neobičajna utrujenost, • občutek omotičnosti,
Hyperkalaemia1
Presnovne in prehranske motnje hiperkaliemija1
Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
300 i.e./kg = 4,4 enote; epoetin alfa 600 i.e./kg = 4,7 enot) kot bolniki, ki so prejemali placebo (2,9 enot).
The safety and efficacy of epoetin alfa in chronic renal failure patients with anaemia before initiation of dialysis or on peritoneal dialysis have not been established.
Anemija pri bolnikih s kronično ledvično odpovedjo pred uvedbo dialize ali na peritonealni dializi Varnost in učinkovitost epoetina alfa pri bolnikih s kronično ledvično odpovedjo z anemijo pred uvedbo dialize ali na peritonealni dializi nista bili dokazani.
How to use Epoetin alfa HEXAL
Kako uporabljati zdravilo Epoetin alfa HEXAL
Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Po več mesecih ali letih zdravljenja s epoetinom alfa so poročali o pojavu PRCA, povzročene s protitelesi.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Metaanaliza podatkov celokupnega preživetja je pokazala ocenjeno točko razmerja tveganja 1,06 v korist kontrolne skupine (95 % IZ: 1,00; 1,12; 53 preskušanj in 13.933 bolnikov).
• in adults on haemodialysis or peritoneal dialysis • in severely anaemic adults not yet undergoing dialysis
• pri otrocih na hemodializi • pri odraslih bolnikih na hemodializi ali peritonealni dializi
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.
radioterapija, kemoradioterapija ali brez terapije) v 53 kontroliranih kliničnih preskušanjih, ki so vključevala številne epoetine.
Treatment of patients with chemotherapy-induced anaemia
Zdravljenje bolnikov z anemijo, ki je posledica kemoterapije
Baseline Characteristics for Subjects with sEPO < 200 mU/mL at Screening
Izhodiščne značilnosti oseb s sEPO < 200 me./ml ob presejanju